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

Board Notices

Rules Relating to Good Pharmacy Practice

Chapter 2 : Professional Standard for Services

2.7 Minimum Standards for the Dispensing of Medicine or Scheduled Substances on the Prescription of an Authorised Prescriber

 

'Dispensing' as defined in terms of the Pharmacy Act means 'the interpretation and evaluation of a prescription, the selection, manipulation or compounding of the medicine, the labelling and supply of the medicine in an appropriate container according to the Medicines Act and the provision of information and instructions by a pharmacist to ensure the safe and effective use of medicine by the patient and 'dispense' has a corresponding meaning' (GN R1158 of 20 November 2000).

 

2.7.1 Dispensing procedures

 

This section must be read and applied in the context of its relevance and pertinence to the various persons authorised to participate in the dispensing process in terms of their scope of practice.

 

The dispensing process is divided into three phases, namely:

Phase 1: Interpretation and evaluation of the prescription.

Phase 2: Preparation and labelling of the prescribed medicine.

Phase 3: Provision of information and instructions to the patient to ensure the safe and effective use of medicine.

 

The three phases may be performed by a pharmacist or pharmacist intern under the direct personal supervision of a pharmacist. Phases 2 and 3 may be performed by pharmacist's assistants (post-basic) under the direct personal supervision of a pharmacist. In terms of the scope of practice of a pharmacist's assistant (post-basic) he/she may read and prepare a prescription, select, manipulate or compound the medicine, label and supply the medicine following the interpretation and evaluation of the prescription by a pharmacist. He/she may also provide instructions regarding the correct use of medicine supplied.

 

Notwithstanding the above, a pharmacist's assistant (post-basic) working under the indirect supervision of a pharmacist may, under certain conditions, in terms of regulation 12 of the Regulations relating to the practice of pharmacy, read and prepare a prescription, select, manipulate or compound a medicine, label and supply medicine in an appropriate container and provide instructions regarding the correct use of the medicine supplied.

 

The person who is responsible for the dispensing of a prescription must ensure that all three phases of the dispensing process have been performed by an appropriately authorised person.

 

2.7.1.1 Phase 1: Interpretation and evaluation of the prescription

 

(a) Receipt of the prescription and confirmation of the integrity of the communication. Adequate procedures must exist for:
(i) identifying the patient, the prescriber and the entity responsible for payment (as applicable);
(ii) ensuring the legality/authenticity of the prescription;
(iii) a permanent copy of a faxed, e-mailed, telephonic or other electronically transmitted prescription or order made for record purposes. A faxed, e-mailed, telephonic or other electronically transmitted prescription or order must be followed by the original prescription or order within seven working days;
(iv) helping the patient to resolve the problem when the prescription cannot be dispensed;
(v) interpreting the type of treatment and the prescriber's intentions;
(vi) identifying the medicine, and checking the pharmaceutical form, strength, appropriate dosage, presentation, method of administration and duration of treatment;
(vii) informing the patient of the benefits and implications of the substitution for a branded medicine of an interchangeable multi-source medicine. Refer section 7.3.11 of this chapter.
(b) Assessment of the prescription to ensure the optimal use of medicine. Each prescription must be professionally assessed by a pharmacist with respect to:
(i) therapeutic aspects (Pharmaceutical and Pharmacological) i.e.
• the safety of the medicine;
• possible contra-indications;
• drug/drug interactions;
• drug/disease interactions;
• treatment duplications;
(ii) appropriateness for the individual and the indication for which the medication is prescribed;
(iii) social, legal and economic aspects.
(c) Pharmacist interventions

Whenever necessary, the pharmacist should communicate with the prescriber regarding any identified problems and work out a plan of action with the prescriber and/or the patient.

(d) For the assessment of a prescription the following information sources can be used:
(i) questions put to the patient or caregiver;
(ii) questions put to the prescriber where doubts arise or further information is required;
(iii) pharmacopoeias, formularies, technical books, electronic sources, professional journals, compendia of pharmaceutical legislation and medicine supply agreements with the health services; and
(iv) outside information from drug information centres, competent authorities and pharmaceutical manufacturers.

