Health Professions Council
Pharmacists Scope of Practice Preliminary Report


Irvine E. Epstein, Q.C., Chair
Arminée Kazanjian, Member
David MacAulay, Member

April 2000

This Preliminary Report should be read
in conjuction with the Post-Hearing Update for the profession.

FOREWORD

This report is the result of the Health Professions Council's review of the scope of practice of pharmacy pursuant to the Terms of Reference from the Minister of Health and Minister Responsible for Seniors. Under the Health Professions Act, the Health Professions Council is a six-person advisory body appointed by the Government of British Columbia to make recommendations to the Minister of Health and Minister Responsible for Seniors about the regulation of health professions.

In this report the Health Professions Council examines how the existing scope of practice of pharmacy should be legislatively defined in order to reflect fairly and accurately the current state of practice and the public interest in the practice of pharmacy.

CONTENTS

EXECUTIVE SUMMARY

I. INTRODUCTION

A. THE NATURE OF THE REVIEW

B. THE PROCESS FOR THE REVIEW

C. THE REGUATION OF PHARMACY

II. THE POLICY BACKGROUND

III. DISCUSSION OF ISSUES

A.SCOPE OF PRACTICE

1. Scope of Practice in Other Provinces

2. Proposed Scope of Practice

  1. Performing physical assessment relating to the initiation or monitoring of drug therapy

  2. Obtaining diagnostic or analytical test results in accordance with previously approved written guidelines or protocols

  3. Initiating or modifying medication therapy in accordance with previously approved written guidelines or protocols

3. Conclusion

B. RESERVED ACTS

1. 1995 Proposal for Reserved Acts

2. . 1999 (Addendum) Proposal for Reserved Acts

  1. Administering Medications

  2. Performing Screening and Monitoring Procedures
  3. Selecting, Recommending and Initiating Drug Therapy

3. Second Consultation Process

4. Conclusion

C. SUPERVISED ACTS

D. RESERVED TITLES

IV. RECOMMENDATIONS

APPENDIX A: TERMS OF REFERENCE

APPENDIX B: RESERVED ACTS LIST




EXECUTIVE SUMMARY

The Health Professions Council has conducted a review of the scope of practice of pharmacy.

The purpose of the review is to provide recommendations to the Minister of Health and Minister Responsible for Seniors regarding four matters: scope of practice statements, reserved acts, supervised acts, and reserved titles.

The Health Professions Council has conducted a detailed consultation process and its recommendations regarding the four elements of the scope review are as follows:

  1. The Council recommends the following scope of practice statement for pharmacists:
  2. The practice of pharmacy is the compounding, dispensing and sale of drugs monitoring drug therapy and advising on therapeutic values, contents and hazards of drugs and devices and identification, assessment and recommendations to prevent or resolve drug related problems.

  3. The Council recommends that compounding or dispensing a drug listed in Schedule I or II of the Pharmacists, Pharmacy, Operations and Drug Scheduling Act be granted to members of the College of Pharmacists. For the purposes of this reserved act, the following definitions shall apply:
  4. "compounding": mixing ingredients, at least one of which is a drug.

    "dispensing": preparing or filling a prescription for drugs.

  5. The Council recommends that a provision be enacted which deals with general principles regarding delegation of reserved acts. The provision would apply generally, not to individual cases. It should require the following:
    • The assigning health professional's governing body must provide assent to the proposed reserved act being performed by someone else
    • The reserved act to be assigned as well as the level of supervision must be clearly defined and circumscribed by the assigning health professional's governing body
    • Where the person to whom the act will be assigned is a member of a self-regulated health profession, his or her governing body must approve of the assignment
    • The instruction to perform the act must be made in writing either by way of a general written protocol or through a case-specific instruction
    • The assigning health professional must be satisfied that the individual who will be performing the act has the necessary skills and training to perform the act safely
    • The assigning health professional must ensure that the person who will be performing the act accepts the assignment.

  6. The Council recommends the following titles or abbreviations thereof be reserved for members of the College of Pharmacists of BC:
    • Apothecary

    • Druggist

    • Pharmacist and

    • Pharmaceutical Chemist.




I.     INTRODUCTION

A.    THE NATURE OF THE REVIEW

This is the preliminary report of the review of the scope of practice of pharmacy by the Health Professions Council (Council).

The review was conducted pursuant to Terms of Reference issued by the Minister of Health and Minister Responsible for Seniors in accordance with section 25 of the Health Professions Act (HPA). The Terms of Reference direct the Council to review the scopes of practice of the recognized health professions, of which pharmacy is one.

The Terms of Reference, which are included as Appendix A to this report, indicate that there are four main elements to the scope of practice review:

  1. scope of practice statements which describe what the profession does, the methods it uses and the purpose for which it does it

  2. reserved acts which are those acts that present such a significant risk of harm that they should be performed only by professionals who are qualified to perform them

  3. supervised acts which are reserved acts, or aspects of reserved acts, which may be performed by persons supervised by health professionals and

  4. reserved titles which are titles that describe a profession's services and which are reserved exclusively for the health profession.




B.     THE PROCESS FOR THE REVIEW

The general process for the review provides for an initial meeting with the profession(s), submission of briefs by the regulatory body and professional association for each profession, a consultation process involving all health professions and interested parties regarding each professions' submission, drafting of a preliminary report, public hearings and a final report.

The Council met with representatives of the College of Pharmacists of BC (College) early in 1995. In June 1995 the College submitted its scope of practice brief. This was the subject of consultation in 1996. The College submitted an Addendum in 1999 which was the subject of a second consultation process. This report contains the Council’s preliminary findings regarding both the original brief and the 1999 Addendum.

This report will be circulated to all health professions and other interested parties who participated in the Council's consultation process. A public hearing is scheduled on June 6, 2000, after which a final report will be issued. Persons or organizations who have made written responses to either the original consultation letters or to this report will be invited to speak at the hearing.




C.     THE REGULATION OF PHARMACY

The first provincial enactment was the Pharmacy Act, SBC 1891, c. 33. It established the Pharmaceutical Association of British Columbia with a Board of Examiners to examine candidates. It provided a list of drugs (schedules) to place restrictions on the sale of certain drugs, and enabled the Board of Examiners to dispense with examination of candidates under certain circumstances. It also empowered the council of the Association to make bylaws. The Pharmacy Act, RSBC 1903-4, c.5, made it unlawful to practise without a certificate anywhere in the province. In 1921 the Pharmacy Act Amendment Act, RSBC 1921, c. 50, required the presence of a licensed pharmacist in every pharmacy, but permitted certified clerks to be left temporarily in charge. The Pharmacy Act Amendment Act, RSBC 1923, c.55 revised the provision regarding the council’s power to make bylaws.

The Pharmacy Act, RSBC 1935, c. 56, repealed and replaced the earlier Pharmacy Act, RSBC 1924, c. 193. It provided a list of prohibitions, including prohibited use of the titles "pharmacist", "druggist", "pharmaceutical chemist", etc. unless registered under the Act. It also introduced a new provision dealing with cancellation of licenses, and with appeals from a cancellation to the Supreme Court. The Pharmacy Act Amendment Act, RSBC 1946, c. 58, permitted the council to suspend a licence pending a hearing by the council, and permitted it to make bylaws and regulations regarding the qualifications for registration as pharmacy students, the period of practical training required, the discipline of registered students, fees to be paid on reinstatement, the striking off the register or suspension of any member for non-payment of fees, etc. It also provided new criteria for medical practitioners to meet in order to be registered. Finally, it required the presence of a licensed pharmacist at all times when a pharmacy is open, thereby no longer permitting certified clerks to be left in charge.

