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Editorial: Documentation vs Opinion on Compounding Regulatory Activities IX

Here are additional sample 483 observations showing lack of United States Pharmacopeia (USP) Chapters <795> and <797> compliance. Some of these observations require attention and correction, as appropriate and applicable, by the inspected pharmacies.

Observations: (Inappropriate Clothing/procedures for the Duties Being Performed)

1. Sleeves are touching the ISO 5 working surface.
2. Shoes and scrubs are stored in an open rack in the bathroom.
3. The forehead, eyes, necks, arms, and/or beard hair are exposed.
4. Hoods and goggles are not used.
5. (?) Nonsterile hairnets, beard covers, facemasks, and disposable lab coats are used.
6. (?) There are no written procedures for sterilizing gowns.
7. Street clothes are not completely covered by the gown.
8. There are no written procedures for proper gowning.
9. Non-shedding foot covers are not being used.
10. Sterile cloth gowns re-used throughout the day without sampling of the sleeves.
11. Open packages of gloves are in the gowning area; no controls to prevent their use in aseptic operations once sterility is compromised.
12. (?) There is no mirror in the gowning room to ensure proper donning of sterile clothing.

Over 1600 International Online Pharmacy Websites Seized
U.S. and international regulators have seized more than $41 million in illegal pharmaceuticals world wide and shut down 1,677 websites as they try to control counterfeit drugs sold over the Internet. The FDA uses federal court warrants to seize website domain names and post messages letting visitors know that people who traffic in counterfeit drugs may face severe penalties under federal law. Also, the message offers a link to a site-www.fda.gov/BeSafeRx-that explains the risks of fake online pharmacies.
http://www.washingtonpost.com/business/international-online-pharmacy-crackdown-shutters-1677-websites-seizes-41m-in-illegal-drugs/2013/06/27/de762e72-df64-11e2-8cf3-35c1113cfcc5_story.html

Residents in Maine Now Able to Import Drugs From Foreign Pharmacies
Maine residents can now purchase prescription drugs from mail-order pharmacies in Canada, the U.K., New Zealand, and Australia. Known as the "Act to Facilitate the Personal Importation of Prescription Drugs From International Mail-Order Pharmacies," the bill now enables purchasing drugs from mail-order pharmacies. Drug companies are selling the same drugs through other countries for less than they do here in the U.S., and the issue is too important for people to pay more for life-saving medicines.
http://www.pharmalive.com/maine-residents-can-now-import-drugs-from-foreign-pharmacies

Prescription Pain Med Overdose Deaths Spike Among Middle-aged Women
A growing public health epidemic is occurring right before our eyes. Drug overdose deaths rose among women, according to a CDC report, focusing on prescription opioids like OxyContin. The prescription drug overdose death rate of women increased 400% from 1999 to 2010, compared with an increase of 250% for men; more men die of prescription analgesic overdoses—about 23,000 in 2010, compared with 15,300 for women. However, women are catching up.
http://www.usatoday.com/story/news/nation/2013/07/02/drug-overdose-deaths-women/2483169/

China Police Probe Staff of Britain's GlaxoSmithKline
In China, Chinese police are investigating the senior staff of British drug firm GlaxoSmithKline (GSK) for suspected "economic crimes." A Hong Kong newspaper said police had detained company employees in three cities: Changsha, the commercial hub Shanghai, and Beijing. The exact nature of the allegations was not specified, but authorities typically use the phrase "economic crimes" when referring to corruption. Industry insiders say that it is common practice for Chinese pharmaceutical firms to offer doctors and hospitals bribes to have their products used.
http://www.channelnewsasia.com/news/business/international/china-police-probe-staff/730392.html

FDA Approves First Non-hormonal Treatment for Menopausal Hot Flashes
The FDA has approved Noven Therapeutics LLC's drug to treat hot flashes associated with menopause—a surprise decision, as an advisory committee to the regulator had voted against its approval. The drug, Brisdelle, is the first approved, non-hormonal treatment for hot flashes, the FDA said in a statement. The generic name for Brisdelle is "paroxetine" and another brand name product, "Paxil." In March, advisers to the FDA voted against Brisdelle, concluding that it did not show enough benefits to offset the risks.
http://www.reuters.com/article/2013/06/28/noven-fda-menopausedrug-idUSL3N0F43NU20130628

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Drugs in Use: Case Studies for Pharmacists and Prescribers
5th Edition
Dodds LJ, ed.
June 2013; Paperback; 736 pages; $69.00

This book provides evidence-based medicine and illustrates how one can optimize drug therapy in response to the needs of individual patients. Covered by about 40 authors, the book consists of 33 chapters covering, among other topics, hypertension, ischemic heart disease, myocardial infarction, stroke, diabetes, kidney injuries, asthma, peptic ulcer, osteoporosis, epilepsy, depression, dementia, substance misuse, oncology, eczema, and psoriasis. Cases are provided along with answers and comments. This is a very interesting and applicable book for pharmacy practice today.

�that during the July 4th time of celebration, it is important to reflect on the standards upon which the currently greatest nation in the world was founded? It is also important to be aware of the loss of these standards as we observe our nation declining in its position of economic strength and social standards for the world.

Be informed! Be active! Keep aware of what is going on professionally, politically, socially, and economically; it's your nation too! Remember, the squeaky wheel gets the grease!

My job is
Keeping faces clean,
Nobody knows,
De stubble I've seen.
      Burma Shave

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

The Compounding Shoppe, Birmingham, Alabama; Scott Wepfer, RPh, scottwepfer@gmail.com. Re-accreditation for Nonsterile Compounding

Hometech Advanced Therapies, Inc., Sharon Hill, Pennsylvania; Kelly Corl, RPh, kjcorl@ram-capital.com. Initial Accreditation for Sterile Compounding