INTRODUCTION:

The misuse of prescription drugs and the illicit sales of pharmaceuticals without proper prescriptions have emerged as significant public health concerns, creating complex challenges for communities around the world. Prescription drug misuse involves the use of medications outside the scope of a healthcare professional's guidance, encompassing scenarios such as overuse, self-medication, or diversion for recreational purposes¹. Illicit sales, on the other hand, refer to the unauthorized distribution and trade of prescription medications without a valid prescription. Illicit drugs are drugs for which non-medical use has been prohibited by drug control authorities because they are believed to present unacceptable risks of addiction to users.

Together, these practices pose significant risks, including adverse health outcomes, increased healthcare costs, and the perpetuation of a thriving black market for pharmaceuticals^2,3. Many studies have recorded associations between illicit drug use and various health-related harms, but determination of whether such associations are causal is more difficult. To make a causal inference it is necessary to document an association between drug use and the adverse outcome, confirm that drug use preceded the outcome, and exclude alternative explanations of the association, such as reverse causation and confounding⁴. This misuse not only jeopardizes individual health but also strains the healthcare system and places an undue burden on public resources. The absence of proper regulatory oversight in such transactions further exacerbates these issues, as unscrupulous actors exploit regulatory gaps for financial gain, often at the expense of public health^5,6,7.

The Amravati District, situated in the state of Maharashtra, India, has witnessed a surge in the misuse of prescription drugs and sale of drugs without valid prescription raising questions about the adequacy of existing regulatory frameworks and public health interventions, these issues have gained prominence due to their potential impact on community well-being and the healthcare system. Prescription drug misuse involves the use of medications in ways or quantities other than prescribed by healthcare professionals, leading to adverse health effects and societal ramifications. This research endeavors to explore various dimensions of prescription drug misuse and the clandestine sale of medications without appropriate prescriptions within the district. By delving into the root causes, prevalence, and consequences of these practices, this research aims to identify the prevalence and patterns of misuse, understand the factors contributing to such behaviors, and assess the extent of illicit sales in the local context. By examining the interplay of socio-economic factors, cultural influences, and healthcare accessibility, this study aims to provide valuable insights into the root causes of prescription drug misuse in Amravati.

Global Context of Prescription Drug Misuse:

The sale of prescription drugs without valid prescription can contribute to their abuse and misuse. Individuals may seek these medications for non-medical purposes leading to addiction, overdose or other health complications. The global context of prescription drug misuse encompasses a wide range of substances, including opioids, benzodiazepines, stimulants, and other psychoactive medications. The World Health Organization (WHO) estimates that millions of people worldwide engage in prescription drug misuse, contributing to a substantial burden on public health systems. This issue is particularly alarming as it poses risks of addiction, overdose, and other adverse health outcomes. Prescription drug misuse has emerged as a formidable global challenge, prompting the World Health Organization to recognize its far-reaching implications on health systems, societal well-being, and economic stability⁸.

This issue is heterogeneous, with various factors contributing to its prevalence and impact on a global scale. One of the key aspects highlighted by the WHO is the illicit sale of prescription drugs without proper prescriptions, a phenomenon that significantly exacerbates the challenges associated with drug misuse.

This illicit trade raises serious concerns regarding both the accessibility and accountability within the pharmaceutical distribution system. Illicit sales often lead to a range of consequences, including the unauthorized access to potent medications, potentially resulting in adverse health outcomes for individuals who self-prescribe or obtain these drugs without proper medical guidance. The absence of proper prescriptions undermines the monitoring and regulation of pharmaceutical distribution channels, making it difficult to trace and control the flow of prescription drugs. The impact of prescription drug misuse extends beyond individual health concerns. It poses a substantial burden on health systems worldwide, straining resources and healthcare infrastructure. Governments and healthcare providers are faced with the challenge of addressing the health consequences of drug misuse. Various international organizations, including the WHO and the United Nations Office on Drugs and Crime (UNODC), are actively working towards addressing prescription drug misuse. Efforts involve the development of guidelines, educational campaigns, and collaborative initiatives to promote responsible prescribing practices and raise awareness about the risks of misuse^9,10. National surveys and monitoring systems are documenting the widespread abuse of prescription drugs, and numerous scientific articles over the years have discussed the problems associated with diversion^11,12,13. A few observers consider the Internet to be a significant source for illegal purchases of prescription drugs^14,15.

