Image reference- https://www.prevention.com/health/a20471095/dangerous-over-the-counter-medicine-combinations/#

OVER THE COUNTER DRUGS: GOOD PRACTICE OR MALPRACTICE

Feb 22, 2022

Over the counter drugs[1], also known as non-prescription drugs are those which one can buy without a doctor’s prescription. On one hand, taking medicines only after having the doctor’s word is rendered necessary, while on the other, over the counter medicines have become a part and parcel of every household’s visit to the pharmacy. One might wonder, why these medicines which are essentially chemicals, are being allowed to be sold freely. Well, that is because they are safe and effective for use[2]. But, with an added condition of ‘if you follow the directions on the label and as directed by your health care professional.’ Under this added condition, the ‘safe and effective for use’ parameter falls into a grey area.

OTC drugs have been useful in cases where patients wish to seek immediate relief from pain, nasal blockage, period cramps, fever, or heavy bouts of cough. This helps patients with mild discomforts to feel alright without spending their time & money at the clinic. The promptness of this process is one of the probable reasons for the popularity of drugs like paracetamol, ibuprofen, and aspirin; all are non-prescription medications.

While talking about such drugs, it becomes important to understand how drugs are regulated and by whom for them to achieve the OTC label. Unfortunately, the term does not have a legal definition in India[3]. Technically, drugs are OTC unless they are specifically stated as prescription-only drugs. Countries such as the US, UK,  Japan, New Zealand have established specific lists and indications for such drugs. Such a list has also been taken out by the CDSCO(Central Drugs Standard Control Organisation, India called the ‘Schedule H’ under the Drugs and Cosmetics Act. Countries such as New Zealand have also fine-tuned their lists to include the varying dosage.  For instance, low-dose ibuprofen (200 mg) is OTC to treat minor pains such as headaches, while high-dose ibuprofen (400, 600, and 800 mg) is a prescription-only medicine used for the treatment of severe pain associated with arthritis[4].

As per US FDA, a brand marketing its product for the OTC label directly or demanding a switch from prescription product to OTC product has to apply to the Division of Nonprescription Drug Products (DNDP). The DNDP then runs several analyses about the consumer studies, post-marketing safety data, and regulatory issues to sanction the product. [5]

Such measures taken by several countries have narrowed down drugs to those which can be safely sold by the pharmacist without a doctor’s sanction. However, a complete guarantee for the safety of these drugs is difficult to harbour. While drugs such as atropine, adrenaline, morphine come under prescription-only medications because of their deleterious side effects and poisoning manifestations, on the other hand, one must not forget that there exists paracetamol poisoning too. Such mishaps occur when the dose taken by the consumer far exceeds the safety level and falls out of the parameter of “safe and effective for use”.

The top dog in this area, currently, is a fever medication as a residue of the COVID pandemic [6]. Drugs like paracetamol, aspirin, and ibuprofen are widely consumed by the public who are not expected to know their hepatotoxic (meaning: injurious to the liver) side effects and abuse potential. Apart from this, major drugs with abuse potential and attention-meriting side effects include codeine-based medicines, cough products, sedative antihistamines, nasal decongestants, and laxatives[7].

The concerning impacts of OTC are accounted by 16.2% for misuse, 2.0% for abuse, and 7.2% for dependence[8]. Even though OTC drugs are not the primary substances of abuse and after the formation of Schedule H, their dependence has considerably reduced, a stricter mechanism of action is required by bodies such as the CDSCO. Establishing separate labels for separate levels of drug approval of patient usage may not be enough, it is also essential to regulate the dose, combinations, and even the number of tablets/capsules/bottles bought in a single visit to the pharmacy. Such measures are essential as every user would not be reading the safety label of the drug.


REFERENCES:

[1] Over the counter drugs. (2018, May 16). FDA. Retrieved November 11, 2021, from https://www.fda.gov/drugs/buying-using-medicine-safely/understanding-over-counter-medicines

[2] Over the counter drugs. (2018, May 16). FDA. Retrieved November 11, 2021, from https://www.fda.gov/drugs/buying-using-medicine-safely/understanding-over-counter-medicines

[3] Marathe PA, Kamat SK, Tripathi RK, Raut SB, Khatri NP. Over-the-counter medicines: Global perspective and Indian scenario. J Postgrad Med. 2020;66(1):28-34. doi:10.4103/jpgm.JPGM_381_19

[4]  Marathe PA, Kamat SK, Tripathi RK, Raut SB, Khatri NP. Over-the-counter medicines: Global perspective and Indian scenario. J Postgrad Med. 2020;66(1):28-34. doi:10.4103/jpgm.JPGM_381_19

[5] Over the counter drugs. (2018, May 16). FDA. Retrieved November 11, 2021, from https://www.fda.gov/drugs/buying-using-medicine-safely/understanding-over-counter-medicines

[6] Shrinivasa M (2022, Jan 23). Unmonitored OTC drug sales for fever a cause for concern. The Times of India: Mysuru edition. https://timesofindia.indiatimes.com/city/mysuru/unmonitored-otc-drug-sales-for-fever-a-cause-for-concern/articleshow/89066824.cms

[7] Cooper R. J. (2013). Over-the-counter medicine abuse - a review of the literature. Journal of substance use, 18(2), 82–107. https://doi.org/10.3109/14659891.2011.615002

[8] Algarni, M., Hadi, M. A., Yahyouche, A., Mahmood, S., & Jalal, Z. (2021). A mixed-methods systematic review of the prevalence, reasons, associated harms and risk-reduction interventions of over-the-counter (OTC) medicines misuse, abuse and dependence in adults. Journal of pharmaceutical policy and practice, 14(1), 76. https://doi.org/10.1186/s40545-021-00350-7

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Tanishka Kochhar

Through my writing I hope to bring my readers closer to the less talked about areas pertaining to health, and be able to change the way people think and do health.

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