The Pharmacy Act Amendment Act, RSBC 1951, c. 61, revised, among others, the definition of "pharmacy" and "drug". It also recognized the full-time Faculty of Pharmacy at UBC. It permitted the executive committee of the council to recommend to the Lieutenant-Governor in Council changes in the schedule of drugs. The Pharmacy Act Amendment Act, RSBC 1957, c. 47, amended the definition of "pharmacy" to authorize the Minister to bring within the scope of the Act those hospitals large enough to have a dispensary run by a qualified pharmacist and to exclude the small hospitals. The Pharmacy Act Amendment Act, RSBC 1960, c. 42, amended the definition of "restricted drugs" to make reference to Schedule F of the Food and Drugs Act of Canada. The definition of "drug" was changed under the Pharmacy Act Amendment Act, RSBC 1964, c. 38, to that used in the Food and Drugs Act.

The Pharmacy Act, RSBC 1974, c. 62, repealed and replaced the Pharmacy Act, RSBC 1960, c. 282. It revised the definition section, constituted the College of Pharmacists of BC, and provided that the council of the Association is to administer the College. It also amended the provision regarding prohibited acts and regarding restrictions on sale of drugs of Schedule A. The act was renamed the Pharmacists Act, RSBC 1979, c. 326.

The Pharmacists, Pharmacy, Operations and Drug Scheduling Act, SBC 1993, c. 62 replaced the 1979 Pharmacists Act. It established the powers of the College of Pharmacists including registration, standards of practice, discipline, and bylaw and rule-making power. The Act also included provisions relating to medicated animal feeds and veterinary drugs.




II.     THE POLICY BACKGROUND

The main impetus for a scope of practice review was the Report of the British Columbia Royal Commission on Health Care and Costs (the Seaton Commission). The Seaton Commission stated that the existing legislation governing the health professions creates persistent jurisdictional disputes and a distinct lack of co-operation among the health professions, despite the fact that all health professional colleges have the same mandate - to protect the public from preventable harm.

The Seaton Commission stated that the primary reason for the jurisdictional disputes was the present regulatory system's reliance on exclusive scopes of practice. Under the exclusive scope of practice model, the various health professions have been granted an exclusive right to practice within a legislatively defined scope of practice. No one, other than a member in good standing of that profession, can perform acts within the profession's scope of practice unless they are granted an exemption.

The Commission concluded:

...exclusive scopes of practice should be narrowed to focus on preventing harm, as has been initiated recently in Ontario. We believe that more appropriate, cost-effective and timely health care could be provided to more patients if B.C. were to follow the Ontario initiative.

(Closer to Home, The Report of the Royal Commission on Health Care and Costs in British Columbia, Volume 2, 1991, p. D-33)

This recommendation is also consistent with legislative initiatives underway in Alberta.

The Seaton Commission was not the first review body to suggest that the present legislative model of exclusive scopes of practice was inappropriate. Restricting professional monopolies (exclusive scopes of practice) was also recommended in an earlier study commissioned by the British Columbia Minister of Health. In discussing the conflicts which may arise between the professional college and the public interest, the issue of exclusive scopes of practice was raised:

It must be emphasized that any professional legislation which unduly restricts the scope of practice of skilled personnel may be contrary to the public interest in greater supply and accessibility of service through the development of team practice. Therefore, it is urged that: Professional legislation should not contain narrow restrictions or rigid definitions of scope of practice which are excessively exclusive that measures should be taken (as indicated below) to reduce the area of interprofessional strain and conflict and that no prosecutions for violations of scope of practice legislation should be undertaken without the prior consent of the appropriate public authority.

Insofar as may be possible with due regard for public safety, professional law should not place rigid restrictions on the scope of practice of allied health personnel, and greater flexibility should be encouraged in the allocation of roles between the health disciplines.

(Professor J.T. McLeod, Public Regulation of the Professions in Health Security for British Columbians, Special Report: Consumer Participation, Regulation of the Professions, and Decentralization (1974), the report of Richard G. Foulkes, B.A., M.D., F.A.P.H.A. to the Minister of Health, Province of British Columbia, Tome Three, p.145)

Thus, the trend in regulatory policy for the health professions has been towards reducing exclusivity in order to enhance interdisciplinary practice, improve accessibility to health care services and increase consumer choice, while at the same time maintaining the fundamental objective of protecting the public.

These policy trends are clearly reflected in the Terms of Reference for the scope of practice review which provide the basis for a new regulatory framework for health professions in British Columbia. The core elements of the new framework are scope of practice statements and reserved acts.

Under the present system, scope of practice statements are exclusive. In the new system, scope statements will not be exclusive but professions may be granted reserved acts.

Reserved acts are those elements of a profession's scope of practice which present such a significant risk of harm that they should be reserved to a particular profession, or shared amongst particular professions. Thus, unlike the present system in which each profession is granted exclusivity within its entire defined scope of practice (subject to specified exceptions), only those acts which present a significant risk of harm will be reserved.

In short, the government has assigned the Council the task of creating a regulatory model based on broad, non-exclusive scope of practice statements and narrowly defined reserved acts.

The government has the responsibility to ensure that those services which are accessible are safe and that the regulatory framework for the practice of health professions protects the public from incompetent, impaired, or unethical practitioners. At the same time, the regulatory framework should not entrench a paternalistic function for professions or reserve exclusive areas of practice simply to enhance professional status and control.

The new system of overlapping scopes of practice and narrow reserved acts removes barriers to interdisciplinary practice and offers greater choice and accessibility to the public. In the Council's view, the public interest is served by professional legislation which promotes quality in the delivery of health care services within safe parameters. Indeed, the Council's primary policy objective in conducting its review is achieving the optimum balance between safe practice and consumer choice.

With this in mind, the Council proposes to consider the practice of pharmacy having regard to the four elements of the scope review.




III.     DISCUSSION OF ISSUES

The main issues raised by this review are the four elements listed above: scope of practice, reserved acts, supervised acts and reserved titles.

A.     SCOPE OF PRACTICE

The scope statement describes what the profession does, the methods it uses, and the purpose for which it does it. Unlike the present legislative scheme, the statement itself does not grant an exclusive scope of practice. Nonetheless, the statement is important because: it defines the area of practice for which the governing body must establish registration requirements and standards of practice it defines the parameters of the profession for members of the profession, employers, courts and educators and it informs the public about the services practitioners are qualified to perform. It is expected that the Council's recommendations will increase overlapping scopes of practice.

The current scope of practice of pharmacists is defined by the Pharmacists, Pharmacy, Operations and Drug Scheduling Act, RSBC 1996, c. 62 (PPODSA) as the practice and responsibility for:

  1. interpretation and evaluation of prescriptions,

  2. compounding, dispensing and added labelling of drugs and devices,

  3. monitoring drug therapy,

  4. identification, assessment and recommendations necessary to resolve or prevent drug related problems in patients,

  5. advising persons of the therapeutic values, content and hazards of drugs and devices,

  6. safe storage of drugs and devices,

  7. maintenance of proper records, including patient records, for drugs and devices,

  8. services, duties and transactions necessary to the management, operation and control of a pharmacy or to provide pharmacy services in a hospital, facility or care centre, and

  9. sale of drugs by harmacists.




