For some time now a lot of debate has been on regarding the issue of Over-The –Counter Drugs (OTC) as well as the concept of self medication. Thus the question arises: would it be regarded as self medication if I bought an OTC to treat myself of an ailment or what? Also, what ethical behaviours must one observe when buying an OTC drug?
According to Wikipedia, “Self-medication is a human behaviour in which an individual uses a substance or any exogenous influence to self-administer treatment for physical or psychological ailments.” It is therefore instructive to note that, “The most widely self-medicated substances are over-the-counter drugs used to treat common health issues at home, as well as dietary supplements.” For instance in 2016, India’s drug regulator declared that a proper definition must be given to OTC drugs if it hoped to achieve any change, adding that it would greatly clarify which medicines are safe for the public to buy.
Here in Nigeria unlike in India, there is no proper definition as to which drugs require a prescription; at the same time, the general public does not have a clear understanding as par which medicines do not require a prescription for sale. Hence the National Agency for Food and Drug Administration and Control (NAFDAC) in collaboration with the Health Ministry and the Pharmaceutical Society of Nigeria (PSN), should see this as a challenge to properly map out a regulation and further enlighten the public on it.
It is extremely important that the regulators draw a separate list of drugs which can be sold without a prescription. Generally people presume that certain drugs they are used to do not require a prescription; by creating a legal demarcation for these drugs, it is bound to help the government better regulate the sector apart from enabling them curtail the unlicensed sales of prescription-only drugs, such as antibiotics.
The importance of OTC drugs
All over the world, OTC medicines are an important class of drugs. This refers to any medicine that can be sold directly to the general consumer; the meaning can be stretched to cover differing categories, and varying from one place to another.
Many at times though it does not necessarily mean that the drugs are factually sold over a counter as the term implies. But from observation, these products are also being bought just as if you’re purchasing provisions from a store.
According to the American Consumer Healthcare Products Association (CHPA), 81% of US adults use OTC drugs as a first-line treatment for inconsequential ailments. The association further suggests that the average consumer makes about 26 trips to buy OTC drugs annually, in contrast to a mere three visits to their doctor. Statistics show that in the US there are over 750,000 retail outlets dealing in OTC products, compared to 54,000 pharmacy stores. Experts warn however, that “Without affordable and accessible OTCs, underserved populations would depend more heavily on the highest cost medical care for minor ailments.”
Usually, OTC drugs are seen as any drug which is not considered prescription-only medicine. For example, in the UK medicines come in three known categories: prescription-only (available from a pharmacist to a specific patient); pharmacy medicines (which can be sold by a pharmacist without prescription); and general sales list (which can be sold anywhere, including supermarkets). The last group takes account of painkillers such as paracetamol, as well as body creams and anti-allergy drugs.
And this kind of categorisation is very useful and important seeing that OTC medicines are harmless for most of the people; they are applied for the treatment of not too serious illnesses, therefore it would not be commercially or medically reasonable to restrict the availability of these drugs. On the other hand, since ethical drugs are by and large very potent, and only appropriate for particular patients, they should not qualify to be on retail sale.
Yet, as experts have agreed, there should be no hard and fast rule to this. This is why sometimes you would still see a prescription drug being reclassified as OTC or the other way round owing to new evidence, and we very well know that there isn’t one rule binding the whole world.
The OTC problem
There is an urgent need to dutifully draw these classifications, and Nigeria will do well to give OTC drugs legal recognition. In the US the OTC market according to the Pew Charitable Trusts, “now includes more than 300,000 products with annual sales of $32 billion. The items are diverse, ranging from antiperspirants and sunscreens to cough and cold medications and pain relievers.”
Not being able to regulate this market in Nigeria should be a source of worry because it increases the risk of improper consumption of OTC medicines. In India for example, a study conducted in 2016 by the India Pharmacopoeia Commission discovered a rising incidence of adverse reactions which led to the conclusion: “The present study reveals that safety of OTC drugs is a matter of grave concern. Therefore stringent safety monitoring and regulations are needed.”
Inadequate regulation is the reason we still see a number of ‘prescription-only’ drugs at our over the counter sales. It is for the same reason that ‘simple’ medicines sometimes looked upon as low-risk such as paracetamol, as well as some higher-risk products get recategorised from time to time in different places at various times.
Antibiotics for instance, are most of the time purchased without a doctor’s prescription, adding to the rising problem of antibiotic resistance. And the downside of this is what we already know – proliferation of illegal drug sales especially with the popular ‘chemist’ shops, whereby the poor communities and ignorant people are the hardest hit. This is because obviously in the event of a perceived poor access to health care, the use of OTC products turns out to be a low-cost alternative. Less privileged members of the public are less likely to seek advice from a doctor regarding their state of health thus setting the tone for greater dangers ahead.
Need for future changes
It is therefore vital for the regulatory bodies and the health authorities to draw up a legal framework for OTC drugs, using international models as point of reference. This will in no small measure, help define which drugs are really OTC, paving the way also for litigation against anyone caught in illegal trade of ethical medicines as OTC drugs. This will further enlighten the public, and have significant implications for Nigeria’s pharma sector in the years to come.