Antibiotic-associated drug-related problems and pharmacist interventions during the Hajj pilgrimage in Saudi Arabia: insights from a retrospective analysis
Original Article

Antibiotic-associated drug-related problems and pharmacist interventions during the Hajj pilgrimage in Saudi Arabia: insights from a retrospective analysis

Ibrahim Abdulaziz AlZaagi1, Fahhad Mashal Alshammari2, Ahmed Saud Ali Alshowaiy3, Abdullah Saud Almutairi3, Mohammed Samit Alhaysuni3, Turki Fawaz Alharbi3, Bander Ibrahim Alomair4, Abdullah Athal Alharbi5, Obied Mathil Almotiry4, Mutlaq Khelaif Al Dhafeeri4, Mohammad Nasser Alalawi2, Bader M. Albalawi1, Munther Saad Alharbi1, Sheraz Ali6,7 ORCID logo

1Pharmacy Department, Mina Al-Wadi Hospital, Makkah, Saudi Arabia; 2Pharmacy Department, Mina Al-Jisr Hospital, Makkah, Saudi Arabia; 3Pharmacy Department, Al-Rass General Hospital, Ar Rass, Saudi Arabia; 4Pharmacy Department, East Arafat Hospital, Makkah, Saudi Arabia; 5Pharmacy Department, Mina New Street Hospital, Makkah, Saudi Arabia; 6Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia; 7School of Dentistry and Medical Sciences, Faculty of Science and Health, Charles Sturt University, Orange, New South Wales, Australia

Contributions: (I) Conception and design: IA AlZaagi, S Ali; (II) Administrative support: FM Alshammari, BM Albalawi, MS Alharbi; (III) Provision of study materials or patients: AS Almutairi, MS Alhaysuni, TF Alharbi; (IV) Collection and assembly of data: ASA Alshowaiy, BI Alomair, OM Almotiry, MKA Dhafeeri, AA Alharbi, MN Alalawi; (V) Data analysis and interpretation: S Ali, IA AlZaagi; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

Correspondence to: Sheraz Ali, PhD. Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, 14 University Drive, Gold Coast, Queensland 4226, Australia; School of Dentistry and Medical Sciences, Faculty of Science and Health, Charles Sturt University, Orange, New South Wales, Australia. Email: shali@bond.edu.au.

Background: The Hajj pilgrimage offers a unique clinical setting because of the increased risk of infectious diseases, the larger number of elderly patients, and polypharmacy. Numerous factors contribute to the rise in drug-related problems (DRPs), particularly those involving antibiotics. Data on antibiotic-associated DRPs and pharmacists’ interventions during Hajj are lacking. This study aimed to characterize DRPs related to antibiotic use among individuals who attended the 2024 Hajj pilgrimage.

Methods: A retrospective cohort study was conducted across five hospitals in the Al-Mashair region (Mina, Arafat, and Muzdalifah) during the Hajj season (June 12–July 6, 2024). The Hospital Information System and Google Drive were employed to acquire data using a custom form. The form recorded patient demographics, drug-related issues, pharmacist interventions, and patient outcomes. Clinical pharmacists identified DRPs by assessing improper drug selection, dosage problems, adverse responses, and drug interactions. Outcomes were clinical improvement, worsening, or stability, confirmed by laboratory values and infection status.

Results: A total of 411 patients with DRPs were identified, with most being male (74.9%) and older adults (mean age 55.01 years). Respiratory conditions (44.0%) and infections (20.7%) were the most common diagnoses. The most frequent DRPs included improper drug selection (43.3%), inappropriate dosing (25.5%), and dose administration issues (25.1%). Penicillin-beta-lactamase inhibitor combinations were the most implicated drug class. DRPs occurred most often in non-intensive care unit inpatient wards (38.4%), with East Arafat Hospital reporting the highest number of cases (46%). Pharmacist interventions such as dose modifications and alternative therapies were widely accepted (86.79% and 98.94%, respectively). Patient outcomes were assessed based on clinical improvement, deterioration, or stability, along with changes in laboratory values and infection status. Older patients were significantly more likely to experience clinical improvement following pharmacist interventions (odds ratio =2.12, 95% confidence interval: 1.358–3.311, P=0.001).