Factors Contributing to Prescription Drug Misuse:

Accessibility and Overprescribing:

The ease of access to prescription medications, coupled with overprescribing practices by healthcare professionals, contributes to the availability of these drugs for non-medical use.

Social and Cultural Influences:

Cultural attitudes towards medication use, coupled with societal pressures and perceptions of pharmaceuticals, can influence patterns of prescription drug misuse.

Internet and Illicit Markets:

The rise of online pharmacies and illicit markets facilitates the easy acquisition of prescription drugs without a legitimate prescription, exacerbating the global scope of the issue.

Lack of Awareness and Education:

In many regions, a lack of awareness and education about the risks associated with prescription drug misuse contributes to its prevalence.

Epidemiology of Prescription Drug Misuse in India: Prescription drug misuse, a form of substance abuse has become a growing public health concern in India. While the misuse of prescription medications has traditionally received less attention compared to illicit drugs, recent years have witnessed an alarming increase in the prevalence of this issue. This phenomenon is characterized by the non-medical use of prescription drugs, including opioids, sedatives, and stimulants, leading to potential health hazards and societal implications. Studies conducted across various regions of India highlight the prevalence and patterns of prescription drug misuse.

The misuse is observed across diverse demographic groups, including age, gender, and socio-economic status. Commonly misused prescription drugs include opioid analgesics for pain management, benzodiazepines for anxiety and sleep disorders, and stimulants for conditions like attention deficit hyperactivity disorder (ADHD)^16,17.

1. Opioids:

· Tramadol: A centrally acting analgesic often prescribed for moderate to severe pain. Its misuse is associated with its opioid-like effects, leading to sedation and euphoria.

· Codeine-based Cough Syrups: Syrups containing codeine, an opioid, are frequently misused for their cough-suppressant and sedative effects.

2. Benzodiazepines: Alprazolam, Diazepam, Benzodiazepines, prescribed for anxiety and sleep disorders, are misused due to their sedative and calming effects. Alprazolam, in particular, is known for its potential for misuse.

3. Antidepressants: Certain antidepressants may be misused for their psychoactive effects. While not as common as opioids or benzodiazepines, their misuse poses risks and challenges.

4. Several factors contribute to the rise of prescription drug misuse in India. Accessibility to prescription drugs without stringent regulations, inadequate prescription monitoring programs, lack of awareness about the risks associated with misuse, and cultural factors influencing healthcare-seeking behaviors all play crucial roles in this epidemic. The misuse of prescription drugs poses severe health consequences, ranging from addiction and overdose to the development of drug-resistant conditions. Opioid misuse, in particular, has been linked to a surge in overdose-related fatalities. The misuse of sedatives and stimulants can lead to adverse mental health outcomes and exacerbate existing psychiatric conditions^18,19.

Reasons for Misuse:

1. Pain Management: Individuals experiencing chronic pain may misuse prescription opioids to alleviate their discomfort. Lack of alternative pain management strategies and inadequate awareness about the potential risks contribute to this phenomenon.

2. Psychotropic Effects: Some individuals misuse prescription drugs, including benzodiazepines and opioids, for their psychoactive properties. Seeking relaxation, euphoria, or altered mental states, users may misuse these medications recreationally.

3. Self-Medication: Limited awareness about the potential risks and consequences of prescription drug misuse may lead to self-medication. Individuals may obtain these drugs without a proper prescription, underestimating the risks associated with their non-medical use.

