الفهرس 
Introduction and Aims of the StudyOnly 14 pages are availabe for public view
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Abstract
Proton pump inhibitors are potent suppressors of acid secretion. They have for many years been the cornerstone of treatment of GERD and in healing and prevention of gastro-duodenal ulcer. Recent evidence indicates signs of harm associated with long-term use of PPIs, such as diarrhea, impaired B12 absorption, hypomagnesemia, C. difficile infection, hip fracture, pneumonia, dementia, acute interstitial nephritis and CKDwhere older people might be at higher risk of these conditions.
Concerns are growing about inappropriate indication and potential overuse both within hospitals and in primary-care setting. In light of these concerns, the aim of the present study was to investigate the extent and appropriateness of prescribed proton pump inhibitors in Alexandria University Students Hospital and with the following specific objectives:
1. To estimate the prevalence of proton pump inhibitor prescription for hospitalized patients.
2. To compare prescription indication of proton pump inhibitor for hospitalized patients with FDA- approved indication.
3. To investigate the different drug-drug interaction between proton pump inhibitor and other prescribed drugs.
A cross sectional study was conducted among adults (18 years and above). The study included 385 patients admitted to inpatient wards of the Internal Medicine Department of Alexandria University Students Hospital.
Data collection was done by auditing the medical records of the patients using a data collection sheet including socio-demographic data, primary cause of admission, history of comorbidities, history of concomitant drugs prescribed during hospitalization, duration of stay at hospital, data about PPIs (indication of prescription, type of PPIs, discharge prescription), checklist (FDA-approved indication, drug-drug interaction with PPIs), and total cost of inappropriate PPIs prescription during hospitalization and at discharge.
Data entry and statistical analysis were done using software Statistical Package Social Science (SPSS) version 23, Statistical analysis was performed in both descriptive and inferential forms.
The study revealed the following main results:
1. Socio-demographic and clinical characteristics of hospitalized patients:
The age ranged between 18 and 83 years with median (IQR) 45 (24-61) years.
About two-thirds (61%) of hospitalized patients were females.
Almost two-thirds (62.9%) of hospitalized patients were married.
Employees constituted more than two-fifths (42.9%) of hospitalized patients, while more than one-quarter (26.5%) were retired.
The median (IQR) duration of stay at hospital was 4 (2-7) days.
More than one-quarter (29.1%) of patients were admitted to the hospital due to pulmonary diseases. Cardiovascular diseases were the primary cause of admission among 18% of hospitalized patients.
More than one-third (39.2%) of the hospitalized patients had pulmonary disease as a comorbidity. Almost one-third of hospitalized patients complained of either cardiovascular diseases (30.9%) or endocrine diseases (30.1%).
More than half (57.1%) of the hospitalized patients received antimicrobial drugs. Less than two-fifths of the hospitalized patients were prescribed either analgesics (38.4%) or antihypertensive drugs (37.9%).
2. Prevalence and pattern of PPIs use among hospitalized patients:
A. Prevalence, types and dose of PPIs
About three-quarters (71.4%) of the study patients used PPIs. Among those who were using PPIs, Pantoprazole 40mg was the most commonlyuseddrug (82.2%) while pantoprazole 20mg drug was prescribed for only 2 patients. More than three-quarters (78.5%) of PPIs users received PPIs in the form of vials. Only 4% of PPIs users received both vials and tablets form during hospitalization. More than three-quarters (76%) of patients on PPIs used PPIs once daily.
B. Appropriateness of prescription
About one-third (32.7%) of PPIs users received the treatment for appropriate indication. Non-steroidal anti-inflammatory use was the indication for appropriate PPIs prescription among two-thirds (66.7%) of the PPIs users. Gastroesophageal reflux disease constituted 23.3% of the indications of appropriate prescription. Only 1.1% of patients received PPIs due to peptic ulcer.
3. Association between socio-demographic characteristics, clinical data, and history of concomitant drugs prescription during hospitalization and PPIs use:
In univariate analysis: age, marital state, occupation, duration of stay at hospital, primary cause of admission (cardiovascular disease, endocrine disease, hematologic disease, pulmonary disease, liver disease, renal disease), history of comorbidities (gastrointestinal disease, cardiovascular disease, pulmonary disease, hematologic disease, renal disease endocrine disease, autoimmune disease, other disease), and history of drug prescribed during hospitalization (antimicrobial drugs, chemotherapeutic drugs, anti-diabetic drugs, antihypertensive drugs, diuretics, anticoagulants, antihyperlipidemic drugs, circulatory disorder drugs, drugs for gout, vitamins, analgesics, mucolytics, and hepatitis C virus drugs) were significantly associated with PPIs use.
In logistic regression analysis: cardiovascular comorbidities, antimicrobial drugs, and duration of stay at hospital were significantly associated with PPIs use.