1. Scope of Practice in Other Provinces

In Ontario, pharmacists are regulated under the Regulated Health Professions Act, SO 1991, c. 18, and the Pharmacy Act, SO 1991, c. 36. The scope of practice is defined in section 3 of the Pharmacy Act as follows:

The practice of pharmacy is the custody, compounding and dispensing of drugs, the provision of non-prescription drugs, health care aids and devices and the provision of information related to drug use.

Bill 22, or the Health Professions Act of Alberta was assented to in May 1999 and is currently awaiting proclamation. Section 3 of Schedule 19 of the Act defines the scope of practice:

In their practice, pharmacists promote health and prevent and treat diseases, dysfunction and disorders through proper drug therapy and non-drug decisions and, in relation to that, do one or more of the following:

  1. assist and advise clients, patients and other health care providers by contributing unique drug and non-drug therapy knowledge on drug and non-drug selection and use,
  2. monitor responses and outcomes to drug therapy,
  3. compound, prepare and dispense drugs,
  4. provide non-prescription drugs, blood products, parenteral nutrition, health care aids and devices,
  5. supervise and manage drug distribution systems to maintain public safety and drug system security,
  6. educate clients, patients and regulated members of the Alberta College of Pharmacists and of other colleges in matters described in this section,
  7. conduct or collaborate in drug-related research,
  8. conduct or administer drug and other health-related programs, and
  9. provide restricted activities authorized by the regulations.

According to information provided by the Alberta Pharmaceutical Association (AphA), there are currently no restricted activities for pharmacists in Alberta. Restricted activities will be the subject of regulations to be proposed and reviewed sometime in the year 2001 or 2002.

The Manitoba Pharmaceutical Act, CCSM, c. P60, defines pharmacists’ scope of practice as follows:

Practice of pharmacy means

  1. responsibility for preparing, distributing and controlling drugs in a pharmacy,
  2. compounding a prescription,
  3. dispensing a drug,
  4. selling a drug by retail,
  5. operating a pharmacy insofar as the operation relates to the practice of pharmacy.

In Quebec, section 17 of the Pharmacy Act, RSQ, c. P-10, gives the following scope of practice statement:

Every act having as its object the preparation or selling, by prescription or not, of a medication or poison constitutes the practice of pharmacy.

The practice of pharmacy includes the communication of information on the prescribed use or, failing a prescription, on the recognized use of medications or poisons, and the making of a record for each person to whom a pharmacist delivers medication or poison on prescription and the pharmacological study of such record.




2. Proposed Scope of Practice

In its initial 1995 brief to the Council the College proposed the addition of the following three points to the current legislative scope of practice definition, to reflect current and emerging areas of patient-focused pharmacy care:

  1. performing physical assessment relating to the initiation or monitoring of drug therapy

  2. obtaining diagnostic or analytic test results in accordance with previously approved written guidelines or protocols

  3. initiating or modifying medication therapy in accordance with previously approved written guidelines or protocols.

The College is asking that these three activities be explicitly stated in the scope of practice statement, which would expand the scope of practice of pharmacists. As well, these encompass acts or activities which form part of certain of the Council's list of reserved acts, specifically reserved acts #1 (diagnosis) and #5 (prescription and administration of a drug listed in Schedule I or II of the PPODSA). The College made a further submission in September 1999 regarding specific reserved acts.

The requests by the College for physical assessments related to initiation or monitoring of drug therapy, for use of diagnostic test results, and for initiating or modifying medication therapy were the subject of much comment in the initial consultation process conducted in 1996. Those original responses will be summarized here, but because these 1995 requests are closely related to the more specific requests for reserved acts outlined in the College's subsequent 1999 brief to the Council, they will be subject to further analysis in the reserved acts section of this report.

The Faculty of Pharmaceutical Sciences at UBC believes the proposed scope of practice statement is a good reflection of the activities that constitute pharmacy practice in BC. It adds that the convenient and relatively wide access that the public has to pharmacists in BC puts pharmacists in a unique position to provide efficient primary care services including general health information, medication education materials, consultation on self-medication products, regular monitoring of prescribed drugs, and referrals to other health professionals. This has been described by the profession as "pharmaceutical care" and the undergraduate curriculum has been moulded to prepare graduates for a patient-centred practice.

The Faculty adds that the three additional points proposed by the College reflect similar legislative initiatives that have taken place in North America.

A number of respondents make generally supportive comments about the College's scope of practice submission. The College is supported by the Ontario College of Pharmacists, the BC Naturopathic Association (BCNA), and the Faculty of Pharmaceutical Sciences at UBC. The Registered Nurses Association of BC (RNABC) has no concerns with the proposed scope of practice and clarifies that its position is only in regard to the relationship between the proposed scope of practice of pharmacists and the scope of practice of registered nurses. The Licensed Practical Nurses Association of BC (LPNABC) foresees no problem with the College's proposed scope of practice. The College of Licensed Practical Nurses of BC (CLPNBC) is concerned about medication counselling and that licensed practical nurses should be able to provide general medication information.




a. performing physical assessment relating to the initiation or monitoring of drug therapy

The use of "assessment" has been discussed by the Council in previous reports and in its Shared Scope of Practice Model Working Paper (Working Paper). The Council recognizes that every health professional who works directly with patients makes some type of "assessment" of the patient. The Council has distinguished "assessment", which is not a reserved act, from "diagnosis" which is described in reserved act #1:

Essentially, diagnosis is the identification of the cause of signs or symptoms. Assessment is a process of observation and evaluation of the physical status or progress of a patient, which may involve observation of symptoms, but does not include naming or identifying a disease, disorder, or condition as the cause of these symptoms.

With respect to physical assessments the Faculty of Pharmaceutical Sciences at UBC states that pharmacists have always been required to use some physical assessment skills in observing and interviewing a patient. It states that the pharmacy curriculum does not devote much time to physical assessment and would require changes if the proposed scope of practice is approved.

Others who responded to the consultation process pointed out that pharmacists do not currently possess physical assessment skills or training.

The BC Medical Association (BCMA) states that whatever physical assessment skills are taught to pharmacy students cannot compare to the medical doctors' pathophysiological approach. The BCMA finds the concept of pharmacists performing physical examinations and then prescribing medications most alarming.

The College of Physicians and Surgeons (CPSBC) strongly supports the submission by the BC Medical Association. It also states that it has very real concerns about the proposed expansion of scope of practice. The CPSBC does not believe that pharmacists have the education and practical experience to undertake physical assessments in a community pharmacy setting. It clarifies however that the context of pharmacy practice in hospitals is quite different.

The BC Society of Medical Laboratory Science (BCSMLS, formerly the BC Society of Medical Technologists) asks what type of physical assessments would be performed by pharmacists. It also asks who will train the pharmacists and whether current fiscal limitations on pharmacy education allow for retraining of pharmacists. Further, the BCSMLS inquires about review programs on pharmacists' expertise in physical assessments, and whether the physical assessment performed by a pharmacist is sufficiently comprehensive to ensure safety in the initiation of drug therapy. Finally, the BCSMLS asks what qualifies as an "institutional setting" for the performance of physical assessments by pharmacists.

