Introduction

Medications abuse is a major global issue,1 involving the use of medicines outside standard prescribing practices and often leading to addiction. Abuse may occur for recreational purpose, intoxication, nervous system stimulation, or euphoria.2 However, data on the scale and prevalence of medication abuse remain limited. Commonly abused medicines include cough suppressants (for example, dextromethorphan), first-generation sedative antihistamines in liquid form (for example, diphenhydramine, promethazine, and dimenhydrinate), and analgesics such as tramadol.3–5 In 2022, a US national survey reported that 1.4 million people aged over 12 or older abused tramadol, while 2.2 million abused non-prescription cough and cold medicine.6 Such abuse is associated with serious health risks, including addiction, cardiovascular effects, agitation, hallucination, and confusion.1,3 Community pharmacists play a key role in reducing medication abuse by counseling patients, restricting access, questioning buyers, and refusing sale when necessary.7

In Thailand, medication abuse is also a major public health concern, although data on its scale and prevalence remain limited. Abuse often involves concoctions mixed with other substances and given specific names. The most well-known is the “4x100” formula, which combines tramadol, cough syrup, first-generation sedative antihistamines in liquid form, boiled kratom leaves, and dark-colored soda. Other variants include “Pro” (promethazine-based) and “Lean” (cough syrup with tramadol).8–11 These drugs are commonly obtained through informal channels such as friends, middlemen, small shops, pharmacies, or social media.10,12–14 and their abuse—driven by curiosity, peer influence, online information, and perceptions of being safer and cheaper than illicit substances.15–17 — has fueled illegal production, as evidenced by raids seizing over seven million tramadol capsules intended for use in the’4X100’ formula.18

The context of drug sales in Thailand differs from that of many other countries, as a fully implemented system separating prescriptions issuance from medication dispensing is not yet in place.19 This situation is commonly observed in developing countries without fully established prescription systems, where patients often request drugs by name, present old packaging, or describe symptoms.20 Drugs in Thailand are classified into four categories, with most community pharmacy medicines failing under the “dangerous drugs” category, with pharmacists may dispense without a prescription.21 This category also includes several drugs that have been abused. Under the Drug Act B.E. 2510, pharmacists are required to be present during all operating hours and to comply with Good Pharmacy Practice (GPP) standards, including reviewing patient history, assessing symptoms, and dispensing appropriately. In practice, however, service data such as buyer information and drug details are not consistently recorded, and the long-standing issue of “hanging-license pharmacies” where pharmacists are absent despite being officially registered, continues to undermine effective regulation.19

The Food and Drug Administration (FDA) of Thailand is responsible for regulating and overseeing health products. In response to concerns about drug abuse, the FDA issued two announcements in 2015 to strengthen the control of “dangerous drugs” in pharmacies. The key provisions include:

List of controlled drugs: The regulations designate 13 drugs as controlled drugs, comprising tramadol, dextromethorphan, and 11 liquid first-generation antihistamines: brompheniramine, carbinoxamine, chlorpheniramine, cyproheptadine, dexchlorpheniramine, dimenhydrinate, diphenhydramine, doxylamine, hydroxyzine, promethazine, and triprolidine. Control measures: (1) Maintaining drug sales records: Pharmacies must document the buyer’s name, drug name, quantity dispensed, and the pharmacist’s signature. Records must be retained for at least three years for inspection. This measure in intended to regulate quantities sold and raise awareness among both sellers and buyers. (2) Compilation of drug sales reports: Pharmacies must submit weekly electronic reports of wholesale drugs sales through the FDA Reporter system to facilitate monitoring and prevent drug diversion. (3) Restrictions on retail sale quantities: (a) tramadol: a maximum of 20 tablets/capsules per transaction; sales are prohibited to individuals under 17 years of age. (b) dextromethorphan: a maximum of 20 tablets/capsules per transaction. (c) dextromethorphan and first-generation antihistamines, in liquid form: a maximum of three bottles per transaction, not exceeding a total volume of 180 milliliters. (4) Limiting monthly wholesale drug sales to pharmacy: Monthly wholesale limits to pharmacies are capped at 1,000 tablets/capsules for tramadol and 2,000 tablets/capsules for dextromethorphan. Exceeding these thresholds requires notification to the FDA. These measures aim to establish concrete mechanisms for regulating the sales of drugs that have been abused while serving as practical enforcement tool for regulatory authorities. And (5) Pharmacists are required to comply with Good Pharmacy Practice (GPP) and personally dispense dangerous drugs: To ensure the rational and responsible sale of medications.22,23

The policy for controlling and regulating the sale of abused drugs has been in effect for many years, however, no data from the Thai FDA are available regarding its effectiveness. Previous research has indicated differences in the perspectives of pharmacy pharmacist and regulatory enforcement pharmacist regarding FDA policy.24 Therefore, it is necessary to examine opinions on the two existing policies governing the control and regulation of drug sales that have been abused, in order to provide a more comprehensive assessment of their implementation and outcomes from the perspective of key stakeholders. The objective of this study is to examine pharmacists’ views on these policies. The findings will inform the development of more effective regulatory measures to ensure appropriate drug sales practices and help prevent further problems related to drug abuse.