4. Association between socio-demographic characteristics, clinical data, and history of concomitant drugs prescription during hospitalization and appropriateness of PPIs use:
In univariate analysis: gender, primary cause of admission (gastrointestinal disease, cardiovascular disease, pulmonary disease, and neurologic disease), history of cormorbidites ( gastrointestinal disease, cardiovascular disease, pulmonary disease, renal disease), and history of concomitant drug prescription during hospitalization (antimicrobial drugs, antihypertensive drugs, anticoagulants drugs, cholesterol drugs, circulatory disorder drugs, corticosteroids, antihistaminic drugs, mucolytics, and drugs affecting central nervous system) were significantly associated with appropriateness of PPIs use.
In logistic regression analysis: gender, pulmonary disease as primary cause of admission, renal comorbidities, and drugs affecting central nervous system were significantly associated with inappropriate PPIs use.
5. Drug-drug interaction with PPIs:
Among PPIusers, about17.8% had the probability of drug-drug interaction between PPIs and other drugs. Among those more than two-thirds (69.4%) received clopidogrel, more than one-fifth (22.4%) received iron salts, and about 8.2% received digoxin.
6. Discharge prescription:
More than two-fifths (42.9%) of the hospitalized patients had PPIs prescription at discharge. Only 34.5% of them received PPIs for appropriate indication. Pantoprazole 40mg tablets were prescribed to about less than three-quarters (73%) of patients prescribed PPIs at discharge. About one-fifth (21%) of the patients who were prescribed PPIs at discharge had omeprazole 20mg tablets prescription. Pantoprazole 20mg tablets were prescribed to only 1% of the patients at discharge.
7. Total cost of inappropriate doses of PPIs during hospitalization and at discharge:
A. During hospitalization
The total number of vials consumed inappropriately was 844 vials with approximately total cost of 58025 LE and the total number of tablets consumed inappropriately was 249 tablets with approximately total cost of 1618.5 LE.
B. At discharge
The total number of tablets prescribed inappropriately was 1513 tablets with approximately total cost of 8329.5 LE.
Conclusions
Based on the results of the current study, the following can be concluded:
• The use of PPIs is widely prevalent among hospitalized patients. About three-quarter (71.4%) among hospitalized patients received PPIs.
• The prevalence of inappropriate PPIs prescription according to FDA-approved indications was 67.3% among hospitalized patients who received PPIs.
• About two-fifths (42.9%) of hospitalized patients had PPIs discharge prescription and about two-thirds (65.5%) of them had inappropriate prescription.
• Pantoprazole 40 mg was widely prescribed among PPIs users whether during hospitalization (82.2%) or at discharge (73%).
• Cardiovascular comorbidity, use of antimicrobial drugs, and duration of stay at hospital were significantly associated with the use of PPIs.
• Gender, pulmonary disease as a primary cause of admission, renal disease as comorbidity, and drugs affecting central nervous system were significantly associated with inappropriate PPIs use.
• Based on FDA guideline, drug-drug interaction was found among 17.8% of patients who had PPIs prescription during hospitalization. The most common drug-drug interaction was with clopidogrel 69.4% followed by oral iron salt 22.4% and finally digoxin 8.2%.
• Beside the adverse effects of inappropriate PPIs prescription for the hospitalized patients, there was also economic burden to the health care system as the inappropriate doses prescribed have cost about 59643.5 LE during stay and about 8329.5 LE at discharge.
Recommendations
A. Recommendations to Ministry of Health and Population:
• Adverse effects reporting system should be well established to follow up and document any side effects of PPIs.
• Continuous education of the pharmacists about the basic principles of rational use of PPIs with special stress on adverse effects and possible drug-drug interactions.
• Desperate need for local setting well-defined PPIs prescribing criteria.
B. Recommendations to physicians:
• Physicians should abide by the FDA guidelines for the prescription of PPIs to avoid patient harm and waste of resources.
• Educate medical team about the data associated with inappropriate PPIs prescription in hospitalsand the adverse effects of long-term PPI uses.
• Focus on proper documentation of evidence-based indication of PPIs prescription in medical records.
• Physicians should carefully assess hospital discharge prescription to avoid continuation of inappropriate prescription of PPIs.
C. Recommendations to pharmacists:
• Having dedicated pharmacists in the ward or during ward rounds, who could monitor PPIs use and undertake medical reconciliation during admission and discharge processes. This could help to limit the prescription of PPIs to patients with more appropriate indication.
• Reporting all possible drug-drug interaction with PPIs and inform the physicians to make changes in PPIs prescription to avoid any DDIs as with clopidogrel and isomeprazole.
D. Recommendations to researchers:
• Further researches are required to detect the inappropriate prescription of PPIs among patients in other hospitals and in private practices.
• Additional studies are required about the adverse effects and DDIs of PPIs.