The Registered Psychiatric Nurses Association of BC (RPNABC) states that not all pharmacists are competent to perform "physical assessments relating to the initiation or monitoring of drug therapy". The RPNABC adds that while the College recognizes that not all pharmacists are competent to perform physical assessments, it should be reflected in the wording for the proposed scope of practice.

The Health Association of BC (HABC, formerly the British Columbia Health Association) does not support "performing physical assessment relating to the initiation or monitoring of drug therapy" because of potential stress that patients experience due to a number of different practitioners performing physical assessments. It also states that there is a lack of convincing need for such an expansion to the scope of practice.

The Nova Scotia Department of Health (NSDOH) states that the term "physical assessment" should be defined. It also suggests that this act be performed in accordance with previously approved written guidelines or protocols. NSDOH also states that two elements of the proposed scope of practice (performing physical assessments… and administering medications…) are not competencies required at licensure.

New Brunswick Health and Community Services (NBHCS) states that "physical assessment" is very broad and needs to be clarified. It further states that in New Brunswick, hospital pharmacists and occasionally, community pharmacists have access to and use tests results for monitoring purposes, and that pharmacists working in institutional settings do modification therapy in accordance with protocols approved by the multidisciplinary Pharmacy and Therapeutics' Committee and the Medical Advisory Committee. It states that pharmacists' role in these areas have proven to be a valuable asset in the delivery of qualify and cost-effective patient care. Finally, NBHCS adds that the process by which the guidelines or protocols are approved be clearly defined and accepted by all relevant health care professions.

The Council has not reserved the assessment process for any health profession. As stated in the Council's Working Paper:

The Council believes it important to distinguish between diagnosis and assessment.…

... all health care practitioners assess a client's progress and response to services rendered....

...In the Council's view, it is the identification of a disease, disorder or condition as the cause of signs or symptoms of the individual which should be a reserved act, and the process of assessment should continue to be in the public domain. Both regulated and unregulated practitioners would be free to perform assessments during the course of providing health care services, subject always to the proposed general risk of harm clause.

"Physical assessment", in the context of the College’s submission, would need to be further defined if it is to be considered for inclusion in the scope of practice statement.




b. obtaining diagnostic or analytic test results in accordance with previously approved written guidelines or protocols

The College has requested that "obtaining diagnostic and analytic test results" be specifically included in pharmacists’ scope of practice. The ability to order and interpret diagnostic testing is an integral part of the reserved act of "diagnosis". The Council has not specifically mentioned ordering and interpreting diagnostic tests as a reserved act. However, in the Council's report on the Recommendations on the Designation of Medical Laboratory Technology, it made the following comments in concluding that Medical Laboratory Technologists met the criteria for designation as a health profession under the HPA. At page 13 of the Council’s report Recommendations on the Designation of Medical Laboratory Technology it stated:

The process of diagnosis frequently requires the use of a number of diagnostic tools, including the results of laboratory testing. Quality-control is an essential part of laboratory testing. The applicant submits, and was supported by testimony from the DAP of the CPSBC, among others, that, without quality-control, laboratory data can be erroneously reported, creating the risk of misdiagnosis. However, it is the responsibility of the diagnostician to consider all of the information available from and about the patient, including the results of laboratory testing, and assess the reliability of the test results in light of all the other information available in order to make a diagnosis...

The Council clearly found that isolated laboratory data were not reliable for diagnostic and treatment purposes unless that data could be assessed along with other diagnostic signs and symptoms by a practitioner trained and educated to make a diagnosis.

The Council further stated:

...In its submission, the applicant raised a concern about quality-control in point-of-care testing. The Council notes that as technology becomes more accessible, patients are increasingly able to self-monitor using point-of-care testing. Creating a reserved act for quality-control will not eliminate point-of-care testing or the need for patients to consult their health-care providers for diagnosis and treatment. The accuracy of test results generated outside diagnostic laboratory facilities must be assessed by the practitioner in the ongoing management of the patient's treatment process.

The Diagnostic Accreditation Program (DAP) of the College of Physicians and Surgeons of BC (CPSBC) made the following comments with regard to the College's request to obtain diagnostic or analytic test results and performing screening/monitoring procedures:

In all laboratory testing, from obtaining the specimen from the patient to reporting the results, there are multiple possible mechanisms which may produce erroneous results. Factors such as adequate patient identification, specimen labeling, appropriate samples, patient preparation, appropriate specimen containers and tube, and instrument calibration and operation, must be controlled in minute detail to avoid errors. Even reagents used in the performance of instrument testing must be tested from batch lot to batch lot, and the performance of the instrument must be compared to other instruments performing the same test...

...Patient testing in hospital may also be conducted with small portable instruments such as those the pharmacists are proposing to use. Such testing is euphemistically called "Point of Care" or "Near Patient" Testing.

The laboratory selects these instruments, the experts in the laboratory set up the quality control and testing procedures, and the laboratory monitors the ongoing performance of the quality control...Point of Care Testing involves the laboratory delegation of the performance of tests to medical personnel who are not trained and certified technologists. Such delegation requires a formal program of training, documentation of the training, and updates as methodology or instrumentation changes.

Records of quality control and maintenance procedures, regularly monitored by the laboratory, are also required. The Diagnostic Accreditation Program and other experts in laboratory medicine have found these procedures critical to maintaining the appropriate quality of reported results from such devices. Further the laboratory assistants to whom this training is usually given are included in the College of Technologists, an application recently approved by the Health Professions Council. Nurses, also regulated as a profession, are the other candidates for training in Point of Care Testing.

This situation is quite different from a pharmacy practice, in which a pharmacist would delegate the testing, likely to a pharmacy assistant or other personnel. The whole mechanism of expert direction, technologist expertise, and documented training would be lacking. This does not serve the public well...When staff are inadequately trained, and ongoing supervision and control is not exercised over the performance of testing, even these "simple" instruments have had significant problems and errors which are of a magnitude to influence clinical decision making. The DAP Guideline for Point of Care Testing is appended for your perusal. Specialist physicians (pathologists) are constantly engaged in fielding inquiries about the results and interpretations of common laboratory tests from doctors, nurses, and other health care professionals. On the basis of this experience, pathologists would support the view that pharmacists simply do not have the expertise to interpret the usual abnormalities of even the most common laboratory test in today's complex medical environment.

The BCSMLS submits its official position statement regarding Point-of-Care Laboratory Testing as well as the position statement of the Canadian Society for Medical Laboratory Science (CSMLS). Both the CSMLS and the BCSMLS endorse point-of-care testing where it enhances patient care and is under the supervision of qualified medical laboratory technologists. The BCSMLS adds:

..the following criteria should be met:

1. Maintenance, calibration and quality control of instruments must be under the supervision of certified Medical Laboratory Technologists wherever testing is performed.

2. Where procedures are already in place for testing to be performed by staff other than certified Medical Laboratory Technologists, Technologists must remain responsible for interpretation of quality control, maintenance, training and continuing education on these instruments.

The apparent simplicity of the instrumentation must not suggest that little or no technical expertise is needed to ensure accurate results.