Materials and Methods

This study adopts a mixed-method approach to achieve a deeper and broader understanding of the topic. Quantitative surveys were conducted with two groups of pharmacists affected by the policy: (1) pharmacy pharmacists, as practitioners directly experiencing its impact, and (2) regulatory enforcement pharmacists, as policy implements. Examining the perspectives of both stakeholder groups allowed for a more comprehensive assessment for the policy’s implementation and outcomes. To complement these findings, qualitative in-depth interviews were conducted with three groups of participants to provide detailed perspectives on policy measures and uncover insights not captured in the survey. Additionally, professor pharmacists specializing in drug abuse research ware included to offer an academic perspective and overall view of the policy. Data collection took place from 17 April to 31 October 2023. Ethical approval was obtained in the form of accreditation number HE662054 from the Human Research Ethics Committee of Khon Kaen University on 17 April 2023. This study was conducted in accordance with Declaration of Helsinki.

Study Setting

This study was conducted nationwide in Thailand, which comprises six regions—Central, Northern, Northeastern, Eastern, Southern, and Western—including Bangkok, the capital city, and 76 provinces. Within the study area, there are 18,426 licensed modern retail pharmacies and 624 licensed modern wholesale pharmacies, totaling 19,050 pharmacies.25 Regulatory enforcement is carried out by the Thai FDA in Bangkok and 76 provincial public health offices, for a total of 77 offices. This study focused on the policy for controlling the sale of drugs that have been abused, enacted and regulated by the Food and Drug Administration of Thailand (Thai-FDA); therefore, the term FDA in this paper refers exclusively to Thai-FDA.

Samples

Quantitative study: This survey component targeted pharmacists divided into two groups:

Pharmacy pharmacists – The population comprised pharmacists from modern retail and wholesale pharmacies across Thailand, totaling of 19,050 pharmacies.25 The sample size was calculated using Yamane’s formula26 at a precision level of 0.05, resulting in a required sample of 392 pharmacies. To account for incomplete data, the researchers increased the sample size by 10%, bringing the total to 440 participants. The sample was selected using an accidental sampling method, with participants serving as representatives of their pharmacies. Inclusion criteria: (1) Pharmacists working in modern retail or wholesale establishments in Thailand and (2) Willingness to provide informed consent and voluntarily participate in the study. Regulatory enforcement pharmacists – The population comprised pharmacists from pharmacists at the Thai FDA and provincial public health officers responsible for drug regulation. The sample include one representative pharmacist officer from the FDA and one from each provincial public health office, totaling 77 participants. Inclusion criteria: (1) Pharmacists at the FDA or provincial public health offices responsible for implementing FDA policies and (2) Willingness to provide informed consent and voluntarily participate in the study.

Qualitative study: This in-depth interview component targeted pharmacist divided into three groups:

Pharmacy pharmacists – Participants were recruited from modern retail and wholesale pharmacies across Thailand. Inclusion criteria: (1) Pharmacists working in modern retail or wholesale establishments in Thailand, (2) Pharmacies that currently maintain or previously maintained sales records of drug listed under the policy and (3) willingness to provide informed consent and voluntarily participate in the study. Regulatory enforcement pharmacists – participants were recruited from the Thai FDA and provincial public health officers responsible for drug regulation. Inclusion criteria: (1) Pharmacists at the FDA or provincial public health offices responsible for implementing FDA policies and (2) willingness to provide informed consent and voluntarily participate in the study. Professor pharmacists specializing in drug abuse research – participants were recruited from academic pharmacists with expertise in drug abuse. Inclusion criteria: (1) Professor pharmacists with research experience in drug abuse and familiarity with policy for monitoring and controlling the sale of drugs that have been abuse, and (2) willingness to provide informed consent and voluntarily participate in the study.Instrument

The survey instrument had two sections. Section 1 gathered general information: for pharmacy pharmacists, this included position, practice type, pharmacy type, region, years in practice, and the average number of drug sales records completed per day; for regulatory enforcement pharmacists, it included region, years of public service, and experience in consumer protection. Section 2 assessed opinions on the policy for controlling the sale of drugs that have been abused across four area: (1) effects on buyers and seller behavior (sale records, individual and retail quantity limits, and compliance with GPP), (2) agreement with policy statement, (3) perceived impact of the policy, and (4) suggestion for improvement. The instrument was developed by the researchers, validated by four experts, and demonstrated acceptable reliability (Cronbach’s alpha = 0.745).

