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PSSA Legislation Webinar Series

WEBINAR EPISODE 3

THURSDAY

1 OCTOBER 2020

19:00

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Mariet Eksteen, MPharm, PCDT, PhD (HPE)

PSSA Professional Development and Support

[email protected]

SCOPE OF PRACTICE

AND DUTIES OF

PHARMACISTS,

INTERNS AND

RESPONSIBLE

PHARMACISTS

mailto:[email protected]

Content

3

This Webinar will cover:

• Scope of practice of a pharmacist, pharmacist intern and community service pharmacist

• Supervision of pharmacy support personnel

• Categories of pharmacies where services may be provided

• Conditions under which a pharmacy shall be conducted

• Services for which a pharmacist may levy a fee and guidelines for levying such a fee or fees

• Authority, duties and responsibilities of responsible person*

• Supplementary training or refresher courses

• Registration of specialities of Pharmacists

Content

4

This Webinar will cover the following legislation:

• Regulations relating to the Practice of Pharmacy (GNR 1158 of 20 November 2000)

• Scopes of practice: Regulation 2-6

• Supervision of PSP: Regulation 14-15

• Pharmacies: Regulation 16-19

• Conditions under which pharmacy shall be conducted: Regulation 20-23

• Managing person: Regulation 24-28

• Regulations relating to the performance of pharmaceutical community service (GNR 1157 of 20 November

2000)

• Rules relating to the services for which a pharmacist may levy a fee and guideline for levying such a fee or fees

(BN 27 of 6 March 2020)

• Regulations relating to supplementary training or refresher courses to be undergone or taken by persons who

are registered in terms of the Pharmacy Act, 1974, and the provision and control over such training and

courses (GNR 1138 of 4 August 1995).

• Regulations relating to the registration of the specialities of pharmacists (GNR 2342 of 5 October 1990)

Disclaimer

I’m not the expert, but I’m willing to collaborate and serve the profession.

Emphasis (red text and yellow highlight) is my own.

Scope of practice of a pharmacist (1)

2. Conditions under which services or acts must be provided or

performed.—The services or acts pertaining to the scope of practice of natural

persons registered in terms of the Act must be provided or performed in

accordance with the Medicines Act and good pharmacy practice and a code of

conduct as published by council in rules.

Department of Health. 2000. Regulations relating to the practice of pharmacy. GNR 1158 of 20 November 2000.


2. Conditions under which services or acts must be provided or

performed.—The services or acts pertaining to the scope of practice of natural

persons registered in terms of the Pharmacy Act must be provided or performed

in accordance with the Pharmacy Act and the Medicines Act [and good pharmacy

practice and a code of conduct as published by council in rules].

Draft regulations out for comment: Department of Health. 2019. Regulations relating to the practice of pharmacy: Amendment Regulations.

Government Gazette 43418, Nr 657 of 12 June 2020.

Scope of practice of a pharmacist (3)3. Acts specially pertaining to the profession of a pharmacist.—Except as provided for in section 29 (3) of the Pharmacy Act,

and sections 23(2)(a)(i) and 34 of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982), the following acts shall be

regarded to be acts specially pertaining to the profession of a pharmacist—

(1) the provision of pharmaceutical care by taking responsibility for the patient’s medicine related needs and being accountable for

meeting these needs, which shall include but not be limited to the following functions:

(a) evaluation of a patient’s medicine related needs by determining the indication, safety and effectiveness of the therapy;

(b) dispensing of any medicine or scheduled substance on the prescription of a person authorised to prescribe medicine;

(c) furnishing of information and advice to any person with regard to the use of medicine;

(d) determining patient compliance with the therapy and follow up to ensure that the patient’s medicine related needs are being met;

and

(e) the provision of pharmacist initiated therapy;

(2) the compounding, manipulation, preparation or packaging of any medicine or scheduled substance or the supervision thereof;

(3) the manufacturing of any medicine or scheduled substance or the supervision thereof;

(4) the purchasing, acquiring, importing, keeping, possessing, using, releasing, storage, packaging, repackaging, supplying or selling of any

medicine or scheduled substance or the supervision thereof; and

(5) the application for the registration of a medicine in accordance with the Medicines Act.



