Drug Compounding Pharmacies: Risks and Oversight Issues (Pharmacology-Research, Safety Testing and Regulation)

https://docs.google.com/document/d/1wfe6uqr_ZbzUoWhbYlxLerdlBSC950F9xADF7zuz0zg/edit

Finally a Compounder Says It: Greed Is Not Good!!

The Compounder Forum:  Greed Is Not Good Read It here

FDA Releases Slew of Warnings to Compounding Pharmacies

FDA Releases Slew of Warnings to Compounding Pharmacies

August 29, 2014

The FDA has stepped up its enforcement of compounding pharmacy quality violations that occurred before a new law took effect that boosted agency powers, a move that some industry players contend is unjust. Read More

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?

U.S. congress debates doping in horse racing

August 30, 2014

Leaders from the horse racing industry spoke before the United States congress to discuss whether the sport needs federal oversight to ban doping. Legislation in the U.S. could be followed by similar bills passed in Europe.
Congress considered legislation regulating horse racing in the 1980’s. Last month, federal authorities arrested members of a Mexican cartel using racehorses bred and trained in the United States for laundering drug money.
Sen. Tom Udall of New Mexico has proposed legislation to ban race-day medication in horse racing. Udall's bill would ban substances such as Lasix, a diuretic that is considered a performance-enhancing drug.

continue to read here

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?

Job Opening Marketing Coordinator (south River Compounding Pharmacy)

Aug. 29, 2014

Marketing Coordinator (south River Compounding Pharmacy)

ConfidentialRichmond, Virginia

Marketing Coordinator Job Description:

Develop an effective marketing program that reaches out to individuals, health
practitioners, local businesses, and organizations. Combine traditional and
non-traditional marketing tools to grow the business with an end result of
life long relationships with our customers. Planning, implementing and
executing a marketing program that shows constant and consistent growth with a
strong ROI.
Creatively contribute to and maintain social media & networking to build/
enhance our brand. Maintain and grow Web-site(s) and E-Commerce store(s).
Perform support tasks for Outside Sales/Marketing Reps

Skills Required:

Minimum 2 year AA degree in marketing with a 4 year BA desired
Minimum 2 years of experience in a marketing position with skills transferable
to job description above, specific to South River Compounding Pharmacy
Experience with and full working knowledge of Constant Contact and Volusion
Previous experience in outside B2B sales desired
Available and willingness to work times and days dictated by the needs of the
business
Project manager level of experience and understanding of event planning and
execution
Excellent record keeping and organizational ability required
Experience in health care field desired

Job Responsibilities:

A. Advertising -- Buys/Placement/Layout
B. Monthly Patient Newsletter -- Create content/Layout/Delivery
C. Monthly Practitioner Newsletter -- Create content/Layout/Delivery
D. Seminars/Events -- Research, Plan, Market, Execute, Analyze
E. Community Outreach
F. Social Media -- Note: Hands on proof of competency and full understanding
will be required by any candidate for the position.
1. Facebook, Twitter, Linkedin, 4square, Google+, Pintrest -- All SM outlets
are used
2. Create overall SM marketing plan
3. Coordinate with staff
4. Post
5. Optimize
6. Update
G. Website(s)/Online Store(s) -- Note: Hands on proof of competency and full
understanding will be required by any candidate for the position.
1. Update as needed with content
2. Coordinate content with staff
3. Optimization
4. Overhaul when needed
H. Outside Marketing/Sales Reps
1. Participate in sales calls
2. Coordinate events for Reps
3. Analyze and record post event information/results
4. Manage doctor lists and reports
quoted from here