The in-depth interview instrument was an interview guide that with questions tailors to three participants groups. Common questions for all groups included: How were you informed about the policy? What are your views on its implementation and outcomes? What are the impacts of the policy? and What are your suggestions for the policy in the future? Additional questions were specific to each group. For pharmacy and regulatory enforcement pharmacists, questions included: How do you implement the policy? What resources do you use to comply with it? Other questions addressed the effects of policy announcements, problems or obstacles encountered, and how participants addressed issues that arose. For retail pharmacists, questions also examined changes in drug quantity and purchasing behavior after policy implementation.

The interview guide was developed by the researchers and reviewed by four experts to ensure content validity.

Data Collection

Quantitative study: For pharmacy pharmacists, the researchers sent formal invitation letters to the presidents of three national pharmacy associations: the Community Pharmacy Association (Thailand), the Thai Pharmacies Association, and the Thai Drugstore Association. An announcement was also posted in the closed Facebook group Pharmacafe, which is exclusively for pharmacists in Thailand. For regulatory enforcement pharmacists, formal letters were sent to the secretary-general of the FDA and to provincial public health officers in all provinces. These letters and the Facebook post included an introduction to the study, an explanation of data collection process, and an invitation to participate. Data were collected through an online questionnaire administered via Google Survey. Participants could join the study by accessing the survey link or scanning a QR code provided in invitation. Completion and submission of the online survey implied informed consent, thereby eliminating the need for a signed consent form.

Qualitative study: For pharmacy pharmacists, the researchers sent formal invitation letters to the president of the Community Pharmacy Association (Thailand). For regulatory enforcement pharmacists, formal letters were sent to the secretary-general of the FDA. These letters provided an introduction to the study, explained the data collection process, and requested the names and contact information of the first interviewees from each group. For the professor pharmacists, the researchers contacted participants directly. The researchers then contacted the first interviewees to introduce the study in detail and explain the in-depth interview process. Once the participants agreed and signed informed consent forms, interviews were scheduled at mutually convenient times. Each in-depth interview was conducted online via Zoom and lasted approximately 20–30 minutes. Permission to audio-record the session was requested, if not granted, detailed noted ware taken instead. Participants were asked to provide the contact detail of additional potential participants. Subsequent participants were recruited using a snowball sampling method, and interviews continued until data saturation was reached.

Data collected were kept confidential and were not be publicly disclosed. Results were reported only in aggregate form, with responses and direct quotes anonymized to prevent identification of individual participants, in accordance with the information sheet approved by the Human Research Ethics Committee of Khon Kaen University. Only participants who had provided informed consent were included in this study. All participants provided informed consent, which included publication of anonymized responses/direct quotes.

Data Analysis

Survey data were analyzed using descriptive statistics (frequency, percentage, mean, and standard deviation), while in-depth interviews were analyzed through content analysis with verbatim transcription. Data were coded, interpreted, analyzed concurrently, and accuracy was verified through methodological and data triangulation, to ensure the reliability of the methods and the information gathered.

Results Socio-Demographic Data Quantitative Study

The survey responses included 440 pharmacy pharmacists, representing 100% participation from all regions of Thailand. The majority, 81.36%, were owner pharmacists, and 91.82% worked full-time in their pharmacies. Nearly all (99.77%) were from retail pharmacies, with an average of 10.58 ± 12.62 years of business operation (Table 1). Over 80% of the respondents were aware of and understood the key aspects of all the measures. And the regulatory enforcement pharmacists provided 47 responses, representing 61.04% participation from all 13 health regions of Thailand. The average number of years they had worked in consumer protection was 8.89 ± 7.58 years (Table 2).

Table 1 Sociodemographic Characteristics of Pharmacy Pharmacist Respondents (n=440)

Table 2 Sociodemographic Characteristics of the Regulatory Enforcement Pharmacist Respondents (n=47)

Qualitative Study

The participants included 17 individuals: eight pharmacy pharmacists (six retail and two wholesale), eight regulatory enforcement pharmacists (three from the Food and Drug Administration (FDA) and five from provincial public health offices), and one professor pharmacist specializing in drug abuse research (Table 3).

Table 3 Sociodemographic Characteristics of In-Depth Interview Pharmacist Respondents

Opinions on the Policy for Controlling and Regulating the Sale of Drugs That Have Been Abused

When categorized by specific policy measures, the pharmacists expressed the following opinions:

Maintaining Drug Sales Records

Nearly 80% of pharmacy pharmacists (79.32%) disagreed that recording buyers’ name helps prevent drug abuse, whereas about half of regulatory enforcement pharmacists (48.94%) agreed (Table 4). Both groups showed partial alignment, with 47.73% of pharmacy pharmacists and 54.75% of regulatory enforcement pharmacists agreeing that drug sales records can reduce the sale of drugs that have been abused (Table 5).

Table 4 Pharmacists’ Opinions on the Policy

Table 5 Pharmacists’ Opinions on the Effects of the Policy on Abused Drugs on Seller and Buyer Behavior

Most respondents indicated unintended consequences: 90.0% of pharmacy pharmacists and 89.36% of regulatory enforcement pharmacists believe the policy has driven at-risk individuals to purchase drugs through alternative channels, such as underground markets or the internet (Table 6).

