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Editorial: Documentation vs Opinion on Compounding Regulatory Activities VII

Here is more on the series looking at some of the U.S. Food and Drug Administration (FDA) 483 reports and observations of State Boards of Pharmacy. We will continue this week listing some of the observations that show lack of compliance with United States Pharmacopeia (USP) Chapters <795> and <797> that require correction by the inspected pharmacies. Please use this series as a review and reminder to all personnel involved in compounding sterile preparations. We will continue our coverage over the next few weeks of this vitally important topic.

Observations: (Equipment Issues; Sterility Testing)

1. Brownish areas (rust?) were observed below air vent on hood and on surface of steel table in cleanroom.
2. Spills and splatters were observed on heating plate and transparent air guard.
3. The ceiling was cracked and peeling.
4. The sink in the International Organization for Standardization (ISO) 7 room was rusted.
5. Tape was used to attach clipboards to outside of ISO 5 total parenteral nutrition (TPN) hood.
6. Sterilization equipment was not validated (verified) for its intended purpose.
7. An 8-inch crack was observed on the wall of the laminar airflow hood (LAFH).
8. Dried-on spray residue was observed on the inner walls.
9. Brown residue was observed on the grate covering the HEPA filter of the ISO 5 workstation.
10. No comparison studies were conducted with manufactured testing on in-house sterility testing.
11. No determination was made of the root-cause failure issues.
12. No review was performed of the batch failure issues.
13. No quality control is in place on the anticipatory compounded preparations.
14. No records for each component were used in a batch of compounded preparation.
15. There was insufficient monitoring of the sterilization cycle.

Massachusetts's Harvard Pilgrim Health Care to Stop Coverage of Compounded Drugs for Adults
Massachusetts's second largest health insurer will soon stop covering compounded drugs because of cost and safety concerns; the decision takes effect August 7. Dr. Michael Sherman, the chief medical officer at Harvard Pilgrim, said the policy applies only to adults. They will consider appeals on a case-by-case basis. The insurer said 4,200 of its members over age 18 have filled a prescription for a compounded medication in the last six months. Their review found that most of the claims it received from patients for compounded drugs were for medications that should not be covered by a health insurer, including cosmetic, anti-aging, weight loss, and homeopathic remedies. Sherman stated, "This is not about denying care. It's about eliminating costs that don't add value." Harvard Pilgrim will continue to cover compounded drugs for those under age 18 because the company's review found appropriate use of the drugs in children.
http://bostonherald.com/business/healthcare/2013/06/mass_insurer_ends_coverage_
of_compounded_drugs

Generic Drug Deals Issue Decided by Supreme Court
Pharmaceutical companies that pay rivals to keep less-expensive generic versions of best-selling drugs off the market can now expect greater federal scrutiny. In a 5-to-3 vote, the justices effectively said that the Federal Trade Commission can sue pharmaceutical companies for potential antitrust violations, a decision that is likely to increase the number of generic drugs in the marketplace and benefit consumers. The decision may shift the balance of power to the generic companies, industry analysts said.
http://www.nytimes.com/2013/06/18/business/supreme-court-says-drug-makers-can-be-sued-over-pay-for-delay-deals.html?_r=0

The Smartphone and Your Medical Records
Medicare Blue Button, a computer program that allows patients to download their medical history into a simple text file on smartphones and personal computers holds a glimpse of the future. The third-party applications that you download help organize your medical history information.

For veterans and Medicare beneficiaries, the Blue Button service is available from the federal government. The delaying factor is that before a patient can download medical information to a computer or a smartphone, the files must first be stored electronically. While there has been a sharp increase in the number of hospitals and doctors using EHRs, a complete electronic system is a long way off. The federal goal is to encourage patients to be more involved in managing their own health, and making medical records and test results accessible to smartphones is in line with those policy goals.
http://www.kaiserhealthnews.org/Stories/2013/June/17/electronic-health-records-blue-button.aspx

HPV Vaccine Recommendation Terminated by Japan
The Health Ministry of Japan has removed its recommendation for HPV vaccinations after hundreds of reports of side effects, including numbness and long-term pain problems, among other issues. The government wants to start investigations on the safety of the vaccine.
http://www.expertbriefings.com/news/japan-terminates-recommendations-for-hpv-vaccines/

FDA Investigating Two Deaths Following Injection of Zyprexa
The FDA is investigating two unexplained deaths in patients who received an intramuscular injection of Zyprexa Relprevv (olanzapine pamoate). The patients died 3 to 4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS). Both patients were found to have very high olanzapine blood levels after death. Under the REMS, patients must receive the Zyprexa Relprevv injection at a REMS-certified health care facility, be continuously monitored at the facility for at least 3 hours following an injection, and be accompanied home from the facility.
http://www.fda.gov/Drugs/DrugSafety/ucm356971.htm

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�that summer begins today? This year's summer solstice, the longest day of the year in the northern hemisphere, occurs on Friday, June 21, 2013. The solstice marks the point of the year when the northern hemisphere is tilted the most towards the sun and marks the official first day of summer. If you believe in a flat earth, it marks that time of year when the giant dragon that wheels around the earth takes a smoke break (or something along those lines)!

Window film can save money during the hot summer months. Many are not aware that the windows of a pharmacy are the source of significant heat, as well as light, and can result in faded packaging and increased cooling bills. Window film is widely used in airports, businesses, and homes and will pay for itself over time. It is available in different shades, allows light in, and blocks many of the harmful rays. It might be worth a consideration!

Extended Stability for Parenteral Drugs
Fifth edition
Bink CD, Nowobilski-Vasilios A
American Society of Health-System Pharmacists, Bethesda, MD
2013; 326 pages; 8.5 � 11" format

The preface states: "The scarcity of published and/or labeled stability data beyond 24 hours at any temperature has been a historically complicating factor in the care of patients in the alternate care site." This fifth edition is part of a continuing drug information project focused on identifying, reviewing, and compiling relevant available information in a concise format. The new edition contains 160 stability monographs, and some monographs contain new information for a number of additional container types and for elastomeric infusion device brands.

Salesmen, tourists,
Camper-outers,
All you other
Whisker-sprouters,
Don't forget your
      Burma Shave

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

Diplomat Specialty Pharmacy, Flint, Michigan; Trudy Thedford, RPh, tthedford@diplomatpharmacy.com. Initial Accreditation for Sterile and Nonsterile Compounding