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Editorial: "Do it right!" vs "Just do it!"

Sorry to the owners of the "Just do it!" slogan but there is NO ROOM for your slogan in pharmaceutical compounding.

If the pharmacist�
   ï¿½is not properly trained,
   ï¿½does not have the proper facilities
   ï¿½does not have the proper equipment
   ï¿½does not have the proper supplies
   ï¿½does not have well-trained, responsible personnel
   ï¿½does not have the right attitude
   ï¿½does not keep up with current practices, standards, etc.
   ï¿½does not keep up-to-date with proper references, periodicals and continuing education
   ï¿½is not dedicated to improving current practices
then that pharmacist has NO BUSINESS COMPOUNDING ANYTHING!!!

"DO IT RIGHT!" or "DON'T DO IT!"

If you "just do it," you may get some or a lot of compounding done correctly, but what about those things that are done incorrectly or not quite up to the standards? One cannot be satisfied with "average" or a grade of "C" in compounding (70% is not acceptable; 80% is not acceptable; 90% is not acceptable; 99% is not acceptable). A compounder must be correct 100% of the time for patient safety.

A pharmacist is no longer a student just trying to graduate. A pharmacist is in the "real world" with "real consequences." No more "do-overs"; no more "begging for a better grade" on an exam. This is what you have trained for and the position you now have with a high salary.

There is another aspect of pharmaceutical compounding that is not generally discussed. In compounding, one is NOT just making a "recommendation" or a "suggestion" to another health professional who is making the final decision. As a pharmaceutical compounder, YOU make the final decision and bear the responsibility for all it involves. It's much easier to just suggest or recommend, but the mark of a true health professional is when you stand as the responsible person for the decisions you make. If you only suggest or recommend, it is easy to cast stones when a responsible person makes an error. However, if you are not in a responsible decision-making position, you're not even in the same ball game! That is not to say that a suggester or recommender is not important. However, a person that is totally responsible for what they do is in a higher league.

As responsible healthcare professionals, we cannot "just do it"; we MUST DO IT RIGHT!


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

Ther-Rx Corporation Decision to Try to Help High-risk Women Have Access to FDA-approved Makena
Ther-Rx Corporation, a subsidiary of K-V Pharmaceutical Company, announced initiatives to reduce the cost of Makena (hydroxyprogesterone caproate injection). Effective immediately, Ther-Rx:

• has reduced the list price of Makena from $1500 to $690 per injection
• will offer supplemental rebates that will result in a substantially reduced cost per injection for state Medicaid agencies
• capped the costs for a full course of therapy to a maximum of three vials (15 injections) for contracted health insurance plans and state Medicaid agencies
• expanded the company's patient assistance program

With the revised pricing structure, KV believes that the use of Makena by eligible patients will deliver net cost savings to government and private insurance plans.
http://www.fiercepharma.com/press_releases/ther-rx-corporation-takes-action-further-ensure-high-risk-women-are-able-ac?utm_medium=nl&utm_source=internal

FDA, KV, and Over-the-top Pricing on Makena
KV Pharmaceutical, armed with exclusive rights to an FDA-approved drug for pregnant women, speculated that it had the market tied up. They slapped a big price tag on the drug and put it on the market for sale. At $1,500 a dose, the company thought it stood to take in significant sales. However, they didn't count on the expectant mothers-and their doctors and government representatives-to fight back (as they were used to getting their doses at $10 to $15 each). The FDA entered into the fray; however, the agency doesn't have the power to tell KV Pharmaceuticals to lower the price, but it can allow pharmacists to keep on compounding the drug as they have for many years. The FDA released their official statement on Wednesday morning (March 30).
http://www.fiercepharma.com/story/fda-thwarts-kvs-over-top-pricing-makena/2011-03-30?utm_medium=nl&utm_source=internal

Artificial Dyes Safe to Eat
A government advisory panel recently voted that there is no proof that foods with artificial colorings cause hyperactivity in most children, and there is no need for these foods to carry special warning labels.

For the first time, agency scientists have decided that while typical children may be unaffected by the dyes, those with behavior problems may see their symptoms worsen by eating foods with synthetic color additives. Artificial coloring is present in numerous popular products like Jell-O, Life Savers candy, Hostess Twinkies, and some cereals. The committee voted 8 to 6 that even a warning was not needed.
http://www.nytimes.com/2011/04/01/health/policy/01fda.html?_r=1

Religious Groups Target Rising Drug Prices
"More and more people can't afford this, and more and more fall back on taking either less pills or half a pill," stated Sister Barbara Aires, coordinator of corporate responsibility in investments for the Sisters of Charity of Saint Elizabeth. The order's say the drugmakers haven't "made a clear case providing fiscal and moral justification for such exorbitant price increases" and they ask the companies to limit increases to the rate of inflation.

The nuns have a point, as price increases for top-selling drugs have hit the highest levels in 10 years, and a recent study found that as many as one-fifth of patients don't fill their prescriptions because they can't afford the drugs. Others stretch their drug supplies by taking lower doses or skipping doses altogether.
http://online.wsj.com/article/SB10001424052748704530204576234900744477830.html

Biological Therapeutics
Greenstein B, Brook DA
Pharmaceutical Press; Paperback; 160 pages; $49.99

Essential reading for one of the most exciting and fastest-growing branches of pharmaceutical science; the treatment of disease using biological medicines derived from living plant and animal tissues. From this description, one might think of pharmacognosy; however, this book is filled with topics practitioners need to know about now and in preparation for the future.

The book is divided into the following chapters: (1) Introduction to genetic manipulation, (2) Vaccines, (3) Hormone-related drugs, (4) The nature of inflammation and mediators of inflammation, (5) Autoimmunity and autoimmune diseases, (6) Treatment of rheumatoid arthritis and other inflammatory disorders with biological drugs, (7) Development of biological antineoplastic drugs, and (8) Stem cell therapy.

This book is recommended for those ready to go into the details of biological therapeutics and its role in contemporary and future drug therapy.

...that colleges of pharmacy need to increase the educational component involving pharmaceutics, compounding, calculations, and chemistry, and decrease the "tag-along" training characteristic of technical trades that have become a large component of pharmaceutical education?

The Old College Try
Contact your alma mater or the state colleges of pharmacy where you practice. Encourage them to increase the science component in the curriculum as well as pharmaceutical compounding laboratories.