Editorial: ACPE Requests Curriculum Content Input: Practicing Pharmacists Should Be Involved In Establishing Accreditation and Curriculum Standards, Part I

The American Council for Pharmacy Education (ACPE) has published a "Draft of Revised PharmD Standards and Guidelines" on their website at www.acpe-accredit.org. They are requesting feedback to be received by ACPE on or before November 1, 2005. IACP is serving as a central point for comments to respond to this very important issue. Individual responses to ACPE can also be submitted because the memorandum is addressed to "ACPE Stakeholders" and we all have a stake in setting these standards for accreditation. We compound and we hire pharmacists who compound; pharmacists are trained in colleges of pharmacy that are accredited by ACPE; therefore, we ALL are stakeholders.

The 46-page document has the following in the current draft related to compounding:
Extemporaneous Compounding/ Parenteral/Enteral

• techniques and principles used to prepare and dispense individual extemporaneous prescriptions
• liquid (parenteral, enteral), solid, semi-solid and topical preparations
• dosage calculations
• sterile admixture techniques

If one considers the tremendous growth and impact of pharmacy compounding today and an estimated 10 to 25% of pharmacists doing some type of compounding, why isn't more of the curriculum devoted to compounding? If one considers a 6 year program (approximately 5 years didactic and 1 year rotations), let's look at the number of hours involved. Each year of a didactic program is about 32 semester hours; each semester hour is about 15 contact hours (excluding laboratories, etc., if any) so there is about 480 contact hours per year for 5 years or 2,400 contact hours. We will not consider the sixth year rotations because those are often outside the college of pharmacy during their last year. Out of 2,400 contact hours, how many hours are spent in the area of pharmacy compounding? The ACPE draft lists about 495 hours for the Pharmaceutical Sciences, which includes Medicinal Chemistry, Pharmacology, Pharmacognosy & Alternative & Complementary Treatments, Toxicology, Bioanalysis/Clinical Chemistry, Pharmaceutics, Pharmacokinetics, Pharmacogenomics/Genetics and Extemporaneous Compounding (Parenteral/Enteral). As one can see, if you divide the 495 hours among all those intensive topics, there is not a lot of time devoted to compounding pharmacy. It should be remembered that compounding pharmacy impacts millions of patients yearly and may have a more significant impact on the health of a patient than many other pharmacy activities. In other words, if a pharmacist does not know how to compound correctly and compounds a preparation incorrectly resulting in harm to the patient, our current system is not working.

Topics related to pharmacy compounding could be included in courses in physical pharmacy, pharmaceutics, dosage forms, calculations, etc. Some colleges do a good job with laboratories and some have no laboratories. If a college has a course in physical pharmacy/pharmaceutics, calculations, etc. the next question is how much contact time do the students have? In some cases, these courses may be integrated into other courses in a team-taught course and it is difficult to determine how much time the students really have in compounding-related courses.

Shelly Chambers Fox, PhD of the Washington State University College of Pharmacy is in charge of conducting a "Pharmaceutics Curriculum Survey" for the Teachers of Pharmaceutics Section of the American Association of Colleges of Pharmacy (AACP). This AACP section is interested in developing an accurate picture of the outcomes of and subject matter taught in pharmaceutics curricula in colleges in North America. This is being accomplished by the use of a survey instrument. The information will be used to develop the AACPs response to ACPE's revised draft of Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree.

As is evident, there is a lot of activity in this area right now and it is something that we have all been talking about for a long time. Now is the time to act and let ACPE know that the current standards are inadequate for training pharmacists in quality compounding. As compounding continues to grow and compounders become involved even more in pharmacogenomics and in biotechnology-related preparations, additional training is going to be required. If nanotechnology comes of age, pharmacists need to be involved there also. Sadly, no one really reads about "pharmacists and nanotechnology"; it's always about "physicians and nanotechnology". We need to start planning for the future role of pharmacists in pharmacogenomics, biotechnology and nanotechnology compounding because we will probably not have our current small molecule drugs to dispense forever; changes will occur but where will we be positioned?

The purpose of the colleges and schools of pharmacy in the U.S. is to train pharmacists for the practice of pharmacy. Who better than to have input into the process of setting standards than practicing pharmacists! More next week.

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

If you are missing a few issues of the International Journal of Pharmaceutical Compounding (IJPC) now is your chance to purchase those missing copies at a reduced rate. IJPC is selling its overstocks for $5.00 each plus shipping. Click here to see a list of those copies available.

Another e-tool to help you compound for your furry customers was added to CompoundingToday.com this week!

CT.com has added an electronic tool at http://compoundingtoday.com/VetTransdermal/ that will help you preview how drugs behave in a transdermal preparation applied to animals.

The Veterinary Transdermal Tool gathers frequently used drugs (mainly in cats and dogs) and provides the drug's pharmacokinetic considerations, oral dose, injectable dose, a forecast for the maximum recommended starting transdermal dose, target for efficacy, information to monitor toxicity and general comments.

One more tool to improve time and efficiency in your daily pharmacy compounding practice! There are more tools to come too!

CompoundingToday.com added articles to its literature search this week that focus on the use of secretin to treat autism. This topic has been discussed on the Compounders Network List during the past week. Here is a representative sample of some of the abstracts added to the database:

• Esch BE, Carr JE. Secretin as a treatment for autism: A review of the evidence. J Autism Dev Disord 2004; 34(5): 543-556.
• Francis K. Autism interventions: A critical update. Dev Med Child Neurol 2005; 47(7): 493-499.
• Horvath K, Stefanatos G, Sokolski KN et al. Improved social and language skills after secretin administration in patients with autism spectrum disorders. J Assoc Acad Minor Phys 1998; 9(1): 9-15.
• Levy SE, Hyman SL. Novel treatments for autism spectrum disorders. Ment Retard Dev Disabil Res Rev 2005; 11(2): 131-142.
• Sturmey P. Secretin is an ineffective treatment for pervasive developmental disabilities: A review of 15 double-blind randomized controlled trials. Res Dev Disabil 2005; 26(1): 87-97.

For more than 25 years pharmacists have used physician DEA numbers as "identifiers" when filing for reimbursement from insurance or medicare/medicaid. By May 2007, the DEA number will have been phased out and a new system, the National Provider Identifier, will go into effect. For more information on this new system go to http://www.cms.hhs.gov/medlearn/npi/npiviewlet.asp

This Regulatory Update has been provided by the International Academy of Compounding Pharmacists. For more information, www.iacprx.org.

IACP Files SBA Complaint on FDA CPGs
On August 4, IACP filed a complaint with the Small Business Administration (SBA) regarding FDA's flawed compounding CPGs. The SBA's Small Business Regulatory Enforcement Flexibility Act (SBREFA) process allows small businesses to file complaints about unfair or excessive regulatory enforcement by a federal government agency, such as FDA. IACP filed the complaint on behalf of its membership. The comments reiterate IACP's concerns with the FDA CPGs being used as enforcement tools against compounding pharmacies and solicit the SBA's support in resolving the issue.

Pharmacy Compounding Accreditation Board (PCAB) Creates New Website
The new site http://www.pcab.info will initially be presented in the form of a newsletter. This web site will be for pharmacists and for communications to pharmacists. Eventually, compounding pharmacy owners will be able to apply for accreditation on-line through the site. Pharmacists will be able to go online and check the status of their application, as well as view news regarding compounding and legal notices. If you have comments or want to suggest changes, they are welcome. The site is a work in progress.

An easy way to disperse methycellulose when forming a suspension or a gel prepartion is to mix the methylcellulose powder with any of the other ingredients that are water soluble first. Then, slowly add the powders to heated water (about 60-70 degrees C.) with stirring. Remove from heat, cool and add the remaining ingredients. This technique will decrease the "clumping" that often occurs when working with methylcellulose and speeds up the process. Be sure and check to confirm that the heated ingrediens are heat-stable.