A Simple and Cost Effective Solution to Assure the Safety of the U.S. Drug Supply
The American consumer remains concerned about the safety and quality of U.S. drug supply and of the importation of prescription drugs. The state's process for oversight is not consistent nationally and minimal for pharmaceutical wholesalers. A simple solution is a single set of international standards and accreditation process such as IMPAC. This accreditation would be at no cost to the states, taxpayer or the consumer and would go a long way to assure quality and safety of prescription drugs.
(PRWEB) October 25, 2005 -- The American consumer remains concerned about the safety and quality of the drug supply in the United States. They are concerned because of the recent recalls, the lack of fully disclosed side-effects for some drugs, and counterfeit drugs. The United States’ own government report, HHS Task Force on Drug Importation, notes that there are vulnerabilities in the U.S. drug supply that may result in various abuses.
There is talk about safety and quality of prescription drugs. But what does that mean? How do you define safety and quality?
“One way is to define safe and high quality practices through written standards that the pharmaceutical industry needs to follow and have a methodology to assure that this industry is complying with these standards,” states Jennifer Fels, Executive Officer for Standards and Surveys at IMPAC. She further notes these standards must be broad in scope. They can not be limited to the dispensing of drugs, but must also include new technologies, consumer safety, drug integrity, chain of custody or pedigree, privacy of information, customer service and education, security, and quality and performance improvement.
Currently, states oversee pharmacy and drug wholesaler practices. The state pharmacy inspectors inspect local pharmacies. Their expertise is in retail pharmacy. If a mailorder pharmacy is located in their state, they inspect it. If the mailorder pharmacy is located in another state, they accept the inspection of the other state. There is no national standard for these inspections. For drug wholesalers or drug distributors, the regulations are minimal. As Giuliani Partners’ Report, Examination and Assessment of Prescription Drugs Importation from Foreign Sources to the United States, notes, “States have a comparatively small number of investigators to monitor licensed wholesalers, given the sheer number of wholesalers, oversight is minimal.”
The prescription drug market is global. It will be global with or without the passage of the federal legislation on importation of prescription drugs. There are over one million U.S. consumers that personally import drugs from around the world. It is often said that ‘the genie is out of the bottle and it will not go back in’. The global drug market is here to stay.
The globalization of the drug market is occurring at a time when the domestic U.S. wholesale distribution system is already under scrutiny and when the states are often understaffed and under funded for pharmaceutical distribution and dispensing oversight. Dana Noble, Executive Officer for Operations for IMPAC, notes, “There is a need for a single set of international quality standards for pharmaceutical distribution and dispensing similar to those we currently utilize for hospital oversight in the United States. It needs to be a gold standard with the bar set high.” IMPAC has developed quality standards for mailorder pharmacies and pharmaceutical wholesale industry. These standards and the accreditation process will address the safety of prescription drugs from the drug manufacturer through the delivery to the consumer.
Accreditation standards and process such as IMPAC can ease the duties and costs for states and potentially the federal government, particularly agencies such as F.D.A (Food and Drug Administration) and CMS (Center for Medicare and Medicaid Services), to provide oversight for pharmaceutical distribution and dispensing. This growing and global market is occurring at a time when states can least afford to hire more inspectors, train them beyond retail pharmacy inspection, and broaden their scope nationally and internationally. IMPAC, like most healthcare accreditation firms such as JCAHO which accredits hospitals, charges the client (pharmacy or wholesaler) for the accreditation survey. Compliance with high quality standards is the responsibility of the pharmacy or wholesaler. It is a cost of doing business. With an international commission such as IMPAC, once the pharmacy or wholesaler is accredited, that accreditation is available to each state. So a national accreditation is not only cost effective for the states and federal government, but also for the industry. IMPAC accreditation would be no cost to the states and federal governments, which means no cost to the taxpayer.
Federal and state governments and agencies need to be assured that the distribution and dispensing of drugs, domestically and internationally, is safe and of high quality. It would be very costly for the states and federal agencies to do it themselves. They should require accreditation for this component of healthcare just as they do for other areas of healthcare such as hospitals and home health. All payers, whether a private commercial carrier or a state or the federal government, should require the pharmacy benefits management programs (PBMs) that they contract with to use only IMPAC accredited mailorder pharmacies and IMPAC accredited drug wholesalers. IMPAC is the most comprehensive method to assure the quality and safety of prescription drugs.
IMPAC is a U.S. based accreditation commission incorporated in Vermont.
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