Conclusions: This research emphasizes the significant role of pharmacists in detecting and addressing antibiotic-associated DRPs during the 2024 Hajj season. Pharmacist-led interventions, particularly dose modifications and alternative therapy recommendations, were associated with high physician acceptance and improved patient outcomes, especially among older adults. These findings underscore the significance of pharmacist-led stewardship programs in high-risk environments, such as mass gatherings, underscoring the necessity of ongoing monitoring and intervention to ensure patient safety and optimize antibiotic utilization.

Keywords: Drug-related problem (DRP); Hajj; intervention; pharmacist; antibiotic


Received: 08 March 2025; Accepted: 11 July 2025; Published online: 04 September 2025.

doi: 10.21037/jhmhp-25-22


Highlight box

Key findings

• This research highlighted the significant role of pharmacists in detecting and addressing antibiotic-associated drug-related problems (DRPs) during the 2024 Hajj season.

• Pharmacist interventions, including alternative therapies and dose modifications, were broadly embraced (86.79% and 98.94%, respectively) and resulted in enhanced patient outcomes.

• Older patients were significantly more likely to experience positive outcomes following pharmacist interventions, with an odds ratio of 2.12 (95% confidence interval: 1.358–3.311, P<0.05).

What is known and what is new?

• The efficacy of pharmacist interventions in enhancing patient outcomes was demonstrated by their critical role in the management of antibiotic-associated DRPs during Hajj.

What is the implication, and what should change now?

• This study emphasizes pharmacists’ importance in recognizing and controlling antibiotic-associated DRPs during Hajj. The incidence of DRPs, especially those linked to prescription selection and dosing, highlights the need for antimicrobial stewardship programs suited to mass gatherings’ unique healthcare challenges.


Introduction

Drug-related problems (DRPs) are pharmaceutical care practitioners’ main clinical concern. DRPs are defined as “any event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes” (1,2). Pharmaceutical practice requires detecting and resolving DRPs to help patients reach their therapeutic goals and achieve optimal medication therapy outcomes (3,4). Medication errors, adverse drug reactions, drug without indication, indicators without drugs, failure to obtain medication, drug interactions, drug noncompliance, and drug poisoning are eight DRPs recognized by the American Society of Health-System Pharmacists (3-5). The neglect of drug-related concerns in patients frequently leads to DRPs, and the failure to identify and treat DRPs may result in clinical issues. DRPs may also increase ambulatory care visits, hospital stays, and death risk; therefore, clinical judgment is needed to resolve DRPs (5-7).

DRPs are present in 5.3% of ambulatory care admissions worldwide, and they are present in 15.1% to 16.9% of hospitalizations. Certain health care standards prevent DRP (3). The frequency of various DRP in institutions that violated healthcare standards was the subject of numerous studies. DRPs may manifest during the following processes: drug ordering/prescribing, transcribing, and verifying, dispensing and delivering, administering, monitoring, and reporting (8-10). Several countries have enhanced the quality and safety of pharmaceutical care to prevent DRPs (11). These endeavours have concentrated on pharmacist interventions that aim to enhance the quality of life of patients and prevent the development of additional illnesses and mortality by addressing non-optimal medication use (8,9). Pharmacist interventions enhance patient care and reduce medical expenses (12). Pharmacist interventions contribute to better patient care and lower healthcare costs. Also, pharmacist’s expertise in pharmacotherapy enables them to review medications, identify root causes of DRPs, and implement preventive measures (13). Pharmacy interventions improve patient care and lower medical costs as they are experts in pharmacotherapy and can assess medications, identify causes, and offer ways to avoid DRPs (13).

