Editorial: The New USP-Pharmacists' Pharmacopeia

At long last, the USP is again useful to pharmacists. Not that it hasn't been of some use, but now we have a new version of the USP especially for compounding and dispensing pharmacists. What has happened to the USP and made it change over the years?

Briefly, the USP was established in 1820 by a group of concerned physicians interested in setting standards for formulations used in the U.S. Other pharmacopeias were available in other parts of the world and as the U.S. was growing, there was a lack of standardization of drugs that pharmacists were collecting, extracting, formulating and providing to patients. Hence, the first USP was published in 1820 for use by pharmacists.

In the late 1800s and 1900s with the industrial revolution, pharmaceutical companies began emerging to mass produce drug products. The USP and NF had already been recognized in 1906 by the Pure Food and Drug Act as two of the official compendia in the U.S. for drug standards. With the formation of the Food and Drug Administration in 1938 for the purpose of enforcing drug standards in the pharmaceutical industry, the agency began their work. Along with this, in the mid 1900s the USP standards were applied to manufacturing as well as to compounding. However, with the rapid growth of the pharmaceutical industry and a decline in the extent of compounding, it was inevitable that the USP would begin an orientation towards standards for pharmaceutical manufacturing.

With the growth of pharmacy compounding in the past 20 or so years, it seems we have been on the "outside looking in". However, the USP began looking at compounding in the 1980s as a result of resolutions passed at the USP conventions and now has assumed a vital role in supporting pharmacy compounding through standards presented as formulation monographs and general chapters in the USP-NF.

However, the USP-NF book is quite large and much of it does not apply to practicing pharmacists. Over ten years ago, we began discussing the possibility of a pharmacopoeia for pharmacists; one that would include compounding and dispensing information that could be practically used on a day to day basis by pharmacists. As compounding continued to grow and the efforts of many "stakeholders", including the pharmaceutical organizations, FDA, U.S. Congress, U.S. Supreme Court, state boards of pharmacy and others, as well as the impact of USP General Chapter <797>, it was apparent that the time had come for the USP standards to be made available in a publication specifically for pharmacists. After at least three prototypes and work by many individuals and USP staff, the USP Board of Trustees approved the publication of the USP-Pharmacists' Pharmacopeia.

In general, the book is divided into two parts: Part I (the light blue pages) is the "official" part of the book and Part II (the white pages") is the "authorized" part of the book.

Part I contains the General Notices and Requirements (Which should be read first), abridged Drug Substance Monographs and Excipients, Compounded Preparation Monographs, Pharmacy-Related General Chapters, Tests General Chapters, Dietary Supplement Monographs and General Chapters and Reference Tables. Part II, the authorized section, contains Compounding Support Information (Basics of Compounding many different dosage forms), selected Pharmacopeial Forum Stimuli articles ("Temperature Fluctuations in Mail Order Shipment", Medication Storage Temperatures on U.S. Ambulances", "Sterilizing Filtrations with Microporous Membranes", "Drug Products Distribution Chain", and many others), Safe Medication Practices, Legal Requirements and Laws and Additional Resources. The book has tabs for the different sections so it is very easy to use.

Another purpose in developing a pharmacopoeia especially for pharmacists is the fact that the regular USP-NF costs approximately $700 and is published every year. The USP-Pharmacists' Pharmacopeia sells for only $225.

The USP-Pharmacists Pharmacopeia is YOUR PHARMACOPEIA and it is very important to support it. The USP, in addition to publishing this book, has also devoted a significant budget for the USP Drug Research Testing Laboratory to support the hiring of additional personnel to conduct stability studies on compounded preparations. This work could not be done by any other organization or group due to the high costs involved and it must be done as valid beyond-use dates for compounding monographs depend upon laboratory studies.

One question has come up several times: "If there is a USP monograph, do we have to compound the preparation identical to the monograph?" The answer is no, you do not, as there are times when the formulation should be changed for specific patients, etc. However, if you do compound the formulation according to the USP monograph, you can place the "USP" abbreviation after the name of the formula on the prescription label and can use the beyond-use date that is listed in the monograph. If you do not compound it according to the USP formula, you must either have documentation of a different beyond use date for the specific formula you used, or use the default, shorter beyond-used dates according to USP General Chapter <795>.

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

Dear CompoundingToday.com Staff:

I reviewed the compoundingtoday.com website with interest as soon as I knew it was up and running. I was pleased to find a number of invaluable items that would help me in my endeavor to have a high quality compounding pharmacy.

I have not encountered a location with more information in one place for compounding pharmacies than on compoundingtoday.com. As I am interested in working on compliance with USP chapters 795 and 797 I not only found the gap analysis tool to help identify areas we can work on to comply but I also found SOP's were available to assist us in process and documentation compliance.

Accurate potency is obviously an issue on which we all need to focus. The Base-Salt-Ester weight tool is invaluable when confirming proper conversion for measurements.

I could go on and on about the wealth of information contained in this one site like the formulas, filter membrane reference and others but I just wanted to say that I think this is one of the most valuable tools we use on a regular basis to help ensure high quality healthcare for our patients.

The only complaint I have is that for all of this to exist in one place, the price is not reflective of the value. The membership should probably cost much more than it does but as I attempt to run a profitable practice, I'm happy it doesn't.

Sincerely,

Jeff Ahl
Red Cross Drug
Blanchard Oklahoma

During this week more than 60 citations related to the topics of iontophoresis, sonophoresis, phonophoresis were added to the literature search database. Access these citations by clicking on "Drug Information" from the left-hand navigation bar at www.compoundingtoday.com. Then choose "Compounding Article Search". This will launch CompoundingToday.com's extensive compilation of citations related to compounding. You can search by publication, keyword or topic.

Here is a sampling of the articles added this week to CT.com:

• Lavon I, Kost J. Ultrasound and transdermal drug delivery. Drug Discov Today 2004; 9(15): 670-676.
• Nirschl RP, Rodin DM, Ochiai DH et al. Iontophoretic administration of dexamethasone sodium phosphate for acute epicondylitis. A randomized, double-blinded, placebo-controlled study. Am J Sports Med 2003; 31(2): 189-195.
• Viscusi ER, Reynolds L, Chung F et al. Patient-controlled transdermal fentanyl hydrochloride vs intravenous morphine pump for postoperative pain: a randomized conrolled trial. JAMA 2004; 291(11): 1333-1341.
• Viscusi ER, Witkowski TA. Iontophoresis: the process behind noninvasive drug delivery. Reg Anesth Pain Med 2005; 30(3): 292-294.
• Wang Y, Thakur R, Fan Q et al. Transdermal iontophoresis: combination strategies to improve transdermal iontophoretic drug delivery. Eur J Pharm Biopharm 2005; 60(2): 179-191.

For Immediate Release
June 15, 2005
Contact Dana Easton
901-383-8119

Joint Commission of Pharmacy Practitioners Investigates Implementation of Medicare Modernization Act and the Prescription Drug Benefit

Member organizations of the Joint Commission of Pharmacy Practitioners held their regularly scheduled quarterly meeting on Thursday, May 19, 2005, in Crystal City, Virginia. The first order of business was to consider implementation strategies for achieving the Future Vision of Pharmacy Practice. Participants agreed that an aggressive plan is needed - a plan characterized by assertion, urgency, and boldness. Member organizations committed to working to support and implement strategies and initiatives designed to achieve the Vision.

Representatives of the International Academy of Compounding Pharmacists then presented to the group their plans to implement a professionally-administered public relations program. The program has as its objective familiarizing various stakeholders with the vital role that pharmacists play in providing compounded prescription medicine dosage forms to patients in a variety of practice settings. There were expressions of unity of the profession with regard to the importance of compounding of prescription medicines. It further was noted that the Accreditation Council for Pharmacy Education will ensure that the compounding of prescription medicines (as a competency to be achieved by pharmacy students) is appropriately addressed in its accreditation standards and guidelines that are currently under revision.

The Commission then turned its attention to the focus of the day's meeting - a discussion and review of progress toward the implementation of the Medicare Modernization Act. This Act contains a prescription drug benefit that will be enjoyed by ambulatory and institutionalized patients who are eligible to receive the benefit. Mr. Larry Kocot, Senior Advisor, Centers for Medicare and Medicaid Services, was present as an invited guest to provide his perspective on progress toward implementation of the Act and, specifically, prescription drug programs.

Mr. Kocot began a question and answer session by briefly describing a timetable culminating January 1, 2006 when the program will become operational. Mr. Kocot indicated that enrollment will determine program success.

During the question and answer session, a variety of questions of specific interest to member organizations were posed to Mr. Kocot. The mechanics of medication therapy management services (MTMS) and the pharmacist's potential roles in MTMS were a common theme in many of the questions posed to Mr. Kocot.

As a follow-up to the informative session, Mr. Kocot agreed to respond to a bank of technical questions that will be prepared by representatives of member organizations, collated, and submitted in writing.

Meeting participants assured Mr. Kocot that the organizations represented by the Commission will be prepared to assist their members in serving the health care needs of individuals who will receive the prescription drug benefit of the Medicare Modernization Act.

During the remainder of the meeting, a variety of topics important to pharmacy practitioners were discussed, with strategies developed so that member organizations could respond to an ever-changing practice environment. Reports of recent activities and programs were provided by each Commission member organization. A number of newsletters, journals, and other educational materials were distributed so that member organizations may better serve pharmacy practitioners and coordinate future projects.

The next regularly scheduled meeting of the Commission is Monday, August, 1 2005, with interim meetings and work activities planned throughout the spring and summer.

JCPP organizational representatives attending the May 19, 2005 meeting:

• Academy of Managed Care Pharmacy
  Judy A. Cahill, Executive Director
  Dianne Kane Parker, President
• American Association of Colleges of Pharmacy
  Lucinda L. Maine, Executive Vice President
  JoLaine Draugalis, President
• American College of Apothecaries
  D. C. Huffman, Jr., Executive Vice President
  Shara Rudner, Regional Director
• American College of Clinical Pharmacy
  Michael S. Maddux, Executive Director
  Barbara Wells, President
• Accreditation Council for Pharmacy Education
  Mike Rouse, Assistant Executive Director
• American Pharmacists Association
  John A. Gans, Executive Vice President
  Gene Lutz, President
• American Society of Consultant Pharmacists
  John Feather, Executive Director
• American Society of Health-System Pharmacists
  Henri R. Manasse, Jr., Executive Vice President
  Mark Woods, President
• National Association of Boards of Pharmacy
  Eleni Anagnostiadis, Director Professional Affairs
• National Community Pharmacists Association
  Bruce T. Roberts, Executive Vice President
  Tony Welder, President