Glossary

A

A priori

Latin for “in advance”; used to describe a research hypothesis, set of conditions, or method of analysis that is firmly decided before a study is initiated.

Used in:
Research: Guidelines on Conducting Research in Pharmacy (2011)

 

Action Level

“An established microbial or airborne particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation”.

Used in:
Compounding: Guidelines for Pharmacies (2014)

Citation: 
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Office of Regulatory Affairs. Guidance for industry. Sterile drug products produced by aseptic processing — current good manufacturing practice. Rockville (MD): The Department; 2004. [cited 2014 Feb 18]. Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070342.pdf

 

Active Ingredient

A component with pharmacological activity that is used in compounding.

Used in:
Compounding: Guidelines for Pharmacies (2014)

Adverse drug event

Injury caused by a medication (or lack of an intended medication). All adverse drug events result in injury to the patient.

Used in:
Hospital Pharmacists: Information Paper on Enhancing Quality and Safety in Medication Use (2010); Hospital Pharmacists: Enhancing Quality and Safety in Medication Use Background Paper (2009)

Citation:
Glossary: adverse drug related consequences. In: MacKinnon N, editor. Safe and effective: the eight effective essential elements of an optimal medication-use system. Ottawa(ON): Canadian Pharmacists Association; 2007. p. 471-4.

Adverse drug reaction

(1) A reaction that has neither therapeutic, prophylactic, nor diagnostic benefit to the patient.

Used in:
Guidelines for drug-use control (2008)

(2) Noxious and unintended response to a drug that occurs at doses usually used in humans for the prevention, diagnosis, or therapy of a disease or for modification of physiologic function.

Used in:
Hospital Pharmacists: Information Paper on Enhancing Quality and Safety in Medication Use (2010); Hospital Pharmacists: Enhancing Quality and Safety in Medication Use Background Paper (2009)

Citation:
Glossary: adverse drug related consequences. In: MacKinnon N, editor. Safe and effective: the eight effective essential elements of an optimal medication-use system. Ottawa (ON): Canadian Pharmacists Association; 2007. p. 471-4.

Adverse event

 


This term has been defined many different ways:
1. An unexpected and undesired incident directly associated with care or services provided to a patient.1
2. An incident that occurs during the provision of health care and that results in injury or death for the patient.1
3. An adverse outcome for a patient, including injury or complication.1
4. An event of commission or omission arising during clinical care causing unintended physical or psychological injury to a patient, their family or friends, and not due to the underlying disease process.2
5. “[CD1] [SI2] Unexpected and undesired incident directly associated with care or services provided to a patient; an incident that occurs during the process of providing health care and that results in patient injury or death; an adverse outcome for a patient, including injury or complication.3

 

Used in:

Hospital Pharmacists: Information Paper on Enhancing Quality and Safety in Medication Use (2010)
Hospital Pharmacists: Enhancing Quality and Safety in Medication Use Background Paper (2009)

Citations:

1The Canadian patient safety dictionary. Ottawa (ON): Royal College of Physicians and Surgeons of Canada; 2003 [cited 2009 Feb 17]. Available from:http://rcpsc.medical.org/publications/PatientSafetyDictionary_3.pdf
2National Steering Committee on Patient Safety. Building a safer system: a national integrated strategy for improving patient safety in Canadian health care. Ottawa (ON): Royal College of Physicians and Surgeons of Canada; 2002 [cited 2009 Feb 127]. Available from: http://www.rcpsc.medical.org/publications/building_a_safer_system_e.pdf
3Glossary: adverse drug related consequences. In: MacKinnon N, editor. Safe and effective: the eight effective essential elements of an optimal medication-use system. Ottawa (ON): Canadian Pharmacists Association; 2007. p. 471-4.

 

Air quality strategy

A comprehensive plan designed to engineer a system of air supply that will achieve the required air quality classifications both on day 1 of operations and at regular times of monitoring and recertification.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Alert level

“An established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow-p to address the potential problem. Alert levels are always lower than action levels”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Office of Regulatory Affairs. Guidance for industry. Sterile drug products produced by aseptic processing — current good manufacturing practice. Rockville (MD): The Department; 2004. [cited 2014 Feb 18]. Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070342.pdf

Alternative/Complementary Medicine (CAM)

“All health care practices that do not receive support from the medical establishment, whether this be through such mechanisms as orthodox medical research funding, sympathetic coverage in mainstream medical journals, or routine inclusion in the basic medical curriculum”.

Used in:

Complementary/Alternative Medicine: Information Paper on the Role of the Pharmacist (1999)

Citation:

Saks M. Introduction. In: Saks M, ed. Alternative Medicine in Britain. Toronto: Clarendon Press; 1992. p. 1-21.

 

 

Anatomical Therapeutic Chemical (ATC) classification system

A standardized drug classification system developed and maintained by the World Health Organization. Drugs “are divided into different groups according to the organ or system on which they act and their chemical, pharmacological, and therapeutic properties.” A drug is assigned an ATC code for the primary therapeutic use of its main active ingredient for each route of administration.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

Anatomical Therapeutic Chemical classification system: structure and principles. Oslo (NO): WHO Collaborating Centre for Drug Statistics Methodology; 2011. [updated 2011; cited 2014 Mar 4]. Available from: http://www.whocc.no/atc/structure_and_ principles/

 

Anteroom

A comprehensive plan designed to engineer a system of air supply that will achieve the required air quality classifications both on day 1 of operations and at regular times of monitoring and recertification.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

WHO guidelines on hand hygiene in health care. Geneva: World Health Organization; 2009. Available from: http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf

 

Antiseptic handrub

“An alcohol-containing preparation (liquid, gel, or foam) designed for application to the hands to inactivate microorganisms and/or temporarily suppress their growth. Such preparations may contain one or more types of alcohol, or other active ingredients with excipients, and humectants”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

WHO guidelines on hand hygiene in health care. Geneva: World Health Organization; 2009. Available from: http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf

Antiseptic handwash

“Washing hands with soap and water, or other detergents containing an antiseptic agent”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

WHO guidelines on hand hygiene in health care. Geneva: World Health Organization; 2009. Available from: http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf

Applied research

Research that is conducted to answer a specific question, with the intention of a direct or immediate application to practice (e.g., determining the effect of prescribing by pharmacists in an intensive care unit) (compare “Basic research”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

"As built" state

The state of a room when the overall installation has been completed, but production equipment has not been installed and no compounding personnel are present.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Aseptic compounding

A type of compounding that aims to maintain the sterility of a sterile drug and other sterile ingredients when assembled with sterile packaging components.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Aseptic preparation area

A room or area designated for the preparation of sterile products. This area includes the critical area and may include a clean room.

Used in:

Guidelines for Preparation of Sterile Products in Pharmacies (2001)

Aseptic Preparation/Technique

The use of procedures in the preparation of sterile products which minimize or prevent the introduction of micro-organisms.

Used in:

Guidelines for Preparation of Sterile Products in Pharmacies (2001)

Aseptic technique

Technique involving procedures designed to preclude contamination (of drugs, packaging, equipment, or supplies) by microorganisms during processing.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Compounding sterile preparations: video training program - companion workbook. Bethesda (MD): American Society of Health-System Pharmacists; 2005

"At rest" state

The condition of a room when the overall installation has been completed, and the production equipment has been installed and is operating, but no compounding personnel are present. As a rule of thumb, cleanrooms should be designed to achieve “at rest” conditions shortly after any compounding activity is completed (eg. PIC/S suggests 15-20 minutes as a general guideline).

Used in:

Compounding: Guidelines for Pharmacies (2014)

Audit

A review or inspection of the conduct of a clinical trial, including documentation, to evaluate whether the protocol, sponsor’s standard operating procedures, Good Clinical Practice, and regulatory requirements were followed.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Authorized release

An established process of checking a preparation so that it can be released for use. The process differs from the final inspection performed to dispense a preparation or product for use by a specific patient or patient population, although the 2 processes may occur almost simultaneously.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Automatic stop order

The practice of automatically terminating a drug order after a specific period if the physician has not specified a limit to the duration of therapy or number of doses. The purpose is to avoid prolonged administration of medications that may inadvertently result in harmful consequences to the patient and unnecessary expense.

Used in:

Guidelines for drug-use control (2008)

B

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Bacterial Endotoxin

A pathogenic pyrogen that is a lipopolysaccharide fraction of the cell membrane of Gram-negative bacteria. When injected, bacterial endotoxin can cause chills, pain, malaise, shock, and even death.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Allen LV. The art, science, and technology of pharmaceutical compounding. 4th ed. Washington(DC): American Pharmacists Association; 2012.

Basic Research

Research that is conducted purely for the purpose of answering a question, without the intention of a direct or immediate application to practice; results are typically not generalizable to the general population (e.g., determining a drug’s mechanism of action) (compare “Applied research”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Batch

Any quantity of a compounded preparation that is homogeneous within specified limits and is prepared according to a single production order.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Batch number

“A distinctive combination of numbers and/or letters that specifically identifies a batch. The batch number appears on the batch records, certificates of analysis, etc”. Also known as lot number.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa (ON): Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php

Batch preparation

Compounding or repackaging of multiple units, not for immediate use, in a single process, by the same operator in accordance with a standardized batch preparation procedure.

Used in:

Guidelines for Preparation of Sterile Products in Pharmacies (2001)

Benchmark

“A standard or point of reference”. Benchmarking may be against a standard or a point of reference, including an internal baseline. Standards may be derived from evidence, practice, or published guidelines.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

Katherine B, editor. The Canadian Oxford dictionary. 2nd ed. Don Mills (ON): Oxford University Press; 2004.

 

Beyond-use date

The date (and time) after which the preparation shall not be used, stored, or transported. The time is calculated from the time compounding of the preparation begins. The term is not interchangeable with “expiration date”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Bioburden

The presence (the number and type) of viable microorganisms in a space or medium (eg. Air, surface).

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Quality assurance of aseptic preparation services. 4th ed. Beaney AM, editor. London: Pharmaceutical Press; 2006.

Biomedical research

“Research with the goal of understanding normal and abnormal human functioning, at the molecular, cellular, organ system and whole body levels, including development of tools and techniques to be applied for this purpose; developing new therapies or devices that improve health or the quality of life of individuals, up to the point where they are tested on human subjects. Studies on human subjects that do not have a diagnostic or therapeutic orientation.”

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Glossary of funding related terms. Ottawa (ON): Canadian Institutes of Health Research; 2010 [cited 2011 Apr 28]. Available from: http://www.cihr-irsc.gc.ca/e/34190.html

 

Biopharmaceutical material

“A pharmaceutical inherently biological in nature and manufactured using biotechnology”.1

Examples include recombinant proteins, antibodies (including monoclonal antibodies), vaccines, blood or plasma derivatives, nonrecombinant culture-derived proteins, and cultured cells and tissues.2

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citations:

1 Rader RA. (Re)defining biopharmaceutical. Nature Biotechnol. 2008;26(7):743-51.

2 Schedule D. In: Food and Drugs Act, R.S.C. 1985, c. F-27.

C

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Capacity plan

A set of written procedures describing the processes to be undertaken if a change is requested (or planned) that will affect the physical environment, equipment, supplies, or processes, or that may affect the quality of a good or service provided. These procedures ensure that changes are considered and approved before being implemented, that the changes either address a problem or improve the system, and that services are not disrupted.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Case-control study

A type of observational study in which an outcome is identified, with participants being classified according to those with and those without the outcome, and participants are then compared to determine how many originally possessed the exposure under study and whether the proportion of those exposed differs between people with the outcome and those without the outcome.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Change control practices

(1)  A set of written procedures “describing the action to be taken if a change is proposed (a) to facilities, environment, materials, equipment, and/or processes used in preparing, packaging, testing, and distributing preparations, or (b) that may affect the quality of a preparation or the operation of the support system”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa (ON): Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/ gmp-bpf/docs/gui-0001-eng.php

(2)  A set of written procedures describing the processes to be undertaken if a change is requested (or planned) that will affect the physical environment, equipment, supplies, or processes, or that may affect the quality of a good or service provided. These procedures ensure that changes are considered and approved before being implemented, that the changes either address a problem or improve the system, and that services are not disrupted.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Changeover procedures

“A logical series of validated steps that ensures the proper cleaning of [work areas] and equipment before the [compounding] of a different [preparation] begins”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa (ON): Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php

Clean (adj.)

The absence of organic matter, salts, and visible soil.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Clean room

(1) An aseptic preparation area with defined environmental control of particulate and microbial contamination (Grade C or D room), constructed and used in such a way as to reduce the introduction, generation and retention

Used in:

Guidelines for Preparation of Sterile Products in Pharmacies (2001)

(2) A room which is designed, constructed, and used in a way that controls the entry, production, and retention of airborne particles in the room to achieve a prescribed classification of air cleanliness based on the concentration of airborne particles.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Whyte W. Cleanroom technology: fundamentals of design, testing and operation. 2nd ed. Hoboken (NJ): John Wiley & Sons; 2010.

Cleaning

The removal of organic matter, salts, and visible soil. It is the first step of any disinfection process.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Buchanan EC. Cleaning and disinfecting. In: Buchanan EC, Schneider PJ, editors. Compounding sterile preparations. 3rd ed. Bethesda (MD): American Society of Health-System Pharmacists; 2009. p. 289.

Client

An individual or group of individuals who receive drug information services.

