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Editorial: Looking Forward 2012, Part I

This week we will start a series on "Looking Forward 2012" at what may be forthcoming for pharmacy and especially for pharmacy compounding. We will briefly discuss topics such as drug shortages, e-prescribing, hospital outsourcing, PCAB accreditation, stability data, third-party difficulties, compounding growth, compounding in the curriculum, new technology, etc.

First, we will look at drug shortages, since we just experienced a record number of 267 shortages in 2011. Reasons given for the drug shortages vary and can include: manufacturing deficiencies leading to production shutdowns, companies ending production of some drugs with narrow profit margins, consolidation in the generic drug industry, and limited supplies of some ingredients. We should not forget that most APIs come from either China or India and may be held up at customs or may not meet U.S. standards (USP or FDA) for use in drugs for the U.S.

It is doubtful that drug shortages will be alleviated any time soon, as they have been going on for years and are getting more numerous. This provides compounding pharmacists an opportunity to "fill the gap" and "meet the needs" for patients.

One thing that is vitally important is that "quality must come first!" If there is any uncertainty about whether to compound something, don't do it! We still hear about mishaps that occurred years ago by compounders, but the errors by manufacturers are quickly forgotten. If there are questions that need resolved, there are many resources out there to help out. It should be approached cautiously and with deep concern about the quality issues involved.

Starting with the January/February 2012 issue of IJPC, we will include a number of commercial product formulations that are in, or have been in, or may in the future be in short supply.


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

Response to Last Week
Editor's Note: In the news item last week entitled "FDA Further Restricts Antibiotics for Livestock" with contact information of:
http://www.nytimes.com/2012/01/05/health/policy/fda-restricts-use-of-antibiotics-in-livestock.html?_r=1&ref=health

a response was received that thought the news item was not altogether factual. We welcome responses, so we are now presenting further information on this topic, including the source for the Federal Register as well as AVMA response to this topic. If this impacts your practice, please read the following to be better informed.
http://www.avma.org/press/releases/120106_cephalosporin-use.asp
http://www.gpo.gov/fdsys/pkg/FR-2012-01-06/html/2012-35.htm

Or, for an easier-to-read format:
http://www.gpo.gov/fdsys/pkg/FR-2012-01-06/pdf/2012-35.pdf

FDA Panelists Tied to Bayer
FDA advisers recently voted that the benefits of four popular Bayer AG birth-control products (Yaz, Yasmin, Bevaz, Safyral) outweigh the blood-clot risk. What was not disclosed was that three of the advisers have been tied to Bayer, serving as consultants, speakers, or researchers. The committee vote was 15 to 11 that the benefits outweighed the risks.
http://online.wsj.com/article/SB10001424052970203436904577153160177537828.html?mod=dist_smartbrief

Sales Pitches Softened by Drug Reps
One thing was noticeably absent from a recent visit that a drug company sales representative paid to a psychiatrist: a sales pitch. The representative provided free drug samples, a lunch of salad and iced tea, and a chance to order diagrams of how the brain works. What wasn't done was a presentation of the drugs' benefits or a request that the doctor write more prescriptions.

Drug reps used to come in with their own agenda, but, now, they are concerned with what the doctor talks about. The soft sell reflects a major shift in how more pharmaceutical companies target physicians as the industry remakes its commercial model in response to changing economic and regulatory conditions. From aggressive, well-rehearsed sales pitches and pressure to boost prescriptions from multiple sales reps from one company, things may be changing. Physicians are under pressure from health plans to curb costs and have less time for, and patience with, persistent sales pitches. The industry has slashed 33,000 sales jobs in the U.S. from its peak five years ago, when 105,000 representatives flooded the zone. In order to adjust to and allow for these changes, some 18 of the top 40 drug makers have reorganized their sales forces to reduce duplication.

It seems that increasing physician satisfaction may be a much better way to promote a pharmaceutical agent than simply telling them to write more prescriptions or what the benefits of certain drugs may be.
http://online.wsj.com/article/SB10001424052970204331304577142763014776148.html

Saying "I'm Sorry" May Not Be Enough!
The Colorado Court of Appeals has ruled that the state board of pharmacy may deny a former pharmacist's application to be a pharmacy intern even though the applicant has shown rehabilitation. The rehabilitation in this situation followed the person's convictions for two pharmacy-related felonies and a petty offense.
http://www.cobar.org/opinions/opinion.cfm?opinionid=8343&courtid=1

Drug Approvals Hit a Seven-Year High in 2011
The FDA has approved 30 new treatments in 2011 compared with 21 last year. The new approvals may help the drug companies overcome a rash of patent expirations. At least 21 medicines will lose a combined $11.5 billion in revenue as a result of patent expirations in 2012, and they will generate more than $4 billion in 2012 from products that were introduced in 2010 and 2011.
http://www.bloomberg.com/news/2012-01-05/drug-approvals-in-u-s-reached-a-seven-year-high-in-2011-on-improved-data.html

5% of Patients Account for Half of Healthcare Spending
According to a recent federal report, 1% of Americans accounted for 22% of healthcare costs in 2009 (about $90,000 a person), and 5% accounted for 50% of healthcare costs, about $36,000 each, the report said. The report may be used to predict which consumers are most likely to drive up healthcare costs and determine the best ways to save money.
http://www.pharmacynewsflash.com/opha/Story.nsp?story_id=167877595

Dietary Supplements
4th ed.
Mason P
$85.00; Hardback; 600 pages

This is a great, easy-to-read book that is monograph-based and includes the most commonly used vitamins, minerals, and dietary supplements. It contains 108 regularly structured and detailed monographs, including potential interactions. In addition, it contains appendices on "Guidance on safe upper levels of vitamins and minerals," and "Drug and supplement interactions." This book is an essential reference resource for pharmacists and other health professionals.

�that if you are not a subscriber to IJPC then you are missing out on valuable information that pays for the price of the subscription many times over throughout the year? Call 1-800-757-4572 or 405 330-0094 x1, or go to www.ijpc.com today!

Temporary Things
Things in life are temporary. If going well, enjoy it, they will not last forever. If going wrong, don't worry, they can't last long either.

Don't stick your elbow
Out so far,
It may go home
In another car.
      Burma Shave

Aseptic Technique Compounding Training
February 8 and 9 by the American College of Apothecaries
Contact: terri@acainfo.org

CPhT Wanted
Are you eager to help shape an evolving technical services program? Letco Medical, a leading supplier of fine compounding chemicals, equipment and supplies, is seeking two expert compounding technical services professionals to support our experienced and specialty pharmacy customers. You will provide direct one-on-one support for more complex technical and application questions, while also developing a methodology and control systems for easy access to more basic technical and formula information. If you are an experienced CPhT, and enjoy working directly with customers to address complex technical and compounding questions, we would like to hear from you. Email resumes to careers@letcomedical.com.