The USP and its Support of Pharmaceutical Compounding

The 2005 USP Convention was recently held on March 9-13 at the Grand Hyatt Hotel in Washington DC. Included among the delegates were a large number of individuals that support pharmaceutical compounding. The USP Conventions have been ongoing since 1820 and currently are held every 5 years. Of what importance is the USP to pharmaceutical compounding? Let me begin by listing a number of accomplishments and activities over the past 5 years.

1. The preparation for publication, later this year, of the USP-Pharmacist�s Pharmacopeia.
2. The development of pharmacy compounding standards (including <795>, <797>) that are important to establish quality standards nation-wide in compounding to protect the public health, as well as USP Chapter <1075> Good Compounding Practices.
3. Over 150 USP-NF monographs related to pharmacy compounding; about 20 new ones for oral liquids have just been approved within the last few months.
4. The USP has hired additional laboratory personnel to begin conducting stability studies on compounded preparations to aid in establishing �Beyond-Use Dates� so the short, default dates can be exceeded with these new stability studies. This is beginning this month.
5. Educational programs to explain the details and assist in the implementation of the USP General Chapters.
6. Initiated the development of the Pharmacy Compounding Accreditation Board by convening stakeholder pharmacy organizations and encouraging them to work together on this accreditation program that is now underway.
7. Has undertaken new initiatives to support compounding; the results of which will be forthcoming over the next few years.

Who are the delegates?
The largest number of delegates include the following: each college of pharmacy has a delegate; each college of medicine has a delegate; each state pharmacy association has a delegate; and each state medical association has a delegate. Major organizations in pharmacy and medicine have delegates, as well as �interested parties�, including public health organizations. There are also a number of international delegates representing various organizations. As is evident, the delegates are primarily pharmacists and physicians.

What is done at the convention?
Generally, the meeting begins with presentations on healthcare and healthcare standards. This year, speakers from the World Health Organization, the Harvard School of Public Health and Princeton University discussed international healthcare, safe delivery of healthcare, and the changing needs in US healthcare, respectively. Then, the business sessions begin. After the various reports and discussion are presented, there are open hearings on the constitution, bylaws and resolutions. Later in the meeting, these are voted on and the Board of Trustees, Officers and the Council of Experts are elected to serve the next 5-year cycle.

What resolution(s) were voted upon that affect compounding and my practice?
The resolution entitled �Compounding Standards and Education� was introduced and approved. it states: �USP resolves to expand its work with appropriate parties involved in compounding, including practitioners, FDA, state boards of pharmacy, and other regulatory authorities, to support and disseminate information about science-based compounding practice.� An approved resolution that affects all pharmacists was entitled �Integrity and Safety of Therapeutic Products�. It states, �USP resolves to work with stakeholders to continue to develop packaging, shipping, distribution, and storage standards and practices that ensure the integrity and safety of all therapeutic products through the distribution and dispensing system. USP further resolves to support educational and allied activities at all levels of distribution, dispensing, and administration (manufacturer through patient) concerning the integrity and safety of therapeutic products.�

There were a total of 13 resolutions passed and they are available at www.usp.org if you are interested in viewing them.

There are a total of 39 Drug Standards Expert Committees established for this 5-year cycle, including the two committees related to compounding activities, �Compounding Pharmacy� and �Sterile Compounding�; the chairs for all 39 of these committees were elected at the meeting.

Become familiar the USP and with the website and visit it regularly to keep up with the activities of the USP. It�s your organization and many pharmacists are actively involved. The topic is management of nonpain symptoms, especially in palliative care.

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

The story published today, "Safety concerns grow over pharmacy-mixed drugs," focuses on compounded inhalation therapies (the story is available here). Go to www.iacprx.org for critical preparation in the case you are contacted by local media or if patients, prescribers or others in your community ask you about these stories and question the benefits of compounded medications. IACP is working on a joint response to the article by the pharmacy profession.

