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As announced last week, IJPC and CompoundingToday.com are starting a series on implementing USP <800>; our goal is to make it as simple and reasonable as possible.
Each week, we will take a "bite-size" chunk, review it, and provide information on its implementation. This will take a few months to cover, but we hope to do so painlessly and systematically. To begin, plan on retaining these newsletters and let's start with the following action items.
- Obtain a copy of USP Chapter <800> at:
https://store.usp.org/OA_HTML/usp2_ibeCCtpSctDspRte.jsp?section=12587&minisite=10020
- Set up a "USP <800>" Notebook and File to keep informational materials together.
- Go to http://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138.pdf and download a FREE copy of the current "NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014". You may want to set up a separate notebook for this because there will be updates, changes, etc., and it is wise to have them all in one place. We will discuss this in detail in a couple of weeks.
- Go to http://www.CompoundingToday.com and download a FREE copy of a USP <800> Gap Analysis for use in your facility that was written and reviewed by knowledgeable practitioners. We will discuss this as we go through the chapter over the weeks, so you may wish to add it to your notebook.
As we progress through the chapter, we will raise questions and accept questions from pharmacists to help clarify any item that may be vague. We will try to get answers to the questions and have a separate Q&A section in this newsletter as needed.
Next Week's Topic: Overview of USP <800>.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
Outrage Over Unaffordable Hepatitis C Treatment
Congress is looking into reasons why veterans are being denied a cure for hepatitis, the cure of which was developed by a doctor working for the Veterans Administration (VA). The doctor got rich, but at $1,000 a dose, the VA can't afford it. The target is Dr. Raymond Schinazi, who played a leading role developing a drug that cures hepatitis C; when he sold his company to pharmaceutical giant Gilead in 2012, he made over $400 million, and he did it all while working seven-eighths of his time for the VA. Schinazi said "So, I'm not full time -- what I do with my remaining time is up to me." Congress wants to know why Schinazi got rich, but the VA got nothing for a drug that one of its own doctors helped develop. "Is it bureaucratic incompetence or is it corruption, or is it a combination of the two?" Congress asked. Schinazi wasn't there to be questioned as he retired just two days ago; it was stated that "The person that's responsible always seems to retire before the investigation starts."
http://www.cbsnews.com/news/congress-outraged-over-hepatitis-c-treatment-va-cant-afford/
Compounder to Make Cheaper Alternative to Retrophin's Thiola
Compounding pharmacy Imprimis Pharmaceuticals Inc. plans to make a cheaper alternative to Retrophin Inc.'s drug, Thiola. Retrophin raised the price of the drug from $1.50 to $30 per tablet after buying the rights from Mission Pharmacal Co. in 2014, Imprimis said. Imprimis' compounded alternative may reduce the cost of the drug by more than 70% and will be available to patients in April.
http://www.reuters.com/article/us-imprimis-drugpricing-idUSKCN0VJ2D6
http://www.fiercepharma.com/press-releases/imprimis-pharmaceuticals-make-lower-cost-compounded-and-customizable-altern?
Possible Fraud Linked to Compounding Creams?
The U.S. Justice Department is investigating possible healthcare fraud involving half a billion dollars linked to compounding creams; an insurance program for veterans may have been the biggest victim. Marketing of these pain creams have surged recently thanks in part to a marketing blitz, including pitches by retired NFL quarterback Brett Favre; they have been promoted to the elderly, athletes, and others. Investigators are looking into allegations that some of the products provide little to no medicinal value, and that some pharmacies sent more product than was ordered, overbilled, or automatically refilled prescriptions without being asked. It has been reported that some companies charged more than $10,000 for a single tube or prescription of cream. The investigation is still in its early stages.
http://www.wsj.com/articles/u-s-probes-possible-fraud-linked-to-compounding-creams-1454790501
North Texas Pharmacy Accused of Paying Kickbacks to Physicians
A north Texas compounding pharmacy has been accused of paying illegal kickbacks to physicians for writing prescriptions. RXpress Pharmacy and related entities in the Dallas area also paid sales representatives commissions to market the pharmacy's services to doctors. These are similar claims to what federal authorities are examining in multistate criminal and civil investigations that have already resulted in indictments and multimillion-dollar civil settlements.
http://www.dallasnews.com/investigations/20160205-north-texas-pharmacy-in-federal-probe-is-accused-of-paying-kickbacks-to-doctors.ece
Syrspend SF and Syrspend SF Grape Suspending Agents by Fagron: FDA Alert-Microbial Contamination with Yeast
The FDA is alerting compounding pharmacies of a voluntary recall of certain lots of SyrSpend SF and SyrSpend SF Grape suspending agents used in compounding of various oral liquid drug products, due to the presence of yeast (Candida galli).
The SyrSpend SF lots include 15I21-U01-026920, 15J26-U05-027457, 15J26-U05-027473, 15I21-U01-027370, and 15J19-U05-027406.
The SyrSpend SF Grape lots include 15G29-U03-025975, 15A05-U03-022765, and 15A05-U06-023277.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor
HumanMedicalProducts/ucm485897.htm
Ipca Labs Cited for Rampant Data Falsification
FDA inspectors have cited data manipulation and falsification at three Ipca Laboratories plants in India showing that it was rampant at that company and enforced by senior managers in the quality-control unit to keep product supply flowing. The warning letter states that employees regularly deleted failed testing data from computers and overwrote them with data that indicated APIs and products met standards. In fact, one Ipca employee told inspectors, "if we find a failure, we set back the date/time setting and re-integrate to achieve passing results." The analyst told inspectors that deleting, overwriting, changing integration parameters, and altering PC date and time settings were done for raw materials, in-process testing, and finished API drugs, the letter says.
http://www.fiercepharmamanufacturing.com/story/fda-warning-ipca-labs-shines-light-rampant-data-falsification/2016-02-09
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