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Rx to OTC switches: risk v/s convenience

As more prescription drugs go the OTC way, is there a way to lessen the risk of self medication? Suja Nair analyses

"The FDA policy has been not to approve a switch of a prescription drug to OTC status until there is sufficient marketing experience as a prescription product, typically at least five years, to ensure that patient and public health will not be adversely impacted" - Alok Saxena, Director (International), Elder Pharmaceuticals

"OTCs help the patients by way of saving time and costs, as it avoids visits to physician and payment of consultancy fee. This shift is more beneficial to large pharma companies, who prefer to shift their off-patent molecules to OTC products to fight generic players" - Dr Saranjit Singh, Professor and Head, Department of Pharmaceutical Analysis, and Dean NIPER

"If the OTC medicines are properly classified, they may become household products which do not harm the patients and in unitary family, members do not have to go to doctors for minor low risk ailments. They can approach pharmacists who can guide them on dosage and other aspects of the medicines" - Dr R B Smarta Managing Director Interlink Marketing Consultancy

Self medication seems to be the simplest thing to do when we are sick, especially when we aware of our illness. But how safe is it to self-prescribe? Practically speaking it is very risky as the danger of self medication can have serious implications, but once you get to know the name of the drug and its over-the-counter (OTC) brand names, then people do prefer it over consulting a doctor and taking a prescription (Rx) drug.

Pharmaceutical companies have to consider a few parameters when deciding if a particular product can be converted from Rx to OTC. The drug in question has to have a significant amount of experience in the market, its safety and stability profile should have been established over the years, and most importantly, the drug is for minor health problems.

According to Dr Saranjit Singh, Professor and Head, Department of Pharmaceutical Analysis, and Dean, National Institute of Pharmaceutical Education and Research (NIPER), "Availability of drugs as OTCs help the patients by way of saving time and costs, as it avoids visits to physician and payment of consultation fee. This shift is more beneficial to large pharma companies, who prefer to shift their off-patent molecules to OTC products to fight generic players." Over the years there has been an increase in the number of Rx drugs becoming OTC. Right now the OTC market size is worth more than $3.5 million, which is significantly going up. Why is it that some drugs are increasingly being available as OTC? Explains Dr R B Smarta, Managing Director, Interlink Marketing Consultancy, "Over time, when Rx medicine is repurchased by the patient on his own, as there is less risk in treating himself due to his own use of the same medicine earlier and getting the expected results, this medicine gets into the fold of OTC. As of today India has not formulated the category of OTC and the definition is still unclear."

Rules of the shift

In India, the OTC phrase has no legal endorsement. Drugs that are not included in the list of prescription-only drugs are considered as non-prescription drugs or OTC drugs. Singh informs that Rx drugs are listed in Schedules H and X of the Drug and Cosmetics Act & Rules (DCA&R), whereas drugs listed in Schedule G (mostly antihistamines) do not need prescription to purchase, though it requires a mandatory text on the label-- 'Caution: It is dangerous to take this preparation except under medical supervision'. Currently, very few medicines classified as 'household remedies' are listed in Schedule K of the DCA&R and can be sold by non drug-licensed stores (eg non-chemists) in villages whose population is below 1,000. However, the drugs under these three schedules are currently not advertised to the public under a voluntary commitment by the pharma industry. As far as approval of drugs and its marketing are concerned, it is the duty of the Food and Drug Administration (FDA) to ensure that the drugs are safe and effective. They are also responsible for the approval of Rx to OTC switches as it requires additional clinical trials to determine the safety and effectiveness of drugs promoted for OTC use. However, Smarta feels that the procedures adopted by FDA are not enough, and apart from the available procedures, FDA may have to put together, along with regulatory authorities, a separate bill regarding the nomenclature of OTC category.

Along the same lines Alok Saxena, Director (International), Elder Pharmaceuticals, says, "The FDA policy has been not to approve a switch of a prescription drug to OTC until there is sufficient marketing experience as a prescription product, typically, at least five years, to ensure that patient and public health will not be adversely impacted." He clarifies that the purpose of this practice is to ensure that a drug has had sufficient use under physician supervision in a large population to enable potentially serious adverse reactions and side effects to materialise and be detected before a drug is approved for self-medication and OTC sale. Reactions that may occur due to chronic or repeated exposure can only be uncovered over a substantial period of time.

