Generic drugs are good, but don’t impose on patients

The current debate on generic drug use is neither new nor unique to Kenya. The question has always been if generic drugs can safely be substituted for more expensive brand names.

The common perception is that generic drugs are of inferior quality or are less effective than original or brand-name medications. This is not so.

In fact, in many countries, including those in the West, generic medicines are encouraged and widely used to promote cost-effective healthcare. So what is the difference between generic and brand name drugs?

Drug discovery is a complex process that takes over over 15 years, from identification of the novel molecule to the clinical and pre-clinical trials.

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 is an expensive venture involving lots of research. It’s on this premise that the original (brand name) drug is more expensive as it undergoes all the steps in the drug discovery process.

The original drug is patented, and the innovator given exclusive rights of production for a given period of time. After the patent lapses, other people can manufacture the drug using the formula that was developed by the innovator, but because they cannot use the brand name, their drugs are generic.

Original and generic drugs are bioequivalent. They have the same rate and extent of absorption, or this may vary slightly.

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.

For this reason, Madison, a medical insurance provider directed doctors to prescribe only generic drugs to their clients, in a bid to reduce healthcare costs.

SPARKED DEBATE

However, this directive sparked debate for various reasons. Firstly, the practitioners’ autonomy in practice. This is important because, while generic and original drugs are similar in safety and efficacy, they may differ in pharmacokinetics — what the body does to the drug and the time course of the drug in the body.

This includes the absorption, distribution, metabolism and elimination of the drug, bundled as pharmacokinetic parameters. The original may differ from the generic in any of these four pharmacokinetic parameters.

The best practice is for doctors to prescribe based on chemical names rather than brand names. Pharmacists have the autonomy to prescribe either branded or generic molecules for patients.

Depending on the condition of the patient, a doctor may prescribe a drug with better pharmacokinetic parameters and therefore the need to allow for autonomy.

Autonomy is also important especially with the use of biologics (drug products produced from living organisms or that have components of living organism).

Insulin, used in the management of diabetes, is a typical example of a common biologic. Insulin is a product of recombinant DNA technology.

Biologic drug molecules have a greater propensity to illicit allergic reactions which can be fatal. Therefore, it is important that 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 providers are not privy to.

COUNTERFEIT DRUGS

Patient beliefs and socio-economic status are also a key component in the healing process, and therefore, an important consideration in the prescription and administration of drugs.

Some patients prefer Cipladon to normal paracetamol tablets like Panadol. Their choice is an important factor that should not be curtailed by insurers.

Conversely, lobbying efforts either by insurance companies or drugs manufacturers to either prescribe generic drugs or brand name drugs, raise ethical questions, because doctors have a duty to provide the highest quality care.

Globally, studies have shown that there is an overall increase in patient confidence and knowledge with regards to generic medicines, especially in developed countries.

The public outcry in Kenya is understandable if we take into consideration that there is high proliferation of counterfeit drugs.

The onus, therefore, is on the Kenya Pharmacy and Poisons Board and other stakeholders like the Kenya Revenue Authority and the Kenya Association of Pharmaceutical Industry, to intensify the war against sub-standard drugs in the country.

In a country with a poor majority, prescribing generic drugs that are approved by the Kenya Pharmacy and Poisons Board is a welcome relief and will ensure the cost of accessing healthcare is brought down considerably.

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Mr Jesse is a medical student at Kenyatta University