Compounding This Week Newsletter from www.CompoundingToday.com
Brought to you by the International Journal of Pharmaceutical CompoundingHeader
July 12, 2013 Volume 10, Issue 28
  In This Issue
 
  Classifieds

To place a classified advertisement please contact: Lauren Bernick lbernick@ijpc.com or 405-513-4236

 
  About
  CompoundingToday
 
  Free Resources
 
  Subscriber
  Resources
 
Associates of Cape Cod - For a rapid and cost-effective endotoxin testing solution.
 
Receive a free compounding CD with new subscription to IJPC.
 
Don't take any chances with USP <797> compliance.
 
Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor

Editorial: Documentation vs Opinion on Compounding Regulatory Activities X

The following are more sample 483 observations showing lack of United States Pharmacopeia (USP) Chapters <795> and <797> compliance. These serve as a good review to confirm compliance in each facility. Some of these observations require attention and correction, as appropriate and applicable, by the inspected pharmacies.

Observations: Temperatures, Storage and Equipment Calibration

  1. Thermometers for refrigerators, autoclave, depyrogenation oven, and incubator are not calibrated.
  2. Preparations to be refrigerated or protected from light left out on countertop all day.
  3. Preparations containing light-sensitive ingredients are placed in clear plastic containers.
  4. Temperatures too high or too low in incubators.
  5. No temperatures recorded at all.
  6. SOPs do not require calibration/testing.
  7. Balances not disinfected between operations; debris found in the crevices.
  8. Sterilization equipment not calibrated to ensure proper operation.


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

 
News

Cyclosporine in Allergic Conjunctivitis
Topical cyclosporine in the treatment of symptoms of allergic conjunctivitis may help patients reduce their dependency on steroids. Affecting an estimated 20% to 30% of the world's population, allergic conjunctivitis' symptoms include tearing, itching, discharge, and photophobia. Primary treatment has included topical corticosteroids, but prolonged use can result in elevated intraocular pressure with subsequent glaucoma, cataract, and increased susceptibility to microbial infection, leading to associated visual morbidity. Although cyclosporin may not replace corticosteroids, it may be considered when a steroid-sparing agent is needed.
http://www.medscape.com/viewarticle/807500

Intranasal Oxytocin Looks Promising for Migraine
Results of a small study of oxytocin administered intranasally indicate that it may be helpful in the management of chronic migraine. The single-dose, placebo-controlled, double-blind study found the oxytocin to be safe and highly effective.
http://www.medscape.com/viewarticle/807277

Kovacaine Mist Nasal Spray as Dental Anesthetic
Oral anesthetic injections in the dentist's chair could soon become a thing of the past. In clinical tests, Kovacaine Mist Nasal Spray was found to be as effective as standard anesthetics in four out of five patients. About 75% of U.S. adults reportedly experience some degree of dental fear.
http://www.nydailynews.com/life-style/health/nasal-spray-replace-needles-dentist-chair-article-1.1391253

Chinese Clinical Trial Misconduct Delays Drugs
U.S. pharmaceutical companies have increasingly been using China for large clinical trials because they're cheaper and there's a larger population of subjects. However, now U.S. regulators have stepped in, questioning sloppy data and irregularities from the world's most populous country. Errors show a pattern of inadequate trial conduct and oversight. Companies will keep having problems with sloppy data and misconduct as long as they keep doing trials in places like China without providing better oversight, said an FDA medical team leader.
http://www.bloomberg.com/news/2013-07-09/chinese-trial-misconduct-delayed-bristol-myers-medicine.html

India Officials Halt Mylan Takeover of Agila
Concerned that ownership of some pharmaceutical companies are falling into foreign hands, the Department of Industrial Policy and Promotion (DIPP) of India has halted plans for U.S.-based Mylan to acquire Agila Specialties, the injectable division of Bangalore-headquartered Strides Arcolab.
http://articles.economictimes.indiatimes.com/2013-07-08/news/40443276_1_agila-specialties-onco-therapies-dipp

Florida Pain-clinic Database May be Abolished
Two years ago, the Florida Prescription Drug Monitoring Program was initiated; now, the governor has tried to kill it, lawmakers won't fund it, and few use it. The program is the subject of new criticism, legal action, and calls that it be overhauled—or abolished.

The Florida Department of Health is discussing further limiting access to records of who writes and fills prescriptions for the most addictive drugs; this action coming in response to allegations that medical data for 3,300 Floridians had been "leaked."
http://www.miamiherald.com/2013/07/06/3488469/statewide-pain-clinic-database.html

Hospital Alarms Pose Patient Risks
A ventilator honks loudly; an infusion pump emits a high-pitched beep-beep every six seconds; a blood pressure monitor pushes out one long tone after another, and other alarms emit from various types of equipment. Most of the noises are false alarms or don't require action; however, up to several hundred alarms per patient per day can cause alarm fatigue and healthcare personnel can become overwhelmed or desensitized by the constant barrage. This sometimes results in their volume being turned down or even shutting them off or ignoring them—actions that can have serious, potentially fatal, consequences.

The Joint Commission has now directed facilities to make alarm safety a top priority or risk losing their accreditation. The FDA received 862 death reports associated with alarms in the seven years that ended December 31, 2012, but the reports provide little information about what happened and don't necessarily mean that alarms contributed to the deaths.
http://www.washingtonpost.com/sf/feature/wp/2013/07/07/too-much-noise-from-hospital-alarms-poses-risk-for-patients/

 
IJPC Now on Facebook

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding

 
Book Review

Compounding Guide for Ophthalmic Preparations
McElhiney LF, PharmD, BS Pharm, FIACP, FASHP, FACA
2013; APhA; Washington DC; 259 pages

Finally, an updated ophthalmic preparations compounding resource! For many years, the only book devoted to ophthalmic compounding was the out-of-print Extemporaneous Ophthalmic Preparations by L.A. Reynolds and R.G. Closson. Now, pharmacists and ophthalmologists have a complete guide to preparing quality compounded ophthalmic medications. This single-source, user-friendly reference contains 176 drug monographs; the monographs provide up-to-date stability information based on reliable references and published stability studies. The first four chapters provide background information; the compounding monographs begin in chapter 5 and continue through chapter 9. The various monograph chapters cover ophthalmic topical liquids, ophthalmic ointments, ocular injections, human blood-derived preparations, and hazardous and biohazardous materials. This easy-to-use book is a must for any compounding pharmacy involved in compounding ophthalmic preparations.

 
Did You Know ...

�that during the summer months many state pharmacy associations conduct their annual conventions? These are great opportunities for getting caught up on news, activities, friends, social gatherings, and professional activities.

 
Tip of the Week

Participate in your state association annual meetings�you'll be glad you did! We all need each other; we are all a part of the pharmacy profession!

 
Looking Back

Oh Burma-Shave!
The schoolboy cried,
At least I'll smell,
As if I tried!
      Burma Shave

Copyright 2013
International Journal of Pharmaceutical Compounding, Inc.
122 N Bryant Ave, Edmond OK 73034
Manage my Email:
Subscribe / Un-Subscribe
Comments or Questions:
info@compoundingtoday.com
Reprints & Permissions: Reprints@ijpc.com