Many newspapers recently carried reports captioned “Adhere to prescription policy: Govt. to GMC docs” . These were followed by reports of the FDA issuing instructions to pharmacies to strictly follow a “dispense against prescriptions only” policy. This gives the impression of a new initiative introducing new guidelines. The move was prompted largely by the murder in Vasco which involved the purchase of sedatives/scheduled drugs over the counter. There is nothing new in this news report. The Goa Medical Council has been issuing a booklet entitled “Guidelines for Prescription Writing and Handling of Prescriptions and Prescription Medicines” since 2012 free of cost, to all new medical graduates who register with the council. This in turn was the culmination of a long campaign by the Voluntary Health Association of Goa, in their attempts to introduce an element of safety in prescriptions.
A prescription is a legal document, whose journey from the practitioners pad to the pharmacy and thereafter is mandated by a number of laws. The Indian Medical Council Act defines who can prescribe allopathic drugs. The Supreme Court has further ruled that a practitioner of one system of medicine may not prescribe drugs from another system (cross practice). The Code of Ethics defines the content and manner in which a prescription shall be written and seeks to curb the doctor-pharma company nexus. The Drugs and Cosmetics Act determines what may or may not be prescribed as a drug; this is further refined by the Narcotics and Psychotropic Substances Act and the Drugs and Magic Remedies Act. The Pharmacy Act and the Drugs Price Control Order oversees the functioning of retail outlets for medicines. Unfortunately as in all other spheres of Indian society, we frame comprehensive laws and then spend the rest of our lives ensuring their breach.
Prescription errors are the cause of about 7000 deaths in the US. Cynics may be tempted to point out that there are far more deaths from road traffic accidents. However these are patients, most of whom did not have life threatening illnesses, who went to qualified and professional people for relief from their illness; and who died purely from mistakes in the very prescription that was issued to provide that relief. Ill effects of prescriptions, referred to as morbidity, cost the economy approximately 77 billion dollars a year; a staggering sum even by American standards. Prescription errors remain the second most frequent cause for litigation and the second most expensive in a survey of 90,000 malpractice suits over seven years. Whatever the vantage point, prescription errors remain a major cause for concern in the US.
What do we know about the situation in India? The short answer is very little. There is ample literature on the question of irrational drug therapy, poly-pharmacy, and the use of banned or dangerous drugs. Little or no research has been done on the question of prescription errors.
990 prescriptions were studied as they arrived at a popular pharmacy in Panjim, over a span of seven days. These were analyzed along the following parameters.
1. Layout: – This included i) the use of a letterhead ii) information about the prescriber and iii) the patients details
2. Clarity: – i) Was the prescription legible and ii) were the instructions clear.
3. Content: – i) Number and type of drugs used ii) duration of therapy iii) whether brand names or generic names were used iv) use of non-allopathic medicines and v) whether injections were used
The findings were published in the “Journal of Post-Graduate Medicine, Vol-51, Pages 9-12”. Regrettably none of the prescriptions showed a 100% compliance. Some of the lapses were quite serious indeed. For example the doctors’ name, qualifications and telephone number were missing in about a third of the prescriptions. The registration number, a vital detail in distinguishing quacks from qualified doctors was present in only 24%. A further disturbing trend was the finding that the public sector doctors were more likely not to disclose their personal details.
A series of three round table conferences involving all stakeholders followed, and resulted in the publication of the guidelines by the GMC. A half day workshop was organized on 16 September 2012, inaugurated by the present CM who was HM at that time, and the booklet released by him. It covered guidelines for doctors, pharmacies, wholesalers, retailers and hospitals; including the storage and inventory criteria.
One of the problems discussed was that public sector OPDs were grossly overworked and writing the doctors name and registration number on each prescription would be time consuming and tedious. This was countered by a suggestion to the DHS that every doctor employed in the public sector whether GMC or otherwise should be issued with a self-inking rubber stamp with his name and registration number. This has never been followed up; “the doctor may leave the health services”. So what? He or she is hardly likely to change the name or registration number!
When I presented a paper on “Prescription Safety” at a seminar at AIIMS, New Delhi, on “Patient Safety” a lively debate ensued between two HODs over my point that illegible handwriting was a major factor contributing to prescription errors, and that doctors must write legibly. The debate was that senior consultants could hardly be expected to improve their handwriting at this stage of their careers! The MCI has now settled the issue with their recent directive on a standard prescription format. Among other details, the prescription must indicate the name and registration number of the doctor, and block capitals used to indicate the name, strength and dosage of the drugs prescribed. Even the size of the prescription pad has been stipulated by the MCI
There are numerous court judgments at various levels, including the Supreme Court, which have reinforced every single requirement in the guidelines. Bad handwriting resulting in wrong drugs or dosage, cross practice, unauthorized sale of scheduled drugs have all been the subject of successful litigation and awards in India.
The laws are in place; the information is available; all that remains is the political will on part of the health care authorities to enforce these rules without fear or favour, and a society ready and willing to observe those rules. Till then we continue with our juvenile preoccupation of stake holders accusing each other of being mercenary.
(Dr Gladstone D’Costa is the Chairman, Accreditation Committee and member, Executive Committee, GMC)