Used in:

Drug Information Services: Guidelines (2015)

Clinical equipoise

“The existence of a genuine uncertainty on the part of the relevant expert community about what therapy or therapies are most effective for a given condition”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Canadian Institutes of Health Research; Natural Sciences and Engineering Research Council of Canada; Social Sciences and Humanities Research Council of Canada. Tri-council policy statement : ethical conduct for research involving humans. Ottawa (ON): The Councils; 2010 [cited 2011 Jan 28]. Available from: http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

Clinical research

“Research with the goal of improving the diagnosis, and treatment (including rehabilitation and palliation), of disease and injury; and improving the health and quality of life of individuals as they pass through normal life stages. Research on, or for the treatment of, patients.”

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Glossary of funding related terms. Ottawa (ON): Canadian Institutes of Health Research; 2010 [cited 2011 Apr 28]. Available from: http://www.cihr-irsc.gc.ca/e/34190.html

Clinical significance

“The clinical significance of a treatment refers to its ability to meet standards of efficacy set by consumers, clinicians, and researchers”.1

“Clinical significance goes beyond statistical significance to identify whether the statistically significant difference is large enough to have implications for patient care”.2

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citations:

1Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59(1):12-19.

2Sloan JA, Cella D, Frost M, Montori V, Gøtzsche PC, Devereaux PJ.; Clinical Significance Consensus Meeting Group. Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clin Proc. 2002;77(4):367-370.

Clinical trial

(1) See “Experimental study”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

(2) “Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamics effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous”.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

ICH harmonised tripartite. Guideline for good clinical practice E6(R1). Current Step 4 version. Geneva (CH): International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 1996 [cited 2012 Oct 11]. Available from: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

Closed-system drug transfer

“A procedure whereby a sterile […] product is prepared by transferring sterile starting material or solutions to a pre-sterilised sealed container, either directly or by using a sterile transfer device, and without exposing the solution to the external environment (such as intravenous infusion services: services for cytotoxic [hazardous] medical products or total parenteral nutrition (TPN))”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. Strasbourg (FR): Council of Europe; 2011 [cited 2014 Feb 21]. Available from: https://wcd.coe.int/ViewDoc.jsp?id=1734101&

Closed-system drug transfer device

A leak-proof, airtight device that mechanically prevents both the transfer of environmental contaminants into the system and the escape of hazardous drug or vapour outside the system.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Cohort study

A type of observational study in which a group is identified as having or not having the exposure under study and is then followed through time (concurrently or nonconcurrently) to determine the outcome under natural or test conditions.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Cold temperature

Temperature between +2⁰C and +8⁰C.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Collaborative healthcare settings

Hospitals, long term care institutions, mental health institutions, rehabilitation institutions, multihospital systems, multidisciplinary family health/primary care clinics, perioperative and ambulatory care clinics, and other healthcare systems.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Commercially available (product

(1) A product that is authorized for use and marketed in a particular country (which, for the purposes of this document, is Canada).

Used in:

Compounding: Guidelines for Pharmacies (2014)

(2) A pharmaceutical product authorized for use in Canada by the Health Protection Branch, Health Canada, i.e. notice of compliance received, a Drug Identification Number (DIN) assigned, and marketed in Canada.

Used in:

Repackaging: Guidelines for Healthcare Facilities (1998)

Comminution

The process of reducing particle size.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Thompson JE, Davidow LW. A practical guide to contemporary pharmacy practice. 3rd ed. Philadelphia (PA): Wolters Kluwer Health/Lippincott Williams & Wilkins; 2009.

Compounding

“The combining or mixing together of two or more ingredients (of which at least one is a drug or pharmacologically active component) to create a final product in an appropriate form for dosing. It can involve raw materials or the alteration of the form and strength of commercially available products. It can include reformulation to allow for a novel drug delivery. Compounding does not include mixing, reconstituting, or any other manipulation that is performed in accordance with the directions for use on an approved drug’s labelling material”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Policy on manufacturing and compounding drug products in Canada (POL- 0051). Ottawa (ON): Health Canada; 2009 [cited 2010 Mar 5]. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/pol_0051-eng.php

Compounding person

A person whose practice is regulated through a legislative framework and who has the responsibility to undertake activities related to aseptic and nonaseptic compounding (pl. compounding personnel).

Used in:

Compounding: Guidelines for Pharmacies (2014)

Concurrent evaluation

Evaluation and (if necessary) intervention that are completed while the patient is undergoing therapy. The patient’s therapy is monitored, and an intervention is performed, if necessary, to address problems such as drug–drug interactions, over- or under-utilization of drugs, or duplicate therapy.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

VA Medication Use Evaluation (MUE) Toolkit, 2nd version. Washington (DC): US Department of Veterans Affairs, Pharmacy Benefits Management Strategic Healthcare Group, and Center for Medication Safety; 2012 [cited 2014 Mar 4]. Available from: http://www. pbm.va.gov/vacenterformedicationsafety/tools/ MUEToolkit.pdf

Confidence interval

A statistical indicator of precision, consisting of a range of values for a specified variable calculated such that the range has a known probability of including the true value of the variable (e.g., a 95% confidence interval is the range within which the true value of the variable will fall in 95% of replications).1,2

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citations

1 Davies HTO Crombie IK. What are confidence intervals and p-values? In: What is…? Series. Hayward Group Limited; 2009 Apr [cited 2011 Apr 28]. Available from: http://www.whatisseries.co.uk/whatis/pdfs/What_are_conf_int.pdf2          

2 Primer on 95% confidence intervals. Philadelphia (PA): American College of Physicians; 2010 [cited 2010 Dec 1]. Available from: http://www.acponline.org/clinical_information/journals_publications/ecp/sepoct01/primerci.htm

Confounding variable

A variable other than the variable that is being tested that might influence the outcome of the study and thus confuse the study results, leading to an erroneous conclusion. A confounding variable is related to the exposure of interest and is independently associated with the outcome of interest, without lying on the causal pathway between exposure and outcome.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Containment device

A device that is designed to control emissions of airborne contaminants and thereby minimizes exposure of people and the environment to hazardous substances. Examples include Class I and Class II biological safety cabinets.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Containment primary clean air device

A primary clean air device that is designed to control emissions of airborne contaminants and thereby minimizes exposure of people and the environment to hazardous substances. Examples include Class II and III biological safety cabinets, negatively pressurized isolators.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Continuous data

Data for which there are an unlimited number of equally spaced categories, making possible a continuum of values.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Contract management

The process of administering a contract from its award to close-out. It includes the monitoring of time, cost, performance, enforcement of contractual terms, final reconciliation of payments, and evaluation of contractor performance and method of supply.

Used in:

Outsourcing: Guidelines for Pharmacy Practice (2011)

Contract management team

The person or people who are “responsible for managing the contract after signing.” (In some cases contract management and negotiation may be done by the same person.)

Used in:

Outsourcing: Guidelines for Pharmacy Practice (2011)

Citation:

Developing and managing contracts: getting the right outcome, paying the right price. Sydney (AU): Australian Government, Department of Finance and Administration, Australian National Audit Office; 2007 [cited 2010 Feb 24]. Available from: www.anao.gov.au/uploads/documents/Developing_and_Managing_Contracts.pdf

Control group

A group that is used for comparison with the study group.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Controlled product

“Any product, material or substance specified by the regulations made pursuant to paragraph 15(1)(a) to be included in any of the classes listed in Schedule II” of the Hazardous Products Act.1 This term is not interchangeable with “controlled substances”.

Schedule II of the Act lists the following classifications of substances:

Class A – compressed gas

Class B – flammable and combustible material

Class C – oxidizing material

Class D – poisonous and infectious material

Class E – corrosive material

Class F – dangerously reactive material

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Part II: Controlled products. In: Hazardous products act, R.S.C. 1985, c. H-3 (2011).

Controlled work area

“An enclosed workplace constructed and operated in such a manner and equipped with appropriate air-handling and filtration systems to reduce to a pre-defined level the introduction, generation and retention of contamination”.1 This area includes the anteroom, cleanroom, and hazardous drugs storage room or area. Also known as “controlled workplace”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Quality assurance of aseptic preparation services. 4th ed. Beaney AM, editor. London: Pharmaceutical Press; 2006.

Controlled-dosage system

A form of drug distribution in which medication orders are filled individually and packaged (such as, in the form of blister cards or cassettes) in accordance with scheduled administration times; also known as monitored dosage system. Each package contains no less than one day’s supply of medication and no more than approximately one month’s supply. Not equivalent to “unit-dose system”.

Used in:

Guidelines for drug-use control (2008)

Creative compliance

The practice of finding ways to accomplish compliance with the letter of the law (or policy, or guideline) while undermining the spirit or the intent behind the words.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

McBarnet DJ. When compliance is not the solution but the problem: from changes in law to changes in attitude. Canberra (AU): Australian National University, Research School of Social Sciences, Centre for Tax System Integrity; 2001 [cited 2014 Jun 24]. Available from: http://asiapacific02.cap.anu.edu.au/sites/default/files/CTSI-WorkingPaper18-full.pdf

Critical area

(1) A grade A area intended to protect sterile products manufactured within the area from any secondary microbial contamination. The critical area within a pharmacy is usually the laminar airflow hood or biological safety cabinet located within the aseptic preparation area or clean room.

Used in:

Guidelines for Preparation of Sterile Products in Pharmacies (2001)

(2) “That part of the controlled workspace where the aseptic manipulation is carried out. Particulate and microbiological contamination should be reduced to levels appropriate to the intended use”. Also known as “critical zone”. This term is not interchangeable with “critical site”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Quality assurance of aseptic preparation services. 4th ed. Beaney AM, editor. London: Pharmaceutical Press; 2006.

Critical incident

“An incident resulting in serious harm (loss of life, limb, or vital organ) to the patient, or the significant risk thereof. Incidents are considered critical when there is an evident need for immediate investigation and response. The investigation is designed to identify contributing factors and the response includes actions to reduce the likelihood of recurrence.”

Used in:

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Citation:

The Canadian patient safety dictionary. Ottawa (ON): Royal College of Physicians and Surgeons of Canada; 2003 [cited 2011 Mar 24]. Available from: http://rcpsc.medical.org/publications/PatientSafetyDictionary_e.pdf

Critical site

An exposed surface or opening at risk of direct contact with contaminated air, moisture, or of touch contamination. This term is not interchangeable with “critical area”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

General chapter <797> pharmaceutical compounding — sterile preparations. In: USP on compounding: a guide for the compounding practitioner. Rockville (MD): United States Pharmacopeial Convention; 2014 [cited 2014 Jul 12].

Critical surface

Surfaces which come in contact with sterilized product or packaging materials.

Used in:

Guidelines for Preparation of Sterile Products in Pharmacies (2001)

Cross-sectional study

A type of observational study in which a population is evaluated at one point in time or over a specified time interval. Can be used only to evaluate association (not causation).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Culture of safety

At the organizational level, “the product of individual and group values, attitudes, perceptions, competencies and patterns of behaviour that determine the commitment to, and the style and proficiency of, an organisation’s health and safety management. Organisations with a positive safety culture are characterised by communications founded on mutual trust, by shared perceptions of the importance of safety and by confidence in the efficacy of preventive measures”.

Used in:

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Citation:

Advisory Committee on the Safety of Nuclear Installations. Study group on human factors, Third report: Organising for safety. London: HMSO; 1993. [As cited in Gadd S, Collins AM. Safety culture: a review of the literature. Sheffield (UK): Health & Safety Laboratory; 2002 [cited 2011 Jun 8]. Available from: http://www.hse.gov.uk/research/hsl_pdf/2002/hsl02-25.pdf ]

Cytotoxic drug

A drug that has a deleterious effect on living cells; usually refers to antineoplastics or drugs used in the treatment of cancer.

Used in:

Guidelines for Drug-Use Control (2008)

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Data and safety monitoring board (DSMB)

“An independent advisory committee who review accumulated safety and efficacy data in a clinical trial and advise the principal investigator and/or the trial steering committee on the future management of the trial”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Glossary of funding related terms. Ottawa (ON): Canadian Institutes of Health Research; 2010 [cited 2011 Apr 28]. Available from: http://www.cihr-irsc.gc.ca/e/34190.html

Decontamination

“Inactivation, neutralization, or removal of toxic agents, usually by chemical means”. Decontaminate intransitive verb

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. Cincinnati (OH): Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health; 2004 [cited 2014 May 22]. Available from:http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf

Defined Daily Dose (DDD)

A standardized unit of measure for drug consumption developed and maintained by the World Health Organization. The DDD is “the assumed average maintenance dose per day for a drug used for its main indication in adults.” A DDD is assigned only to drugs that have an Anatomical Therapeutic Chemical (ATC) code.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

Anatomical Therapeutic Chemical classification system: structure and principles. Oslo (Norway): WHO Collaborating Centre for Drug Statistics Methodology; 2011. [updated 2011; cited 2014 Mar 4]; Available from: http://www.whocc.no/atc/structure_and_ principles/

Demarcation line

A line, real or virtual, that divides a physical area into at least 2 subsections. (In an anteroom, the “dirty side” of the demarcation line is where personnel don head covers and foot covers before crossing the demarcation line to the “clean side”, where a surgical scrub is performed, appropriate garb is donned, and other appropriate measures are taken before entering the cleanroom.)

Used in:

Compounding: Guidelines for Pharmacies (2014)

Dependent variable

A variable that changes in response to the intervention or the independent variable. Dependent variables are used to assess outcomes in a research study (compare “Independent variable”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Descriptive research

Observations not driven by a specific hypothesis. May consist of a case report, a case series, or a description of a population (including evaluation of drug utilization). Also known as a descriptive study.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Descriptive statistics

Statistics that are used to summarize and describe the data collected (compare “Inferential statistics”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Directional hypothesis

A hypothesis that anticipates the type of relationship between variables; expressed in general terms as “when this, also that”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Disinfect

To kill bacteria, fungi and viruses, reducing the microbial load on a surface.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Buchanan EC. Personnel cleansing and garbing. In: Buchanan EC, Schneider PJ, editors. Compounding sterile preparations. 3rd ed. Bethesda (MD): American Society of Health-System Pharmacists; 2009. p. 61-8.

