1. REQUEST FOR SALES DATA MEPROBAMATE-CONTAINING MEDICINES:
The South African Health Products Regulatory Authority is concerned about the potential misuse and abuse of meprobamate-containing preparations in South Africa. According to the International Narcotic Control Board (INCB) drug use statistics, South Africa is the third largest user of meprobamate globally. This high usage is attributed to the irrational prescribing and use of meprobamate-containing analgesics, not the use of meprobamate as a sedative/hypnotic.
Additionally, data provided by the South African Police Service (SAPS) shows a large quantity of meprobamate-containing medicines being found and confiscated during random seizures.
Globally, there is a trend towards banning meprobamate-containing medicines. The European Medicines Agency (EMA) suspended all marketing authorisations for meprobamate-containing oral medicines due to the serious side effects associated with the medicines, in 2016.
SOUTH AFRICAN APPROACH
The South African Health Products Regulatory Authority (SAHPRA) is currently in the process of reviewing the scheduling status of meprobamate and meprobamate-containing medicines.
There is a paucity of data on the sale of meprobamate-containing medicines at all levels of the supply chain i.e. manufacture, wholesale, distributor, retail.
In order to inform future regulatory steps, SAHPRA therefore requests manufacturers, wholesalers and distributors to submit sales data (domestic, import and export) of all codeine-containing preparations for the time period January 2018 to date, within 60 days from publication of this notice. Information submitted should include the date; registration number; proprietary name of medicine; dosage form; quantity sold; purchaser’s name; and purchaser’s address, on the template accessible here.
Consolidated sales data should be submitted to Ms Momeena Omarjee at momeena.omarjee@sahpra.org.za.
2. REQUEST FOR SALES DATA CODEINE-CONTAINING MEDICINES:
There is widespread abuse of codeine-containing preparations nationally and globally. In South Africa and neighbouring countries, the abuse of codeine-containing cough preparations specifically amongst the youth, is concerning. These preparations are available without a prescription in South Africa, whilst most neighbouring countries have either banned codeine-containing cough medicines or up-scheduled all codeine-containing medicines to prescription-only status.
It is alleged that the cough preparations registered and available OTC in South Africa are finding their way, illicitly, onto the market in neighbouring countries. This is despite the fact that the current Schedules assign Schedule 6 status to all codeine-containing medicines intended for export.
Globally, there is also a trend towards up-scheduling codeine to prescription-only status, on the basis that there are safer, more effective alternative products available over-the-counter which do not contain codeine, and many non-drug options to manage pain. It is also noted that there are also several over-the-counter medicines available for treating cough, cold and flu symptoms which do not contain codeine. Research has shown that current over-the-counter low-dose codeine-containing medicines for pain relief offer very little additional benefit but high health risks, when compared to similar medicines without codeine.
SOUTH AFRICAN APPROACH
The South African Health Products Regulatory Authority (SAHPRA) is currently in the process of reviewing the schedule status of codeine and codeine-containing medicines.
There is a paucity of data on the sale of codeine-containing medicines at all levels of the supply chain i.e. manufacture, wholesale, distributor, retail.
In terms of Section 19(2) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965.
2)“The Authority may by notice in writing require any person who manufactures or sells medicines,medical devices or IVDs or administers or prescribes any medicine, medical devices or IVDs on whose direction any medicine is administered to furnish it, within a period stipulated in such notice, with any information which such person has in his or her possession or which such person is in a position to obtain regarding such medicine, medical device or IVD.”
3. CODEINE CARE INITIATIVE:
SAHPRA has noted and takes cognisance of the opinion and comments of industry on the most effective method to control access to codeine-containing medicines. Up-scheduling codeine is likely to be inadequate to address the abuse problem in its entirety. Persons who are currently misusing, overusing or abusing codeine are unlikely to change behaviour and use, based only a scheduling change. Scheduling would also not address the potential diversion of codeine-containing medicines from regulated distribution channels.
Communication to Industry Codeine care initiative
Industry, through various associations, has previously proposed a Codeine Care Initiative (CCI) as a tool to identify and curb the illicit abuse of codeine-containing products.
SAHPRA RECOMMENDATION
SAHPRA, through previous industry engagement, has reviewed and highlighted concerns with the initial proposal of the Codeine Care Initiative. Areas of concern highlighted were:
•the requirement for purchasers to submit information not required in terms of the existing law;
•the reliance on identity documents, which some legitimate purchasers may not have at handor be in possession of;
•potential breaches of the Protection of Personal Information Act (No. 4 of 2013);
•the inability to include licensed sellers other than community pharmacies that are connectedelectronically; and
•the ability of the Initiative to address diversion from regulated channels.
SAHPRA therefore invites the various industry and professional associations to submit proposals for the amendment and strengthening of the intervention and to make legally enforceable proposals regarding alternatives to re-scheduling codeine to prescription-only status.
Input to be provided to Ms Momeena Omarjee at momeena.omarjee@sahpra.org.za by the 29 February 2020.