[Congressional Record Volume 143, Number 82 (Thursday, June 12, 1997)]
[Senate]
[Pages S5626-S5627]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




     SENATE RESOLUTION 99--RELATIVE TO OVER-THE-COUNTER MEDICATIONS

  Mr. DASCHLE submitted the following resolution; which was referred to 
the Committee on Labor and Human Resources:


                               S. Res. 99

       Resolved,

     SECTION 1. FINDINGS.

       The Congress finds the following:
       (1) The Food and Drug Administration has proposed that the 
     content and format of over-the-counter (OTC) drug product 
     labels be made more user-friendly to help consumers better 
     understand how to properly use these medications.
       (2) Almost 60 percent of total OTC drug product sales of 
     $29,000,000,000 are made by community retail pharmacies, 
     where a pharmacist is available for consultation with the 
     consumer about the product.
       (3) A significant number of potent prescription medications 
     have been switched to OTC status over the last few years and 
     others are likely to be switched over in the next few years. 
     Many consumers may be unaware of the potential problems that 
     may occur when OTC and prescription drugs are inappropriately 
     used together, and should be encouraged to consult with their 
     doctor and pharmacist. The pharmacist may have the only 
     complete record of all the medications being taken by the 
     consumer that would help avoid these problems.
       (4) Pharmacists can help the consumer select the most cost-
     effective OTC drug product based on the symptoms presented to 
     the pharmacist.
       (5) Interaction with the pharmacist on using OTC drug 
     products is particularly important for older Americans, who 
     already use one-third of all prescription drug products and 
     one-third of OTC drug products. As the population ages, older 
     Americans are expected to use almost half of all OTC drug 
     products by the year 2000. According to recent studies, the 
     health care system, including the Medicaid and Medicare 
     programs, incur billions of dollars in unnecessary costs each 
     year as a result of medication-related problems.
       (6) The importance of consumer interaction with the 
     pharmacist about OTC drug products was recognized by Congress 
     when it required that Medicaid prospective drug utilization 
     review programs include screening for ``serious interactions 
     with nonprescription or OTC medications''.
       (7) Encouraging pharmacist interaction with consumers on 
     OTC drug products is consistent with recent attempts by 
     consumer groups, the pharmacy community, and the Food and 
     Drug Administration to increase the quality and quantity of 
     written and oral information being provided to consumers with 
     their prescription medications.

     SEC. 2. CONSULTATION.

       It is the sense of the Senate that the Food and Drug 
     Administration should include a provision in the 
     Administration's new final regulation on the content and 
     format of over-the-counter drug labels which requires that 
     such labels include the phrase ``Consult your doctor or 
     pharmacist''.

  Mr. DASCHLE. Mr. President, today I am submitting a resolution that 
recognizes the essential role our Nation's community pharmacists play 
in protecting the public health and educating consumers about over-the-
counter [OTC] medications.
  The Food and Drug Administration has proposed revisions to the 
content and format of OTC product labels to make them more informative 
and consumer-friendly. Among these changes, FDA has proposed adding to 
OTC labels the recommendation: ``Ask your doctor or pharmacist.'' The 
FDA is currently soliciting comments on this proposed change, 
particularly on the benefits and appropriateness of referring consumers 
to pharmacists for guidance on OTC medications. By demonstrating strong 
support for a labeling change that refers consumers to pharmacists as 
well as to doctors, this resolution acknowledges the relevant expertise 
of community pharmacists and the contribution they make in assuring 
proper use of OTC medications.
  Each year, millions of Americans purchase medications such as 
painkillers, allergy medications, cold and flu remedies, and other 
products to treat nonacute medical conditions. Most of these products 
are purchased at pharmacies, where an on-site pharmacist is always 
accessible to help the consumer select the medication that is most 
appropriate and cost effective for them. The labeling change this 
resolution supports acknowledges that consumers face an intimidating 
array of medication options, and it reinforces the fact that 
pharmacists have the experience and expertise to help consumers make 
the right choice about their medications.
  Making this labeling change is also a matter of public health. A 
significant number of potent prescription medications are now available 
on an over-the-counter basis, and many more are likely to be 
introduced. Most consumers are unaware of the potential problems that 
may occur when prescription drugs and OTC products are taken together. 
In some cases, the pharmacist may be the only health professional with 
a complete record of all medications being taken by the consumer. The 
pharmacist's intervention may well prevent tragic consequences.
  Recommending that consumers consult with their pharmacist is 
particularly important for older Americans, who already use one-third 
of all prescription and OTC drug products. With the aging of the 
population, older Americans are expected to use almost half of all OTC 
medications by the year 2000. As OTC products proliferate and more 
potent medications become available, the risks to seniors and other 
consumers compound. It makes sense to foster the pharmacist-consumer 
link to minimize the potential problems that may result from this 
trend.
  Finally, this labeling change can save the health system money. 
According to recent studies, Medicare, Medicaid, and the health care 
system as a whole incur billions of dollars in unnecessary costs each 
year as a result of

[[Page S5627]]

medication-related problems. Input from the pharmacist can help reduce 
this wasted spending, and more importantly, prevent the needless pain 
and suffering this spending reflects.
  For these reasons, I ask my colleagues to join me in urging the FDA 
to turn a good idea into a reality and make this labeling change. It is 
a minor revision that could make a major difference as consumers 
negotiate the increasingly complex array of medications available 
without a prescription.

                          ____________________