USP-Part 5: Resolutions of the 2005 USP Convention, Concluded

RESOLUTION: PROMOTING SAFE MEDICATION USE AND DISPOSAL
USP resolves to work with appropriate constituencies to continue to develop programs to promote safe medication use and disposal.
This resolution addresses a problem of concern by many national organizations in pharmacy today. With the increase in prescribing of drugs, lack of compliance and relative short expiration and beyond-use dates, patients and health-care practitioners need to be aware of disposal problems associated with their drug products. The first part of this resolution may involve the development of a core curriculum of safe medication management and the second part may involve the assessment of the environmental and public health impact of the disposal of medications to determine whether or not USP can make a unique contribution towards addressing this issue.

RESOLUTION: EVIDENCE-BASED METHODOLOGIES AND ALGORITHMS FOR DECISION SUPPORT USED IN E-PRESCRIBING AND PHARMACY COMPUTER SYSTEMS
USP resolves to work with appropriate stakeholders to continue to develop evidence-based methodologies and algorithms for decision support in areas such as drug-drug interactions, and to expand efforts to other alerts and recommendations for use in e-prescribing technologies and pharmacy computer systems.
Furthermore, USP resolves to explore the feasibility and advisability of extending this approach to other information domains in the interest of the public health and patient care.
Computerized health information systems are fast-becoming an integral component of health care, including interactions between healthcare providers to modify diagnostic and therapeutic decisions. Current systems on the market vary widely. USP's efforts may assist in developing evidence-based methodologies and algorithms for decision support and provide standardized data sets to ensure uniform information availability for e-prescribing and pharmacy computer systems.

RESOLUTION:USP CONVENTION
Using the recommendations of the Resolution 18 Committee to the Board of Trustees, USP charges the Council of the Convention, as an ongoing responsibility, to review the purpose, role and composition of the Convention membership and examine the voting procedures used during the Convention.
The USP Convention is a dynamic entity that is constantly changing in membership and activities. The Council of the convention provides an opportunity for an in-depth assessment of the current Convention by the parties most interested and vested in the outcomes of USP activities. The issues related to structure and composition are many and complex and go to the very heart of USP's credibility and authority and are best discussed in a deliberative and inclusive approach. This will be undertaken by the new Council of the Convention.

RESOLUTION: EXPANDED OUTREACH
USP resolves to expand its efforts to engage stakeholders who are affected by USP standards, but who have not been fully involved in USP processes, including but not limited to groups concerned with Human Biologics, Animal Health, Biotechnology, and Device Manufacturers, in USP committees and programs.
In the past, there have been a number of USP stakeholders that have not actively participated in the USP process, even though the USP has actively sought their input. This resolution emphasizes that USP will continue to encourage such groups to participate in the future. USP's processes must be transparent and participative and attempt to engage all who are affected by it's standards.

RESOLUTION: ORGANIZATIONAL OUTREACH
USP resolves to expand its efforts to engage pharmacy and other healthcare practitioner organizations in discussions related to USP's public health program activities. Efforts should be made to continue this dialogue on a regular, periodic basis to help build understanding among all organizations.
This resolution has special application to pharmacy practitioners. It proposes a more robust and directed interaction between USP and its practitioner constituencies, specifically including but not limited to pharmacy practitioner organizations.
Discussions during this 5-year cycle could include (1) USP's plans for activities related to the medication-use process, (2) the role of USP in supporting pharmacy practitioner organizations such as the Joint Commission of Pharmacy Practitioners in activities that focus on pharmacy practice with a view to avoiding redundancy in activities, and (3) collaborative opportunities between USP and pharmacy practitioner organizations in improving public health.

SUMMARY
As is evident from the resolutions passed at the USP Convention this year, pharmacy practice has again become an important part of USP life. No longer is USP just a pharmaceutical industry-related organization. USP was originally established for pharmacy and remained so for over its first 140 years or so. For the past 40 or so years, its emphasis has been on pharmaceutical industry standards. Now, it is striving to attain a balance in the establishing of standards for pharmaceuticals, regardless of where they are manufactured or compounded. In addition to product and preparation standards, USP also has established practice standards.

USP has opportunities for anyone to let their opinion be known; it's up to each individual to take advantage of that. We will try to keep you informed of activities related to pharmacy.

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

Looking for articles on Diabetic Neuropathy? Check out CT.com's literature section. We added more than 40 articles this week related to diabetes. Here is a sampling:

• Adriaensen H, Plaghki L, Mathieu C et al. Critical review of oral drug treatments for diabetic neuropathic pain-clinical outcomes based on efficacy and safety data from placebo-controlled and direct comparative studies. Diabetes Metab Res Rev 2005; 21(3): 231-240.
• Cowell RM, Russell JW. Nitrosative injury and antioxidant therapy in the management of diabetic neuropathy. J Investig Med 2004; 52(1): 33-44.
• Duby JJ, Campbell RK, Setter SM et al. Diabetic neuropathy: An intensive review. Am J Health Syst Pharm 2004; 61(2): 160-173.
• Richter RW, Portnoy R, Sharma U et al. Relief of painful diabetic peripheral neuropathy with pregabalin: A randomized, placebo-controlled trial. J Pain 2005; 6(4): 253-260.
• Sima AA, Calvani M, Mehra M et al. Acetyl-L-carnitine improves pain, nerve regeneration, and vibratory perception in patients with chronic diabetic neuropathy: An analysis of two randomized placebo-controlled trials. Diabetes Care 2005; 28(1): 89-94.

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

The International Academy of Compounding Pharmacists provided this regulatory update

BET Decision Update
The Kentucky federal court overseeing the case involving BET Pharm, LLC will potentially reconsider the March 23rd ruling on BET's motion to dismiss, as the court recently issued an order establishing a briefing schedule for motions for reconsideration. Read more>>

Office Use Legislation Enacted in Texas
Thanks to the considerable time and effort invested by many Texas members, Texas governor Rick Perry signed SB 492 into law on May 9. SB 492, a bill authorizing pharmacies to compound medications for a practitioner's office use, becomes effective on September 1, 2005. Congratulations, Texas compounders!

Office Use Legislation Approved by Colorado Legislature
HB 1209 was approved by the Colorado legislature on April 29, 2005 and referred to the governor for signature. Read more>>

...this lady showed up in your pharmacy with a sick Iguana and a prescription for an oral anti-fungal for her large green pet. The Iguana looks sad...you think, but you definitely know its owner is desperate. This being the first Iguana you've encountered, you tell the owner you'll have the prescription ready in a few hours. Then you...

1. start looking at that old binder from a previous class, it's 300 pages thick and you can't find any tips for flavoring for an Iguana.
   • spend 30 minutes locating all your IJPC copies. It appears the "animal compounding" copy has grown legs and walked.
   • decide you have no clue how to flavor for this Iguana so you take a break to think about where you can learn how to flavor for an Iguana.
   • Remember www.compoundingtoday.com
2. You Join www.compoundingtoday.com and learn that Iguanas like orange and watermelon but they also like their foods to smell good. You make the medication and greet the owner and the Iguana with a smile!

Here is what else you'll get at CompoundingToday.com

• New Educational Conference/Events Calendar
New Compliance Sections:
• USP
• FDA
• DEA
• NIOSH
• New Compounding Tools
• Bacterial Endotoxin Levels in Sterile Preparations Tool
• Updated Flavor Tools
• 872 compounding formulas
• 256 standard operating procedures
• 1339 articles from 475 publications
• 24 Weekly Newsletters Archived