Table 6 Pharmacists’ Opinions on the Impact of the Policy

For policy development, 90.68% of pharmacy pharmacists favored elimination sales records and revising the list of regulated drugs for appropriateness. By contrast, 95.74% of regulatory enforcement pharmacists supported allowing the FDA/Provincial Public Health Offices to accept electronic drug sales records (Table 7).

Table 7 Pharmacists’ Opinions on the Recommendations for Policy Development

Qualitative Findings

Interviews revealed that drug sales records remain paper-based and require a pharmacist’s signature, despite pharmacies use electronic drug sales systems, leading to redundancy.

Drug sales records are collected and kept at the pharmacy, but the data system does not integrate with the FDA, and the FDA does not utilize the information in any meaningful way. This raises a question for business owners: why are we doing this? As a result, they feel reluctant to comply. If it were beneficial, they would want to do it. But if it serves no real purpose and only wastes paper, resources, and time, then what’s the point? - Participant No. 8

Pharmacists described the measure as a waste of funds, paper, and ink, while also increasing the workload for pharmacists and staff. In response, some pharmacies stopped selling certain drugs to reduce the number of records. Others bypassed the law by recording false buyer names or by obtaining drugs through unofficial channels, known as “white bill” purchases. Furthermore, participants noted that high-risk buyers often resorted to underground markets or online sources.

Participants recommended either eliminating sales records entirely or developing an electronic system, with government authorities accepting digital records. Such a system would enhance monitoring and prevention of drug abuse, reduce resource waste, and lessen the workload for pharmacy staff. Pharmacies still using paper records could continue temporarily but should be encouraged to transition to electronic systems.

Compilation of Drug Sales Reports

A majority of regulatory enforcement pharmacists (59.57%) considered the FDA Reporter system highly beneficial for monitoring and tracking drug abuse.

Regarding policy development, 80.0% of pharmacy pharmacists and 89.36% of regulatory enforcement pharmacists supported implementing an information system accessible to pharmacies for monitoring drug abuse trends. Furthermore, 44.63% of pharmacy pharmacists and 93.60% of regulatory enforcement pharmacists favored developing a system to integrate pharmacy data with electronic reporting platforms (Table 7).

Qualitative Findings

Interview findings indicated that pharmacists regarded the FDA Reporter system as a valuable mechanism for tracking pharmaceuticals and preventing their diversion into underground markets. Nevertheless, the system has not achieved its intended objectives, as reports are often incomplete and the data are not immediately usable, requiring additional processing before analysis. Consequently, the system’s full potential remains unrealized. Moreover, wholesale pharmacists raised reservations regarding the reporting process.

When we enter data into the FDA Reporter, it must be exported for the pharmacist to sign, then re-imported into the system for approval. Since the report format is identical in both the FDA Reporter and the POS system, the process feels redundant, - Participant No. 16.

Pharmacists also emphasized that reports from the FDA Reporter system do not encompass the entire drug distribution chain.

Wholesalers purchase drugs from the company and then supply them to pharmacies. If we trace the process, wholesalers are supposed to file reports as well, right? However, pharmacies that purchase these drugs are not required to issue invoices or go through this reporting process, which is why the FDA remains unaware of these transactions. If control measures were stricter, wholesalers might resort to issuing ‘white bills’ to bypass reporting requirements and save time. It has even reached the point where companies are providing fake customer names—this is the reality, - Participant No. 12.

Participants recommended enhancing the FDA Reporter to enable real-time reporting and integration with wholesalers through host-to-host system, thereby ensuring coverage of the entire drug distribution chain. Such improvement would reduce redundancy and alleviate the burden of data entry. Furthermore, the system should be user-friendly and capable of supporting data analysis to facilitate tracking and monitoring efforts. As an interim measure, wholesalers should be permitted to submit reports in Excel format while the enhanced system is being developed.

Restrictions on Retail Sale Quantities

About 40.45% of pharmacy pharmacists and 57.45% of regulatory enforcement pharmacists believed that limiting the quantity of drugs sold per person per transaction helps reduce drug abuse (Table 5).

However, most respondents identified unintended consequences: 61.41% of pharmacy pharmacists and 63.83% of regulatory enforcement pharmacists observed that high-risk buyers circumvent the limit by purchasing from multiple pharmacies or making several smaller purchases at the same pharmacy (Table 6).

Regarding policy development, 73.64% of pharmacy pharmacists and 72.34% of regulatory enforcement pharmacists recommended that the FDA review the maximum allowable quantity of drugs per person per transaction (Table 7).

Qualitative Findings

Interview finding indicated that pharmacists felt this measure was not as effective as intended, as high-risk buyers were not deterred by the quantity limits. Instead, they repeatedly purchased drugs until they obtained the desired amount.

