How safe are over-the-counter medicines?
Medicine should always be used with the advice your pharmacist gives you, which is free by the way.
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You often hear someone advising a friend, on a specific medicine to use, say, ‘Go and buy such and such a product, it is available as an OTC, you do not need a doctor’s prescription … and it is safe’.
‘I then wonder on what basis they state that it is safe and if the other person understands what an ‘OTC’ is?,’ says Dr Johann Kruger, owner of EDNA Medical Distributors.
OTC’s of course refers to over-the-counter medicine which is available from your pharmacy directly to you as a patient or consumer.
Dr Johann gives us the lowdown on over-the-counter medicine.
The term OTC originated from the way you obtain this category of medicine from a pharmacy in the sense that it had to be kept ‘behind a sales counter’ so that it is not directly accessible to patients or anybody who needs to purchase such a product.
There are several good reasons why it should not be directly accessible which we will discuss a bit later. The more modern way of referring to that category of drug is ‘Pharmacist only medicine’ or ‘Pharmacist prescribed medicine’ and the implication of this wording is that a pharmacist or pharmacist assistant, working directly under the supervision of a pharmacist, must handle the sale of that medicine to a patient, that a permanent record of that medicine is kept on an electronic (or manual) profile of that patient, and that there must be interaction with the patient regarding the purchase of that medicine.
The patient can of course, from regular use of the medicine or by advice from someone else or own research, decide to purchase the medicine out of their own choice, but there should be a consultation with the pharmacist or assistant regarding the safety of the use of the medicine considering the patient’s medical history or drug-drug interactions, or even food-drug interactions. The pharmacist, on the other hand, might advise the patient on the use of a particular OTC drug after discussing the signs and symptoms of the patient with the patient or caregiver.
OTC medicine falls in the category of a Schedule 0 or Schedule 1 or Schedule 2 medicine and is available directly to patients via the route described above and which is, as a result of the safety profile of the particular drug and is classified as such by the South African Healthcare Regulatory Authority (SAHPRA), who, after thorough screening of the drug on a National and International basis determined its safety for self-medication.
Healthcare authorities worldwide might from the outset of the drug registration (for example, paracetamol) decide that the drug is safe under certain conditions for patients to use at their discretion or, as the case was with Ibuprofen, that used to be only available on a Dr’s prescription, determine that the drug, after reviewing its history of use, at a certain dose, is safe for self-medication and thus classify it as an OTC drug.
This ‘safety’ however is provisional – if you stick to the recommended dosage, stick to the treatment period, are not allergic to the ingredients, do use other drugs or even food that might interact with the drug to be used, and do not have an underlying condition that you might not be aware of (for example, inhibited liver function with paracetamol).
Some of these OTC drugs have large potential for addiction, especially the combination painkillers that contain codeine and antihistamines as they not only clear up the pain but also stops anxiety and makes you sleep better – often the result is that the drug gets used for its side effects namely sedation and induction of sleep and then the possibility of addiction is extremely high.
Never use a drug in a dosage higher than recommended, for a treatment period longer than prescribed and at a dosage higher than prescribed! OTC drugs are not allowed to be sold to children under the age of 14 years unless certain provisions are adhered to.
All these factors do not mean that you should not self-medicate but it must be remembered that medicine is not like, for example, cement or paint; it should always be used with the advice your pharmacist gives you (which is free by the way) and the use of that shared with your medical practitioner upon your visits to him or her!
Details: www.edna.co.za or www.medwell.co.za