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Abstract

Over-the-counter (OTC) drugs are widely used for self-medication and minor health issues without the need for a prescription. This study aims to evaluate the current trends and level of public awareness regarding the use of OTC medications. A cross-sectional survey was conducted among a diverse population, including students, working professionals, and elderly individuals. The questionnaire focused on the frequency of OTC drug use, reasons for self-medication, knowledge of drug side effects, and sources of drug-related information. Results indicate that while a significant portion of the population frequently uses OTC drugs, there is a concerning lack of awareness about proper usage, potential drug interactions, and side effects. Many respondents rely on advice from non-medical sources such as friends, family, or online platforms. The study highlights the urgent need for educational initiatives and stricter regulations to promote the safe use of OTC medications. Enhancing public awareness can prevent misuse, reduce health risks, and ensure better health outcomes.

Keywords

Over the counter drugs, Self-medication, OTC drugs Practices, Survey on OTC ADCs

Introduction

Over-the-counter (OTC) drugs are medications that can be purchased without a prescription and are commonly used for the treatment of minor ailments such as headaches, colds, allergies, and digestive issues. With increasing accessibility and aggressive marketing, the use of OTC drugs has become a widespread practice globally, including in developing countries like India. While these drugs offer convenience and cost-effectiveness, their misuse due to lack of proper knowledge can lead to adverse effects, drug interactions, resistance (in case of antimicrobials), and masking of serious health conditions. In recent years, the trend of self-medication has grown significantly, especially among younger populations and individuals with limited access to healthcare facilities. Despite their widespread use, there remains a lack of public awareness regarding appropriate dosage, indications, contraindications, and potential risks associated with OTC drug use. This situation raises concerns about public safety and underscores the importance of understanding the patterns and knowledge levels associated with OTC drug consumption. According to WHO definition, self- medication is the selection and use of medicines by individuals to treat self- recognized illnesses or symptoms?. The World Health Organization reports that rational use of medicines occurs when patients receive adequate medication for their clinical needs, at doses corresponding to individual requirements, and at the lowest possible cost for the patient and the community. Taking this definition into account, an effective drug treatment requires patient compliance and supervision of medical professional together.

OTC medicines can be classified into two categories:

• First category OTC medicines are those which were non-prescription medicines since the time they were introduced.

• The second category OTC medicines are those that had been prescription medicines initially but were later shifted to the OTC category.

The WHO Anatomical Therapeutic Chemical (ATC) classification divides them into ten categories:

  • Cough and cold preparations
  •  Antacids
  •  Laxatives
  •  Antithrombotic agents
  •  Analgesics
  •  Antihistamines
  •  Dermatological
  •  Throat preparations
  •  Nasal preparations
  •  Antidiarrheals

Over-the-counter (OTC) drug regulation and safety:

In India:

The Central Drugs Standard Control Organization (CDSCO) regulates all medicines, including OTC drugs. However, India does not have a well-defined legal category for OTC drugs. Medications not listed in Schedule H, H1, or X of the Drugs and Cosmetics Act are often sold as OTC.

Globally: USA (FDA): Drugs are categorized as Rx (prescription) or OTC. For OTC approval, the FDA assesses active ingredients, labeling, and intended use.

Safety Concerns: Despite being considered safe, OTC drugs can pose risks if misused or overused Self-medication risks: Wrong diagnosis, drug interactions, or masking of serious illness.

Side effects: NSAIDs may cause gastric irritation or kidney damage; antihistamines may cause drowsiness.

MATERIALS AND METHODS:

A prospective, cross- sectional and questionnaire base study was conducted among medical the details and purpose of study were explained to students and informed consent was obtained from each respondent. There was one set of questionnaires, consisting of 10 questions related to OTC drugs, it’s about their Knowledge, attitude and practice distributed by using Google form.  All the data was pooled on the given mail and the result was analysed in descriptive statistics.