Pharmacists also reported that the measure has made it more difficult for patients to access medications, as they must visit the pharmacy more frequency. For example, cancer patients requiring continuous use of tramadol faced additional challenges, particularly during the COVID-19 pandemic when demand for medications surged. Furthermore, pharmacists emphasized that this measure undermines their professional discretion, as pharmacists are typically responsible for determining the appropriate and reasonable amount of medication to dispense.

I once encountered a pharmacy that sold a large quantity of liquid medicine. When we conducted an inspection, everything appeared to be in order, however, upon reviewing the names, we wondered, ‘Why are they all adult names, and why is this person repeatedly purchasing syrup?’ Was it wrong? Technically, no. but it raised suspicion that the medication might be used inappropriately, as the pattern seemed implausible. The pharmacy maintained that they were selling according to the regulations, - Participant No. 6.

Participants suggested that the quantity limit should be reconsidered, granting pharmacists greater discretion to dispense reasonable amounts based on their professional judgment.

Limiting Monthly Wholesale Drug Sales to Pharmacies

About half of pharmacy pharmacists (49.55%) and nearly two-thirds of regulatory enforcement pharmacists (63.83%) believed that limiting the quantity of wholesale drugs supplied to pharmacies helps reduce drug abuse (Table 5).

Perceived impact varied between groups: 44.32% of pharmacy pharmacists reported that monthly limits left them with insufficient stock for resale, whereas 51.06% of regulatory enforcement pharmacists considered this only a minor issue (Table 6).

Regarding policy development, 73.64% of pharmacy pharmacists and 80.90% of regulatory enforcement pharmacists recommended that the FDA review the monthly limit on wholesale drug sales (Table 7).

Qualitative Findings

Interviews revealed that pharmacists felt the policy of limiting monthly wholesale drug sales to retail pharmacies has not yet achieved its intended objectives. Because wholesale sales reports submitted through the FDA Reporter system are retrospective, wholesalers cannot verify the total monthly quantity of each drug purchased by each retail pharmacy at the time of sale. Moreover, participants noted that the measure prompted retail pharmacies to reduce their purchases, leading to higher drug prices and, in some cases, shortages—particularly during the COVID-19 pandemic. Under normal circumstances, however, the measure was considered appropriate.

Participants suggested that the FDA enhance the FDA Reporter system to enable real-time tracking of wholesale drug sales. Opinions were divided regarding the list of regulated drugs: some favored regular updated to reduce the reporting burden, while others argued that broadly regulating entire drug groups was necessary to prevent substitution with unregulated alternatives. Respondents agreed, however, that any revisions should be undertaken with meticulous attention to detail.

Pharmacist Requirements to Comply with Good Pharmacy Practice (GPP) and Personally Dispense Dangerous Drugs

More than half of pharmacy pharmacists (55.91%) and nearly three-quarters of regulatory enforcement pharmacists (74.47%) believed that requiring pharmacists to comply with Good Pharmacy Practice (GPP) standards and personally dispense dangerous drugs effectively reduces the sale of drugs that have been abused (Table 5).

Qualitative Findings

Interview findings indicated that pharmacists play a key role in asking questions during the dispensing process to ensure appropriate drug use. They identified “hanging the license pharmacies” where no pharmacist is present during operating hours, as a primary factor contributing to drug abuse.

The policy requiring pharmacists to supervise the dispensing process is appropriate. I believe that as long as ethical standards are upheld, it will be effective. If pharmacists truly take control, we can address this issue, particularly by managing the drug purchasing process within the pharmacy. It’s impossible for a pharmacist to follow GPP and be unaware of secret cough medicine sales, - Participant No. 7.

The real issue is whether a pharmacist is present at the pharmacy. Violations occur when products are sold without proper oversight. In some cases, the problem is obvious-like when someone comes in to buy ‘green-yellow.’ a local term referring to tramadol capsules. Are they really treating cancer? Probably not. We have the right to refuse a sale if we determine it is unsafe or inappropriate. The FDA should trust in pharmacists’ existing practices while ensuring full compliance with Good Pharmacy Practice (GPP). Medication use in the pharmacy must be rational and well-regulated, - Participant No. 11.

Pharmacists further suggested that enforcement adopt a more integrated social approach, involving collaboration with government agencies, civil society, educational institutions, and pharmacy networks to monitor and address the issue. They also emphasized the importance of educating at-risk groups, prosecuting offenders, and referring individuals who abuse drugs to rehabilitation programs.

