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   Table of Contents      
ORIGINAL ARTICLE
Year : 2019  |  Volume : 5  |  Issue : 3  |  Page : 113-120

Proton Pump Inhibitors: Prescribing Practices, Appropriateness of Use, and Cost Incurred in a Tertiary Care, Public, Teaching Hospital in New Delhi, India


Department of Pharmacology, Maulana Azad Medical College and Associated Hospitals, University of Delhi, New Delhi, India

Date of Submission26-Apr-2019
Date of Decision12-Sep-2019
Date of Acceptance21-Sep-2019
Date of Web Publication17-Dec-2019

Correspondence Address:
Vandana Roy
Department of Pharmacology, Maulana Azad Medical College and Associated Hospitals, University of Delhi, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mamcjms.mamcjms_40_19

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  Abstract 


Aims and Objectives: Proton pump inhibitors (PPIs) are the most commonly used drugs in healthcare systems. Their inappropriate use has been reported in several studies. This study was undertaken to assess the prescribing practices, appropriateness of use, and cost incurred on PPI in a tertiary care, public, teaching hospital in India. Methods: A total of 500 inpatients’ records and 600 outpatients’ prescriptions were analyzed. Extent of prescribing, dosing information given, and cost incurred on the use of PPI in both inpatients and outpatients was assessed. The appropriateness of PPI prescribed was analyzed only among inpatients. Results: PPIs were prescribed to 62.2% inpatients and 27% outpatients. Extent of use of PPI was maximum in medicine department in both inpatients (78.5%) and outpatients (44.5%). Complete dosing information was seen in 9.9% (inpatients) and 30.2% (outpatients) prescriptions. In all the prescriptions of outpatients, tablets/capsules were prescribed whereas in inpatients, 79.74% PPI were prescribed as injections. All PPIs were prescribed by branded generic names except three prescriptions in inpatients of the medicine department. Most common PPI prescribed was pantoprazole by the name of PANTOP in both inpatients and outpatients. The use of PPI was appropriate in 7.4% cases, inappropriate in 91% of the cases, and probable in 1.6% cases. Total cost incurred on the prescriptions of inpatients and outpatients was Rs. 10,04,102. Of this cost, Rs. 1,20,085 (11.95%) was spent on PPI. Cost incurred on PPIs in inpatients was Rs. 1,12,621 (11.65%) and in outpatients was Rs. 7463.67 (19.93%). Maximum cost was incurred on pantoprazole in both inpatients and outpatients. Conclusions: PPIs are being prescribed inappropriately to many patients resulting in a waste of economic resources. Lack of regular audits and feedback to prescribers could be the contributing factors. Educational interventions in rational prescription of PPIs are required to encourage their proper utilization for patients.

Keywords: Gastrointestinal, overutilization, pantoprazole, proton pump inhibitors


How to cite this article:
Verma N, Tayal V, Roy V. Proton Pump Inhibitors: Prescribing Practices, Appropriateness of Use, and Cost Incurred in a Tertiary Care, Public, Teaching Hospital in New Delhi, India. MAMC J Med Sci 2019;5:113-20

How to cite this URL:
Verma N, Tayal V, Roy V. Proton Pump Inhibitors: Prescribing Practices, Appropriateness of Use, and Cost Incurred in a Tertiary Care, Public, Teaching Hospital in New Delhi, India. MAMC J Med Sci [serial online] 2019 [cited 2020 Feb 24];5:113-20. Available from: http://www.mamcjms.in/text.asp?2019/5/3/113/273281




  Introduction Top


Proton pump inhibitors (PPIs) are among the most commonly prescribed drugs for various acid-related gastrointestinal (GI) disorders in healthcare systems.[1] Guidelines and recommendations for the use of PPIs in different clinical conditions have been published.[2],[3],[4],[5] Despite the availability of guidelines, nonjudicious use of these drugs has been reported in several studies.[1],[6],[7],[8],[9],[10] Between the years 2001 and 2015, PPI prescriptions have been reported to have increased manifold across countries.[10],[11],[12],[13],[14] Some of the important factors resulting in overuse of PPIs may include availability of low-cost generic PPIs, their easy accessibility as over-the-counter drugs, better effectiveness of PPI than other acid-suppressant drugs, failure of prescribers to reevaluate the need for continuation of therapy, and inappropriate stress ulcer prophylaxis.[7],[12] PPIs are often given routinely to patients who are prescribed nonsteroidal antiinflammatory drugs (NSAIDs) even in the absence of risk factors.[4],[7] This practice can increase the likelihood of adverse drug effects and also cause a waste of economic resources.[15] Short-term PPI administration is generally well tolerated. However, continuous use of PPIs has been reported to increase the risk of infection, osteoporosis, and other serious adverse reactions such as hypomagnesemia, fractures, hepatic, renal, skin, and bone marrow toxicity, and anaphylaxis.[16] Moreover, use of PPIs has been linked to an increased risk of community-acquired pneumonia, Clostridium difficile diarrhea, and Campylobacter jejuni gastroenteritis.[16]