Dispense

To provide a medication in accordance with a medication order; does not include administration of the medication.

Used in:

Guidelines for drug-use control (2008)

Drug information

“The provision of unbiased, well-referenced, and critically evaluated information on any aspect of pharmacy practice”.

Used in:

Drug Information Services: Guidelines (2015)

Citation:

Malone PM, Kier KL, Stanovich JE, Malone MJ. Drug information — a guide for pharmacists. New York (NY): McGraw‐Hill; 2012.

Drug information centre

A defined area physically separated from the pharmacy dispensary, where the drug information service operates.

Used in:

Drug Information Services: Guidelines (2015)

Drug information pharmacist

A pharmacist who specializes in research, documentation, and provision of drug information using a modified systematic approach.

Used in:

Drug Information Services: Guidelines (2015)

Drug information services

The services provided by the drug information service. The provision of drug information services incorporates a variety of activities and typically occurs in response to one of three types of situations:
a) a request from a caregiver or patient for a specific patient or group of patients;
b) a need identified through general safe medication practices or by the hospital/regional formulary system committee (such as a pharmacy and therapeutics committee or pharmacotherapeutic committee); or
c) a request from a person or organization (such as a lawyer or pharmaceutical company).

Used in:

Drug Information Services: Guidelines (2015)

Drug recall

A request for removal of a defective medication from stock and the subsequent fulfillment of the request. A drug recall usually occurs when a particular lot of a medication is of substandard quality or when a particular medication produces unexpected side effects.

Used in:

Guidelines for drug-use control (2008)

Drug related morbidity

Failure of a therapeutic agent to produce the intended therapeutic outcome, or the biosocial manifestation of unresolved drug-related problems.1 Drug-related morbidity is an unintended patient injury with a scientifically plausible relationship to either drug therapy or an untreated indication for drug therapy.2 All drug-related morbidity results in injury, whereas only a small percentage of drug-related problems result in injury, and those injuries would not be serious.

Used in:

Hospital Pharmacists: Information Paper on Enhancing Quality and Safety in Medication Use (2010)
Hospital Pharmacists: Enhancing Quality and Safety in Medication Use Background Paper (2009)

Citations:

1Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990 Mar;47(3):533-43.
2Hepler C. Understanding adverse drug therapy outcomes. In: Hepler C, Segal R, editors. Preventing medication errors and improving drug therapy outcomes. Boca Raton (FL): CRC Press;2003. p. 29-72.

Drug Therapy Problem

“Any undesirable event or risk experienced by the patient that involves, or is suspected to involve, drug therapy, and that interferes with achieving the desired goals of therapy and requires professional judgment to resolve”.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Citation:

Cipolle RJ, Strand LM, Morley PC. Pharmaceutical care practice: the patient-centered approach to medication management services. 3rd ed. New York: McGraw-Hill; 2012.

Drug use control

A system of knowledge, understanding, judgments, procedures, skills, controls, and ethics that ensures optimum safety in the distribution and use of drugs.

Used in:

Guidelines for drug-use control (2008)

Citation:

Brodie DC. Drug-use control: keystone to pharmaceutical service. Drug Intell Clin Pharm.1967;1:63-65.

Drug use criteria

Predetermined rules or standards against which elements of drug use can be tested, such as efficiency, effectiveness, safety, and appropriateness.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

Brodie DC. Drug-use control: keystone to pharmaceutical service. Drug Intell Clin Pharm.1967;1:63-65.

Drug use evaluation (DUE)

“A system of ongoing, systematic, criteria-based evaluation of drug use that will help ensure that medicines are used appropriately”.1

The terms “DUE” and “drug utilization review” (DUR) are interchangeable.1, 2

See related term, “medication-use evaluation”.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citations:

1 Holloway K, Green T. Drug and Therapeutics Committees: A Practical Guide. Geneva (CH): World Health Organization; 2003 [cited 2014 June 18]. Available from: http://apps.who.int/medicinedocs/pdf/ s4882e/s4882e.pdf

2WHO International Working Group for Drug Statistics Methodology, WHO Collaborating Centre for Drug Statistics Methodology, WHO Collaborating Centre for Drug Utilization Research and Clinical Pharmacological Services. Introduction to Drug Utilization Research. Geneva (CH): World Health Organization; 2003 [cited 2014 3 March]. Available from: http://whqlibdoc.who. int/publications/2003/924156234X.pdf

 

Drug use evaluation (DUE) core group

A team dedicated to providing drug use evaluation services. The core group may be composed of pharmacy personnel only, but ideally it will be multidisciplinary, with membership that includes pharmacists, physicians, and nurses and others as warranted.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Drug Use Evaluation (DUE) Program (or service)

A multidisciplinary, structured program (or service) to undertake drug use evaluations.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Drug utilization review (DUR)

See “Drug use evaluation”.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Drug-use control

A system of knowledge, understanding, judgments, procedures, skills, controls, and ethics that ensures optimum safety in the distribution and use of drugs.

Used in:

Guidelines for drug-use control (2008)

Practice Management: Guidelines for Managing Pharmacy Practice in Healthcare Facilities (2007)

Citation:

Brodie DC. Drug-use control: keystone to pharmaceutical service. Drug Intell Clin Pharm. 1967;1:63-65.

Drug-use evaluation

The prospective or concurrent analysis of the pattern of use of drugs against a pre-determined set of criteria, followed by assessment, implementation of corrective action, and reassessment.

Used in:

Guidelines for drug-use control (2008)

Drugs and therapeutics committee

A committee that is composed of representatives from pharmacy, medicine, nursing, hospital administration, and other disciplines, serving as a policy-recommending body on all matters relating to the use of medications in a hospital. May be known by other names (e.g., pharmacy and therapeutics committee).

Used in:

Drug Use Evaluation Services: Guideline (2014)

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e.g.

“For example” [Latin: exempli gratia],1 as distinct from “i.e.”[Latin: id est]. Used in this documentation where lists of examples are not exhaustive.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Barber K, editor. The Canadian Oxford dictionary. 2nd ed. Don Mills (ON): Oxford University Press; 2004.

Education

The acquisition of new knowledge, skills or attitudes that takes place in response to instruction.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Consumable items, specifically packaging containers (e.g., syringes, parenteral solution bags, bottles) or compounding aids (e.g., needs, transfer sets), used in aseptic and nonaseptic compounding.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Entry to care

The process of admitting a person to a healthcare facility as an inpatient or registering a person in an emergency department or outpatient program.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Error

“Failure to complete a planned action as it was intended or when an incorrect plan is used in an attempt to achieve a given aim”.

Used in:

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Citation:

The Canadian patient safety dictionary. Ottawa (ON): Royal College of Physicians and Surgeons of Canada; 2003 [cited 2011 Mar 24]. Available from: http://rcpsc.medical.org/publications/PatientSafetyDictionary_e.pdf

Essential medicines

″Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility″.

Used in:

National Pharmacare: Position Statement (2017)

Citation:

Towards realising access to essential medicines for all: a vision for 2035. Boston (MA): Lancet Youth Commission on Essential Medicines Policies; 2016 [cited 2017 Feb 28]. Available from: http://ycemp.com/file/2016/11/YCEMP_Full- Report_081116.pdf

Evidence-based medicine

(1) “The integration of best research evidence with clinical expertise and patient values”.1

Used in:

Journal Clubs Guidelines (2010)
Drug Information Services: Guidelines (2015)

Citation:

1What is EBM? Toronto: University Health Network, Centre for Evidence Based Medicine; 2004 [cited 2009 Nov 18]; Available from: http://www.cebm.utoronto.ca/intro/whatis.htm

(2) The practice of integrating the best available evidence from systematic research with clinical expertise to make decisions about the care of individual patients.2,3

Used in:

Drug Information Services: Guidelines (2015);Drug Use Evaluation Services: Guidelines (2014)

Citations:

2What is EBM? [Internet]. Toronto (ON): University Health Network, Centre for Evidence‐Based Medicine; 2000-2015 [cited 2015 Jun 9]. Available from: http://www.cebm.utoronto.ca/intro/whatis.htm

3 Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ. 1996;312(7023):71-2.

Excipient

Any component in a preparation that is not an “active ingredient”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Exclusion criteria

Criteria used to define who is ineligible to participate in a study (compare “Inclusion criteria”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Experimental study

A study in which participants are assigned to a study group or a control group before the study conditions are imposed. Also known as a clinical trial (compare “Observational study”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Expiration date

“(a) in the case of a drug in dosage form, the earlier of the following dates, expressed at minimum as a year and month: (i) the date up to and including which the drug maintains its labelled potency, purity and physical characteristics, and (ii) the date after which the manufacturer recommends that the drug not be used; and (b) in the case of an active ingredient, whichever of the following dates is applicable, expressed at minimum as a year and month: (i) the retest date, or (ii) the date after which the manufacturer recommends that the active ingredient not be used”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Part C: Drugs. Division 1: General. In: Food and Drug Regulations, C.R.C., c. 870 (2014).

Explicit criteria

Drug- or disease-oriented criteria that are usually standardized measures and not dependent on individual patient characteristics. Explicit criteria are more reproducible and reliable than implicit criteria.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

Dimitrow MS, Airaksinen MS, Kivelä SL, Lyles A, Leikola SN. Comparison of prescribing criteria to evaluate the appropriateness of drug treatment in individuals aged 65 and older: a systematic review. J Am Geriatr Soc. 2011;59(8):1521-30.

Expression of interest

A document that is completed by persons or companies who are interested in submitting a proposal in response to a request for proposal.

Used in:

Outsourcing: Guidelines for Pharmacy Practice (2011)

External validity

The extent to which the study results can be generalized to certain populations, settings, treatment variables, and measurement variables. Also known as generalizability (compare “Internal validity”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Campbell DT, Stanley JC, Gage NL. Experimental and quasi-experimental designs for research. Chicago (IL): R. McNally; 1966.

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Failure mode and effects analysis (FMEA)

“A systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change”.

Used in:

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Citation:

Failure modes and effects analysis (FMEA) tool. Cambridge (MA): Institute for Healthcare Improvement; [no date; cited 2011 Jun 9]. Available from: http://www.ihi.org [Type “failure modes and effects analysis” in the search function to access this paper.]

Feasibility

Characteristic of a study indicating whether the variables that have been defined in the study objectives can be measured.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

First Air

The air that leaves the HEPA filter in a unidirectional manner and is virtually free of particulate matter.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

General chapter <797> pharmaceutical compounding — sterile preparations. In: USP on compounding: a guide for the compounding practitioner. Rockville (MD): United States Pharmacopeial Convention; 2014 [cited 2014 Jul 12].

Formative evaluation

Evaluation or assessment that takes place during an educational program. It may apply to evaluation of both the learner and the educational program.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Formulary

A dynamic compilation of medications that have been approved for use within a health care institution, along with relevant information and related policies, reflecting the current clinical judgement of the pharmacy and therapeutics committee.

Used in:

Guidelines for drug-use control (2008)

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Generic substitution

The use of another product that is chemically identical with the drug form prescribed in terms of strength, concentration, dosage form, and route of administration.

Used in:

Guidelines for Drug-use control (2008)

Goal

A statement describing a desired end result. In the context of a hospital department, goals are based on the mission and vision of the department and are presented in proactive, broad, long-range terms. A goal is therefore a general philosophical commitment indicating the conceptual direction of the department over a period of time.

Used in:

Guidelines for Drug-use control (2008)

Good Clinical Practice

“A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected”.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

ICH harmonised tripartite. Guideline for good clinical practice E6(R1). Current Step 4 version. Geneva (CH): International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 1996 [cited 2012 Oct 11]. Available from: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

Good preparation practices

The component of a quality assurance program which ensures the preparation of pharmaceutical products occurs in a consistent manner to achieve the appropriate standard of quality.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Pharmaceutical Inspection Convention, Pharmaceutical Inspection Cooperation Scheme. PIC/S guide to good practices for the preparation of medicinal products in healthcare establishments. PE 010-4. Geneva (CH): PIC/S Secretariat; 2014 [cited 2014 Mar 25]. Available from: http://www.picscheme.org/publication.php

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Hazardous

Exhibiting one or more of the following characteristics in humans and/or animals: carcinogenicity, teratogenicity, or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity; also, structure and toxicity profiles of new drugs that mimic existing drugs deemed hazardous by the five previous criteria.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. Cincinnati (OH): Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health; 2004 [cited 2014 May 22]. Available from: http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf

Hazardous drug list

A list of hazardous drugs defined by the organization.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Hazardous medication

A medication that exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity; also, structure and toxicity profiles of new drugs that mimic existing drugs deemed hazardous by the five previous criteria.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Citation:

National Institute for Occupational Safety and Health. NIOSH report on occupational safety and health for fiscal year ... under Public Law 91-596. Rockville (MD): U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease Control. p. v.

Health policy and system research

“Health policy and systems research (HPSR) is an emerging field that seeks to understand and improve how societies organize themselves in achieving collective health goals, and how different actors interact in the policy and implementation processes to contribute to policy outcomes. By nature, it is inter-disciplinary, a blend of economics, sociology, anthropology, political science, public health and epidemiology that together draw a comprehensive picture of how health systems respond and adapt to health policies, and how health policies can shape − and be shaped by − health systems and the broader determinants of health”.