Discussion

More than 80% of pharmacy pharmacists reported understand the key aspects of the FDA’s policies on controlling drug sales, consistent with the previous studies.24,27

Maintaining drug sales records has not achieved its intended objective of reducing drug abuse. While records are kept, they are not actively used for monitoring, and most pharmacy pharmacists oppose recording buyers’ names, considering it ineffective, whereas regulatory enforcement pharmacists hold the opposite view. Unlike the present study, earlier research found that most respondents regarded recording buyer names as a standard pharmacy practice for maintaining patient service records, with only a few opposing it. In practice, pharmacies typically record patient information such as gender and age but not names, and many pharmacists consider sales record to contribute little value to improving pharmacy practice.27 Although GPP standards and Pharmacy Council regulations require patient names to be recorded,28,29 similar to regulation in Singapore that mandate collection names, identification numbers (NRIC/FIN), and contact details when dispensing “pharmacy only medicine”,30 pharmacies in Thailand do not consistently collect such data. This aligns with previous research in other countries indicating that pharmacists rarely record information to monitor medication use when dispensing non-prescription drugs.7 The measure has also produced unintended effects, with high-risk buyers shifting to alternative channel and pharmacies reporting increased workloads and wasted resources from maintaining sale records. In the some cases, pharmacies have discontinued of the sales certain drugs to reduce record-keeping, chosen to pay fines in place of maintaining records, or bypassing requirements through unofficial channels such as “white bills” to avoid records keeping, which arise because the regulation does not cover all steps in the drug distribution chain.24,27 Recommendations for improving this measure include either eliminating the requirement to maintain drug sales records31 or having the FDA transition to an electronic system for recording drug sales through pharmacy management software (POS), develop a reporting system for pharmacies that do not use electronic sales management programs, and accepting these electronic records alongside the existing paper-based system, while utilizing the data to monitor this issue and inform policy development.27 This approach is consistent with practices in other countries where pharmacy service information is recorded electronically.32 In addition, the FDA should regularly review and revise the list of controlled drugs, given the large number of items included, to ensure its continued appropriateness. This aligns with previous research indicating that pharmacists believe certain controlled drugs should be reviewed, revised, or removed from the list.31

Compilation of drug sales reports is valuable for tracking and preventing the diversion of drugs into underground markets. However, it has not achieved its the objectives due to the incomplete data and the lack of immediate usability. This aligns with previous researches indicating that the reporting process through the FDA Reporter system is complicated and redundant, requiring data adjustments before it can be effectively utilized.33,34 These limitations have contributed to issues such as the illegal production of drugs and their distribution through underground channels via “white bills” to evade reporting.35 Recommendations for improving this measure include enhancing the FDA Reporter system to make it more accessible, integrating it with wholesale pharmacies via a host-to-host connection, and ensuring real-time data coverage of the entire drug distribution chain.24,27 The system should function similarly to the Track and Trace system used in the United States, where real-time online tracking monitors drug distribution throughout the supply chain.36

Restrictions on retail sales quantities have not achieved their intended purpose of reducing drug abuse. Pharmacists reported that high-risk buyers circumvent the rule through “pill shopping” obtaining the same drug pharmacies27 and often request specific brands to avoid detection.37–39 The measure has also created barriers for chronic patients who require continuous treatment, focusing more frequent pharmacy visits. Overall, the policy appears to burden patients rather than pharmacies, as the drugs involved are neither high-value nor widely distributed. Pharmacists recommended removing the restriction and allowing professional discretion in determining appropriate quantities.27

Limiting on monthly wholesale drug sales to Pharmacies has not achieved its objectives due to limitations of the FDA Reporter system, which cannot verify the total quantity of drugs purchased by retail pharmacies at the point of sale.27 Although pharmacists acknowledged that the restriction has reduced the sale of abused drugs, it has also created supply shortages, as some wholesalers no longer distribute certain medicines, forcing pharmacies to purchase directly from manufacturers. To address these issues, pharmacists recommended developing a real-time FDA Reporter system and reviewing the list of regulated drugs.

Pharmacist requirement to comply with Good Pharmacy Practice (GPP) and personally dispense dangerous drugs is regarded as effective in reducing abuse, as professional standards ensure appropriate symptom assessment and dispensing.28,29 However, the primary challenge stems from “hanging the license” pharmacies, where no pharmacist is present during operating hours.24,40 To strengthen enforcement, respondents suggested strict government oversight to ensure pharmacist presence, with case of noncompliance referred to the Pharmacy Council for ethical review.

In addition, a collaborative approach involving school,27 pharmacy networks,38 and other stakeholders was recommended to support monitoring and prevention among at-risk groups.

This study highlights urgent policy action needed to strengthen control of drugs that have been abused. Policymakers should modernize regulatory frameworks by adopting electronic sale records, enhancing the FDA Reporter system for real-time monitoring, and revising regulations to accept digital data and signatures, Sales quantity limits should be removed to enable pharmacists’ professional discretion, while strict enforcement of Good Pharmacy Practice (GPP) with mandatory pharmacist presence must be prioritized to ensure safe and accountable drug distribution.

