Study design

This study utilized a cross-sectional descriptive design combining structured questionnaires with a simulated patient (SP) methodology to evaluate the extent of community pharmacists’ (CPs) involvement in patient counselling, health education, and health promotion [13]. The study sought to compare self-reported practices of CPs with actual pharmacist-patient interactions observed through simulated patient visits. Across-sectional survey was conducted in parallel with the simulated patient method to provide a comprehensive assessment of pharmacists’ engagement in these key aspects of healthcare delivery. Similar designs have been successfully used in pharmacy practice research to capture both self-reported and observed behaviours [8].

Study setting

The study was conducted across all 17 constituencies in Nairobi, Kenya, between 13^th December, 2022 and 28^th February, 2023. Community pharmacies included in the study were selected based on their registration status and active licensure with the Pharmacy and Poisons Board (PPB). The study location was chosen due to the high density of pharmacies and the significant role they play in primary healthcare within urban settings.

Study population and sampling

Eligibility criteria

Sampling design

Sampling technique

A stratified random sampling approach was employed to ensure equitable representation across all 17 constituencies in Nairobi. Pharmacies were first categorized into clusters based on their respective constituencies. A proportional random sampling strategy was then applied to select a representative number of pharmacies from each cluster. This method facilitated an unbiased selection process, thereby enhancing the reliability and generalizability of the study findings [13].

Sample size determination

At the time of the study, there were 1,213 registered community pharmacies in Nairobi. The minimum sample size was calculated using Yamane’s formula: n=N/ (1+N(e)²), where n is the sample size, N is the population size, and e is the margin of error. Using a 95% confidence level and a 10% margin of error, the required sample size was 92 pharmacies. Due to logistical constraints, 60 pharmacies were randomly selected and included in the study. The unit of sampling was the pharmacy, with one pharmacist representative per pharmacy.

Data collection

Survey instrumentation and pilot testing

Data collection employed structured questionnaires and simulated patient (SP) scorecards. Both instruments were adapted from previously validated studies in comparable settings [8,11] and were modified to fit the Kenyan community pharmacy context. To ensure clarity and contextual appropriateness, the tools were pretested in six community pharmacies not included in the final sample. Feedback from this pilot informed refinements such as improving question wording, eliminating redundancies, and adjusting scoring criteria.

Simulated patients participated in a two-day standardized training that included role-play and calibration sessions under faculty supervision. To establish scoring consistency, two independent raters assessed pilot encounters, and inter-rater reliability was confirmed with Cohen’s kappa (κ = 0.82), indicating strong agreement and supporting the reliability of the observational scoring process.

The pilot study primarily assessed clarity, feasibility, and inter-rater reliability of the SP checklist. Formal internal consistency testing (e.g., Cronbach’s alpha) was not conducted due to the small pilot sample size. Additionally, although the questionnaire was adapted from previously validated instruments, no additional psychometric validation (such as internal consistency analysis) was performed for the survey tool itself. This limitation has been acknowledged in the manuscript.

During the main study, the structured questionnaires were administered to community pharmacists to assess self-reported counselling, health education, and health promotion practices. Immediately after each encounter, SPs completed scorecards evaluating the quality of pharmacist–patient interactions against predefined criteria. This parallel data collection approach enabled comparison of pharmacists’ reported practices with their observed behaviours.

Cross-sectional survey

A structured questionnaire was distributed to the selected community pharmacists. The questionnaire consisted of three main sections: demographic information, patient counselling practices, and pharmacists’ involvement in health education and promotion. Responses were measured using a three-point Likert scale (always discussed, discussed sometimes, and never discussed) to assess the extent of pharmacist engagement in these key areas.

Simulated patient method

To complement the cross-sectional survey, a simulated patient (SP) methodology was employed. Three senior (5th-year) pharmacy students were recruited and underwent a two-day training program involving role-play and calibration sessions supervised by faculty. The training ensured that all SPs could consistently portray the assigned case scenarios and accurately complete evaluation checklists.

