Reported adverse events are an important tool for implementing a risk management program. An important contributing factor in the evolved AEs the condition of chronically ill patients taking a drug daily over the course of many years. Another factor the large number of patients taking multiple prescriptions’ drugs all together, increasing the potential for drug-drug interactions. Its worth to mention that unlike the small, carefully selected, homogenous test groups in the conducted clinical trials, users of on-market drugs are highly heterogeneous, bringing a complex range of potential factors of diverse populations and race, physical condition and compliance.
Realistically speaking it is very difficult for detecting the precise cause (or causes) of AEs, pharmaceutical companies cannot try to eliminate risks to all patients; but, they must determine the practical strategy needed for controlling certain risk associated with their newly launched or marketed drugs. Risk assessment, as epidemiologists define, is the probability of the occurrence of harm and the severity of that specific harm; requires expert judgment from different involved parties as from: company scientists and clinicians in R&D, data collected and analysed by strategic personnel, counseling of FDA executives and other experts view.
Building a risk management program
The pharmaceutical industries manufacturing drugs are dealing and treating human being lives. Consequently it is considered a special industry manufacturing products (drugs) which need special care and a significantly higher safety standards than those imposed on other industries. As a result, even when the incidence of AEs and signal detection is low, drugs can still be withdrawn from the market judged on the seriousness of the incidences and its occurrence in many areas of the world.
Patients are always looking for the perfect drug, which gives rapid cure, low cost, and with no side effects. Pharmaceutical companies from their side are trying to overcome this challenge which seems to be not so realistic especially within a complicated highly competitive business, with its social and political implications.
Decisions in balancing between risk and benefit
The role of pharmaceutical companies is to decide how to manage the results of an AE signal. Some drug companies develop and prepare the safety programs that are implemented from the moment drugs when enter their product portfolio. Also collecting and analysing data in an advance way is an important tool in drug safety and risk management program. In this concern, whatever the approach selected, each program needs to be reasonably relevant to the nature of the risk. When a signal of a potential side effect is detected it should be documented with its response.
The following recommendations could be taken in consideration, dealing with the drug safety and risk management, others could be included based on pharmaceutical companies’ diversified strategies:
- Review of previously conducted clinical trials.
- Implement a signal monitoring program, is a must to determine as soon as possible any harm evolved from their drugs either newly launched or already in market.
- Regularly fill in the needed data in the PSURs (Periodic Safety Update Reports) which is an important tool to follow up and update worldwide the safety data of drugs.
- Any signal detected should be carefully identified with the adverse event that could potentially occur.
- The validation of the signal and its analysis should be done carefully considering the variable demographic issues such as age and gender.
- Randomised safety trials could be conducted by pharmaceutical companies to implement information and different education program to HCPs (Health Care Professionals) and patients.