The College’s 1995 submission was unclear with regard to the use of diagnostic and analytic test results by pharmacists and inclusion of this in their scope of practice. It has requested "obtaining diagnostic or analytic test results in accordance with previously approved written guidelines or protocols". Given its submission as a whole, which refers to use of these results, including point-of-care testing and the ability to initiate and monitor medication therapy, it is likely that what the College requested does not fall within pharmacists’ current scope of practice.

In its submission the BC Association of Laboratory Physicians (BCALP), medical doctors with specialty certification in laboratory medicine, comment with regard to pharmacists obtaining diagnostic or analytic test results:

The activities included under this heading involve the practice of medical laboratory technology and the practice of medicine. The delivery of these services involves the performance of two reserved acts:

    1) Making a diagnosis, identifying a disease, disorder or condition as the cause of signs or symptoms of the individual

    2) Performing the following physically invasive or physically manipulative acts:

      a. procedures on tissue below the dermis, below the surface of a mucous membrane, in or below the surface of the cornea, in or below the surfaces of the teeth, including the scaling of the teeth

Although the applicant’s summary might suggest that the pharmacists only propose to perform test procedures, the explanatory text shows that they do not intend to limit themselves to test performance. Phrases like "t; offer a diagnosis", determine if they have iron deficiency anemia offer definitive advice (about iron deficiency anemia) to the patient indicate they intend to diagnose and treat health conditions.

The Council concurs with the submission of the BCALP. Diagnosis is the foundation upon which all of the other reserved acts rest. Other reserved acts either flow from diagnosis as treatment or assist in establishing a diagnosis. Use of diagnostic test results is not supported by evidence of pharmacists’ education and training as practitioners with the ability to diagnose. It may represent advanced pharmaceutical practice, in certain limited circumstances, or it may refer to a delegated medical act, under the category supervised (or delegated) acts. In either case, it falls outside of pharmacists’ general scope of practice and would not be appropriate for inclusion in a scope statement which is intended to assist the public and other health professionals in understanding what the profession is trained to do.




c. initiating or modifying medication therapy in accordance with previously approved written guidelines or protocols

This specific request more properly falls within the reserved acts section of this report and will be discussed there.

3. Conclusion

The Council believes that it is not necessary or useful to itemize every facet of a profession's scope of practice. Rather, a scope of practice definition should be sufficiently descriptive so that other health professions and members of the public alike can understand what the particular health professional does.

The Council carefully reviewed the 1995 brief, the 1999 addendum, the current scope of practice of pharmacy in other provinces, and the responses to the consultation process. The 1999 addendum was largely a request for expanded practice and reserved acts related to prescription and administration of drugs. Prescription and administration of drugs will be dealt with in the reserved acts section of the report. The Council recognizes pharmacists’ role in advising and monitoring drug therapy in conjunction with the more traditional function of compounding, dispensing and sale of drugs and related devices.

Therefore, the Council recommends the following scope of practice for pharmacists:

The practice of pharmacy is the compounding, dispensing and sale of drugs monitoring drug therapy and advising on therapeutic values, contents and hazards of drugs and devices and identification, assessment and recommendations to prevent or resolve drug related problems.




B.    RESERVED ACTS

The rationale underlying the granting of reserved acts is to protect the public by limiting provision of those particularly dangerous acts to members of specific professions who are qualified to perform them. Only those acts which present a significant risk of harm will be reserved. The Council developed a list of reserved acts, and included it in a report it issued in July 1998, the Shared Scope of Practice Model Working Paper (Working Paper). As a result of the responses and consultation process the list has been revised from time to time. The current list is attached as Appendix B.




1. 1995 Proposal for Reserved Acts

The Council emphasizes there are no exclusively reserved acts. Each profession which requests any reserved act is considered individually on its own merits and without regard to whether any other profession has been granted the same reserved act. In its 1995 submission, the College proposed the following four functions to be reserved for pharmacy with "joint exclusivity" with other specified professions.

  • dispensing all prescription medications
  • distributing all limited-access medications (nonprescription medication products which must be sold from the Dispensary Area of licensed pharmacies)
  • providing nonspecific and patient-specific drug information and medication counselling
  • developing and implementing medication therapy policies, drug utilization review programs, and prescribing guidelines.

The first two of the College's requests for reserved acts (dispensing all prescription medications and distributing all limited-access medications) fall within the Council's reserved act #5:Prescribing, compounding, dispensing or administering by any means a drug listed in Schedule I or II of the Pharmacists, Pharmacy, Operations and Drug Scheduling Act. These two reserved acts are currently within pharmacists’ scope of practice and the Council agrees that they should be granted non-exclusively to pharmacists.

The third and fourth proposed reserved acts do not appear to carry a significant risk of harm, nor has the College provided evidence or documentation to indicate such risk. While these activities are properly included in pharmacists’ scope of practice, there is no need to include such activities in the reserved acts list.




2. 1999 (Addendum) Proposal for Reserved Acts

In its addendum of September 7, 1999, the College requests three additional reserved acts which are detailed below. The College states that the profession of pharmacy continues to experience major shifts in its focus moving from a product-oriented practice to a patient care practice. The focus on direct patient care is reflected in the College’s Framework of Professional Practice which replaces the Statement of Competencies referred to in the College’s 1995 submission. The College states that the Framework of Professional Practice describes the roles, functions and activities performed by competent pharmacists.

The College proposes the following three reserved acts for pharmacists:

  1. Administering medications, including parenteral, intradermal, subcutaneous, intramuscular and intravenous injections.
  2. Performing screening and monitoring procedures using pharmacy-based laboratory tests, including the associated quality control functions, and interpreting and communicating the results.
  3. Selecting, recommending and initiating the drug therapy, dose and route of administration when a qualified practitioner has made a diagnosis.

The College also states that pharmacists can serve the public by advocating and providing immunization in programs such as the following which is included in the College’s proposed reserved act 1:

Promoting pharmacist-coordinated pneumonia and/or influenza vaccination programs in community pharmacies and other ambulatory care settings.

Providing pharmacy-based immunizations for international travel.

Using influenza vaccination programs as an opportunity for conducting prospective, comprehensive immunization screening.

As supporting rationale for its position, the College cites Pharmaceutical Care as a means of clarifying and expanding the pharmacists' role in the health care system of the next century. The 1995 submission uses a definition of Pharmaceutical Care from Hepler and Strand as follows:

Pharmaceutical Care is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. These outcomes are (1) cure of a disease, (2) elimination / reduction of a patient's symptomatology, (3) arresting or slowing of a disease process, or (4) preventing a disease or symptomatology.

Pharmaceutical care involves the process through which a pharmacist co-operates with a patient and other professional in designing, implementing, and monitoring a therapeutic plan that will produce specific therapeutic outcomes for the patient. This in turn involves three major functions: (1) identifying potential and actual drug-related problems, (2) resolving actual drug-related problems, and (3) preventing potential drug-related problems.

61b1103} InfoTip=Stores your documents, graphics, and other files. e's 1999 brief quotes a 1997 statement from the World Health Organization (WHO), in conjunction with the International Pharmaceutical Federation, which acknowledged that:

Pharmacists all over the world are the most numerous and easily accessible health outlets for the general public. Trained in public health questions, with long experience of entering into dialogue with and providing education and information to the general public, pharmacists are well placed to participate in health education and prevention campaigns.

