The current debate on generic drug use is neither new nor unique to Kenya. Globally, there is a lot of debate and discussion about generic and branded medicines.
The question has always been about the authenticity of generic drugs— if they can safely be substituted for the more expensive brand names.
Locally, one of the medical insurers recently sparked a debate when it directed doctors to prescribe only generic drugs to their clients.
So where is the difference? The common perception is that generic drugs are of inferior quality and decreased effectiveness compared to the original or brand-name medications. However, this is not so. In fact, in many countries, including developed countries, generic medicines are encouraged and widely used in their healthcare systems as part of promoting more cost-effective health care treatments.
The process of drug discovery and development is a complex and tedious process and takes over 15 years. That’s from the identification of the novel molecule to the clinical and pre-clinical trials. The pre-clinical trials involve the use of animals to establish the safety and efficacy of the newly discovered molecules while the clinical trials involve human beings.
Drug discovery therefore is an expensive venture involving lots of research. It’s on this premise that an original drug is expensive as the original drug undergoes all the steps in the drug discovery process. The original drug is of course patented, and the innovator given exclusive rights of production for a given period of time.
When the patent is broken, other people are allowed to manufacture the drug; this is less tedious and complex and also less expensive and hence generic drugs. Little research is done as the formula is available and the safety and efficacy of the drug is already established.
It’s important to note, that original and generic drugs are bioequivalent, or show only a slight variation -- hey have the same rate and extent of absorption, or this may vary only slightly.
Put in simpler terms, the amounts of drug, that reaches the bloodstream for both the generic and the original drugs are equal or almost equal, and this is what is needed to achieve the therapeutic goal.
The concerns of insurers to have prescribers and dispensers give generic drugs is therefore a legitimate concern especially in a bid to reduce healthcare cost holistically to enable us achieve Universal Healthcare for all. It is, however, important to consider the practitioners’ autonomy in practice.
While generic and original drugs are similar in safety and efficacy, they may differ in pharmacokinetics— what the body does to the drug and technical defined as the time course of the drug in the body and this includes the absorption, distribution, metabolism and elimination of the drug which are all bundled as pharmacokinetic parameters.
A generic and an original drug may therefore differ in any of these four pharmacokinetic parameters. Depending on the situation of the patient, a doctor may have a preference of a drug with better pharmacokinetic parameters and therefore the need for the autonomy.
This autonomy is also important especially with the advancement of medicine and the use of biologics which are drug products produced from living organisms or have components of living organism.
A typical example of a biologic product commonly used is insulin, which used in diabetes. Insulin is a product of recombinant DNA technology. Biologic drug molecules have a greater propensity to illicit allergic reactions which can be fatal; it is therefore important healthcare professionals take a key role in determining the biologic compound for a patient.
This can be informed by the patients’ medication history or family history facts that insurance groups are not privy to.
Patient beliefs and socio-economic status are also very key component often healing process, and therefore an important consideration in the prescription and administration of drugs. Some patients prefer Cipladon to normal paracetamol tablets like Panadol. What this mean is that their choice is an important factor that can’t be gagged by insurers.
In prescription of drugs, the best practice is for doctors to prescribe based on chemical names rather than brand names. And pharmacists have the autonomy to prescribe either branded or generic molecules for patients.
Conversely, lobbying efforts either by insurance companies or drugs manufacturers to either prescribe generic or brand names raise ethical questions. Doctors have a duty to provide the highest quality care.
David Jesse, medical student, Kenyatta University.