Evaluation of Regulatory Compliance in Narcotic and Controlled Drug Dispensing: A Simulated Client Study in Community and Hospital Pharmacies

Abstract

Narcotic and controlled medicines comprise a group of pharmaceutical substances with considerable potential for misuse, dependence, and addiction. Because of their abuse potential, these medicines are subject to strict regulatory control. In Pakistan, narcotic and other drugs with significant potential for abuse are regulated under the relevant schedules of the Pakistan Drug Rules, 2017. Despite the availability of regulatory provisions governing their sale and dispensing, concerns remain regarding the quality of pharmacy services and the competency of personnel involved in medicine dispensing. Factors such as the absence of qualified pharmacists, inadequate prescription verification, and inappropriate handling of controlled medicines may contribute to their misuse. Effective enforcement of existing regulations is therefore essential to minimize inappropriate access to and use of these medicines.

The study was designed to assess the dispensing practices related to narcotic and controlled medicines in community and hospital pharmacies using a simulated client methodology. Specifically, it aimed to determine how frequently these medicines were supplied to clients and to evaluate dispensing practices against applicable regulatory requirements and recommended standards.

A descriptive cross-sectional study was carried out between April 2023 and March 2024 in 130 community/retail and hospital pharmacies. A simulated client approach was employed to observe actual dispensing practices in routine pharmacy settings. A structured questionnaire was also used to document relevant information while maintaining confidentiality of the participating pharmacy personnel. The collected data were entered and analyzed using the Statistical Package for the Social Sciences (SPSS), version 20.
Of the 130 pharmacies assessed, 103 (79.2%) were community/retail pharmacies, while 27 (20.8%) were hospital pharmacies. Among the personnel encountered during the assessment, 51 (39.2%) were dispensers, 20 (15.4%) were pharmacists, 53 (40.8%) were pharmacy technicians, and 6 (4.6%) were salespersons. Overall, 115 (88.5%) pharmacies refused to supply the requested medicines to the simulated clients, whereas 15 (11.5%) supplied at least one of the requested medicines. The medicines supplied were alprazolam in 10 cases (7.69%) and bromazepam in 5 cases (3.8%). These medicines were generally supplied only after repeated insistence by the simulated client, and the quantities dispensed were limited to one or two tablets of alprazolam or bromazepam. Prescription-related inquiries were made by 117 (90.0%) respondents, whereas 13 (10.0%) neither asked for a prescription nor sought information regarding the purpose of medication use.
The findings indicate that although the majority of pharmacies demonstrated a cautious approach toward supplying narcotic and controlled medicines, instances of dispensing without appropriate prescription verification were still observed. The simulated client assessment further revealed considerable variation in dispensing practices among pharmacists, pharmacy technicians, dispensers, and salespersons. The limited availability of pharmacists in many pharmacies represents an additional concern for ensuring appropriate oversight of controlled medicines. Strengthening regulatory monitoring, improving the professional knowledge of pharmacy personnel, ensuring the presence of qualified pharmacists, and reinforcing prescription-verification procedures are recommended to promote responsible dispensing and reduce the potential for misuse and abuse of narcotic and controlled medicines.