Michelle Llamas, DrugWatch: July 31, 2019 Update.
Consumers should always read drug labels to make sure they are taking a medication correctly and safely as well as to learn about possible side effects. Unfortunately, these labels can be challenging for the average person to digest.
If you struggle to make sense of the information on your drug labels, you are not alone.
“Several studies have shown that patients often have difficulty in reading and understanding medication labels, which may lead to medication errors such as taking the wrong medication or the wrong dose,” said Mireille Hobeika, who received her doctorate in pharmacy from the University of Saint Joseph in West Hartford, Connecticut.
Understanding drug labels is even more important for people with chronic illnesses and seniors. They have the greatest risk of medication errors or interactions because they tend to take multiple medications.
There are two kinds of drug labels: over-the counter drug labels — also called Drug Facts — and prescription drug labels, which include many pages of safety information, such as pharmacy information sheets, medication guides and prescribing information.
Before you start taking a new medication, review the drug label with your doctor and pharmacist and let them know of any health conditions you have and any medications and supplements you take.
- Were patients in the study like you in terms of age, sex and race? Look for at least 30 patients like you in the study. It might not provide you the most relevant data if people in the study aren’t similar enough to you.
- Were patients in the study like you in terms of medical diagnosis? For example, if it’s a cancer drug, did the study involve people with your type of cancer? The same goes for drugs that treat other diseases. Data might be less relevant to you if you are not represented by patients in the study.
- Is the drug tested in people who failed at other treatments? The FDA approves some higher risk drugs for people with no other treatment options.
If a drug has an FDA-approved medication guide, pharmacists are supposed to give it to patients with their prescription, but this doesn’t always happen. And not all drugs have them.
The FDA requires manufacturers to write medication guides in easy-to-understand language for patients. You can find these medication guides on the drug manufacturer’s website or on DailyMed.
The blood thinner Coumadin, also known under the generic name warfarin, has a medication guide. Similar to the Drug Facts on an OTC label, the medication guide tells patients the most important prescription drug information in simple language.
INFORMATION IN A MEDICATION GUIDE
- What is the most important information I should know about the drug? The most serious risks, side effects and symptoms you should look for are detailed here.
- What is the drug? Here you can find the condition or symptoms the drug treats.
- Who should not take the drug? This section describes diseases or health conditions that may worsen with use of the drug. It also addresses people who may be allergic to the drug.
- Before taking the drug. If you have diseases or health conditions listed in this section, talk to your doctor before taking the medication.
- How should I take the drug? This section explains the special instructions on how to take the drug. It reminds people to take the drug only as directed by their doctor.
- What are the possible side effects of the drug? This section includes side effects information and brief explanations about each side effect. Sometimes it includes information on tests your provider may run or symptoms to watch for.
- How should I store the drug? Information on how to store the drug is included here. Some drugs are sensitive to heat or cold and some may need refrigeration.
- What are the ingredients in the drug? Check this section for the active and inactive ingredients. Tell your provider if you are allergic to any ingredients in the drug.
Is Side Effect Information Always Accurate?
Side effect information on drug labels usually comes from clinical trial data collected before a manufacturer sells the drug. Sometimes the label will get an update based on side effect reports the FDA receives after the drug has been on the market. This information is called postmarketing data.
“If side effects are known, they should always be included on the label, but some side effects aren’t known until years after a product goes on the market,” Zuckerman said.
Drug manufactures can face lawsuits if they know about a side effect but fail to warn consumers and doctors.
“Back when I took Levaquin in 2006, there were no black box warnings on fluoroquinolones,” said Brummert, who suffered multiple ruptured tendons after taking the antibiotic. “The first warning came in 2008 for tendon ruptures, and that black box only stated that people over 60 were at risk. Adverse reactions I have suffered that are still not included in the warnings are autonomic and central nervous system dysfunction and neurodegenerative disorders.”
Brummert said she discovered the FDA had admitted to these side effects in a hidden document obtained through a Freedom of Information Act request.
What Should You Do If You Don’t Understand a Label?
If you have tried reading a drug label and don’t understand it, don’t be afraid to ask for help. Your health care provider and pharmacist are there to assist you.
“Before leaving the doctors’ office, patients should make sure they are well informed about the name of the drug and why they are taking it, the medical conditions this drug treats, how many times per day should they take it, how long will it take this drug to work, when should they stop taking it, are there any side effects that they should know about and any situations where they should not be taking the drug,” Hobeika said.
If you leave your health care provider’s office without the information you need to take your medicine safely and effectively, the pharmacy from where you pick up your medication can help. Your pharmacist can answer questions about OTC and prescription medications.
- Check the label to make sure your name is on it. If it isn’t, talk to the pharmacist.
- Check the label to make sure you can read and understand the name of the medicine, directions and colored warning stickers on the package. If the letters are too small to read, ask your pharmacist to print it in a larger type.
- Are the directions on the package the same as those you and your provider discussed? If not, tell the pharmacist.
- Ask if there are special instructions on how to store the medicine. Should it be kept in the refrigerator or a dry place?
- Ask if there is anything you shouldn’t eat or drink while taking the medicine.
- Ask if it’s safe to take the drug with other prescriptions or OTC medicines you’re taking.
Read the full article here.