An extension of the validity of prescriptions in terms of an amendment to the Medicines and Related Substances Act No. 101 of 1965

by Neil Kirby, Director and Head of the Healthcare & Life Sciences practice and Zamathiyane Mthiyane, Senior Associate

On 30 April 2020 the Minister of Health published, in GNR481, a notice excluding Schedule 2, 3 and 4 Substances (“the Scheduled Substances”) from certain provisions of the Medicines and Related Substances Act No. 101 of 1965, as amended (“the Medicines Act”) (“the Notice”).

The effect of the Notice on the Scheduled Substances is as follows:

• prescriptions for the Scheduled Substances, which were previously valid only for three months, are now valid for six months. Thus, pharmacists must have the requisite Scheduled Substances to fulfil potential demand;

• consequently, patients do not need to consult with a healthcare practitioner, within the timeframes during which the prescriptions remain valid, for purposes of obtaining a new prescription. Consultations with healthcare practitioners for purposes of issuing new prescriptions are also held to enable the healthcare practitioner to, inter alia, determine whether or not patients are responding the Scheduled Substances prescribed and, if not, change the dosage of the Scheduled Substances or the Scheduled Substance in totality. No provision has been made for healthcare practitioners to perform the aforementioned duty in the Notice;

• however, the Scheduled Substances may not be dispensed for a period longer than twelve months from the date of the issue of the initial prescription;

• in instances where a prescription was issued six months before the date of Notice, repeat prescriptions may be issued for a period of only of a further six months;

• the Notice is silent on the payment of the Scheduled Substances by medical schemes in terms of the Medical Schemes Act No. 131 of 1998 and the respective medical schemes’ rules and managed care protocols, taking into account that currently repeat prescriptions for Schedule Substances are currently available on a three month basis; and

• the Notice applies only until November 2021 at which time the exemption provided in terms of the Notice lapses and the provisions of the Medicines Act, once again, apply. The Notice does not deal with practical issues such as how the aforementioned provision will practically work in the event that the extended period of the prescription has not expired as at November 2021 in so far as only half the prescription has been dispensed.

A copy of the Notice can be found here.