| 3.9.1 | Pharmacy human resources |
| 3.9.1.1 | Pharmacist's assistant (basic) |
A pharmacist's assistant registered in the category pharmacist's assistant (basic) may perform the following services or acts under the direct personal supervision of a pharmacist in a pharmacy:
| (a) | the sale of Schedule 1 medicines or scheduled substances; |
| (b) | assist with the compounding, manipulation or preparation of a non-sterile medicine or scheduled substance according to a formula and Standard Operating Procedures approved by the responsible pharmacist; |
| (c) | assist with the manufacturing of a non-sterile medicine or scheduled substance according to a formula and Standard Operating Procedures approved by the responsible pharmacist; |
| (d) | the re-packaging of medicine; |
| (e) | the distribution and control of stock of Schedule 1 to Schedule 5 medicines or scheduled substances; and |
| (f) | the provision of information to individuals in order to promote health. |
| 3.9.1.2 | Pharmacist's assistant (post-basic) |
A pharmacist's assistant registered in the category pharmacist's assistant (post-basic) may perform the following services or acts under the direct personal supervision of a pharmacist in a pharmacy:
| (a) | the sale of Schedule 1 and Schedule 2 medicines or scheduled substances; |
| (b) | assist with the compounding, manipulation or preparation of a non-sterile or sterile medicine or scheduled substance according to a formula and Standard Operating Procedures approved by the responsible pharmacist; |
| (c) | assist with the manufacturing of a non-sterile or sterile medicine or scheduled substance according to a formula and Standard Operating Procedures approved by the responsible pharmacist; |
| (d) | the re-packaging of medicine; |
| (e) | the distribution and control of stock of Schedule 1 to Schedule 6 medicines or scheduled substances; |
| (f) | the ordering of medicine and scheduled substances up to and including Schedule 6 according to an instruction of a person authorised in terms of the Medicines Act to purchase or obtain such medicine or scheduled substance; |
| (g) | the reading and preparation of a prescription, the selection, manipulation or compounding of the medicine, the labelling and supply of the medicine in an appropriate container following the interpretation and evaluation of the prescription by a pharmacist; |
| (h) | the provision of instructions regarding the correct use of medicine supplied; and |
| (i) | the provision of information to individuals in order to promote health. |
In terms of regulation 12 of the Regulations relating to the practice of pharmacy, a pharmacist's assistant registered in the category pharmacist's assistant (post-basic) may perform the acts or provide services as prescribed in (e), (f), (g), (h) and (i), as well as the reading and preparation of a prescription, the selection, manipulation or compounding of medicine and the labelling and supply of medicine in an appropriate container under the indirect personal supervision of a pharmacist: Provided that such indirect personal supervision will take place only under the following circumstances:
| (a) | the services are provided or acts are performed at a primary health care clinic or any other facility as approved by Council; |
| (b) | only re-packaged medicines or patient-ready packs are provided; |
| (c) | written and up-dated protocols and Standard Operating Procedures are available describing clearly the responsibility of the pharmacist's assistant and pharmacist under whose indirect personal supervision the pharmacist's assistant performs the acts and provides the services; and |
| (d) | the pharmacist under whose indirect personal supervision the pharmacist's assistant performs the acts and provides the services visits the pharmacist's assistant at the primary health care clinic or other facility as approved by Council for purposes of supervision and support, which visits must be documented and take place at least once a month. |
The scope of practice of a student—
| (a) | A pharmacy student 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 (basic) under the direct personal supervision of a pharmacist in a pharmacy. |
| (b) | A pharmacy student who has successfully completed his or her second year of study may provide or perform all 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. |
| (c) | A pharmacy student may, for purposes of education and training, and under the auspices or a provider approved to offer education and training for a qualification in pharmacy and with whom such student is enrolled, provide or perform all the services or acts pertaining to the scope of practice of a pharmacist under the direct personal supervision of a pharmacist. |
| (d) | The services or acts referred to in (c) must be provided or performed in accordance with a programme developed by the provider and approved by Council. |
The scope of practice of a pharmacist intern—
| (a) | A pharmacist intern may provide or perform all 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. |
| (b) | 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. |
| 3.9.1.5.1 | The following services and/or acts are regarded to be acts specially pertaining to a pharmacist— |
| (a) | 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: |
| (i) | evaluation of a patient's medicine-related needs by determining the indication, safety and effectiveness of the therapy; |
| (ii) | dispensing of any medicine or scheduled substance on the prescription of a person authorised to prescribe medicine; |
| (iii) | furnishing of information and advice to any person with regard to the use of medicine; |
| (iv) | determining patient compliance with the therapy and follow-up to ensure that the patient's medicine-related needs are being met; and |
| (v) | the provision of pharmacist-initiated therapy; |
| (b) | the compounding, manipulation, preparation or packaging of any medicine or scheduled substance or the supervision thereof; |
| (c) | the manufacturing of any medicine or scheduled substance or the supervision thereof; |
| (d) | 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 |
| (e) | the application for the registration of a medicine in accordance with the Medicines Act. |
| 3.9.1.5.2 | The scope of practice of a pharmacist is as follows: |
| (a) | the acts specially pertaining to the profession of a pharmacist as prescribed in (1.5.1) above; |
| (b) | the formulation of any medicine for the purposes of registration as a medicine; |
| (c) | the distribution of any medicine or scheduled substance; |
| (d) | the re-packaging of medicines; |
| (e) | the initiation and conducting of pharmaceutical research and development; and |
| (f) | the promotion of public health. |
| 3.9.2 | Authority, duties and responsibilities of a responsible pharmacist |
In terms of the Pharmacy Act, every pharmacy must, except in such circumstances and subject to such conditions as may be prescribed, be conducted under the direct personal supervision of a responsible pharmacist, whose name must be displayed conspicuously over the main entrance of such pharmacy and who must be registered as such with Council.