Statistical analysis: The data obtained by Google forms and the data was analysed into percentages

RESULT:

The results of the present study are presented According to knowledge & practice in the Google

form of graphs which were shown below:

The questionnaire structured to collect data from healthcare professionals are:

1. What does OTC stand for?

A. Over the Clinical

B. Over the Counter

C. Official Treatment Code

D. Over the Capsule

2. OTC drugs are primarily intended for:

A. Chronic diseases

B. Minor health issues

C. Surgical procedures

D. Psychiatric disorders

3. What regulatory body approves OTC drugs in the United States?

A. WHO

B. FDA

C. CDC

D. NIH

4. The major risk of OTC drug misuse is:

A. Immediate cure

B. Severe side effects

C. Faster absorption

D. Longer shelf life

5. The phenomenon where consumers treat themselves without professional advice is called:

A. Self-medication

B. Self-efficacy

C. self-absorption

D. none

6. Awareness campaigns for OTC drugs primarily focus on:

A. Reducing hospital profits

B. Promoting irrational use

C. Safe and informed use

D. Increasing brand sales

7. OTC drug abuse can lead to:

A. Enhanced sports performance

B. Dependency and health risks

C. Better sleep quality

D. Increased concentration

8. An important step in promoting OTC drug awareness includes:

A. Increasing TV ads

B. Restricting access completely

C. Educating the public on safe usage

D. Removing OTC drugs from markets

9. Rx to OTC switch" means:

A. OTC drugs are bann

B. drugs are reclassified as OTC after safety reviews

C. OTC drugs need a prescription again

D. New drugs become available

10. Which of these is a sign of OTC drug misuse?

A. Taking recommended doses

B. Taking drugs longer than advised

C. Following medical advice

D. Asking pharmacist for help

Question analysis given in below graph:

1. What does OTC stand for?

Figure 1:

2. OTC drugs are primarily intended for:

Figure 2:

3. What regulatory body approves OTC drugs in the United States?

Figure 3:

4. The major risk of OTC drug misuse:                    

Figure 4:

5. The phenomenon where consumers treat themselves without professional advice is called:

Figure 5:

6. Awareness campaigns for OTC drugs primarily focus on:

Figure 6

7. OTC drug abuse can lead to:

Figure 7:

8. An important step in promoting OTC drug awareness includes:

figure 8:

9. Rx to OTC switch" means:

figure 9:

10. Which of these is a sign of OTC drug misuse?

Figure 10:

DISCUSSION:

The survey was conducted among a sample of 100 individuals of varying age groups, educational backgrounds, and occupations to assess their awareness and usage trends of over-the-counter (OTC) drugs. The results reveal a significant reliance on OTC medications for minor health issues, along with both positive and concerning trends regarding public awareness and usage behavior. A majority of the respondents (78%) reported using OTC drugs without consulting a healthcare professional. Paracetamol, antacids, and cold medications were among the most frequently used OTC products. The main reasons cited for using OTC drugs were convenience (62%), past experience with similar symptoms (47%), and cost-effectiveness (39%). The awareness level about potential side effects, drug interactions and correct dosage was moderate to low. About 60% were unaware that frequent use of OTC analgesics could lead to complications such as liver damage or stomach ulcers. Similarly, only 34% of respondents knew that certain OTC drugs could interact with prescription medications. There was a noticeable trend where younger respondents (ages 18-30) were more likely to self-medicate compared to older age groups. Educated individuals (graduates and above) demonstrated slightly higher awareness but still lacked complete understanding of drug safety.