The case scenarios focused on two commonly encountered conditions—diabetes mellitus and acne vulgaris—chosen because they require not only pharmacological management but also comprehensive patient counselling, health education, and wellness promotion.

Each of the 60 selected pharmacies was visited once during the study period. Pharmacists were unaware of the specific timing of these visits, thereby reducing the risk of contamination bias or altered behaviour. During each visit, SPs interacted with the pharmacist as genuine clients, following the standardized case scripts.

A structured checklist was used immediately after each encounter to assess key aspects of the pharmacist–patient interaction, including patient history-taking, appropriateness of dispensing, medication counselling, and provision of health education [14]. The checklist parameters mirrored those in the pharmacist-administered questionnaires, enabling direct comparison between self-reported and observed practices.

For quality assurance, two independent raters reviewed all SP-completed checklists. Any discrepancies were discussed and resolved by consensus. This dual coding process strengthened the reliability of the observational data and minimized subjective bias.

Scenario 1: Diabetes medication request without prescription

Scenario

Simulated patient 1 visited community pharmacies requesting Treviamet (sitagliptin/metformin) 50/1000 mg without presenting a prescription or offering additional information unless prompted by the pharmacist. Upon further inquiry, the simulated patient provided the following details:

• The medication was intended for personal use.
• They had been diagnosed with diabetes 14 months prior.
• Their last HbA1C test, conducted seven months ago, was 13%.
• A recent fasting blood glucose test (three weeks ago) showed a reading of 9 mmol/L.
• Their last medical review was seven months ago.

Pharmacists were assessed based on their ability to identify the need for a prescription, provide proper counselling on diabetes management, and offer lifestyle modification advice.

Scenario 2: Over-the-counter acne treatment request

Scenario

Simulated patient 2 visited community pharmacies requesting benzoyl peroxide and tretinoin for acne treatment. When questioned by the pharmacist, the patient provided the following information:

• The medication was for personal use.
• The patient had inflammatory acne.
• No previous treatments had been attempted.

Pharmacists were evaluated on their willingness to provide counselling on proper acne treatment, correct medication use, potential side effects, and lifestyle modifications to prevent acne flare-ups.

Scenario 3: Severe acne consultation

Scenario

Simulated patient 3 presented at the community pharmacies seeking pharmacist guidance on managing severe inflammatory acne. The patient provided the following details upon further questioning:

• They had been experiencing recurrent acne for the past 24 months.
• Acne flare-ups lasted about two months before subsiding.
• They had previously used tretinoin and benzoyl peroxide but found them ineffective.
• They had only used medications during flare-ups, discontinuing treatment once improvements were noticed or when acne worsened during therapy.

Pharmacists were assessed based on their ability to take a thorough patient history, provide appropriate counselling on acne treatment adherence, and recommend either over-the-counter treatments or referral to a dermatologist if necessary.

Each simulated patient interaction was evaluated using a structured checklist assessing pharmacists’ inquiry about patient history, provision of counselling, medication guidance, and health education efforts.

Ethical considerations

This study adhered to ethical research principles, ensuring participant confidentiality and obtaining informed consent. The study received approval from the United States International University-Africa (USIU-A) Institutional Review Board (IRB) approval number USIU-A/IRB/F068 and the National Commission for Science, Technology, and Innovation (NACOSTI) licence number NACOSTI/P/22/22465. To maintain anonymity, the names and locations of pharmacies were not recorded, and simulated patients were identified numerically.

Data analysis

Data from structured questionnaires and simulated patient (SP) checklists were entered and cleaned using Microsoft Excel before being analyzed with SPSS version 18. The analysis focused primarily on descriptive statistics, including frequencies, percentages, means, and ranges, to summarize pharmacists’ self-reported practices and observed behaviours during SP visits.

Comparisons between self-reported and observed practices were presented descriptively to highlight gaps in counselling, history-taking, and health education. Patient satisfaction scores from SP visits were reported as mean values with ranges to provide an overall impression of interaction quality.

