Prescription Pattern and Adverse Drug Reactions Associated with Proton Pump Inhibitors in a Tertiary Care Teaching Hospital: A Prospective Observational Study

Proton pump inhibitors (PPIs) are potent suppressors of gastric acid secretion and are widely used in the treatment of acid peptic disorders such as gastroesophageal reflux disease (GERD), peptic ulcer disease, Zollinger-Ellison syndrome, and for prevention of NSAID-induced gastropathy. Since their introduction, PPIs have largely replaced H2 receptor antagonists due to superior efficacy and tolerability.

Commonly prescribed PPIs include omeprazole, pantoprazole, rabeprazole, lansoprazole, and esomeprazole. These agents irreversibly inhibit the H+/K+ ATPase pump in gastric parietal cells, resulting in prolonged acid suppression. Although generally safe, increasing evidence suggests that long-term or irrational use may be associated with adverse outcomes such as headache, diarrhea, hypomagnesemia, vitamin B12 deficiency, fractures, Clostridium difficile infection, and drug interactions.

In clinical practice, PPIs are often prescribed empirically, continued without reassessment, or used prophylactically without clear indications. Drug utilization studies are useful tools to assess prescribing trends, identify irrational use, and improve patient safety. Monitoring adverse drug reactions is equally important for safer pharmacotherapy.

 Hence, the present study was undertaken to evaluate the prescription pattern and ADR profile associated with PPIs in a tertiary care teaching hospital.

Study Design

Prospective observational study.

Study Setting

Department of Pharmacology in collaboration with the Departments of General Medicine and Gastroenterology at a tertiary care teaching hospital.

Study Duration

12 months.

Study Population

Patients receiving any proton pump inhibitor in outpatient or inpatient departments.

Sample Size

320 patients.

 Inclusion Criteria

·        Patients aged ≥18 years.

·        Patients prescribed any PPI during study period.

·        Patients willing to provide informed consent.

 Exclusion Criteria

·        Patients unwilling to participate.

·        Critically ill patients unable to provide history.

·        Patients with incomplete prescription records.

 Data Collection

Relevant data were collected using a structured case record form:

·        Age, gender

·        Diagnosis/indication

·        Type of PPI prescribed

·        Dose, frequency, route, duration

·        Concomitant medications

·        Whether indication was appropriate as per standard guidelines

·        Adverse drug reactions during follow-up

 ADR Assessment

Reported ADRs were assessed using WHO-UMC causality scale and categorized as certain, probable, possible, unlikely, or unclassified.

 Statistical Analysis

Data were entered in Microsoft Excel and analyzed using SPSS version 20. Results expressed as percentages, mean ± SD. Chi-square test used for categorical variables. p <0.05 considered statistically significant.

 Ethical Approval

Study approved by Institutional Ethics Committee prior to initiation.

Demographic Profile

A total of 320 patients receiving proton pump inhibitors were included in the study. Among them, 186 (58.1%) were males and 134 (41.9%) were females, showing a male predominance. The mean age of the study population was 46.8 ± 15.2 years.

Mean age = 46.8 ± 15.2 years

 Indications for PPI Prescription

The most common indication for prescribing PPIs was gastroesophageal reflux disease (GERD), accounting for 110 (34.4%) cases, followed by gastritis in 84 (26.3%) patients. Peptic ulcer disease was observed in 58 (18.1%) patients, while NSAID prophylaxis and dyspepsia accounted for 38 (11.9%) and 18 (5.6%) cases respectively. Other miscellaneous indications were noted in 12 (3.7%) patients.

 

Pattern of PPI Use

Pantoprazole was the most frequently prescribed proton pump inhibitor, used in 175 (54.7%) patients. Omeprazole was prescribed in 69 (21.6%) cases, followed by rabeprazole in 46 (14.4%) and esomeprazole in 30 (9.3%) patients. Regarding route of administration, oral PPIs were prescribed in 227 (70.9%) patients, whereas injectable formulations were used in 93 (29.1%) patients.

 

 

Appropriateness of Prescription

Out of 320 prescriptions analyzed, 248 (77.5%) were considered appropriate according to standard treatment guidelines, whereas 72 (22.5%) were categorized as inappropriate. Common examples of irrational prescribing included routine stress ulcer prophylaxis in low-risk patients and continuation of therapy without reassessment.

 

Adverse Drug Reactions

A total of 52 patients (16.3%) experienced adverse drug reactions during the study period. Headache was the most commonly reported ADR in 16 (30.8%) patients, followed by diarrhea in 12 (23.1%) patients. Nausea, abdominal pain, dizziness, and rash were also reported.

 

Severity of ADRs

Most ADRs were mild in nature and observed in 39 (75.0%) patients. Moderate reactions were seen in 11 (21.2%) patients, while severe ADRs were uncommon and reported in only 2 (3.8%) patients.

 

WHO-UMC Causality Assessment

Based on WHO-UMC causality assessment scale, 24 (46.2%) ADRs were categorized as probable, 22 (42.3%) as possible, and 6 (11.5%) as unlikely.

 

 

The present study demonstrated that pantoprazole was the most commonly prescribed PPI, similar to previous Indian studies due to its favorable safety profile, lower interaction potential, and availability in injectable form. GERD and gastritis were the most common indications.

A notable finding was that 22.5% prescriptions were inappropriate. Overuse of PPIs has been reported globally, especially for prophylactic purposes in patients without clear risk factors. Such irrational use increases cost burden and risk of adverse effects.

The incidence of ADRs in our study was 16.3%, with headache and diarrhea being the most common, consistent with established literature. Most ADRs were mild and self-limiting. Serious reactions were rare.

This study highlights the importance of regular prescription audits, guideline-based therapy, and pharmacovigilance systems.

 Limitations

1. Single-center study.
2. Moderate sample size.
3. Long-term complications such as fractures and micronutrient deficiency were not assessed.

Follow-up duration limited.

Pantoprazole was the most frequently prescribed PPI in this tertiary care hospital. Though PPIs were largely prescribed appropriately, a substantial proportion lacked justified indications. Adverse drug reactions were mostly mild, with headache and diarrhea being common. Rational prescribing practices, deprescribing when unnecessary, and active pharmacovigilance are essential to improve patient safety.

 Recommendations

1. Use PPIs only for evidence-based indications.
2. Review necessity during follow-up visits.
3. Avoid prolonged empirical use.
4. Encourage ADR reporting.
5. Conduct regular prescription audits.

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