Minimum standards for procurement, storage and distribution are stipulated in items 2.3.1 to 2.3.7 above and must be met. The following additional standards relate more specifically to institutional pharmacies.
| 2.4.1 |
Selection of pharmaceuticals |
| (a) |
A Pharmacy and Therapeutics Committee (PTC) must be in place for the selection of Pharmaceuticals and the promotion of rational drug use. |
| (b) |
A pharmaceutical code list and/or formulary and/or the Essential Drug List must be used as the basis for medicine therapy and the promotion of the rational use of medicine. This system includes a formulary of approved pharmaceutical substances as well as a policy and procedures for the approval and provision of medicine not included in the formulary as required. |
| (c) |
The Pharmacy and Therapeutics Committee must be responsible for the formulary. |
| (d) |
Pharmaceutical usage review programmes must be developed to ensure maximum patient benefit on the most cost-effective basis. |
| 2.4.2 |
Procurement and storage |
| (a) |
The pharmaceutical storage area(s) must be under control of the responsible pharmacist. |
| (b) |
Delivery of medicines must be made directly to the pharmacy. Where delivery is not direct to the pharmacy, procedures must be established and followed to ensure secure receipt of medicinal products and their onward passage to the pharmacy. |
| (c) |
Procurement and stock control of medicinal products and all other items dealt with by the pharmacy must be the responsibility of a pharmacist. There must be written procedures, which must be updated regularly, covering all activities. |
| (d) |
The responsible pharmacist must establish and maintain adequate records of purchases for inventory control and satisfaction of legal and audit requirements. |
| (e) |
The responsible pharmacist is accountable for: |
| (i) |
The selection of medicinal products with due regard to quality and registration status, in co-operation with the Pharmacy and Therapeutics Committee; |
| (ii) |
adherence to central contract or purchasing agreements (as applicable); |
| (iii) |
the maintenance of up-to-date price records to ensure that the most favourable prices are obtained (as applicable); |
| (iv) |
establishing and maintaining adequate records of purchases for inventory control and satisfaction of legal and audit requirements; |
| (v) |
the establishment and maintenance of a system for reporting errors and withdrawing defective products. |
| (f) |
All orders must be on official documents carrying a unique order number. There must be only a small number of authorised signatories. Telephonic orders must be confirmed in writing immediately. |
| (g) |
The responsible pharmacist must ensure that all areas where medicines are stored are of acceptable standard. |
| (h) |
The responsible pharmacist must ensure that all medicine storage areas are inspected regularly (at least monthly) to at least ensure that: |
| (i) |
Medicines and scheduled substances are stored and handled in accordance with the pharmaceutical manufacturer's requirements; |
| (ii) |
no expired or obsolete medicines are stocked; |
| (iii) |
medicines requiring special environmental conditions are stored properly; |
| (iv) |
stock levels are adequate to ensure the continuous supply and accessibility of medicine at all times, including the availability of essential drugs as per the latest edition of the EDL / Formulary (as applicable); |
| (v) |
inflammable substances are stored separately and in an appropriate manner; |
| (vi) |
disinfectants and preparations for external use are stored separately from medicines for internal use; and |
| (vii) |
medicines are pre-packed only in accordance with the provisions of the Medicines Act. |
| (i) |
Adequate inventory control systems for pharmaceutical stock held in the pharmacy and or pharmacy store as well as for ward and clinic pharmaceutical stock must be maintained by: |
| (i) |
Establishing minimum and maximum stock/re-order levels; |
| (ii) |
stock control accounting for pharmaceutical products, received into and removed from stock; |
| (iii) |
identification and proper disposal of expired, deteriorated, recalled or obsolete pharmaceutical products and the timely return of items for credit; |
| (iv) |
recording of orders, usage as well as financial data for analysis, interpretation and planning by pharmacists, the Pharmacy and Therapeutics Committee and pharmaceutical services (as applicable). |
| 2.4.3 |
Distribution of pharmaceuticals to wards, departments, theatres, clinics (WDTC) and other outlets |
| (a) |
Distribution of medicines within a hospital/institution must take place under the direction and control of a pharmacist and must be in accordance with regulation 36 of the General Regulations published in terms of the Medicines Act. |
| (b) |
For each WDTC, and other outlet(s), agreement must be reached with nurses and clinicians for those items, which are to be held as stock. Stock levels must be determined from analysis of previous issues and agreed with nursing staff. |
| (c) |
A stock list must be prepared for WDTC and other outlets. |
| (d) |
A copy of the stock list must be made available to nursing staff who will be responsible for obtaining supplies of stock, and to prescribers servicing the ward. |
| (e) |
Written SOPs must be provided on how supplies of stock medicines are to be obtained from the pharmacy together with an indication of nurses' responsibilities for signing approved requisition documents, which comply with the latest requirements of the Medicines Act. |
| (f) |
Procedures must define normal action to be taken by pharmaceutical staff for routine stock replacement and action to be taken in the case of incomplete documentation or other queries. |
| (g) |
A record must be kept for a minimum period of 5 years of the quantity of each item supplied and each requisition must be dated and signed. |
| (h) |
Procedures must be agreed upon for the return of empty stock packs to deter potential misuse. |
| (i) |
Procedures must be established to ensure that adequate control of issues is maintained and that regular review of stock ranges are carried out to minimise wastage and overstocking. |
| (j) |
Regular stock checking by pharmacy personnel must be undertaken at least monthly to ensure that stock rotation is maintained in all medicine storage areas in the hospital/institution. |
| (k) |
Where applicable, procedures must be agreed upon with nursing staff to allow pharmacist's assistants access to medicine storage facilities with the prior agreement of the nurse-in-charge or other responsible person. |
| (l) |
Procedures must ensure that a thorough stock-check is carried out prior to topping up to agreed stock levels. |
| (m) |
When a topping up list is drawn up by pharmacist's assistants, the order must be signed by the nurse-in-charge or other responsible person. The order must be sent to the pharmacy for processing in accordance with the agreed stock control system, whether electronic or manual. |
| (n) |
Stock must not be returned to the pharmacy without the agreement of the nurse-in-charge or other responsible person. A written record of its removal must be made on the topping-up list. |
| (o) |
Stock rotation must be practised. |
Stamp Duties Act, 1968 (Act 77 of 1968)
