Writing in the May edition of DIA’s Global Forum magazine, Toshiyoshi Tominaga of the Asia-Pacific Self-Medication Industry (APSMI) looks at the landscape for OTC medicines in the Asia-Pacific region today. Tominaga highlights how, against the backdrop of a drop in formal medical interventions due to COVID-19 infection fears, countries are more than ever having to balance the risks and benefits inherent in patients treating themselves with OTC products.
The ongoing COVID-19 pandemic has restricted the opportunities of formal medical intervention for patients in general. Hospitals and clinics are explicitly or implicitly requesting patients seeking only elective treatment to postpone their visits, on account of staff and resource exhaustion as well as fear of their inadvertently transmitting the deadly virus to the vulnerable. Many patients are already reluctant to see a doctor, unless they have a serious condition, for fear of contracting the disease in waiting rooms.
At a more macroscopic level, the pandemic has damaged almost every nation’s economy, seemingly leading to an inevitable decrease in the resources that can be allocated to medical care, especially after emergency countermeasures including the free inoculation against the disease. The situation magnifies the importance of self-care. But there are considerable differences in the drugs that can be used for self-treatment across countries or regions, reflecting each country’s or region’s unique risk/benefit judgment. The “new normal” demands, however, re-adjustment of the balance.
Needless to say, drugs that can be safely used based solely on the judgment of people without medical training are limited; they must have well-established efficacy/safety profiles and be generally recognized as safe. The target diseases should basically be restricted to self-limiting ones with self-recognizable symptoms. But even within the limitations, expanding the accessibility of drugs available without a prescription should substantially empower patients. The expansion is realized through two forms of re-classification: from prescription-only drugs (Rx) to non-prescription or over-the-counter drugs (OTCs), and within OTCs, from pharmacy-only drugs to general sales drugs.
A regulatory decision as to whether to increase the accessibility of drugs hinges on a determination of whether the benefit to be gained by doing so can be justified in light of any additional risk posed by self-medication. The elements of the benefit are not limited to pharmacological gains, such as a user being able to more rapidly obtain relief from unpleasant symptoms, but includes such elements as “enhanced consumer involvement” and “economic benefits” (mentioned in the British guideline “How to change the legal classification of a medicine in the UK”). The risk is the added possibilities of the user’s misuse, abuse, and symptoms of underlying conditions being masked because of less stringent oversight by medical professionals. Another important factor affecting the balance is how knowledgeable the users are about health and medicine in general and the drug in particular. “Health literacy” can lessen the users’ potential risk, increase their potential benefits, and generally work favorably in the setting of self-treatment.
Risk Tolerance Varies by Region
The elements of risk and benefit assessed in the context of health literacy in a particular population are rarely objectively assessed. This contrasts with what happens when approving a novel substance, whose efficacy and safety are frequently assessed quantitatively with clinical trials. As a result, the risk/benefit comparison is affected by society’s regulatory, economic, and political situation as well as its preference and aims. This explains why in some cases a country may decide against switching an Rx ingredient to OTC: Pharmacists might not be able to sufficiently guide the consumer at the point of sale, while the same drug has already been sold in supermarkets in other countries for years.
Risk tolerance regarding OTC products should be higher in a society where there are many uninsured people who must pay prohibitively high prices for prescription drugs than in a society with more comprehensive health insurance coverage. A society that exhibits a greater overall aversion to the potential side effects of medical products should prefer that drugs be used under the close supervision of doctors and pharmacists. When telemedicine becomes more of a normal practice, doctors’ current skepticism regarding in vitro diagnostics and smart phone applications might fade.
As the secretary to the Asia-Pacific Self-Medication Industry (APSMI, which consists of OTC industry associations from China, Chinese Taipei, Korea, Japan, Indonesia, Philippines, and Thailand, as well as several OTC manufacturers operating in the region), I have observed that OTCs are more conservatively regulated in Asia than in Europe and America; OTC sales are limited to licensed outlets (pharmacies and lesser licensed drug stores), like in most of the European countries, but not the US, which has no federal-level regulations on retailing OTC drugs. Some countries in the region have guidelines that identify the characteristics of Rx-to-OTC switchable ingredients, but even such countries seldom have effective regulatory pathways to implement switching. To give one example: While omeprazole was first re-classified as an OTC product in Sweden in 1999, it was switched to OTC status in Chinese Taipei in 2018 for the first time in the region, with no Asian country to date following suit.
This hesitation is partly because the regulations of OTCs are often not completely developed or separated from those for Rx in Asian countries. But one could argue that it also derives from the expected roles of society or the regulatory authority: Asian societies tend to be more paternalistic towards their members and more reluctant to expose consumers whom they do not expect to have a high level of health literacy. Consumers in Asia also do not seem to be particularly eager to undertake the freedom (and personal responsibility) of using drugs on their own. This tendency, if indeed reflective of reality, is neither positive nor negative; it is merely a matter of how each society chooses to spend its resources, influenced by local culture and norms.
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