A descriptive exploratory study was conducted, which gathered insights from pharmacists actively engaged in the pharmacy business and provided a broader picture of views, experiences, preferences, and practices of pharmacists related to the CSSA medicines issues. A web-based cross-sectional survey was developed, and the questionnaire was distributed to the target population. The questionnaire was shared through social media to reach out to the maximum number of pharmacists. An online questionnaire was designed using Google Forms, and its online link was shared through various social media platforms. The participants could view the questions by simply clicking on the shared link and answering the questions.

The study was conducted between March 2025 and June 2025 among personnel involved in the private pharmacy business sector in Pakistan. The sampling frame included pharmacists, pharmacy owners, wholesalers, distributors, and managerial staff working in private retail and supply chain settings. The study reporting followed established best practices for cross-sectional observational research, with a transparent description of study design, sampling approach, questionnaire development, measurement of variables, and descriptive statistical analysis, consistent with STROBE guidelines.

The study respondents consisted of business personnel and pharmacists working in the private sector in different domains of pharmacy business in Pakistan, including community pharmacists, hospital pharmacists, industrial pharmacists, regulatory pharmacists, supply chain pharmacists, and wholesale and distribution pharmacists. Participants from academia or regulatory institutions were included only if they had current or previous experience in the private pharmacy business or pharmaceutical supply chain activities.

The questionnaire /instrument was developed using information from a literature review and findings from qualitative and quantitative studies with respect to issues in combating CSSA drugs. Those studies captured attitudes, perceptions, knowledge, and experiences of business professionals, drug law experts, and pharmacists. The participants of the research highlighted the role of pharmacists to help in combating CSSA drugs and suggested various ways and means to counter this menace.

The questionnaire comprised structured items, including awareness of substandard and falsified (SF) medicines, perceived supply chain vulnerabilities, regulatory training exposure, and business governance practices. The questionnaire/instrument comprised four main components. Part A consists of demographic data of respondents. It included gender, residential area, education, and total years of experience in their sector of work. Part B consists of perceptions on training on drug regulations, prevalence of CSSA drugs, and perceptions of the participants regarding CSSA drugs.

The World Health Organization classifies poor-quality medicines under the umbrella term SF medical products. In Pakistan, however, national drug laws and regulatory practice employ legally defined categories referred to as CSSA drugs. To ensure legal accuracy and respondent comprehension, the questionnaire used the CSSA terminology as recognized under national regulations. These categories conceptually overlap with the WHO SF framework; however, reported prevalence in this study is based on CSSA categories rather than internationally standardized SF prevalence.

The instrument was tested for face and content validity by two researchers from the field of pharmacy practice and administration, who were experts in conducting qualitative as well as quantitative studies, especially in the areas of pharmacy policy and practice. For face validity, the questionnaire /instrument was evaluated and responses were collected from the other members of the research team at Punjab University College of Pharmacy before launching the survey. Content validity was achieved by refinement of the questions during instrument/questionnaire development, keeping in view the data already collected, during the pilot stage. Content validity was assessed by two subject-matter experts in pharmacy practice and pharmaceutical regulation. The questionnaire was revised in the light of suggestions received. The instrument was pilot tested among a small group of pharmacy professionals to improve clarity and flow; no substantive content changes were made. Missing responses were handled using pairwise deletion, and denominators are reported for each item.

The convenience sampling method was adopted to reach out to the desired participants. The sample size was calculated by Raosoft calculator by assuming 5% margin of error, 95% confidence interval, and a prevalence of 50%. The sample size came out to be 351 participants. A total of 351 individuals were approached, of whom 166 accessed and completed the questionnaire, yielding a response rate of 47.29%. To improve the response rate, the questionnaire/instrument was designed to be succinct and pithy so that all areas relevant to the research were covered. The researcher made repeated phone calls to participants to persuade them to participate in the research, as the response rate was low. Web-based link was sent to pharmacists through WhatsApp groups, Facebook, and email, and reminded them time and again to fill out the questionnaire. As the questionnaire was a bit lengthy, people were reluctant to fill it out. However, the researcher personally contacted all the pharmacists and motivated them to participate in the research. Due to the use of convenience sampling and online recruitment, the sample may not be fully representative of all private pharmacy business stakeholders in Pakistan.