Demographic characteristics of participants

A total of 60 community pharmacies were included in the study, with 48 community pharmacists responding to the survey. Among the respondents, 55% (n = 26) held diplomas in pharmacy, while 45% (n = 22) possessed a bachelor’s degree in pharmacy. The majority (68%) had over five years of experience in community pharmacy practice, whereas 32%(n = 15) had been in practice for fewer than five years. The study also revealed that 72% (n = 35) of pharmacists worked over 10 hours per day, reflecting the high workload and demanding nature of community pharmacy operations in Nairobi. These findings underscore the potential impact of long working hours on pharmacists’ ability to engage in patient counselling and health education effectively.

Pharmacists’ self-reported practices in patient counselling and health education

Survey responses indicated that 71% (n = 34) of pharmacists reported routinely inquiring about patient history, including medication history, symptoms, and allergies, before dispensing medication. Additionally, 66.67% (n = 32) of pharmacists claimed to provide comprehensive drug information, covering indications, dosage, contraindications, drug interactions, and potential side effects. However, only 50%(n = 24) reported actively engaging in patient education on disease prevention and non-pharmacological treatment approaches, such as lifestyle modifications for chronic conditions like diabetes and hypertension. The findings suggest that while pharmacists acknowledge the importance of patient counselling, its implementation remains inconsistent.

Findings from simulated patient interactions

Scenario 2: Over-the-counter acne treatment request

In the acne treatment scenario, 48% (n = 23) of pharmacists correctly identified the appropriate first-line treatment and provided counselling on the use of benzoyl peroxide and tretinoin. However, 36% (n = 17) recommended non-specific analgesics or alternative skincare products without clear justification, and 16% (n = 8) failed to provide structured counselling on acne management. Notably, only 30% (n = 14) of pharmacists discussed additional lifestyle modifications, such as proper skincare hygiene and dietary considerations for acne control. This lack of comprehensive counselling may contribute to suboptimal treatment outcomes for patients managing acne-related concerns.

These findings are consistent with evidence from other low- and middle-income countries, where counselling on OTC dermatological products is often suboptimal due to workload pressures, limited dermatology training in pharmacy curricula, and a transactional orientation toward sales [11,16].In contexts like Kenya, where pharmacies often serve as the first point of care for dermatological conditions, strengthening pharmacists’ role in counselling and patient education is critical to ensure safe and effective self-care.

Scenario 3: Severe acne consultation

For the simulated patient presenting with severe inflammatory acne, 55% (n = 26) of pharmacists recommended continuing the use of over-the-counter treatments, despite the patient reporting poor results with previous medications. Only 20% (n = 10) of pharmacists advised the patient to seek medical consultation with a dermatologist for further evaluation and treatment. Additionally, 45%(n = 22) provided limited counselling, focusing solely on product selection without discussing adherence, potential side effects, or alternative treatment approaches. These findings raise important concerns regarding the clinical management capacity of community pharmacists in Kenya when faced with complex dermatological conditions. Under PPB guidelines, pharmacists are expected to recognize “red-flag” presentations and appropriately refer patients to higher levels of care. Failure to provide timely referral not only risks therapeutic delay but also increases the likelihood of complications such as scarring, antimicrobial resistance from inappropriate antibiotic use, and psychosocial distress. Similar trends have been observed in other low- and middle-income countries, where pharmacists often manage severe dermatological conditions at the OTC level rather than initiating referral pathways, reflecting both gaps in training and limited enforcement of referral guidelines. Strengthening dermatology-focused content in pharmacy curricula and implementing structured CPD modules may help address these deficiencies and promote safer, more patient-centred care.

Comparison of self-reported practices and simulated patient observations

A significant discrepancy was observed between pharmacists’ self-reported practices and their actual counselling behaviour during simulated patient visits. While 71% (n = 34) of pharmacists claimed to routinely inquire about patient history, only 15.26% (n = 7) actively engaged in a thorough patient assessment when observed in practice. Similarly, although 66.67% (n = 32) of pharmacists reported providing comprehensive drug information, only 26.67% (n = 13) of simulated patients received adequate guidance regarding medication use. These inconsistencies highlight a gap between perceived and actual pharmacist performance in patient counselling and health education.

