| 1.6.1 |
Classification and management of facility |
| (a) |
The provision of services and/or acts regarded to be acts specially pertaining to the scope of practice of a pharmacist (pharmaceutical services) in a primary health care clinic or mobile clinic must be managed, monitored and supervised by the responsible pharmacist of the institutional pharmacy in a public health facility from which the services are managed or by a pharmacist designated by a province or a local authority, e.g. a district pharmacist, who shall be accountable to Council for compliance with the applicable legislation relating to the services which pertain to the scope of practice of a pharmacist in the primary health care clinic(s) under his or her supervision. |
| (b) |
In cases where the pharmaceutical services in a primary health care clinic or mobile clinic are not provided by a pharmacist, they must be provided by a pharmacist's assistant (post-basic) working under the indirect supervision of a pharmacist or alternatively a person licensed to dispense medicine in terms of section 22C(1)(a) of the Medicines Act |
| (c) |
The responsible pharmacist of the institutional pharmacy in a public health facility from which the services are managed/provided or the pharmacist designated by a province or a local authority in 1.6.1(a) above must submit to Council, a list of the names and details of the primary health care facilities which are managed by the responsible pharmacist or the designated pharmacist on a form approved and provided by Council. Council must be notified in writing by the relevant pharmacist of any change to the information provided, within 30 days of the change taking place. |
| (d) |
The details of the primary health care facilities managed by the responsible pharmacist of an institutional pharmacy in a public health care facility or a pharmacist designated in 1.6.1(a) must be recorded by Council. |
| (e) |
At primary health care clinics where the service is provided by a pharmacist's assistants) (post-basic) in accordance with his/her scope of practice, indirect supervision may only take place under the following circumstances: |
| (i) |
a pharmacist must visit and document visits to the clinic for purposes of monitoring, supervision and support at least once a month; |
| (ii) |
a pharmacist based at the pharmacy from which the service is provided or the pharmacist designated in 1.6.1(a) must provide written and updated protocols and Standard Operating Procedures describing clearly the responsibility of the pharmacist's assistant; |
| (iii) |
re-packaged medicines or patient-ready packs must be provided to the facility. |
| (f) |
The name of the pharmacist's assistant (post-basic) on duty must be displayed conspicuously in or outside the dispensary for purposes of identification of such person(s) by the public. |
| (g) |
The pharmacist's assistant (post-basic) on duty must wear a name tag or badge indicating his/her name and designation for the purposes of identification of such person by the public. |
| (h) |
At primary health care clinics where the service is provided by licensed dispensers (e.g. doctors or nurses), a pharmacist must visit the clinic for purposes of monitoring and support on a monthly basis. |
| (i) |
The name of the licensed dispenser(s) on duty must be displayed conspicuously in the primary health care clinic for purposes of identification of such person(s) by the public. |
| (j) |
The licensed dispenser on duty must wear a name tag or badge indicating his/her name and designation for the purposes of identification of such person by the public. |
| (k) |
Compounding of medicine may only be performed at a primary health care clinic by a pharmacist or a pharmacist's assistant (post-basic) under the indirect supervision of a pharmacist provided that the necessary equipment for the compounding of medicine as described in section 1.2.11.4 of this manual is available in the clinic. |
| 1.6.2 |
Designation of dispensary or medicine room |
In a primary health care clinic where—
| (a) |
the services are provided by a pharmacist's assistant (post-basic) there must be a suitable room assigned for use as a dispensary; |
| (b) |
the services are provided by a licensed dispenser in the consulting rooms in the primary health care clinic there must be a suitable room designated as a medicine room for use as a storage area for medicine. In such a facility the following standards must be observed: |
| (i) |
the dispensing must be done in the consulting room(s) and not in the medicine room; |
| (ii) |
no medicine may be stored in the consulting room(s) except in situations where there is an air-conditioner installed and the temperature is controlled; |
| (iii) |
where medicine is stored only in the medicine room, medicines or scheduled substances must be transported to the consulting room(s) on a daily basis in, for example, a lockable medicine trolley or tray; |
| (iv) |