As health professionals, they are in permanent contact with decision-makers in the epidemiological, diagnostic and therapeutic fields they participate in the actual treatment and follow-up on patients, and they make a major contribution to the collection, analysis and communication of health data.

The College of Physicians and Surgeons of BC (CPSBC) responds to the College as follows:

The International Pharmaceutical Federation statement, notwithstanding its publication in association with the WHO, makes dubious claims that are not supported by strong, clear evidence. It is very doubtful whether "pharmacists all over the world are the most numerous and most easily accessible health care outlets". It is also very doubtful whether "they are in permanent contact with decision makers in the epidemiological, diagnostic and therapeutic fields". Furthermore, because pharmacists may "participate in the actual treatment and follow up on patients" and may contribute to the "collection, analysis and communication of health data", it does not follow that the proposed expansions of scope of practice are justified .




a. Administering Medications

With respect to administering medications, the College states that pharmacists are well positioned to take on the new role of administering medications because their knowledge of pharmacology and therapeutics and their ability to identify and resolve drug-related problems are an integral part of their training, standards and practice. The College further states that pharmacists routinely anticipate adverse drug reactions and monitor the outcomes of medication therapy.

The College states that currently 31 pharmacy regulatory boards in the United States have granted pharmacists the authority to administer medications and/or immunizations through their definition of the terms "practice of pharmacy" or "dispense". The College argues that with certain modifications to the existing PharmaNet system, pharmacists could maintain immunization profiles within the current patient record.

The College also argues that pharmacists can play a key role in other types of medication administration such as the administration of parenteral nutrition solutions.

The College states that pharmacists who offer medication administration programs will comply with current accepted guidelines and recommendations recognized by health care providers involved with medication administration. Pharmacists will also follow algorithms for the medication administration, including obtaining a patient history and consulting with previous medical providers.

Comments of respondents to the consultation process regarding this reserved act will be consolidated at page 25 with comments on "selecting, recommending and initiating drug therapy", as they overlap significantly.




b. Performing Screening and Monitoring Procedures

With respect to performing screening and monitoring procedures, the College states that since pharmacists are "closest to home", they have the potential to serve as the source of useful screening and monitoring programs, which could offer long-term benefits to patients and the health care system. The College states it is prepared to ensure that pharmacists evaluate the accuracy and reliability of any tests and testing equipment used in the process of monitoring their patients. It then cites the following examples of screening and monitoring procedures:

  • Blood pressure screening and monitoring.

  • Cholesterol measurement.

  • Blood glucose testing.

  • Pregnancy testing.

  • Hemoglobin assessment.

  • Other services such as PSA marker tests (for prostate cancer), H.pylori tests and osteoporosis marker tests.

The College emphasizes the need for a team approach composed of physicians, pharmacists and patients. Physicians need to be informed of results while pharmacists need to ensure that patients are provided with copies of self-care monitoring measures and are encouraged to seek medical evaluation when appropriate.

The Manitoba Pharmaceutical Association (MPA) states that the proposed examples of screening and monitoring procedures are consistent with guidelines established in Manitoba. However, the MPA argues that the pharmacist must have additional training to perform and interpret results, or have trained personnel on site. It states that if follow-up and referral is not included in the listed screening procedures it will not amount to enhanced patient care.

The BC Association of Laboratory Physicians (BCALP) states:

The application provides some specific instances where public harm might result. The section on hemoglobin assessment was particularly worrisome. There are many causes of low hemoglobin, of which iron deficiency is but one. The approach outlined by the pharmacists is dangerous as it could delay appropriate investigation and treatment of the cause of the anemia (e.g. occult malignancy, bleeding ulcer). Serious treatable conditions may well be masked by supplemental iron therapy precluding early diagnosis and cure of potentially life threatening lesions. Iron deficiency in males of any age and postmenopausal females warrants investigation for blood loss, which usually arises from the gastrointestinal tract and may be the first sign of a malignant tumor or ulcer. In addition, the comment about hemoglobin assessment shows little insight into the nature of iron deficiency. Body depletion of iron stores occurs before anemia develops. Many Canadian women or children may have symptomatic iron deficiency without anemia. The pharmacist who uses the hemoglobin level to determine the need for iron supplementation could very well cause harm. Another concerning example is that of cholesterol testing. As cholesterol is but one risk factor for atherosclerosis, a high-risk patient who receives a good cholesterol reading at a pharmacy may falsely conclude that their atherosclerosis risk is low.

The College of Physicians and Surgeons of BC (CPSBC) states that the performance of pharmacy based laboratory tests for screening and monitoring purposes is not advisable and not in the public interest.

The CPSBC also has a concern with the limited ability of pharmacists to interpret test results that often require consideration of multiple factors, by a physician, to properly evaluate their significance. It states that pharmacists are not qualified to fully interpret the medical significance of results. The CPSBC then makes specific comments about the listed examples:

  • Blood pressure measurements: The CPSBC states the pharmacists’ ability to make an accurate reading is not sufficient to competently interpret possible medical significance of a particular reading or give appropriate advice. Advice and evaluation of this measurement requires medical confirmation.
  • Cholesterol measurement: The CPSBC states that as a "stand alone" test, cholesterol measurement is doubtful.
  • Blood glucose monitoring: The CPSBC states this is best done by the patients themselves but sees no reason why pharmacist cannot assist those who do not have the capability to test themselves,
  • Pregnancy: The CPSBC states that most women prefer to do this themselves but again, sees no reason why a pharmacist cannot assist.
  • Hemoglobin assessment: The CPSBC reiterates its comment on the limited ability of pharmacists to appraise the significance of results.
  • Other services: The CPSBC states that PSA marker tests alone carry the risk of false reassurance that H.pylor tests are only a minor part of the total diagnostic work-up of patients and that the evaluation of osteoporosis is complex and controversial and beyond pharmacists’ capabilities.

In sum, the CPSBC states that the tests by themselves are inadequate and interpretation and advice by a pharmacist are insufficient. Additionally, it states that there could be increased costs to the public as issues of conflict of interest need to be addressed. Specifically, pharmacists stand to profit from the sale of products they prescribe or recommend on the basis of the tests they carry out themselves.

The Council has commented in this report at pages 13 to 17 about the use of diagnostic or analytic test results and physical assessment. The submissions have indicated that the use of laboratory data, performance of tests and physical assessment by means of blood pressure and other monitoring procedures are not currently included in the education and training of pharmacists. The Council has concluded at page 17 that all of these tests are adjunct to the reserved act of diagnosis which pharmacists are not trained to perform.




c. Selecting, Recommending and Initiating Drug Therapy

Finally, with respect to selecting, recommending and initiating drug therapy, the College refers to its 1995 submission and its proposal to "recognize the initiation and modification of drug therapy in accordance with previously approved written guidelines or protocols". The College states that it has since been determined that the authority for this activity exists in the current legislation in section 31(2)(b) of the PPODSA. The full section provides as follows:

Terms of a prescription

31 (1) A registrant must not dispense a prescription drug or device in any manner or in a quantity that is not authorized in the prescription unless the change is permitted by subsection (2) or section 30.