4. Scope of practice of a pharmacist.—The following services or acts shall forpurposes of the Pharmacy Act be regarded to be services or acts pertaining to the scope ofpractice of a pharmacist:

(1) the [Acts]acts specially pertaining to the profession of a pharmacist asprescribed in regulation 3;

(2) the formulation of any medicine for the purposes of registration as a medicine;

(3) the distribution of any medicine or scheduled substance;

(4) the repackaging of medicines;

(5) the initiation and conducting of pharmaceutical research and development; and

(6) the promotion of public health.


Scope of practice of a pharmacist intern (1)

5. Scope of practice of a pharmacist intern.—A pharmacist intern may

provide or perform all of the services or acts pertaining to the scope of practice of

a pharmacist’s assistant registered in the category pharmacist’s assistant (post-

basic) under the direct personal supervision of a pharmacist in a pharmacy.

6. A pharmacist intern may, for the purposes of education and training, provide

or perform all of the services or acts pertaining to the scope of practice of a

pharmacist under the direct personal supervision of a pharmacist in a pharmacy.


Scope of practice of a pharmacist intern (2)

5. Scope of practice of a pharmacist intern.—A pharmacist intern may

provide or perform all of the services or acts pertaining to the scope of practice of

a pharmacist’s assistant registered in the category [pharmacist’s assistant (post-

basic)] pharmacy technician under the direct personal supervision of a

pharmacist [in a pharmacy].

6. A pharmacist intern may, for the purposes of education and training, provide

or perform all of the services or acts pertaining to the scope of practice of a

pharmacist under the direct personal supervision of a pharmacist in a pharmacy.



Performance of community service

“pharmaceutical community service” means the provision of services or the

performance of one or more or all of the acts forming part of the scope of

practice of a pharmacist in a public health facility or a complex of health facilities

in accordance with these regulations;

Department of Health. 2000. Regulations relating to the performance of pharmaceutical community service. GNR 1157 of 20 November 2000.

Supervision of pharmacy support personnel (1)

14. Supervision of pharmacy support personnel.—A pharmacist may

not—

(1) have under his or her direct personal supervision more than three

pharmacists’ assistants in a pharmacy; or

(2) subject to regulation 12, have more than five pharmacists’

assistants (post-basic) under his or her indirect personal supervision.


Supervision of pharmacy support personnel (2)

14. Supervision of pharmacy support personnel and pharmacist interns

(1) A pharmacist may have a maximum of five pharmacy support personnel under his or her supervision:Provided that –

(a) the pharmacist has no more than three pharmacist's assistants (learner basic), pharmacist's assistants(learner post- basic), pharmacy technicians (learner), or pharmacy technicians (trainee) under directsupervision; and

(b) a pharmacist who is the tutor to a pharmacist intern may have a maximum of four pharmacy supportpersonnel under his or her supervision of which only two may be pharmacist's assistants (learner basic),pharmacist's assistants (learner post -basic), pharmacy technicians (learner), or pharmacy technicians(trainee).

(2) A pharmacist who is a tutor of a pharmacist intern undergoing an internship at a provider of aneducation and training programme approved by the council for purposes of registration as a pharmacist,may act as tutor to a maximum of five such interns and no pharmacy support personnel.



Categories of pharmacies (1)

Chapter VI – Services which may be performed in the various categories of pharmacies

16. Manufacturing pharmacy

17. Wholesale pharmacy

18. Community or institutional pharmacy

19. Consultant pharmacy


Categories of pharmacies (2)Scope of practice / Acts pertaining to profession of

pharmacy

Manufacturing Wholesale Community /

Institutional

Consulting

the provision of pharmaceutical care by taking responsibility for the patient’s medicine

related needs and being accountable for meeting these needs*

(information and

advice)

(information and

advice)● ●

the compounding, manipulation, preparation or packaging of any medicine or

scheduled substance ●

the manufacturing of any medicine or scheduled substance ●

the purchasing, acquiring, importing, keeping, possessing, using, releasing, storage,

packaging, repackaging, supplying or selling of any medicine or scheduled substance*● ● ●

the application for the registration of a medicine in accordance with the Medicines Act ● ● ● ●

the formulation of any medicine for the purposes of registration as a medicine; ●

the distribution of any medicine or scheduled substance; ● ●

the repackaging of medicines ● ●

the initiation and conducting of pharmaceutical research and development ● ● ● ●

the promotion of public health ● ●

Provision of primary care drug therapy ●

Conditions under which a pharmacy shall be conducted

20. Conditions under which a pharmacy shall be conducted.—The services provided or actsperformed in the various categories of pharmacy shall be performed in accordance with—

(1) good pharmacy practice as published by council in rules; and

(2) the code of conduct as published by council in rules for pharmacists and other persons registeredin terms of the Pharmacy Act; and

(3) the provisions of applicable legislation.