Not many studies regarding the extent of prescribing and appropriateness of use of PPI are reported from developing countries.[17],[18],[19] Further, there is lack of data regarding cost incurred on PPI use in clinical practice in India. Hence, the present study was conducted to determine the same.


  Material and Methods Top


A cross-sectional, observational study was conducted in the Departments of Pharmacology, Medicine, Surgery, and Orthopedics of a large tertiary care, teaching hospital in Delhi, India. The catchments area of the hospital is very large and receive patients from not only Delhi but also neighboring states. The study was approved by the Institutional Ethics Committee. Written informed consent was obtained from all the patients.

Six hundred outpatients’ prescriptions (medicine 200, surgery 200, and orthopedics 200) and 500 inpatients’ records (medicine 200, surgery 200, and orthopedics 100) were analyzed between May and July 2015. Convenience sample was taken for the study. Departments of Medicine, Surgery, and Orthopedics were selected to study the extent of PPI prescribing because in medicine department, patients with serious conditions, associated comorbidities, and varying ages are admitted. Hence, multidrug therapy is a norm in these patients, whereas in surgery and orthopedics departments, use of analgesics especially NSAIDs is common whose important side effect is gastric intolerance. Because of these particular reasons, we expected higher use of PPIs in these departments.

The data for both were collected in a pretested, structured proforma. The proforma was divided into the following parts: patient demographic details, dosing information of PPI such as name, dose, frequency, duration, route, and dosage form, any documented instructions about when it has to be taken (time of the day and relation to meals), any documented indications for prescribing PPIs, and cost of PPI.

The extent of prescription, completeness of prescription information, appropriateness of use of PPI, and cost incurred on the PPI was determined.

The extent of prescription of PPI was determined by calculating the total percentage of prescription encounters with PPI. The total percentage of prescription encounters with drugs used for reducing gastric acidity was also determined.

Prescription information of PPI was considered complete if all the dosing information as asked in the proforma was written.

Appropriateness of PPI prescribed was assessed only in inpatients. They were categorized into three groups.
  1. Appropriate: If the case sheet had a documented recommended indication for a PPI use.
  2. Inappropriate: If there was any case sheet without a documented recommended PPI indication or without justification.
  3. Probable: Any indication was deemed probable when PPIs might have been indicated, for example, suspected gastrointestinal bleeding, but there was no clear evidence that bleeding actually occurred or absence of definitive investigation such as endoscopy, etc.


The indications were matched with the approved indications for prescribing PPI as listed in Appendix 1.[2],[3],[4],[5] The percentage of appropriate prescriptions for PPI was calculated.

The cost incurred on the PPI was calculated for each individual patient by multiplying units of PPI prescribed with the cost of individual unit. The total cost as well as the percentage of cost on PPI was determined in both inpatients and outpatients. The Indian currency “Rupee” (INR) was used to determine the cost for PPIs (1 US dollar equals to INR 73.67).

The cost of the PPI was obtained from the hospital administration, as medicines are supplied by the hospital free of cost to the patient. For medicines not available in the hospital, the cost of the medicine for that brand available in the market was taken from Drugs Today,[20] a commonly used commercial drug compendium and current index of medical specialities (CIMS).[21]

Statistical analysis

Results are expressed in percentages, median, and interquartile range. Comparison of data in different departments and among inpatients and outpatients was performed using descriptive statistics.