Over-the-Counter (OTC) Drugs Availability in India: In India, the regulatory system governing the availability of pharmaceuticals over the counter without a prescription is affected by safety, public health, and the potential for abuse. The regulatory authority understands the importance of making certain pharmaceuticals, such as basic analgesics, antipyretics, and cold treatments, available without a prescription. The availability of over-the-counter drugs in India helps to increase healthcare access, particularly for common diseases and minor health conditions. The OTC availability of drugs raises concerns about responsible usage and potential misuse. Maintaining a balance between accessibility and appropriate medication practices is critical to ensuring that persons can receive necessary treatments while minimizing the risk of addiction or bad effects connected with specific medications. India's regulatory authorities regularly examine and update the list of over-the-counter pharmaceuticals, taking into consideration safety data, evolving health trends, and international best practices^20,21.

Selling medications without a valid prescription poses various concerns to patient safety and well-being. Recognizing and addressing such risks is critical to ensuring safe pharmaceutical practices. The key considerations are.

Improper Medication Use: Patients who obtain prescriptions without permission from their doctor may not receive the necessary information on proper dosage, administration, and potential side effects. This lack of control can lead to incorrect pharmaceutical use, putting patient safety at risk.

Delayed or Inadequate Treatment: The absence of a healthcare professional's evaluation can cause delays in diagnosing underlying health concerns. Patients may not obtain timely and adequate care, negatively impacting their overall health.

Lack of medication Review: In order to spot any drug interactions, pharmacists are essential in going over a patient's prescription history. This crucial step is frequently missed when there is no prescription, which raises the possibility of dangerous drug interactions.

Unmonitored Polypharmacy: Patients who get prescription drugs without a doctor's supervision may unintentionally take more than one medication. When several medications are taken without adequate supervision, the risk of negative drug reactions and interactions increases dramatically.

Self-Diagnosis: Without the assistance of a medical professional, patients may try to diagnose themselves. This self-diagnosis may result in the wrong health concerns being identified, which may lead to unsuitable or inefficient therapies.

Masking Underlying issues: Some symptoms may indicate more serious underlying health issues. Without a proper diagnosis and evaluation, selling drugs without a prescription may conceal these disorders, allowing them to progress uncontrolled.

Lack of Follow-up: When providing prescription medications, pharmacists frequently evaluate patients for treatment efficacy and possible side effects. In the absence of a prescription, there is no structured follow-up, leaving patients without the essential monitoring and modifications to their treatment regimens.

Missed Opportunities for Counseling: Patients buying drugs without a prescription may miss out on vital advice from pharmacists. Counseling is essential for ensuring adequate medication adherence, discussing potential side effects, and addressing any concerns the patient has.

Antimicrobial Resistance: The sale of antibiotics without a prescription contributes to the global challenge of antimicrobial resistance. Overuse of antibiotics can result in the emergence of bacterial strains that are resistant to treatment, making infections more challenging to cure.

Possibility of Substance Abuse: Drugs that have the potential to be abused, such opioids and some sedatives, may be supplied without the necessary supervision. This could have an impact on society and public health by increasing the likelihood of substance abuse and addiction.

COVID-19 Impact: The COVID-19 pandemic has led to significant modifications in the healthcare environment, affecting many parts of the pharmaceutical industry, including the sale of medications without legal prescriptions. Two prominent contributors to this impact are the growing use of telemedicine and the increased reliance on online platforms.

Telemedicine and Remote Consultations: The pandemic has accelerated the use of telemedicine and remote consultations as the primary methods by which individuals can get prescription drugs and medical advice. In order to limit face-to-face communication and stop the virus from spreading, healthcare professionals are using virtual platforms more and more to interact with patients.

