How You Can Practice Pharmaceutical Safety

When you pick up a prescription or get a vaccination, it’s paramount that you trust the medication is safe. In the U.S., a system of laws, procedures, and personal responsibility combine to ensure drug safety, or pharmacovigilance.

Physician Paul Beninger is a professor at Tufts University School of Medicine, where he teaches pharmacoepidemiology in the Master of Public Health program. Before coming to Tufts, Beninger worked for many years as a regulator in the U.S. Food and Drug Administration (FDA) and as an executive in the pharmaceutical industry, specializing in pharmacovigilance. He recently shared his insight into how pharmacovigilance works in the U.S., why you can trust the drugs on the market, and how to maintain drug safety for yourself and others.

Beninger stresses that drug safety is an ever-evolving process and that pharmaceuticals are frequently evaluated and re-evaluated. “There’s a whole apparatus of agencies and people constantly working to keep drugs safe.”

Drug Safety Evolves

The country’s current drug and biologics regulatory system began in 1902, when Congress mandated standards for the safety, purity, and potency of ingredients in drugs made from animals after children died from contaminated ingredients. Since then, 17 additional major laws directed at pharmaceutical safety were put into place, requiring pharmaceutical companies to demonstrate that their drugs are effective, creating drug approval processes, and establishing standards for medical devices. 

Today, pharmacovigilance refers to the science and regulatory activities related to the detection, assessment, understanding, prevention, and communication of adverse effects from drugs and medical devices, Beninger said. “It’s the full spectrum of everything that has to do with the safe use of drugs, vaccines, and all other medical products.”

One mainstay of modern drug development is the clinical trial process, meant to ensure that safe and effective dosages of medications are identified before a drug is put on the market. The early stages of the clinical trial process are designed to establish the doses that are safe in human participants. The next stages evaluate which doses are effective in treating specific health problems. And when possible, drugs are also compared to already-existing treatments. If all goes well, the FDA approves the drug for marketed use.

Pharmacovigilance is a “24/7 activity” that continues after drug trials conclude, and the public is part of that surveillance, Beninger says. Anyone, including physicians and patients, can and should report adverse effects of medications directly to the FDA via the MedWatch report form, which the FDA takes into account when periodically re-assessing that drug’s safety.

Personal Drug Safety

Beninger stresses the importance of taking medications exactly as they’re prescribed and storing them properly, as some may need to be refrigerated or kept out of the light. Consumers should also be careful to only take medications that haven’t expired, as expired medications may be less effective. 

With children in mind, parents should keep medications in child-resistant packaging whenever possible. Parents should also have age-appropriate conversations with their children about the possible dangers of accidentally ingesting medication, Beninger said.

He also recommends reading your medication’s patient insert—a written resource included with each prescription that explains common side effects, when to take the medication, and what to do if you skip a dose. “Learn how things work, learn about where you can find information that you need to be safe, and learn how to report adverse effects,” Beninger said. 

The FDA’s medication guide provides accurate information about the side effects and uses of medications on the market. If you have any questions about the drugs you’re taking, the FDA’s Drug Information Pharmacists can help interpret the information included on drug packaging or the patient insert. Additionally, a drug company’s website can be a useful resource, as they are legally obligated to provide accurate information and are prohibited from exaggerating claims or obscuring potential side effects.

Adverse Interactions

 Harmful drug interactions can occur in a wide array of scenarios. For example, medications can interact with undiagnosed medical conditions. One of your medications could affect the way another medication works. And herbal, vitamin, or mineral supplements, as well as food and alcohol, can also interact with your medication. Even common foods and drinks can cause serious interactions with medications. For example, grapefruit juice can increase the side effects of drugs meant to lower cholesterol, called statins, and can render some blood pressure drugs ineffective. Other common foods that can interact with some drugs include dairy, leafy greens, and cured meats.  

You can find out about possible interactions by reading the drug labels on your medication. Beninger recommends reviewing any special instructions about interactions given from the health care professional who prescribed the medication. 

Keeping an up-to-date medication list in your car or wallet that you can easily give to doctors or that emergency responders can access if needed. They can use that list to avoid giving you medications that may interact with your current prescriptions. “If they don’t know what you’re on they can’t help you as readily,” he said.

If you suspect you’re experiencing an adverse drug interaction or reaction, or fear you may have ingested an incorrect dose, Beninger recommends calling a poison center, which can connect you with specially trained nurses, pharmacists, and doctors who will be able to assist with the problem. 

Preventing Antimicrobial Resistance

Following the instructions provided by the patient insert can also help combat antimicrobial resistance—when antimicrobial drugs become ineffective to treat pathogens like fungi or bacteria. 

To prevent antimicrobial resistance as a consumer, make sure to take antibiotic medications only when they’ve been prescribed to you. “Don’t take the drugs that have been prescribed for your family members, or give drugs prescribed for one child to another,” Beninger said. Ensure that you complete a course of antibiotics that has been prescribed—even if you’re feeling better. 

Taking expired antibiotics also increases the risk that antimicrobial resistance will spread, since expired antibiotics may be less effective. If you have left-over antibiotics, don’t discard them in toilets or sinks. Rather, return them to the pharmacy to ensure that they’re disposed of properly.