Keeping up to date with legislation
General Regulations under the Medicines Act – Knowing the Changes
25 August 2017 saw the dawn of a new era in terms of the General Regulations published under the Medicines and Related Substances Act, 101 of 1965. Not only do the General Regulations (2017) open the door for the establishment of the South African Health Products Regulatory Authority (SAHPRA), but the regulations also see the acknowledgement of information technology within the medicines arena, with the introduction of the electronic prescriptions. What is new? What has changed? What has been left out?
The General Regulations (2017) sees a whole new index, with old regulations now having new numbers, as well as the grouping of the regulations into eight new sections or chapters. For those in the regulatory environment, getting used to the new regulation numbers will take some adjustments. For ease of reference the table below shows the eight sections of the regulations, the new regulation numbers (compared to the old) and the new titles of the regulations.
Over the next few editions of e-Pharmaciae we will be highlighting some of the substantive changes made in the General Regulations (2017).
Regulation 8 – Personal medicinal use by persons entering republic
Previously Regulation 16 under the heading “Possession of specified quantities of scheduled substances for personal medicinal use by persons entering or departing from the Republic”
- Regulation 8 no longer addressees the quantity of medicines for personal use that one may take when leaving the country. It is therefore assumed that the requirements thereof, shall be in accordance with the medicines regulation of the country/countries to which the person is going to. This means that a pharmacist may potentially dispense six months of medicine at once on a valid prescription, for such patient to take out of the country.
- Persons entering the country may now bring in 6 months of medicines for personal use, being Schedule 3 – Schedule 5 (no mention is made of specified 5). The quantity of Schedule 6 medicine remains at 30 days. The impact of this amendment is that pharmacists may not have to face the situation of prescriptions from medical practitioners not registered in South Africa having to be endorsed or “reissued” by locally registered medical practitioners.
Regulation 33 – Particulars which must appear on prescription for medicine
(Previously Regulation 28 under the heading “Particulars which must appear on a prescription or order for medicine”)
- Regulation 33 only addresses the particulars for a prescription. Regulation 34 has been added as a new regulation that addresses the particulars which must appear on an order for medicines or scheduled substances.
- Electronic prescriptions are also permissible provided that the electronic prescription must have an advanced electronic signature as per Section 13 of the Electronic Communications and Transactions Act, 2002. An advanced electronic signature is an electronic signature which results from a process which has been accredited i.e. it is a product/service offered by a service provider who has applied to and been approved by the .za Domain Name Authority/Accreditation Authority.
- Requirements to be included on the prescription:
- Name, qualification, registration number and address of prescriber; (Note that the prescriber’s ‘practice number’ being the BHF number has been replaced with their registration number with the relevant statutory health council);
- The name, identification number and address of the patient; in the case of a neonate, the details of the parent/guardian, and in the case of a veterinarian prescription, the person to whom the medicine/scheduled substance is to be sold; (Identity number is a new requirement);
- The date of issue of the prescription;
- The approved name or proprietary name of the medicine;
- Dosage form;
- Strength of the dosage form and the quantity of the medicine – Schedule 6 must have the quantity in figures and words;
- Instructions for the administration of the dosage, frequency of administration and withdrawal period in the case of medicines for food producing animals;
- The age and gender of patient, or species of animal; and
- Number of times the prescription may be repeated.
- Irrespective of what format the prescription is in, the pharmacist must verify the authenticity of the prescription. (This was previously only stated for faxes, emails, telephone or other transmitted prescriptions.)
- In the event of a fax, verbal or other electronically transmitted prescription (other than that with an authentic signature) a permanent copy must be kept. In the case of a verbal prescription, a signed prescription must be obtained within 7 days.
- The prescriber must keep diagnostic records and only where there is patient consent, provide the diagnosis or diagnostic code. (Reference to the ICD10 code has been added.)
Regulation 39 – Repackaging of medicines into patient-ready packs
(Previously Regulation 33 under the same heading)
- The regulation heading makes mention of patient-ready packs, but the wording and reference to patient-ready packs have been from the regulation content.
- The new regulation makes no reference to temperature, humidity control and a separate area for repacking as was the case in the old regulation. The regulation simply states that repackaging must be carried out in accordance with GMP.
Regulation 40 – Vigilance
(Previously Regulation 37 under the heading “Adverse drug reaction”)
- The change in the regulation heading is a strong indicator of the changes within the body of the regulation. Of noticeable inclusion in the regulation is the reference to healthcare providers, veterinarians and any other person who may inform SAHPRA of any suspected adverse drug reaction or new or existing safety, quality or effectiveness concerns.
- It is necessary that Regulation 40 be understood by all healthcare providers, who should play an active role in medicine vigilance.