This change has transformed the conventional method of getting prescriptions and made it possible for people to visit medical specialists from a distance. The emergence of telemedicine indicates that people can obtain prescriptions without physically visiting a medical facility, having effects on drugs sales. Due to the possibility of more relaxed standard restrictions to remote prescription issuing compared to in-person consultations, this changing situation may have an impact on the selling of pharmaceuticals without valid prescriptions^22,24.

Legal and Regulatory Framework in India for Pharmacist:

1. Drugs and Cosmetics Act, 1940:

The Drugs and Cosmetics Act, 1940 is the primary legislation that regulates the import, manufacture, distribution, and sale of drugs in India. It classifies drugs into prescription drugs and over-the-counter (OTC) drugs. Section 42 of the Act prohibits the sale of prescription drugs without a valid prescription from a registered medical practitioner²⁵.

Prescription Requirements:

According to the Act, certain drugs are categorized as prescription drugs, which means they can only be sold with a valid prescription from a registered medical practitioner.

Schedule H and H1 Drugs:

Schedule H and H1 of the Act include a list of drugs that are meant to be sold only on the prescription of a registered medical practitioner. These schedules are periodically updated.

2. Narcotic Drugs and Psychotropic Substances Act, 1985:

The Narcotic Drugs and Psychotropic Substances Act of 1985 is an important legislation in India that addresses the control and regulation of activities associated with narcotic drugs and psychotropic substances. Enacted to combat the rising concerns related to the misuse and abuse of these substances, the Act establishes stringent measures aimed at preventing their unauthorized usage and distribution. Its primary focus is on curbing the illicit trade, trafficking, and consumption of substances that possess a high potential for abuse and addiction. This comprehensive legislation encompasses various aspects of the handling of narcotic drugs and psychotropic substances. It extends its regulatory framework to cover the entire spectrum of activities, including the manufacture, sale, transport, warehousing, use, consumption, import inter-State, export inter-State, import into India, export from India, and transshipment of these substances. By addressing each stage of the supply chain, the Act aims to create a strong system that mitigates the risk of diversion and misuse.

The Act incorporates provisions to ensure strict compliance with the defined regulations. It outlines penalties for offenses such as illegal production, cultivation, possession, and trade of narcotic drugs and psychotropic substances. Additionally, it establishes the Narcotics Control Bureau (NCB) as the central agency responsible for coordinating actions to combat illicit drug trafficking and enforce the provisions of the Act. The NCB plays a crucial role in coordinating with various law enforcement agencies to curb the illegal drug trade across the country²⁶.

3. Pharmacy Act, 1948:

The Pharmacy Act of 1948 stands as a crucial legislative framework in India, designed to comprehensively regulate both the education and practice of pharmacy within the country, authorize with the objective of ensuring the highest standards in pharmaceutical education and professional practice, the Pharmacy Act plays a fundamental role in shaping the landscape of pharmacy services in India. One of the primary aspects addressed by the Pharmacy Act is the delineation of qualifications necessary for individuals to practice pharmacy. It outlines the educational prerequisites, professional training, and licensing requirements that aspiring pharmacists must fulfill to be eligible for practice. This meticulous standardization of qualifications is essential in maintaining the integrity and competency of the pharmaceutical workforce. The Pharmacy Act serves as a vigorous mechanism for setting and upholding standards related to the sale of drugs. Pharmacists, as guardians of public health, are entrusted with the responsibility of dispensing prescription medications. This critical role not only ensures that patients receive the right medications as prescribed by healthcare professionals but also acts as a safeguard against the unauthorized sale of prescription drugs without a valid prescription²⁷.

4. Medical Council of India (MCI) Regulations:

The MCI, established under the Indian Medical Council Act, aimed to maintain high standards of medical education and practice across the country. The regulatory framework provided by the MCI encompassed various aspects of medical professionalism, including ethical standards, education, and practice guidelines. Prescribing medications without a valid medical reason and engaging in the unauthorized sale of prescription drugs are actions explicitly denounced by the regulatory body. These practices not only violate established medical ethics but also pose significant risks to patient health and well-being. Similarly, the unauthorized sale of prescription drugs without a valid prescription is considered a breach of professional conduct. This practice can lead to the misuse and abuse of potent medications, contributing to public health risks such as drug resistance, adverse reactions, and the potential for addiction²⁸.