  Results Top


Demographic details of inpatients and outpatients who were prescribed PPIs are mentioned in [Table 1].
Table 1 Demographic details of patients prescribed PPI in inpatients and outpatients

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Prescribing pattern of PPIs in inpatients and outpatients

Extent of prescribing

Among 500 inpatients, 80.6% patients were prescribed drugs for reducing gastric acidity and 62.2% patients were prescribed PPI as a drug of choice [Figure 1]. Thus, PPIs constituted 77.1% of the acid-suppressant drugs prescribed. The extent of use of PPI was maximum in the medicine department.
Figure 1 Prescription of proton pump inhibitor in inpatients

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Among 600 outpatients, 80.33% patients were prescribed gastric acidity-reducing drugs. However, only 27% patients were prescribed PPI that constituted 33.6% of the acid-suppressant drugs prescribed. The extent of use of PPI was maximum in medicine department [Figure 2].
Figure 2 Prescription of proton pump inhibitor in outpatients

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The most common PPI prescribed overall was pantoprazole followed by omeprazole and only one outpatient was given rabeprazole. Pantoprazole was prescribed in 74% of outpatients and 99.6% of inpatients who were prescribed PPIs. All the PPIs were prescribed by branded generic name except in three inpatients of medicine department who were prescribed pantoprazole by international nonproprietary name. In all departments, the most common branded generic medicine used was PANTOP followed by PANTOCID [Table 2]. All PPIs were prescribed in their recommended doses once daily, that is, omeprazole 20 mg, pantoprazole 40 mg, and rabeprazole 20 mg.
Table 2 Details of PPIs and their brands prescribed in inpatients and outpatients

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Dosing information was complete in prescriptions of 30.2% outpatients and 9.9% inpatients. Most of the prescriptions analyzed had the dose, dosage form, frequency, and duration of intake but only few prescriptions had information about when it has to be taken in relation to the time of the day and meals.

Injections (79.74%) among inpatients and tablets/capsules in outpatients (100%) were the dosage form prescribed [Table 3]. In medicine department, majority of inpatients were given injection PANTOCID whereas in surgery department, injection PANTOP was prescribed in majority of inpatients [Table 2]. Majority of inpatients (medicine 96.8%, surgery 66%, orthopedics 100%) and some outpatients (medicine 53%, surgery 26.6%, orthopedics 10%) were prescribed multiple medications ranging from 4 to 12. The median number of drugs intake by the inpatients was seven in medicine (interquartile range, IQR = 3), four in surgery (IQR = 2), and four in orthopedics (IQR = 4) department. In outpatients, the median number of drugs per prescription was four in medicine (IQR = 3), three in surgery (IQR = 1), and two in orthopedics (IQR = 1) department.
Table 3 Dosage form of PPI prescribed in inpatients and outpatients

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Among inpatients, concomitant use of NSAIDs was observed in 34.39%, 80.9%, and 100% patients in medicine, surgery, and orthopedics department, respectively. In outpatients, 35.22%, 56.45%, and 88.88% patients in medicine, surgery, and orthopedics department, respectively, were prescribed NSAIDs concomitantly.

Appropriateness of PPI prescribed

The appropriateness of PPI prescribed was analyzed only among inpatients according to the recommended guidelines.[3],[4],[5],[6] The case notes on admission were reviewed to determine the possible reasons for PPI initiation that were then cross-referenced against a list of accepted indications [Appendix 1]. The use of PPI was found to be appropriate in 7.39%, probable in 1.6%, and inappropriate in 91% patients. The percentage of inappropriate prescriptions of PPI was 90% in medicine, 92% in surgery, and 100% in orthopedics department.

Cost incurred on PPI

The total cost incurred on all medicines of inpatients and outpatients was INR 10,04,102. Of this amount, INR 1, 20, 085 (11.95%) was spent on PPIs. Among inpatients INR 1, 12, 621 (11.65%) and in outpatients INR 7463.67 (19.93%) of the total expenditure on medicines was spent on PPIs [Table 4]. Maximum cost was incurred on pantoprazole in both inpatients and outpatients. The unit cost of tablets of PANTOP (40 mg) and PANTOCID (40 mg) was INR 6.46 and INR 7.50, respectively. The unit cost of vials of PANTOP and PANTOCID (40 mg) for injection was INR 54.11 and INR 50.33, respectively. The unit cost of tablets of OMEZ (20 mg) and OCID (20 mg) was INR 3.37 and INR 3.171, respectively.
Table 4 Cost incurred on PPI in inpatients and outpatients

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  Discussion Top


Several studies mostly from developed countries have shown that PPI are overutilized and used indiscriminately in many cases without valid indications.[9],[10],[12] There are very few studies assessing the prescribing practices, appropriateness of use, and costs incurred on PPI from India.[18],[19],[22] This is the first study from India wherein the appropriateness of use of PPI in inpatients and cost incurred on PPI in both outpatients and inpatients has been assessed.