Used in:

National Pharmacare: Position Statement (2017)

Citation:

Alliance for Health Policy and Systems Research. What is health policy and systems research (HPSR)? Geneva (CH): World Health Organization; 2017 [cited 2017 Mar 25]. Available from: http://www.who.int/alliance-hpsr/about/ hpsr/en/

Health services research

“Research with the goal of improving the efficiency and effectiveness of health professionals and the health care system, through changes to practice and policy. Health services research is a multidisciplinary field of scientific investigation that studies how social factors, financing systems, organizational structures and processes, health technologies, and personal behaviours affect access to health care, the quality and cost of health care, and, ultimately, [the public’s] health and well-being”.

This type of research includes topics related to pharmacy practice such as safe medication practises, seamless care, pharmacoeconomics, pharmacoepidemiology, and quality management.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Glossary of funding related terms. Ottawa (ON): Canadian Institutes of Health Research; 2010 [cited 2011 Apr 28]. Available from: http://www.cihr-irsc.gc.ca/e/34190.html

Healthcare organization

An organization that provides healthcare services such as, but not limited to, acute care, long-term care, ambulatory care, community pharmacies, and home care.

Used in:

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Healthcare workers

All personnel who work in a healthcare setting, including, but not limited to, employees, physicians, emergency service personnel, home care personnel, public health personnel, persons who are not directly involved in patient care (e.g., administrative staff), contract employees, volunteers, and students. Any of these people may be exposed to infectious agents that can be transferred between patients and healthcare workers.

Used in:

Influenza Immunization for Healthcare Workers: Statement (2014)

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

High-alert medications

“Drugs that bear a heightened risk of causing significant patient harm when they are used in error”.

Used in:

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Citation:

Definitions of terms. Toronto (ON): Institute for Safe Medication Practices Canada; 2000-2010 [cited 2012 Jan 23]. Available from: http://www.ismp-canada.org/definitions.htm

High-efficiency particulate air (HEPA) filter

A filter that traps 99.97% of particulate matter 0.3 micrometre size or greater to provide ultra clean air.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa (ON): Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php

Homeopathic preparations

“Any drug that is composed only of one or more ingredients for which a homeopathic monograph is defined in the current edition of the Homeopathic Pharmacopeia of the United States (HPUS) or in the Pharmacopée Française (Ph.F) is considered to be a ‘homeopathic preparation’”.

Used in:

Complementary/Alternative Medicine: Information Paper on the Role of the Pharmacist (1999)

Citation:

Drugs Directorate (Canada). Drugs Directorate Guidelines. Homeopathic Preparations: Application for Drug Identification Numbers. Ottawa: Health Protection Branch, Health Canada:1990.

Hospital

(1) A facility that is approved or designated by a federal, provincial, or territorial government, in accordance with the appropriate laws, to provide health services to persons suffering from diseases or illness; may also be used to refer to other organized health care settings.

Used in:

Guidelines for drug-use control (2008)

(2) Institution providing medical and/or surgical treatment; may refer to related healthcare facilities.

Used in:

Journal Clubs Guidelines (2010)

(3) An institution providing acute or long-term care, which may include corporately-related healthcare facilities that are served by the institution’s pharmacy service.

Used in:

Outsourcing: Guidelines for Pharmacy Practice (2011)

(4) An institution comprising one or more facilities that provide health services to persons suffering from diseases or illnesses.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

 

Hot cell

“A shielded enclosure for handling highly radioactive materials and serves as an isolator, providing a clean environment for the preparation of radiopharmaceuticals”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Cyclotron produced radionuclides. Guidance on facility design and production of [18F] fluorodeoxyglucose (FDG). Vienna (AT): International Atomic Energy Agency; 2012.

Hypoallergenic

This labelling term indicates a lowered potential for producing an allergic reaction, however, it is not an appropriate measure of the ability of a product to induce a human IgE antibody response. It cannot be interpreted to mean natural rubber latex (NRL)-free.

Used in:

Natural Rubber Latex Sensitive/Allergic Patients: Guidelines for Preparing Medications (2001)

Hypothesis

An unproved theory, question, idea, or supposition put forward to provide a basis for further investigation or argument.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Hypothesis-driven research

Research that requires a priori establishment of a hypothesis, collection of data, and analysis of the data with inferential or descriptive statistics. Hypothesis-driven research can be further subdivided into basic (“bench-top”) and applied research (defined above).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

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i.e.

“That is to say” [Latin: id est],1 as distinct from “e.g.” [Latin: exempli gratia].

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Barber K, editor. The Canadian Oxford dictionary. 2nd ed. Don Mills (ON): OxfordUniversity Press; 2004.

Implemented

Accomplished or achieved and incorporated into practice.

Used in:

Drug Information Services: Guidelines (2015)

Drug Use Evaluation Services: Guidelines (2014)

Implicit criteria

Person-specific criteria that result from the clinician’s application of clinical information, knowledge of the literature, and professional judgment to the individual patient’s situation. Implicit criteria are more subjective, less reproducible, and more time-consuming to apply than explicit criteria.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

Dimitrow MS, Airaksinen MS, Kivelä SL, Lyles A, Leikola SN. Comparison of prescribing criteria to evaluate the appropriateness of drug treatment in individuals aged 65 and older: a systematic review. J Am Geriatr Soc. 2011;59(8):1521-30.

"In operation" state

The condition where the installation (equipment) is complete and working with the specified number of compounding personnel operating in the area.1,2

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citations:

1Pharmaceutical Inspection Convention, Pharmaceutical Inspection Cooperation Scheme. PIC/S guide to good practices for the preparation of medicinal products in healthcare establishments. PE 010-4. Geneva (CH): PIC/S Secretariat; 2014 [cited 2014 Mar 25]. Available from: http://www. picscheme.org/publication.php

2Eudralex. The rules governing medicinal products in the European Union. Volume 4 EU guidelines to good manufacturing practice. Medicinal products for human and veterinary use. Annex 1: Manufacture of sterile medicinal products. Brussels (BE): European Commission: Enterprise and Industry Directorate-General; 2003 [revised 2008; cited 2014 Feb 18]. Available from: http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf

Inactive ingredient

Any component in a preparation that is not an active ingredient. Also known as an “excipient”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Incident

An event, process, practice, or outcome that is noteworthy by virtue of the hazards it creates for patients or the harms it causes to them.

Used in:

Hospital Pharmacists: Information Paper on Enhancing Quality and Safety in Medication Use (2010)
Hospital Pharmacists: Enhancing Quality and Safety in Medication Use Background Paper (2009)

Citation:

National Steering Committee on Patient Safety. Building a safer system: a national integrated strategy for improving patient safety in Canadian health care. Ottawa (ON): Royal College of Physicians and Surgeons of Canada; 2002 [cited 2009 Feb 127]. Available from: http://www.rcpsc.medical.org/publications/building_a_safer_system_e.pdf

Inclusion criteria

Criteria used to define who is eligible to participate in a study (compare “Exclusion criteria”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Independent double check

“A procedure in which 2 individuals, preferably 2 licensed practitioners, separately check each component of the work process”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Proceedings from the ISMP Sterile Preparation Compounding Safety Summit: Guidelines for SAFE preparation of sterile compounds. Horsham (PA): Institute for Safe Medication Practices; 2013 [cited 2014 Feb 18]. Available from: https://www.ismp.org/Tools/guidelines/IVSummit/IVCGuidelines.pdf

Independent variable

The intervention variable that is proposed to alter the dependent (outcome) variable (compare “Dependent variable”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Indigenous people

Of or relating to Métis, Inuit, and First Nations people, regardless of where they reside.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Individual patient prescription system

A form of drug distribution in which medications are dispensed by the pharmacy service in patient-specific labelled prescription containers.

Used in:

Guidelines for Drug-use Control (2008)

Inferential statistics

Statistics that are used to draw inferences or conclusions from data (compare “Descriptive statistics”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Informed consent

A formal process by which an individual agrees to be a trial participant, after being informed appropriately and thoroughly about the study.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Ingredient

Any pro-drug, drug, or excipient that is used in the preparation of a drug formulation. See also “active ingredient” and “inactive ingredient”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Institutional review boards (IRBs)

(1) Bodies “set up by research institutions to ensure the protection of rights and welfare of human research subjects participating in research conducted under their auspices. IRBs make an independent determination to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected, as required by federal regulations and local institutional policy”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Glossary and acronym list. Bethesda (MD): National Institutes of Health, Office of Extramural Research; 2010 [cited 2011 Jan 27]. Available from: http://grants.nih.gov/grants/glossary.htm

(2) “An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects”.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

ICH harmonised tripartite. Guideline for good clinical practice E6(R1). Current Step 4 version. Geneva (CH): International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 1996 [cited 2012 Oct 11]. Available from: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

Institutional review committee

A formal committee whose purpose is to review and approve clinical drug trials for that particular institution. It may also be known as a Clinical Trials Committee, Research Ethics Committee or Investigational Review Board.

Used in:

Clinical Trials: Guidelines on the Use of Drugs in Healthcare Facilities (2001)

Instruction

The purposeful arrangement of information and environment (facilities, techniques, media, instructional strategies) to promote learning.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Instructional goals

Broad statements of purpose for the educational program.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Instructional strategy

The way the educational program is put together to present the new information using the desired instructional techniques and media to help the learner achieve the performance objectives.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Instructional techniques

Procedures or methods of instruction that are selected to help learners achieve the objectives or to internalize the content or message.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Intent-to-treat

“Analyzing participant outcomes according to the group to which they were randomized, even if they did not receive the planned intervention [or remain in the study until its end]. This principle preserves the power of randomization, thus ensuring that important known and unknown factors that influence outcomes are likely to be equally distributed across comparison groups”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Guyatt G. Users’ guides to the medical literature: essentials of evidence-based clinical practice. 2nd ed. New York: McGraw-Hill Medical; 2008.

Internal peer review

An independent review of the drug information provided by a drug information pharmacist.

Used in:

Drug Information Services: Guidelines (2015)

Internal validity

The extent to which a study measures what it set out to measure. Answers the question of whether the experimental treatments that were applied made a difference in the research (compare “External validity”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Campbell DT, Stanley JC, Gage NL. Experimental and quasi-experimental designs for research. Chicago (IL): R. McNally; 1966.

Interobserver variation

The variation in results or outcomes arising as a result of differences in perceptions or in collection and interpretation of data by different observers in the study (compare “Intraobserver variation”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Intraobserver variation

The variation in results or outcomes arising as a result of differences in perceptions or in collection or interpretation of data by the same individual (i.e., an individual data collector) at different times in the study (compare “Interobserver variation”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Investigational drug

(1) A medication approved by the Health Protection Branch for limited clinical use in Canada by approved investigators. This includes a new drug or a novel use of a commercially available drug, being investigated according to a prescribed protocol for administration and evaluation.

Used in:

Clinical Trials: Guidelines on the Use of Drugs in Healthcare Facilities (2001)

(2) A medication approved by Health Canada for limited clinical use by approved investigators.

Used in:

Guidelines for drug-use control (2008)

Investigational product

“A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use”.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

ICH harmonised tripartite. Guideline for good clinical practice E6(R1). Current Step 4 version. Geneva (CH): International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 1996 [cited 2012 Oct 11]. Available from: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

Investigator’s brochure

Document (developed by the sponsor) that includes preclinical and clinical data for an investigational product.

Note: The reader is referred to the Food and Drugs Regulations for a complete list of the information to be included in the brochure.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

Division 5: Drugs for clinical trials involving human subjects. In: Food and Drug Regulations, C.R.C., c. 870., (2012).

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Job analysis review

A review of the skills, knowledge, attitudes, prerequisites and education required to perform a job.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Journal club

A journal club is a group of individuals who meet regularly to evaluate critically the clinical application of recent articles in the medical literature.

Used in:

Journal Clubs Guidelines (2010)

Citation:

Milbrandt E, Vincent J. Evidence-based medicine journal club. Crit Care 2004;8:401-2.

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Knowledge translation

“A dynamic and iterative process that includes synthesis, dissemination, exchange and ethically-sound application of knowledge to improve the health of [the public], provide more effective health services and products, and strengthen the health care system.1 This process takes place within a complex system of interactions between researchers and knowledge users which may vary in intensity, complexity and level of engagement depending on the nature of the research and the findings as well as the needs of the particular knowledge user”.2

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Drug Use Evaluation Services: Guidelines (2014)

Citations:

1 More about knowledge translation at CIHR. Ottawa (ON): Canadian Institute of Health Research; 2014 [cited 2014 Mar 20]. Available from: http://www.cihr-irsc.gc.ca/e/39033.html

2 About knowledge translation. Ottawa (ON): Canadian Institutes of Health Research; 2009 [cited 2011 Feb 3]. Available from: http://www.cihr-irsc.gc.ca/e/29418.html

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Learner

The person to whom instruction is targeted.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Learning

The acquisition of new knowledge, skills or attitudes.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Learning style

The way individuals learn new things, solve problems, deal with others, and cope with situations.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Legislative framework

A collection of related acts, regulations, standards of practice, and code of ethics.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Literature review

Analytical or non-analytical summation of published knowledge about a specific subject. Literature reviews do not involve the collection of original data or observations, but they may involve novel analysis of aggregated data.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

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Manipulation

The actions taken to alter a drug product by means other than compounding and repackaging, e.g., reconstituting a powdered drug product by following the manufacturer’s directions.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Master formula

“A document or set of documents specifying the raw materials with their quantities and the packaging materials, together with a detailed description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls”. Also known as formula or recipe.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa (ON): Health Canada, Health Products and Food Branch Inspectorate;2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php

Master process

A document or set of documents specifying the materials, together with a detailed description of the procedures and precautions, including in-process controls, required to produce a specific finished product.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Master production documents (MPDs)

A collection of preparation dossiers as well as processing related standard operating procedures.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Material Safety Data Sheet

A document that presents information about a particular chemical product. Providing more information than the product label, the Material Safety Data Sheet should state the product’s hazards (health, fire, reactivity, and environmental), how to work safely with the product, what to expect if the advice is not followed, how to respond to an incident, what the symptoms of overexposure look like, and how to respond to them.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Material safety data sheets (MSDSs) — general. Ottawa (ON): Canadian Centre for Occupational Health & Safety; 2006. [cited 2014 Feb 19]. Available from:http://www.ccohs.ca/oshanswers/legisl/msdss.html

Medical record

A patient’s medical chart or health care record.