21. Only pharmacists or pharmacist interns and pharmacist’s assistants under the direct personalsupervision of a pharmacist, may handle scheduled substances in a pharmacy.

22. Every pharmacy shall, except in such circumstances and subject to such conditions as may bepublished in rules by the council, be conducted under the direct personal supervision of a responsiblepharmacist whose name must be displayed conspicuously over the main entrance of such pharmacy.

23. The name of the pharmacist(s) on duty must be displayed conspicuously in the pharmacy for purposesof identification of such person(s) by the public.


Rules relating to the services for which a pharmacist* may levy a fee and guidelines for levying such a fee or fees (1)

1. A pharmacist may levy a fee or fees for one or more of the services that may be provided in the various categories of pharmacies as prescribed in

the Regulations relating to the practice of pharmacy (GNR.1158 of 20 November 2000), subject to the guidelines for levying such a fee as approved by the

Council from time to time.

2. A pharmacist who wishes to levy a fee or fees for the services referred to in Annexure B must comply with the provisions of these rules.

3. Services for which a pharmacist wishes to levy a fee or fees must be provided in accordance with Regulation 20 of the Regulations relating to the practice

of pharmacy (GNR.1158 of 20 November 2000).

4. Council may add services for which a fee or fees may be levied as listed in Annexure B to the Schedule from time to time. The fee that may be charged

for such a service may be based on a fee for a comparable service or procedure appearing in Annexure B.

5. A pharmacist must ensure, when a service for which he or she wishes to levy a fee or fees involves the supply of medicine, whether supplied on a

prescription or not, that the patient for whom such medicine is supplied is furnished with adequate advice or information for the safe and effective use of the

medicine(s) supplied by him or her, whether such medicine(s) is supplied personally (face-to-face) or by any other means.

6. Services for which a pharmacist may levy a fee or fees may not be advertised in any manner that—

(a) is not factually correct;

(b) is misleading;

(c) harms the dignity or honour of the pharmacy profession;

(d) disparages another pharmacist;

(e) is calculated to suggest that his or her professional skill or ability or his or her facilities or that of the pharmacy owner, as the case may be, for

practising his or her profession or rendering the service(s) concerned are superior to those of other pharmacists.

SAPC. 2020. Rules relating to the services for which a pharmacist may levy a fee and guidelines for levying such a fee or fees. BN 27 of 6 March 2020

(Government Gazette No. 43073)

Rules relating to the services for which a pharmacist* may levy a fee and guidelines for levying such a fee or fees (2)

7. A pharmacist may not tout or attempt to tout for services for which he or she wishes to levy a fee or fees.

8. A pharmacist may not levy a fee or fees for a service for which he or she is not trained or for which prior authorisation from the Council is required

before he or she may provide such service(s) until such authorisation is obtained. Acceptable documentary evidence of training, experience or

competence, must be provided if and when required by the Council, which could include but shall not be limited to—

(a) the successful completion of further education and training at a provider accredited by a competent authority; or

(b) practical experience gained under controlled circumstances and the mentorship of a competent person or authority; or

(c) the successful completion of continuing professional development (CPD) courses offered by a provider accredited by a competent authority.

9. A pharmacist may provide any one or more of the services referred to in Annexure B without levying a fee or fees.

10. A pharmacist who wishes to levy a fee or fees for the services referred to in Annexure B must inform patients regarding the fee to be levied prior

to providing any of the services listed in the schedule.

11. A pharmacist who wishes to levy a fee or fees for the services referred to in Annexure B must display a list of services and fees conspicuously in

the pharmacy.

12. A pharmacist who wishes to levy a fee or fees for the services referred to in Annexure B must indicate clearly on the invoice and/or receipt

provided, the service for which a fee is levied and the amount of the fee per service.

Guidelines for the levying of a fee or fees

13. The guidelines published herewith as Annexure A shall constitute the only guidelines for levying a fee or fees for any one or more of the services

referred to in Annexure B.