(2) A registrant may dispense a drug or device contrary to the terms of a prescription

  1. if the prescription quantity of the drug or device does not conform to available package sizes,
  2. if it is within the specifications established under a therapeutic interchange program or protocol approved by the governing body of a hospital or by the council,
  3. if it within the specifications established under a protocol intended to optimize the therapeutic outcome of treatment with the prescribed drug or device that has been approved by the council, or
  4. if the variance is permitted for professional reasons described in the bylaws.

The College states that section 31(2)(b) provides for the authority to establish collaborative drug therapy agreements which are signed by the relevant practitioners (physicians, dentists) and by pharmacists. These collaborative agreements will give pharmacists authority to do things such as initiating drug therapy. The agreements will usually include a mechanism for reporting back to the practitioner.

The College states its Council has recently approved the first collaborative drug therapy protocol, and other pharmacists are being encouraged to consider using the existing authority to enhance their ability to provide service to patients and assistance to other health professionals.

The Council questions the College’s interpretation of section 31(2)(b) as granting pharmacists the authority to prescribe or administer drugs. Section 31(2) refers to dispensing. According to information provided to the Council as a result of the consultation process, pharmacists are not trained and educated to prescribe or administer drugs by any means.

The College further states that the BC Minister’s Health Advisory Council on Women’s Health, the BC Women’s Hospital and Health Care Centre, and the Society of Obstetricians and Gynecologists of Canada contacted the College to discuss women’s access to emergency contraception. The College states that some organizations specifically requested that the College implement a process whereby women could obtain emergency contraception directly from pharmacists without a physician’s prescription. This prompted the College to seek amendments to the PPODSA that would allow independent prescribing of drugs listed in a schedule regulation to the PPODSA. The College therefore proposes that the Council recommend appropriate changes to the definition of the practice of pharmacy.

In conclusion, the College states that its Council would need to develop guidelines and procedures to address the expanded clinical functions of pharmacists so that adequate supervision can be maintained. This development of standards of patient care will involve representatives from the professions which currently possess independent prescribing authority. Finally, the College states that pharmacists will need to know their scope of practice that specific training in the new function areas will be required as well as adequate legal definition and realistic standards of practice, in order to assess the performance of individual practitioners.




3. Second Consultation Process

Upon receipt of the College's additional proposal for reserved acts, the Council conducted a second consultation process, in the fall of 1999. Several respondents support the proposals. Those supporting include Dr. Reginald E. Smith, Clinical Pharmacist, who suggests that the College establish a certifying process where advanced training is recognized and required for wider drug prescribing privileges.

Others support the proposals with some qualifications. The Alberta Pharmaceutical Association (APhA) generally supports the College's proposals and commented that the APhA council has recently approved a competency-based program for pharmacists administering parenteral medications and also guidelines for pharmacists involved in sale of and counselling about point-of-care testing products. AphA is also concerned about the lack of discussion of sexually transmitted diseases and AIDS when BC pharmacists dispense post-coital contraception and encourages BC pharmacists to address this issue.

The Manitoba Pharmaceutical Association (MPA) supports the proposals but states that a pharmacist’s ability to administer the listed forms of injections vary greatly with the individual pharmacist. The MPA suggests to separate this proposed addition into two categories: invasive and non-invasive administration. Pharmacists who want to perform invasive administration would require additional training and knowledge to perform the function and also to manage any emergent critical patient response. The MPA agrees that pharmacists’ accessibility is a key component to overall patient care.

The MPA points out that there has been a trend to move certain prescription items to non-prescription status by the federal government. Once a medication is non-prescription, many governments and third party payers de-list the medication as a product covered under the "drug program". The MPA states this tends to devalue the medication and the pharmacists’ involvement in treatment plans and does not necessarily accomplish decreased care costs. The patient will still attend the practitioner’s office and challenge the prescriber to issue an order for "something covered". The MPA states that it is therefore important to recognize the role of the pharmacist.

The majority of responses to the College's 1999 proposal for reserved acts comment on the lack of evidence of education and training of pharmacists to perform those reserved acts, with the exception of dispensing prescription medications. Respondents in this category include the College of Physicians and Surgeons of BC (CPSBC), the Diagnostic Accreditation Program (DAP), the BC Medical Association (BCMA), the Registered Nurses Association of BC (RNABC), the BC Society of Laboratory Science (BCSLS), Manitoba Health and the Nova Scotia Department of Health (NSDOH). The latter points out:

...two elements of the proposed additions to the scope of practice require competencies not specified in the National Association of Pharmacy Regulatory Authority's Professional Competencies for Canadian Pharmacists at Entry to Practice . They are:

-Performing physical assessment relating to the initiation or monitoring of drug therapy (proposed in January 1996) and

-Administering medication, including parenteral, intradermal, subcutaneous, intramuscular and intravenous injections (proposed in September 1999).

The CPSBC is strongly opposed to expansion of the pharmacist’s role in selecting, recommending and initiating drug therapy by way of proposed amendments to the PPODSA. The CPSBC argues that while it supported the issue of emergency contraception by allowing pharmacists to dispense the medication without prescription, it does not justify the quantum leap to permitting the College to unilaterally add other drugs to an independent prescribing schedule. The CPSBC states:

  • Pharmacists should not be permitted to independently administer medications by injections as this would significantly increase risk to the public as pharmacists are not qualified to deal with serious potentially fatal reactions that not uncommonly occur. If pharmacists are allowed to administer medications by injections, there should be very clear definition of what they can and cannot administer without prior approval of a physician.
  • Any immunization activity by pharmacists should only be under the direction of the public health officer.
  • Intravenous administration of "nutrition solutions" in a home-care setting should be under the direction and supervision of a physician with the assistance of a home-care nurse. The CPSBC does not believe pharmacists have the practical training and experience to achieve the minimum level of competence that should be considered necessary in the public interest.

The BC Medical Association (BCMA) states there is no evidence that patient health care would be enhanced by the administration of medications by pharmacists. It contends that the goal of assuring continuity of care is unlikely to be achieved by introducing a further health care professional. It also argues that administering medications through the listed forms of injections has been part of the training of nurses and physicians, but not that of pharmacists.

The BCMA further states that concerns have been raised regarding pharmacists’ ability and education to respond appropriately to an adverse drug reaction. Also, it is unclear if pharmacists will develop treatment rooms on the premises of drug stores, and whether facilities would be available for the patients to recover after administration of the medication. The BCMA questions the claim of easy accessibility of pharmacists if they were to administer medication in separate rooms. The BCMA raises other concerns such as liability, insurance and the on-call availability of a pharmacist to deal with the sequelae of his/her ministrations.

While the College has used the term "in accordance with preapproved protocols and procedures", it appears that the College is requesting a type of independent practice, unsupervised by other health practitioners. There has been no evidence of formal training or certification for advanced practice in these reserved acts. Nor is there any evidence of an objective measure of competency for pharmacists who would perform these reserved acts. The Ph.D. program at UBC includes advanced competencies in some of the areas requested by the College, however there appears to be no certification or competency monitoring in place for evaluating the continuing competency of these graduates. In addition, it appears that the College is advocating that all of its members would be qualified to practice these reserved acts in community pharmacies.