Patient satisfaction and medication labelling

Simulated patients assessed their interactions with pharmacists based on communication clarity, counselling effectiveness, and overall satisfaction. The results showed that 59% (n = 28) simulated patients rated their pharmacist encounters between 0–5 on a 20-point scale, indicating a generally low level of satisfaction. Additionally, 75% (n = 36) of pharmacists failed to provide verbal counselling beyond stating the drug name and dosage, while 64% (n = 31) of prescriptions lacked critical labelling details, including the patient’s name, dosage schedule, and administration instructions. The lack of comprehensive labelling and verbal counselling poses a potential risk to medication safety and adherence.

Discrepancies between self-reported and observed practices

A key finding of this study was the substantial gap between pharmacists’ self-reported practices and their observed behaviour during simulated patient (SP) visits. While 71% (n = 34) of pharmacists indicated that they routinely asked about patient history, only 15.3% (n = 7) were actually observed doing so. Similarly, although 66.7% (n = 32) reported providing comprehensive drug information, only 26.7% (n = 13) of SP encounters reflected adequate counselling. This mismatch between perception and practice highlights a persistent disconnect that has been noted in other low- and middle-income countries (LMICs), including Ethiopia, Nigeria, and Saudi Arabia, where pharmacists often over-report counselling activities compared to what is observed in practice.

Several factors may explain these discrepancies. High patient loads and commercial pressures in community pharmacies may limit the time pharmacists can dedicate to detailed counselling. Inadequate training in communication skills and lack of reinforcement of counselling standards during pharmacy education also contribute to limited patient engagement. Furthermore, weak enforcement of existing regulatory frameworks in Kenya, such as those from the Pharmacy and Poisons Board, may reduce the incentive for pharmacists to consistently provide patient-centred care.

Regulatory adherence and ethical considerations in medication dispensing

One of the most concerning findings was the frequent non-adherence to prescription regulations. In the diabetes management scenario, 60% (n = 29) of pharmacists dispensed Treviamet without a valid prescription, despite its clear classification as a prescription-only medicine. Such practices raise serious ethical and regulatory concerns, as unsupervised use of antidiabetic medicines can result in inappropriate dosing, dangerous drug interactions, poor glycaemic control, and heightened risk of complications such as hypoglycaemia.

This behaviour is not unique to Kenya; “Similar findings have been reported in Ethiopia, where [8] observed a marked gap between self-reported counselling and observed counselling practices among community pharmacists. Non-prescription dispensing is also common in Kenya and other Sub-Saharan African countries [8,9,17].These patterns point to systemic issues, including weak regulatory enforcement, economic dependence on medicine sales, and insufficient accountability mechanisms in community pharmacy practice. Moreover, inadequate training on ethical standards and the absence of consistent inspection frameworks may create an environment where regulatory non-compliance becomes normalized.

Despite many pharmacists acknowledging the importance of counselling and education, simulated patient visits demonstrated inconsistencies in history-taking, medication counselling, and adherence to prescription regulations. One possible contributing factor is the lack of dedicated consultation spaces in many community pharmacies in Nairobi, which may limit opportunities for confidential and comprehensive counselling. Similar infrastructural constraints have been reported in other low- and middle-income countries, where the absence of private counselling areas has been identified as a barrier to effective patient education and pharmacist–patient communication [11].

Limitations in disease prevention and non-pharmacological counselling

The study also highlighted gaps in pharmacists’ engagement in preventive health counselling and non-pharmacological management. While half of the pharmacists reported providing education on disease prevention, lifestyle modifications, and non-pharmacological interventions, only 30% of simulated patient encounters had such advice. This lack of engagement is particularly concerning in the management of chronic diseases such as diabetes and hypertension, where lifestyle modifications play a crucial role in treatment outcomes. Additionally, the limited discussion of lifestyle factors in acne management suggests a need for improved pharmacist training in dermatological conditions and patient education strategies. Although these findings show an improvement those found by [18] where none of the pharmacists involved in the study educated simulated patients on drug interactions, adverse reaction and any non-pharmacological alternatives there is more that can be done.