METHODOLOGY:

A cross sectional study was conducted in which a validated self-administered questionnaire was made containing demographic information of pharmacist such as name, gender, years of experience as a pharmacist, location of pharmacy (urban, rural), which is kept confidential and other information like prescription drug sales, sale of drugs without prescription, information about customers buying drugs without prescription, observations and suspicions about drug misuse, customer interactions, pharmacist's professional role and responsibilities Some of the questions are answerable as Yes and No, some are open ended responses and some questions are provided with specific range of options these are specifically based on observation of individual purchasing drugs by pharmacists. This questionnaire based observational survey contain 15 questions. The questionnaires were filled by the respondents and returned back within the next 10 minute.

Design of the Study is as:

1. Questionnaire was prepared based on the topics such prescription drug misuse, sale of drugs without valid prescription and some related to personal views of the pharmacists.

2. Questionnaire survey forms were finalized and printed.

3. All the medical stores were physically visited and the views of the pharmacists were collected on the survey forms.

4. The collected data was evaluated.

Points To Be Considered For The Preparation Of The Questionnaire:

1. Background Information: Basic demographic details, such as the pharmacist's name, years of experience, and the name of the pharmacy.

2. Legal Awareness: Include a question to assess the pharmacist's knowledge about the Drugs and Cosmetics Act, 1940, to understand their awareness of relevant legal regulations.

3. Conceptual Familiarity: Inquire about the pharmacist's familiarity with the concept of prescription drug misuse to assess their awareness and understanding of the issue.

4. Dispensing Practices: Exploring the daily dispensing practices by asking about the total number of prescription drugs dispensed daily and the number dispensed without a prescription.

5. Customer Demographics: Investigate the demographics of customers visiting the pharmacy without a valid prescription, including the number of male and female customers.

6. Customer Behavior: Assess the age group of frequent buyers for drugs without a valid prescription to identify patterns and potential target groups.

7. Customer Frequency: Determine whether the pharmacist observes any customers visiting frequently, with or without a valid prescription, to understand customer behavior.

8. Observations of Misuse: Investigate whether the pharmacist has observed any customers exhibiting signs of prescription drug misuse in the past three months.

9. Refusal of Dispensing: Assess if the pharmacist has ever refused to dispense a prescription medication due to suspicions of misuse, exploring their proactive role in preventing misuse.

10. Post-COVID Sales Impact: Investigate whether the pharmacist has noticed a surge in the sale of drugs without a prescription after the COVID-19 pandemic to understand potential shifts in consumer behavior.

11. Training and Education: Exploring the pharmacist's belief in the necessity of additional training or education on recognizing and addressing prescription drug misuse, gauging their receptiveness to ongoing professional development.

Questionnaire:

1. Do you know about Drugs and Cosmetics Act 1940, Pharmacy Act, 1948?

2. Are you familiar with the concept of prescription drug misuse?

3. How many prescription drugs do you dispense daily?

4. How many drugs do you dispense daily without prescription?

5. How many Male and Female customer visits the pharmacy during the last 3 months without a valid prescription?

6. Which age group is Frequent buyer for drug without a valid prescription?

7. In the past month, have you observed any customers exhibiting signs of prescription drug misuse?

8. According to your observation what percent of customers request for Schedule H and Schedule X drugs without a valid prescription monthly?

9. Which are the commonly dispensed drugs without valid prescription?

10. Do you observe any customer visiting frequently with or without a valid prescription?

11. Have you ever refused to dispense a prescription medication due to suspicions of misuse?

12. Do you see any surge in sale of drugs without prescription after covid 19?

13. Do you believe that your role as a pharmacist should include referring individuals to medical professionals for suspected misuse cases?

