(NaturalNews) The FDA is considering a new prescription program also referred to as the "New Paradigm" that would enable certain prescription drugs to be available without a prescription if they met certain criteria that ensured "conditions of safe use." The program would involve a variety of medications that treat so-called "common conditions" (i.e. hypertension, diabetes, elevated cholesterol, migraine headaches, asthma, flu, allergies, smoking cessation etc.) The FDA's apparent rationale behind this proposal is based on evidence from the National Journal
that shows that people in the U.S. have poor medication adherence due to a variety of factors (i.e. costs, time, need for multiple physician visits, lack of a prescription drug plan and so on) that ultimately hamper the prescription and medication renewal processes. In addition, the FDA believes that these factors dissuade people from taking potentially lifesaving medications which further contributes to the under-treatment of common medical conditions.
Suggested Methods to Implement the New Prescription Paradigm
Although the FDA has not yet decided how to expand access of certain prescription medications, one key element of their proposal surrounds a pharmacist-driven patient care program that would likely involve patient counseling, patient monitoring, drug interaction prevention and simple diagnostic testing. Another element of the proposal, suggested by the FDA, may involve having a physician prepare the initial prescription for the medication with subsequent access to the medication without a prescription if "conditions of safe use" are met. Lastly, the FDA
believes various technologies like pharmacy-based kiosks or internet based questionnaires may help support their proposal by helping patients properly self-diagnose and select the appropriate medication(s) for their condition(s).
What Supporters and Opponents of the "New Paradigm" are Saying
Supporters of this initiative (i.e. American Pharmacists Association
) believe the FDA proposal would help improve access to prescription medications for the public (especially the uninsured), reduce healthcare expenditures, increase access to health screenings, reduce unnecessary doctor office visits, reduce the burden on our existing healthcare system, and allow physicians to have more time to focus on more critically ill patients.
On the other hand, opponents of this initiative (i.e. American Academy of Family Physicians
and the American Medical Association
) believe the plan may not reduce the overall costs of healthcare since there are too many unknowns relating to the patient's level of care, possible lack of monitoring and potential health risks that could ensue without physician involvement. Furthermore, opponents of this proposal believe it will merely transfer medication costs from insurance companies and third party payers back to the consumer.
Drug Companies Likely to Benefit the Most From The "New Paradigm"
Based on the FDA's "New Paradigm" proposal, it would seem this initiative would enable more complex therapies that have been rejected in the past (i.e. statin drugs
which no longer have patent exclusivity or are nearing patent expiration) to have a route for OTC (over-the-counter) sales. Thus, if the FDA's proposal is approved, the pipeline of potential drug candidates to enter the very profitable OTC market may expand greatly regardless of the consequences this proposal may have on our integrated healthcare system.
Sources for this article include:http://www.ncbi.nlm.nih.gov/pubmed/15519288?dopt=Abstracthttp://www.ncbi.nlm.nih.gov/pubmed/18471457http://www.ncbi.nlm.nih.gov/pubmed/16516588http://www.ncbi.nlm.nih.gov/pubmed/17696570http://drugstorenews.comhttp://www.pharmacistactivist.com/2012/March_2012.shtmlhttp://abcnews.go.comhttp://www.ibtimes.com/articles/193730/20110806/otc-statins.htmhttp://online.wsj.comhttp://www.drugstorenews.comhttp://www.usatoday.comhttp://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm297128.htmhttp://www.ozpharmagroup.comhttp://www.pharmacytimes.comhttp://www.amcp.org/data/jmcp/Review-499-508.pdfhttp://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0171-0001http://www.advisory.com/Daily-Briefing/2012/03/02/New-Rx-paradigmhttp://www.eyeonfda.comAbout the author:
Daniel C. Mizzi, R.Ph., Pharm.D.
Registered clinical pharmacist/staff writer with a sincere interest in natural/integrative medicine and author of the blog-site "The OTC Guide to Common Medical Conditions" http://otcguide.blogspot.com/