In an interesting medical negligence case, the National Consumer Disputes Redressal Commission (NCDRC) upholding the order of Delhi Consumer Commission held an ophthalmologist guilty of limited medical negligence for “not writing the dose and duration of use of medicine” in the prescription though the doctor has advised the patient orally [pronounced 16 January 2013, First Appeal No. 692 of 2006]. In this case, the patient was prescribed Mitomycine–C eye drop after a minor surgery. Mitomycine is a chemotherapeutic agent. It is not available as eye drop and the eye drop is prepared by dissolving the drug power injection in sterile water for injection in the vial. The patient had continued the use of the eye drop for several months though it should not be used for more than two weeks or so leading to the loss of eyesight in that eye. One injection may lasts around two weeks only. While the patient was found at fault for not using the medicine properly (eye drop for limited period as advised), the doctors was also found to be negligent on account of not writing the duration of treatment with the eye drop or not given the written precaution against the prolonged use.
The standard dictionary defines prescription as a written direction by a physician for the preparation and use of a medicine or remedy. In simplest sense, it is an instruction from a prescriber to a dispenser to supply the medicines to the patient. The World Health Organization’s (WHO) Guide to Good Prescribing published as early as 1994 addresses the issue of writing a prescription. It advises to have at least the following information: Name and address of the prescriber with contact telephone number; Date of prescription; Name and address of the patient including age especially for children and elderly; Name and strength of the medicines; Dosage forms and the total number of units; Information for the package label; and Prescriber’s signature. Each point has its own significance and all the points are very important. Once all the points are completely written, then only a prescription is complete otherwise an incomplete prescription. Incomplete prescription leads to confusion and raises safety and legal issues. We have seen the problems of incomplete prescription in the medical negligence case described above.
There have been two initiatives taken by Medical Council of India (MCI): Encouraging prescribing in generics and draft proposal (awaiting Government’s nod) for writing the name of the medicines in capital only. Prescribing in generics in public health facilities would bring a lot of benefit to the system and the patients. But, prescribing in generics in private prescription would bring more confusion than really helping patients. There is no assurance that the patient would get the most economically priced medicines. In general, when a prescription in generics is presented to the pharmacy, which brands would the pharmacist (or the drug seller) give the patient: obviously the brand that gives maximum financial incentive. The patient remains in the same position. Selection of brand just shifts from the prescriber to the dispenser. The second initiative “to direct the physicians to write the name of the medicines in capital” only is a very welcome move. Once it is implemented after getting Government’s approval, it would benefit the pharmacist or the dispenser and the patient. This would help reducing the problems associated with illegible hand writing. There are many sounds alike and look alike medicines. The change of just a single alphabet misleads to disastrous meaning. Just citing two examples: A-Z (multivitamin of Alkem Lab), AZ (azithromycin of Kopran Lab) and ABZ (albendazole of Kare Health Specialities); Celin (vitamin C) and Celib (celecoxib for arthritis). The writing in generics may solve this name confusing issue to some extent. The physicians especially in public health facilities may have an argument telling they are more concerned with patient care than spending time in writing the prescription in capital. The use of pre-printed format and part of which can be filled up by the physician’s assistant can address the issue of overburden with the patient care. There is no alternative to write the prescription in complete and with clarity.
There are few issues which are often overlooked but are very important from safety aspects. One is the period of validity. Once a prescription is written, how long the prescription would be honoured by the pharmacy or pharmacists for dispensing the medications. The patients are often in habit of bringing the very old prescriptions for buying medicines. The dispensing of narcotics and/or psychotropic substances in an old prescription and their consequent misuse may cause serious issues. Another area of the prescription is clearly writing the number of refills. The patients may continue using the habit forming medicines for long time. The Schedule H and X medicines are to be dispensed only once unless the prescriber intended. “Dispensed’ stamp of the retail pharmacist may solve this issue if properly implemented. The prescription often has instructions: as before or as directed which needs to be avoided. Maximum daily dose (number of units) should also be made mandatory requirement.
While the prescriptions are valid document on the treatment of the individuals, there is absolutely no uniformity on writing them. There are no global norms on prescription writing but some countries do have. British National Formulary has prescription writing guideline but our National Formulary is silent. Neither the Medical Council of India nor the Drugs and Cosmetics Act (and Rules) has defined the prescription or its structure. Legally defining the structure of the prescription and professionally enforcing them would go in a long way promoting good prescription (writing) practice and in the interest of healthcare professionals and the patients as well! Some initiatives taken by the Goa Voluntary Health Association and Maharashtra FDA are worth looking. The interest of three main stakeholders: patient, pharmacist and the physician is to be taken into account while formulating prescription writing guidelines.
(The authors are with Department of Pharmacy, Annamalai University, Annamalai Nagar – 608 002)