Consumer Updates Can a Dietary Supplement Treat a Concussion? No!

Consumer Updates Can a Dietary Supplement Treat a Concussion? No!

Compounding Group Taps Former Express Scripts Official

 

The United Compounding Network, which was launched last month to negotiate with payers and pharmacy benefit

managers on reimbursement for compounded drugs, named its key leaders, including a former high-level manager from

Express Scripts, a PBM which has drawn the ire of compounders for recently restricting its coverage of such products.

UCN Wednesday (Aug. 27) named David Ott as president and Diana Baumohl as vice president of business development.

Ott held executive positions with Anthem/ WellPoint Health Networks and worked most recently as founder and

principal consultant of Innova Health Solutions, UCN said. Baumohl has worked more than 20 years in the healthcare

industry, including “a variety of executive management positions at Express Scripts, Inc. (ESI),” UCN said in a press

release. “As VP of Business Development, her understanding of the market from both sides will guide UCN’s efforts in

working with compounding pharmacies and payors.”

The network will include state-regulated compounding pharmacies that, based on accreditation and quality standards,

meet a higher bar. The network plans to negotiate reimbursement levels and provide other services, such as standardized

claims billing.

In July Express Scripts started blocking compounding coverage of more than 1,000 bulk ingredients because of increased

prices. It is among other PBMs and payers making recent coverage changes for compounded drugs. The separate Patients and

Physicians for Rx Access — which includes participation from the International Academy of Compounding Pharmacists,

physicians and patients — also recently formed to fight the coverage restrictions. — Alaina Busch McBournie
quoted from here

Wow!! Here are some of the Reasons Prescribers and Patients Should Beware of Compounded Medications including Compounded Pain and Scar Creams!!

Anonymous said...

Safety issues are generally detected and mitigated during drug development, otherwise they would not meet the rigor of multidisciplinary review and approval by regulatory authorities prior to the granting market approval. Even with approval by authorities, some drugs will have unresolved safety signals or missing information that must be addressed in the post marketing setting, through the gathering of information, analysis and related decision-making.

There are numerous theoretical basic science, animal and clinical science safety signals related to any proposed multi-ingredient transdermal formulation intended for the far reaching indications for which the compounded creams are marketed-- from scar removal to the treatment of cardiovascular circulatory problems. There are also very serious safety signals related to prior compounded cream deaths.
The pervasively marketed, patent-holding compounded pain creams simply have not been investigated and vetted prior to marketing--they are experimental. But you would not know that from their promotion.

August 30, 2014 at 6:23 PM

More Great Comments From Readers!! Must Read!!

		at 6:23 PM
	"...GMP requirements" above should read "...GMP requirement exemptions" on The New Federal Compounding Law by Mike Corrado Remove content | Delete | Spam	Anonymous	at 5:56 PM
	Under 503A, compounded drugs that meet stipulated conditions are exempt from 3 provisions of the FFDCA, and, they may still be held to other provisions for which they are not exempt. Guidance available here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377052.pdf If you read most recent FDA warning letters, making drugs under unsanitary conditions can result in adulteration charges, wether or not conditions are being met for new drug, labeling, and GMP requirements. Bird feathers fungus and filth should not make their way into FDA-approved or compounded pharmaceuticals, regardless of whether or not they are intended for sterile administration. on The New Federal Compounding Law by Mike Corrado Remove content | Delete | Spam	Anonymous	at 5:54 PM
	Non-sterile compounds are covered under the original 503A, which was substantially weakened by the Supreme Court ruling but which may have been corrected under DQSA, with clarifications regarding false and misleading claims. But I agree--non-sterile compounds can be just as dangerous, and are currently heavily marketed through sophisticated programs. Check out this patent for "compounded transdermal pain management," including 30-40% by weight of ketamine, intended for mixture with other potent and potentially toxic substances, including clonidine, and local anesthetics implicated in previous compounded drug deaths and for which FDA has taken prior enforcement actions: https://www.google.com/patents/US20130085171?dq=ininventor:%22Charles+D.+HODGE%22&hl=en&sa=X&ei=SkkCVKXEA43BggSp7IHACw&ved=0CFAQ6AEwBw on Second Question of the Day August 30, 2014 Did Congress make a huge mistake by not including nonsterile compounded medications in the DQSA because they may pose just as big a risk as sterile compounded medications?