NEWS
08/23/1995

<TITLE> FDA ANNOUNCES PATIENT EDUCATION PROGRAM </TITLE>
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P95-6                                Food and Drug Administration
FOR IMMEDIATE RELEASE                Don McLearn (301) 827-6242


             FDA ANNOUNCES PATIENT EDUCATION PROGRAM
     The Food and Drug Administration today proposed a program to
give patients more and better information about the prescription
drugs they use.  The program establishes specific goals and
standards that would significantly increase the distribution and
quality of written information about prescription drugs to be
provided by pharmacists and other health professionals.
     The proposal provides for clearly-presented leaflets that
would give consumers information on proper use of the product and
possible hazards, like drug interactions. 
     "Consumers deserve clear, readable information to help them
use drugs correctly," said HHS Secretary Donna E. Shalala.  "This
effort will give American consumers more control over their own
health care.  It should be especially helpful to older persons who
often need to know the importance of using drugs according to the
prescribed schedule, and who may need to know about drug
interactions as well."
     Assistant Secretary for Health Philip R. Lee, M.D., who heads
the U.S. Public Health Service, said: "The FDA targets for the
dissemination of written drug information match the goals set forth
in the Public Health Service program Healthy People 2000. This 
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program will help educate patients about their medications and
empower them to take a more active role in their own health care."
     FDA Commissioner David A. Kessler, M.D., drew a comparison
between this program and the food label education program. 
"Consumers and patients want to know more about the foods they eat
and the drugs they take.  This program will increase patient
participation in decisions about their health, and encourage
adherance to medical regimens, resulting in savings of health care
dollars."
     The first goal of the proposal is that by the year 2000 at
least 75 percent of consumers who have new prescriptions filled 
will receive written, adequate and useful information about their 
medication. Under the proposal, the information would have to meet
quality standards for both content and format, which are to be 
established by the agency in close cooperation with health care
professionals and consumer organizations.
     After reaching this goal, FDA's program would seek to make
sure that by the year 2006, such written information is given to at
least 95 percent of recipients of new prescriptions. 
     The proposed rule describes seven characteristics of useful
written medication information for patients:  scientific accuracy,
consistency with a standard format, nonpromotional tone and
content, specificity, comprehensiveness, understandable language
and legibility.  FDA intends to hold public meetings to further
define these characteristics.
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     To meet the proposed standards, the written leaflet would have
to include such information as the product's approved uses,
circumstances under which it should not be used, serious adverse
reactions, proper use of the medication and cautions related to
proper use. 
     The proposal provides incentives for the private sector to
reach the program's goals by setting criteria and letting health
professionals select and distribute the necessary information. 
     The agency is proposing to work with private organizations on
how pharmacists can meet specific goals by the year 2000 and 2006. 
It offers two alternatives if the program does not succeed in
achieving the goals.
     After the public comment process, the agency will decide how
to proceed if the goals are not met.  Under one option, FDA would
require that FDA-approved written information be distributed with
all prescription drugs.  Under the other option, the FDA would seek
public comment in the year 2000 or 2006 on how a mandatory patient
leaflet program should be established or whether other steps could
be taken to meet the patient information goal.  As it has in the
past, the FDA will continue to require patient information leaflets
for drugs that pose a serious and significant public health       
concern.     
     In recent years, the widespread use of computers by 
pharmacists and a law requiring oral counseling for Medicaid      
patients have increased the amount of drug information provided to 
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consumers.                           
     According to a new FDA survey, the proportion of patients who
received substantial written information about their prescription
drugs rose from 23 percent in 1992 to 55 percent at the end of last
year although the quality of that information appears to vary
greatly.  The aim of the patient education program is to bring
helpful medication facts to all those who need them, and to make
sure that the information is useful, reliable and adequate.
     FDA is a PHS agency within HHS.
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