The American Pharmacists Association (APhA), the nation's first-established and largest professional society of pharmacists, applauds recent progress by the pharmaceutical industry and the federal government to make medications and pharmacist services more accessible to the Americans who need them.
Basic affordability of medications is a stumbling block for many--particularly America's seniors, people with low incomes, and the uninsured. Today's armamentarium of sophisticated and highly targeted medications is a boon to health. However, the boon is only as real as the access. Too many Americans feel they have no choice but to illegally cross borders (either physically or via the Internet) or to frequent "storefront pharmacies" in the U.S., from which consumers access the illegally imported drugs. In doing so, they risk unwittingly obtaining inferior or counterfeit products, and rely on "patient-care relationships" with Internet pharmacists and physicians who exist virtually in name only.
The U.S. has the safest medication regulation and distribution system in a world where experts estimate eight percent of medications are counterfeit (according to the World Health Organization.) The American system prevents the movement of most counterfeit medications into the country and greatly facilitates their identification and recall in the rare event that one slips through the net. But consumers who rely on illegally imported drugs have no such protection. Nor are they protected from medications with poor packaging and labeling or from drugs that have been contaminated or degraded due to unsafe shipping and storage practices.
Prescription Medications Move to Over-the-Counter StatusThe move of certain prescription medications over-the-counter (OTC) is one avenue toward appropriate access and affordability. In fall 2002, Claritin(r) (an allergy medication) went OTC. This week, the move of Prilosec OTC(r) was approved by the U.S. Food and Drug Administration (FDA), for consumers with frequent heartburn. These are two examples of high-profile "Rx-to-OTC" transitions. We expect this trend to continue, because it is good news for Americans. No longer will consumers need to complete an appointment with a physician or other prescriber to obtain medications of proven value for certain conditions. When a medication moves OTC, the safety and efficacy of the proposed OTC version of the entire medication "package" (the medication itself, along with its labeling and packaging) is extensively tested by the manufacturer. These tests are followed by rigorous FDA review. APhA supports the movement of appropriate products to non-prescription status, when determined appropriate by the FDA.
Speed the Move of Generic Medications to Market A second avenue is to speed the move of generic medications to market. Earlier this month, the FDA announced new regulations and review procedures to streamline the process for making safe, effective generic drugs available to patients. The new rule will limit a drug company to only one 30-month "stay" of a generic drug's entry into the market for resolution of a patent challenge. The FDA is also implementing changes in its review procedures intended to help improve the speed and reduce the cost of determining that a new generic drug is safe and effective, and therefore can be made available to patients. The improvements in the efficiency of review procedures are expected to save consumers billions more by generally reducing the time for approving new generic drugs.
APhA applauds the Bush administration's focus on this avenue to lower prescription drug costs and to strengthen the FDA Office of Generic Drugs. We also are closely monitoring actions by the Senate, which recently adopted an amendment to the Medicare Pharmacy Benefit legislation. The amendment, based upon S 1225, the Greater Access to Affordable Pharmaceuticals Act, prospectively applies a limit of one 30 month stay on FDA approval of generic medications. APhA supports this effort by the Senate to facilitate the ability of generic manufacturers to make available biologically equivalent versions of medications that have been proven safe and effective.
Medicare Prescription Drug Benefit A third avenue to make medications more accessible is to increase access by the nation's seniors to prescription medication, and to the pharmacist services to help ensure that seniors use their medications safely and effectively. APhA applauds Congress for taking what appears to be real action to address the national shame of seniors who can afford neither the medications nor the pharmacist services they need.
"I want to underscore APhA's support for these recent initiatives," said APhA Executive Vice President John A. Gans, PharmD. "We badly need approaches like these that will ensure that more Americans can get the medications they need. The most expensive medication is the one that doesn't work; therefore, we also need to ensure that Americans get access to the pharmacist services that will enable them to make the best use of their medications.
Note to Media: APhA has a new resource for media--our APhA OTC Media Advisors. These are pharmacists who are experts on over-the-counter (OTC) medications and who are prepared to speak with the media on OTC-related topics. To learn more, read our news release on this new resource -- http://www.aphanet.org/news/03otc_media.htm. Also visit our APhA OTC Media Advisors Web area -- http://www.aphanet.org/OTC_Advisors/main.htm This area offers access to the APhA OTC Media Advisors, via APhA's Public Relations Department, as well as to several tipsheets on OTC-related topics.
The American Pharmacists Association is dedicated to improving medication use and advancing patient care. Founded in 1852 as the American Pharmaceutical Association, APhA is the first-established and largest professional association of pharmacists in the United States. Our more than 50,000 members include pharmacists, scientists, student pharmacists, pharmacy technicians and others interested in advancing the profession.
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