SUMMARY:

Over-the-counter (OTC) drugs are medications that can be purchased without a doctor's prescription. They are widely used to treat common health issues such as headaches, colds, fever, allergies, and digestive problems. Their easy availability and low cost have led to a global rise in their use. However, self-medication using OTC drugs also brings risks, such as incorrect usage, side effects, drug interactions, and masking of serious diseases. Recent surveys suggest a growing trend in the usage of OTC drugs in both developed and developing countries. In the United States, the OTC market is well-regulated by the FDA through a monograph system that defines safe ingredients, doses, and labeling. In India, the Central Drugs Standard Control Organization (CDSCO) is responsible for regulation, but the country still lacks a clear, official list of OTC medicines. As a result, many prescription drugs are sold over the counter in practice, raising safety concerns. Public awareness of the proper use of OTC drugs is limited, especially in rural and semiurban areas. Many people rely on pharmacists, friends, or advertisements rather than professional medical advice.

CONCLUSION:

The survey on trends and awareness of Over-the-Counter (OTC) drugs highlights several important insights into the usage patterns, consumer knowledge, and potential risks associated with OTC medications. As the availability of OTC drugs continues to grow, their role in self-medication practices becomes increasingly significant. From the collected data, it was evident that a large proportion of the population prefers OTC drugs for common ailments such as headaches, colds, fevers, and digestive problems. This preference is driven by factors such as ease of access, cost-effectiveness, time-saving nature, and perceived safety of these medications. Many individuals choose OTC drugs as a first-line option before seeking professional medical advice. However, the survey also revealed gaps in awareness and responsible usage. A significant number of participants admitted to not reading labels or instructions before consumption. Additionally, knowledge about drug interactions, contraindications, and potential side effects was limited among users. This lack of information can lead to inappropriate use and may result in adverse effects or drug dependency. The survey further showed that people often rely on advice from friends, family, or the internet instead of consulting pharmacists or healthcare professionals. This highlights a need for stronger patient education and pharmacist intervention in guiding proper drug use. Age, education level, and urban or rural background were found to influence awareness and behavior. Younger and more educated individuals displayed relatively better knowledge, whereas older or less educated participants were more likely to misuse OTC drugs or remain unaware of safety information.

