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Home > From a legal perspective-Pieter Theron LL.B


(B.Pharm – North-West University, Potchefstroom. LLB – University of the Free State, Bloemfontein)
Associate, Elsabe Klinck & Associates (Pty) Ltd

Elsabé Klinck & Associates is a dynamic health care consulting service, focusing on law, regulation and policy in the health sector. They are committed to overcoming challenges in health care regarding policy and law. Their consultants are intensely aware of how these factors influence health care professionals, pharmaceutical companies, medical device companies and other health care stakeholders.

Optometrists Prescribing Medicine

Optometrists Prescribing Medicine: Increased access to healthcare or a possible increase risk for medical-legal claims?

pillsThe HPCSA Board of Optometry recently gained an expansion on the scope of practice for optometrists. Subsequently, the amended schedules to the Medicines and Related Substances Act, No. 101 of 1965 (the Medicines Act) were published, as Annexure 3’s to Schedules 1 to 4 to the Act added by Government Notice 620 in Government Gazette 40041 of 3 June 2016.

In terms of the Medicines Act, a ‘scheduled substance’ is defined as: “means any medicine or other substance prescribed by the Minister under section 22A”. This section 22A, under sub-section (2) empowers the Minister of Health to, “on the recommendation of the Authority”, prescribe the Schedules for medicine. Amendments to these schedules can be done in terms of the powers of the Minister according to section 37A of the Medicines Act. All medicines are subject to a scheduling process on the basis of the substances (active pharmaceutical ingredients) they contain. From the Department of Health and Medicines Control Council (MCC) document on the Scheduling of Medicine, 2.36 Schedulingof Medicines June 2014, the primary consideration in scheduling a substance is its safety profile, in relation to the therapeutic indications for its use. It should also be noted that a substance may be listed in more than one schedule, based on dosage form, route of administration, strength, indication, dose, duration of treatment or a combination of these factors. The scheduling allows for different levels of regulatory control over these pharmacological substances. A higher schedule, e.g. schedule 4, therefore has a lower safety profile than a lower schedule, e.g. schedule 2, and vice versa.

The implication of the above is that the optometrist must understand, and by implication agree to, the increased risk (safety profile) for higher schedules to the patient, user, public. Optometrists should therefore mitigate any of these risks by, for example –

  1. Know the prescribed product in terms of indications, dosage, contra-indication, side-effects, drug interactions and other special precautions.
  2. Obtain written informed consent by discussing the health status, the available options, the benefits and risks with the patient, as is required by the National Health Act, No 61 of 2003. Patients also have the right to refuse this health care at any stage, but must understand the implications of such a refusal.

Any medicinal treatment should be viewed as wholly as possible, and should therefor always include consideration to the known side-effects, drug interactions and other special precautions. These can be found by review of the package insert of any of the relevant medicine or by utilising recognised up to date literature, for example South African Medicines Formulary (SAMF) or Monthly Index of Medical Specialist (MIMS). The ‘side-effects’ normally list all the known possible effects that might be experienced by the patient. They may range from ‘not common’ and ‘not severe’ to ‘very common’ and/or ‘severe’. When prescribing and using the treatment, providers and patients, should always consider if the benefits of using the medicine outweigh the possible side-effects that can be experienced. From the package insert or literature, ‘special precautions’ should, in application and review, be separated and differentiated from that of the ‘contra-indications’. ‘Special precautions’ are the warnings, things to consider and look out for should a patient use the specific medicine with a known condition or with other medication. This must be drawn to the attention of the patient explicitly, and the prescriber must ask relevant questions so as to assess as to whether such a prescription would be acceptable or not. The medication may still be used in some of these instances, but the treatment should be closely monitored by the prescriber and should be discontinued in cases where adverse symptoms occur. ‘Contra-indications’ are those conditions, that if present or known with the patient the treatment should under no circumstances be used by these patients. Again, it is vitally important that the prescriber asks and assesses whether such circumstances are indeed present or not.

Optometrists should always when discussing the health status, the available options, the benefits and risks with the patient, do so in a plain and understandable language keeping in mind the literacy levels of the patient. They should also be given the opportunity to ask questions and have these answered in the same understandable language used to discuss the treatment.


It is clear that with the expansion to the scope of practice, optometrists require increased awareness, enhanced consent and record-keeping and a good understanding of pharmacology and medicines package inserts. Not only should the optometrist ensure knowledge about the medicines, but should also take into consideration all other known illnesses / conditions of the patient, and have clear and open communication with the patient regarding their health status and the implications of medicinal treatment.

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