 

2.7.1.2 Phase 2: Preparation and labelling of the prescribed medicine

 

2.7.1.2.1 Selecting or preparing the medicine includes the following activities:

 

(a) Patient-ready packs/pre-packed medicines are correctly selected.
(b) Preparation of extemporaneous preparations. Where applicable, the pharmacy must have adequate facilities for the extemporaneous dispensing of individual prescriptions. When medicines are compounded in a pharmacy this must be done in accordance with the details laid down in section 2.18.
(c) Counting must be done on a clean counting tray and the final dosage form placed in a suitable container.
(d) The container of the medicine must be clearly labelled with the correct directions along with any other information for the safe, proper and effective use of the medicine. Cautionary/advisory labels and instructions must always be used.
(e) All dispensing procedures, whether performed by a pharmacist, pharmacist intern or pharmacist's assistant (post-basic), must be carefully checked for accuracy and completeness.
(f) Signing the prescription. Accountability must be accepted by the pharmacist or other authorised person who signs the prescription or copy of the prescription accepting liability for the correctness of the dispensing of the medicine and confirming that the medicine was supplied.

 

2.7.1.2.2 Labels

 

(a) Labelling of dispensed products must be clear, legible and indelible. Lettering must as far as possible be mechanically printed.
(b) The following information must be indicated on the label in accordance with Regulation 8(4) of the General regulations published in terms of the Medicines Act:
(i) the proprietary name, approved name, or the name of each active ingredient of the medicine, where applicable, or constituent medicine;
(ii) the name of the person for whose treatment such medicine is sold;
(iii) the directions in regard to the manner in which such medicine should be used;
(iv) the name and business address of the person authorised to sell such a medicine;
(v) date of dispensing; and
(vi) reference number. 2.7.1.2.3 Record keeping regarding the supply of medicine regulation 11 of the General Regulations published in terms of the Medicines Act, specifies the information that must be recorded when medicine is supplied.

 

2.7.1.2.3 Record keeping regarding the supply of medicine

 

Regulation 11 of the General Regulations published in terms of the Medicines Act, specifies the information must be recorded when medicine is supplied.

 

2.7.1.2.3.1 Schedule 1 record

 

According to regulation 11 the following information must be recorded with regard to the supply of Schedule 1 medicines without a prescription:

(a)        the name of the person to whom it was sold;

(b)        its name and quantity; and

(c)        the name of the pharmacist, pharmacist intern or pharmacist's assistant who sold it.

 

2.7.1.2.3.2 Prescription book

 

According to regulation 11, a prescription book or other permanent record in respect of Schedule 2, 3, 4, 5 and 6 medicines or substances must be kept on all premises where prescribed medicines are dispensed or sold and must contain the following details:

(a) the name of the medicine or scheduled substance;
(b) the date on which the prescription was dispensed;
(c) the dosage form and quantity of the medicine or scheduled substance;
(d) the name and address of the patient, or, in the case of a prescription issued by a veterinarian, the name and address of the person to whom the medicine or scheduled substance was sold;
(e) where applicable, the name of the medical practitioner, dentist, veterinarian or any other authorised person who issued the prescription; and
(f) prescription reference number.

 

A prescription record must be retained at the business address of the seller for a period of at least five years after the date of the last entry made therein.

 

2.7.1.3 Phase 3: Provision of information and instructions to the patient to ensure the safe and effective use of medicine

 

2.7.1.3.1 Supply to the patient

 

(a) Advising a patient or the patient's agent/caregiver (physical presence is preferred) must be carried out by a pharmacist or other authorised person.
(b) A patient information leaflet, containing the information as prescribed in the General Regulations published in terms of the Medicines Act should be available at the point of dispensing.
(c) Information must be structured to meet the needs of individual patients
(d) Pharmacists must ensure that any information or services offered by a pharmacy to patients in the area of health promotion are safe, up-to-date and in accordance with the relevant local and national guidelines.
(e) Information provided to patients regarding their medicine use must always be done with professional judgement and the prescriber should be contacted when necessary.