Pharmacists’ role in dermatological counselling

The findings related to acne management further reinforce the need for enhanced pharmacist training. Although nearly half (48%) of pharmacists correctly identified appropriate first-line treatments for acne, a substantial proportion (36%) recommended non-specific analgesics or alternative skincare products without clear justification. Furthermore, only 20% of pharmacists recommended referral to a dermatologist for patients presenting with severe acne. This indicates a lack of confidence or knowledge regarding appropriate referral pathways and comprehensive dermatological counselling, underscoring the necessity of continued professional development in this area.

Patient satisfaction and medication labelling

Simulated patients assessed their encounters with pharmacists using a structured 0–20 satisfaction scale adapted from [8], which evaluates communication clarity, counselling effectiveness, and overall satisfaction. This scale has been previously validated in pharmacy practice research and was selected for its ability to capture multiple dimensions of patient–pharmacist interaction in a simple numeric format. To ensure reliability, simulated patient scorecards were independently reviewed by two faculty supervisors, and discrepancies were resolved by consensus.

In this study, satisfaction scores ranged from 0 to 15, with a mean of approximately 6 out of 20, reflecting generally low levels of satisfaction. Nearly 59% (n = 28) of encounters were rated between 0–5, indicating poor engagement and limited communication. In addition, 75% (n = 36) of pharmacists provided no counselling beyond stating the drug name and dosage, while 64% (n = 31) of dispensed medicines lacked critical labelling details such as patient name, dosage schedule, and administration instructions. These findings underscore the risks of poor counselling and inadequate labelling for medication safety and adherence.

Implications for policy and practice

The findings of this study have significant implications for pharmacy practice, regulatory bodies, and pharmacy education. There is an urgent need for continued professional development programs to enhance pharmacists’ competency in patient counselling, particularly in chronic disease management, dermatological conditions, and lifestyle modification strategies. Regulatory agencies must also strengthen enforcement measures to ensure adherence to prescription guidelines and improve medication labelling standards. Additionally, pharmacy education curricula should place greater emphasis on communication skills and patient-centred care approaches to better prepare future pharmacists for their roles in healthcare delivery.

Limitations

While this study provides novel insights into community pharmacy practice in Nairobi, certain boundaries should be acknowledged. First, this study relied solely on descriptive statistics, which limited the ability to examine associations between pharmacist characteristics and counselling practices. Future studies with larger datasets should incorporate inferential analyses to explore these relationships more comprehensively. Second, although unannounced simulated patient (SP) visits were used to minimize bias, the possibility of subtle behaviour modification (Hawthorne effect) cannot be completely ruled out. Third, we did not include qualitative triangulation, which could have enriched understanding of the contextual drivers behind observed practices. Fourth, the sample focused on Nairobi pharmacies, which offers valuable urban insights but may not fully represent rural or regional variations. Fifth, the achieved sample size (48 pharmacists) was lower than the calculated minimum required sample of 92, primarily due to logistical challenges. This reduced sample size may limit the generalizability of the findings. Sixth, although the tools were adapted from validated instruments and pilot tested, formal psychometric validation—such as internal consistency testing (e.g., Cronbach’s alpha)—was not performed, which may limit the overall measurement robustness. Finally, although SPs underwent structured training and inter-rater reliability was acceptable, minor subjective variation in scoring may have remained.

Recommendations for future research

Further research is needed to explore the barriers preventing pharmacists from fully engaging in patient counselling and education. Qualitative studies could provide deeper insights into pharmacists’ perceptions of their roles, workload challenges, and potential strategies for improving counselling practices. Additionally, intervention studies evaluating the effectiveness of targeted training programs in enhancing pharmacists’ counselling skills and regulatory compliance would be valuable in guiding future practice improvements.