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Issue dated - 08th August 2002

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Diphenoxylate unsafe, yet promoted

Doctors and pharmacists should address the hazardous effects to patients and regularize the usage of the drug based on therapeutic principles, say A N Nagappa & S Asif Ansari

Pharmaceutical companies many a time indulge in unethical promotion and marketing of potentially hazardous drug in spite of the awareness of danger. All though stringent laws and regulations exist, there is a systematic evasion of these laws. There are many instances where a pharmaceutical company is accused of detailing the product highlighting its benefits and hiding its adverse reactions, hence with intent to maximize sales.

The pharmaceutical companies’ objectives should not be only profit but also concern for the health of people. We find various categories of drugs which are abused by prescribers, pharmacists and patients. The manufacturer and also the regulators are not paying much attention to control such practices. There are reports of using non staining iodine ointment as a psycho-stimulant drug by college students.

There are many abuses of tranquilizers, anitbiotics, vitamins, cough syrups etc. The Diphenhydramine hydrochloride syrup is used by college students for psychedelic effects, codeine phosphate syrup as euphoriants. These drugs and formulations are sold in open market under various schemes to boost their sales. What will happen to the students and public who are addicted to these preparations?

A case study of Diphenoxylate Hydrochloride will highlight the callous attitude of the manufactures, regulatory agencies, prescribers, pharmacists etc, towards the patient and the public. The patient or public being not well-versed with intricacies of drug effect, will usually rely on prescribers and pharmacists and ask for remedies which will relive him of the symptoms and discomfort.

It becomes the responsibility of the prescribers, pharmacists to safeguard the health of patient or public. This is because there is no transparency and least accountability by the prescribers or pharmacists who are found to indulge in prescribing and dispensing medicines without giving proper reason for the usage.

The pharmaceutical companies under competitions and market forces are found to indulge in fierce competitive practices. There are instances of lucrative offers to the prescriber in sales campaigns. Moreover the pharmacists are also offered huge bonus offers like ‘‘sell one and get one free offer,’’ ultimately prescriber and pharmacists priority gets changed from patient care to product sales. Diphenoxylate Hydrochoride is a drug which is recommended for specific kinds of diarrhoea like viral diarrhoea, its paediatric use is banned as this drug is found to cause central nervous system toxicity. Hence it is useless to administer this drug in infectious diarrhoea of bacterial origin, because it gives the opportunity for toxins and bacteria to remain in intestinal tract for long time. The toxins destroy the lining of the intestinal tract leading to further loss of water and electrolytes. However in children, it should not be used. Even in older children there are problems. Diphenoxylate causes accidental poisoning in toddlers. Signs of dehydration are also masked by it causing fatal toxic reactions.

Moreover, Diphenoxylate Hydrochloride with atropine sulphate is not on WHO’s essential drug list. In spite of all these regulation and restrictions, lomotil and lomofen are freely marketed in the drug stores as effective remedy.

Conclusion

Drug safety is one of the high priorities having a bearing on the health of people. Many diseases get aggravated due to over-indulgence of drugs.

There is a need for all concerned to address these issues and regularize the usage of the drugs based on therapeutic principles. A patient’s health is more important than a company’s sales. This must be understood, practiced by government, manufacturers, prescribers and pharmacists.

The writers are with pharmacy group, Birla Institute of Technology and Science, Pilani, Rajasthan

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