Pharma cos, docs fail to warn about drugs' side-effects, patients suffer
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
instances of patients suffering serious side-effects after taking prescribed
medications, as they were unaware of the drug's possible adverse reaction.
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.
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 patient the 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 side effects 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.
“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?
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