A previous study in Saudi Arabia found that serious drug-drug interactions and inappropriate antibiotic use were among the most frequently reported DRPs in general hospital environments. Antibiotics, proton pump inhibitors, and statins were frequently implicated (14). In more intricate environments, such as intensive care units (ICUs), the DRP landscape is characterized by adverse drug events and ineffective treatment outcomes, and antibiotics had a significant role (15). The significance of pharmacists in the identification and resolution of DRPs through clinical interventions is emphasized by these findings. Despite the increasing body of evidence, there is still a gap in the comprehension of DRP patterns in distinctive, high-pressure environments, such as the Hajj pilgrimage, where factors such as overcrowding, infectious disease risk, and polypharmacy coincide (16,17). Hajj, one of the Islamic pillars and the largest mass gathering, is performed annually by millions of Muslims in Saudi Arabia (18). The Hajj pilgrimage offers a unique clinical setting because of the increased risk of infectious infections, the larger number of elderly patients, and polypharmacy. Numerous factors contribute to the rise in DRPs, particularly those involving antibiotics. Data on antibiotic-associated DRPs and pharmacists’ interventions during Hajj are lacking, despite pharmacists’ critical role in lowering these risks. Even though the Hajj pilgrimage presents a unique set of challenges in the management of antibiotic therapy due to its vast patient volume and diverse medical requirements, there is a substantial void in research on antibiotic-associated DRPs and pharmacist interventions in this context (19-21). It is essential to comprehend the way these issues are addressed and the effect they have on patient outcomes to enhance the safety and efficacy of medication during periods of high demand. The objective of this study, which is the first of its kind in Saudi Arabia, is to assess the efficacy of pharmacist interventions, the types and frequencies of DRPs, and the resultant patient outcomes during Hajj. The research will improve medication safety practices, refine stewardship protocols, and offer valuable insights for enhancing healthcare strategies in similar high-pressure environments by providing a comprehensive assessment of these factors. We present this article in accordance with the STROBE reporting checklist (available at https://jhmhp.amegroups.com/article/view/10.21037/jhmhp-25-22/rc).


Methods

Study design and setting

We conducted a retrospective cohort study in the hospitals located at the Al-Mashair region (Mina, Arafat, and Muzdalifah) of Makkah from June 12, 2024 to July 6, 2024, during the Hajj 2024 season. The study involved five hospitals and their associated pharmacies (inpatient, outpatient, and emergency departments).

Data collection

We utilized data collected during Hajj 2024 using a specialized form designed to capture antibiotic-associated DRPs and pharmacist interventions. This form was available through the Hospital Information System (HIS) Care Ware and a Google drive form. The form was designed to capture detailed information, including patient demographics, prescription details, pharmacist assessments, intervention approvals, patient outcomes, and pharmacist information. This form was approved by the Pharmacy Therapeutic Committee at the Pharmaceutical Care Department in the first medical cluster in Makkah as this department is responsible for all hospitals in the Makkah region. A stewardship program was routinely implemented in these hospitals to increase awareness and encourage healthcare professionals to report DRPs without fear of blame or punishment. The Patient Safety Department in the Makkah region encourages all healthcare professionals (e.g., doctors, pharmacists, and nurses) to report DRPs. Healthcare professionals who record a greater number of DRPs are awarded at the conclusion of the Hajj season. DRP reports were collected anonymously to ensure confidentiality and promote transparent reporting.

The form collected patient-specific details such as name, weight, file number, height, age, gender, allergies, ward, and room-bed. Prescription details included the antibiotic prescribed, date, diagnosis, dose, duration, frequency, route of administration, prescribing physician, and culture and sensitivity results (if available). The pharmacist’s assessment section identified DRPs and classified errors, such as inappropriate drug selection, dosage issues, adverse reactions, and interactions. It also captured the pharmacist’s recommendations for intervention, including changes in route, dose, frequency, duration, or rate of administration, and whether these recommendations were accepted, accepted with modifications, or rejected by the healthcare team. Patient outcomes were classified as improved, stable, or deteriorated based on clinical notes and discharge summaries. Details of the assessing pharmacist, including name, date, signature, and stamp, were also included. Patient safety pharmacists systematically evaluated these forms to ensure comprehensive analysis of reported DRPs, pharmacist interventions, and patient outcomes. We strengthened data accuracy via standardized data collection forms to minimize bias and cross-referencing entries with the HIS.

