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Last week, we finished looking at the "Final Guidances" for 503A pharmacies.
This week we will begin looking at the "Draft Guidances" for 503A pharmacies. These draft guidances are NOT FINALIZED; when they become finalized, they will represent the current thinking of the FDA on the specific topics.
Copies can be obtained free of charge at the URL listed below each one. The complete list of final and draft guidances for both 503A and 503B facilities is available at:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatory
Information/Guidances/ucm452240.htm
503A DRAFT GUIDANCES
Following Thanksgiving, we will start looking at the Draft Guidances individually.
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
Just Released: U.S. GAO Report on Drug Compounding
For a copy of the just-released report, go to:
http://www.gao.gov/products/GAO-17-64
West Virginia Pharmacy Implements Genetic Testing
Fruth Pharmacy of Point Pleasant, West Virginia has launched the Rxight pharmacogenetic program for patients. It includes a genetics test to reduce the potential for adverse drug reactions. Pronounced "Right," Rxight is described by its manufacturer as the broadest, most comprehensive pharmacogenetic program available. It was developed by MD Labs, a CLIA certified high-complexity laboratory. The program is designed to help determine if the medications people take and the dosage levels are right for them based on their DNA. It covers over 200 prescription and over-the-counter (OTC) medications; it provides information on medications covering 14 therapeutic classes, including pain, blood pressure, blood thinner, ADHD, anxiety, depression, diabetes, cancer, respiratory issues, and other medications. This program is an aid in individualizing patient therapy rather than using the "one size fits all" approach.
http://www.drugstorenews.com/article/fruth-pharmacy-rolls-out-genetic-testing
(Editor's Note: This activity combined with pharmaceutical compounding can better personalize and enhance individualized drug therapy.)
Robot-dispensing Use On the Rise
The UCSF looks after about 600 patients on a typical day, and each of those patients, on average, take 10 different medications during their stay. An excess of 200 staff ensure patients receive their prescriptions, but, behind the scenes, is a group of pharmacy robots sorting through various medications, picking drugs in the proper dosages, and packaging them for nurses to administer.
At hospital pharmacies, robots (like the PillPick-manufactured by SwissLog) pick, package, and dispense individual dosage units, often barcoded to confirm the dispensing of the correct medication. After verification by pharmacists, the drugs are sent to the patients. Reports suggest that the global pharmacy automation market was valued at $3.5 billion in 2015 and will increase to $5.5 billion in 2021.
http://www.cnbc.com/2016/11/15/duane-reades-need-for-speed-pharmacy-robots-are-on-the-rise.html
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Tip of the Week
Why not take this opportunity to work for the profession to minimize the FDA's self-expansion and intrusion into the states' responsibilities for governing the practice of pharmacy, including pharmaceutical compounding? The increased regulations and standards are not scientifically based, have no impact studies related to their implementation, and are severely impacting patient access to individualized compounded medications! What good are overly rigid standards if patients are made to suffer because of them? Whatever happened to "common sense" regulations and standards?
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