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Editorial: Documentation vs Opinion on Compounding Regulatory Activities V

This continues the series looking at some of the 483 observations and Board of Pharmacy activities. This week we will list some of the observations that show lack of compliance with United States Pharmacopeia (USP) <795> and <797> and require correction by the pharmacies. This can be used as a tool to have all those involved in sterile compounding to review their SOPs and actual practices that involve each of these observations. We will cover more of these over the next few weeks.

Observations:

1. Improper sanitization of hands after touching unsanitized objects.
2. Working over equipment in a way that obstructs air flow.
3. Gloves are not sanitized sufficiently frequently in the course of a procedure.
4. The frequency of glove replacement is not defined in the SOPs.
5. Leaning inside front edge of the LAFH with exposed face while processing injectables.
6. Trash/sharps containers and other items are placed against the air intake of the hood.
7. Resting the hands and elbows on the work surface of the LAFH without re-sanitizing.
8. No filtration step done during the final filling of containers for sterile injectables.
9. Insufficient sanitizing of packaging components.
10. Wiping the bare skin with gloved hand and not changing gloves.
11. Kneeling on hands and knees on the cleanroom floor and not re-gowning or changing gloves.
12. Donning gloves inside the ISO Hood.
13. Employee not wearing sterile hood, goggles, hair net, or face mask.
14. Leaving the cleanroom to retrieve materials while still wearing the gown; not re-gowning on re-entry.
15. While washing hands, failure to let water run from fingertips to elbows.
16. White particles of powder on floor of cleanroom.
17. Employee wearing in-ear headphones; the cord comes in contact with the ISO 5 working surface.
18. Simulation process is not similar to the routine filling processes.
19. Failure to handle/store components in a manner to prevent contamination; component exposed to unclassified air.
20. No additional sanitizing steps after multiple entries into a multidose vial.

Expensive Makena Making a Comeback
K-V Pharmaceutical Co. was in bankruptcy court last year amid disappointing sales of its flagship medicine Makena and an outcry over the drug's high price. Today, however, sales of Makena are surging. Although K-V slashed the price of the drug by half, a bigger reason for the gains, say many physicians, is an aggressive K-V campaign touting Makena as a safe alternative to cheaper versions of the drug made by compounding pharmacies. K-V is promoting its drugs by raising concerns about the safety of compounded medicines and reminding them of the potential for malpractice lawsuits should their patients fall ill after using a drug prepared by a compounder.
http://online.wsj.com/article/SB10001424127887323398204578486823468922276.html?cb=logged0.8107529012258263

Importation of Injectable Nutrition Drugs Allowed by FDA
The U.S. FDA announced that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the U.S. and available to patients. This action addresses shortages of drugs needed to treat premature infants, patients unable to eat or drink. The FDA is exercising regulatory discretion for Fresenius Kabi to import trace elements and phosphate injection from its Norway plant so the drugs can reach Americans in need. Other manufacturers of TPN components, including Hospira are also working to increase supplies of these critical drugs.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm354272.htm

Olympia Pharmacy Recalling Sterile Compounded Preparations
Olympia Pharmacy has notified the public of a voluntary multi-state recall of all sterile drugs compounded by the pharmacy that have not reached their beyond-use date listed on the label. The recall is due to concerns associated with prior quality control procedures impacting sterility assurance. The recall includes all sterile preparations Olympia Pharmacy supplied to patients and offices of licensed medical professionals with a use-by date of 09/25/2013 or earlier. To date, the company has received no reports of injury or illness associated with the use of the affected products.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm354614.htm

Older Drugs More Effective than New Drugs
Even after spending more than $50 billion annually since the mid-2000s to discover new medications, PHARMA companies have barely improved on old standbys developed decades ago. Newly published research shows that the effectiveness of new drugs, as measured by comparing the response of patients on those treatments to those taking a placebo, has plummeted since the 1970s. The consequences for the pharmaceutical industry could get worse under the new healthcare law that established an independent research institute to compare the effectiveness of different treatments for the same condition. If the study is correct, then "comparative effectiveness research" could conclude that older drugs, which are more likely to be generics, are better than pricey new brand names that deliver the most profits for drug makers.
http://www.reuters.com/article/2013/06/03/health-drugs-effectiveness-idUSL2N0EC1E720130603

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�that the unfortunate events leading to deaths and recalls of compounded preparations should never have occurred; and would not have occurred if total compliance to USP and state board of pharmacy standards were strictly followed?

One should not be involved in pharmaceutical compounding if not adequately trained, prepared, and working in USP-compliant facilities.

'Twould be more fun,
To go by air,
If we could put,
These signs up there!
      Burma Shave

The University of Tennessee Plough Center for Sterile Drug Delivery, formerly known as the Parenteral Medications Laboratories, has been the "gold standard" for training industry pharmacists in aseptic processing for 40 years. The Center is also open to compounding pharmacists desiring high-level training in sterile compounding.

This 40-hour course ("The Comprehensive Industrial Course in the Preparation of Parenteral Products") is offered four times a year. Participants work in teams to prepare a small volume parenteral (SVP) product and perform relevant quality-control tests and environmental evaluations. Emphasis is on sterilization processes and proper procedures and techniques employed in aseptic processing.

With more than 24 hours of hands-on training, the lab program provides experience in planning and preparation of SVP dosage forms. Each team consisting of no more than five members, will compound and aseptically fill a protein formulation, which will then be lyophilized. The team will also perform the sterility test in an isolator, the bacterial endotoxin test, and the particulate matter test. Other experiences will include autoclave validation, environmental monitoring, filter integrity testing, and visual inspection of liquid and lyophilized vials.

Dates: Future dates for the course include July 22-26, 2013 and October 28-November 1, 2013. All courses are held on the campus of the University of Tennessee, Memphis. For more information, please go to:
http://www.uthsc.edu/pharmacy/parenterals/