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Package Inserts

Posted Oct 6th, 2008 by Patient Assistance Team
When you pick up a prescription, it’s not a bad idea to ask for the package insert. You don’t have to read the whole thing, don’t have to read any of it – but you can learn a lot just by looking.

The package insert is the official, FDA approved information about the drug. It tells the results of studies – what the drug has been shown to be useful for, in what doses, and what side effects are likely to happen. This is the information that your physician and pharmacist should be going over with you, but probably don’t. Some drugs have an easy to read version called a patient package insert, and many pharmacies also give out a summary sheet that’s supposed to give you information about the drug – but the official package insert is the real thing. Because there’s only one insert to every bottle of medication, the pharmacy may not have a copy available, but it doesn’t hurt to ask.

In theory, the package insert contains information that can’t be understood without special training – but you can still spot one thing without reading a word: a black box warning. Every drug has a list of possible adverse effects, but these aren’t always useful, because when lots of people take the same drug, the list of reported side effects gets long, and often contradicts itself. Many drugs have been reported to cause both diarrhea and constipation, insomnia and wakefulness, weight loss and weight gain. In contrast, a black box warning is at the top of the page, in bold letters, with a box around it, and is the most serious warning the FDA can give. Because these warnings may apply only in special situations, such as warnings about drug interactions, or the use of drugs in patients with specific conditions, the warning may not apply to you, but if there is a black box warning, you may want to ask you physicians and pharmacist for more information.

Recently, the FDA added black box warnings to a number of psychotherapeutic drugs. These warnings apply to the use of some psychotherapeutic drugs in elderly patients with dementia, and warn of increased mortality. If you’re the caregiver for an elderly patient with dementia, you may want to review these drugs and perhaps discuss them with the prescriber.

If you have any drug allergies, particularly a penicillin allergy, take the time to discuss this with your physician. Lots of people don’t, and most physicians don’t ask – and it can be important.

An allergy is a very specific type of adverse reaction. Most of the time it just causes a rash or an itch, but sometimes it can be severe, even fatal. A report of an allergy is an absolute contraindication against using a drug, or one that may cause the same reaction. For example, people with penicillin allergies shouldn’t receive other antibiotics that are chemically related to penicillin. Unfortunately, some of the most useful antibiotics, including those used to prevent surgical infections, are related to penicillin. There are alternatives, but they aren’t as good,

But lots of people use the term "allergy" to discuss adverse reactions that aren’t allergies at all. A stomach upset probably isn’t an allergic reaction, nor is a loose stool. Before you report an allergy, it may be best to determine whether it’s a real allergy, or some other type of reaction that would still let you take the medication safely.

Have you had your flu shot this year? Lots of people skip flu shots because they don’t always work, because the shots cause a reaction, or because of the price. This may be a reasonable decision; anyway it’s a personal decision. But the new philosophy is that immunizations aren’t just for personal protection, they’re for the protection of other people you may come into contact with. Health care workers should always get flu shots, even if they don’t feel they need them personally. The same thing applies to people who work in nursing homes, or who live in homes with very old or very young family members. It may be more important for the caregiver to have a flu shot than for the people they’re caring for to be immunized.

If price is a factor, lots of communities have free immunization programs – and hospitals and some pharmacies offer low cost immunizations as well. If you work in a nursing home or hospital, or if you live with an elderly person or a child under the age of two, get your shot. It isn’t always about you.