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Editorial: New Series in the International Journal of Pharmaceutical Compounding Beginning January/February 2014!
Beginning with the January/February 2014 issue of the International Journal of Pharmaceutical Compounding (IJPC), we will be starting three new series, including (1) Sterile Compounding, (2) Laboratory Testing, and (3) Tips for Compounding.
Sterile Compounding will be an educational series authored by Laura Thoma of the University of Tennessee College of Pharmacy. Laura is the Director of the Plough Center for Sterile Drug Delivery Systems and Professor, Department of Pharmaceutical Sciences. She teaches the hands-on training program in aseptic processing for the pharmaceutical industry, and this program is also available for compounders who do high-risk level compounding on a medium to large scale, anyone that sterilizes by steam or hot air, or does depyrogenation. This is the 50th year for this program. One can learn more about the author by checking out Plough Center's website at www.ploughcenter.com.
Laboratory Testing will be authored by Drs. Tom Kupiec and Nicole Vu and staff. This series will cover issues that laboratories are confronted with to serve both GMP manufacturers and GCP compounders and interfacing with the FDA. This series will start with issues related to USP <71> Sterility Testing.
The third new series will be "Tips for Compounding Pharmacists" and will cover various tips that can be used to enhance quality compounding. It will cover both nonsterile and sterile compounding and will be presented both in print and with the use of animated technology.
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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Bupivacaine and Propofol Recalled by Hospira
Metal particles have been found in vials of one lot each of bupivacaine and propofol from Hospira Inc. They confirmed a complaint of the presence of iron oxide in 30-mL glass vials of Marcaine brand 0.25% bupivacaine hydrochloride injection, lot 25-220-DD. The lot in question consists of single-dose, preservative-free vials with an expiration date of January 1, 2015. The other recalled product is propofol injectable emulsion, 1%, lot 27-570-DJ, packaged as 200 mg in 20-mL glass vials with an expiration date of March 1, 2015; this lot was recalled after the company detected particulates composed mostly of iron in a retained sample.
http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=3975
Big PhRMA and the Rx Import Law
Maine's new law allows for the importation of prescription drugs via Internet pharmacies. This has the drug industry concerned that its image is about to take another hit. The state of Maine says it's about cost, but the Maine Pharmacy Association (PhRMA) says it concerns patient safety. Maine's law reflects a first-of-its-kind departure from federal restrictions on drug imports. The law allows the direct purchase of drugs from online pharmacies located in Canada, New Zealand, Australia, and the UK. PhRMA, various Maine pharmacy and retail groups, and independent pharmacies filed suit in September seeking to nullify the law after their entreaties to the FDA and the Drug Enforcement Administration failed to elicit a reaction. The lawsuit contends the state law violates a provision in the 1938 FD&C Act strictly prohibiting importation of foreign drugs unapproved by the FDA.
http://www.fdanews.com/newsletter/article?issueId=17282&articleId=159687
Drug Disposal
Alameda County has a prescription drug disposal program with a couple dozen locations, including pharmacies, police, and fire stations where bins are available for the collection of everything from narcotics to inhalers. A county ordinance requiring pharmaceutical manufacturers to design and pay for a comprehensive drug take-back program has been introduced, as they say that this is not something taxpayers should be paying for. The thinking behind this new bill is that when products have reached their lifecycle, it should be the responsibility of the manufacturers to have a way of properly disposing of those products. In the U.S., even though some states and the federal government have considered similar measures, no such bills have been passed. PhRMA is not necessarily opposed to take-back programs; however, if pharmaceutical companies have to pay for them, the costs will be passed on to consumers.
http://www.capradio.org/articles/2013/10/22/california-county-takes-on-pharmaceutical-companies-over-drug-disposal/
FDA Presents Their Approach to Personalized Medicine
The FDA has outlined its approach for regulating new personalized therapies and devices. Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development, outlines the fundamental ways in which the FDA has modified its traditional approaches to drug and device regulation in the new era of products that are tailored toward specific patient subtypes, rather than broad diagnostic groups.
"We're very, very excited about this report because I think it captures the broad context of what's happening in science and medicine today and the role of the FDA as we enter the era of personalized medicine, and for us, personalized medical product development," FDA commissioner Margaret A. Hamburg, MD, said in a press briefing held at the FDA headquarters.
With the advances in science and technology and the understanding of both the underlying mechanisms and the human response to disease, there are now so many more opportunities to target therapies in exciting ways and really improve the care that can be offered and the effectiveness of treatments. With the approval of trastuzumab (Herceptin, Genentech) for the treatment of HER2-positive breast cancers, the FDA has approved more than 100 drugs that contain specific information about biomarkers in the labeling. Recently, the FDA has approved 4 different cancer drugs for use in patients with tumors that have specific genetic characteristics that are identified by companion test kits. Two recent approvals also demonstrate the extent to which science and technology are advancing personalized medicine and influencing the way the agency does business. Kalydeco (Vertex Pharmaceuticals), is the first-ever drug to address the underlying cause of cystic fibrosis among patients with a specific gene mutation.
http://www.medscape.com/viewarticle/813401
Detect Untruthful, Misleading Drug Ads by Participating in an FDA New Program!
The FDA has launched an online learning course aimed at educating healthcare professionals about potentially untruthful or misleading drug ads and promotional materials. The e-learning course offers continuing education credits for healthcare professionals. Medical, pharmacy, nursing, and other healthcare-related schools are encouraged to incorporate these cases into their coursework. The program covers a range of promotional materials including a website, journal ad, and TV ad, and touch upon numerous promotional practices that don't comply with our regulations.
http://www.drugstorenews.com/article/fda-introduces-e-learning-program-about-untruthful-misleading-drug-ads
FDA's Shorter Drug Approval Times Questioned
New drugs receiving an expedited review by the FDA are being tested on fewer patients, leaving many safety questions unanswered even after they are approved. The reported study examined the development times, clinical testing, and risks associated with 20 new drugs approved in 2008; eight were given expedited review and 12 standard review. Expedited drugs underwent a median of 5.1 years of clinical testing before being approved, compared with 7.5 years for those that underwent a standard review. Also, in many cases, safety monitoring trials that were supposed to be conducted after the products were approved were either not conducted, not completed, or not submitted to the FDA.
http://www.reuters.com/article/2013/10/29/us-usa-fda-jama-idUSBRE99R12920131029
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