 

2.7.1.3.2 Monitoring patient outcomes

 

(a) The pharmacist or pharmacist intern under the personal supervision of a pharmacist must assess the patient for signs of compliance, effectiveness and safety of the therapy.
(b) The pharmacist should identify areas for modification, implementation of modifications (taking into account legal requirements), revise the patient record and record the action taken.

 

2.7.2 Supervision of dispensing and sales/supply

 

(a) Dispensing must be done by or under the supervision of a pharmacist in accordance with applicable legislation.
(b) In a pharmacy with only one pharmacist present, this pharmacist must be able to supervise activities in the medicines sales area (as applicable) at the same time as supervising dispensing.
(c) A pharmacist responsible for supervising the dispensing, sale or supply of any medicine in a pharmacy bears the associated legal and professional responsibility.
(d) Every prescription dispensed in a pharmacy must be seen by a pharmacist and judgement made by him/her as to what action is necessary.
(e) The pharmacist must exercise judgement to ensure fulfilment of professional duties to the patients in the best possible way. The pharmacist must thus be able to delegate to pharmacist's assistants (post-basic) tasks that he/she is confident can be undertaken by them and fall within the scope of practice of a pharmacist's assistant (post-basic). The pharmacist must be available in the pharmacy to intervene, to advise and to check the dispensing of any prescription under his/her supervision.
(f) Systems must be developed to ensure that the distribution of medicines is reliable and secure to the point of delivery.

 

2.7.3 Safety in dispensing procedures

 

2.7.3.1 Interpretation of prescription

 

(a) In cases of uncertainty, the pharmacist or pharmacist intern must make every effort to contact the prescriber. If it is impossible to contact the prescriber, the pharmacist must use his/her professional judgement and decide, in all circumstances, what course of action would be in the best interest of the patient.
(b) Where the problem cannot be resolved and if there appears to be a potential risk to the patient, the pharmacist may decide not to dispense the prescription even if the prescriber confirms that the product should be dispensed. In taking this decision, however, the pharmacist should assess the relative harm, which may result from this refusal and use his/her professional judgement to decide what course of action would be in the best interest of the patient.
(c) The prescription must be endorsed according to any action taken e.g. telephonic confirmation of an unusual dosage, etc.

 

2.7.3.2 Forged prescriptions

 

A pharmacist must be aware of the probable methods of prescription forgery and exercise reasonable care to satisfy himself/herself that prescriptions are genuine.

 

2.7.3.3 Dispensing containers

 

(a) The container must be appropriate for the product dispensed, bearing in mind the need to protect the product from moisture and sunlight as well as from mechanical stresses imparted by transport and use of the product.
(b) All containers intended for medicinal products must be protected and kept free from contamination.
(c) All solid dose oral preparations must be dispensed in a re-closable container or in unit packaging of strip or blister type unless:
(i) the original pack is such as to make this inadvisable;
(ii) the patient is elderly or handicapped and will have difficulty in opening the re-closable container; or
(iii) a specific request is made that the product shall not be dispensed in a re-closable container.
(d) Advice must be given to keep all medicines out of the reach of children.

 

2.7.3.4 Reuse of containers

 

(a) Plastic containers and caps for solid or liquid dose preparations must not be reused.
(b) Under no circumstances may re-closable child resistant closures be used more than once.
(c) Glass containers may be reused only after satisfactory cleaning and drying.

 

2.7.3.5 Reuse of medicines

 

A pharmacist must use his/her professional knowledge/judgement in relation to reuse of medicines as follows:

(a) Medicines brought in by patients remain the patient's own property. Under no circumstances may they be used by anyone else.
(b) Medicines returned from a hospital ward:
(i) All expired medicines must be destroyed.
(ii) Only blister packs may be considered for re-use provided that the pharmacist is confident that the correct storage conditions have been adhered to.
(iii) The continued use of patients' own medicines while in hospital may be necessary in special circumstances. Appropriate safeguards are required.

