When you last visited your doctor for a stomach infection, did your doctor warn you about the possible side-effects of the prescribed antibiotic, or was there a `medication guide’ in the pack to alert you? Probably not. When 10-year-old Ruchi was prescribed a widely sold antibiotic -ciprofloxacin -for her ENT infection, neither did her doctor inform her parents about the complications, nor was a medication guide available. The pharma company which manufactures the antibiotic too abdicated its responsibility to list possible side-effects.
So when Ruchi took the medicine for 15 days, she developed serious skeletal deformities. The antibiotic meant to cure her nearly crippled her.
Ruchi is not alone. There are numerous such instances of patients suffering serious side-effects after taking prescribed medications, as they were unaware of the drug’s possible adverse reaction. In some instances, they may have been plain unlucky , but in most cases, it was owing to scarce product information by pharma companies and doctors and not communicating safety risks to patients.that were neither communicated by doctors who are extremely busy , nor by pharma companies themselves.
So are patients here being given the short shrift? It appears to be the case, as companies in India are not communicating safety risks and adverse reactions associated with certain medications through package inserts and neither are the doctors informing patients about the same. This is even as global regulatory agencies like the US Food and Drug Administration recommend companies to educate patients about routine side-effects and alert them with additional warnings.
The problem is on several fronts. “The lax system of approval of drugs in India, profit-oriented pharmaceutical companies who care two hoots (about patients), and doctors who are nearly all-dependent on field force do not convey clearly to the patientthe possible side-effects of a prescribed drug,“ says editor of medical journal MIMS CM Gulhati, who has been championing the cause of safe drugs for decades.
Awareness of safety risks and side-effects is critical when it comes to children and pregnant women. This is because some antibiotics and painkillers are not recommended for use during pregnancy , while some have been banned for lactating women. Doctors are also advised not to prescribe drugs like antibacterials, acid suppressants, codeine (cold and cough remedies) and anti-diarrhoeals to children below 12 years. Most doctors do not ask female patients if they are pregnant or breastfeeding. Hence, if certain drugs not permitted during these situations are administered, it may lead to serious side-effects in such cases.
Companies feel communicating safety information to patients is akin to advertising, and hence would be in violation of the Drugs and Magic Remedies Act. But drugs controller general GN Singh told TOI, “It is the companies’ responsibility to communicate the sideeffects and adverse events of medicines to ensure patient safety.”
TOI contacted several companies with queries on the need to educate patients through “clear and efficient labels“, detailing safety risks and precautions. Most pharma companies did not wish to be quoted on the issue. “Since it’s not mandatory to provide package insert or a patient medication guide, individual medicine strips do not carry it. Only certain medicines carry these inserts in a pack of 5 to 10 strips,“ an executive with a leading company said. He added that with rising inputs costs have been rising for the industry, and packaging is perhaps one way where the industry can cut costs.
“It is important that doctors explain common drug reactions to the patient. Also, patients should read the `contraindications and warnings and precautions’ sections carefully,“ says Dr Anoop Misra, chairman of Delhi-based Fortis-C-DOC. According to him, it is the duty of pharmaceutical companies to update package inserts in the event of a newly described adverse effect -which should be disseminated to both doctors and patients. Domestic companies, however, take refuge in laws which do not make it binding on them to provide a medication guide.
While Indian pharma companies have adopted several global practices voluntarily, why have they chosen to ignore an important aspect of patient safety? More importantly , why hasn’t the law been tightened?
“Package inserts by 5-10% companies are practically useless as they are microscopic, and hence cannot be read. The language used is also technical, which may not be comprehensible to patients.In any case, these are meant fonly or use by medical practitioners as they clearly state,“ an industry expert said.
At the same time, pharmacovigilance for every new and old drug prescribed needs to be monitored, and all adverse events reported by the company , and communicated by the drug regulator, says endocrinologist Dr Shashank Joshi. Keeping in mind the challenge of literacy here, some feel that it’s the responsibility of the doctor to counsel patients regarding side-effects. “They also need to be available for patients’ queries,“ says Leena Menghaney , a lawyer and activist working on public health.
