Protect Your Access to Compounded Medications &
Freedom to Prescribe for Health Care Providers

  Compounded medications expand therapeutic options, allowing physicians to solve their patients' medication problems and improve compliance, which can literally make a life-saving difference for thousands of patients. Pharmaceutical manufacturers continually use their extensive resources to lobby influential politicians and the FDA to severely limit or even eliminate the inherent right of pharmacists to compound. While the recent media focus has been on bio-identical hormone replacement therapy, customized medications also significantly improve the quality of life for countless patients with chronic or terminal illness, for example:
1.) Most medications are not commercially available in lower doses, dosage forms, or flavors that are palatable or suitable for children.
2.) Topical gels can be used instead of injections to provide needed drugs for hospice patients who can not have oral intake or can not swallow, or do not want to spend their last days hooked to an IV or receiving multiple injections.
3.) Patients with multiple chemical sensitivities can receive the medications they need because compounding  pharmacists can prepare medications that are free of dyes, preservatives, sugar, lactose, and other unnecessary excipients.

   The ability to provide a necessary medication in palatable or simple-to-administer dosage forms improves compliance and therapeutic outcomes, even saving the lives of patients (especially children) who might otherwise refuse therapy.

   Millions of Americans have critical medical needs that are unmet by one-size-fits-all manufactured pharmaceuticals. For them, compounded medicines -prescribed by licensed medical practitioners and prepared by licensed, specially-trained pharmacists- are often their only treatment option. Federal legislation that restricts compounding will severely restrict patients access  and doctors ability to prescribe these medicines.

   Draft legislation that has been circulated by Senators Edward Kennedy (D-MA), Richard Burr (R-NC) and Pat Roberts (R-KS) would significantly broaden the FDA's authority over pharmacy compounding and significantly deny access to critical compounded medications, while imposing new limits for prescribers. This legislation is expected to be attached to the Prescription Drug User Fee Act (PDUFA) that must be re-authorized by September 2007, and if this legislation is passed with this attachment, federal regulators - not the doctor - will decide what medicines can be prescribed. For example, new legislation could make it illegal to compound medications that are FDA-approved but are commercially available in a different dose or dosage form. Pharmaceutical manufacturers would prefer that patients adjust to using the medicine, versus having a compounding pharmacy customize a medicine for the patient. This is because compounding pharmacies can purchase the drug as a bulk chemical (from the same source as the manufacturer uses) and then the manufacturer is left out of the loop and loses money. The so-called Safe Drug Compounding Act of 2007 would:

1.) Severely restrict which compounded medications can be prescribed and eliminate the availability of many critical, commonly compounded medications including sterile preparations routinely prescribed by physicians in hospitals.
2.) Open the door for outside interests - particularly pharmaceutical manufacturers - to unduly influence the regulation of compounded medicines.
3.) Create onerous regulations that do little to improve patient safety while significantly raising health care costs and impeding the ability of small, community pharmacies to survive.
4.) Allow the federal government to determine when compounded medicines are needed - a decision that has always been and should always be made by a doctor or other licensed prescriber.
5.) Call upon the FDA to write regulations for sterile compounding when stringent USP standards are already in place.
6.) Prohibit some functions of community and hospital pharmacy practices that are explicitly allowed by state laws, as well as override long established laws in most states that allow for office use of compounded preparations by physicians.
7.) Require the prescriber to document patient need beyond the prescription, which is one short step away from requiring doctors to document medical need for prescribing medications for off-label use.

   Compounding pharmacies are currently regulated by their state board of pharmacy. We encourage legislators to continue working with state boards of pharmacy, the U.S. Pharmacopeia (USP), and the recently established Pharmacy Compounding Accreditation Board (PCAB) to improve pharmacy practice. 

   Ultimately, this bill, or any like it, would eliminate important treatment options and be extremely detrimental to the medical community and patient health. We encourage all health care professionals and patients to act now to reject this dangerous legislation in its entirety, and are providing tools you can use to inform your elected representatives about the value of and need for compounded medications. Protect your freedom and your access to compounded medications.

Visit www.iacprx.org/Kennedy to learn more and take action NOW!

Copyright 2007, Storey Marketing - Monthly Website Updates. All rights reserved. Questions regarding this article should be directed to the staff at Pharmacy Innovations.