New Delhi: A crucial study by the Indian Council of Medical Research (ICMR) has uncovered significant irregularities in drug prescriptions at major government hospitals in the country.

The research, part of the ICMR’s Rational Use of Medicines (ICMR-RUM) task force project, found that 45 percent of prescriptions deviated from standard treatment guidelines, with nearly 10 percent involving “unacceptable deviations”.

The study — which was published in the health research agency’s Indian Journal of Medical Research in February — scrutinised 7,800 prescriptions from outpatient departments of 13 tertiary care hospitals and medical colleges, including the All India Institute of Medical Sciences (AIIMS) in New Delhi and Bhopal, KEM Hospital in Mumbai, Post Graduate Institute of Medical Education & Research (PGIMER) in Chandigarh, and Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) in Puducherry. 

Christian Medical College (CMC) in Vellore was the only non-government hospital included in the analysis, which spanned from August 2019 to August 2020.

The prescriptions that could lead to drug interactions (reactions between two or more drugs with unwanted results) lack of response, increase in cost, preventable adverse drug reactions and antimicrobial resistance were categorised as “unacceptable”, indicating that one or more drugs mentioned in such prescriptions were harmful or unnecessary for the patients.

According to two authors associated with the project, this is the first of its kind study in the country.

The observational analysis showed that most prescriptions classified as “unacceptable” had heartburn medicine pantoprazole.

Other medications frequently involved in these “unacceptable” prescriptions were a fixed-dose combination of rabeprazole and domperidone, used for gastroesophageal reflux disease (GERD), and oral enzyme preparations for acid reflux, gas, bloating, and diarrhoea. 

The conditions most often associated with these “unacceptable” deviations were upper respiratory tract infections and hypertension, according to the study, titled Evaluation of prescriptions from tertiary care hospitals across India for deviations from treatment guidelines & their potential consequences.

The potential consequences of deviations were an increase in cost, adverse drug reactions, drug interactions, lack of therapeutic response and antimicrobial resistance, noted the authors.

“While it is reassuring that 90 percent of the prescriptions analysed were acceptable, I would still call these results worrying because the project involved facilities where the poorest of the patients come, and where the deviations are occurring despite the doctors mostly prescribing drugs without any influence of the pharmaceutical companies,” Dr Yashashri Shetty, lead author of the study, told ThePrint.

An assistant professor with the Department of Pharmacology and Therapeutics at the KEM Hospital in Mumbai, Shetty also cited how pantoprazole, a common acidity blocker, was randomly prescribed to a very high number of patients without much thought to drug interactions.

“For instance, some drugs for heart ailments won’t work in patients who also consume pantoprazole, yet we found examples of such problematic prescriptions,” she explained. 

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The study involved the collection and analysis of 7,800 prescriptions, of which 4,838 were deemed “complete” — meaning they clearly specified the drug’s formulation, dosage, duration, and frequency of administration. 

These prescriptions spanned various medical specialities, including community medicine, general medicine, surgery, obstetrics and gynaecology, paediatrics, dermatology, ophthalmology, ENT, and psychiatry. 

Each complete prescription was then assessed for adherence to the local standard treatment guidelines (STG) and the final step was to assign an appropriateness score to them. 

Score 3 (highest score) was assigned to prescriptions that were complete and adhered to either local STGs or national or international treatment guidelines. 

Score 2 was assigned to those prescriptions that deviated from the local STGs/national or international treatment guidelines, but the deviations were considered acceptable, irrespective of whether the prescriptions were complete or incomplete.

Score 1 was assigned to all prescriptions whose deviations from the local STGs/national or international treatment guidelines were considered unacceptable. 

Of the 4,838 complete prescriptions, 2,667 (55.12 percent) were termed as appropriate and in accordance with the guidelines, while the remaining were categorised as “inappropriate”. Overall, 9.8 percent of prescriptions were those with “unacceptable deviations”.

The study observed that pantoprazole was the most frequently prescribed drug, leading to unacceptable deviation followed by the fixed-dose combination (FDC) rabeprazole with domperidone and oral enzyme preparations. 

“The drugs identified in prescriptions with unacceptable deviations were pantoprazole, rabeprazole and domperidone combination, trypsin/chymotrypsin (oral enzymes), serratiopeptidase, ranitidine, azithromycin, cefixime, amoxicillin and clavulanic acid combination and aceclofenac,” noted the researchers.  

It appears that the above drugs were prescribed to not only treat the symptoms but also to treat potential side effects of the drugs prescribed, they said, adding that for patients with pain as a presenting symptom, analgesics were co-prescribed with pantoprazole. 

Gastroprotective drugs are to be prescribed if the patient has a risk for developing a peptic ulcer, and unnecessary prescribing of pantoprazole may lead to potential side effects, such as abdominal bloating, oedema and rash, warned the researchers.

Similarly, the study observed that a rabeprazole and domperidone combination along with antacids was prescribed for functional dyspepsia (indigestion), which is not recommended in national or international guidelines.

According to the study, the prescriptions with “unacceptable deviations” could have been prescribed by the junior doctors who have to cater to a large number of patients and are not able to prioritise and multitask within the fixed time allocated for OPD duties.

Additionally, inadequate emphasis on rational prescribing in medical curriculum and drug promotion by pharmaceutical industries may also have contributed to the inappropriate prescribing and non-compliance with guidelines, it highlighted. 

“However, a comparison was not made between the prescribing practices of senior and junior doctors. Unfortunately, it is the patient who has to bear the consequences of the irrational prescribing practices,” the authors wrote.

According to senior pharmacologist Nilima A. Kshirsagar, who was formerly the national chair for clinical pharmacology at ICMR and a co-author of the study, as a corrective measure, the health research agency had started organising training on rational prescribing of drugs for doctors. 

“While junior doctors make the irrational prescriptions out of lack of knowledge and experience, in the case of senior doctors, it is likely due to lack of updated knowledge in the treatment guidelines for various conditions,” she told ThePrint.

The researchers have also listed administrative directives as a potential intervention for the issue of irrational prescription of drugs.

(Edited by Richa Mishra)

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