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Compounding Pharmacists Call on American Association of Equine Practitioners to Amend Policies that Restrict Treatment Options, Endanger Horses
FOR IMMEDIATE RELEASE
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
Compounding Pharmacists Call on American Association of Equine Practitioners to Amend Policies that Restrict Treatment Options, Endanger Horses
MISSOURI CITY, Texas The International Academy of Compounding Pharmacists today called on the American Association of Equine Practitioners (AAEP) to amend its policies that assert compounding from bulk pharmaceutical ingredients is illegal and that require compounding pharmacies exhibiting at AAEP’s upcoming Annual Convention to agree not to compound from bulk ingredients.
“These policies do not serve the interests of veterinarians or their patients,” said L.D. King, executive director of IACP. “Compounding from bulk, also known as active or pure ingredients, is a vital, common and legal practice on which many patients rely. Virtually no compounding pharmacy can comply with AAEP’s compounding policy. Rather, such policies benefit primarily drug makers whose products veterinarians will be forced to prescribe absent any other options.”
For the third straight year, AAEP is requiring all compounding pharmacies exhibiting at its annual convention to sign a so-called Compounding Compliance Form stating they agree to abide by FDA policy regarding veterinary compounding. Such policy says that compounding from bulk ingredients is illegal. A federal district court, however, ruled that this is not the case; “pharmacies may compound drugs for non-food animals from bulk ingredients,” Judge Robert Junell said in the case, Medical Center Pharmacy et al. v. Gonzalez et al.
Many veterinarians prescribe medications that are compounded from bulk ingredients. For example, some medications are compounded from bulk ingredients so that flavoring agents can be added or so that delivery forms (e.g., injections) can be modified to facilitate patient compliance. In addition, some medications are compounded from bulk ingredients because the finished drug product contains an excipient to which the equine patient is allergic. Some finished drug products are simply unavailable due to shortage or because they are discontinued for non-safety reasons. When veterinarians determine patients need those drugs, compounding from bulk ingredients is their only option.
In a November 29 letter to AAEP, Mr. King asked AAEP to amend its policies for the sake of practitioners and patients. Additionally, IACP offered to work with AAEP to identify a practicing pharmacist to serve on AAEP’s Drug Compounding Task Force, which currently has no pharmacists. IACP also called on AAEP to fully disclose its financial ties to veterinary pharmaceutical manufacturers that have a financial interest in restricting and eliminating compounded medications as well as a long history of attempting to do so.
For more information regarding AAEP’s financial ties to drug makers, please visit http://www.compoundingfacts.org/ and click on “Setting the Record Straight.”
Resources:
About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect and promote the art and skill of the compounding pharmacy profession. We represent more than 2,000 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.
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Pharmacy Profession Gravely Concerned by Anti-Patient Compounding Bill
FOR IMMEDIATE RELEASE
March 7, 2007
Media contact
See below
Pharmacy Profession Gravely Concerned by Anti-Patient Compounding Bill
WASHINGTON A coalition of nine pharmacy organizations representing more than 60,000 pharmacists today expressed grave concerns over proposed legislation that would restrict patients’ access to vital compounded prescription medications and create onerous, new requirements for both prescribers and pharmacists. The American Pharmacists Association, the National Community Pharmacists Association, the International Academy of Compounding Pharmacists, the American College of Apothecaries, the American Society of Consultant Pharmacists, the National Alliance of State Pharmacy Associations, the Massachusetts Pharmacists Association, the North Carolina Association of Pharmacists, and the Kansas Pharmacists Association expressed their concerns in a joint letter to expected sponsors of the Safe Drug Compounding Act of 2007, Senators Edward Kennedy (D-Mass.), Pat Roberts (R-Kan.) and Richard Burr (R-N.C.).
The draft legislation “would not have the intended effect on patient health you desire,” the organizations noted in the letter. “Instead, the proposal would negatively impact patient access to necessary compounded prescription medications and create onerous, new requirements for prescribers and pharmacists. We strongly urge you to reconsider introducing this draft legislation.”
“This proposed legislation would disrupt long-standing and well accepted medical and pharmacy practices,” the organizations continued, “and it would set precedents for the disruption of non-compounding practices, such as the prescription of medications for off-label use. Most importantly, it would negatively impact patient care by placing undue and counter-productive restrictions on licensed prescribers and pharmacists, while doing nothing to stop the rogue compounding practices that exist.”
The organizations also noted in the letter: “The profession has taken great strides over the last decade to improve pharmacy compounding practice. U.S. Pharmacopeia standards and State Board of Pharmacy regulations are increasingly rigorous. Furthermore, the establishment of the Pharmacy Compounding Accreditation Board which is co-managed by the undersigned as well as the U.S. Pharmacopeia has started accrediting compounding pharmacies that meet high standards of practice. We would encourage Congress to work with these institutions to address any concerns with pharmacy compounding.”
