QMC 8 – Help, My patient is freaking out over package inserts!

Package insert causing mayhem! Haha.

Package Insert

Package Insert: Legal Requirement for all drugs

It’s weird how this question came in. Dr. MC, says, “My patient was prescribed textbook medications for his condition. He’s read the package insert and he’s freaking out. How can I convince him that this is what’s best for him!”

Why is this question weird, you ask? Because as of this week, I’m teaching students how to create and write package inserts and patient information leaflets.

If you’ve seen most package inserts, they are scary. Long page, fine script, lots of don’ts and negative stuff. A good package leaflet is usually neutral but that’s not what we’re discussing.

If you’re faced with a similar situation, then see below:

1.Make time

When dealing with patients who come back waving the leaflet, you must prepare to spend some time with these guys. Even if it means keeping them till the very end. You can’t just shoo em in and out.  Give them your time and attention.

2. Listen to what they’re saying

Often they will have questions that are justified. “Doctor does this drug really thin my blood?” Listen to their questions and write it all down.  Maybe they’re scared of the side effects(usually the case) or maybe they’ve read what the leaflet is also prescribed for, “But Doc, it says here this is also given to patients who had a heart attack. I didn’t have a heart attack, did I? Will I have one soon?” Just listen. Don’t wait to bombard them with your explanation. Once you listen, wait, pause for dramatic effect. Let them know this isn’t new information for you. You know this stuff. Just because they’re new at it, doesn’t mean you are. Give them the sense that you have a handle of the drug and it’s effects. And if you don’t give the leaflet a cursory look.

3. Explain the risk/ benefit ratio

Ideally, you should be explaining this to your patients BEFORE you prescribe. For me, no matter what I’m prescribing, I always take 20 seconds to tell the patient of potential side effects. Not only does it make me look smart (wink), but it also tells my patient that I’m truly concerned about them. And that at the first sign of something going wrong, they must notify me.

Also make it very clear, “If you don’t take this medicine, what’s the alternative? The drug is meant to thin your blood, because otherwise it has a propensity to clot. Your tests, X and Y have proven so.” Explain that this is the standard treatment. If you know the statistics then mention that as well. Justify everything you’re doing.

4. Be Honest 

Don’t lie. If the insert says that dizziness could be a side effect, then agree that it can be a potential side effect.  Don’t lie and say “These things really don’t happen.” Patients won’t believe you.

5. Stress the importance of the Package Insert

The Package Insert was created to inform the public.  Establish with your patient that all drugs are chemical molecules that have effects. The drugs have been studied and the entire spectrum of side effects is mentioned on an insert by law to inform people of the potential side effects even rare ones. This is usually done so as to prepare people for all eventualities.  Don’t tell patients to ignore the Package insert. In fact, encourage them to read and ask you any questions they may have. Often I ask patients to get back to me in a week, by mailing my nurse or phoning in to say they’re doing better or having any effects, just so they know I’m interested in knowing if they’re experiencing any effects.

Take a look at this paper about the effect of a package insert on patients here. Most of the patients who are frightened by them return to their GP’s for a discussion. No Biggie.

Let me know if this worked for you. And other superstar docs out there, do you have a better way of dealing with this. I’d love to know!




Liked it? Take a second to support Pamela Q. Fernandes on Patreon!

Leave a Reply, I'd love to hear from you