Are drugs prescribed rationally and according to standard guidelines in India?

Sir,

Paracetamol is the most common cause of intentional and unintentional poisoning in most parts of the world. Hepatotoxicity associated with paracetamol overdose is well recognized and so I appreciate the efforts of authors of “Therapeutic misadventure with paracetamol in children” in your Nov-Dec, 2010 issue for raising the issue of overdose of paracetamol in children.[1] I strongly believe that physicians, especially general practitioners and pediatricians, should educate parents about the potential for hepatotoxicity with paracetamol overdoses. Patients (or parents in case of pediatric patients) should always be given clear instructions on the appropriate dose and suggested formulations and also be made aware of the many over-the-counter paracetamol preparations that contain combination formulations.

The US Federal Drug Administration is currently evaluating paracetamol regarding the following:

Safe dose of paracetamol for adults and children.

Safe dose of paracetamol in combination with other drugs and alcohol.

I have some queries and comments for the authors and other interested readers.

I think the six pediatric clinical case histories are inconsistent, incomplete, and unacceptable in many ways. For example, the weight of the children is missing in cases #2, #4, and #6 and there is no standard format used to describe the case histories, which makes comparison unnecessarily difficult.

I would have found it more helpful had the real values of laboratory data like CBC, LFT, and renal parameters been presented with the normal values in parenthesis in standard format rather than being random.

The dose, duration, and route of administration of N-acetylcysteine (NAC) were not clearly mentioned in the last five cases.

For case #1, it was mentioned that the child was prescribed oral NAC but the medication was not administered. Why was this?

I think the treatment plan was based on [Figure 1], but there was no citation provided to assess its validity.

Liver function abnormalities are nearly universal in dengue fever, a situation seen in case #5. Why were the findings attributed to paracetamol in this case?

According to reference #9 citing guidelines from Australia and New Zealand, the patients in cases #5 and #6 do not fit into the category of receiving a toxic dose that requires treatment with NAC.

In addition, this article opens up a Pandora's Box concerning the use of mefenamic acid in children as seen in cases #4 and #6. The discussion of mefenamic acid and its use in children illustrates an important issue in child health care. Mefenamic acid is quite often prescribed as an antipyretic for children in India. This happens despite the unfavourable risk/benefit ratio of mefenamic acid, availability of safer drugs and doubts about its safety in children.[2] Even if the physicians, other health care personnel, or parents have not experienced any adverse effects of mefenamic acid, the question still remains whether the risk of using the drug is worth any benefit for children. Meta analyses of many clinical studies and standard text books of pharmacology do not recommend the use of mefenamic acid in children.[3] I think these sources and standard guidelines should be given more weight in making recommendations on treatment in the absence of clear evidence that mefenamic acid is safe and effective.

I would like to conclude with a question. Are drugs being prescribed rationally and accordingly to the standard guidelines in India?