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Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, July 1, 2014
Novartis Unit Charged By Japan Over Research Data
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2014 Pharmacy Creations 6/23/14--warnings regarding this practice in a Warning Letter issued on October 31, 2006, and in a meeting with FDA on June 11, 2008. Domperidone is not the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, nor is it a component of an FDA-approved human drug product, nor does it appear on a list developed by the Secretary under section 503A(b)(1)(A)(i)(III) of the Federal Food Drug, and Cosmetic Act (FDCA) [21 U.S.C.§353a].
Second Question of the Day July 1, 2014 How many times does an animal or human take a compounded medication based on preference of the patient or the doctor? Is this a valid, legal reason?
How many times does a doctor prescribe a compound simply because he or she prefers a compounded preparation nor because their is a legitimate basis for the compounded preparation? How many times does the doctor provide false documentation for the compounded preparation? Shouldn't the justification be patient-specific rather than a general theory such as all kids have trouble taking pills so the medication needs to be made into a sucker. This general statement is false: some kids can take pills; some can't. Likewise, a general statement that animals are hard to give pills should not be a valid basis. For example, I have been successful giving most of the cats I have owned pills and in fact sometimes the pills are easier to give to a cat than a liquid preparation in a dropper. Should it be a valid basis simple because a doctor thinks the compounded preparation works a little better than the commercially available even though the commercially available still works? For example assume there is a commercially available drug to treat infertility in females. In studies, it works 90 percent of the time and the female ends up having a baby. Assume also compounding pharmacies make a very similar if not identical commercially available drug to treat infertility in females. Studies by compounding groups suggest this preparation works 95 percent of the time but of course the studies required by the FDA for the drug to be approved and commercially available have not been done. The patient has never tried the commercially available or the compounded preparation. The doctor prefers the compounded preparation because he likes to help the pharmacist stay in business so he or she always prescribes it. Problems? Legal? Illegal? Should the doctor be prosecuted? Fined? Should the pharmacist who clearly knows what is happening be prosecuted? Fined? How can it be patient-specific and valid when the patient has no idea if the commercially available will work? What if the patient tries the commercially available for six months with no success and then the doctor prescribes the compounded medication? Doesn't this change the legality of the prescription, but again how many times is this being done in actual practice?
One Way Drug, LLC (dba Partell Specialty Pharmacy), Las Vegas, NV 5/30/2014
One Way Drug, LLC (dba Partell Specialty
Pharmacy), Las Vegas, NV
- 483 Issued 5/30/2014119 (PDF - 1.3MB)
Express Scripts Ends Coverage for 1,000 Compound Drug Ingredients
The latest, and perhaps, the most drastic response comes from Express Scripts ESRX -0.38%, which this week will begin blocking coverage for approximately 1,000 active ingredients – an assortment of ointments, creams and powders – that are widely used by compounding pharmacies to create countless topical treatments, an Express Scripts executive tells Pharmalot.
Over the past two years, Express Scripts has seen the number and cost of prescriptions for compounded medicines used for treating scars, wrinkles and pain rise dramatically.
For instance, the average cost for each prescription rose to $1,100 from $90, and for about a dozen such medications, the actual cost jumped by more than 1,000%. Consequently, the amount spent by its clients for compounded drugs increased to roughly $171 million in this year’s first quarter, up from $28 million during the comparable period in 2012.
“It’s an issue of waste,” says Glen Stettin, senior vice president for clinical, research and new solutions. “For nearly all of these products, there’s already a commercial preparation already available – a generic or brand-name product approved by FDA. And there is no evidence to support their use at all.”
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