Sunday, November 1, 2009

What's the purpose of those package inserts that come attached to your medications?

Medication package inserts, or as I like to call them, 1001 reasons to not take this medicine, are informational documents included with all medications, prescription and OTC (over-the-counter) medications.

The package insert follows a standard outline of information provided: pharmacology, indications, off-label uses, contraindications, warnings, precautions, adverse reactions, abuse and dependence, over dosage, dose and administration, manufactured forms and recommended storage.

Typically a patient will present to the office with a myriad of complaints, for example, a patient with anxiety and panic attack. These patients will have a plethora of complaints and serious concern that "something bad is going to happen." Complaints commonly made by anxious patients include but are not limited to the following: impending doom, chest pain, shortness of breath, numbness in the fingers, dizziness, fatigue, poor sleep, thoughts racing, rapid heart rate, irregular heart rate, upset stomach, memory problems, etc. Many anxious patients will present with this many complaints and additional ones that they fixate on and really want to know what is causing of all of this. That being said, the patient and I have a meaningful conversation about what is most concerning to the patient and what treatment strategy they interested in pursuing.

I feel that stuffing an evidenced-based treatment regime down the throat of a patient who is not ready for that therapy is only delaying treatment and ultimately destroying credibility between myself and the patient. Some patients are very motivated and want some reassurance and then would like to make an effort to fix the problem with little or no medications. Other patients are wholly in the grip of anxieties hand. For these patients, very good medications with rather minimal side effects and very good evidence-based efficacy exist. With either patient, the question is, do the benefits of the therapy out weight the risks?

The office visit is concluded and those patients who chose a medication, take their prescription to their local pharmacy to be filled. Upon pick-up and purchase of the medicine, attached is the package insert to which I refer.

Many patients, especially those with anxiety, are by far the biggest population of people who read these documents. To be honest, I don't think I have every read one.

Now here's where the problem exists for me as a physician. The patient and I have discussed the symptoms, the diagnosis, the medications and the risks and benefits and in one fell swoop many of these anxious patients will actually pay for the medicine but will decide to not take the medicine.

I see the patient at a follow-up visit with many of the same complaints and I ask, "How is the medication we started last time working?" and the patient says, "I didn't take it."
From a physician perspective, this is very frustrating. I have learned to anticipate this scenario and play devils advocate in an attempt to prepare the patient for the package insert.

I have patients call me days later and ask, "Is this new medication going to interact with the other medications that I'm taking?" To ease the mind of my patients and the population as a whole, I have an electronic medical record (EMR) which will not let me prescribe two medications that interact, in some way, without a warning and having to manually override the system. Do all doctors have EMRs? The answer is no, but the federal government is mandating that all medical records be paperless by 2012.

These package inserts have generated a lot of calls to my office regarding certain risks of taking this medication. I have to remind the patient of the original symptom complex they presented with and asking for a solution. Medications are relatively safe and do a good job at improving quality of life for the most part. While some people may have an opinion about the FDA, the bottom line is, they do a reasonable job and provide over site for an industry that is constantly inventing new products. The vitamin industry, by comparison, doesn't have any oversight, nor do they provide package inserts. Vitamins can be just as risky if not more risky than traditional medicines because of their lack of regulation.

As it relates to anxiety, I recently was directed to a website by a patient for a new anxiety medication. Touts itself as relieving your stress, no prescription required, asserts you can be stress free if you take these pills. The website was very well done, soothing colors, beautiful imagery and then at the bottom of the site was the price, $24.99 for 1 month. That's where I about lost it. $24.99, are you kidding me? This company is probably making money hand over fist with absolutely zero regulations on the claims that it makes. By the way, the bottle was filled with a mix of B vitamins. My medication, on the other hand, has many double-blinded randomized controlled trials showing almost proven efficacy and costs only $4 for 1 month at Wal-mart.

The bottom line is that these package inserts are medical-legal documents that absolve any and all persons associated with this medication, except the prescriber, from legal responsibility.

I wish the package inserts would have at the top of the sheet in bold letters "NOT TAKING THIS MEDICINE WILL ALMOST GUARANTEE YOUR SYMPTOMS TO CONTINUE TO WORSEN." Maybe that's too harsh, but the sentiment is real. A patient had a complaint bad enough or persisted long enough that they presented to a doctors office for a solution. A solution was given and at just that critical point before the patient administered the medication, the package insert reared its ugly head in an effort to terminate or delay therapy.

My advice is, take the package insert with a grain of salt, along with your pill as prescribed by your doctor. Remember, this perspective isn't about getting patients to take pills but rather trying to improve treatment outcomes in those patients who asked for a pill to fix their problem.

Info about package inserts.

Bryan Glick, DO