Misuse and Abuse of Over the Counter Medication: A Growing Public Health Concern

Kalyani Patil, Ankita Taskar, Sakshi Benke, Komal Ahire, Bhavisha Chaudhari, Vinod Bairagi,

doi:10.5281/zenodo.17991170

Review Paper | Open Access
Volume 02 | Issue 12 | Article Id IJSRT/250312073

Misuse and Abuse of Over the Counter Medication: A Growing Public Health Concern
Kalyani Patil* Ankita Taskar Sakshi Benke Komal Ahire Bhavisha Chaudhari Vinod Bairagi
K.B.H.S.S institute of pharmacy Malegaon, camp Nashik

Abstract

Over-the-counter (OTC) medications sold by pharmacies can assist people in managing their symptoms on their own. Over-the-counter medications can be abused, though, as the risks and addiction are becoming more well acknowledged. The current understanding of OTC medication abuse is outlined in this review. Over-the-counter (OTC) drugs are frequently utilized for self-care because of their price, ease of use, and efficiency in treating minor conditions.However, their increasing misuse (inappropriate or excessive use) and abuse (intentional non- medical or recreational use) have emerged as significant public health concerns. Commonly misused categories include analgesics, cough and cold preparations, antihistamines, laxatives, and decongestants, each associated with risks such as organ toxicity, psychological disturbances, dependence, and accidental poisoning. Addressing this issue requires a multifaceted approach involving stricter regulation, pharmacist intervention, public awareness campaigns, pharmacovigilance, and policy measures. Balancing the accessibility of OTC drugs with effective safeguards is essential to prevent misuse while ensuring their continued role in promoting responsible self-Context & Importance – Highlight the global burden of OTC misuse (statistics, WHO reports).

Keywords

OTC medicine Misuse And Abuse drug , self-medication , Public health issue , regulation

Introduction

There are other ways for people to get medications besides the conventional method of getting prescriptions from doctors. The direct purchasing of medications is a noteworthy substitute. The community or retail pharmacy, from which the metonymic phrase over-the-counter (OTC) is derived and used to denote such products, is the most notable example of this. It is frequently argued that the availability of over-the-counter (OTC) medications offers a number of advantages, such as easy access, a wider selection of medications, and the chance for people to actively participate in their own health and illness management. OTC medications can both be prescribed and purchased directly by individuals (Bond & Bradley, 1996; Nettleton, 2006). Usually, the selection of medications that are accessible in this manner is more constrained than those that are prescribed, with limitations on dosages and indications. However, there has been a persistent tendency toward deregulation, with some medications moving from being available solely with a prescription to being available over-the-counter (OTC) and, more recently, increasing access through online pharmacies (Bessell et al., 2003). The public often perceives OTC medicines as inherently safer than prescription medicines (Bissell et al., 2001; Hughes et al., 2002; Raynor et al., 2007). However, evidence highlights that OTC medicines can pose risks as well as benefits (Lessenger & Feinberg, 2008). These risks include misuse, abuse, and the potential for addiction or dependency. Specific categories of OTC medicines have been implicated, such as stimulants, laxatives, sedatives, and dissociative substances like dextromethorphan. Notably, Lessenger and Feinberg (2008) observed that while such risks exist, the literature addressing OTC abuse remains sparse. Their review, for example, omitted opiate-based OTC analgesics, which are widely available in many countries in combination with ibuprofen or paracetamol. These products raise significant concerns due to their association with addiction as well as gastrointestinal or hepatic damage (Reay, 2009; Frei et al., 2010). In fact, only one previous review (Reed et al., 2011) has explicitly looked at this problem, concentrating mostly on OTC medications and some prescription medications that contain codeine.