REFERENCES

  1. Abraham, B., Sreeja, P., Sarju, D., & San, S. (2015). Study on self-medication patterns and perspectives of over-the-counter (OTC) drugs. International Journal of Pharma Research and Review, 4(11), 30–34.
  2. Matoulkova, P., Dosedal, M., Rýeková, B., & Kubaná, A. (n.d.). A questionnaire-based survey of residents of retirement communities.
  3. Gupta, V. K., Gupta, C. D., & Patel, J. R. (n.d.). Assessment of awareness and attitudes towards over-the-counter (OTC) drugs amongst urban population: A questionnairbased study.
  4. Kohli, E., & Buller, A. (n.d.). Factors influencing consumer purchasing patterns of generic versus brand name over-the-counter drugs.
  5. Saleem, M. T. K., Sankar, C., Dilip, C., & Azeem, A. K. (2012). Self-medication with over-the-counter drugs: A questionnairebased study. Radix International Journal of Research in Marketing, 1(12), [pages not provided]. ISSN: 2250–3986.
  6. Patel, S. B. (n.d.). Self-medication: Awareness and attitude among undergraduate medical students in a tertiary care medical college, Dhule.
  7. Wazaify, M., Shields, E., Hughes, C. M., &McElnay, J. C. (n.d.). Societal perspectives on over-the-counter (OTC) medicines.
  8. Shoaib, M. H., & Yousuf, R. I. (n.d.). Survey based study on the use of non-prescription drugs among pharmacists and non-pharmacists.
  9. Lakshmi, A. K., Sasikala, B., Sreelalitha, N., Vigneshwaran, E., & Reddy, Y. P. (2012). Assessment of knowledge, perception, and attitudes on medications in the general population. Editorial Board, 6(2).
  10. Bessell, T. L., Anderson, J. N., Silagy, C. A., Sansom, L. N., & Hiller, J. E. (2003). Surfing, self-medicating and safety: Buying non-prescription and complementary medicines via the internet. BMJ Quality & Safety, 12(2), 88–92.
  11. Lynch, S. S. (2023). Overview of over-the-counter drugs - drugs. MSD Manuals. Retrieved May 11, 2023, from https://www.msdmanuals.com/en-in/home/drugs/over-the-counter-drugs/overview-of-over-the-counter drugs#: ~:text=At%20one%20time%2C%20most%20drugs, products%20without%20notificat ion%20to%20users
  12. Meghana, G., Sreegreeshma, S. K., Ravikumar, R. J., & Venkateswara, R. K. (2021). Review of regulations governing switching drugs from RX to over the counter in the USA, India, and EU. Asian Journal of Pharmaceutical and Clinical Research, 12–19.
  13. Wikipedia contributors. (2023, April 18). Over-the-counter drug. Wikipedia. Wikimedia Foundation. Retrieved April 18, 2023, from https://en.wikipedia.org/wiki/Over-the counter_drug
  14. Switching drugs from RX to OTC status – A regulatory perspective. (n.d.). ResearchGate. Retrieved April 16, 2023, from https://www.researchgate.net/publication/312175214_Switching_Drugs_from_Rx_to_OTC_status_ _A_Regulatory_Perspective
  15. IMARC Group. (2023). India over the counter (OTC) drugs market size, share 2023– 2028. Retrieved April 18, 2023, from https://www.imarcgroup.com/India-over-the-counter-drugs-market
  16. Maps of India. (n.d.). O.T.C. market in India. Retrieved April 18, 2023, from https://www.mapsofindia.com
  17. India OTC market size & share analysis – industry research report – growth trends. (n.d.). Mordor Intelligence. Retrieved April 18, 2023, from https://www.mordorintelligence.com/industry-reports/India-otc-drugs-market
  18. Compliance Online. (n.d.). Regulatory requirements: Prescription to OTC switches – USA & India [PDF]. Retrieved May 11, 2023, from https://www.complianceonline.com/articlefiles/Regulatory_Requirements_Prescription_to_OTC_Switches_USA_India.pdf
  19. Das, S. (2018). OPPI OTC Task Force releases Shaping India’s OTC policy 2018. Express Pharma. Retrieved April 18, 2023, from https://www.expresspharma.in/oppi-otc-task-force-releases-shaping-Indias-otc-policy-2018/
  20. Harrington, P., & Shepherd, M. D. (2002). Analysis of movement of prescription drugs to over-the-counter status. Journal of Managed Care Pharmacy, 8(6). http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=6696
  21. Mead, W. J. (2005). Approval and marketing of non-prescription or OTC human drugs. In I. R. Berry (Ed.), The pharmaceutical regulatory process (pp. [insert page numbers]). Marcel Dekker.