Sample size

We expect a moderate number of DRP occurrences in our research, potentially ranging from 30 to 50 cases, due to the temporary and distinctive nature of the Hajj pilgrimage. However, there is no prior research or incidence data on antibiotic-associated DRPs that occur during the Hajj season. This study included all forms that document antibiotic-associated DRPs, pharmacist interventions, and patient outcomes that were collected from the pharmacies of the five participating hospitals during the Hajj season from June 12, 2024 to July 6, 2024. The official Hajj period for 2024 was scheduled from June 14 to 19. To account for delayed cases, we extended the data collection period until July 6.

Statistical analysis

Data analysis was performed via SPSS (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, version 26.0. Armonk, NY, USA). Descriptive statistics, including frequencies and percentages for categorical variables and means and standard deviations for continuous variables, was used to summarize the data. Also, we employed the Chi-squared tests and logistic regression analysis to identify significant associations between DRPs, interventions, and patient outcomes. All reported P values were two-sided, with a significance level of P<0.05.

Ethical considerations

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ministry of Health, Saudi Arabia (GCMGM-30-9-2024) and individual consent for this retrospective analysis was waived. This study complies with the ethical standards for human data research and ensures that the use of anonymized data reduces the potential risks to participants.


Results

During 1-month study period, 411 patients found to have DRPs were recruited into the study. Most elderly patients had a mean age of 55.01 years (Table 1). Two third of the patients were male (74.9%). Nearly half of the patients (44.0%) visited hospitals due to respiratory conditions (Table 1). Other diagnoses apart from respiratory conditions were infections (20.7%), followed by gastrointestinal issues (6.8%). Other conditions were found in 43 patients (10.5%) (Table 1). Among these 43 patients, leucocytosis was the most common condition, reported in 6 cases, followed by chickenpox with 5 cases. Other conditions were cellulitis, headaches and generalized fever.

Table 1

Characteristics of patients (n=411)

Variable Value
Gender
   Male 308 (74.9)
   Female 103 (25.1)
Age (years) 55.01±17.66
Diagnosis
   Respiratory conditions 181 (44.0)
   Infection 85 (20.7)
   Gastrointestinal issues 28 (6.8)
   Heat illness 25 (6.1)
   URTI and other renal conditions 18 (4.4)
   Neurological conditions 16 (3.9)
   Musculoskeletal and injury related condition 11 (2.7)
   Unspecified 4 (1.0)
   Others 43 (10.5)

Data are expressed as n (%) or mean ± standard deviation. URTI, upper respiratory tract infection.

Characteristics of DRPs

A total of 411 DRPs were identified. The three majority of DRPs were the improper drug selection (43.3%), inappropriate frequency or duration of medicine (25.5%), dosing issues, i.e., either under dosage or over dosage (25.1%). Other DRPs were identified in 5 patients (1.2%). The list of all the DRPs is presented in Table 2.

Table 2

Frequency and percentage of DRPs (n=411)

DRPs Frequency (%)
Inappropriate drug selection 178 (43.3)
Dosing issues 103 (25.1)
Inappropriate frequency or duration 105 (25.5)
Inappropriate route 11 (2.7)
Therapeutic duplication 7 (1.7)
No indication 2 (0.5)
Others 5 (1.2)

DRPs, drug-related problems.

Common drugs associated with DRPs

A total of 40 drugs were involved in DRPs. The drug classes mostly involved in causing DRPs were found to be penicillin and beta-lactamase inhibitor combination (15.8%). The frequency of drug groups causing DRPs is shown in Table 3. Other drugs included clindamycin, levofloxacin, doxycycline, ceftazidime, fluconazole and others.

