Is the medicine you're taking safe?-A A +A
To Your Health
Friday, August 30, 2013
TO ANSWER this thorny question, in the midst of so many drugs and medicines that have flooded the Philippine market, since the Generics Act was approved, let' take a look at the journey some drugs take, before they end up in the shelves of drugstores or into the medicine cabinets of patient-consumers.
Traditionally drugs were derived from natural sources. From plants, there is aspirin, specifically from the bark of Chinese willow tree; or the life-saving digitalis for congestive heart failure from a plant called Digitalis lanata. The first insulin used came from the beta cells of the pancreas of cows. And almost all health professionals know that Fleming, a Dutch microbiologists isolated the active component of Penicillin from a yeast-like streptococcal bacteria, in his laboratory in London. Serendipity or a very pleasant, surprise happenstance adds dramatic color to the discovery of Orlistat ( Xenical) from a soil brought home by a Roche employee vacationing in the south of Spain. Or of course, who would forget the very popular antibiotic Ilosone, an erythromycin isolated from a soil from Iloilo.
Today, however, laboratory researchers use traditional, conventional knowledge, along with chemical science, to develop synthetic drugs, whose advantage is that chemically-developed drugs are relatively free from impurities, usually found in natural-derived medicines. In addition, researchers and drug developers can manipulate the molecular structure of substances such as antibiotics, so that a slight change in chemical structure makes the drug more effective or efficacious and hopefully with lesser side effects therefore , safer. Drugs that share similar characteristics are grouped together as a pharmacologic class or family.
Example are the beta adrenergic blockers, whose names end with the suffix " olol'. The specific use or the so-called "indication" determines the therapeutic class of the drug.
During the infancy of pharmacology, drugs were found by trial and error.
Nowadays, medicines are developed under very strict conditions following systematic scientific as well as clinical protocol. The Food and drug Administration (FDA) monitors new drug development which can take years to complete. In the phase l of new drug or investigational drug, the drug is tested on healthy volunteers. Phase II involves trials with people who have the disease which the drug is thought to be effective. In Phase III, large numbers of patients in various medical centers and hospitals, spread all over the world, to detect some drug idiosyncrasy by virtue of the racial stock of the patients. This huge and widespread sampling provides vital information as to side effects, adverse effects. Tolerability profile. It is only when, the clinical trials of phase III are done and evaluated strictly by the FDA, in this case the US FDA 9 Europe has its own EMEA).
Will the investigational drug get its much desired approval. Phase IV is a voluntary postmarket surveillance or monitoring for the use of the drug approved in phase III. The pharmaceutical company receives reports from physician and health professionals about the therapeutic as wells adverse effects of the drug. It must be emphasized at this point that, some medicines, after much research funds have been put into its development, after so-many double-blind clinical studies have been made involving it, may, unfortunately be found to have some toxic effects, and re removed and retrieved from the market after its initial release.
Next Week. The Question about Bioequivalence of Branded and Generics Drugs
Published in the Sun.Star Baguio newspaper on August 31, 2013.