ABC'S PRIMETIME LIVE INVESTIGATES PHARMACY COMPOUNDING
Either next Thursday, March 31st or April 7th, ABC's Primetime Live also will focus on pharmacy compounding. IACP's president, Patsy Angelle and IJPC Editor-in-Chief Loyd Allen, were in New York today completing interviews for the program. The interviews seem to focus on the Shiri Berg tragedy in which a patient died following an overdose of an occlusion of a 10% lidocaine gel to much of her body. IACP will have further information available immediately following the airing of this program.

CONSUMER HEALTH GROUP ISSUES CITIZEN PETITION TO FDA
The Consumer Health Alliance for Safe Medication (CHASM) filed a petition to FDA today calling for increased federal regulation of pharmacy compounding. This group also held a press conference today highlighting their efforts with the citizen petition regarding the labeling and advertising of compounded aqueous-based drugs for inhalation. To view a copy of the petition, click here . The FDA Commissioner is required to reply to the petition. IACP is exploring options on how best to respond to this issue.

FEDERAL COURT FINDS COMPOUNDED MEDICATIONS ARE SUBJECT TO FDCA
A Federal District Court in Kentucky issued a decision in the BET Pharmacy case that rejected outright IACP and BET's claim that compounded drugs are not subject to the provisions of the Food, Drug, & Cosmetic Act (FDCA). The Court also rejected BET's claim that pharmacies are exempt from FDA inspection. View a copy of the decision here . IACP will follow up shortly with an analysis of this case and next steps of appeal.
Copyright 2005 International Academy of Compounding Pharmacists. All Rights Reserved.

Here is a sampling of citations from abstracts added to compoundingtoday.com last week related to the topic of pain management. For more abstracts related to pain management go to:http://compoundingtoday.com/articles/SearchNew.cfm

• Beard S, Hunn A, Wight J. Treatments for spasticity and pain in multiple sclerosis: A systematic review. Health Technol Assess 2003; 7(40): iii, ix, x, 1-111.
• Cherny NI. Taking care of the terminally ill cancer patient: Management of gastrointestinal symptoms in patients with advanced cancer. Ann Oncol 2004; 15(Suppl 4): iv, 205-213.
• Fine PG. Analgesia issues in palliative care: Bone pain, controlled release opioids, managing opioid-induced constipation, and nifedipine as an analgesic. J Pain Palliat Care Pharmacother 2002; 16(1): 93-97.
• Negro S, Asuara ML, Sanchez Y et al. Physical compatibility and in vivo evaluation of drug mixtures for subcutaneous infusion to cancer patients in palliative care. Support Care Cancer 2002; 10(1): 65-70.
• Scott MA, Letrent KJ, Hager KL et al. Use of transdermal amitriptyline gel in a patient with chronic pain and depression. Pharmacotherapy 1999; 19(2): 236-239.
• Vella-Brincat J, Macleod AD. Haloperidol in palliative care. Palliat Med 2004; 18(3): 195-201.

Help Stop Audit Abuse! Join PCCA As We Launch the PBM Audit Protection Fund! Audits by Pharmacy Benefit Managers (PBMs) pose one of the most serious threats to pharmacies. PAAS National, an audit-consulting firm, estimates that the chance of a pharmacy being audited is now one in three, with average recoupment or charge back in excess of $27,000. These audits are particularly oppressive for compounding pharmacies. Research has indicated that Medco, the largest PBM, has the most aggressive audit policies and has exhibited a very limited willingness to work with pharmacies to correct alleged audit shortcomings. We believe that legal action must be taken immediately to suspend and stop arbitrary audits, as well as pursue further action to recoup monies wrongfully retracted from compounding pharmacies, and to seek damages and legal fees. Help us reach our goal to raise an additional war chest of at least $500,000. Join forces with others to ensure that litigation is brought forth. Collectively compounding pharmacies can do what no individual pharmacy has the resources to do: Challenge Medco.

There have been many differing opinions about third parties over the years but on this issue we can all agree � a clear abuse of compounding pharmacies is occurring. Invest in your future! To make a donation contact: Cristy Lafuente, PBM Audit Protection Fund - Phone: (281) 701-9858; E-mail: clafuente@aol.com; Fax: (713) 961-7303; Address: 3805 W. Alabama, #5105, Houston, TX 77027