The College has submitted its Framework of Professional Practice (FPP) which describes the roles, functions and activities performed by competent pharmacists. The FPP links to the Professional Competencies for Canadian Pharmacists at Entry to Practice. This Professional Competencies document has been adopted by ten Canadian pharmacy regulatory organizations. The College states that the FPP is the foundation document for all entry-level and continuing competency assessment activities administered by the College.

The College also submitted its plans for developing a C.A.R.E. (Continuing Assessment, Reflection and Enhancement) Program which was anticipated to replace and expand the Quality Assurance (QA) Program. The primary focus of the C.A.R.E program appeared to be toward developing a self-assessment tool for pharmacists to monitor their own practices and to report back to the College. Unfortunately, the College has not provided any follow up on this initial information provided to the Council in 1996 when the C.A.R.E. program was in the planning stages.

The College has indicated that there are advanced practitioners of pharmacy in certain clinical and hospital pharmacies in Canada. As well, in the U.S. there are advanced pharmacy practitioners who diagnose, prescribe and administer medications.

Professional pharmacist organizations in Canada have supported this concept. The Faculty of Pharmaceutical Sciences supports expanded practice and Pharmaceutical Care and is willing to expand the curriculum to provide education and training in the advanced practice areas.

If the College is requesting that pharmacists be delegated reserved acts from physicians or other health professionals who are granted THOSE reserved acts, that would fall under the supervised (or delegated) acts principles. At least three respondents supported this position: The Nova Scotia Department of Health (NSDOH), the Health Association of BC (HABC), and the College of Physicians and Surgeons of Manitoba (CPSM).

However, if the College is requesting that a form of advanced pharmacy practitioner be allowed to independently initiate and perform those reserved acts, there must be evidence of uniform training beyond the basic pharmacy curriculum, as well as objective evidence of competency which is formally assessed, established and accepted by the College as well as the profession of pharmacy, including uniform standards of practice, none of which have been provided to the Council.

Without evidence of an existing program to assure continuing competency for those practitioners who are already practising in an expanded role within certain institutions, the Council cannot recommend granting reserved acts to pharmacists on the assumption that formal competency assurance and training programs will be developed at some future time.




4. Conclusion

The supervised acts principles will apply until such time as independent practice of pharmacists in this area is developed to the point where there is sufficient uniform education, training, and competency monitoring to ensure public safety. Physicians may continue to delegate reserved acts pursuant to established protocols in the limited circumstances where it would be appropriate for pharmacists to perform the reserved acts requested: initiation, administration, or modification of drug therapy.

The Council has concluded that the following reserved act is currently within the documented competency of members of the College.

Therefore, the Council recommends that compounding or dispensing a drug listed in Schedule I or II of the Pharmacists, Pharmacy, Operations and Drug Scheduling Act be granted to members of the College of Pharmacists. For the purposes of this reserved act, the following definitions shall apply:

"compounding": mixing ingredients, at least one of which is a drug.

"Dispensing": preparing or filling a prescription for drugs.




C.     SUPERVISED ACTS

The Criteria and Guidelines attached to the Terms of Reference state that although reserved acts may only be performed by professions to whom they have been specifically granted, it may be appropriate for other persons to perform them or aspects of them, under the supervision of members of those professions. The Criteria and Guidelines also indicate that where Council is satisfied that a reserved act may be performed under supervision it may recommend training and qualification requirements, limitations regarding where the act may be performed and the degree of supervision required.

The College proposes no change to the current regulations which allow pharmacists to supervise pharmacy technicians to perform the preparatory and distributive functions of dispensing pharmaceuticals.

Therefore, the Council recommends that a provision be enacted which deals with general principles regarding delegation of reserved acts. The provision would apply generally, not to individual cases. It should require the following:

  • The assigning health professional's governing body must provide assent to the proposed reserved act being performed by someone else
  • The reserved act to be assigned as well as the level of supervision must be clearly defined and circumscribed by the assigning health professional's governing body
  • Where the person to whom the act will be assigned is a member of a self-regulated health profession, his or her governing body must approve of the assignment
  • The instruction to perform the act must be made in writing either by way of a general written protocol or through a case-specific instruction
  • The assigning health professional must be satisfied that the individual who will be performing the act has the necessary skills and training to perform the act safely
  • The assigning health professional must ensure that the person who will be performing the act accepts the assignment.




D.     RESERVED TITLES

Reserved titles are titles reserved exclusively to a health profession. Reserved titles afford a means for consumers to identify the different types of health care providers, to distinguish the qualified from the unqualified, and to differentiate those practitioners who are regulated from those who are not. Titles must adequately serve the public in describing the practitioner and the services being provided and must distinguish the practitioner from others performing services outside the jurisdiction of the college.

The College proposes no change to section 21(1)(d) of the PPODSA which reserves the following titles for use by pharmacists:

  • Chemist

  • Pharmaceutical chemist

  • Druggist

  • Apothecary

  • Pharmacist

  • R.Ph.

  • R.Pharm.

Most respondents did not question the titles currently reserved for pharmacists with the exception of the title "chemist". A number of respondents including the College of Physicians and Surgeons (CPSBC), the BC Society of Medical Technologists (BCSMT) and New Brunswick Health and Community Services felt that "chemist" was misleading and restrictive, since there are other professional groups that use this title.

The BCSMT suggests using "chemist" only in conjunction with "pharmaceutical".

In Ontario, the following titles and any abbreviation or variation thereof are reserved:

  • apothecary

  • druggist

  • pharmacist

  • pharmaceutical chemist

The Council accepts that reservation of the title "chemist" may be misleading to the public.

Therefore, the Council recommends the following titles or abbreviations thereof be reserved for members of the College of Pharmacists of BC:

  • Apothecary

  • Druggist

  • Pharmacist and

  • Pharmaceutical Chemist.




IV.     RECOMMENDATIONS

  1. The Council recommends the following scope of practice statement for pharmacists:
  2. The practice of pharmacy is the compounding, dispensing and sale of drugs monitoring drug therapy and advising on therapeutic values, contents and hazards of drugs and devices and identification, assessment and recommendations to prevent or resolve drug related problems.

  3. The Council recommends that compounding or dispensing a drug listed in Schedule I or II of the Pharmacists, Pharmacy, Operations and Drug Scheduling Act be granted to members of the College of Pharmacists. For the purposes of this reserved act, the following definitions shall apply:
  4. "compounding": mixing ingredients, at least one of which is a drug.

    "dispensing": preparing or filling a prescription for drugs.

  5. The Council recommends that a provision be enacted which deals with general principles regarding delegation of reserved acts. The provision would apply generally, not to individual cases. It should require the following:
    • The assigning health professional's governing body must provide assent to the proposed reserved act being performed by someone else
    • The reserved act to be assigned as well as the level of supervision must be clearly defined and circumscribed by the assigning health professional's governing body
    • Where the person to whom the act will be assigned is a member of a self-regulated health profession, his or her governing body must approve of the assignment
    • The instruction to perform the act must be made in writing either by way of a general written protocol or through a case-specific instruction
    • The assigning health professional must be satisfied that the individual who will be performing the act has the necessary skills and training to perform the act safely
    • The assigning health professional must ensure that the person who will be performing the act accepts the assignment.

  6. The Council recommends the following titles or abbreviations thereof be reserved for members of the College of Pharmacists of BC:
    • Apothecary

    • Druggist

    • Pharmacist and

    • Pharmaceutical Chemist.