SAPC. 2020. Rules relating to the services for which a pharmacist may levy a fee and guidelines for levying such a fee or fees. BN 27 of 6 March 2020

(Government Gazette No. 43073)

Authority, duties and responsibilities of responsible person* (1)

24. Authority, duties and responsibilities of the nominee, managing director of a company or managerof a close corporation entitled to carry on the business of a pharmacist.—The nominee appointed as such for acompany or close corporation entitled to carry on the business of a pharmacist must—

(1) complete and submit the application forms approved and provided by council in respect of theregistration of the company or close corporation entitled to carry on the business of a pharmacist and ifapplicable, its pharmacy business;

(2) ensure that the company or close corporation which owns a pharmacy does not carry on the business of apharmacist without a managing director or manager, as the case may be;

(3) pay the applicable fees as determined by council in respect of the company or the close corporation and ifapplicable, its pharmacy business;

(4) furnish the information prescribed in terms of the Regulations Relating to the Registration of Persons andthe Maintenance of Registers; and

(5) ensure that there is compliance at all relevant times—

(a) with the requirements which entitled such company or close corporation to own a pharmacy; and

(b) with the conditions of registration of the pharmacy.



25. The managing director of a company or the manager of a close corporation entitled to carry on the business of a pharmacist must—

(1) undertake the overall administration of the pharmacy business, which includes but is not limited to the regulation of pharmacy matters, humanresources, or matters relating to processes regarding medicines or scheduled substances including procedures and record keeping and shall be responsibleto council for any act performed by or on behalf of such company or close corporation, including any omission to perform an act required to be performed byor on behalf of such owner which may involve disciplinary action by council, unless he or she can satisfy council that the responsibility for such act restsupon the nominee, responsible pharmacist or a pharmacist other than him-, or herself employed by such company or close corporation;

(2) ensure that there is compliance with good pharmacy practice as published by council in rules;

(3) ensure that a responsible pharmacist is appointed for each pharmacy wherein or from which the company or close corporation conducts business;

(4) be part of the decision making process affecting the pharmacy business;

(5) supervise every responsible pharmacist appointed by the owner of a pharmacy business, if applicable;

(6) ensure that the pharmacy owner complies with all the conditions of—

(a) ownership of such pharmacy business; and

(b) registration of the pharmacy; and

(7) ensure that no person is appointed to perform any act falling outside the scope of practice of the category in which such person is registered or whichhe/she is not authorised to perform in terms of the Act;

(8) report in writing any non-compliance with subregulations 25 (2), 25 (3), 25 (5) or 25 (6) to the management of such pharmacy business and furnishCouncil with a copy thereof; and

(9) not introduce or carry out any instruction or order from management with regard to the pharmacy business of the pharmacy owner which could amountto a contravention of legislation applicable to such pharmacy business.


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26. A pharmacist who owns a pharmacy as a sole owner shall have theduties and responsibilities as set out in regulations 24 and 25 of theseregulations relating to his or her pharmacy business.

27. A pharmacist designated in the partnership agreement of partnership ofpersons who owns a pharmacy shall have the duties and responsibilities as setout in regulations 24 and 25 of these regulations relating to such pharmacybusiness.

Handout 1: Department of Health. 2000. Regulations relating to the practice of pharmacy. GNR 1158 of 20 November 2000.


28. The responsible pharmacist contemplated in regulation 25 (3) must—

(1) ensure that he or she in fact continuously supervises the pharmacy in which he or she has been appointed;

(2) have appropriate qualifications and experience in the services being rendered by such pharmacy;

(3) ensure that persons employed in such pharmacy and who provide services forming part of the scope of practice of a pharmacist are

appropriately registered with council;

(4) notify council immediately upon receiving knowledge that his/her services as responsible pharmacist have been or will be terminated;

(5) take corrective measures in respect of deficiencies with regard to inspection reports of council or in terms of the Medicines Act; and

(6) in addition to the general responsibilities also—

(a) ensure that unauthorised persons do not obtain access to medicines or scheduled substances or the pharmacy premises outside of

normal trading hours;

(b) establish policies and procedures for the employees of the pharmacy with regard to the acts performed and services provided in the

pharmacy;

(c) ensure the safe and effective storage and keeping of medicine or scheduled substances in the pharmacy under his or her direct

personal supervision; and

(d) ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or

scheduled substances.

Handout 1: Department of Health. 2000. Regulations relating to the practice of pharmacy. GNR 1158 of 20 November 2000.