Table 3

Common drugs associated with the occurrence of DRPs (n=411)

Individual drugs Class of drug Mechanism of action Frequency Percentage
Amoxicillin with clavulanate Penicillin + beta-lactamase inhibitor Amoxicillin inhibits cell wall synthesis; clavulanate inhibits beta-lactamase, preventing bacterial resistance 65 15.8
Ceftriaxone Cephalosporin (3rd generation) Prevents bacterial cell wall synthesis by binding with transpeptidases 50 12.2
Azithromycin Macrolide Inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit 43 10.5
Amoxicillin Penicillin Inhibits bacterial cell wall synthesis by binding with penicillin binding proteins (PBPs) 40 9.7
Piperacillin/tazobactam Penicillin + beta-lactamase inhibitor Piperacillin inhibits cell wall synthesis; tazobactam inhibits beta-lactamase enzymes 34 8.3
Cefepime Cephalosporin (4th generation) Prevents bacterial cell wall synthesis by binding with transpeptidases 27 6.6
Ciprofloxacin Fluoroquinolone Inhibits bacterial DNA gyrase and topoisomerase IV 23 5.6
Metronidazole Nitroimidazole Disrupts DNA synthesis by generating toxic metabolites in anaerobic bacteria and parasites 21 5.1
Vancomycin Glycopeptide Inhibits bacterial cell wall synthesis by binding to D-alanyl-D-alanine residues of peptidoglycan 21 5.1
Meropenem Carbapenem Prevents bacterial cell wall synthesis by binding with trans peptidases 10 2.4
Aciclovir Antiviral (nucleoside analogue) Inhibits viral DNA synthesis by acting as a guanine analogue, incorporating into the viral DNA chain 8 1.9
Cefuroxime Cephalosporin (2nd generation) Prevents bacterial cell wall synthesis by binding with trans peptidases 8 1.9
Others 61 14.8

DRPs, drug-related problems.

Table 4 shows the frequency and percentage of DRPs in different various ward of hospital. DRPs occurred mostly in the non-ICU (inpatient) wards (38.4%), followed by ICU, which had 110 occurrences (26.8%), and the Outpatient category, reporting 86 occurrences (20.9%). The Emergency Department recorded 54 occurrences (13.1%), while the Discharge category had the least with 3 reported cases (0.7%).

Table 4

Type of wards associated with the occurrence of DRPs (n=411)

Ward category Frequency Percentage
Non-ICU (inpatient) 158 38.4
ICU 110 26.8
Outpatient 86 20.9
Emergency Department 54 13.1
Discharge 3 0.7

DRPs, drug-related problems; ICU, intensive care unit.

Name of hospitals and occurrence of DRPs

Table 5 presents the frequency and percentage of DRPs identified across various hospitals. The East Arafat Hospital reported the highest occurrence of DRPs, with 189 cases (46.0%). This was followed by Mina Alwadi reporting 108 cases (26.3%). The Mina Emergency hospital had 77 occurrences (18.7%), while Mina Bridge reported 24 occurrences (5.8%). Lastly, Mina New Street had the fewest, with 13 cases (3.2%).

Table 5

Name of hospitals and occurrence of DRPs (n=411)

Hospital Frequency Percentage
East Arafat Hospital 189 46.0
Mina Alwadi 108 26.3
Mina Emergency 77 18.7
Mina Bridge 24 5.8
Mina New Street 13 3.2

DRPs, drug-related problems.

Type of pharmacists’ interventions and physician’s acceptance

The most frequent intervention was modifying dose frequency or duration, which occurred in 116 cases (28.22%), with a high acceptance rate of 101 (86.79%). The second most common intervention was changing the dose, reported in 105 cases (25.55%), also achieving a substantial acceptance rate of 90 (85.71%). Pharmacists suggested alternative therapies in 94 cases (22.87%), achieving an impressive acceptance rate of 93 (98.94%) and only one instance of rejection. Other interventions included stopping the medication (74 cases, 18.00%), with a lower acceptance rate of 57 (77.03%), while interventions like changing the route of administration (10 cases, 2.43%) and additional/combination therapy (7 cases, 1.70%) received full acceptance (100.00%). The interventions drug monitoring (3 cases, 0.73%) and patient counseling (2 cases, 0.49%) were also fully accepted. The pharmacist interventions provided for all the DRPs identified are shown in Table 6. Table 7 shows the association between demographic variables and patient outcomes.