 

2.7.3.6 Confidentiality

 

No information may be divulged about the affairs of any person obtained in the course of dispensing a prescription except to a person authorised to have access to such information and acting within his/her lawful jurisdiction. More information regarding this minimum standard can be found in the Code of Conduct as published by Council in rules.

 

2.7.3.7 Recalls

 

(a) A pharmacist must comply immediately with any warning about or recall of defective medicines.
(b) Every pharmacy must have a recall policy.
(c) A pharmacist must actively participate in any arrangements made for warning the profession of problems associated with medicines, and must inform appropriate bodies of hazards which come to their attention.

 

2.7.3.8 Personal hygiene

 

(a) High standards of personal cleanliness must be observed in dispensing.
(b) Direct contact between the dispensed product and the operator's hands must be avoided.
(c) Cuts or abrasions must be covered with a suitable occlusive dressing. A person with an open lesion or readily transmittable infection must report to the pharmacist who will decide whether they may be engaged in the dispensing process.
(d) No personnel may smoke or prepare or consume food in any area where medicines are dispensed, sold or supplied.

 

2.7.3.9 Expiry dates

 

(a) Expired medicine must not be dispensed or supplied to the public.
(b) Particular care must be taken with prescriptions for several months' treatment. Ideally, prescriptions should be for a maximum of 28 days' treatment but, where a quantity covering a longer period is dispensed, the pharmacist must ensure that the product will still be in date at the end of that period.
(c) A record of the expiry dates of all medicine procured by the pharmacy must be kept.
(d) Pharmacists in hospitals/institutions or registered nurses in charge of units must return excessive and short-dated stock to the pharmacy timeously.
(e) Those items which have expired must be recorded and priced.
(f) The destruction of expired medicine must only take place in accordance with the General Regulations published in terms of the Medicines Act.

 

2.7.3.10 Adverse drug reaction reporting

 

Adverse drug reactions must be reported to the patient's medical practitioner, as well as to the MCC in accordance with guidelines published in this regard (GN R7659 of 2 May 2003).

 

2.7.3.11 Generic substitution

 

Section 22F of the Medicines Act states that:

(1) A pharmacist shall—
(a) inform all members of the public who visit his or her pharmacy with a prescription for dispensing, of the benefits of the substitution for a branded medicine of an interchangeable multi-source medicine; and
(b) dispense an interchangeable multi-source medicine instead of the medicine prescribed by a medical practitioner, dentist, practitioner, nurse or other person registered under the Health Professions Act, 1974, unless expressly forbidden by the patient to do so.

 

(2) If a pharmacist is forbidden as contemplated in subsection (1)(b), that fact shall be noted by the pharmacist on the prescription.

 

(3) When an interchangeable multi-source medicine is dispensed by a pharmacist, he or she shall note the brand name or where no such brand name exists, the name of the manufacturer of that interchangeable multi-source medicine in the prescription book.

 

(4) A pharmacist shall not sell an interchangeable multi-source medicine—
(a) if the person prescribing the medicine has written in his or her own hand on the prescription the words 'no substitution' next to the item prescribed;
(b) if the retail price of the interchangeable multi-source medicine is higher than that of the prescribed medicine; or
(c) where the product has been declared not substitutable by the Medicines Control Council.

 

NOTE: Interchangeable multi-source medicine— is defined in terms of the Medicines Act as medicines that contains the same active substances which are identical in strength or concentration, dosage form and route of administration and meet the same or comparable standards, which comply with the requirements for therapeutic equivalence as prescribed.

