USP-Part 4: Resolutions of the 2005 USP Convention, Continued

RESOLUTION: STANDARDS FOR NOMENCLATURE AND LABELING
USP resolves to collaborate with appropriate partners to continue to establish standards for labeling and nomenclature that support the safe and proper use of therapeutic products, including but not limited to initiatives that:
   *Provide references for the identification of multi-ingredient products;
   *Address recurring medication errors, particularly in the area of look-alike/sound-alike names, labeling, and packaging;
   *Reduce medication errors, particularly in the area of look-alike/sound-alike names, by encouraging the use, in the practice setting, of only the generic names for new single-active-ingredient products marketed after January 1, 2006; and,
   *Encourage the uniform use of USP-NF dosage form nomenclature.
Due to the vast array of drug names and related terminology and their use and application by different groups, it is deemed desirable to continue efforts in making the use of nomenclature and labeling standardized to minimize medication errors. The use of generic names for single-entity products will be one step towards that goal.

RESOLUTION: USP INTERNATIONAL PRESENCE
USP resolves to continue to work with international governmental and nongovernmental bodies to increase the impact of its public health programs internationally. Furthermore, USP resolves to provide assistance to improve regulatory mechanisms and to build capacity to monitor drug quality for countries that lack appropriate resources.
The USP-NF is used in many countries throughout the world and has many great opportunities of impacting public health programs. This resolution recognizes that potential and encourages USP to assist other countries to enhance drug quality where resources are lacking.

RESOLUTION: INTERNATIONAL HARMONIZATION
USP resolves to continue its efforts to harmonize compendial standards with the Pharmacopeial Discussion Group (PDG) and other pharmacopeias.
This is a continuing effort to establish uniform standards for drug products in many countries of the world.

RESOLUTION: DRUG INFORMATION PROGRAMS
USP resolves to work with interested parties to develop information programs concerning therapeutic products for special patient populations in need of targeted information.
Under the Medicare Modernization Act, USP was given the responsibility to develop and revise the Model Guidelines. These Model Guidelines are a list of drug categories and classes that drug plans may use to design the structure of their formularies for the Medicare prescription drug benefit. USP also may create information programs for Medicare beneficiaries and other special patient populations including but not limited to the elderly, children, pregnant women, ethnic groups, and mentally retarded and developmentally disabled patients, and for veterinary products for animal use.

Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

There were 41 citations added to CompoundingToday.com's literature search this week related to pain management specifically treatments involving compounding. Here are a sampling of those citations:

• Argoff CE, Katz N, Backonja M. Treatment of postherpetic neuralgia: A review of therapeutic options. J Pain Symptom Manage 204; 28(4): 396-411.
• Breivik H. Opioids in chronic non-cancer pain, indications and controversies. Eur J Pain 2005; 9(2): 127-130.
• Collins SD, Chessell IP. Emerging therapies for neuropathic pain. Expert Opin Emerg Drugs 2005; 10(1): 95-108.
• Harden RN. Chronic neuropathic pain. Mechanisms, diagnosis, and treatment. Neurologist 2005; 11(2): 111-122.
• Stacey BR. Management of peripheral neuropathic pain. Am J Phys Med Rehabil 2005; 84(3): S4-S16.

There are several places you can obtain drug shortage information on the Internet but here is a quick and easy reference of the most recent drugs posted in the short supply category.

For more information and an extensive list of every drug in short supply, see:
http://www.fda.gov/cder/drug/shortages/default.htm#Current
http://www.ashp.org/shortage/index.cfm

Whether you're looking for a 16-hour CE course somewhere tropical or planning to travel to Cairo and want to hit a pharmacy meeting, www.compoundingtoday.com has a listing of compounding pharmacy conferences, CE and events from around the world. Check it out from www.compoundingtoday.com under the navigation bar on the left, "Education".

The International Academy of Compounding Pharmacists provided this regulatory update

NAPRA Extends Deadline for Comments on Compounding Guidelines
On May 1, the Board of Canada's National Association of Pharmacy Regulatory Authorities (NAPRA) announced that it would extend the deadline for receiving comments on the "Guidelines for Pharmacy Compounding" to allow for increased input from external stakeholders. All comments should be filed with NAPRA by 5:00 p.m. EST, Thursday, June 30th , 2005. Contact Jennifer at IACP for more information.

Midland Compounding Lawsuit Update
On April 28, plaintiffs in the Midland, TX compounding lawsuit filed a response to the Asthma groups' amicus brief in support of the government's motion to dismiss. On May 6, IACP filed a reply to the government's collective response to amicus briefs opposing their motion to dismiss. IACP provides additional evidence supporting the argument that the FDCA does not give FDA authority to regulate compounding. Both filings are available on IACP's website.

Bill Requiring Coverage of HRT Introduced in U.S. Congress
On March 17, Representative Barbara Lee (D-CA) introduced the Menopausal Hormone Replacement Therapies and Alternative Treatments and Fairness Act (HR 1410). HR 1410 would require group health plans, individual insurance policies, and the Medicare and Medicaid programs to provide coverage for hormone replacement therapy (HRT) and alternative therapies for the treatment of menopausal symptoms if the therapy is recommended by a licensed health care provider. Under the bill, a group health plan or a health insurance issuer that provides benefits for outpatient prescription drugs could not exclude or restrict benefits for HRT or alternative therapies.

Compounding Bill Introduced in North Carolina Legislature
On April 20, HB 1481, a bill clarifying the NC Board of Pharmacy's jurisdiction over pharmacy compounding practice, was introduced in the North Carolina House. The bill requires compounding pharmacies to obtain a permit from the Board and permits the Board to impose a fee, not to exceed $500, for this registration. For more information on the bill, see IACP's North Carolina State Updates.