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
Saturday, November 23, 2013
18th Question of the Day November 23, 2013 How much will a doctor, dentist or hospital's liability increase if they do not use a pharmacy that has voluntarily registered as an outsourcing facility for its compounded preparations? Will doctors and dentists now be required to explain the difference between a compounded preparation that is FDA regulated and one that is not and at the same time highly recommend that a patient use a FDA regulated facility? Should they be required to do this? Should this not be their responsibility? Isn't it ultimately up to the consumer as to where they obtain their compounded preparations?
Subscribe to:
Post Comments (Atom)
3 comments:
This "question of the day" does not make logical sense. Let me explain:
The "compounding part" of the DQSA has mostly to do with "administered compounded drugs" obtained from outsourcing facilities to physicians and veterinarians to them to administer directly to their patients (e.g. injecting into their body; implanting a pellet under their skin; bathing their heart with sterile cardioplegia solution during open heart surgery; etc). In these situations, the patient has little (if any) chance to request that only FDA-licensed drugs (manufactured, wholesaled, or outsourced) are used.
As for "prescribed compounded meds" that are sold directly to the patient by the pharmacy (and sometimes, illegally, by the physician) for the patient to administer to themselves, the DQSA appears to call that "traditional compounding" and the DQSA doesn't really apply.
I agree the liability to physicians (and veterinarians) who administer compounded drugs NOT obtained from an FDA-licensed outsourcing facility just went WAY UP! I see no defense, other than "asset protection" by threatening to go bankrupt to discourage personal injury lawyers from taking a case on contingency. And since "actual damages" (such as the medical care provided to NECC victims to treat their fungal meningitis; lost wages; etc) is NOT capped by medical malpractice reform (that limits awards for "pain and suffering" or "loss of companionship"), a medical doctor could lose lots of assets (such as their "accounts receivable" of payments not yet received from Medicare and other insurance companies).
It would behoove physicians to administer meds ONLY from FDA-licensed manufacturers, wholesalers, or outsourcing facilities. For patients who are purchasing drugs directly from a pharmacy, for "sterile/injectable drugs" at high risk (such as compounded eye drops) - they should also ask for names of reputable compounding pharmacies that have voluntarily registered. It would be interesting to interview Chuck Leiter, of Leiter's pharmacy (well known for quality eye meds). I'll almost guarantee you that his pharmacy will register as an outsourcing facility.
Kenneth Woliner, MD
www.holsticfamilymed.com
Point taken, but sometimes the law and judges don't make logical sense with the results that are reached.
That's why it is called "the legal system", not "the justice system". LOL!
Regardless, a medical doctor who doesn't care about their liability (because they are totally asset protected; they are a narcissist who thinks they are too perfect to ever have anything bad happen; or they are a sociopath who don't realize rules apply to them too) will still make decisions more based upon profit margin than on patient safety. Patients are not knowledgeable enough about what questions to ask, hence the need for the "professions" to self-regulate and keep up certain professional standards.
Right now, the biggest stumbling block are state employees in each Department of Health Bureau of Enforcement who have the mindset of "good enough for government work" and do not aggressively inspect pharmacists / dispensing practitioners, nor do they pursue investigations and prosecutions (because doing so makes more work for them to do). That is a future question of the day, I suppose ...
Kenneth Woliner, MD
www.holisticfamilymed.com
Post a Comment