Limitations

This study may have some limitations, as it focuses solely on interviews and surveys with pharmacy pharmacists and regulatory enforcement pharmacists. Consequently, the findings may not be fully generalizable or represent the perspectives of all stakeholders. Nevertheless, the study provides key insights into pharmacists’ views on the effects and impact of drug regulation policy, as well as the development of policy recommendations for effectively regulating drug sales and preventing drug abuse.

Conclusion

Current measures to control retail and wholesale drug sales have fallen short of their intended goals, while enforcing Good Pharmacy Practice (GPP) and requiring pharmacists to personally dispense dangerous drugs has proven more effective. However, these measures have unintentionally driven drug purchases to alternative channels, increased pharmacy workloads, and led some pharmacies to discontinue sales. Policy makers must act decisively by modernizing drug regulation through electronic reporting systems, eliminating rigid retail quantity limits in favor of pharmacists’ professional judgment, and enforcing full pharmacist presence during operating hours to safeguard safe and responsible drug distribution.

Acknowledgments

This research is part of a thesis on Regulatory Impact Assessment: A Case Study in Thai FDA’s Controlling and Monitoring Policy of Selling Drugs That Have Been Abused. The study was funded by the Thai FDA, and the researchers express sincere gratitude for the support provided.

Disclosure

The authors report no conflicts of interest in this work.

References

1. Cooper RJ. ‘I can’t be an addict. I am.’ Over-the-counter medicine abuse: a qualitative study. BMJ Open. 2013;3(6):e002913. doi:10.1136/bmjopen-2013-002913

2. Asanangkonchai S, Chittrakarn S, Thaikla K, Tantirangsee N. Misuse of Medications: Basic Knowledge and Problem Situations in Thailand. Bangkok: Office of the Narcotics Control Board, Ministry of Justice; 2012.

3. Schifano F, Chiappini S, Miuli A, et al. Focus on Over-the-Counter drugs’ misuse: a systematic review on antihistamines, cough medicines, and decongestants. Front Psychiatry. 2021;12:657397. doi:10.3389/fpsyt.2021.657397

4. Reines SA, Goldmann B, Harnett M, Lu L. Misuse of tramadol in the United States: an analysis of the national survey of drug use and health 2002-2017. Subst Abuse Res Treat. 2020;14:117822182093000.

5. Fuseini A, Afizu A, Yakubu YH, Nachinab G. Facilitators to the continuous abuse of tramadol among the youth: a qualitative study in Northern Ghana. Nursing Open. 2019;6(4):1388–1398. doi:10.1002/nop2.353

6. Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results From the 2022 National Survey on Drug USE and Health. Vol. 2023. Rockville: Centre for Behavioral Health Statistics and Quality,Substance Abuse and Mental Health Services Administration; 2023.

7. Sansgiry S, Bhansali A, Bapat S, Xu Q. Abuse of over-the-counter medicines: a pharmacist’s perspective. Integr Pharm Res Pract. 2016;6:1–6. doi:10.2147/IPRP.S103494

8. Yueran S. The meaning of using cough medicine among Muslim adolescents. In: Chaowrainguen S, Charoenrat B, editors. Cultural Research and Health Risks: Accidents, Drug Abuse. Nonthaburi: Social and Health Research Institute; 2018:167–175.

9. Kiron P, Kalayasiri R. Misuse of prescription drugs (tramadol, Pro, Lean. 4(100).

10. Academic Center for Narcotic Drugs. Article on 4x100. 2018. Available from: https://nctc.oncb.go.th/article_attach/4x100.pdf. Accessed August8, 2022.

11. Bulaed S, Boonsang T, Rongmaung D. Experience of addiction 4X100 of the teenagers in La Sub district of Krabi Province. Ganesha J. 2015;11(2):41–49.

12. Thaikla K. Marketing and Offenses Related to Narcotics on the Internet Worldwide in 2020. Chiang Mai: Institute of Health Sciences Research, Chiang Mai University; 2020.

13. Lapanupat K. Adolescents’ purchasing behavior of cough medicine for recreational use in the betong municipality area. In: [Special Problem, Master of Public Administration Program, General Administration]. Chonburi: Burapha University; 2011.

14. Chaikun N. Sources of cough medicines abused by the addicts in a Southern Province. Thai J Pharm Pract. 2017;9(2):516–524.

15. Hamontri A. The success of community in protection and solution of problem of youth risking to drug addition in Angthong Province. J MCU Nakhondhat. 2018;5(2):434–451.

16. Saiphoklang O, Wongboonsin K, Wongboonsin P, Phuengpan UB, Cottler L. The situation and relationship of misuse of drugs with risky health behaviors among Thai adolescents. J Demogr. 2015;31(2):37–59.

17. Thai Food and Drug Administration. Side effects of 4x100 (Pro drugs). Available from: https://oryor.com/oryor_miniweb/knowledge_detail.php?cat=2&id=7. Accessed March8, 2022.