Supplementary training (1)

1. In this Schedule “the Act” means the Pharmacy Act, 1974 (Act No. 53 of 1974), and any expression to which a meaninghas been assigned in the Act shall bear such meaning and, unless the context otherwise indicates—

“primary care drug therapy” means the supplementary training to be undertaken by a pharmacist who wants to sell in hisown discretion to any person for personal use certain medicines listed in Schedule 3, Schedule 4 and Schedule 5, published withthe regulations in terms of the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), in accordance withthe provisions of that Act;

" `primary care drug therapy' means diagnosing a health need, prescribing and supplying of medicine to meet the health needof a patient or group of patients or, where necessary, the referral to another health care professional by a pharmacist who hasreceived the necessary authorisation from the council and is the holder of a permit issued in terms of the Medicines Act;"

“refresher course” means a course which keeps a registered person abreast of developments in a specific subject or subjectarea, knowledge of which was gained during the pre-registration period and which does not give a registered person additionalprofessional competency, powers or recognition but which the council may require a registered person to undergo;

“registered person” means a person registered in terms of the Act;

“supplementary training” means training approved in terms of section 33 (1) of the Act which gives a registered personadditional professional competency, powers or recognition in terms of the Act or any other law, and which, after successfulcompletion thereof and the payment of the prescribed registration fees, is entered in a register kept in accordance with section14 of the Act, and “supplementary training course” has a corresponding meaning.

Department of Health. 1995. Regulations relating to supplementary training or refresher courses to be undergone or taken by persons who are

registered in terms of the Pharmacy Act, 1974, and the provisions and control over such training or courses. GNR 1138 of 4 August 1995.


2. The following supplementary training courses and persons or educational

institutions that may offer such courses have been approved by the council for

the purpose of these regulations:

Family planning Department of Health

PU for CHE (North-West University)

UPE (Nelson Mandela University)

Primary Care Drug Therapy SAPC (certificate of favourable evaluation in PCDT)



Department of Health. 1995. Regulations relating to supplementary training or refresher courses to be undergone or taken by persons who are

registered in terms of the Pharmacy Act, 1974, and the provisions and control over such training or courses. GNR 1138 of 4 August 1995.


2. The following supplementary training courses and persons or educational

institutions that may offer such courses have been approved by the council for

the purpose of these regulations:

Family planning Department of Health



Primary Care Drug Therapy SAPC



SAPC 2020 List of accredited providers https://www.sapc.za.org/Media/Default/Documents/Updated%20list%20of%20providers%20-

%20November%202020.pdf

https://www.sapc.za.org/Media/Default/Documents/Updated%20list%20of%20providers%20-%20November%202020.pdf

Specialists of Pharmacy (1)

1. In these regulations “the Act” shall mean the Pharmacy Act, 1974 (Act No.

53 of 1974), and any expression to which a meaning has been assigned in the Act

shall bear such meaning and—

“register of specialists” shall mean the register referred to in regulation 3;

“specialist” shall mean a pharmacist whose speciality has been entered in the

register of specialists;

“speciality” shall mean one of the fields of pharmacy set out in regulation 2.

SAPC. 1990. Regulations relating to the registration of the specialities of pharmacists. GNR 2342 of 5 October 1990.

Specialist of Pharmacy (2)

2. The following specialities with the designation of the specialist indicated opposite each

are hereby prescribed in terms of section 28 (1) (b) of the Act:

Clinical Pharmacokinetics Clinical Pharmacokinetics

Radio-pharmacy Radio-pharmacist

https://www.pharmcouncil.co.za/HEI_Providers_Courses

SAPC. 1990. Regulations relating to the registration of the specialities of pharmacists. GNR 2342 of 5 October 1990.

https://www.pharmcouncil.co.za/HEI_Providers_Courses

Specialist of Pharmacy (3)

Anticipated specialist:

❑Clinical Pharmacist

❑Public Health

❑Industrial Pharmacist

Proposed specialists:

❑Pharmaceutical Supply Chain Specialist Working Group volunteers needed!

Conclusion

1. Each pharmacy must have a Law Compendium – keep it up to date!

2. Pharmacists has a UNIQUE and IRREPLACABLE scope of practice which cannot be delegated.

Be proud of your scope and deliver professional conduct of the highest standard.

3. Responsible pharmacist is called responsible for a reason!

4. Keep records and document incidents.

5. Thank you for being GREAT!