2-18. THE HISTORY OF PATIENT PACKAGE INSERTS
Patient package inserts are not totally new to the outpatient pharmacy. Since the
1960s, various products have been required by the Food and Drug Administration
(FDA) to be dispensed with information statements. These information statements were
designed to provide useful information about various drugs/medical products to the
patient. Examples of drugs that still require special patient information are is
oproterenol inhalation products and estrogenic drug products (See paragraph 2-20a for
a complete listing).
2-19. THE PURPOSE OF PATIENT PACKAGE INSERTS
The purpose of the PPI is to provide patients with useful information about the
prescription drugs they are taking in the hope that this will help the patients wisely use
the drugs. Wise patient use of medications has long been a concern of the FDA.
Various studies have shown that many patients do not receive any information about
the drugs that they are taking. Furthermore, those patients who receive verbal
information frequently forget that information as soon as they leave the pharmacy. It is
hoped that printed material, written in a non-technical way, can provide patients with
information that they can read, understand, and remember in order for them to wisely
use their prescription drugs.
2-20. DRUGS/DRUG CLASSES WHICH REQUIRE PATIENT INFORMATION
a. Seven drug classes are currently required to be dispensed with special
patient information. The current requirements for these drugs will not change; they
must still be dispensed with the patient information. The seven-drugs/drug-classes that
currently require patient information are:
(1)
Oral contraceptives.
(2)
Estrogens.
(3)
Medroxyprogesterone acetate injectable drug products.
(4)
Isoproterenol inhalation drug products.
(5)
Oral postcoital contraceptives.
(6)
Intrauterine devices regulated as contraceptives.
(7)
Progestational drug products.
2-12
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