Medicine impact of OTC abuse:

There have been reports of OTC medication abuse in numerous nations, with varying items being implicated. Five major categories constantly surfaced in spite of this diversity: cough preparations (especially those containing dextromethorphan), sedative antihistamines, decongestants, laxatives, and codeine-based medications (especially compound analgesics). Disparities in the kinds of medications that are abused seem to be a result of both regional variance and aspects related to study design or methodology. Particularly noticeable was geographic variance, with some nations abusing certain medications more frequently than others. National regulatory frameworks and variations in product availability had an impact on this trend. Adolescent misuse of cough drugs containing dextromethorphan has been documented in the United States, but codeine-based analgesics and cough medications have been extensively linked in a number of other countries. Similarly, regulatory variations led to variation: prescription-only medications can be purchased without a prescription in some areas. According to Albsoul-Younes et al. (2010), pharmacists in Jordan frequently reported abusing benzodiazepines and antibiotics, partly because supply laws were not strictly enforced. Notwithstanding this global diversity, a number of recurring motifs surfaced. For example, in identifying five major categories of over-the-counter medications linked to OTC usage, the Jordanian study mirrored results from several other studies: cough preparations, analgesics, antihistamines, laxatives, and sympathomimetic decongestants (see Table II). This classification is in line with previous research by Matheson et al. (2002) and MacFadyen et al. (2001), who observed that the product that pharmacists in Scotland suspected of being misused the most was Nytol, a brand of the antihistamine diphenhydramine. Likewise, Hughes et al. (1999b) presented comparable results that closely match the methodological strategies used in later research like Orriols et al. (2009).

Definition of OTC medication:

Over-the-counter (OTC) medications are medical supplies that, in compliance with national regulations, can be bought directly by customers without a prescription. The common cold, headaches, musculoskeletal discomfort, heartburn, and allergies are among the mild, self-limiting illnesses for which these drugs are mainly prescribed as first-line or initial therapy. A drug's safety record and shown effectiveness play a major role in determining whether it is classified as over-the-counter. The World Health Organization (WHO) acknowledges self- medication as a crucial part of the changing healthcare system, placing special focus on socioeconomic position, education, and consumer awareness. For instance.

Example of Some OTC drug and their Uses:

Sr. No	OTC Drugs	Uses
1)	Antacids (such as Mylanta, Rolaids, and Tums)	Upset stomach, heartburn.
2)	Antidiarrheal medications (such as peptido-bismol, Imodium A-D, and kaopectate)	Diarrhea.
3)	Decongestant (such as Dipetapp or Sudafed)	Stuffy and runny nose. Postnasal drip. Allergies.

Prescription and Over-The-Counter Medication Lifecycle:

Prescription and over-the-counter (OTC) drugs are categorized according to a number of criteria, such as the drug's intrinsic toxicity, intended use, dosage form, posology, and general safety profile. When deciding whether to reclassify a medication into a more restricted (upward) or less limited (downward) category, post-marketing safety data are also crucial. Typically, medicines used in the management of catastrophic or life-threatening diseases remain under the prescription category and are subject to stringent regulatory oversight throughout their lifecycle, unlike OTC medicines. For a direct-to-consumer product, a New Drug Application (NDA) may be filed in the US. However, the majority of FDA-approved over-the-counter medications first come to market as prescription medications with NDA approval before being converted to over-the-counter status under NDA rules; this procedure is known as a Rxto-OTC transition. However, in addition to meeting the fundamental requirements of toxicity, intended use, dosage form, posology, and safety, a new chemical entity (NCE) or prescription medication must also satisfy additional regulatory requirements that support its appropriateness for non-prescription sale in order to be reclassified to over-the-counter (OTC) status.

Reason of self –medication:

In a populous nation like India, the pitifully low doctor-to-patient ratio creates an atmosphere that encourages the widespread use of over-the-counter (OTC) medications.

Several factors contribute to this growing preference, including both socio- economic and cultural drivers:

1. Use of a previous prescription

2. Saving time and avoiding delays

3. Advice from family members

4. High consultation fees for doctors

5. Overcrowded medical centers and long waiting times

6. Mistrust of medical professionals

7. Nursing advice

8. A pharmacist's advice

9. Ignorance, poverty, and common misconceptions

10. Forceful pharmaceutical promotion

11. Medicines are easily accessible outside of pharmacies.

12. Additional personal or contextual factors

The escalating issue of illegal drug use:

OTC drugs, such as antacids, cough syrups, antihistamines, and pain relievers, are commonly abused, either for recreational purposes, self-medication, or dependency. Typical instances consist:

Cough syrups containing codeine are frequently taken in excess due to their euphoric effects, which can result in addiction and dependency. Paracetamol and other painkillers are frequently misused, which can occasionally cause serious hepatotoxicity and, in the worst situations, death. Weight-loss pills and laxatives are commonly abused, especially by younger people, which might result in metabolic issues and gastrointestinal problems. OTC medicine use increased during the COVID-19 pandemic as people looked for quick fixes for flu-like symptoms like fever, cough, sore throat, and body aches without first seeing a doctor.This trend was largely driven by restricted access to medical facilities, fear of infection, and the urgency for self- management. Consequently, patterns of self-medication and potential misuse of OTC products intensified during this period.

Reason of OTC drug side effect:

Self-medication used inappropriately to treat illnesses and symptoms might result in needless drug use and its side effects. Among the dangers connected to over-the-counter drugs:
Overuse or underuse of medications that work might have disastrous consequences.
Incorrect self-treatment and misdiagnosis can occur when a patient takes the wrong over-the-counter drug, which could conceal or exacerbate a potentially dangerous but curable illness.
A risk-benefit ratio that is unfavorable, especially for disadvantaged groups. Easily available medications have a high potential for abuse and misuse.
High potential for misuse and abuse of easily accessible medicines.
Lack of consumer awareness regarding safety information provided on labels.
Inadequate or unclear labeling of OTC products.
Socio-economic constraints, which drive individuals to self-medicate instead of seeking professional care.
Polypharmacy, where the use of multiple medications without medical supervision increases the risk of harmful drug interactions

Commonly Misused Over-The-Counter (OTC): -

OTC	Medical Use	How it is misused
1)Acetaminophen	Pain Fever	Unintentional overdose with multiple products containing acetaminophen; dose Exaggeration (frequency and amount); use in the incorrect health condition; potentiation by product metabolized by the liver (Alcohol)
2) Non-steroidal Anti- Inflammation (NSAIDs)	General signs of Inflammation	Use of multiple NSAIDs; dose exaggeration (frequency and amount); use in the Incorrect health condition; suicide attempt.
3) Salicylates	Pain Fever Inflammation Blood thinner	Unintentional dose Exaggeration (frequency and amount); use in the Incorrect health condition; interaction with other OTCs or prescribed drug; suicide attempt.
4) Dextromethorphan (DXM)	cough	Use of multiple products containing DXM dose exaggeration (frequency and amount) Confusion with volumes; use in the incorrect health condition abuse for recreational effects; Potentiation by other Licit and / or illicit drugs.
5) Pseudoephedrine	Cold Decongestant	Unintentional use of Multiple products containing pseudoephedrine; dose Exaggeration; use in the incorrect health Condition; abuse for Recreational effects; Sport doping.
6) Laxatives	Emptying of Gastrointestinal tract	Unintentional dose Exaggeration (frequency and amount) Intentional misuse to lose weight.
7) Anihistamines	Cold Allergies Insomnia Motion sickness	Unintentional use of Multiple products containing pseudoephedrine; dose Exaggeration (frequency and amount); use in the Incorrect health condition; abuse for recreational effects; suicide attempt.

OTC drug addiction treatment:

Detoxification is typically the initial stage of treatment for people addicted to specific over-the-counter medications. Cognitive behavioral therapy and other therapeutic modalities that have been shown to be effective in promoting recovery come next.

OTC drug detoxification:

This program offers medical management to alleviate withdrawal symptoms and prevent severe complications or emergencies. It also provides clinical support to address the psychological effects associated with OTC drug withdrawal."

OTC drug rehab:

Rehabilitation programs provide structured and ongoing support to help individuals overcome substance abuse. This program also incorporates behavioral therapies and guidance to encourage positive life change and reduce addictive behaviors. The most common approaches used in the treatment of OTC drug addiction include:

1) Instructional workshops

2) Counseling for behavior

3) Support groups for recovery

4) Development of life skillsude

Commonly misused OTC drug:

