The Pharmacist’s Role in Informed Consent
Informed consent occurs when a patient is given sufficient information to understand the
need, reason, use, side effects and adverse reactions of a medication and decide whether
or not to use a prescribed medication. Pharmacists have the duty to educate and ensure
patients are well informed partners in their own medical care (IC what every rph should
know).
An uneducated patient can not fully understand the complete implications of medication
usage. In this instance the health care team has not fulfilled its duty to the patient.
Patients no longer follow the advice of their physicians without question. Thirty to fifty
percent of patients do not use their medication as prescribed due to lack of information
(IC).
The 1947 Nuremberg trials revealed the Nazi’s unethical use of prisoners in cruel,
tortuous and life-threatening experiments. This lead to the development of the
Nuremberg Code of Ethics and informed consent (IC). Ten principles ensured subject
safety during research, including voluntary consent and disclosure of the risks and
benefits of participation.
The birth defects associated with Thalidomide use prompted informed consent in the
everyday medical practice. In a 1962, President John F. Kennedy endorsed a consumer
bill of rights detailing the right of the consumer to be informed when choosing treatment.
The World Medical Association emphasized human rights protection in medical research
by adopting the Declaration of Helsinki in 1964 as its official set of guidelines for
research involving human subjects. All subjects are to be informed of the risks and
benefits of participation in the research and participation must be voluntary and free from
coercion (IC).
The 1966 Fair Packaging and Labeling Act required all consumer products in
interstate commerce, including medications and medical devices, to include consumer
information on the product label.
In 1970 the FDA (Food and Drug Administration) directed manufacturers to include
package inserts for patients describing risks and benefits of oral contraceptives. Written
information sheets soon accompanied both prescription and nonprescription medications
(IC).
Most states soon adopted health and safety codes requiring the patient's informed consent
for treatment. Professional organizations also formulated ethical guidelines. The APhA
(American Pharmaceutical Association) Code of Ethics for Pharmacists promotes respect
for patient autonomy, understandable communication, and confidentiality.
Litigation in federal and state courts alleged negligence on the part of providers who
failed to inform patients of treatment risks. Overall, courts have supported patients if the
evidence revealed that the provider knew, but failed to disclose, important information.
The U.S. Supreme Court ruled in the case of Cruzan v Director, Missouri Department of
Health in 1990, the doctrine of informed consent includes the constitutionally protected
right of a competent person to refuse treatment. Such court decisions have broadened the
concept of informed consent to extend to all clinicians involved in direct patient care. No
longer a guiding ethical standard, informed consent is a fundamental patient right
protected by law.
The patient has a fundamental right to autonomy, choosing the best treatment for them
considering the information they have received. If patient is unable to provide informed
consent, practitioners are required by law to provide treatment consistent with established
best care practices for the patient's condition (IC).
Factors preventing informed consent include embarrassment of a particular medical
condition. Patients may withhold important information. Without full knowledge of
medical history the pharmacist cannot provide complete information necessary for
informed consent to the patient.
Consent may be verbal or written and must be an interactive process. If a patient agrees
to take the medication but cannot repeat back the intended use and possible side effects,
informed consent has not obtained. Even with repeated instruction, important medical
information may not be understood or retained by the patient. Simplify the message and
provide the most critical information first.
Illiterate patients can not read medication labels, handouts or information sheets.
Informational handouts with pictures may be useful.
Benefits and attendant risks may not be known for off-label use of medication. Patients
should be informed of the off-label use and generalized medication information should be
provided.
Language barriers are increasingly common. Printed information in the patient’s
language often contains minimal information.
For maximal instruction and
understanding a professional interpreter (not than a friend or family member) should be
obtained.
The pharmacist must equally participate on the healthcare team to fulfill the obligation
for informed consent. The pharmacist must never undermine the patient’s confidence in
the other healthcare team members. Concerns regarding a patient’s healthcare plan
should be discussed with the provider.
Knowledge is the cornerstone of informed consent empowering the patient to be the final
decision maker.