Reference

  1. Abraham, B., Sreeja, P., Sarju, D., & San, S. (2015). Study on self-medication patterns and perspectives of over-the-counter (OTC) drugs. International Journal of Pharma Research and Review, 4(11), 30–34.
  2. Matoulkova, P., Dosedal, M., Rýeková, B., & Kubaná, A. (n.d.). A questionnaire-based survey of residents of retirement communities.
  3. Gupta, V. K., Gupta, C. D., & Patel, J. R. (n.d.). Assessment of awareness and attitudes towards over-the-counter (OTC) drugs amongst urban population: A questionnairbased study.
  4. Kohli, E., & Buller, A. (n.d.). Factors influencing consumer purchasing patterns of generic versus brand name over-the-counter drugs.
  5. Saleem, M. T. K., Sankar, C., Dilip, C., & Azeem, A. K. (2012). Self-medication with over-the-counter drugs: A questionnairebased study. Radix International Journal of Research in Marketing, 1(12), [pages not provided]. ISSN: 2250–3986.
  6. Patel, S. B. (n.d.). Self-medication: Awareness and attitude among undergraduate medical students in a tertiary care medical college, Dhule.
  7. Wazaify, M., Shields, E., Hughes, C. M., &McElnay, J. C. (n.d.). Societal perspectives on over-the-counter (OTC) medicines.
  8. Shoaib, M. H., & Yousuf, R. I. (n.d.). Survey based study on the use of non-prescription drugs among pharmacists and non-pharmacists.
  9. Lakshmi, A. K., Sasikala, B., Sreelalitha, N., Vigneshwaran, E., & Reddy, Y. P. (2012). Assessment of knowledge, perception, and attitudes on medications in the general population. Editorial Board, 6(2).
  10. Bessell, T. L., Anderson, J. N., Silagy, C. A., Sansom, L. N., & Hiller, J. E. (2003). Surfing, self-medicating and safety: Buying non-prescription and complementary medicines via the internet. BMJ Quality & Safety, 12(2), 88–92.
  11. Lynch, S. S. (2023). Overview of over-the-counter drugs - drugs. MSD Manuals. Retrieved May 11, 2023, from https://www.msdmanuals.com/en-in/home/drugs/over-the-counter-drugs/overview-of-over-the-counter drugs#: ~:text=At%20one%20time%2C%20most%20drugs, products%20without%20notificat ion%20to%20users
  12. Meghana, G., Sreegreeshma, S. K., Ravikumar, R. J., & Venkateswara, R. K. (2021). Review of regulations governing switching drugs from RX to over the counter in the USA, India, and EU. Asian Journal of Pharmaceutical and Clinical Research, 12–19.
  13. Wikipedia contributors. (2023, April 18). Over-the-counter drug. Wikipedia. Wikimedia Foundation. Retrieved April 18, 2023, from https://en.wikipedia.org/wiki/Over-the counter_drug
  14. Switching drugs from RX to OTC status – A regulatory perspective. (n.d.). ResearchGate. Retrieved April 16, 2023, from https://www.researchgate.net/publication/312175214_Switching_Drugs_from_Rx_to_OTC_status_ _A_Regulatory_Perspective
  15. IMARC Group. (2023). India over the counter (OTC) drugs market size, share 2023– 2028. Retrieved April 18, 2023, from https://www.imarcgroup.com/India-over-the-counter-drugs-market
  16. Maps of India. (n.d.). O.T.C. market in India. Retrieved April 18, 2023, from https://www.mapsofindia.com
  17. India OTC market size & share analysis – industry research report – growth trends. (n.d.). Mordor Intelligence. Retrieved April 18, 2023, from https://www.mordorintelligence.com/industry-reports/India-otc-drugs-market
  18. Compliance Online. (n.d.). Regulatory requirements: Prescription to OTC switches – USA & India [PDF]. Retrieved May 11, 2023, from https://www.complianceonline.com/articlefiles/Regulatory_Requirements_Prescription_to_OTC_Switches_USA_India.pdf
  19. Das, S. (2018). OPPI OTC Task Force releases Shaping India’s OTC policy 2018. Express Pharma. Retrieved April 18, 2023, from https://www.expresspharma.in/oppi-otc-task-force-releases-shaping-Indias-otc-policy-2018/
  20. Harrington, P., & Shepherd, M. D. (2002). Analysis of movement of prescription drugs to over-the-counter status. Journal of Managed Care Pharmacy, 8(6). http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=6696
  21. Mead, W. J. (2005). Approval and marketing of non-prescription or OTC human drugs. In I. R. Berry (Ed.), The pharmaceutical regulatory process (pp. [insert page numbers]). Marcel Dekker.

Photo
Vaishnavi Landkar
Corresponding author

Shraddha Institute of Pharmacy, Washim. Maharashtra, India

Photo
Harish Kumar Rathod
Co-author

Shraddha Institute of Pharmacy, Washim. Maharashtra, India

Photo
Dr. Swati Deshmukh
Co-author

Shraddha Institute of Pharmacy, Washim. Maharashtra, India

Vaishnavi Landkar*, Harish Kumar Rathod, Dr. Swati Deshmukh, A Survey on Trends and Awareness of Over the Counter (OTC) Drugs, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 5, 3690-3698. https://doi.org/10.5281/zenodo.15484443

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