Laxatives
Diet pills (Ephedra)
GI ailments: Digene, Zinetac, Uri enzyme, Lomotil, Dulcolax
Skin ailments: Airol, Caladryl, Betadine, Candid, Flutivate, Soframycin
Cough suppressants: Dextromethorph
Pain relievers: Acetaminophen, Ibuprofen
Nasal decongestants: Pseudoephedrine
Antihistamines/Motion sickness: Dimenhydrinate, Diphenhydramine.
Stimulant: CaffeineNutritional supplements: Becosules, Coba Dex, Shelcal, Protinex, Ferrodal

OTC drug withdrawal symptoms:

Regular abuse followed by a sudden reduction or cessation of some OTC drugs may lead to withdrawal symptoms. These symptoms can include:

Mood swings
Anxiety
Irritability
Agitation
Disorientation

Safety of over-the-counter medications:

Special attention to OTC medicine safety is needed in a number of crucial areas, such as. OTC medication safety during pregnancy - guaranteeing safe use to avoid harm to the mother and fetus. Children's over-the-counter pharmaceutical safety: addressing formulations, proper dosage, and abuse risk. The safety of over-the-counter medications in emergency situations: assessing their function,

Classification of over the counter drug:

FDA-approved over-the-counter medications

The U.S. Food and Drug Administration (FDA) has approved a wide range of over-the-counter (OTC) medications, which include:

a) Analgesics and Gastrointestinal Agents: NSAIDs, antacids, antidiarrheals.

b) Allergy and Respiratory Products: Antihistamines, allergy medications, bronchodilators, antiasthmatics, cold remedies.

c) Antimicrobial and Personal Care Products: Antimicrobials, antiperspirants, contraceptives, vaginal products.

d) Dermatological Products: Dandruff treatments, athlete’s foot treatments, sunburn therapies, sunscreens

e) Dental and Oral Care Products: Dentifrices, other dental care products.

f) Gastrointestinal Support: Emetics, antiemetics, laxatives.

g) Ophthalmic Products: Eye drops and related preparation

h) Nutritional Supplements: Vitamins and minerals.

Pharmacists' efforts to curb the abuse and overuse of over-the- counter medications:

In order to identify possible instances of overuse or misuse of over-the-counter (OTC) pharmaceuticals, pharmacists noted that they rely on customer behaviors, attitudes, and established processes. The majority of pharmacists reported that individuals who misuse or abuse OTC drugs can often be identified through their physical appearance, mannerisms during conversations, and facial expressions. Many pharmacists also highlighted behavioral patterns such as frequent visits to the pharmacy, repeatedly requesting the same product, asking for large quantities at once, visiting during peak hours to blend in with crowds, avoiding questioning, and refusing alternative options as common indicators of misuse or abuse. Some patients openly confess the illicit use of these medications, according to a lesser percentage of pharmacists. When asked about methods to identify problematic use, nearly half of pharmacists reported using the WWHAM mnemonic protocol, which involves asking five key questions:

W = Who is the patient?

W = What are the symptoms?

H = How long have the symptoms been present?

A = Action taken so far?

M = Medication currently being taken.

Public awareness, trends, and the function of digital platforms:

Online Promotional Strategies for OTC Products:

The rapid expansion of online platforms and widespread internet penetration has made digital promotion a crucial component of selling over-the-counter (OTC) products. Unlike prescription medicines, OTC products can be purchased without a doctor’s prescription, making them especially suitable for direct-to-consumer marketing. With rising health consciousness and increasing digital engagement, consumers often research products and self-care solutions online before making a purchase. This shift has opened up new opportunities for pharmaceutical companies and health brands to market their OTC products through diverse online platforms.

CONCLUSION: -

In conclusion, while OTC medications are a boon for accessible healthcare, their misuse can quickly turn them into a bane. To address this growing concern, India must implement stricter regulations, ensure effective enforcement, and strengthen public education campaigns. Such measures will help safeguard public health while preserving the vital role of OTC drugs in promoting responsible self-care. For the prevention of OTC drug abuse, pharmacists must be well informed about the medications with a high potential for misuse. As key healthcare providers, pharmacists play a vital role in counseling patients; therefore, effective communication and patient-centered strategies can significantly reduce the risk of abuse. Additionally, a strong pharmacovigilance program, supported by a well-structured healthcare system, is essential to regulate OTC drugs with high abuse potential and ensure better management in preventing misuse.

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