No company is out there making a drug for just one person. They want to make medicines that are broadly useful, and able to solve the problems of many people all over the world. Trouble is, everything from gender to ethnicity and even to tiny genetic mutations can have an effect on the way drugs are absorbed by the body. This means making a medication that will work for many people can be a pretty tough challenge to pull off.
Enter pharmacoepidemiology, the study of the use and effects of drugs in a large number of people. Through this discipline, it’s possible for greater understanding—and greater safety—to be arrived at in the development process.
Here’s a quick primer on what pharmacoepidemiology entails and what it can accomplish.
Pharmacoepidemiology Discovers the Real-World Effects of a Drug
Laboratory testing, for all its benefits and necessity, is limited in its capacity to illuminate the precise effects a drug will have when it is used by a large population. Pharmacoepidemiology helps get to the root of this, employing different kinds of studies to get an idea of what effects a drug can have when out in the world. This might take the form of studies of drug use or adverse reactions, leaning on methods like statistical and quantitative analysis to discover important patterns and trends that would arise or have arisen when a drug enters popular use. Pharmacoepidemiological work can be done both before and after a drug has been put on the market.
Detection of dangerous medicines is of the utmost importance for pharmaceutical companies, so pharmacoepidemiological processes are common undertakings. If you pursue a career in the pharmaceutical industry after completing your pharmacovigilance diploma, you could see many of these initiatives taking place.
Pharmacoepidemiology Can Be Particularly Useful for Medicines Like Vaccinations
Though all medications have potentially broad applicability, and can therefore benefit from pharmacoepidemiological research, there are some that stand to enjoy particular gains from employing this type of process in their pre- and post-marketing stages. Vaccinations, for instance, are not restricted to people with particular conditions or of particular genders—they are generally intended to be used by just about everyone of age. With so many different backgrounds and variables to account for, these kinds of medications are therefore especially likely to benefit from quantitative exploration of how they work within the diverse population that takes or will take them.
Whatever the medication being tested, the same requirements of using representative test populations, correct analytical procedures, and close attention to detail is critical to ensuring data is accurate and informative.
Professionals With Pharmaceutical Training May See Pharmacoepidemiology’s Limitations
Pharmacoepidemiology can glean valuable information, but is not a perfect solution for discovering what a drug will do in the wider population. One reason for this is that it is difficult to control for variables when studying people out in society. Lesley Wise, PhD, a pharmacoepidemiology expert, offered an example in an article titled “Risks and benefits of (pharmaco)epidemiology.” Psychiatric conditions were observed in a number of smokers taking a drug called “varenicline” as a stop-smoking aid, potentially suggestive of the condition being a side-effect of the drug. However, Wise noted “Smokers are known to have an increased risk of certain psychiatric conditions compared with the general population, and smoking cessation is also known to have an adverse emotional effect with irritability and depression reported,” making it unclear as to the cause of the symptoms.
In other words, professionals with pharmaceutical training should not expect pharmacoepidemiology to be a perfect solution for getting objective data about the effects of a drug, as some circumstances may make the data unreliable. Instead, it should be considered a useful tool to employ alongside others for a more complete picture of a drug’s effectiveness.
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