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:

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
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

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:

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:

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

(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:

“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:

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)

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:

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:

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:

“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:

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:

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:

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:

Compounding: Guidelines for Pharmacies (2014)

Citation:

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:

“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

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:

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:

"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:

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”.

“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:

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:

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:

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:

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 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:

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:

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:

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.)

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:

“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:

“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:

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

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:

“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”.

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:

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:

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:

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)

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.

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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:

(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:

(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:

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:

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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

Used in:

Compounding: Guidelines for Pharmacies (2014)

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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)

(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)

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)

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)

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)