Table 6

Type of pharmacists’ interventions and physician’s acceptance (n=411)

Type of pharmacist intervention Total The outcome of intervention
Accepted Accepted with modification Rejected
Change dose frequency or duration 116 (28.22) 101 (86.79) 14 (12.07) 1 (0.86)
Change dose 105 (25.55) 90 (85.71) 14 (13.33) 1 (0.95)
Recommend alternative therapy 94 (22.87) 93 (98.94) 0 1 (1.06)
Drug discontinuation 74 (18.00) 57 (77.03) 7 (9.46) 10 (13.51)
Change of administration route 10 (2.43) 10 (100.00) 0 0
Additional/combination therapy 7 (1.70) 7 (100.00) 0 0
Drug monitoring 3 (0.73) 3 (100.00) 0 0
Patient counseling 2 (0.49) 2 (100.00) 0 0

Data are expressed as n (%).

Table 7

Demographic variables and patient outcome (n=411)

Characters Patient outcome (improved) Patient outcome (not improved/deteriorated) χ2 P value
Gender 0.788 0.38
   Male 171 (55.5) 137 (44.5)
   Female 51 (49.5) 52 (50.5)
Age 18.20 <0.001
   16–50 years 52 (39.1) 81 (60.9)
   51 years and above 171 (61.5) 107 (38.5)
Total 223 (54.2) 188 (45.8)

Data are expressed as n (%).

Factors associated with physician acceptance of pharmacist intervention

Table 8 shows logistic regression odds ratios (ORs) for the association between potential factors leading to physician acceptance of pharmacist intervention. For recommended intervention type, drug discontinuation was 17.87 times more likely to be rejected by physician compared to other interventions [OR =17.87; 95% confidence interval (CI): 1.96–162.77]. Although drug discontinuation accounted for 18% of all pharmacist interventions, the wide CI observed in the logistic regression likely reflects the relatively smaller sample size and variability in physician acceptance within this subgroup. Other intervention types are not statistically significant. DRP categories, age and gender of patient or pharmacist do not have significant relationship on acceptance of intervention.

Table 8

Factors associated with physician acceptance of pharmacist intervention

Factors N P value OR (adjusted) 95% CI for OR
Lower boundary Upper boundary
Recommended intervention type
   Additional/combination therapy (ref.) 6
   Change dose 104 0.20 7.726 0.25 236.24
   Change duration/frequency of dose 77 0.69 2.024 0.15 27.55
   Change route of administration 10 0.99 0.000 <0.001 <0.001
   Drug discontinuation 72 0.01 15.815 1.56 155.43
   Drug monitoring 3 0.99 0.000 <0.001 <0.001
   Patient counseling 2 >0.99 0.000 <0.001 <0.001
Age of patients
   50 years and below 133 0.64 0.734 0.22 2.38
   51 years and above (ref.) 278
Gender of patients
   Female 103 0.42 1.667 0.51 5.41
   Male (ref.) 308
Gender of pharmacists
   Male 171 0.19 0.054 <0.001 0.57
   Female (ref.) 51
DRP category
   Inappropriate drug selection 173 0.85 0.814 0.02 31.54
   Dosing issues 100 0.03 0.269 0.09 0.76
   Inappropriate frequency or duration 157 0.49 0.314 0.01 8.64
   Inappropriate route 10 0.54 0.382 0.02 7.46
   Therapeutic duplication 5 0.09 <0.001 <0.001

CI, confidence interval; DRP, drug-related problem; OR, odds ratio; ref., reference.