The data were entered into the Statistical Package for Social Sciences (SPSS) software. The descriptive statistics were used to describe demographics and practice characteristics. Percentages and frequencies were used for categorical variables, while means and standard deviations were calculated for the continuous variables. The analysis was primarily descriptive, as the study aimed to explore perceptions and experiences.

Participation was voluntary, and informed consent was obtained electronically before survey initiation. No identifiable personal data was collected, and responses were anonymized. The study was approved by the Institutional Review Board (IRB) of the University of the Punjab, Lahore, Pakistan (Letter No: D/191/FIMS).

The total number of respondents was 166, out of which a major portion constituted male pharmacists; 75.3% (n = 125), while only 24.7% (n = 41) were females. The majority of the respondents were in the age group 36.48 + 11.03(SD), and the majority had been in the pharmacy business or domain for 11.19 ± 10.17 years. Most of the respondents, 30.1% (n = 50), belonged to community pharmacy, 19.9% (n = 33) were industrial pharmacists, whereas 15.1% (n = 25) were regulatory affairs pharmacists. Moreover, 12% (n = 20) pharmacists were also associated with the private teaching institutions. Persons related to sales and marketing were 10.2 % (n = 17). The majority of participants, 83.7% (n = 139), hailed from urban areas, while 16.3 % (n = 27) were from rural areas. The detailed demographics are given in Table 1.

The study intended to explore the involvement of private sector pharmacy personnel in training on drug regulations. Most of the respondents, 55.4% (n = 92), confessed that they did not get any training on drug regulations, while only 44.6% (n = 74) did. As to whether they had any previous formal training or education about CSSA drugs, 74.1% (n = 123) replied positively. Only 25.9% (n = 43) of the study sample had not previously received formal training regarding CSSA drugs. Furthermore, Figure 1 shows the types of education or training opportunities that the participants had in the past regarding CSSA drugs. The most common kinds of training were conferences and workshops (Figure 2).

Regarding the question of where participants received training in pharmacy law, the majority received training during their undergraduate studies and on-the-job (OJT) training, 21.7% and 14.5%, respectively (Figure 3). Regarding the questions where the training program or education should be provided on CSSA drugs, 53.6% (n = 89) respondents recommended education and training program during undergraduate degree at university level, 22.9% (n = 38) of the study population said that it should be OJT training, 14.5% (n = 24) said it should be during registration with pharmacy council and 9% (n = 15) preferred it to be imparted during postgraduate program like masters/PhD. Moreover, 44.6% (n = 74) liked that their education and training on CSSA drug issues be imparted through workshops, 24.7% (n = 41) preferred short certificate courses, and 22.9% (n = 38) preferred conferences as a mode of training. However, some participants, 5.4% (n = 9), selected distance learning as an appropriate mode of training (Table 2).

The opinions of participants were sought about the degree to which such drugs were present in the market. The majority, 74.7% (n = 124), acknowledged the presence of such drugs in society, whereas 18.1% (n = 30) declined to accept their presence, and 7.2% (n = 12) said that they did not know about it. The extent of perceived prevalence of substandard drugs in society was evaluated, and 28.9% (n = 48) of respondents considered the presence of substandard drugs in the range of 11%–30% in the pharmacy business sector, whereas 24.1% (n = 40) perceived it between 1%–10% and 31%–50%, respectively. However, 10.8% (n = 18) of participants believed it is in the range of 51%–70%, and 3.6% (n = 6) thought it is more than 70% in the market. Regarding the perceived prevalence of spurious drugs, 33.1% (n = 55) considered it in the range of 2%–10%. whereas 19.9% (n = 33) perceived it between 31% and 50%. However, 19.3% (n = 32) of respondents believed it is in the range of 11%–30%, and 13.3% (n = 22) think it is about 0%–1% in society. Similarly, for the perceived prevalence of counterfeit drugs, 38.6% (n = 64) considered it in the range of 2%–10%, whereas 22.3 % (n = 37) perceived it in between 11% and 30%. As far as the perceived prevalence of adulterated drugs is concerned, 31.9% (n = 53) considered it in the range of 02%–10%, whereas 15.1% (n = 25) perceived it in between 0%–1% and 31%–50%, respectively (Table 3).

