In India, a lot of news is being made about the changed regulation, that makes it mandatory for Practitioners to put the name of Generics on prescriptions and not Brands. Contradictory media reports are not of much help. In this article, I will take you through what the regulation requires so that you can your ask EMR Vendor for the changes that need to be done to your prescription printout to make sure you are compliant.
The Medical Council of India before October 2016 required
1.5 Use of Generic names of drugs: 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.
This bit of ¦ as far as possible was changed on 8th October 2016. Instead, they came out a with a revised Clause 1.5, which now states
1.5 Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs.
It is another matter that guidelines from MCI are not generally enforceable by law, till such time a complaint is filed against the Practitioner for violation of the same.
However, the Indian Prime Minister, Shri Narendra Modi announced in April 2017 at a speech in Surat, of his intent to make prescribing by Generics, mandatory for Practitioners by introducing a new legislation. That is what set the cat amongst the pigeons. He is known to execute what he says and a law to make this mandatory will surely come, it is only a matter of time now. What do you need to look for in your EMR to make sure your clinic is in compliance today with the MCI guidelines and will be compliant tomorrow too if such a regulation is passed.
1. List of Generics
To prescribe Generics, you need a list to choose from. The National Drug Formulary (NFI) was last updated in 2011 (4th Edition) and is woefully outdated with only 500 odd generics in it. Compare this to the 1,00,000 brands in India, and you know using the NFI is not adequate by a long shot. CIMS is the other source of information for the list of generics. However, they do not provide digital access to their pharmacopoeia for primary healthcare EMR vendors, keeping their list out of your reach. So you are left with the last option, the resourcefulness of your EMR vendor.
Ask your EMR vendor how many generics they have in their EMR for you to prescribe from. There is no right answer here, but for the sake of comparison, Clinicea has 19,000+ generics as on date.
2. Ability to Bring your Own
Even the best of efforts may not be 100% exhaustive, as there exists no authoritative source for this data. So your EMR vendor must be flexible enough to add at their end or provide you the option to add new Generics to this list, to keep it updated.
3. Brand and Generic; not OR
A lot of Practitioners prefer to prescribe a specific brand for its known efficacy as well as be compliant by offering a generic option for that brand. Your EMR software must allow for mapping a brand to a generic or to a set of generics, such that even though you prescribe a brand the prescription can include both the brand and the associated generic/s.
4. Customizable Prescription
MCI guidelines require that when printing the prescription which contains both the brand and the generic, the generic name should be in CAPS. Your prescription layout should be customizable to support such formatting changes, and open-ended for more such changes as they get introduced.
Clinicea does all of the above, and has an exhaustive list of generics which is regularly updated, fully supports brand and/or generics, as well as has customizable prescriptions.