Used in:

Guidelines for drug-use control (2008)

Medication discrepancy

A drug-related event in which an error in the drug process is detected and corrected before the situation reaches the patient; does not involve the administration (or lack thereof) of a drug to a specific patient, but does include the unexplained loss or theft of a medication. Compare “medication incident”.

Used in:

Guidelines for drug-use control (2008)

Medication distribution service

A hospital system coordinated by the pharmacy service that is used to provide medications to the patient in a controlled manner.

Used in:

Guidelines for drug-use control (2008)

Medication error

Failure to complete a planned course of action as it was intended or use of an incorrect plan at any point in the process of providing medications to patients. Preventable event that can occur at any stage in the medication-use process, leading to patient harm or inappropriate medication use when the medication is in the control of the healthcare professional. Only a small percentage of medication errors result in injury. Any that do result in injury are also classified as adverse drug events. However, not all adverse drug events are classified as medication errors.

Used in:

Hospital Pharmacists: Information Paper on Enhancing Quality and Safety in Medication Use (2010)
Hospital Pharmacists: Enhancing Quality and Safety in Medication Use Background Paper (2009)

Citation:

The Canadian patient safety dictionary. Ottawa (ON): Royal College of Physicians and Surgeons of Canada; 2003 [cited 2009 Feb 17]. Available from:http://rcpsc.medical.org/publications/PatientSafetyDictionary_3.pdf

Medication incident

(1) A patient-related event that involves the incorrect administration of a medication to a specific patient or the omission of administration of a prescribed drug. Compare “medication discrepancy”.

Used in:

Guidelines for drug-use control (2008)

(2) “[Any] preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Medication incidents may be related to professional practice, drug products, procedures, and systems, and include prescribing, order communication, product labelling/ packaging/ nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use”.

Used in:

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Citation:

What is CMIRPS and how does it work? Canadian Medication Incident Reporting and Prevention System; 2011 [cited 2011 June 16]. Available from: http://www.cmirps-scdpim.ca/?p=10 [CMIRPS is a collaboration of Health Canada, the Canadian Institute for Health Information, and the Institute for Safe Medication Practices Canada.]

Medication night cabinet

A suitable locked storage area (e.g., a cupboard, room, cart) containing supplies of repackaged medications that might be required when the pharmacy service is closed.

Used in:

Guidelines for drug-use control (2008)

Medication profile

A record of patient-specific information used to monitor drug therapy. This record includes all medications prescribed and dispensed for the patient.

Used in:

Guidelines for drug-use control (2008)

Medication reconciliation

A process designed to prevent medication errors at patient transition points

Used in:

Guidelines for drug-use control (2008)

Medication safety

(1) “Freedom from preventable harm with medication use”.

Used in:

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Citation:

Definitions of terms. Toronto (ON): Institute for Safe Medication Practices Canada; 2000-2010 [cited 2012 Jan 23]. Available from: http://www.ismp-canada.org/definitions.htm

(2)

The aspect of healthcare that encompasses all elements of medication usage, such as incidents, unwanted effects, interactions, processes and systems for safe use, as well as effective communication.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Citation:

Picton C, Wright H. Medicines Optimisation: Helping patients to make the most of medicines. London: Royal Pharmaceutical Society; 2013 [cited 2015 Aug 7]. Available from: http://www.rpharms.com/promotingpharmacy-pdfs/helping-patients-make-the-most-of-their-medicines.pdf

 

Medication use evaluation (MUE)

A method of improving overall medication use processes with the goal of improving patient care. MUE is similar to DUE but is meant to encompass the entire medication-use process (prescribing, transcribing, preparing, dispensing, administration, and monitoring of drugs). (MUE is the term preferred by the Joint Commission and the American Society of Health-System Pharmacists, whereas DUE is used in other jurisdictions.)

See related term, “drug use evaluation”.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

VA Medication Use Evaluation (MUE) Toolkit, 2nd version. Washington (DC): US Department of Veterans Affairs, Pharmacy Benefits Management Strategic Healthcare Group, and Center for Medication Safety; 2012 [cited 2014 Mar 4]. Available from: http://www. pbm.va.gov/vacenterformedicationsafety/tools/ MUEToolkit.pdf

Medication-use process

A continuous, complex closed-loop process that consists of the following interconnected stages: procurement, prescribing, order transcription, order processing, preparation, dispensing, administration, and monitoring.

Used in:

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Citation:

Lee M, Chong J, Daniels R. Optimal drug distribution systems in acute care facilities. In: MacKinnon NJ, editor. Safe and effective: the eight essential elements of an optimal medication-use system. Ottawa (ON): Canadian Pharmacists Association; 2007. p. 203-232.

Medications

Therapeutic products that contain a drug, as well as natural health products, vitamin and mineral supplements, and herbal remedies, regardless of whether the substances were not obtained with a prescription. Used interchangeably with “drugs”.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Citation:

Natural Health Products Regulations, SOR/2003-196.

Medium

A means of communication that carries information between a source and a receiver. Instructional media carry a message with an instructional purpose.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Meta-analysis

The process of combining results of previous research studies on a specified topic to generate a statistical summary of overall effect size.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Minimal important difference

“The smallest difference in score in the outcome of interest that informed patients or informed proxies perceive as important, either beneficial or harmful, and that would lead the patient or clinician to consider a change in the management”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Brozek JL, Guyatt GH, Schünemann HJ. How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure. Health Qual Life Outcomes 2006;4:69.

Modified systematic approach

A seven-step method used to research drug information inquiries:
“Step I. Secure demographics of requester
Step II. Obtain background information
Step III. Determine and categorize ultimate question
Step IV. Develop strategy and conduct search
Step V. Evaluate and analyze the information
Step VI. Formulate and provide response
Step VII. Conduct follow-up and documentation”.

Used in:

Drug Information Services: Guidelines (2015)

Citation:

Nathana JP. Drug information — the systematic approach: continuing education article. J Pharm Pract. 2013 Apr;26(2):78–84.

Monitor

An individual who oversees the conduct of a clinical trial on behalf of the sponsor to ensure that the investigators and others are following all applicable regulatory requirements.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Multiple-dose container

A unit that is formulated to contain more than one dose of a drug.

Used in:

Compounding: Guidelines for Pharmacies (2014)

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Narrative review

A literature review addressing a clinical question of interest, without a systematic approach to evaluating the literature of interest. Narrative reviews are more prone to bias than are systematic reviews. Because they simply report on previously published findings, without imposing a critical, predesigned framework of appraisal or statistical analysis, narrative reviews are not generally considered a form of research.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Natural Health Products (NHPs)

“Substances or combinations of substances consisting of molecules and elements found in nature, and homeopathic preparations, sold in dosage forms for the purpose of maintaining or improving health and treating or preventing diseases/conditions”.

Used in:

Complementary/Alternative Medicine: Information Paper on the Role of the Pharmacist (1999)

Citation:

Advisory Panel on Natural Health Products. Final Report of the Advisory Panel on Natural Health Products: Regulatory Framework for Natural Health Products. Ottawa: Therapeutics Products Programme;1998.

Natural rubber latex (NRL)

Produced from the sap of the Hevea brasiliensis treat, it is used to manufacture both “dipped” NRL products (i.e. medical gloves, catheters and condoms) and “dry” NRL products (i.e. vial stoppers, syringe plungers and intravenous injection ports). Dry NRL products are less likely to cause IgE-medicated type 1 allergic reactions than dipped NRL products, perhaps due to a washing and a coagulation process, which may reduce the final concentration of residual NRL proteins.

Used in:

Natural Rubber Latex Sensitive/Allergic Patients: Guidelines for Preparing Medications (2001)

Near miss

(1) An incident that has the potential to result in harm but fails to do so for any of a variety of reasons.

Used in:

Hospital Pharmacists: Information Paper on Enhancing Quality and Safety in Medication Use (2010)
Hospital Pharmacists: Enhancing Quality and Safety in Medication Use Background Paper (2009)

Citation:

National Steering Committee on Patient Safety. Building a safer system: a national integrated strategy for improving patient safety in Canadian health care. Ottawa, ON: Royal College of Physicians and Surgeons of Canada; 2002 [cited 2009 Feb 127]. Available from: http://www.rcpsc.medical.org/publications/building_a_safer_system_e.pdf

(2) "An event that could have resulted in unwanted consequences, but did not because either by chance or through timely intervention the event did not reach the patient”.

Used in:

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Citation:

Definitions of terms. Toronto (ON): Institute for Safe Medication Practices Canada; 2000-2010 [cited 2012 Jan 23]. Available from: http://www.ismp-canada.org/definitions.htm

Needs analysis

A process to identify problems, including the nature of the problem, how important it is, why it exists, and possible ways of addressing the problem.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Negotiation team

“The person or people who develop the contract and negotiate the contract through to contract signing”. (In some cases contract management and negotiation may be done by the same person.)

Used in:

Outsourcing: Guidelines for Pharmacy Practice (2011)

Citation:

Developing and managing contracts: getting the right outcome, paying the right price. Sydney (AU): Australian Government, Department of Finance and Administration, Australian National Audit Office; 2007 [cited 2010 Feb 24]. Available from: www.anao.gov.au/uploads/documents/Developing_and_Managing_Contracts.pdf

Nominal data

Data that can be classified into a discrete number of categories that cannot be ranked or numbered (e.g., patients who lived or died, interventions deemed appropriate or inappropriate) (compare “Ordinal data”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Non-formulary drug

A drug not listed in the hospital formulary.

Used in:

Guidelines for drug-use control (2008)

Nonaseptic compounding

A form of compounding that involves mixing a drug and other ingredients without the aim of maintaining sterility of the preparation.

Used in:

Compounding: Guidelines for Pharmacies (2014)

NRL allergy

There are two types of NRL allergy:
a) Allergic contact dermatitis is a type IV, delayed hypersensitivity to chemicals added to NRL during processing, and is characterized by an initial acute eczematous dermatitis often with vesicle formation. Typical presentation occurs 48-96 hours after exposure and skin may subsequently become dry, cracked and thickened.
b) Allergic immunoglobulin E (IgE)-mediated systemic reaction is a type 1 immediate hypersensitivity with symptoms that may include rticarial, flushing, edema, rhinoconjuctivitis, asthma and anaphylaxis. Life threatening allergic reactions have most often been associated with mucosal, inhalation or parenteral exposure to NRL proteins.

Used in:

Natural Rubber Latex Sensitive/Allergic Patients: Guidelines for Preparing Medications (2001)

NRL sensitivity

Is a “nonallergic” irritant contact dermatitis, characterized by redness, dryness, cracking, scaling and vesicle formation on exposed areas. With repeated exposure to NRL, sensitization may be increased and may progress to a systemic allergic reaction.

Used in:

Natural Rubber Latex Sensitive/Allergic Patients: Guidelines for Preparing Medications (2001)

NRL-safe

Due to the ubiquitous presence of NRL products, a health care facility cannot provide an NRL-free environment for patients or employees. However, many steps can be taken to provide an NRL-safe environment by minimizing NRL exposure and adopting latex-precautions procedures.

Used in:

Natural Rubber Latex Sensitive/Allergic Patients: Guidelines for Preparing Medications (2001)

Null hypothesis

See “Null statement”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Null statement

A statement of no significant relationship between or among the variables of interest (e.g., “The efficacy of Drug A does not differ from the efficacy of Drug B”). Also known as “null hypothesis”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

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Objectives

he concrete steps that are required to achieve identified goals. In the context of a hospital pharmacy service, objectives include action plans indicating the person(s) responsible; they have identified start and completion dates; they are realistic and measurable; they are written annually; and they are monitored to determine if they are being achieved.

Used in:

Guidelines for drug-use control (2008)

Observational analytic study

A study in which the exposure of interest occurs spontaneously, not as the result of action by an investigator (compare ”Experimental study”). Can be categorised into these types of studies: “Case-control study”, “Cohort study, and Cross-sectional study.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Observational assessment

A systematic means to assess the knowledge, skills, and attitude of a person by measuring behaviour while looking at the process being performed by that person.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Observational audit

A means of systematically gathering information about how well a process is working, by observing processes and behaviours; it is not intended to assess the competency of the individual person performing the process.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Ordinal data

Data that can be classified into ordered categories, although the interval between categories may not be uniform (e.g., a visual analogue scale for pain).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Outcome

“Outcomes are events, variables, or experiences that are measured because it is believed that they may be influenced by the intervention.”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

International clinical trials registry platform (ICTRP): About registries. Geneva (CH): World Health Organization; 2011 [cited 2011 Feb 3]. Available from: http://www.who.int/ictrp/network/trds/en/index.html

Outcome measure(s)

Measurements of the results achieved. (See Primary outcome and Secondary outcome).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Outsource

To obtain a good or service by contract from a source that is outside of the healthcare facility’s corporate structure.

Used in:

Outsourcing: Guidelines for Pharmacy Practice (2011)

Outsourcing process

A set of activities undertaken by an organization to outsource a good or service. The process typically includes the following activities:
1. Deciding to outsource
2. Planning to outsource
3. Undertaking the tendering process
4. Finalizing the contract
5. Managing the contract
6. Terminating the contract

Used in:

Outsourcing: Guidelines for Pharmacy Practice (2011)

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Packaging

“The collection of different components (e.g. bottle, vial, closure, cap, ampoule, blister) which surround the pharmaceutical product [or preparation] from the time of production until its use”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 9: Guidelines on packaging for pharmaceutical products In: WHO Technical Report Series, No. 902. In. Geneva, CH: World Health Organization; 2002 [cited 2014 Feb 24]. Available from: http://www.gmpua.com/World/WHO/Annex9/trs902ann9.pdf

Packaging material

Those packaging components in direct contact with the sterile product.

Used in:

Guidelines for Preparation of Sterile Products in Pharmacies (2001)

Participant

“An individual whose data, or responses to interventions, stimuli, or questions by a researcher are relevant to answering a research question; also referred to as “human participant,” and in other policies/guidance as “subject” or “research subject”.

Note: In keeping with spirit of the Tri-council policy statement,4 this set of guidelines prefers the term “participant” over “subject” because the term reflects a more active role played by individuals, rather than the more passive role that the term “subject” connotes.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-council policy statement ethical conduct for research involving humans. Ottawa (ON): Interagency Advisory Panel on Research Ethics; 2010 [cited 2013 Jan 22]. Available from: http://pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

Particulate matter (for injectable preparations)

Unnecessary undissolved particles, excluding gas bubbles, that are present in the product or preparation.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Patient safety

“The reduction and mitigation of unsafe acts within the health care system, as well as through the use of best practices shown to lead to optimal patient outcomes”.1
“Freedom from accidental injury”.2

Used in:

Hospital Pharmacists: Information Paper on Enhancing Quality and Safety in Medication Use (2010)
Hospital Pharmacists: Enhancing Quality and Safety in Medication Use Background Paper (2009)

Citations:

1 The Canadian patient safety dictionary. Ottawa(ON): Royal College of Physicians and Surgeons of Canada; 2003 [cited 2009 Feb 17]. Available from:http://rcpsc.medical.org/publications/PatientSafetyDictionary_3.pdf
2 Kohn LT, Corrigan JT, Donaldson MS, editors. To err is human, building a safer healthcare system. Washington( DC): National Academy Press;1999.

Patient self-administration of medication program

An organized program in which patients are taught how to administer their own medications in the hospital, in accordance with the policies and procedures of the pharmacy service and the hospital as a whole.

Used in:

Guidelines for drug-use control (2008)

Patient-centered care

A multifaceted approach to care that welcomes patients and their families as valued partners with healthcare providers in the design, delivery, and assessment of the care given to the patient.

The care is holistic, empowering, and tailored to meet the needs of the patient (and their family).1 It takes into account the patient’s preferences; lifestyle; physical, cultural, and psychosocial supports; goals; needs and expectations; and what people think about their care.2

At the level of a collective group of patients or the public, patient-centred care influences system-wide changes to the design and delivery of healthcare.3

Also known as patient- and family-centred care or person-centred care (pl.people-centred care).

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Citations:

1 Farrar M, chair. An inquiry in patient centred care in the 21st century: implications for general practice and primary care. London: Royal College of General Practitioners; 2014 [cited 2016 Feb 29]. Available from: http://www.rcgp.org.uk/policy/rcgp-policy-areas/~/media/Files/Policy/A-Z-policy/RCGP-Inquiry-into-Patient-Centred-Care-in-the-21st-Century.ashx%20p%204

2 de Silva D. Helping measure person-centred care. London: Health Foundation; 2014 [cited 2016 Feb 10]. Available from: http://www.health.org.uk/sites/health/files/HelpingMeasurePersonCentredCare.pdf

3 What is person-centred care and why is it important? London: Health Innovation Network: South London; no date [cited 2016 Feb 10]. Available from: http://www.hinsouthlondon.org/system/ckeditor_assets/attachments/41/what_is_person-centred_care_and_why_is_it_important.pdf

Performance objectives

Clear statements of what the learner is expected to be able to do at the end of the education program.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Person

Any individual, including personnel, contract workers.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Personal protective equipment

“Equipment or clothing worn to minimize exposure to chemical hazards in the workplace”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Personal protective equipment (PPE). Ottawa (ON): Health Canada; 2008. Available from: http://www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs-sesc/pdf/pubs/occup-travail/personal-individuelle/personal-individuelle-eng.pdf

Personnel

Any number of employees or healthcare workers of the organization.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Pharmaceutical

“A drug other than a drug listed in Schedule C or D to the [Food and Drugs] Act”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Part C: Drugs. Division 1A: establishment licenses. In: Food and Drug Regulations, C.R.C., c. 870. (2014).

Pharmaceutical care

A patient-centred “practice in which the practitioner takes responsibility for the patient’s drug-related needs, and is held accountable for this commitment”.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Citation:

Cipolle RJ, Strand LM, Morley PC. Pharmaceutical care practice: the patient-centered approach to medication management services. 3rd ed. New York: McGraw-Hill; 2012.

Pharmaceutical isolator

A device that uses a system of physical barriers to enclose a controlled workspace.1 Its workspace is separated from the surrounding environment, ensuring that manipulations inside the space are not compromised by aspects of the outside environment. There are 2 types of pharmaceutical isolators: those suitable for handling hazardous substances (either aseptically or nonaseptically) and those that provide a grade A (ISO class 5) environment for exposure of critical sites during aseptic compounding.2,3

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

1 International clinical trials registry platform (ICTRP): About registries. Geneva (CH): World Health Organization; 2011 [cited 2011 Feb 3]. Available from: http://www.who.int/ictrp/network/trds/en/index.html.

2 <800> hazardous drugs - handling in healthcare settings [draft document]. Rockville (MD): United States Pharmacopeial Convention; [cited 2014 Mar 28]. Available from: http://www.usp.org/usp-nf/notices/compounding-notice

3 Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme. Recommendation: isolators used for aseptic processing and sterility testing. Geneva (CH): PIC/S Secretariat; 2007 [cited 2014 Jun 3]. Available from: http://www.picscheme.org/pdf/29_pi-014-3-recommendation-on-isolators.pdf

Pharmacist

A person who meets the requirements of a pharmacy regulatory body.

Used in:

Guidelines for drug-use control (2008)

Pharmacoeconomics

The economic evaluation of clinical, economic, and humanistic facets of pharmaceutical interventions in the healthcare system. Techniques include cost-minimization, cost-effectiveness, cost-utility, cost–benefit, and cost-of-illness analyses.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

Frequently used terminology. Lawrenceville (NJ): International Society for Pharmacoeconomics and Outcomes Research; 2014. Available from: http://www. ispor.org/Terminology

Pharmacosurveillance

“The monitoring of drug safety, for example, by means of spontaneous adverse-effect reporting systems, case-control and cohort studies”.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

WHO International Working Group for Drug Statistics Methodology, WHO Collaborating Centre for Drug Statistics Methodology, WHO Collaborating Centre for Drug Utilization Research and Clinical Pharmacological Services. Introduction to Drug Utilization Research. Geneva (CH): World Health Organization; 2003 [cited 2014 3 March]. Available from: http://whqlibdoc.who. int/publications/2003/924156234X.pdf

Pharmacy and therapeutics committee

A committee that is composed of representatives from the pharmacy service, medicine, nursing, hospital administration, and other disciplines which serves as a policy-recommending body on all matters relating to the use of medications in a hospital. May be known by other names, e.g., pharmacology committee, pharmacotherapy committee.

Used in:

Guidelines for drug-use control (2008)

Pharmacy care plan

“A treatment plan that is founded on pharmaceutical care and which is developed according to the standards of care. The plan includes all of the following activities: establishing goals of therapy, determining interventions to prevent or resolve DTPs [drug therapy problems], and scheduling followup monitoring”.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Citation:

Fernandes O, Toombs K, Pereira T, Lyder C, Bjelajac Mejia A, Shalansky S, et al. Canadian Consensus on Clinical Pharmacy Key Performance Indicators: Knowledge Mobilization Guide. Ottawa (ON): Canadian Society of Hospital Pharmacists; 2015 [cited 2016 Feb 23]. Available from: http://www.cshp.ca/productsServices/cpKPI/CSPH-Can-Concensus-cpKPI-Knowledge-Mobilization-Guide.pdf

Pharmacy control number

A unique number assigned to each batch of repackaged product. This number can be used to trace back to the repackaging record, lot number, and original expiry date. Where computerized packaging equipment does not allow a unique number, the manufacturer’s number can be used.

Used in:

Repackaging: Guidelines for Healthcare Facilities (1998)

Pharmacy education

The educational design and capacity to develop the workforce for a diversity of settings (e.g., community, hospital, research and development, academia) across varying levels of service provision and competence (e.g., technical support staff, pharmacists and pharmaceutical scientists) and scope of education (e.g. undergraduate, postgraduate, lifelong learning).

Used in:

Education: Statement on Collaborative Development, Delivery, and Evaluation of Pharmacy Curricula (2011)

Pharmacy practitioners

Pharmacists, pharmacy technicians (regulated, where applicable), pharmacist students, and pharmacy technician students.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Pharmacy service

A system that integrates the application of the pharmacist’s specialized knowledge with the distribution of medications to ensure optimal medication therapy for patients.

Used in:

Guidelines for drug-use control (2008)

Pharmacy team

Pharmacy practitioners, pharmacy assistants, and others who provide very similar services as pharmacy assistants.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Phase I

“Initial safety studies on a new drug, including the first administration of the drug into humans, usually conducted in healthy volunteers. These trials may be conducted in patients when administration of the drug to healthy volunteers is not ethical. Phase I trials are designed mainly to determine the pharmacological actions of the drug and the side effects associated with increasing doses. Pharmacokinetic as well as drug-drug interaction studies are usually considered as Phase I trials regardless of when they are conducted during drug development as these are generally conducted in healthy volunteers. Phase I trials also include trials in which new drugs are used as research tools to explore biological phenomena or disease processes”.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

Abbreviations/definitions. Ottawa (ON): Health Canada; 2008 [cited 2012 Dec 18]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_definitions-eng.php#principal

Phase II

“Clinical trials to evaluate the efficacy of the drug in patients with medical conditions to be treated, diagnosed or prevented and to determine the side effects and risks associated with [the] drug. If a new indication for a marketed drug is to be investigated, then those clinical trials may generally be considered Phase II trials”.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

Abbreviations/definitions. Ottawa (ON): Health Canada; 2008 [cited 2012 Dec 18]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_definitions-eng.php#principal

Phase III

“Controlled or uncontrolled trials conducted after preliminary evidence suggesting efficacy of the drug has been demonstrated. These are intended to gather the additional information about efficacy and safety that is needed for further risk/benefit assessment of the drug. In this phase, clinical trials are also conducted in special patient populations (e.g., renal failure patients), or under special conditions dictated by the nature of the drug and disease”.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

Abbreviations/definitions. Ottawa (ON): Health Canada; 2008 [cited 2012 Dec 18]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_definitions-eng.php#principal

Phase IV

“All studies performed after the drug has been authorized by the regulator for the market, and related to the authorized indication. These studies are often important for optimizing the drug's use. They may be of any type but must have valid scientific objectives. Commonly conducted studies include safety studies and studies designed to support use under the authorized indication such as mortality and morbidity studies, or epidemiological studies”.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

Abbreviations/definitions. Ottawa (ON): Health Canada; 2008 [cited 2012 Dec 18]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_definitions-eng.php#principal

PICO framework

(1) The design of a question so that it provides specific information about the patient (or problem), intervention, comparison interventions, and outcome.

Used in:

Journal Clubs Guidelines (2010)

Citation:

Richardson WS, Wilson MC, Nishikawa J, Hayward RS. The well-built clinical question: a key to evidence-based decisions. ACP J Club. 1995;123(3):A12-3.

(2) Framework for design of a research question so that it provides specific information about the patient (or problem), intervention, comparison interventions, and outcome.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Richardson WS, Wilson MC, Nishikawa J, Hayward JS. The well-built clinical question: a key to evidence-based decisions. ACP J Club. 1995 Nov-Dec;123(3):A12-A13.

PICOTS

Aspects of the design of a well-built clinical or research question to provide specific information about the Patient (or persons), Interventions, Comparison intervention, Outcome, Time frame, and Study design.1, 2

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

1 Richardson WS, Wilson MC, Nishikawa J, Hayward RS. The well-built clinical question: a key to evidence-based decisions. ACP J Club. 1995;123(3):A12-3.

2 Haynes RB, Sackett DL, Guyatt GH, Tugwell P. Clinical epidemiology how to do clinical practice research. Philadelphia (PA): Lippincott Williams & Wilkins; 2006.

Point estimate

“The results of a study which represent the best estimates of the treatment” (e.g., relative risk or odds ratio).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Guyatt G. Users' guides to the medical literature: essentials of evidence-based clinical practice. 2nd ed. New York: McGraw-Hill Medical; 2008.

Policy

A general statement of principle pertaining to a specific issue, task, or service.