18. Thaipost. The Thai FDA raided a 4x100 drug production site in Taling Chan area, shocking discovery! evidence of distribution of 7 million capsules found. Available from: https://www.thaipost.net/main/detail/22118. Accessed March8, 2022.

19. Sriviriyanupap W. Developing indicators and method of drug classification according to Thai law. Thai J Pharm Sci. Available from http://www.tjps.pharm.chula.ac.th/ojs/index.php/tjps/article/view/164. Accessed 2022.

20. MdS M, Sherer PP, Sumpradit N, Sringernyuang L. Understanding the complexities of drug transactional interaction between the patient and pharmacist: a scoping review. Asia-Pacific Soc Sci Rev. 2022;22(2):article8.

21. Office of the Council of State. Drug Act B.E. 2510 and Amended Version. Bangkok: Office of the Council of State; 2019.

22. Announcement of the Thai food and drug administration regarding the criteria, methods, and conditions for the sale of medicines. Royal Gazette. 2015.

23. Announcement of the Thai food and drug administration regarding the list of dangerous drugs that must be recorded for drug sales.Royal Gazette.132, Part 179D (Aug 4;2015.Thai

24. Suttapanich L. Opinions of licensees for selling modern drugs and authorities on the measures for controlling antitussives and antihistamines with potential misuse in Prachuab Khiri Khan province. Thai J Pharm Pract. 2017;9(2):329–337.

25. Division D, Food, Administration D. Number of licenses for pharmaceutical businesses nationwide, 2022 [2022. Available from: https://www.fda.moph.go.th/sites/drug/Shared%20Documents/Statistic/Licensee-20221223.pdf. Accessed February9, 2023.

26. Yamane T. Statistics, an Introductory Analysis. 2nd ed. New York: Harper and Row; 1967.

27. Lochid-amnuay S, Chalongsuk R. Evaluation of measure implementation of inappropriate drug use selling report. Thai Bull Pharm Sci. 2019;14(1):65–78.

28. The Pharmacy Council of Thailand. The Pharmacy Council Announcement 8/2011 on Standards of practice for pharmaceutical care management in pharmacy profession B.E. 2554. Available from: https://www.pharmacycouncil.org/share/file/file_1633.54%E0%B8%9B%E0%B8%A3%E0%B8%B0%E0%B8%81%E0%B8%B2%E0%B8%A8%E0%B8%AA%E0%B8%A0%E0%B8%B2%E0%B8%AF_%E0%B8%97%E0%B8%B5%E0%B9%888_2554.pdf. Accessed March3, 2024.

29. Ministry of Public Health Announcement on determining places, equipment, and practices for community pharmacy practice in current drug sales premises under the Drug Law B.E. 2557. Royal Gazette.

30. Health Sciences Authority. Updates on reclassified medicines. 2022. Available from: https://www.hsa.gov.sg/announcements/reclassified-medicines/updates-on-reclassified-medicines. Accessed August2, 2023.

31. Thongbai U. Study on the policy and measures to control drug distribution in pharmacies by bookkeeping. Thai J Pharm Pract. 2017;9(1):53–65.

32. Wright J, Bond C, Robertson HD, Matheson C. Changes in over-the-counter drug misuse over 20 years: perceptions from Scottish pharmacists. J Public Health. 2016;38(4):793–799.

33. Bhutiangkul A. Development of the pharmaceutical ingredient importation database and signal detection of the importation for potential misuse of active pharmaceutical ingredient. Thai Food Drug J. 2021;28(1):84–95.

34. Chomngamdee C, Upakdee N. Reporting system of high-risk drug abuse of Thai food and drug administration: a case study of tramadol. Thai Food Drug J. 2565;29(3):86–97.

35. Fangnil P. Guidelines for Developing Regulatory Systems for Active Pharmaceutical Ingredients (Apis) or Semi-Finished Pharmaceutical Products Containing Active Ingredients with Emphasis on Proactive Approaches. Bangkok: Thai Food and Drug Administration; 2019.

36. U.S. Food and Drug Administration. Drug Supply Chain Security Act (DSCSA). 2022. Available from: https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa. Accessed August2, 2023.

37. MacFadyen L, Eadie D, McGowan T. Community pharmacists’ experience of over-the-counter medicine misuse in Scotland. J R Soc Promot Health. 2001;121(3):185–192. doi:10.1177/146642400112100316

38. Hughes GF, McElnay JC, Hughes CM, McKenna P. Abuse/misuse of non-prescription drugs. Pharm World Sci. 1999;21(6):251–255. doi:10.1023/A:1008788726842

39. Sweileh WM, Arafat RT, Al-Khyat LS, Al-Masri DM, Jaradat, Jaradat NA. A pilot study to investigate over-the-counter drug abuse and misuse in Palestine. Saudi Med J. 2004;25(12):2029–2032.

40. Santisetthsin P, Thananithisak C. Public and community pharmacist opinions toward the control measure of tramadol drug dispensing. Srinagarind Med J. 2014;29(6):559–566.