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Editorial: United States Pharmacopeia 101, Part I

This week we are beginning a series on the United States Pharmacopeia (USP), to be followed by a series on the National Formulary (NF). The reason for this series is that the USP and NF standards impact pharmacy practice but far too many pharmacists and pharmacy students have a very limited knowledge of the USP.

Mission of USP 34: The mission of the USP is to improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. (2012)

Object of the first USP: The object of a Pharmacopoeia is to select from among substances which possess medicinal power, those, the utility of which is most fully established and best understood; and to form from them preparations and compositions, in which their powers may be exerted to the greatest advantage. It should likewise distinguish those articles by convenient and definite names, such as may prevent trouble or uncertainty in the intercourse of physicians and apothecaries. (1820)

From a 272-page 5.5" � 8.5" book in 1820 to a 3-volume 4,638 page 8.5" � 11" book, published originally every 10 years to the current publication rate of every year, the USP, as well as the United States Pharmacopeial Convention, has changed. We will look at these changes and their impact on pharmacy over the next several issues.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Tranexamic Acid Used in America's Battlefields is Now Increasing in the USA
A simple, inexpensive generic drug has been saving lives on America's battlefields by slowing the bleeding of even gravely wounded soldiers. However, its low cost has slowed its entry into American emergency rooms, where it might save the lives of bleeding victims of car crashes, shootings, and stabbings—up to 4,000 Americans a year, according to a recent study. Because there is so little profit in it, the companies that make it do not extensively promote it. A ray of hope though, the drug is edging slowly closer to adoption as hospitals in New York and other major cities debate adding it to their pharmacies.
http://www.nytimes.com/2012/03/21/health/tranexamic-acid-cheap-drug-is-found-to-staunch-bleeding.html?_r=1&ref=health

FDA Considering Expanding Over-the-counters
The FDA is considering expanding the list of drugs that can be purchased without a prescription. The agency has discussed whether cholesterol, asthma, migraine, and blood-pressure medications should be sold over-the-counter, a regulatory change intended to lower costs and ease access to drugs for people with chronic ailments. Some have also urged that any expansion of nonprescription drugs include birth control.

The FDA has been discussing ways to enhance pharmacists' roles in chronic treatments or supplement drug labels in an interactive way that helps people determine whether they have a condition and need a drug.
http://www.bloomberg.com/news/2012-03-23/doctors-press-fda-in-push-for-birth-control-without-prescription.html

'Pink Slime' Producer Halts Production at Some Plants
The power of the media has been at work for the last two weeks. The company that makes "pink slime," a product used for many years, suspended operations in three of its four plants where the beef ingredient is made. The term "pink slime" has been used by its opponents. Called lean finely textured beef, the low-cost ingredient is made from fatty bits of meat left over from other cuts. The bits are heated and spun to remove most of the fat. The lean mix then is compressed into blocks for use in ground meat and then exposed to ammonium hydroxide gas to kill bacteria, such as E. coli and salmonella. The process results in a product that is as much as 97% lean beef.

The company hopes that when people can start to understand the truth that their business will return. The Federal Agency says the ammonia-treated filler, known in the industry as "lean, finely textured beef," meets food safety standards; however, critics say the product could be unsafe and is an unappetizing example of industrialized food production.
http://www.usatoday.com/money/industries/food/story/2012-03-26/Pink-slime-maker-halts-production-at-some-plants/53786918/1

�that Diclofenac 1% Topical Gel (Volataren 1% Gel) is still in short supply and is an easily compounded preparation? See www.CompoundingToday.com for formulas.

Career Cautions
With the developing over supply of pharmacists, one may need to be cautious in encouraging large numbers of young people to enter into the profession.

Understanding Pharmacy Calculations
2nd ed.
O'Sullivan TA, Albrecht LS
$44.95; 309 Pages; 8.5" � 11" Soft Cover

This book is uniquely organized in sections on (1) Things you'll use very day, (2) Understanding expressions of drug amounts, (3) Calculations used when compounding medications, (4) Calculations to determine patient-specific doses, and (5) Parenteral nutrition calculations. Within each section are the different topics one would expect in a pharmacy calculations book. A nice feature in this book is a very good presentation on total parenteral nutrition calculations with problems. The book is easy-to-use and read and is of a proper size to actually perform the calculations in the book. It is well written and easy-to-understand and is recommended for students, technicians, and practitioners.

On curves ahead,
Remember, sonny
That rabbit's foot
Didn't save the bunny.
      Burma Shave

PCAB is proud to announce the accreditation of the following pharmacy:

Rockwell Compounding, Rye, New York; Steve Cosentino, RPh, Owner, and Dr. Nicholas Trikounakis, Pharmacist; Initial Accreditation for Sterile and Nonsterile Compounding

Please join us in congratulating them for their achievement.

Pharmacy for Sale
Compounding Pharmacy/Laboratory & infrastructure located in Weatherford, Oklahoma home of SWOSU School of Pharmacy. Housed in a 2800 sqft building on seven acres. Equipped with a modern telephone system, two chemical vent hoods, two biological safety cabinets, two laminar flow hoods, and 16 X 10 clean room. Miscellaneous equipment includes analytical balances, evaporating vacuum system, heated tube sealer, temperature controlled centrifuge, heated chamber, and laboratory glassware. $225,000.
Pete Huerta DPh, PhD 580-302-0904.