March 24 is National Adverse Drug Event Awareness Day. I wish I didn’t have to know that, but since 2006, I’ve been disabled from adverse reactions from Levaquin- a fluoroquinolone antibiotic. Over 30 tendon ruptures, nerve damage, bone and muscle pain, brain fog, neurodegeneration, autonomic and central nervous system damage. I could go on but we’d be here all day.
I have a unique perspective on adverse drug reactions.
I’m a harmed patient. I also work for the U.S. Department of Health and Human Services. I’m an SGE (Special Government Employee) at the U.S. Food and Drug Administration and I collaborate with the Centers for Disease Control and Prevention. I’m also a team leader and patient safety expert at the American Society of Pharmacovigilance STRIPE Initiative. In addition, I’m a contributor at Drugwatch, Medshadow Foundation, and Health Web Magazine.
The combined experience allows me to help others so that they can make informed decisions about their health. Trust me, what you don’t know can hurt you, and sometimes the treatment is worse than the illness.
“But Rachel, all drugs have side effects”. I get that one a lot. Side effects are things like dry mouth or constipation. Adverse drug events are completely different in that it flips your world upside down and sideways. We’re talking about life-changing, often permanent, health problems that stem from a medication.
In the next few weeks I am going to be writing more content around Adverse Drug Event Awareness Day and this is my jumping off point. Every patient has the right to information regarding their health and well-being in order to make informed decisions. Finding the balance between lack of transparency and wading through vast amounts of information often comes down to asking the right questions.
Had I known that Levaquin was not appropriate for my particular health issue, and had I asked questions, I’d have been able to give informed consent.
The following are 12 questions to ask your doctor when the subject of new medication is introduced. It comes from years of personal experience as well as professional experience being a patient safety advocate. I will also explain why asking these questions are important. Having as much information as possible allows you to paint a complete picture about what you feel is best for you and to determine the risk-benefit ratio.
Questions to Ask If Your Doctor Brings Up a New Medication
- Do you mind if I record this conversation with my phone so I can have it to refer to when I do my research?
- Why is this important?: Recording a conversation means that you won’t have to rely on your memory to recall information during your visit. It also increases the likelihood that there will be more transparency about the risk vs benefit ratio of a new medication.
2. For what condition is this medication prescribed?
- Why is this important?: Drugs often have more than one use. Understanding why a drug is being prescribed increases your knowledge of the medication and the condition for which is it prescribed.
3. Is it being prescribed off-label? If so, is there another medication specific to my condition?
- Why is this important?: Prescription drugs are often prescribed for uses other than what the FDA has approved. This is legal, and in fact common. The FDA regulates the approval of a drug, not how it is prescribed. At least one in five outpatient prescriptions are prescribed off label and doctors are not necessarily required to inform a patient that a medication is being prescribed off label. Off label use is not necessarily a bad thing but it is important that a patient is fully aware of what they are taking and for what condition.
4. What are the risks associated with this medication and do the benefits outweigh those risks?
- Why is this important?: Adverse reactions (ADRs) or adverse events (ADEs) can have a major impact on the health and well-being of patients. It’s something that I found out the hard way. I was never informed of the adverse reactions associated with Levaquin, many of which are permanent. Sometimes, unfortunately, the treatment can be worse than the illness for which it is prescribed. FDA approved does not always mean that a product is safe. Having a complete picture of the risk vs. benefit helps patients make an informed decision about their care and appropriate use of the medication.
5. Is this a new medication? If so, is there an older, more tried-and-true medication available?
- Why is this important?: Newer doesn’t always mean better. There is no regulation requiring new medications to be better than older medications before they are approved by the FDA. The FDA approves approximately 20-25 new and unique medications annually. Of those, only four or five represent major advances for conditions with no decent treatment choices. The remaining new medications offer only marginal improvements or are combinations of what is already on the market, which are called “me too” drugs.
6. Is this medication necessary to my well being or are there alternative treatments I can try first?
- Why is this important?: There may be other medications to consider for your condition. Some medications may be more effective but carry greater risks. There is also cost to consider. In some cases, medication may not be needed at all and other treatments may be available.
7. Will this medication interact with my other medications and/or other health conditions?
- Why is this important?: Drug interactions may make your medication less effective, cause unexpected side effects, or increase the action of another drug. Medications can react with other medications, food, or beverage.
8. What are the Black Box warnings for this medication and where can I report adverse events?
- Why is this important?: Black Box warnings are the strictest warning put in the labeling of prescription drugs by the FDA when there is reasonable evidence of association of a serious hazard with the drug, which can be life-threatening. Asking about Black Box warnings can help to protect your health and life. If you do experience an adverse reaction, it is important to report it to the FDA’s MedWatch, which can be found here.
9. What happens if I do not take this medication?
- Why is this important?: You know what is best for you. You may decide that a medication has too many side effects, costs too much money, or you may think you might get better with alternative treatment. Asking what happens if you do not take a certain medication allows you to make an informed decision about what is best for you.
10. What is the cost of this medication and will insurance cover it?
- Why is this important?: Many patients may face high out of pocket costs for prescription drugs each month, especially for those with chronic or multiple conditions. Even insured patients feel the burden. When the cost is too high, a patient may stop taking the medication, and this could be detrimental to the patient. Understanding the cost of prescription medications and whether it is covered by insurance can help prevent complications from stopping a medication cold.
11. Do you have any written information about this medication?
- Why is this important?: Patients need accurate information to help them use their medications safely and effectively. Having written information to refer to helps patients fully understand everything they need to know.
12. Have you ever received any gifts or financial benefits from the company that makes this medicine?
- Why is this important?: Doctors are not required to disclose payments they receive from pharmaceutical companies to prescribe their drugs. Patients want to know that the medication being prescribed is because it is in their best interest, not because doctors receive money to do so. Understanding these ties is important. Many brand name drugs are expensive and carry dangerous adverse reactions. As a patient and consumer, you have the right to know whether your doctor has close pharmaceutical ties. You can find out here.