Discussion

Antimicrobial resistance is a worldwide public health crisis that jeopardizes our ability to effectively treat bacterial infections. One of the key drivers of antimicrobial resistance is the misuse and overuse of antimicrobials in humans (22). This study aimed to characterize DRPs related to antibiotic use among individuals who attended the 2024 Hajj pilgrimage.

Respiratory illnesses were the leading cause for seeking medical attention at the hospitals studied. The current study aligns with previous research reports, confirming that respiratory infections are a common reason for antibiotic prescriptions among pilgrims across different periods (23,24). This is true because respiratory transmission of infectious pathogens often requires close proximity, which is a characteristic feature of the Hajj pilgrimage (25).

This study indicated that inappropriate antibiotic selection was the most common DRP (43.3%) recorded. Though the method utilized to evaluate appropriateness of antibiotics prescription varied, the high prevalence of inappropriate antibiotic use in hospital settings is well-documented in various studies. For example, a single-center prospective quasi-experimental study in Ethiopia also reported that 54% of antimicrobials prescribed were not necessary (26). A systematic review and meta-analysis that assessed the appropriateness of antimicrobial use for respiratory tract infections in outpatients found that the pooled rate of inappropriate antimicrobial prescriptions was 45% (27). Inappropriate antibiotic prescriptions were recorded in 75.5% of the studied subjects with respiratory tract infections in Tunisia (28). These findings highlight the ongoing gap and the need for a dedicated antimicrobial stewardship team to ensure the effectiveness of the AMSP and achieve better clinical outcomes.

Interestingly, studies conducted in Saudi Arabia outside the Hajj period have also identified antibiotic prescribing errors, though with slight variations in patterns and prevalence. For instance, a review of prescriptions from 25 primary healthcare centers in Riyadh found that inappropriate antibiotic selection was the most common error, accounting for 53.9% of cases (29). The modest reduction in such DRPs observed in the current study may be attributed to the strict regulatory measures and enhanced supervision implemented specifically during this annual mass gathering [Circular on Hajj Medication Distribution and Control; Saudi Food and Drug Authority (SFDA) (2022)].

The current study identified amoxicillin-clavulanic acid as the antibiotic class most frequently linked to DRPs. Since respiratory illnesses were the most common conditions encountered at the hospitals studied, it is evident that antimicrobials effective against the pathogens responsible for RTIs were prescribed more frequently. Amoxicillin or amoxicillin-clavullinic acid combinations has been proven to be effective in treating respiratory infections, sinusitis, exacerbations of chronic obstructive pulmonary disease, and bronchiectasis (30). Thabit et al. from the Kingdom of Saudi Arabia also reported amoxicillin to be the most prescribed antibiotic [defined daily dose (DID) =11.708] followed by oral azithromycin (DID =7.395) (24). The more frequent the medicine is prescribed, the higher the risk of drug therapy problem is. Additionally, since the subjects studied were Hajj attendees, who are at an increased risk of respiratory infections, physicians may have been more inclined to over-treat respiratory infections of various origins with the medications mentioned above due to diagnostic uncertainty. On the other hand, Bekele et al., from Ethiopia, reported that ceftriaxone was the antibiotic most frequently implicated in drug therapy problems in a relatively younger population, based on their study on drug therapy issues in infectious disease patients (31). The differences observed in the two studies may be attributed to factors such as the nature of the study participants, the guidelines followed, and the variations in prescribing trends among physicians in the two settings.

Pharmacists’ intervention included modifying dose frequency or duration, changing the dose, suggestion of alternative therapies, stopping the medication, changing the route of administration, and additional/combination therapy, drug monitoring, and patient counselling. Physicians’ acceptance rates for each intervention ranged from 77.3% to 100%, with the suggestion to stop the medications having the lowest acceptance rate, and the suggestions for alternative routes and the addition of medicines having the highest acceptance rates. The current study revealed that drug discontinuation recommendations were 17.87 times more likely to be rejected by physicians compared to other interventions. This finding is in line with a study on the acceptance of prospective audit and feedback in antimicrobial stewardship programs by Langford et al. from Canada which reported that recommendations to decrease antibiotic exposure had lower odds of acceptance (32). Exaggerating the benefits while minimizing the risks, along with the tendency to favor action over inaction, may be reasons why physicians may lean towards increasing antibiotic use rather than decreasing it.