14. Should pharmacists be involved in the development of harm-reduction programs for individuals misusing prescription drugs?

15. Do you believe additional training or education on recognizing and addressing prescription drug misuse is necessary for pharmacists?

RESULT AND DISCUSSION:

This is the first study in which we evaluated and compared information and vision on awareness of the Drugs and Cosmetics Act1940 and the Pharmacy Act 1948 among community pharmacists in the Amravati district. The current study had a total response rate of 100 percent. The findings revealed that young pharmacists had higher levels of knowledge and opinion than older pharmacists. As they were students of pharmacy once, this is not surprising as pharmacy students are exposed to all the essentials of handling of prescription and drug misuse in their syllabus during the academic years. It was also visible in the knowledge-based research question to the community pharmacist and they want to know more about misuse of prescription and illicit sale of drug without prescription.

The pharmacies included in the study are physically visited to have one-on-one interactions with the pharmacists. The pharmacist filled and signed this form, which was then collected. The data was divided into two groups depending on urban and rural regions in order to improve assessment. The survey provided insight into the pharmacist's awareness of the misuse of drugs. During the survey, it was discovered that some pharmacists were unaware and lacked basic information about the legal and regulatory framework, whereas others were aware and knowledgeable about the general consideration and were cooperative in nature, willing to share their views and information based on their experience.

The pharmacists who were unaware were given basic knowledge about the legal and regulatory framework, and they were encouraged to avoid dispensing drugs without a prescription and customers frequently visiting pharmacies to purchase drugs for non-medical purposes. During the survey we also encountered certain hurdles with the pharmacists, which were as follows: pharmacists are not cooperative, feeling uncertain owing to lack of knowledge, unwilling to reveal their identify, using excuses like lack of time, avoid answering demographic questions.

Some of the data obtained from the pharmacists is expressed in the form of graphs given below.

Sale of drug with and without valid prescription shows vast variations as the data collected was from various locations but on average prescription drugs dispense daily was 70% while the 30% drugs are sold without valid prescription and the male population was 80% and female population contribute 20%, of this 25% customers request for Schedule H and Schedule X drugs without a valid prescription monthly. The commonly dispensed drugs without valid prescription mostly are Analgesics, Antipyretics, Antacids and Gastrointestinal Medications, Antiemetics, Vitamins and Supplements.

On further splitting of overall data on the basis of urban and rural region key differences can be observed in pharmacy practice ethics and pharmacist’s personal views as well as the dispensing of drugs without valid prescription is more compared to urban region.

CONCLUSION:

This study clarifies community pharmacists' knowledge of the legal and ethical pharmacy practice in the Amravati district. The thorough analysis and comparison of data showed that the pharmacists surveyed had an impressive 100% response rate. A significant pattern surfaced, indicating that younger pharmacists had greater knowledge and opinions than their more senior associates. The findings also revealed a range of awareness among pharmacists, with some lacking fundamental knowledge about the legal and regulatory framework.

The statistics also revealed considerable differences in the sale of medications with and without legitimate prescriptions in various areas. On average, 70% of prescription medications were supplied daily, with 30% being sold without a legitimate prescription. Male consumers represented more frequent visits as compared to females. Overall, with a quarter of customers demanding Schedule H and Schedule X medications without a legitimate prescription. An in-depth study comparing urban and rural areas revealed significant disparities in pharmacy practice ethics and pharmacists' personal perspectives. Notably, giving medications without a legal prescription was more common in rural locations. This study emphasizes the need for focused initiatives to increase knowledge among pharmacists, especially in rural areas, and emphasizes the critical role of education in promoting responsible pharmaceutical practices.

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Received on 19.02.2024 Modified on 23.03.2024

Res. J. Pharmacology and Pharmacodynamics. 2024;16(2):65-72.

DOI: 10.52711/2321-5836.2024.00012