Used in:

Guidelines for drug-use control (2008)

Populations at risk for developing NRL sensitivity/allergy

Individuals at highest risk include those with myelomeningocele (spina bifida), congenital genitourinary abnormalities, or patients who have had multiple surgical procedures. Other groups at risk include health care workers who frequently wear NRL gloves, rubber industry workers and atopic individuals who have asthma, eczema, rhinitis, etc.

Used in:

Natural Rubber Latex Sensitive/Allergic Patients: Guidelines for Preparing Medications (2001)

Power

Statistical term describing a study’s ability to detect a statistically significant difference or association if one truly exists.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Pre-printed order

A document showing pre-determined procedures and actions that are accepted by the clinical team for use in the management of a specific diagnosis or following a specific diagnostic procedure. The physician can use the pre-printed form to individualize any element of a particular drug order.

Used in:

Guidelines for drug-use control (2008)

Prefilter

A non-HEPA filter that is installed on the upstream side of the exhaust filter to increase shelf-life of the HEPA filter.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Section 8 — Ventilation tools. J Oncol Pharm Pract. 2007;13(3 Suppl):31-42.

Preparation

A drug or dosage form or dietary supplement or device that was made using compounding procedures.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Preparation dossier

A collection of information about a particular formulation of a preparation, including specifications for ingredients, specifications for packaging material and other supplies, the master formula, sampling procedures, standard operating procedures for critical processing, and reference material.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Primary clean air device

A device (such as a cabinet, isolator, workbench or workstation) or room that provides a grade A (ISO class 5) environment for exposure of critical sites during the compounding of aseptic preparations. For radiopharmaceuticals, these devices also include hot cells and closed radiological protection workstations.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Primary outcome

“The main outcome(s) used to determine the effects of the intervention(s). Most trials should have only one primary outcome”. (Compare “Secondary outcome measure”.)

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

International clinical trials registry platform (ICTRP): About registries. Geneva (CH): World Health Organization; 2011 [cited 2011 Feb 3]. Available from: http://www.who.int/ictrp/network/trds/en/index.html

Primary packaging

A container that comes into direct contact with the preparation (e.g. infusion bag, vial, or syringe).

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 9: Guidelines on packaging for pharmaceutical products In: WHO Technical Report Series, No. 902. Geneva (CH): World Health Organization; 2002 [cited 2014 Feb 24]. Available from: http://www.gmpua.com/World/WHO/Annex9/trs902ann9.pdf

Primary sources of information

Sources that provide first-hand direct evidence (or research) about a particular topic, without interpretation or evaluation.

Used in:

Drug Information Services: Guidelines (2015)

Citation:

Identifying primary, secondary, and tertiary sources. Wilmington (NC): University of North Carolina Wilmington. William Madison Randall Library; 2014 [cited 2015 Jun 9]. Available from: http://library.uncw.edu/guides/primary_secondary_and_tertiary_sources

Principal functions

The main areas of responsibility for a pharmacy service.

Used in:

Guidelines for drug-use control (2008)

Principal investigator

“The leader of a research team who is responsible for the conduct of the research, and for the actions of any member of the research team”. Where the clinical trial is funded by a sponsor, the principal investigator is responsible to the sponsor.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

ICH harmonised tripartite. Guideline for good clinical practice E6(R1). Current Step 4 version. Geneva (CH): International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 1996 [cited 2012 Oct 11]. Available from: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

Procedure

Detailed guidelines for implementing policy.

Used in:

Guidelines for drug-use control (2008)

Process validation

A system of “establishing documented evidence with a high degree of assurance that a specific process consistently produces [a preparation] meeting predetermined specifications and quality characteristics.” The validation may occur prospectively, concurrently, or retrospectively.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa (ON): Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php

Processing record

The documented evidence of the steps undertaken to compound a preparation.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Product

A manufactured pharmaceutical dosage form.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Prospective drug use evaluation

Evaluations and (if necessary) interventions that are performed to assess the appropriateness of the treatment plan and to identify and resolve any drug therapy related problems before the patient receives the drug.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

VA Medication Use Evaluation (MUE) Toolkit, 2nd version. Washington (DC): US Department of Veterans Affairs, Pharmacy Benefits Management Strategic Healthcare Group, and Center for Medication Safety; 2012 [cited 2014 Mar 4]. Available from: http://www. pbm.va.gov/vacenterformedicationsafety/tools/ MUEToolkit.pdf

Prospective study

A study that identifies a group of participants at the outset and then follows the group forward in time to look for the outcome of interest (compare “Retrospective study”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Protocol

The document that outlines the procedures of a clinical trial.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Purchaser

A legal entity that agrees to enter into a contractual relationship with a vendor. Term is synonymous to “Contract giver” in PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments.

Substance that, “when injected in sufficient amounts into the mammalian body, will cause a rise in body temperature”.

Used in:

Outsourcing: Guidelines for Pharmacy Practice (2011)

Pyrogen

Substance that, “when injected in sufficient amounts into the mammalian body, will cause a rise in body temperature”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Halls NA. Effects and causes of contamination in sterile manufacturing. In: Halls NA, editor. Microbiological contamination control in pharmaceutical clean rooms. Boca Raton (FL): CRC Press; 2004. p. 1-22.

Q

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Quality assurance

(1) The wide collection of policies, procedures, and other arrangements made to ensure that pharmaceutical products are prepared to requisite standards of quality.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Pharmaceutical Inspection Convention, Pharmaceutical Inspection Cooperation Scheme. PIC/S guide to good practices for the preparation of medicinal products in healthcare establishments. PE 010-4. Geneva (CH): PIC/S Secretariat; 2014 [cited 2014 Mar 25]. Available from: http://www.picscheme.org/publication.php

(2)

“The planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled”.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Citation:

Quality assurance vs. Quality control. Milwaukee (WI): American Society for Quality; no date. Available from: http://asq.org/learn-about-quality/quality-assurance-quality-control/overview/overview.html

Quality control

(1) The component of Good Preparation Practice which is concerned with sampling, specifications and testing, and with the organization’s procedures to document and release preparations. Quality control ensures that the necessary and relevant procedures and tests are performed and that all starting and packaging materials and products (intermediate and finished) are released for use if their quality meets the requisite standard.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Pharmaceutical Inspection Convention, Pharmaceutical Inspection Cooperation Scheme. PIC/S guide to good practices for the preparation of medicinal products in healthcare establishments. PE 010-4. Geneva (CH): PIC/S Secretariat; 2014 [cited 2014 Mar 25]. Available from: http://www.picscheme.org/publication.php

(2)  “The observation techniques and activities used to fulfill requirements for quality”.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Citation:

Quality assurance vs. Quality control. Milwaukee (WI): American Society for Quality; n. d. Available from: http://asq.org/learn-about-quality/quality-assurance-quality-control/overview/overview.html

Quality improvement

(1) Activities intended to increase the likelihood of desired health outcomes consistent with current professional knowledge.

Used in:

Hospital Pharmacists: Information Paper on Enhancing Quality and Safety in Medication Use (2010)
Hospital Pharmacists: Enhancing Quality and Safety in Medication Use Background Paper (2009)

Citation:

Chassin MR, Galvin RW. The urgent need to improve health care quality. Institute of Medicine National Roundtable on Health Care Quality. JAMA 1998 Sep 16;280(11):1000-5.

(2) An approach to enhancing performance by systematically and continuously making and evaluating changes to the system.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Quality management

A systematic process to assess, control, communicate, and review risks to the quality of the drug product or preparation across the lifecycle of the product or preparation. Also known as “quality risk management”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

ICH Expert Working Group. ICH topic Q9 quality risk management. Geneva (CH): International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2005 [cited 2014 Feb 24]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf

Quality of care

The degree to which healthcare services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.1
Quality of care has 6 dimensions:2
a. Accessibility: Services are obtained in the most suitable setting within a reasonable time and distance.
b. Appropriateness: Services are relevant to the user’s needs and are based on accepted or evidence-based practice.
c. Effectiveness: The services provided are based on scientific knowledge to achieve desired outcomes.
d. Acceptable/patient-centred: The choice of services considers the preferences and goals of individual patients.
e. Efficiency: Resources are optimally used in achieving desired outcomes.
f. Safety: Risks are mitigated to avoid unintended or harmful results

Used in:

Hospital Pharmacists: Information Paper on Enhancing Quality and Safety in Medication Use (2010)
Hospital Pharmacists: Enhancing Quality and Safety in Medication Use Background Paper (2009)

Citations:

1 Institute of Medicine, Committee to Design a Strategy for Quality Review and Assurance in Medicare. A strategy for quality assurance. Washington (DC): National Academy Press; 1990.
2 Quality of care: a process for making strategic choices in health systems. Geneva (CH): World Health Organization; 2006 [cited 2008 Dec 4]. Available from:http://www.msc.es/organizacion/sns/planCalidadSNS/pdf/excelencia/opsc_sp6.pdf

Quarantine

Effective restriction of the availability of a product for use (physically or by system), until it is approved for release by a person in authority to do so.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa (ON): Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php

R

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Randomization

Method of selection of study participants whereby each individual or entity in the target study population has an equal opportunity of being included in any arm of the study. Also known as “random assignment”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Raw material

Any substance of defined quality used in the preparation of a sterile product, but excluding packaging materials.

Used in:

Guidelines for Preparation of Sterile Products in Pharmacies (2001)

Repackage

To remove drugs from the manufacturer’s original package and place within another form of packaging (such as, strip packaging, blister packaging).

Used in:

Guidelines for drug-use control (2008)

Repackaging

“Breaking up a manufacturer’s original package of a drug for the purpose of dividing and assembling the drug in larger or smaller quantities for redistribution or sale” within the practice of pharmacy.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Policy on manufacturing and compounding drug products in Canada (POL-0051). Ottawa (ON): Health Canada; 2009 [cited 2010 Mar 5]. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/pol_0051-eng.php

Request for proposal

An invitation to potential bidders to submit a proposal for the provision of a good or service.

Used in:

Outsourcing: Guidelines for Pharmacy Practice (2011)

Research

“An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation”.1

Healthcare-related research is typically categorized into the following areas of study,1 all of which are applicable to pharmacy practice: biomedical research; clinical research; health services research; and social, cultural, environmental, and population health research (see individual definitions).

The term “research” can be used to describe many endeavours in pharmacy practice, including systematic reviews, descriptive studies, and hypothesis-driven research (see individual definitions).

Citations:

1 Canadian Institutes of Health Research; Natural Sciences and Engineering Research Council of Canada; Social Sciences and Humanities Research Council of Canada. Tri-council policy statement: ethical conduct for research involving humans. Ottawa (ON): The Councils; 2010 [cited 2011 Jan 28]. Available from: http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf

2 Glossary of funding related terms. Ottawa (ON): Canadian Institutes of Health Research; 2010 [cited 2011 Apr 28]. Available from: http://www.cihr-irsc.gc.ca/e/34190.html

Research integrity

“The coherent and consistent application of values and principles essential to encouraging and achieving excellence in the search for, and dissemination of knowledge. These values include honesty, fairness, trust, accountability, and openness”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Expert Panel on Research Integrity. Honesty, accountability and trust: fostering research integrity in Canada. Ottawa (ON): Council of Canadian Academies; 2010 [cited 2010 Oct 28]. Available from: http://www.scienceadvice.ca/uploads/eng/assessments%20and%20publications%20and%20news%20releases/research%20integrity/ri_report.pdf

Retrospective drug use evaluation

Evaluation that is performed after the patient has received the drug. Such an evaluation is designed to detect patterns of inappropriate use with the goal of future prevention.

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

VA Medication Use Evaluation (MUE) Toolkit, 2nd version. Washington (DC): US Department of Veterans Affairs, Pharmacy Benefits Management Strategic Healthcare Group, and Center for Medication Safety; 2012 [cited 2014 Mar 4]. Available from: http://www. pbm.va.gov/vacenterformedicationsafety/tools/ MUEToolkit.pdf

Retrospective study

A study that uses previously recorded information about events that occurred in the past to assemble data about patients, follow-up, and outcomes (compare “Prospective study”).

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Room temperature

Temperature between 20 and 25⁰C.

Used in:

Compounding: Guidelines for Pharmacies (2014)

S

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Sample

A component group within a larger group or population (i.e. “Target population”). The sample is used in conducting research, and conclusions are drawn from the results as if the research had been performed using the larger group.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Secondary outcome

An outcome that is of secondary interest or that is measured at time points of secondary interest. It may involve the same event, variable, or experience as those of primary interest; it may also be measured at time points other than that of the primary outcome. (Compare “Primary outcome.”)

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

International clinical trials registry platform (ICTRP): About registries. Geneva (CH): World Health Organization; 2011 [cited 2011 Feb 3]. Available from: http://www.who.int/ictrp/network/trds/en/index.html

Secondary packaging

A container that comes into contact with the primary packaging of a preparation or product but does not come into direct contact with the preparation (e.g. an outer wrap containing at lese one packaged preparation). See also “primary packaging”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Secondary sources of information

Sources that provide an interpretation or evaluation of information obtained from primary sources.

Used in:

Drug Information Services: Guidelines (2015)

Citation:

Identifying primary, secondary, and tertiary sources. Wilmington (NC): University of North Carolina Wilmington. William Madison Randall Library; 2014 [cited 2015 Jun 9]. Available from: http://library.uncw.edu/guides/primary_secondary_and_tertiary_sources

Selection bias

An error due to systematic differences in characteristics between those who take part in a study and those who do not.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Aschengrau A, Seage GR. Essentials of epidemiology in public health. 2nd ed. Sudbury (MA): Jones and Bartlett Publishers; 2008.