The extent of utilization of drugs for reducing gastric acidity was high in both inpatients and outpatients. An earlier survey conducted in an emergency setting also revealed that majority of the resident doctors prescribed acid-suppressant agents to a high proportion of their patients and 92% of them considered PPI as their first choice among acid-suppressing drugs.[17] This choice may be driven by the fact that PPIs have entered the market more recently and they are also considered to be more efficacious and safer than other acid-suppressant drugs.[1],[9]

The use of PPI was more in inpatients (62.2%), an observation similar to other studies, wherein utilization of PPI therapy in inpatients has ranged from 30.6% to 90.8%.[6],[7],[10],[12],[23] Inpatients have multiple comorbid serious conditions necessitating multidrug therapy. Many doctors feel that PPI are needed to prevent stress ulcers.[19],[24]

The use of PPIs was maximum in medicine department both in inpatients and outpatients and least in orthopedics department. Similarly, in an earlier study, use of pantoprazole was reported to be higher (72.6%) in the medicine department than in the surgery department (47.1%).[25] This may be because patients admitted in medicine department have multiple comorbidities and they receive more drugs as was also observed in this study. It is pertinent to note that more patients in surgery and orthopedics were prescribed NSAIDs. It is possible that doctors prescribed PPIs concomitantly to the patients to prevent gastritis. However, prescribing PPI to all patients who are prescribed NSAIDs is not rational.[24] Even prescribing PPI routinely to most inpatients without clear-cut indications is not scientifically acceptable. Indications for prescribing PPI are clearly stated in guidelines.[2],[3],[4],[5]

Majority (79.74%) of inpatients were given pantoprazole by injections. Similarly, widespread use of parenteral PPIs has been reported from other medical institutions as physicians generally prescribe parenteral PPIs in place of oral PPIs to obtain better treatment efficacy.[17],[19],[26] However, evidence suggests that oral therapy is highly effective, similar in effectiveness to intravenous (IV) PPIs at equivalent doses and actually only a small proportion of patients with upper GI bleeding require parenteral use of PPIs.[27] It has also been revealed in a study that the most common cause for inappropriate use of IV PPIs was stress ulcer prophylaxis and most inappropriate IV prescriptions of PPI were ordered by postgraduate students and junior doctors.[19] Thus, there is a need for developing institutional protocols and conducting training programs for emphasizing appropriate prescribing practices with regard to parenteral PPIs. A recent report from China revealed a 10.4-fold increase in PPI utilization over a 10-year period (between 2004 and 2013) with the greatest increase (15.7 fold) observed with the injectable PPIs.[14] One reason explained in their setting for overuse of injectables was the financial incentives involved. However, in the government public setup, such financial incentive seems unlikely for prescribing parenteral PPIs.

In the hospital list of essential medicines, the PPIs listed are omeprazole capsule 20 mg for both inpatients and outpatients and pantoprazole injection 40 mg for inpatients.[28] Doctors are advised to prescribe drugs given in the list only and by using generic names. However, we observed that only select few branded generic PPIs were being prescribed to all patients and these were not listed in the hospital list of essential medicines. Possible reason could be that branded medicines are thought to be of better quality than nonbranded generic drugs. Promotion by representatives of pharmaceutical companies also cannot be ruled out. Evaluation of reasons why the prescribers use brand names for drugs while prescribing in general and PPIs in particular is needed to increase understanding of this practice.

Dosing information was incomplete in majority of medical records of both inpatients and outpatients. An important instruction related to intake of oral PPIs before meals was not mentioned. All this indicates a need for education of healthcare providers in rational prescribing.

Although the magnitude of inappropriate prescriptions (91%) in this study was high, it coincides with the results found in some other studies.[23],[24],[29]

While analyzing the case records, we looked for other plausible reasons for prescription of PPI by the doctor. These could be age of patient ≥60 years, comorbid conditions (≥3), diagnosis of GI pathology, prolonged stay in hospital (≥4 days), number of concomitant drugs prescribed (≥4), and whether NSAIDs/steroids prescribed concomitantly. However, these indications do not come under the recommended guidelines. If we were to consider the above indications as a justifiable reason for prescribing PPIs, then the percentage of inappropriate prescriptions decreases. In absence of evidence, such indications would require to be considered on a case by case basis by the doctors to justify whether prescribing PPI would be appropriate in that situation.

