In SA, the regulation and registration of medicines and medical devices is regulated by the Medicines Control Council (MCC). The MCC ensures that all new medicines comply with the necessary requirements for safety, quality and efficacy by reviewing the scientific, medical and ethical issues related to any application for the registration of a new medicine.
In the performance of its duties, the MCC applies the guidelines set out by the Medicines and Related Substances Act, (Act 101 of 1965), which oversees the manufacture, distribution, sale, and marketing of medicines. The scheduling of medicines is also used to evaluate and control the prescribing and dispensing thereof.
Medicines and Related Substances Act
In terms of the Medicines and Related Substances Act, ‘medicine’ is defined as any substance or mixture of substances used or alleged to be suitable for use, or manufacture, or sale in:
- The diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof, or
- Restoring, correcting or modifying any somatic or psychic or organic function.
Any medicine falling within this definition is subject to regulation and once approved by the council will be kept on the medicines register. The control of medicines and scheduled substances ensures that no person can sell or have in her or her possession, any medicine or scheduled substances except in accordance with the prescribed conditions of the MCC and the Medicines and Related Substances Act.
A ‘schedule 0’ substance may be sold in an open shop and a ‘schedule 1’ substance may only be sold by a pharmacist, a manufacturer of pharmaceutical products, a wholesale dealer in pharmaceutical products, a medical practitioner or dentist entitled to prescribe such substance, or a healthcare practitioner or person registered under the Health Professions Act (Act 56 of 1974).
The same categories of persons may also sell any substance which falls into the ‘schedule 2 to 6’, on condition that several requirements are met. For example, a permanent record must be kept of every sale in a prescription book and this prescription or order must be kept for at least five years from the date of the sale.
Over time the MCC and The Independent Community Pharmacy Association (ICPA) have identified the increased potential for abuse of codeine and codeine derivative products because of the addictive nature of this very effective painkiller.
Codeine is an ingredient in many over the counter schedule 2 medicines and is commonly used to treat colds, flu and pain meaning it does not require a prescription. As an individual’s body becomes accustomed to using codeine, increased doses are required to achieve the calming effect the drug gives its users. Some of the symptoms of codeine addiction include:
- Depression or anxiety.
- Loss of appetite.
- Mood swings and irritability.
- Nausea and dizziness.
When sold as over the counter medicines, it is very difficult to regulate and monitor the purchase of codeine products.
The role of pharmacists
The role of pharmacists in the prevention of codeine abuse has been acknowledged and the concept of pharmaceutical care is encouraged whereby pharmacists and healthcare practitioners take responsibility for their patient’s drug therapy needs. In terms of the Good Pharmacy Practice Requirements, a pharmacist’s first concern must be the welfare of the patient and of the public in general.
In addition, a pharmacist’s main role in providing healthcare is to promote the rational and economic prescribing of medicines and optimal use thereof. This places an element of accountability on those dispensing as a custodian of medicines whose role is to weigh up the risks and benefits of each treatment. When dispensing potentially addictive medication, the onus is thus on the pharmacist to ensure that the patient is given the correct advice.
Further, to prevent the up-scheduling of codeine products, the Codeine Care Initiative was created. Up-scheduling codeine products would be detrimental to a responsible patient using the medication correctly because that patient would need to spend time and money consulting with a doctor to obtain medication which could be readily available for minor complaints and illnesses.
In addition, up-scheduling would have a significant financial impact on pharmacies and pharmaceutical companies. South Africa is one of the highest consumers of codeine in the world and one of the few countries allowing the sale of codeine products over the counter and is therefore not unique in its desire to further regulate codeine products. In several countries awareness has been raised on the abuse of pharmaceutical preparations not requiring prescriptions. To align South Africa with international standards, pharmacists need to be able to view a person’s codeine medicine purchase history.
The Codeine Care Initiative goes further than existing regulations to curb the potential abuse and misuse of codeine and involves various role-players such as independent and corporate pharmacies, social welfare organisations and the narcotics unit of the South African Police Service to name a few.
While it is a requirement that records be kept of all schedule 2 drugs, this exercise has been argued as ineffective because purchase records are only kept at the particular pharmacy where the purchase was made, meaning an individual would be able to obtain schedule 2 drugs at one pharmacy and then visit another pharmacy shortly after to purchase more schedule 2 drugs, the second pharmacist being unaware of the first purchase.
When purchasing codeine products individuals will need to provide the pharmacist with their identity number or passport number. By creating a national database or registry of consumers, pharmacists will be able to conduct patient usage checks using their own dispensing software.
The aim of this registry is to:
- Empower pharmacists to abide by their legal and ethical duties to safeguard the best interest of patients using codeine. Information and advice on the use and potential abuse of codeine must be provided to all patients, as well as where to obtain help for addiction, if necessary;
- Adhere to the record-keeping requirements imposed by the Medicines and Related Substances Act.
- Encourage pharmacists to determine whether or not the possession and use of codeine is lawful.
- Aid pharmacists in providing de-identified aggregated statistics to regulators on codeine sales. This information is required to assist regulators in developing appropriate future interventions regarding codeine sales.
The registry therefore aims to assist pharmacists in identifying unlawful possession and use, which would otherwise have gone undetected. The pharmacist will then be in a position to make a judgment call about dispensing the codeine containing product. He or she could also educate the patient about addiction and refer him or her for counselling and rehabilitation if necessary.
The Codeine Care Initiative will assist in tracking the use of codeine to determine whether the consumption of codeine in South Africa is excessive. It will also instill a culture of responsible medicine use among individuals, pharmacists, healthcare professionals and pharmaceutical manufacturers. By identifying the patterns of misuse and potential abuse, regulations can be put into place which ensure that codeine products are used for the therapeutic purpose for which they were intended.
Author: Roxann van Rugge, Professional Trainer and Legal Advisor to the Daly Morgan Group