The organizations outlined several concerns in the letter, noting that the proposed legislation would:
- Insert the FDA into the physician-patient relationship by giving the Agency the authority to determine broadly when compounded medications are needed;
- Create new requirements for physicians to document when compounded medications are needed, duplicating the underlying purpose of a prescription, pursuant to which a product is compounded. Allowing FDA to regulate compounded medications in this way is one short step away from requiring doctors to document medical need for prescribing medications for off-label use and restricting the practice altogether;
- Prohibit well-established compounding practices authorized by stringent state pharmacy laws and regulations. For example, this bill would restrict the ability of prescribers to prescribe and administer compounded medications for office use, a critical function explicitly allowed by many State Boards of Pharmacy that enables prescribers to prescribe and administer certain compounded medicines that patients cannot administer themselves, such as injectables;
- Broadly eliminate the availability of many critical, commonly compounded sterile preparations, particularly those commonly prescribed by physicians in hospitals;
- Call for FDA to establish federal requirements for sterile compounding that duplicate and supersede those already established by the U.S. Pharmacopeia while also requiring these medications to carry a label reading: “This drug was not prepared using FDA’s manufacturing standards for sterile drugs;”
- Severely restrict interstate distribution of compounded medications, a move that will endanger many patients served by pharmacies practicing near state borders, “snowbird” patients whose hometown pharmacies continue to serve them during winter months, and patients living in rural communities who may be hundreds of miles away from the nearest compounding pharmacy;
- Dilute the FDA’s already strained resources. Compounding pharmacies are already regulated by their State Board of Pharmacy. FDA’s resources should remain focused on addressing the overwhelming backlog of manufactured drugs pending approval and strict oversight of the source ingredients that both pharmacies and manufacturers use;
- Give wider authority over compounded medications to a federal agency, the FDA, thereby removing the current authority of State Boards of Pharmacy. Just as State Boards of Medicine regulate medical practice, State Boards of Pharmacy regulate pharmacy and their regulatory authority should be preserved. The FDA, while acknowledging the need for legitimate pharmacy compounding and expressing strong interest in taking over the regulation of this aspect of pharmacy practice, is not the appropriate regulatory agency to oversee this practice. FDA’s recent record on this front is not strong, as evidenced by the fact that FDA has yet to revise poorly written compliance policy guides despite three and four year-old requests of more than one hundred Members of Congress to do so;
- Prematurely establish a new regulatory structure before these issues are resolved in an ongoing federal case, Medical Center Pharmacy v. Gonzalez. In August 2006, a Federal District judge ruled in this case that compounded drugs for humans are not new, unapproved drugs subject to the Federal Food, Drug and Cosmetic Act and that pharmacies in compliance with all state regulations are exempt from FDA inspections. This decision is currently under appeal; and
- Create onerous regulations that do little to improve patient safety while significantly impeding the ability of community pharmacies to continue to provide these services for their patients and prescriber community.
For more information, please contact:
American Pharmacists Association
Gail Street
202-628-4410
gstreet@aphanet.org
National Community Pharmacists Association
Robert Appel
703-682-8200
robert.appel@ncpanet.org
International Academy of Compounding Pharmacists
Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
Resources
Joint Pharmacy Letter Outlining Concerns with the Safe Drug Compounding Act (.pdf)
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IACP Calls on NAMS to Disclose Financial Ties to Wyeth
FOR IMMEDIATE RELEASE
February 7, 2007
Contact: Joshua Wenderoff
202-777-3502
jwenderoff@clsdc.com
IACP Calls on NAMS to Disclose Financial Ties to Wyeth
MISSOURI CITY, Texas The International Academy of Compounding Pharmacists (IACP) today called on the North American Menopause Society (NAMS) to fully disclose its financial ties to Wyeth when dispensing advice to patients and practitioners that directly benefits the pharmaceutical giant.
Within the last few weeks, NAMS has simultaneously promoted the benefits of Wyeth’s products and denigrated alternatives to those products. Yet in its press releases and editorials and in interviews with the media, NAMS and its leaders consistently fail to disclose that they receive funding from Wyeth. On CNN’s Larry King Live late last year, NAMS’s executive director, Dr. Wulf Utian, explicitly denied financial ties to Wyeth, despite clear evidence to the contrary on NAMS’s own website.
“NAMS has the right to dispense medical advice to practitioners and patients, but practitioners and patients also have a right to know if NAMS has a conflict of interests,” said L.D. King, executive director of IACP. “When NAMS suggests, as it did late last month, that Wyeth’s products may benefit younger women, it should disclose that it receives funding from Wyeth. Similarly, when NAMS advises patients against taking alternatives to Wyeth’s products, as it has on Larry King Live and elsewhere, it should disclose its ties to Wyeth. When dealing with NAMS, IACP or any other healthcare organization, the media has a responsibility to ask: ‘Do you receive funding from corporate interests that might benefit financially from your actions?’”
Wyeth funds research, awards, annual meetings, lectureship funds, educational programs and other activities of NAMS. This includes:
- Endowing a $200,000 fund for the NAMS/Wyeth Wulf H. Utian Endowed Lectureship;
- Providing “generous grants to help support not only the Society’s Mission, but also the special activities of the 17th Annual Meeting;” and
- Contributing at least $8,000 a year in partnership fees for NAMS’s “2006 Partner in Menopause Education.”
Citations for these and other examples of NAMS’s financial ties to Wyeth can be found online at www.compoundingfacts.org/info.cfm.
About IACP
The International Academy of Compounding Pharmacists is a non-profit association founded in 1991 to protect, promote and advance the compounding pharmacy profession. We represent more than 1,800 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs. Visit http://www.iacprx.org/ to learn more about pharmacy compounding.
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