Essentials of Healthcare Product Labeling
55
Evolution of Patient-Oriented
Labeling for Prescription Medicines
Patient-oriented labeling for prescription med-
icines has been a compulsory standard in many
countries for years. In contrast, there is no US
requirement for sponsors to prepare and submit
patient-oriented labeling for all prescription
products for FDA review and approval, result-
ing in an inconsistent situation with respect to
written drug information.
Beginning in the late 1960s, the FDA
required labeling written in nontechnical lan-
guage – Patient Package Inserts (PPI) – to be
provided to patients with certain medicines, such
as isoproterenol inhalers and products contain-
ing estrogen, to inform them of specific risks. In
1974, the agency initiated a project to investigate
whether requirements for patient labeling should
be expanded, based on the position that “…pre-
scription drug labeling that is directed to patients
will promote the safe and effective use of prescrip-
tion drug products and that patients have a right
to know about the benefits, risks, and directions
for use of the products.”1 In 1980, the FDA issued
a final rule to require manufacturers to provide
a PPI for dispensing with new prescriptions.
The initiative aimed to increase patient knowl-
edge about the product and thereby encourage
its optimal use. At the time, consumers were in
favor of PPIs, but there was some opposition
among healthcare professionals.2 This regulation
was withdrawn two years later as unnecessarily
burdensome, costly, and contrary to requirements
set forth in the 1981 Executive Presidential Order
12291 for promulgating new regulations.3,4
During the decade following withdrawal
of requirements for sponsors to develop PPIs
for all prescription products, the FDA periodi-
cally assessed the leaflets prepared by voluntary
programs and found substantial variation in the
written information’s usefulness.5 To align with
the Public Health Service “Healthy People 2000”
initiative’s goals, the FDA published perfor-
mance standards in 1995 for written patient drug
information distribution and quality. At the same
time, it proposed a regulation requiring patient
labeling, specifically Medication Guides, for
certain products that pose serious risk of harm
“requiring immediate distribution of FDA-
approved patient information.”3
While the FDA was reviewing comments on
the proposed rule on Medication Guides in 1996,
Congress passed Public Law 104-180,6 which
formally established a voluntary private-sector
initiative to develop a long-range action plan to
meet the FDA’s performance goals for both oral
Patient Labeling in the US
Cathleen O’Connell, PhD, MS, RPh,
Christine Holzmueller, and
Hoi Lam Chan, MPH, BPharm (Hons)
CHAPTER 6
55
Evolution of Patient-Oriented
Labeling for Prescription Medicines
Patient-oriented labeling for prescription med-
icines has been a compulsory standard in many
countries for years. In contrast, there is no US
requirement for sponsors to prepare and submit
patient-oriented labeling for all prescription
products for FDA review and approval, result-
ing in an inconsistent situation with respect to
written drug information.
Beginning in the late 1960s, the FDA
required labeling written in nontechnical lan-
guage – Patient Package Inserts (PPI) – to be
provided to patients with certain medicines, such
as isoproterenol inhalers and products contain-
ing estrogen, to inform them of specific risks. In
1974, the agency initiated a project to investigate
whether requirements for patient labeling should
be expanded, based on the position that “…pre-
scription drug labeling that is directed to patients
will promote the safe and effective use of prescrip-
tion drug products and that patients have a right
to know about the benefits, risks, and directions
for use of the products.”1 In 1980, the FDA issued
a final rule to require manufacturers to provide
a PPI for dispensing with new prescriptions.
The initiative aimed to increase patient knowl-
edge about the product and thereby encourage
its optimal use. At the time, consumers were in
favor of PPIs, but there was some opposition
among healthcare professionals.2 This regulation
was withdrawn two years later as unnecessarily
burdensome, costly, and contrary to requirements
set forth in the 1981 Executive Presidential Order
12291 for promulgating new regulations.3,4
During the decade following withdrawal
of requirements for sponsors to develop PPIs
for all prescription products, the FDA periodi-
cally assessed the leaflets prepared by voluntary
programs and found substantial variation in the
written information’s usefulness.5 To align with
the Public Health Service “Healthy People 2000”
initiative’s goals, the FDA published perfor-
mance standards in 1995 for written patient drug
information distribution and quality. At the same
time, it proposed a regulation requiring patient
labeling, specifically Medication Guides, for
certain products that pose serious risk of harm
“requiring immediate distribution of FDA-
approved patient information.”3
While the FDA was reviewing comments on
the proposed rule on Medication Guides in 1996,
Congress passed Public Law 104-180,6 which
formally established a voluntary private-sector
initiative to develop a long-range action plan to
meet the FDA’s performance goals for both oral
Patient Labeling in the US
Cathleen O’Connell, PhD, MS, RPh,
Christine Holzmueller, and
Hoi Lam Chan, MPH, BPharm (Hons)
CHAPTER 6