Behind the pills

Having a choice of OTC drugs is advantageous to consumers as it give them autonomy, faster and more efficient access to effective treatment. Many drugs have been transferred from Rx to OTC and the trend still continues. Tylenol, Advil, Benadryl, Motrin, Tagamet, Gelusil, Revital and Rogaine were some of the drugs successfully switched from prescription-only to OTC category. Usually, the nature of products that are switched are for common ailments like cough, cold, acidity, pain, etc. OTC drugs are sometimes preferred over Rx drugs for many reasons. For instance, for oral drugs the indications for usage is different; also the recommended doses differ as they are normally lower to the Rx. The OTC drug ibuprofen, which is available as both generic and brands like Advilin 200-mg tablets, is used for pain, fever and dysmenorrhoea. Its recommended dose is usually 200 to 400 milligrams three or four times daily, however, with Rx ibuprofen, commonly known as Motrin, dosage may be from 400, 600 to 800 milligrams three or four times daily. In order to get any drug approved as OTC it has to go through many regulations, for instance, the evaluation of evidence that the drug is safe to be used by consumers by using information on the product label. In Rx drugs the doctor determines the need of the drug after the proper diagnosis of the disease.

The pros …

Explaining the positive consequence of a switch from Rx to OTC status, Saxena says that the switch would affect the cost of treatment for many consumers as it will become more affordable and approachable for them. In Rx drugs the doctors can only prescribe the medicine, whereas with the OTC drug it is the patient who makes the decision. But there is a debate on whether this decision is safe in the hands of the patient, who has only his past experiences to go on. One wrong judgment can either make or take his life. On this point, Smarta opines, "If the OTC medicines are properly classified, they may become household products which do not harm the patients and in a unitary family, members will then not need to go to doctors for minor low risk ailments. They can approach pharmacists who can guide them on dosage and other aspects of the medicines." However, he sounds a cautionary note, saying that for this (the use of OTC drugs) to be safe and successful there is also a need to have the pharmacist system ready before such transactions.

… and cons

While the benefits to consumers of Rx-to-OTC switches may be substantial, they also involve some degree of risk, as usage typically expands and physician supervision diminishes. Singh points out that most OTC product packs in India at present do not provide necessary information, like symptoms and diseases in which the product may be used, conditions under which the product is not to be used, possible interaction or side effects, specific age categories, how much to take, what action needs to be taken in the case of an overdose, etc. Also, there is no source from where information can be obtained on risks involved in combining OTCs with prescription drugs. Another pain point is that product labels and leaflets, if any, are generally written in English, which is not understood by nearly 80 percent of India's population. On the same lines Sexena says that clinical trials required for initial product approval also do not involve sufficient numbers of patients (typically less than 2,000) or any chronic or repeated exposure to evaluate low-incidence events or latent events, no matter how serious. While such limited studies may well establish a degree of safety and efficacy and a favourable risk/benefit ratio for patients under direct physician care, the demand still varies when it comes to price and accessibility.

Need of the hour

Whatever may be the reasons, one thing is for sure that OTC product use, though not as trust worthy or risk free as Rx product use, are still sometimes preferred over the latter. Thus, the only thing to do is to channel this shift in a more orderly and safe manner. Stating the different ways to promote safe usage of OTC drugs by means of literature, Saxena says that all retailers and pharma companies have to comply with FDA norms, and also abide by their guidelines. Hence, surprise checks by FDA inspectors and immediate penalisation may lead to better control for both companies and retailers. Any drug can be misused knowingly and unknowingly. Hence, public control on the same may not be possible but repeated warning while advertising may be a solution for awareness. Agreeing to the same, Singh points out that for certain crucial OTC products like anti-histaminics, the Canadian system of 'under-the-counter' should be followed. Under this system, certain crucial drugs do not require a prescription, but an individual who wants to purchase such drugs would receive counselling by pharmacists. Further, he says, "Here there is a big responsibility for the manufacturer to provide information by the best possible way to retailers as well as the patients."

However, Singh points out that the sad part is that pharmacists manning chemist shops in India tend not to pass on essential information to patients, for which they need to be trained. The chemist or seller must have adequate knowledge of OTC drugs, so that they can guide patients regarding the safe usage of OTC drugs. For this, marketing representatives of the manufacturer should take initiatives to properly train chemists. The manufacturer must provide drug facts indicating necessary information, along with OTC products in regional language, so that patient is aware of the product in totality.

suja.nair@expressindia.com