A significant number of participants had previous exposure to CSSA drugs in the past, 42.8% (n = 71), while the majority, 57.2% (n = 95), had no such experience in their professional life. As to whether pharmacy businesses operated and manned by pharmacists can play an effective role in combating CSSA drugs, 90.4% (n = 150) endorsed this viewpoint, and only 9.6 % (n = 16) did not agree with this statement. Participants were also asked to opine about the effectiveness of drugs manufactured by multinational companies (MNCs) and imported drugs compared to locally manufactured drugs. The majority, 59.6% (n = 99), considered the drugs manufactured by MNCs to be more effective, while 40.4% (n = 67) did not agree with the statement. Similarly, 56% (n = 93) perceived that imported drugs were more effective compared to local drugs, but 44% (n = 73) did not consider local drugs inferior to imported drugs. The perception of participants regarding the current law and legislation, and the quantum of punishment, was also evaluated. The majority, 59% (n = 98), considered the penalties of CSSA drugs as insufficient, whereas 41% (n = 68) were satisfied with the current penalties awarded to drug law offenders (Table 4).

The majority of participants (74.1%, n = 123) hold wholesalers/distributors responsible for the overall spread of CSSA drugs, while 25.9 % (n = 43) do not consider them responsible. The vast majority, 82.5% (n = 137) hold wholesalers /or distributors liable for violation of drug laws along with the pharmaceutical manufacturers, while 17.5% (n = 29) did not agree with this notion. Similarly, 89.8% (n = 149) were of the view that medicines should only be sold to retail outlets and health care establishments by a pharmaceutical manufacturer/authorized agent (distributor)/importer/indenter and not by unauthorized wholesaler/stockist. Almost 86.7% (n = 144) of respondents were of the opinion that multiple intermediaries/middlemen/stockists in the pharmaceutical supply chain facilitate the supply of SF drugs to pharmacies. About 86.7% (n = 144) also considered the warranty of medicines issued by wholesalers without being an authorized agent of the manufacturer as illegal (Table 4).

The majority, 67.5 % (n = 112), perceived that the media was not playing a positive or responsible role regarding news about CSSA drugs. Similarly, the majority, 81.9 % (n = 136), considered the use of information technology tools like 2D barcode, RFID, and hologram technology as useful in combating CSSA drugs. Regarding the responsibility of the spread of CSSA drugs in society, the majority, 53.01% (n = 88), believed that unlicensed /unknown manufacturers are responsible for the prevalence of CSSA drugs. Almost 11.44% (n =  19) of respondents considered unauthorized wholesalers to be responsible for this spread (Table 4).

This study has several limitations. First, the reported prevalence values reflect respondents’ perceptions and experiences rather than the objectively measured prevalence of CSSA medicines. Second, the use of convenience sampling via social media may have introduced selection and nonresponse bias, limiting generalizability. These limitations are inherent to exploratory surveys but are acknowledged to ensure appropriate interpretation. The responses were self-reported; therefore, the study may be subject to recall and social desirability bias. Also, the cross-sectional design precludes causal inference, and findings reflect perceptions rather than objectively verified supply chain data.

The study highlighted that loopholes exist in the pharmaceutical supply chain system, which exacerbate the spread of CSSA drugs. The study emphasized the need for training and infrastructure development, and ensuring the secure supply chain through a robust regulatory system, coupled with a clear vision and policy based on merit and transparency instead of empty rhetoric.