The recent discussion is mostly about whether untrained people can or
should read the "Product Package Insert", a printed sheet (microscopic
type) that is required to be enclosed at the factory, or the correspond-
ing entry in the Physicians' Desk Reference, a huge annual book (which
is also available online, I'm told).
It may help hesitant beginners to know that, while the writing is done
by doctors and others who may not be good at clarity, each drug entry
follows a somewhat standard format, that helps in finding what you want:
DESCRIPTION: What the drug's made of, including all the inactive
ingredients such as dye, just in case you are allergic to any of them.
CLINICAL PHARMACOLOGY
Mechanism of Action: Even though it may work, exactly how is often
unknown, but that shouldn't bother you.
Pharmacodynamics: What they think it does; you don't need details.
Pharmacokinetics: Where it goes in the body and how it gets there.
Special Populations: For example, those with impaired liver function.
Clinical Studies: In simple language, how FDA tests came out.
INDICATIONS: When and why to prescribe it.
CONTRAINDICATIONS: When not to, for example with other drugs that may
interact.
WARNINGS: The most serious possibilities, that the doctor should note.
PRECAUTIONS: Possibilities less serious, often with a paragraph for
each. In the original Tasmar PI, the first death from
suspected fulminant liver failure, and another from a
syndrome resembling neuroleptic malignant syndrome but
due to abrupt withdrawal of Tasmar, are buried here.
Information For Patients: What they tell the doctor to
tell you, about impaired driving ability, nausea, etc.
This sometimes is a separate sheet that you get from the
pharmacist, after you ask him for the PI.
ADVERSE REACTIONS: Collection and tables of all the other things
reported by test subjects through their doctors.
You probably want to look only at the most
frequent, at the top of the list. The only important
ones are those significantly different from placebo.
DRUG ABUSE AND DEPENDENCE: Boilerplate.
OVERDOSAGE: Required info, but not usually of much interest.
DOSAGE AND ADMINISTRATION: If you want to compare your doctor's advice
with that of the drug maker.
HOW SUPPLIED: How to recognize your medicine if you lose the label.
Cheers,
Joe
--
J. R. Bruman (818) 789-3694
3527 Cody Road
Sherman Oaks, CA 91403-5013
