Prescribing generic drugs using a generic name: Are we teaching it right?
The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002, state that “Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs.” (1). Undergraduate medical students are introduced to drug nomenclature early on during their pharmacology course. They are told that generic name or, more appropriately, non-proprietary name (usually international non-proprietary name INN), is to be used while writing prescriptions. However, not enough emphasis is placed on explaining the nuances of the terms “generic drugs” (unbranded), “branded (innovator) drugs” and “branded generics”, probably because they are not important in that time context. Subsequently these issues are usually never dealt with in an academic context. Generic drugs are produced by pharmaceutical companies once an innovator drug is off patent. Innovator drugs and branded generics have unique brand names of their own while the latter is more economical to varying degrees since no clinical trials need to be conducted to establish its efficacy and safety. The Indian drug market is essentially composed of branded generics with huge price differences between some of them while branded (innovator) drugs and unbranded generics account for only a small percentage (2). Pharmacies and drug stores other than in government- run hospitals and clinics hardly stock unbranded generic drugs. When a prescription is received for an unbranded generic drug it is likely that the pharmacist would dispense his/her favourite branded generic instead. Even when unbranded generics are available there are concerns among the prescribers regarding the efficacy and safety of low cost generics. In such a scenario, asking doctors to prescribe using generic name only serves to avoid dispensing errors due to look-alike, sound-alike brand names and illegible prescriptions (nonetheless important). The emphasis placed on writing prescriptions using generic names in undergraduate education when neither the hospitals nor the pharmacies/drug stores indent (unbranded) generic drugs seems somewhat misplaced and probably demoralising.
In the United States, the emphasis is on prescribing generic drugs over branded (innovator) drugs because of the huge cost difference between the two. The percentage of branded generics in the market is not as high as in India. Moreover, the Orange book published by the United States Food and Drug Administration provides assurance to health professionals as well as the public regarding the quality of the approved generics (branded and unbranded) (3). It is imperative that the Indian health agencies ensure availability of unbranded generics in all places, at all times, and in adequate amounts. Also important is to ensure that suitable measures are taken to satisfy the general concern regarding the quality of such products. Unless this is ensured, we would not be completely justified in asking our students to write generic names in the prescription when we know that no such (unbranded) generics actually exist to be dispensed, nor is the pharmacist bound to give out the cheapest brand of a drug by law.
Ashwin Kamath ([email protected]), Associate Professor, Department. of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, 575 001, INDIA
- Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 [cited 2015 Nov 27]. Available from: http://www.mciindia.org/Rules-and-Regulation/Ethics%20Regulations-2002.pdf.
- Srinivas I. The myth of branded generics. Econ Pol Wkly. 2014 Sep 20 [cited 2015 Nov 27]; 49(38). Available from: http://www.epw.in/commentary/myth-branded-generics.html.
- US Department of Health and Human Services. Approved drug products with therapeutic equivalence evaluations. 35th ed. USA; 2015 [cited 2015 Nov 27]. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf.