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October 5, 2012 Volume 9, Issue 40
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Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor

Editorial: Another Tragic Situation!

Compounding pharmacists have saved thousands of lives the past year in providing medications that have been in short supply or discontinued, and continue to do so today. However, the press ignores that and simply reports on the adverse events! This week, there was a tragic event reported about another contaminated injection, and this reveals some difficulties we still experience in the profession. A number of things may be causative, but this editorial relates to the training of pharmacy students.

It is critically important that students be thoroughly educated about quality compounding and proficient in both nonsterile and sterile activities. Part of the problem may be in academia, part of it may be in a lack of organizational programming, part of it may be in a lack of state board of pharmacy laws and regulations, and I'm sure there are other reasons. The USP has Chapters <795> and <797> standards in place that are designed to minimize events such as those that recently occurred. However, the standards must be implemented and followed to the letter. Also, pharmacies should be PCAB accredited.

With up to about 25% of pharmacists involved in compounding, why do colleges of pharmacy not emphasize this important aspect of pharmacy instead of giving it a "once over"? Many pharmacy students are graduating without knowledge of how to properly compound quality preparations and manage pharmacy technicians who compound; this shows we have a problem in academia, AACP, and ACPE. It's time that our educational institutions wake up and better prepare pharmacists for the practice of pharmacy. It should be noted that many of the colleges do a great job and more are making curricular changes, however, there are many that have a lot of work to do in this area!

On a positive note, there are many pharmacy students interested in compounding, and the compounding competition activities are gearing up for this year. The highly popular 3rd Annual 2012-2013 Student Pharmacist Compounding Competition (SPCC) is being held from mid-October 2012 to January 2013 in local colleges of pharmacy. The National Championship will be hosted by the University of Florida College of Pharmacy in Gainesville, Florida on March 22-24, 2013. The competition is sponsored by Medisca, and we (IJPC) look forward to being a part of this program again this year. For more information, see the following link: http://www.spcc.medisca.com/

Despite the serious events that occasionally occur, compounding pharmacy is still one of the safest methods to obtain necessary medications (even safer than manufactured drug products), as reported previously in this column using data supplied by the FDA.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington-The Science and Practice of Pharmacy

 
News

Steroid Injections Linked to Deadly Outbreak
Authorities are investigating the role of a specialized pharmacy in Massachusetts in an outbreak of meningitis killing four patients and affecting 26 people in five states (18 in Tennessee and eight spread through North Carolina, Florida, Virginia, and Maryland); they received spinal steroid injections to relieve back pain.

On September 26, the New England Compounding Center recalled three lots of steroid injections containing methylprednisolone. Officials said they have yet to pinpoint the precise cause of the cases of fungal meningitis, but they are focusing their investigations on possible contamination of a sanitizing iodine solution, an anesthetic, or the steroid injection itself.
http://online.wsj.com/article/SB10000872396390444223104578034720599010186.html?mod=dist_smartbrief

Ultraviolet Device Kills Superbugs
Microorganisms lurking on bed rails, tables, doorknobs, and other surfaces in hospitals are causing a more than $30-billion problem for the U.S. healthcare system. Now, a new device has been introduced that is a portable disinfection system using pulses/bursts of the inert gas xenon at a rapid speed and high intensity in an ultraviolet flash lamp, producing UVC radiation. At certain wavelengths, this UV light penetrates the outer coatings of bacteria, viruses, mold, and spores. Xenex's CEO says "The light acts like a needle—it pierces the cell walls and prevents them from replicating."

This method is used in addition to traditional surface cleaning. The device is turned on with a remote control after the room is free of occupants. The entire process takes about 10 minutes and leaves no residue or gas in the room.

Xenon UV light is advantageous to hospitals because it's less expensive, quicker, and less harmful than traditional ways of automated sterilization, like using hydrogen peroxide gas or mercury lamps. It is used in sterilizing water and is approved by the FDA for the disinfection of food.
http://www.medpagetoday.com/HospitalBasedMedicine/InfectionControl/35040

Pain Patients Shopping Around to Fill Their Prescriptions
Formerly getting all prescriptions from one pharmacy, now a 40-year-old resident of North Port, Florida, has to crisscross five towns, making at least 30 visits to a half-dozen pharmacies every month to get her prescriptions filled. Many pharmacies in the state have curbed their supplies of opioids and put new restrictions on dispensing them in the face of a government crackdown on painkiller abuse.

