Whose job is it to explain side effects? Doctors? Pharmacists? Pharma? Yours?

Eliyahu Tulshinski

February 29, 2024

Whose job is it?

Frontline News recently reported that many pharmaceuticals cause the very ailment they are supposed to treat and that FDA officials concede that, “no pharmaceutical is a hundred percent safe.” So whose job is it to warn patients of potential side effects?

The patient's job?

The FDA appears to put the onus on patients to discover the potential adverse reactions that may take place after taking a pharmaceutical, advising people to initiate conversations with their doctors about adverse effects and to check product inserts:

There are several ways to learn about side effects for your prescription drugs and to reduce your risk of experiencing a side effect.

Ask your health care professional about any possible side effects and what, if any steps should be taken to reduce the risk when you are prescribed a drug . . .
Ask your health care professional for information about the drug when you receive your prescription (FDA approved labeling for patients include Medication Guides and Patient Information). These documents will include possible common and serious side effects.
Read the pharmacy label and any stickers that may be attached to the prescription bottle or box. [Emphases added.]

The doctor's job?

Professor Derjung Tarn reported on the extent to which “physicians communicate the adverse effects of medications,” determining that in theory they should follow each pharmaceutical's “Patient Counseling Information section for healthcare providers.” He deems, however, that it's not practicable for physicians to do so. The professor adds that there's actually no data available on just how much adverse event information is commonly passed on by doctors:

Guidelines specify the content of adverse effect education for medications associated with common adverse events, such as warfarin, NSAIDs and aspirin. In addition, according to the US Food and Drug Administration (FDA), prescribing information must include a Patient Counseling Information section for healthcare providers to use when counseling patients.

However, the information in the FDA prescribing information is voluminous and incompatible with office discussion. Physicians have little guidance about which adverse medication reactions to discuss with patients and it is unknown which potential adverse effects are commonly discussed by physicians. [Emphases added.]

MedShadow also examined the extent to which doctors should mention side effects, concluding that doctors have lots of leeway in order to allow them to avoid discouraging the use of a medication. Like the FDA, they appear to ultimately put the onus on patients to get information on adverse effects:

People are different, and doctors are called upon to use judgment all the time. Even doctors who try to relay all possible side effects are challenged to know when to stop. Listing all the rare adverse events could scare the patient out of getting needed care.

Which side effects are common enough to be mentioned, and which are rare enough to be left unsaid?

This is a good discussion to have with your doctor. You might not want to know all the possible minor irritations that could be caused by a medicine. A warning of the most significant possible adverse events and a general comment that any new symptoms are probably from the medicine might be all the information you want.

Others might want to discuss the drug in detail and have a strategy for coping with side effects. It’s your body, your appointment, and the doctor is your consultant. Ask for the information you want and know when to say, “Enough.” [Emphases added.]

The pharmacist's job?

Publications directed at pharmacists encourage them to share side effect information in order to fill the gap between what patients hear from their doctors and what they need to know.

Many of these journals emphasize discussing medications in ways that “don't scare” the patients. Rxrelief, for example, titled one article: "Don’t Scare Your Patients: How to Communicate Side Effects Without Scaring Patients."

Don’t Scare Your Patients: How to Communicate Side Effects Without Scaring Patients …

There is now a lack of communication between patients and healthcare providers about medications, and as a result, patients are not getting all of the information they need about the benefits and risks of their medication. To put patients at ease, pharmacists need to give them the information they need, listen to their concerns and show empathy …

The pharmacist should learn about all the medications that the patient is taking. Then, the pharmacist should talk with the patient to see how well the person understands why he or she is receiving the particular prescription. The pharmacist also needs to address any concerns or issues the patient may have …

When the pharmacist talks about the medication, he or she needs to cover the following issues – the name and potency of the drug, why the physician has prescribed it and how it works, how to take it, how long to take it, how it will help, possible side effects, the amount of time elapsed before the patient will see improvement, and what to do if the patient misses a dose …

Talking About Side Effects With Pharmacy Patients

The pharmacist needs to inform the patient about potential common and severe side effects, what the patient can do to prevent or minimize them, and what the patient should do if he or she experiences any of the side effects, which includes contacting his or her physician, pharmacist or another healthcare provider.

When talking to the patient, the pharmacist needs to use language that the patient understands and lay out the information in a logical order. [Emphases added.]

Another publication geared toward pharmacists, SingleCare, lays out six ways to avoid frightening patients:

How to explain side effects without scaring patients

There are always risks when taking drugs—whether they are prescription or over-the-counter medications … As a pharmacist, you have to fully understand, and clearly explain the potential risks to everyone who picks up a prescription.

How do you explain side effects without scaring patients? …

1. Stay calm.

One of the best ways to put patients at ease is to model composure and compassion when speaking to them …

2. Explain all the details.

Everything is a little scarier when you don’t know what to expect …

3. Suggest calming techniques.

Remind patients that the medication was specially chosen to make them feel better and return to good health … Offer ways to fend off initial anxiety, like taking some deep breaths together, to help patients stay calm and process the information.

4. Get to the root of the anxiety.

Tell patients, “if you communicate a specific reason why you are anxious (for example, you’re worried about becoming addicted to pain medication), that can help me offer more specific advice" …

5. Remind patients that serious side effects are unlikely.

… Richard Harris, M.D., Pharm.D., founder of Great Health and Wellness, reassures the patient that none of the side effects are set in stone or absolutely imminent … “I let them know that we are covering a wide range of possibilities and none of them may actually happen. Also, that few medications when used properly lead to permanent or terminal side effects.”

6. Focus on the positives.

… “review the direct benefit of the medication over the potential side effects” … Patients who are worried about adverse effects are less likely to take their medications. By taking the time to soothe their fears, you’re making sure they’ll be feeling better, sooner.

Judging by these publications, doctors cannot be relied upon to provide sufficient information about side effects and patients cannot be relied upon to read and understand the warnings in package inserts, but pharmacists can fill in the missing information about potential side effects, albeit in a non-alarming way designed to make the patient better informed without running the risk of discouraging them from opting out of using the drug.

Check back for the next installment of our series on adverse events as we look at Big Pharma's involvement in how doctors discuss side effects with patients.

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