| 3.9.2.1 | Duties and responsibilities of the responsible pharmacist |
The responsible pharmacist must—
| (a) | ensure that he or she in fact continuously supervises the pharmacy in which he or she has been appointed; |
| (b) | have appropriate qualifications and experience in the services being rendered by such pharmacy; |
| (c) | 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; |
| (d) | notify Council immediately upon receiving knowledge that his/her services as responsible pharmacist have been or will be terminated; |
| (e) | take corrective measures in respect of deficiencies with regard to inspection reports of Council or in terms of the Medicines Act; and |
| (f) | in addition to the general responsibilities also: |
| (i) | ensure that unauthorised persons could not by lawful means obtain access to medicines or scheduled substances or the pharmacy premises outside of normal trading hours; |
| (ii) | establish policies and procedures for the employees of the pharmacy with regard to the acts performed and services provided in the pharmacy; |
| (v) | ensure the safe and effective storage and keeping of medicine or scheduled substances in the pharmacy under his or her direct personal supervision; and |
| (vi) | ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances. |
| 3.9.2.1.1 | Circumstances and conditions under which a responsible pharmacist may be absent from his/her pharmacy |
The following are circumstances and conditions under which a responsible pharmacist may be absent from his/her pharmacy:
The responsible pharmacist may be absent from his/her pharmacy subject to the conditions mentioned in paragraph 2.1.1.2 hereunder to—
| (a) | fulfil his or duties and responsibilities as prescribed in terms of the Pharmacy Act (refer paragraph 2.1 above); |
| (b) | provide pharmaceutical services at a pharmacy of which he or she is not the responsible pharmacist; |
| (c) | undertake the overall management of the pharmacy concerned, which could include but is not limited to the regulation of pharmacy matters, human resources, or matters relating to processes regarding medicines or scheduled substances including procedures and record keeping, as well as compliance with relevant labour legislation. |
A responsible pharmacist may be absent from his or her pharmacy under the circumstances as mentioned in item 2.1.1.1 above, but subject to the following conditions:
| (a) | When the responsible pharmacist is the only pharmacist employed by the pharmacy concerned and no locum could be employed for the period that the responsible pharmacist would be absent from his or pharmacy, the responsible pharmacist may be absent only if— |
| (i) | [Rule 3.9.2.1.1.2(a)(i) repealed by Board Notice 50, GG 38511, dated 27 February 2015] |
| (ii) | Schedule 1 to 6 substances are locked away in an area of which the key must be in the personal possession of the responsible pharmacist; |
[Rule 3.9.2.1.1.2(a)(ii) substituted by Board Notice 50, GG 38511, dated 27 February 2015]
| (iii) | in the case of written prescriptions a locked box is provided to ensure the confidentiality of prescriptions; |
| (iv) | no verbal prescriptions are received in the pharmacy for the period in question; and |
| (v) | a sign informing members of the public that no pharmacist is present is displayed conspicuously. |
| (b) | If another pharmacist or a locum is available in the pharmacy concerned to provide pharmaceutical services in the absence of the responsible pharmacist, the responsible pharmacist may be absent only if suitable mechanisms or procedures or policies were in place— |
| (i) | to ensure that no person performs any act falling outside the scope of practice of the category in which such person is registered or which he/she was not authorised to perform in terms of the Act; |
| (ii) | to ensure that unauthorised persons do not obtain access to medicines or scheduled substances or the pharmacy premises outside of normal trading hours; |
| (iii) | for the employees of the pharmacy with regard to the acts performed and services provided in the pharmacy; |
| (iv) | to ensure the safe and effective storage and keeping of medicine or scheduled substances in the pharmacy; and |
| (v) | to ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances. |
| (c) | The responsible pharmacist will remain responsible to Council for any act performed by or on behalf of the responsible pharmacist, including any omission to perform an act required to be performed by or on behalf of the responsible pharmacist which may involve disciplinary action by Council. |
[Rule 3.9 substituted by Board Notice 83, GG 31378, dated 29 August 2008, and numbered accordingly for ease of reference]