control of access to the medicine room and the consulting room(s) (as applicable) must be of such a nature that only licensed dispenser(s) has direct access to medicines. |
| 1.6.3 |
Condition of a dispensary or medicine room |
| (a) |
The walls, floors, windows, ceiling, woodwork and all other parts of the dispensary or medicine room must: |
| (ii) |
be kept in such good order, repair and condition as to enable them to be effectively cleaned and to prevent, as far as is reasonably practicable, any risk of infestation by insects, birds or rodents. |
| (b) |
Countertops, shelves and walls must be finished in a smooth, washable and impermeable material which is easy to maintain in a hygienic condition. |
| (c) |
Light conditions, temperature and humidity within the dispensary or medicine room must comply with the requirements for the storage of medicine, other pharmaceutical products, and packaging materials. |
| (d) |
The dispensary, its fittings and equipment must be adequate and suitable for the purpose of dispensing. |
| (e) |
The working surface area in a dispensary must be sufficient for the volume of prescriptions dispensed. |
| (f) |
The temperature in the dispensary/medicine room must be below 25° C. |
| (g) |
The dispensary/medicine room must have the following fixtures/fittings: |
| (i) |
an air-conditioner in good working order; |
| (ii) |
a refrigerator in good working order (see below); |
| (iii) |
a wash hand basin with hot and cold water. |
| (h) |
In facilities where there is a designated dispensary, a suitable area for the furnishing of advice and a waiting area for patients must be provided which comply with the standards laid down in sections 1.2.12 and 1.2.13 respectively. |
| 1.6.4 |
Storage areas in a dispensary or medicine room |
| (a) |
Storage areas must have sufficient shelving constructed from smooth, washable and impermeable material, which is easy to maintain in a hygienic condition. |
| (b) |
No medicines may be stored on the floor. |
| (c) |
Storage areas for medicines must be self-contained and secure. |
| (d) |
Storage areas must be large enough to allow orderly arrangement of stock and proper stock rotation. |
| 1.6.5 |
Equipment for dispensary or medicine room or consulting room |
There must be adequate, suitable equipment for the dispensing of medicine in the facility. Each item must be clean, in good repair and of suitable material. Equipment must be specific for the medicines which may be dispensed in the primary health care facility. The list given below provides a standard—
| (a) |
A suitable means of counting tablets and capsules. This equipment must be cleaned regularly so that cross-contamination between products is avoided. |
| (b) |
A range of graduated, stamped glass or plastic measures suitable for the medicines dispensed in the facility. |
| (c) |
A refrigerator equipped with a suitable thermometer and capable of storing medicines at temperatures between 2° C and 8° C. The refrigerator must be cleaned, defrosted and checked periodically to ensure efficient running. This refrigerator must be used only for storing pharmaceutical products. Where applicable, a freezer for the storage of ice packs must be available. |
| (d) |
A suitable range of dispensing containers for medicine. The use of child-resistant closures is encouraged. |
| (e) |
Labels for the dispensing of medicines. Labels and labelling must comply with the requirements of regulation 8 of the General Regulations published in terms of the Medicines Act. |
| (f) |
Suitable refuse receptacles. |
The following reference sources must be available in a primary health care clinic or a mobile clinic where the dispensing of medicine takes place:
| (b) |
the latest edition of Daily Drug Use (Tincture Press Publications) or another drug interactions reference source; |
| (c) |
the latest edition of either MDR or SAMF; |
| (d) |
a Good Pharmacy Practice Manual, |
provided that there is access to a telephone or other means of communication with an institutional or other pharmacy, e.g. district or sub-district hospital if further information is required.
| 1.6.7 |
Control of access to dispensary or medicine room |
| (a) |
The pharmacist's assistant (post-basic) or licensed dispenser in charge must ensure that every key, key card or other device, or the combination of any device, which allows access to a dispensary/medicine room when it is locked, is kept only on his/her person or the person of a pharmacist's assistant (post-basic), licensed dispenser or a pharmacist (as applicable) at all times. |
| (b) |
Control of access to the dispensary, medicine room and/or consulting room(s) (as applicable) must be of such a nature that only authorised personnel have direct access to medicines. |
| (c) |
A procedure must be in place to ensure access to the dispensary, medicine room and/or consulting room(s) (as applicable) in an emergency situation in compliance with the Occupational Health and Safety Act, 1993. |
Protection of Businesses Act, 1978