Strengths and limitations

This study’s strengths include its emphasis on the distinctive Hajj pilgrimage setting, the exhaustive data collection of a validated form, and the inclusion of data from five hospitals, which enhances generalizability. Accurate DRP documentation was fostered by interdisciplinary collaboration, incentivized reporting, and anonymity. The findings were further fortified by robust statistical analyses. Nevertheless, the retrospective design of the study restricted the ability to draw causal inferences, and the single-season timeframe may not accurately represent the variability that occurs from year to year. In addition, it also inherently restricted our ability to evaluate additional covariates. The limited scope and bias risks of the study were exacerbated by the restricted focus on antibiotic-associated DRPs and the reliance on self-reported data. The lack of follow-up data restricted insights into long-term outcomes, and context-specific findings may limit broader applicability. We did not employ a standardized classification system for DRP categorization, which may restrict the comparability of our findings with those of other studies as pharmacists’ clinical judgment and institutional protocols were employed to determine classification. Also, this retrospective study is limited by potential confounders and lack of adjustment for variables such as pharmacist experience, patient comorbidities, and underreporting of mild DRPs.

Study implications and future research

This study emphasizes pharmacists’ importance in recognizing and controlling antibiotic-associated DRPs during Hajj. The incidence of DRPs, especially those linked to prescription selection and dosing, highlights the need for antimicrobial stewardship programs suited to mass gatherings’ unique healthcare challenges. Pharmacist interventions, including dose modification and therapeutic recommendations, were well-received, demonstrating their importance in patient outcomes. Standardized pharmacist interventions in mass gatherings should be developed and tested to reduce DRPs and improve patient safety. Pharmacist-driven initiatives’ long-term cost-effectiveness and impact on healthcare resource use must also be examined. Comparative research across healthcare systems and settings may help optimize pharmacist functions in diverse situations. Future longitudinal research across multiple Hajj seasons and broader geographic settings is needed to validate and expand upon our study findings.


Conclusions

This study highlights the critical role of pharmacists in identifying and resolving antibiotic-associated DRPs during the 2024 Hajj pilgrimage. Penicillin-beta-lactamase inhibitor combinations, particularly amoxicillin-clavulanate, were the most frequently implicated drug class, with common DRPs including inappropriate drug selection, dosing errors, and administration issues particularly in non-ICU wards. Pharmacist-led interventions, such as dose modifications and alternative therapy recommendations, were highly accepted by physicians and significantly improved patient outcomes, particularly among older adults. These findings underscore the importance of pharmacist-led stewardship programs and the need for ongoing monitoring and targeted interventions to enhance patient safety and optimize antibiotic use in high-risk, mass gathering settings.


Acknowledgments

None.


Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jhmhp.amegroups.com/article/view/10.21037/jhmhp-25-22/rc

Data Sharing Statement: Available at https://jhmhp.amegroups.com/article/view/10.21037/jhmhp-25-22/dss

Peer Review File: Available at https://jhmhp.amegroups.com/article/view/10.21037/jhmhp-25-22/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jhmhp.amegroups.com/article/view/10.21037/jhmhp-25-22/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ministry of Health, Saudi Arabia (GCMGM-30-9-2024) and individual consent for this retrospective analysis was waived.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.


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doi: 10.21037/jhmhp-25-22
Cite this article as: AlZaagi IA, Alshammari FM, Alshowaiy ASA, Almutairi AS, Alhaysuni MS, Alharbi TF, Alomair BI, Alharbi AA, Almotiry OM, Dhafeeri MKA, Alalawi MN, Albalawi BM, Alharbi MS, Ali S. Antibiotic-associated drug-related problems and pharmacist interventions during the Hajj pilgrimage in Saudi Arabia: insights from a retrospective analysis. J Hosp Manag Health Policy 2025;9:29.

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