 

2.7.4 Pricing of prescriptions and services

 

(a) Pricing of the prescription or copy of the prescription (where applicable) must include the following:
(i) all information necessary to prevent a member of a medical aid scheme from gaining any benefit to which he/she would not otherwise be entitled; and
(ii) the final price paid by the patient/member or an indication of the total cost of the account rendered if payment is not effected.
(b) Pricing of prescriptions must be in accordance with the Regulations relating to a transparent pricing system (GN R55310 of 30 April 2004).
(c) Pricing for approved services must be in accordance with the Rules relating to services for which a pharmacist may levy a fee and guidelines for the levying of such fee or fees (once published).
(d) The advertising of prices must be in accordance with regulation 45 of the General Regulations published in terms of the Medicines Act. Logos or pack shots may not be used.
(e) Prices for services, including dispensing, must not be advertised in a manner that—
(i) is calculated to suggest that a pharmacist's professional skills or ability or his/her facilities for practising his/her profession or rendering his/her professional services are superior to those of other pharmacies; or
(ii) could be construed as touting or attempting to tout for prescriptions or business with regard to the sale of medicines or the provision of approved supplementary services.

 

 

2.7.5 Minimum standards specifically relating to the collection and the delivery of medicines to patients from a community or institutional pharmacy

 

2.7.5.1 Purpose

 

The purpose of this standard is to regulate activities relating to the collection by and the delivery of medicines to patients from a community or institutional pharmacy.

 

2.7.5.2 General considerations

 

(a) All efforts must be made to enable access to counselling of the patient by a pharmacist relevant to their healthcare needs;
(b) When a person other than a pharmacist delivers medicines to a patient or a patient's caregiver, the pharmacist must furnish written instructions, that shall include the patient's details and information regarding the correct use of medicine, and a patient information leaflet (where applicable);
(c) All medicines should, whenever possible, be delivered to patients at an agreed time or date; and
(d) In the absence of an adult (i.e. a person above 14 years old as defined by the Medicines Act) or another person entitled by law to receive the medicine, it must be retained and stored under appropriate conditions until delivery can be affected or be returned to the pharmacy.

 

2.7.5.3 Collection of medicines from the pharmacy

 

Definition[s]:

 

Agent – a person nominated, either formally or informally, by the patient

Caregiver: a person who has accepted responsibility for looking after a patient

 

The caregiver or agent may not practice the scope of practice of a pharmacist

(a) A patient's agent or caregiver may collect medicines and accept information pertaining to a particular patient provided that the pharmacist is satisfied that patient safety, confidentiality and medicine quality is maintained and the patient has provided written consent;
(b) The patient's caregiver may only collect medicines for a patient or patients who are under their direct care, a patient's agent may only collect medicines for a patient or patients who have given written consent for such collection, and in the case of multiple patients the pharmacist must satisfy themselves that the patient's agent or caregiver is the appropriate person to give the medicines to.

 

2.7.5.4 Transportation for the delivery of medicines

 

(a) Transportation of medicines must be in such a way that it is secure and limits access to medicines by persons allowed to have access to medicine in law only, prevents any contamination and ensures integrity to the manufacturers product specifications;
(b) The vehicle should allow orderly storage to ensure safety, quality and efficacy of pharmaceutical products during transportation;
(c) Where relevant and to the extent that it is applicable, cold chain management must be observed, and delivery must prove compliance with the minimum standards for thermolabile pharmaceutical products;
(d) Personnel transporting pharmaceutical products must be appropriately trained and shall provide the suitable documentation as proof for this function and they must ensure that the correct procedures are followed to maintain the cold chain within the manufacturer's specification;
(e) At any stage of transportation, a delivery document must show evidence that the transport requirements, inter alia temperature control have been met;
(f) Damage to containers or any other event or problem which occurs during transit must be reported to and recorded by the responsible pharmacist of the pharmacy from which the pharmaceutical products were sent;
(g) Upon arrival the person responsible for the transportation of the pharmaceutical products must inform the patient or patient's caregiver, that the package contains pharmaceutical products and provide information about specific storage requirements (as applicable); and
(h) Proof of delivery (signed by the patient or the patient's caregiver) must be presented to the pharmacy to ensure that the medicines have been received.

 

[Rule 2.7.5 substituted by Notice No. 431, GG 40892, dated 6 June 2017]

 

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10 These Regulations were republished under Notice No. R. 1102, GG 28214, dated 11 November 2005]