Oral contraceptives are unusual in that Congress mandates that each patient
receive a package insert with the pills to supplement the information provided
by medical care practitioners when obtaining informed consent to the use of
these pills. Medical care practitioners cannot rely on the patient’s reading this
package insert. Effective informed consent requires that the patient receive the
information—not merely that the information be available. Since the patient
will not receive the package insert until after the decision to take the pills has
occurred, it is arguable that even a patient who reads the insert has already
committed to the treatment.
Congress established a warning requirement for these pills because it believed
that “the safe and effective use of oral contraceptive drug products requires
that patients be fully informed of the benefits and the risks involved in their
use.” Although this law is aimed at persons dispensing and manufacturing oral
contraceptives, it provides a useful benchmark for medical care practitioners
counseling patients. The federal law requires patients to be given the following
information with a prescription for oral contraceptives:
Package Insert for Oral Contraceptives
The name of the drug.
A summary including a statement concerning the effectiveness of oral
contraceptives in preventing pregnancy, the contraindications to the
drug’s use, and a statement of the risks and benefits associated with
the drug’s use.
A statement comparing the effectiveness of oral contraceptives to other
methods of contraception.
A boxed warning concerning the increased risks associated with cigarette
smoking and oral contraceptive use.
A discussion of the contraindications to use, including information that
the patient should provide to the prescriber before taking the drug.
A statement of medical conditions that are not contraindications to use
but deserve special consideration in connection with oral contraceptive
use and about which the patient should inform the prescriber.
A warning regarding the most serious side effects of oral contraceptives.
A statement of other serious adverse reactions and potential safety
hazards that may result from the use of oral contraceptives.
A statement concerning common but less serious side effects which may
help the patient evaluate the benefits and risks from the use of oral
contraceptives.
Information on precautions the patients should observe while taking oral
contraceptives, including the following:
– A statement of risks to the mother and unborn child from the use of
oral contraceptives before or during early pregnancy;
– A statement concerning excretion of the drug in human milk and
associated risks to the nursing infant;
– A statement about laboratory tests that may be affected by oral
contraceptives; and
– A statement that identifies activities and drugs, foods, or other
substances the patient should avoid because of their interactions with
oral contraceptives.
Information about how to take oral contraceptives properly, including
information about what to do if the patient forgets to take the product,
information about becoming pregnant after discontinuing use of the
drug, a statement that the drug product has been prescribed for the use
of the patient and should not be used for other conditions or given to
others, and a statement that the patient’s pharmacist or practitioner
has a more technical leaflet about the drug product that the patient
may ask to review.
A statement of the possible benefits associated with oral contraceptive
use. (21 CFR, sec. 310.501)
Medical care practitioners should obtain the mandated package insert for each
oral contraceptive that they prescribe and discuss the relevant insert with the
patient as part of the informed consent for taking oral contraceptives. This is
best done with a detailed consent form that follows the package insert for the
oral contraceptives being prescribed. The medical care practitioner should give
the patient a copy of the insert irrespective of where she will obtain the pills. If
the medical care practitioner also gives the patient a starter pack or otherwise
dispenses oral contraceptives, the law requires that the patient be given a
package insert with the pills: “Each dispenser of an oral contraceptive drug
product shall provide a patient package insert to each patient (or to an agent of
the patient) to whom the product is dispensed, except that the dispenser may
provide the insert to the parent or legal guardian of a legally incompetent
patient (or to the agent of either).”
