While there are various aspects of business risks and realities for pharmaceuticals, drug safety is the top agenda in most instances. Even for well marketed, researched and accessible drugs, this can be a problem. Pharmacovigilance is a unique term derived to describe business models that cater to this issue.
Normally companies operate on a four-pillar structure of scientific abilities, intellectual property, regulation/politics and commercialization. Most companies believe that during the pre-marketing clinical trials and post marketing, reporting standards are sufficient to cater to the regulation and bio-safety pillar.
Understanding latency and late offset reactions
This is where the concept of latency period becomes important. Latency period is a term used to define the time period that has elapsed between the drug intake and the appearance of an adverse reaction. A challenge is that the reaction may take place following years of drug intake, demanding stringent feedback system.
The greater the time elapses between the drug reaction and intake, the complex it becomes for authorities such as Medicines and Healthcare Products Regulatory Agency (MHRA) to ensure safety. Some examples make it evident that even drugs that are well established in the market may lead to adverse reactions following a large latency period.
Isoniazid is a well-established drug for treatment of tuberculosis. Subsequent studies have found that it has a large latency period and has been associated with liver abnormalities. Then there have also been reports of unpredictable immune system hypersensitivities.
Depression medications provide a large example subset for adverse reactions. Such cases are not only well documented, but many cases have been brought to trial as well. Paxil birth defects have become a source of lawsuits against the drug maker. In this case, the drug ingestion by pregnant women is associated with birth defects like malformations. These types of reactions should be carefully monitored by drug companies.
As the above examples indicate, the scope of adverse reaction doesn’t merely center on the drug taker, but their children as well. Consider the case of diethylbestrol (DES) drug given to patients to prevent miscarriage. Findings associate the drug with development of adenocarcinoma as well as vaginal cancer in adult children.
The most important thing to note in all of these examples is that the drugs didn’t lead to adverse reactions in clinical trials. This indicates that clinical trials are not the only yardstick for safety.
Pharmacovigilance and drug development
In the current era, pharmacovigilance is more important than ever. The prime reason is that the new class of drugs revolves around biotechnology and molecular therapies. These therapies have lesser precedents as well as research when it comes to safety regulation.
For example, it would take time to determine the latency period of a new series of drugs such as those revolving around gene therapy or retrovirals. In the case of gene therapy, pharmaceuticals are targeting faulty genes. How it will affect patients in the coming five to ten years is a difficult analysis. Therefore, it is imperative for pharma businesses to evolve regulation systems.
Companies can also look at the Yellow Card model developed by the MHRA in UK: it is an online reporting resource for drug safety. It is also advisable for drug companies to develop databases and resources that closely examine the new drugs that they are marketing.
Remember that as a pharmaceutical, the safety of the drug is not merely dependent on the clinical trial study. Subsequent to launching the product in the market, close monitoring and regularity standards should be implemented to avoid/minimize long term issues related to drug safety.