Shall

(1) A mandatory requirement.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Outsourcing: Guidelines for Pharmacy Practice (2011)

Drug Use Evaluation Services: Guidelines (2014)

(2) Denotes an expectation or a practice that is widely accepted as being required.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Drug Information Services: Guidelines (2015)

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Should

A recommendation, something that is advised but not mandatory.

Used in:

Outsourcing: Guidelines for Pharmacy Practice (2011)
Journal Clubs Guidelines (2010)

Research: Guidelines on Conducting Research in Pharmacy (2011)

Medication Incidents: Guidelines on Reporting and Prevention (2012)

Compounding: Guidelines for Pharmacies (2014)

Drug Information Services: Guidelines (2015)

Drug Use Evaluation Services: Guidelines (2014)

Social, cultural, environmental and population health research

“Research with the goal of improving the health of the … population, or of defined sub-populations, through a better understanding of the ways in which social, cultural, environmental, occupational and economic factors determine health status”.

Used in:

Glossary of funding related terms. Ottawa (ON): Canadian Institutes of Health Research; 2010 [cited 2011 Apr 28]. Available from: http://www.cihr-irsc.gc.ca/e/34190.html

Special Access Programme (SAP)

A Health Canada program that provides access to non-marketed drugs for practitioners who are treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or are unavailable. The SAP authorizes the manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada. Drugs considered for release by the SAP include pharmaceutical, biologic, and radiopharmaceutical products not approved for sale in Canada.

Used in:

Guidelines for drug-use control (2008)

Sponsor

“An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial”.

Used in:

Clinical Trials: Guidelines for Pharmacies in Healthcare Institutions (2013)

Citation:

ICH harmonised tripartite. Guideline for good clinical practice E6(R1). Current Step 4 version. Geneva (CH): International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 1996 [cited 2012 Oct 11]. Available from: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

Stability

The extent to which a product (or preparation) keeps the same properties as it had when it was manufactured (or prepared).

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

General chapter <1191> stability considerations in dispensing practice. In: USP on compounding: a guide for the compounding practitioner. Rockville (MD):United States Pharmacopeial Convention; 2014 [cited 2014 Jul 12].

Stability test

An assessment of how the properties of a preparation changes over time in specific conditions (e.g., temperature).1

The test includes assessing the specific attributes that are likely to affect the preparation in terms of its safety, quality, and/or efficacy; these attributes include the chemical (e.g. chemical integrity, potency), physical (eg. Homogeneity, suspension rate), microbiological (e.g. sterility), and toxicological properties of the preparation.2

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citations:

1 General chapter <1191> stability considerations in dispensing practice. In: USP on compounding: a guide for the compounding practitioner. Rockville (MD):United States Pharmacopeial Convention; 2014 [cited 2014 Jul 12].

2 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Stability testing of new drug substance and products Q1A(R2). Geneva, (CH):1992 [revised 2003; cited 2014 Jul 11]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf

Standard

A “quality or measure serving as a basis or example or principle to which others conform or should conform or by which the accuracy or quality of others is judged”.1

In DUE, compliance with predetermined standards or criteria is assessed and reported.2

Used in:

Drug Use Evaluation Services: Guidelines (2014)

Citation:

1 Katherine B, editor. The Canadian Oxford dictionary. 2nd ed. Don Mills (ON): Oxford University Press; 2004.

2 VA Medication Use Evaluation (MUE) Toolkit, 2nd version. Washington (DC): US Department of Veterans Affairs, Pharmacy Benefits Management Strategic Healthcare Group, and Center for Medication Safety; 2012 [cited 2014 Mar 4]. Available from: http://www. pbm.va.gov/vacenterformedicationsafety/tools/ MUEToolkit.pdf

Statistical significance

A measure of “how likely [it is] that any apparent differences in outcome between treatment and control groups are real and not due to chance”.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Leung WC. Balancing statistical and clinical significance in evaluating treatment effects. Postgrad Med J. 2001;77(905):201-204.

Sterile

(1) The absence of micro-organisms capable of reproducing themselves.

Used in:

Guidelines for Preparation of Sterile Products in Pharmacies (2001)

(2) “Free from viable microorganisms”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa(ON): Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php

Sterility assurance level

The probability of not more than one viable microorganism surviving a sterilization process.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

von Woedtke T, Kramer A. The limits of sterility assurance. GMS Krankenhhyg Interdiszip. 2008;3(3):Doc19.

Stewardship

The responsible use of resources in taking care of someone or something.

Stewardship “involves balancing competing influences and demands”.

Used in:

Pharmacy Practice in Hospitals and Other Collaborative Healthcare Settings: Position Statements (2016)

Citation:

Health systems: Stewardship. Geneva (CH): World Health Organization; [cited 2016 August 2]. Available from:http://www.who.int/healthsystems/stewardship/en/

Stop the line

To immediately stop and report, at any point, any activity that could cause harm.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Furman C, Leviton J. Patient safety alert system that uses principles from auto manufacturing increases reporting and improves safety in a medical center. Rockville (MD): US Department of Health and Human Services, Agency for Healthcare Research and Quality; 2008. [updated 2013 Sep 25; cited 2014 March 27]. Available from: http://www.innovations.ahrq.gov/content.aspx?id=1698#top

Summative evaluation

Assessment or evaluation that takes place after an educational program is finished. It may be applied to evaluation of both the learner and the educational program.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Surgical hand antisepsis

Washing or rubbing the hands, using an antiseptic product, to eliminate transient flora and reduce resident skin flora. The antiseptics used usually have persistent antimicrobial activity and thus will inhibit the growth of microorganisms on the gloved hand.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

WHO guidelines on hand hygiene in health care. Geneva (CH): WorldHealth Organization; 2009. Available from: http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf

Synthetic rubber

Petroleum-based rubber or butyl rubber are examples of synthetic rubbers. They do not pose a hazard to NRL sensitive/allergic individuals

Used in:

Natural Rubber Latex Sensitive/Allergic Patients: Guidelines for Preparing Medications (2001)

Systematic review

A literature review which provides a comprehensive, critical assessment of the available published data on a specific subject to address a research question. It includes the use of inclusion and exclusion criteria for evidence to be considered, a detailed, comprehensive search strategy for identifying literature, and a priori rules for combining research results. It may or may not include meta-analysis to produce an overall point estimate.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Systems-based

Having a focus on systems, processes, or products, not individuals.

Used in:

Medication Incidents: Guidelines on Reporting and Prevention (2012)

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Target population

The population about which we wish to draw conclusions.

(See “Sample”.)

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Woodward M. Epidemiology: study design and data analysis. 2nd ed. Boca Raton (FL): Chapman & Hall/CRC; 2005.

Telehealth

“The delivery of health services, expertise, and information at a distance through the use of information technology and telecommunications”.

Used in:

Journal Club Guidelines (2010)

Citation:

Barber K, editor. The Canadian Oxford dictionary. 2nd ed. Don Mills (ON): Oxford University Press; 2004.

Telephone drug order

A medication order given over the telephone by a legally qualified prescriber. Compare “verbal drug order”.

Used in:

Guidelines for drug-use control (2008)

Tertiary sources of information

Sources that provide compilations, analyses, or digests of secondary sources.

Used in:

Drug Information Services: Guidelines (2015)

Citation:

Identifying primary, secondary, and tertiary sources. Wilmington (NC): University of North Carolina Wilmington. William Madison Randall Library; 2014 [cited 2015 Jun 9]. Available from: http://library.uncw.edu/guides/primary_secondary_and_tertiary_sources

Therapeutic interchange

A process in which drug products that are chemically different but considered by the pharmacy and therapeutics committee to be therapeutically equivalent are interchanged according to hospital policies.

Used in:

Guidelines for drug-use control (2008)

Toxicology service

A service that provides information to healthcare professionals and/or the public for the assessment of potential toxic effects and the management of drug or chemical exposures.

Used in:

Drug Information Services: Guidelines (2015)

Traditional Herbal Medicines

“Finished drug products intended for self-medication that contain, as the active principles, herbal ingredients that have received relatively little attention in world scientific literature, but for which traditional or folkloric use is well-documented in herbal references”.

Used in:

Complementary/Alternative Medicine: Information Paper on the Role of the Pharmacist (1999)

Citation:

Drugs Directorate (Canada). Drugs Directorate Guideline. Traditional Herbal Medicines (Revised). Ottawa: Health Protection Branch, Health Canada;1995.

Training

Education that is focused on development of specific skills, often in a work-related context.

Used in:

Education Programs: Guidelines to Develop Programs for Hospital Pharmacists (1996)

Trituration

The process of reducing the particle size of a solid by continually rubbing the solid in a mortar with a pestle.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Thompson JE, Davidow LW. A practical guide to contemporary pharmacy practice. 3rd ed. Philadelphia (PA): Wolters Kluwer Health/Lippincott Williams & Wilkins; 2009.

Type I error

The error that occurs when data from a sample indicates that there is a statistically significant difference or association, even though a true difference or association is not present in the population.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Type II error

The error that occurs when data from a sample indicates that there is no statistically significant difference or association, even though a difference or association exists in the population.

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

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Uncertainty principle

In clinical research, a construct based on the notion that there should be genuine uncertainty at the beginning of a randomized clinical trial regarding which arm of the trial may prove to be superior, after taking into account the risks and benefits of the treatments under study.1,2 Such uncertainty may exist at the level of the community, the individual clinician, or the patient.2

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citations:

1 Sackett DL. Why randomized controlled trials fail but needn’t: 1. Failure to gain “coal-face” commitment and to use the uncertainty principle. CMAJ. 2000 May 2;162(9):1311-1314.

2 Sackett DL. Uncertainty about clinical equipoise [letter]. CMAJ. 2001;164(13):1831-1832.

Underuse

Failure to provide a healthcare service when it would have produced a favourable outcome for a patient.

Used in:

Hospital Pharmacists: Information Paper on Enhancing Quality and Safety in Medication Use (2010)
Hospital Pharmacists: Enhancing Quality and Safety in Medication Use Background Paper (2009)

Citation:

Chassin MR, Galvin RW. The urgent need to improve health care quality. Institute of Medicine National Roundtable on Health Care Quality. JAMA. 1998 Sep 16;280(11):1000-5.

Unidirectional airflow

“An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Office of Regulatory Affairs. Guidance for industry. Sterile drug products produced by aseptic processing — current good manufacturing practice. Rockville (MD): The Department; 2004. [cited 2014 Feb 18]. Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070342.pdf

Unit-dose distribution

A form of drug distribution in which orders for each patient are filled individually and packaged in unit-of-use packages. Each package contains one dose. Typically, no more than a 24-hour supply of doses is available in the patient care area at any time.

Used in:

Guidelines for drug-use control (2008)

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Validation

“The documented act of demonstrating that any procedure, process, and activity will consistently lead to the expected results. Includes the qualification of systems and equipment”.

Used in:

Compounding: Guidelines for Pharmacies (2014)

Citation:

Good manufacturing practices (GMP) guidelines - 2009 edition, version 2. Ottawa (ON): Health Canada, Health Products and Food Branch Inspectorate; 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0001-eng.php

Variable

Any characteristic that can be classified or measured. (See Confounding variable, Dependent variable, and Independent variable.)

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Vendor

A legal entity that offers a contract. Term is synonymous to "Contract acceptor" in PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments.

Used in:

Outsourcing: Guidelines for Pharmacy Practice (2011)

Verbal drug order

A medication order given verbally, other than by telephone, by a legally qualified prescriber. Compare "telephone drug order".

Used in:

Guidelines for drug-use control (2008)

Viable

Capable of living, growing, and/or dividing in particular environmental conditions.

Used in:

Compounding: Guidelines for Pharmacies (2014)

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Ward Stock

Medications that are stocked in the patient care area at all times and are not individually labelled for a specific patient's use.

Used in:

Guidelines for drug-use control (2008)

Webinar

An Internet-based communication method in which participants log onto a website to hear, in real time, a presentation that is being given in another location. The participants hear the speaker, see the slides on their respective computers, and are able to ask questions verbally.

Used in:

Journal Club Guidelines (2010)

Well-built clinical question

(1) A question that seeks specific knowledge about the diagnosis or clinical management of a patient or problem. Such questions use the PICO framework.

Used in:

Journal Clubs Guidelines (2010)

Citation:

Richardson WS, Wilson MC, Nishikawa J, Hayward RS. The well-built clinical question: a key to evidence-based decisions. ACP J Club. 1995;123(3):A12-3.

(2) A question that seeks specific knowledge about the diagnosis or clinical management of a patient or problem. Such questions typically use the "PICO framework".

Used in:

Research: Guidelines on Conducting Research in Pharmacy (2011)

Citation:

Richardson WS, Wilson MC, Nishikawa J, Hayward JS. The well-built clinical question: a key to evidence-based decisions. ACP J Club. 1995 Nov-Dec;123(3):A12-A13.

WHMIS (Workplace Hazardous Materials Information Systems)

(1) A system set forth in federal and provincial legislation to ensure that information regarding hazards of materials used in workplaces is provided to employers and employees.

Used in:

Compounding: Guidelines for Pharmacies (2014)

(2) Mechanism whereby suppliers provide information about the hazards of material produced or sold in, imported to, or used within Canadian workplaces to employers and in turn to employees; required by federal legislation.

Used in:

Guidelines for drug-use control (2008)

Workstation

The area where a preparation is made.

Used in:

Compounding: Guidelines for Pharmacies (2014)