Medicines and Prescription: Pause before you pop the pill

Medicines

By Christina Dsouza Lasrado 

“Laughter is the only medicine without side-effects.”  Unfortunately, the same cannot be said of the medicines we take every day. The term ‘side-effects’ has become shorthand for a wide range of reactions, including those technically classified as ‘adverse drug reactions’ or ADRs.

Here’s why it matters. In 2019, the World Health Organisation (WHO) estimated that there were 421 million hospitalisations globally. A study in Singapore found that 12.4% of hospital admissions involved ADRs. Other studies placed that share between 5 to 10%. Assuming a median of 7.5%, that’s roughly 30 million ADR-related hospitalisations annually worldwide.

A study on hospitalisation trends in India looked at National Sample Surveys (NSS) data from 1995-2014: The estimated hospitalisations were 37 per 1000 people, which amounted to 42 million people. Using the same trend rate, the estimated hospitalisations for India work out to 90.7 million in 2024. ADRs would account for 6.8 million hospitalisations, or 68 lakh people.

Despite their widespread impact, ADRs rarely feature in the public health discourse. Recent media coverage about weight-loss drugs and their ‘miraculous’ effects has triggered some news reporting about side effects, but mostly through the lens of celebrity endorsements. The focus, however, remains cosmetic, not clinical. Patient safety remains largely ignored.

ADRs fall into two broad categories. Type A reactions are dose-dependent, predictable, based on the pharmacology (how drugs work at the cellular level, how they are distributed and absorbed in the body etc.). That’s why your doctor may prescribe ‘Pan D’ alongside antibiotics to manage stomach acidity. Type B reactions are ‘bizarre’, not predictable based on medicine’s pharmacology.

A more comprehensive approach is the ‘DoTS’ system: classifying ADRs based on the Dose, Time course of its appearance and its severity, and Susceptibility of the patient based on genetic predispositions, and other biological factors.

Polypharmacy – the prescribing of several medicines at a time – is a common phenomenon in India yet rarely flagged as a risk factor for ADRs. A study of 13 hospitals across 4 regions in India found that nearly 84 per cent of prescriptions had more than one drug. A typical prescription in India has three or more drugs.

Pharmacovigilance is the process which tracks the effects of approved drugs and medicines, oversees drug safety and requires reporting of ADRs. In India, the Pharmacovigilance Programme of India (PvPI), has 567 active ADR monitoring centres or AMCs nationwide through which ADRs can be reported. Yet, several studies show under-reporting of ADRs.

India uses spontaneous reporting, which is voluntary, by doctors or patients using the appropriate forms, submitted at ADR monitoring centre. Such reporting accounts for just 7% of all ADR reports.

Which begs the question: Who is accountable for ADR reporting in the absence of mandatory reporting? Let’s review what there is.

1. Hospital-based surveillance is not consistently implemented, because of the lack of awareness even among doctors and healthcare professionals (HCPs). One hospital-based study found that only 22% of HCPs reported ADRs, 52% confessed a lack of knowledge about ADRs, and 31% admitted to being unmotivated to report.

2. On top of that a Delhi High Court decision clarified that doctors in India are not mandated to tell patients about the side-effects.

3. Pharmaceutical companies are expected to use cohort monitoring or post-marketing surveillance via periodic safety update reports (PSURs). Critics point to an inherent conflict of interest here.

4. Qualified pharmacists, the key sources of safety advice in other countries, like the US, are absent from Indian drugstores.

5. That leaves ‘drug inserts’ (the fine print paper chit included in the drug box) as the sole formal patient safety mechanism. However, those inserts are a punishment to read even for the urban educated patient. Rural patients may not even have recourse to translations.

Patient safety isn’t really about the patient when it comes to ADRs.

Chronic illnesses like diabetes, CVD, cancer, hypertension, etc. will dominate prescribing patterns. Patients may have to manage multiple conditions simultaneously, risking complex drug interactions. So what solutions are possible for patient safety that are patient-centric?

1) Making ADR reporting mandatory is a long-term process; it may require legislative action, and for patient advocacy groups to push hard for it over time.

2) Educating the hospital system, and HCPs through continuing medical education (CME) programs is a medium-term solution, because it needs behavioural change.

3) Introducing a comprehensive course on ADRs in medical school is another medium-term solution requiring advocacy with the National Medical Council.

One quickly implementable solution in the short-term is to allow pharmaceutical advertising, like the USA and New Zealand have. In their TV ads, companies are required to list and clearly state all possible ADRs in taking that medicine. Patients can discuss potential ADRs with their physicians before they jointly make the appropriate medicinal choices.

Let’s not forget that patient safety is about the patient.

(Christina Dsouza Lasrado is studying Public Policy at the Takshashila Institution.)

Views are personal, and do not represent the stance of this publication.