There are several studies from all over the world which attest to the fact that PPIs are prescribed inappropriately not only during hospitalization but also at the time of discharge and in outpatient settings.[6],[7],[8]

PPIs are more expensive than other acid-suppressant agents hence inappropriate prescription of PPI is of concern more so in resource-limited settings.[30] During the study period, we noted that 10% to 20% of total expenditure on medicines was being spent on PPI, which is a large amount. Reasons for this high expenditure could be attributed to the greater use of injections as well as a higher cost of branded generic PPIs. Considering that most were for inappropriate indications, there has been waste of economic resources.

Patients were prescribed branded generic drugs not available in the hospital. The maximum cost was incurred on pantoprazole as it was the costliest and the most common PPI prescribed to both inpatients and outpatients. It has been shown earlier in a study that omeprazole 20 mg and 40 mg is the cheapest in both oral and injectable form, respectively, and pantoprazole 40 mg has the costliest brand among injectable PPIs.[31] In a government hospital of a resource-limited country, where medicines are given free of cost to patients, it is important to see that medicines are used rationally.

In addition to the cost burden, inappropriate prescribing of PPIs can lead to adverse drug reaction. It is a matter of great concern, especially in the elderly, who often have multiple comorbidities and are on multiple medications and are thus at an increased risk of long-term PPI-related adverse outcomes as well as drug-to-drug interactions.[32] Patients were prescribed medications ranging from 4 to 12 in number. Adverse reactions that occur may be mistakenly considered as a part of the patients’ problem, not attributed to the drug. Unawareness of these by doctors may aggravate the problem of irrational use of PPI. Hence, more conscious prescribing is needed when PPIs are used in hospital practice. A survey done has revealed that very few resident doctors were aware of adverse effects of PPIs such as increased risk of community-acquired pneumonia, Clostridium difficile infection and hip fractures.[17] We did not monitor the patients for adverse drug reactions.

Limitations of the study

  1. For assessing appropriateness of PPIs prescribed, only inpatients case records were used. This is because outpatient department prescriptions often do not have a diagnosis written and very less clinical findings are mentioned, which were required for evaluating appropriateness of PPI prescribed.
  2. The study was purely observational, all data being obtained only from prescriptions of the patients and no attempt was made to intervene or question the physicians on their reasons for prescribing PPIs. So, it is difficult to differentiate whether inappropriate prescribing was due to mere inadequate documentation of indication or due to wrong selection of PPI for that indication.
  3. In cost evaluation, we did not consider if the hospital pharmacy substituted a branded drug with a generic one.
  4. We did not monitor the incidence of adverse reactions or drug interactions occurring with PPIs that could have given valuable information.



  Conclusion Top


PPIs are being commonly prescribed as branded generics in the hospital mostly inappropriately. About 80% of inpatients were given PPIs by injections. Around 10% to 20% of total cost incurred on medicines was on PPIs and moreover the costliest PPI (pantoprazole) was most commonly used by the prescribers. The hospital is incurring wasteful expenditure on prescribed PPIs. There is an urgent need to formulate hospital guidelines for prescribing PPIs, introducing prescription restrictions, and conducting continuing education programs to sensitize the doctors regarding rational use of PPIs. Findings of this study are a cautionary note regarding prescription of PPIs in this large public health facility.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Appendix 1

Indications for use of proton pump inhibitors[2],[3],[4],[5]
  1. Gastric and duodenal ulcers
  2. Gastroesophageal reflux disease
    1. Nocturnal acid breakthrough
    2. Reflux esophagitis
  3. Erosive esophagitis
  4. Self-treatment for heart burn
  5. Hypersecretory conditions, for example, Zollinger Ellison syndrome
  6. Nocturnal dyspepsia
  7. Prevention and treatment of NSAID-induced gastric ulcers for certain cases, depending upon risk factors that are
    1. Age > 65 years
    2. Drugs −
      1. High dose of NSAIDs
      2. Concurrent use of aspirin, corticosteroids, or anticoagulants
    3. Previous history of peptic ulcer (complicated/uncomplicated)
      1. If risk is
      2. Low − prescribe NSAIDs alone
      3. Medium − prescribe NSAID + PPI/misoprostol
      4. High − prescribe COX-2 inhibitor + PPI
      • If peptic ulcer is healed, then PPI given on “as needed basis.”
  8. Prophylaxis of stress-related ulcers
    1. After profound Illness
    2. Trauma requiring intensive care
      1. Severe coagulopathy and mechanical ventilation for longer than 48 hours
      2. History of UGI bleeding
      3. Sepsis
      4. ICU admission longer than 7 days
      5. Occult GI bleeding for more than 5 days


Treatment with high-dose glucocorticoids.



 
  References Top

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