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*Last Updated May 1, 1999*
BACKGROUND
Elderly individuals consume large
quantities of over-the-counter drugs, especially pain relievers,
sedatives, and laxatives. Conversion of additional drugs to over-the-counter
status carries with it a number of potential risks of particular
importance to the elderly, including:
1. Overdosage due to self-prescription of doses
and frequency of administration;
2. Adverse reactions due to pharmacologic
actions, drug hypersensitivity, or inappropriate drug combinations,
or inadvertant "double-dosing" of drugs due to lack of
understanding of generic names or generic equivalents;
3. Inadvertent polypharmacy due to
self-prescription or the presence of multiple drugs within over-the-counter
preparations;
4. Increased costs due to self-prescription;
5. Inadequate drug information and
warnings concerning side effects, contraindications, and drug interactions;
and/or
6. Package inserts that are difficult
to read because of small type size or, because of technical language
used, difficult to understand.
POSITIONS
1. The Food and Drug Administration
(FDA) should require understandable and readable (large print) labels
on all over-the-counter drugs.
2. Before a drug is released as an
over-the-counter drug, age-specific complications should be carefully
reviewed and considered, together with projections of possible effects
of increased drug use after conversion, based on data obtained from
previous conversions of similar drugs to over-the-counter status.
3. Follow-up studies on altered patterns
of drug use by age category (including noted rates of drug side
effects) as a result of conversion from a prescription to an over-the-counter
drug should be mandated. These studies should be financed by over-the-counter
drug manufacturers but evaluated by the FDA.
4. The conversion of prescription
to over-the-counter drugs should occur only when there is a significant
net cost savings to the consumer and appropriate studies on the
safety and efficacy of the conversion (outlined above) have been
completed.
5. Specific warnings covering adverse
effects the drug may have on diseases most commonly seen in the
elderly (e.g., NSAIDS in patients with congestive heart failure).
6. There should be clear labeling
as to the generic names and class of the drug. Also included should
be names of drugs which may be similar in pharmacologic effects.
7. Specific contraindications to
use of the drug should be listed, including commonly used prescription
drug classes to be avoided.
Developed by the AGS Public
Policy Committee and approved March 1986 by the AGS Board of Directors.
Reviewed November 1990. Reviewed April 1993. Reviewed May 1999.
The American Geriatrics Society, The Empire State Building,
350 Fifth Avenue, Suite 801, New York, NY 10118, 212-308-1414, Fax:
212-832-8646, info.amger@americangeriatrics.org.
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