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Editorial: United States Pharmacopeia 101, Part VIII

This is the eighth in the series on the United States Pharmacopeia (USP), actually the United States Pharmacopeia-National Formulary (USP-NF). In this part, we will look at the journey of the NF from its beginning to now.

When the American Pharmaceutical Association (APhA) was organized in 1852, the only authoritative and recognized book of drug standards available was the USP III. Its scope, then as now, was restricted to drugs of established therapeutic merit. Because of strict selectivity, many drugs and formulas that were accepted and used by the medical profession were not granted admission to early revisions of the USP. As a type of protest, and in keeping with the original objectives of the APhA to standardize drugs and formulas, certain pharmacists, with the sanction of their national organization, prepared a formulary containing many of the popular drugs and formulas denied admission to the USP, as presented last week. The first edition was published in 1888 under the title National Formulary of Unofficial [Unofficinal] Preparations, and this reflected the protest mood of the authors, since the USP had earlier adopted the term "official" as applying to the drugs for which it provided standards. The title was changed to National Formulary (NF) on June 30, 1906, when President Theodore Roosevelt signed into law the first federal Pure Food and Drug Act, designating both the USP and NF as establishing legal standards for medicinal and pharmaceutical substances. Thus the two publications became official compendia.

The early editions of the NF served mainly as a convenience to practicing pharmacists by providing uniform names of drugs and preparations and working directions for their small-scale preparation when prescribed by physicians. Before 1940, the NF, like the USP, was revised every 10 years. After that date, new editions appeared every five years, with supplements issued periodically as necessary.

In 1975, the United States Pharmacopeial Convention, Inc. purchased the NF, unifying the official compendia and providing the mechanism for a single national compendium.

The first combined compendium, comprising the USP XX and NF XV, became official on July 1, 1980. All monographs on therapeutically active drug substances appeared in the USP section of the volume, whereas all monographs on pharmaceutical agents (excipients) appeared in the NF section. This format has been continued in subsequent revisions. The USP 23-NF 18, which became official in 1995, was the first edition to drop the use of roman numerals in favor of Arabic numerals to indicate the edition. The USP-NF became an annual publication in 2002 with USP 25-NF 20. The current edition is USP 35-NF 30.


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

Z-Pak Linked with Deadly Heart Risk
Azithromycin (Zithromax), widely used for bronchitis and other common infections, seems to increase chances for sudden deadly heart problems, a rare but surprising risk found in a 14-year study. It is more expensive than other antibiotics, but it's popular because it often can be taken for fewer days. However, study results suggest physicians should prescribe other options for people already prone to heart problems.

A Vanderbilt University study analyzed health records and data on millions of prescriptions for several antibiotics given to about 540,000 Tennessee Medicaid patients from 1992 to 2006. They found 29 heart-related deaths among those who took Zithromax during five days of treatment; their risk of death was more than double that of patients on another antibiotic, amoxicillin, or those who took none.
http://www.boston.com/lifestyle/health/articles/2012/05/16/antibiotic_linked_
with_rare_but_deadly_heart_risk/

United Kingdom Lawmakers Moving on Drug Shortages
Exporters selling drugs for higher prices internationally are causing shortages of medicines in Britain. The All-Party Pharmacy Group (APPG) says the government needs to consider ways to curb this so-called parallel trade, allowed under European Union rules and which can distort the distribution of prescription drugs. The action taken by drug manufacturers to try to solve the problem has made the situation worse, it involved introducing quotas for drugs in a bid to stop exports. The practice, called parallel trade, is also a headache for countries such as Greece where the government has slashed prices for certain medicines by up to a quarter as part of its austerity drive, leading to increased exports.
http://news.yahoo.com/uk-lawmakers-urge-action-medicine-shortages-070452108--finance.html

Sumatriptan and Naproxen Sodium Combo Helps Teens With Migraines
New research shows that a two-drug combination that relieves migraines in adults also works well in adolescents. There are no FDA-approved abortive [migraine] treatments for children. This is the first really large-scale abortive treatment study for adolescents. Treatment of children and adults with migraine are similar.

The study involved almost 600 teens and preteens, 12 to 17 years old and the drug group doses were 10 mg sumatriptan and 60 mg naproxen, 30/180 mg and 85/500 mg, respectively. Study results showed that between 23% and 29% of those who took one of the doses of sumatriptan/naproxen reported being pain-free within two hours of taking the drug vs. 10% in the placebo group.
http://consumer.healthday.com/Article.asp?AID=664671

India Vows Reforms After Probe Slams Drug Approval Process
India's health ministry has promised to review alleged irregularities in how it clears new medicines and to tighten existing rules on drug approval after a parliamentary investigation uncovered major flaws in the process. It has set up a special committee to review alleged irregularities and to propose measures to bring about "systemic improvements" in India's existing drug approval procedures. It has also tasked the committee to overhaul the workings of India's drug regulator, Central Drugs Standard Control Organization.
http://online.wsj.com/article/SB10001424052702304070304577397753036005824.html?mod=dist_smartbrief

Pharmacy Students Finding Weaker Job Market
In 2006, there was one pharmacy school in Tennessee (Memphis) and now there are six, including the new schools at Lipscomb, Belmont, and Union University, all graduating their first classes this spring. With all the new pharmacy schools in Tennessee graduating their first classes, some experts worry it may get harder to find jobs as the supply of new pharmacists exceeds demands. Belmont and Lipscomb universities in Nashville will graduate 149 new pharmacists into the workforce this month.

Both APhA and ASHP have both issued warnings about the rapid growth of new schools. The influx of new students is creating a serious shortage of qualified faculty and a heavy student debt load.
http://www.knoxnews.com/news/2012/may/13/pharmacy-students-finding-weaker-job-market/

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�that the first annular solar eclipse visible in the U.S. in nearly 18 years will occur on Sunday, May 20?

CREDIT: Hinode/XRT

If you are interested in "pictures from space," an outstanding free website is "Astronomy Picture of the Day," at: http://apod.nasa.gov/apod/astropix.html

Move west, young astronomer!
If you can, the first annular solar eclipse visible in the U.S. in nearly 18 years may be an event to share with your kids and grandkids. But before you buy tinted safety glasses or start making your pinhole projector (Never look at the sun with the naked eye!), you should know: When it comes to viewing the solar eclipse in the U.S., only those lucky folks who are west of the Mississippi River will be able to see a partially-eclipsed sun, according to NASA.
http://en.wikipedia.org/wiki/Solar_eclipse_of_May_20,_2012
http://www.space.com/15657-annular-solar-eclipse-occurs-may20.html

Violets are blue,
Roses are pink,
On graves of those,
Who drive and drink!
      Burma Shave

PCAB is proud to announce the following accreditations:

Lima's Professional Pharmacy 1, Eureka, California; Dr. Scott Lemmon, QCO; lemmon@suddenlink.net: Initial Accreditation for Sterile and Nonsterile Compounding.

Millers of Wyckoff, Wyckoff, New Jersey; David Miller, RPh, President; dmiller@millerspharmacy.com: Initial accreditation for Sterile and Nonsterile Compounding effective May 4, 2012.

Please join us in congratulating these pharmacies on their achievements.