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Pharmacy Act, 1974 (Act No. 53 of 1974)

Board Notices

Rules Relating to Good Pharmacy Practice, 2008

1.9 Control over Medicines

 

Principle: A pharmacist must at all time exercise proper and/or reasonable care in respect of and control over medicines.

 

In adhering to this principle the following should be taken into consideration:

 

1.9.1 General guidelines

 

(a) A pharmacist has a professional responsibility to exercise control over all medicinal and related products, which are purchased or supplied.
(b) All pharmacists should keep abreast of current thinking, including legislation on safety and use of medicines and other products associated with maintenance or promotion of health.
(c) Action must be taken promptly on such matters as product recall.
(d) A pharmacist must not purchase, sell or supply any product where the pharmacist has any reason to doubt its safety, quality or efficacy.
(e) A pharmacist must be satisfied that both the supplier and the source of any medicine purchased are licensed in terms of section 22C(1)(b) of the Medicines and Related Substances Act 101 of 1965 and recorded in terms of the Regulations relating to the ownership and licensing of pharmacies, with the Pharmacy Council. Due regard must be paid to the storage conditions before purchase and to the labels, leaflets, appearance, origin and subsequent chain of supply of the medicine concerned.
(f) Medicines may only be sold/supplied to persons who are appropriately authorised to be in possession of such medicines.

 

1.9.2 Counterfeit and stolen medicines

 

(a) Counterfeiting in relation to medicine includes the deliberate and fraudulent mislabelling with respect to the identity and/or source of the medicine. A pharmacist must report to the Medicines Control Council or other competent authority any instance where he/she suspects that he/she has been offered or has been supplied with counterfeit medicines. He/she must isolate and withhold from sale or supply any such medicinal products.
(b) A medicine registered with the Medicines Control Council must have the registration number on each pack. A pharmacist must not accept medicinal products that are not so labelled.
(c) The purchase, possession, sale, supply or dispensing of an unregistered medicinal product, except where specifically permitted by legislation, is considered by Council to be unprofessional conduct, and subject to disciplinary action by Council in terms of Chapter V of the Pharmacy Act.

 

1.9.3 Foil or blister packs

 

Medicinal products should not be accepted other than in their original outer packaging and should not be removed from a manufacturer's blister or foil pack in order to create a bulk dispensing pack. They may, however, be removed at the time of dispensing for an individual patient at the pharmacist's discretion to assist patient compliance.

 

1.9.4 Re-use of medicines

 

A pharmacist should not re-dispense a medicine, previously returned to the pharmacy by another patient, which had been in that patient's possession.

 

1.9.5 Medicine misuse

 

(a) A pharmacist must exercise professional judgment to prevent the supply of unnecessary and excessive quantities of medicines and other products, particularly those that are liable to be misused or abused.
(b) Many scheduled medicines have a potential for misuse or dependency. Care should be taken with their supply even when it is legally authorised by prescription or signed order. A pharmacist should be alert to the possibility of medicine dependency in health care professionals and patients, should make enquiries to ensure that such medicines are to be used responsibly and should refuse to dispense these medicines when circumstances warrant such refusal.
(c) Certain non-prescription medicines and non-medicinal products are likely to be misused/abused, which in this context usually means—
(i) consumption over a lengthy period; and/or
(ii) consumption of doses substantially higher than recommended.

Requests for such products should be dealt with personally by the pharmacist and sale should be refused if it is apparent that the purchase is not for a genuine medicinal purpose or if the frequency of purchase suggests overuse.

(d) When a pharmacist becomes aware that a patient is abusing a substance, that patient should be referred to an appropriate practitioner or institution.
(e) The products which are abused are subject to change and pharmacists should keep abreast of local and national trends.

 

1.9.6 Medicines used to reduce intoxication

 

A pharmacist must not purchase, supply or advise a person to buy any preparation, whether classified as a medicine or not, which is claimed to mask the signs of intoxication, which indicate unfitness to drive a vehicle or operate heavy equipment which can present a hazard to the public, by accelerating the removal of alcohol from the body or otherwise.

 

1.9.7 Indirect supply of medicines (mail order/courier pharmaceutical service)

 

Although it is preferable for a pharmacist to give medicines directly to the patient /caregiver, when it is necessary to sell, supply or deliver medicine or scheduled substances by or through the mail/courier to a patient or to members of the public or to a person who receives medicine on behalf of the patient, the pharmacist must ensure that—

(a) the medicine is packaged in such a manner that it will guarantee the safety, quality and efficacy of medicines in accordance with the registration requirements for such medicine in terms of the Medicines Act, throughout the delivery process;
(b) a control system is implemented that will enable the pharmacist to detect and correct a delay in the delivery process;
(c) a report back system is introduced to ensure that problems with medicine distribution and delivery are detected timeously;
(d) where available a patient information leaflet is provided.
(e) medicines which are prescribed for acute ailments or conditions (i.e. immediate need, not repeatable and non-chronic conditions) shall not be delivered to patients by mail/courier;
(f) medicines that are registered to be stored in conditions under 8ºC shall not be delivered to patients by mail/courier unless cold chain management is ensured.

 

1.9.8 Emergency supply of medicine or scheduled substances

 

A pharmacist must do everything reasonably possible to assist a person in need of emergency medical treatment or emergency supply of medicines in accordance with section 22A of the Medicines and Related Substances Act.

 

Reference to the provisions of the following act, rule or regulation applying to pharmacists can be made, but it is not an exhaustive list with regard to the above:

Sections 22A and 22C(1)(b) of the Medicines and Related Substances Act 101 of 1965