What medicines do you need prescriptions for and who is authorised to write those prescriptions is not a straight-forward matter. In his latest #InsideTheBox column, Dr Andy Gray explains how the system works now and sets out how it might be improved.
In South Africa, medicines are scheduled in a few broad categories: those that can be bought anywhere, in a spaza shop or supermarket; those that can only be bought in a pharmacy, but without a prescription; those that require a prescription from an authorised prescriber; and finally those that are prohibited, except in individual and exceptional cases. There are, in fact, nine Schedules, from S0 to S8.
The process for deciding which schedule will apply starts with an assessment of the evidence, focused primarily on the safety of the active substance in the medicine. Schedules are made and updated by the Minister of Health, on the recommendation of the South African Health Products Regulatory Authority (SAHPRA). In making its recommendations to the Minister, SAHPRA can also request input from an advisory committee, comprised of academics and practitioners.
Who, though, is an authorised prescriber in South Africa?
At first glance, the answer seems obvious - doctors (medical practitioners) who are registered by the Health Professions Council of South Africa (HPCSA). However, one can quickly think of others who prescribe medicines, such as dentists (limited to conditions that are within their scope of practice) and veterinarians (for animals, but not for human patients or themselves).
Every year, Statistics South Africa asks participants in the General Household Survey where they would first seek care if someone in their family is ill or injured. Two-thirds respond that their first port of call would be a public sector clinic. The majority of such clinics are operated by professional nurses. For many South Africa, therefore, the prescriber they are most likely to encounter is neither a medical practitioner nor a dentist, and yet they expect to be provided with medicines, including medicines that are scheduled as prescription-only.
In the immediate post-1994 era, many amendments to health-related laws included a section along the lines that "This Act binds the State". The intention was to make it absolutely clear that, contrary to the principle inherited from English law, the State was subject to the same law as everyone else. In other words, if a medicine was prescription-only, that status would apply in both the public and the private sectors.
South Africa's National Drug Policy was issued in 1996, but has never been revised. Whether it remains fit-for-purpose is questionable. Nonetheless, one of the short policy statements in the document still informs current legislation and practice; it states simply: "At primary level, prescribing will be competency, not occupation, based." In other words, provided competency can be assured, the range of authorised prescribers can be extended beyond medical practitioners, dentists and veterinarians.
Implementation of the policy was enabled by amending South Africa's medicines law in 1997. The amendment allowed the Minister of Health, on the recommendation of SAHPRA, to add annexures to the Schedules, specifying which medicines could be prescribed by other "authorised prescribers". Before being extended such prescribing privileges, these health professionals would have to be deemed competent by their statutory health councils. In some cases, this would require completion of additional training, beyond the primary qualification on which they were registered to practise. In other cases, this training is incorporated in the primary qualification. To date, the Minister has gazetted annexures for a range of emergency personnel, optometrists, podiatrists, dental therapists and oral hygienists.
Where does that leave the professional nurses who are the backbone of the primary healthcare clinics relied upon by the majority of patients?
A new Nursing Act was passed in 2005 and all sections of that Act were brought into effect by 2008. This Act enables the registration of specialist nurses who would be able to prescribe medicines, on completion of a prescribing qualification and training.
No progress has however been made in accrediting such qualifications or in creating the necessary specialist registers.
Partly, the reason for not making any progress is that a "back door" was left open, including a critical portion of the previous Act in the new Nursing Act. Section 56(6) of the 2005 Act mirrors section 38A of the 1978 Act. The section enables the medical practitioner in charge of a national, provincial or local government health service to issue a permit to a nurse, allowing that nurse to prescribe and dispense medicines independently.
There are some restrictions, in that an existing 1984 regulation limits the nurse to medicines containing substances in Schedule 4 and below. Updating that regulation could enable nurses to provide much-needed mental health and palliative care services, which often require access to Schedule 5 and Schedule 6 medicines.
What of competency?
Although there is a stated preference for nurses to have undergone some additional training, that is not a legally binding requirement. Additional certification is required for nurse initiation and management of antiretroviral therapy (NIMART), but even that is not entrenched in law.
A convenient "back door" has, it appears, provided an excuse for failing to complete the process envisaged in the Nursing Act, aligned with medicines legislation.
There is an additional problem - no medicines are listed in the Schedules for clinical associates, and they cannot rely on section 56(6). Clinical associates are mid-level health care providers, registered with the Health Professions Council, who were introduced in South Africa in 2008. As previously reported (see here and here), failing to comply with all of the processes to enable clinical associates to prescribe legally has severely limited their usefulness to the health system.
What about the private sector?
A number of organisations have been designated by the Director-General of Health in order that they may also use the "back door" provision in the Nursing Act. The majority of nurses in occupational health services and other private sector settings rely on a more general exception from the Director-General, in the form of Section 22A(15) permits, allowing them to "acquire, possess, use or supply" specific medicines. The same provision is relied on by pharmacists who have untaken additional training and are recognised as primary care drug therapy (PCDT) practitioners. An extension to HIV-related services (PIMART) is on hold, pending a ruling from the Supreme Court of Appeal.
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If all of this sounds impossibly convoluted, spare a thought for the range of allied health practitioners who can prescribe within their disciplines, such as homeopaths and Chinese Traditional Medicine practitioners. They are also subject to the same medicine laws. At present, none of the products they provide have been included in higher, prescription-only schedules.
There is a general truism that medicines are not ordinary articles of trade. It cannot be denied that all medicines are, to some extent, associated with risks and that access to some medicines should be restricted. The legal approach is to make them prescription-only. The corollary has to be that those authorised to prescribe must be competent to do so, regardless of their professional registration. The enabling provisions exist in South African law and are working. However, in the case of public sector nurses and clinical associates, the "back door" approach has been too easy, and expediency has won over principle. Both efficiency and effectiveness are needed to gain the greatest benefit from medicines.
*Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is the second of a new series of #InsideTheBox columns he is writing for Spotlight.
Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.
