Aimed at stalling quackery and to help patients have more choice while buying medicines between a costlier brand and its generic version, Maharashtra Food and Drug Administration (FDA) is the first state drug regulatory body in the country to mandate and issue a model medicine prescription format for the patient safety at large.
The format was formally issued by Maharashtra Chief Minister Prithviraj Chavan on February 28, 2014 in the presence of State FDA officials to address the compelling need for safe and efficacious supply of medicines for patient safety.
A model medicine prescription format is now in the process of being circulated to all the stakeholders including patients, physicians and doctors with effect from February 28, 2014.
After long deliberations, a consensus based “Model Medicine Prescription Format” was designed for all the stake holders as a legal mandatory prescription format. Says a senior FDA official, "The format will bring about transparency and accountability and ensure implementation of Drugs and Cosmetics Act, 1940 effectively. The act mandates that a prescription format need to be adopted across the country. This will bring about very positive results and would go a long way in raising health status of people."
The format is comprehensive as it includes doctor's full name, his qualification, patient's details, name of the generic or its equivalent along with the dosage, strength, dosage form, dosage instruction, name and address of medical store with pharmacist's name and date of dispensing and doctor's signature and stamp.
A model prescription format committee was formed on July 24, 2013 under the chairmanship of Mahesh Zagade, former commissioner, FDA comprising office bearers from Maharashtra Medical Council (MMC), Maharashtra Council of Indian Medicine (MCIM), Maharashtra Veterinary Council (MVC), Maharashtra Dental Council (MDC), Indian Pharmaceutical Association (IPA), Indian Medical Association (IMA), National Integrated Medical Association (Maharashtra Branch) and Maharashtra State Pharmacy Council (MSPC).
The format is designed based on a scientific health care approach, attributed, inter-alia to judicious use of medicines. However, if medicines are administered improperly, the adverse impact of medicines on human body and mind becomes catastrophic that includes organ failure, health complications, death and drug resistance and this has been recognized internationally.
As per the FDA format, it is statutory requirement to mention name of the prescriber on cash or credit memo of the drugs under Rule 65(3) and authenticate prescription. Therefore, the prescription shall bear doctor’s full name as mentioned in her or his registration certificate. To know competency and genuineness of prescriber, the prescription shall bear doctor’s primary qualification such as MBBS or BAMS followed by subsequent qualifications. Prescription shall bear the registration number of doctor’s registration with their respective council. The registration number should be prefixed with letters indicating the council in which doctor has registered her or his name.
The FDA format also states that it is statutory requirement to mention the address of the prescriber on the cash or credit memo of the drugs under Rule 65 (3) and the patient and pharmacist should know where the prescriber is practicing and, therefore, prescription shall bear complete address of clinic or hospital where the prescriber is practicing. The prescription shall have telephone number and e-mail address of prescriber.
As per the Rule 65 (10) prescription shall be dated and prescription shall specify the name and address of the person for whose treatment it is given or name and address of the owner of the animal if the drug is meant for veterinary use.
The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 under Indian Medical Council Act 1956 under Code of Medical Ethics at 1.5 prescribes as “Every physician should as far as possible prescribe drugs with Generic names and he or she shall ensure that there is a rational prescription and rational use of drugs”. Therefore, prescription shall bear the name of medicine as generic name. The name of medicine should be in Capital letters in legible manner. If the prescriber is not sure about generic name he shall add following instructions on the prescription above her or his signature. “Or any other cheaper generic medicine as per choice of patient.”
Prescription shall invariably bear strength of the medicine. Eg. paracetamol tablets 500 mg., amoxycillin capsules 250 mg and shall also bear a proper dosage form of medicine prescribed. eg. tablets, capsules, syrups, creams etc.