In the Philippines, we have the Generics Law which requires doctors to write prescriptions only in generics. It also prohibits government agencies to use brands in the procurement process. This “procure-by-generics” rule is very important because it assures fair competition amongst sellers of that generic drug. Contrast that to a “procure-by-brand” rule which practically ensures the market goes only to that specific seller who has that brand in stock.
For the rest of this article, we will presume that generic drugs are as effective as branded drugs (this topic is for another day — or even for another blog), and that all generic drugs on the market have been tested adequately by the responsible quality assurance agencies to have met minimum standards. Bottomline: generic drugs and branded drugs have the same effectivity and efficacy.
Assuming that generic drugs are functionally similar to branded, in health informatics, we need to be able to identify a drug consistently across disparate information systems. The question is: do we use codes for generic drugs or codes for branded drugs? I have met several doctors and public health officials who insist that the drug codes should be generics because that is required by law. They also think that generic drugs cannot be coded to the brand because they DO NOT have brand!
Wrong.
If we are going to build databases that store transactions for drugs, we should use coding systems that go down to the brand level. Contrary to what many people think, generic drugs have “brands” that differentiate them by name from others — this is their manufacturer. An example is shown below.
To fully comprehend the need for coding to the brand, we need to understand the four important steps in drug management that require drug codes. In order, they are:
- Drug registration
Before drugs are allowed to be sold in any country, they must be registered with an official agency tasked for that purpose. In the US, this is the Food and Drugs Administration or FDA. In the Philippines, it is also called by the same name (but it used to be called BFAD). Due to the specific requirements of registration, each drug should be coded down to the brand (even down to form and strength) to differentiate them from each other. If they are coded by generics ONLY, FDA will not be able to distinguish one brand of that generic with that of another.
But what if the drug is being registered as a generic drug? There is still a “brand” linked to it which is the manufacturer’s name. So paracetamol UNILAB is different from paracetamol WYETH. So each of these should have a different brand code although they will share the same generic code “paracetamol”.
- Procurement
Now when government agencies buy drugs, they should not refer to brands or else that would constitute unfair competition and favoritism (euphemisms for graft and corrupt practices). It is also prohibited by RA 9184 or the Procurement Law. Informatics-wise, this means each branded drug must refer to the same generic code so that when a procurement for a specific generic code is made, a list of registered brands (from the FDA list) can be made available to the purchasers.
- Clinical administration
Once purchased, these drugs reach the health facilities (eg, hospitals and clinics). Here, if the facility has an electronic medical record, the drugs given to patients by mouth or by injection or by other routes are digitally recorded. We should use the brand/form/strength code in the EMR and not the generic code. If we just code using generics, we will not be able to find out which brand was actually given to the patient. This is important because of the next step, adverse drug reaction reporting.
- Adverse drug reaction reporting
If a patient dies or develops an allergy due to the drug administered, this is an adverse drug reaction. It should be reported to the FDA so that the FDA can find out which drugs to pull out from the market so the public is protected from further injury. But if the EMR coded only for the generic code, FDA might pull out all generic drugs when in fact, it may have been just a specific brand causing all the problems.
And that is why drugs should be branded down to the brand.
The big question is: where do we get these standard codes for the Philippines?
Suggestions are welcome. The reader is kindly directed to read more on RxNORM, a database of drug codes created and maintained by the National Library of Medicine in Bethesda, Maryland. Its structure offers a structured look at how these kinds of drug coding systems should be built.