The clampdown by Florida and at least seven other states has left some pain-sufferers struggling to get their medicine. That has put drug-enforcement and public-health officials at odds with some doctors and patients legitimately prescribed the analgesics.

In Florida, where the DEA closed part of a Walgreen's distribution center September 14 over the issue of opioid drugs ending up on the black market, some pharmacies have stopped stocking the drugs or can't get them from wholesalers, which fear law-enforcement scrutiny.
http://online.wsj.com/article/SB10000872396390443720204578004873138298306.html?mod=dist_smartbrief

Drug Companies Discount Coupons
A magazine ad for AndroGel shows a discount card that allows consumers to pay "as little as $10 per month." GSK announces in another magazine that it offers discount coupons for the popular inhaler Advair, and a TV commercial for Nexium notes that if consumers can't afford the heartburn drug, its manufacturer, AstraZeneca, "may be able to help."

Drug companies say the coupons help Americans get the medicine they need, however, the insurance industry is concerned that they drive patients toward more expensive brand-name drugs, leaving insurers to cover the full cost, which then gets passed on to consumers in the form of higher premiums.
http://www.washingtonpost.com/national/health-science/drug-companies-fend-off-competition-from-generics-by-offering-discount-coupons/2012/10/01/c7a393be-f05f-11e1-ba17-c7bb037a1d5b_story.html

Bogus Resum� and PHARMA CEOs
Richard Gonzalez is to become CEO of an Abbott Laboratories spinoff. However, his corporate bio lists overstated educational information. Gonzalez is a veteran of Abbott Laboratories for more than 30 years. However, several years ago, when Gonzalez was on its board of directors, his BIO claimed he had an undergraduate and graduate degree in biochemistry. Now his bio merely says he studied at the University of Houston and worked as a research biochemist at the University of Miami School of Medicine. The bogus degree information was included in several of Abbott's Securities and Exchange Commission filings and by various media outlets before being quietly corrected a few years back. As one critic said when looking for a CEO,

�most places are looking for a person's experiences, what a person has done and achieved or led, and those degrees are not as important.�But it's a matter of integrity, too. If this person told an outright lie or misrepresented his academic background, I don't care how experienced he is. You can't have that.�It's game over.

However, Abbott spokeswoman Melissa Brotz dismissed Gonzalez's bad info as an innocent mistake by whoever prepared the biography, steering blame away from Gonzalez.
http://articles.chicagotribune.com/2012-09-30/business/ct-biz-0930-phil-resumes--20120930_1_abbvie-abbott-spokeswoman-melissa-brotz-spinoff

India to Put Price Controls on 348 Essential Drugs
A panel of ministers in India has recommended price regulation for 348 drugs deemed essential, up from 74 earlier, a move that is likely to hit prices of costly brands sold by domestic as well as multi-national drugmakers. If approved, the new policy would regulate prices of about 27% of the total drugs sold in India. India is the world's fourth-largest drug market by volume and 14th largest by value; its annual drug sales are about 650 billion rupees at the retail level, while government agencies buy about 110 billion rupees of medicines at discounted rates every year. Even though patented drugs are not covered by this policy, India is considering a mechanism to regulate prices of medicines which are covered by patent protection
http://in.reuters.com/article/2012/09/27/india-drugs-pricing-idINDEE88Q0A020120927

 
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Did You Know ...

�that compounding pharmacists have more interaction with physicians in solving patient problems than almost any other practice of pharmacy?

 
Tip of the Week

Pharmacy compounding should never be entered into for economic reasons. It is a highly sophisticated, technical, and clinical practice of pharmacy and requires dedication and commitment to practicing the right way!

 
Looking Back

Romances are wrecked,
Before they begin,
By a hair on the coat,
Or a lot on the chin!
      Burma Shave

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