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Tuesday, December 31, 2013
December 31, 2013 Law regulating compounding pharmacies falls short
HealthDay News -- Additional steps are needed for regulating compounding pharmacies beyond those outlined in the Drug Quality and Security Act of 2013, some are warning.
Kevin Outterson, JD, LLM, from the Boston University School of Law, discusses limitations of the Act, passed after a 2012 fungal meningitis outbreak originated at a New England compounding pharmacy.
His insights were recently published online in the New England Journal of Medicine.
Although the new Act goes some way to improve regulation, including reenactment of Section 503A, additional legislation is needed at the state level to avoid similar tragedies as the one that originated at the New England Compounding Center (NECC) in Framingham, Mass.
Many states do not mandate compliance with the sterile-compounding requirements, and most do not carefully regulate out-of-state compounding pharmacies, according to Outterson. Federal government has ceded much of the regulatory authority to states and they must ensure minimum quality standards are met, without triggering drug shortages.
continue to read here
Kevin Outterson, JD, LLM, from the Boston University School of Law, discusses limitations of the Act, passed after a 2012 fungal meningitis outbreak originated at a New England compounding pharmacy.
His insights were recently published online in the New England Journal of Medicine.
Although the new Act goes some way to improve regulation, including reenactment of Section 503A, additional legislation is needed at the state level to avoid similar tragedies as the one that originated at the New England Compounding Center (NECC) in Framingham, Mass.
Many states do not mandate compliance with the sterile-compounding requirements, and most do not carefully regulate out-of-state compounding pharmacies, according to Outterson. Federal government has ceded much of the regulatory authority to states and they must ensure minimum quality standards are met, without triggering drug shortages.
continue to read here
Another Compounding Sales Opening in Georgia
Sales Representative Compounding Pharmacy
Towne Lake Family Pharmacy - Greater Atlanta Area
We are looking for independent sales professionals with experience calling into physician practices in Orthopedics, Pain Management, Sports Medicine, Podiatry, Rheumatology, Neurology, Family Practice, Internal Medicine.
A history of close personal relationships with physicians and their staff is a must in order to drive brand preference and referrals.
Job requires enthusiastic, self-motivated, self-directed individual to effectively manage the territory and work independently.
We offer a 20% share of the reimbursement with annual income potential of $250K+.
We welcome people seeking full-time or part-time positions.
Desired Skills and Experience
Professional and ethical character is of the utmost importance, while displaying a positive, can-do, team-oriented attitude.
Know the pain therapy market well and have represented pain products and /or have a solid list of physicians who treat acute and chronic pain.
Can demonstrate strong track record of success.
Excellent organizational, analytical and follow-up skills.
Must have a valid driver’s license in good standing.
quoted from here
Know the pain therapy market well and have represented pain products and /or have a solid list of physicians who treat acute and chronic pain.
Can demonstrate strong track record of success.
Excellent organizational, analytical and follow-up skills.
Must have a valid driver’s license in good standing.
quoted from here
About this company
Towne Lake Family PharmacyWe specialize in formulating topical transdermal pain cream compounds used to treat both acute and chronic neuropathic and inflammatory pain.
Topical treatment is used as a replacement or adjunct to oral opioid pain management therapy eliminating most major side effects as well as avoiding addiction.
Many patients are unable to take oral medications due to gastrointestinal (stomach, liver, kidneys), issues, which can significantly affect the patient’s quality of life.
Towne Lake Family Pharmacy is locally owned and offers superior customer service which includes facilitating prescription medication and expediting home medication delivery for patients WITHIN 24 HOURS BY LICENSED PHARMACISTS. We manage the claims process for patients, our experienced and devoted staff has worked closely with physicians and has extensive experience dealing with insurance companies AND coordinating
California Board of Pharmacy Enforcement and Compounding Committee Agenda for January 10, 2014
| January 10, 2014 | Department of Consumer Affairs 1625 N. Market Blvd. 1st Floor Hearing Room Sacramento, CA 95834 | Agenda |
Answer to my Fourth Question of the Day on December 31, 2013 Regarding the cost of compounded pain medications: Thank you Dr. Kenneth Woliner for the comment
Sue,
Yes. The compounded pain creams may be useful for patients (or not), and are EXTREMELY LUCRATIVE FOR COMPOUNDING PHARMACIES and the sales reps they employ to get prescriptions from doctors all around the country (not just locally). Sometimes they are also lucrative to the prescribing physician through illegal kickbacks and split-fee relationships (e.g. Florida Board of Medicine v. David R. Balding, M.D. DOH 93-02958 - where the doctor was getting a 25% kickback on all compounded ketoprofen creme prescriptions - ALL IN CASH, as to not have a paper trail - http://ww2.doh.state.fl.us/FinalOrderNet/folistbrowse.aspx?LicId=42705&ProCde=1501&discpln=DISCPLN)
The way the SCAM part of this works is that:
- Active Pharmaceutical Ingredient (API) suppliers "artificially inflate" the "Average Wholesale Price (AWP) of the raw material drugs used in these creams by 1,000%, but will sell the API's to compounding pharmacies for a tenth of the AWP.
- Compounding Pharmacies bill insurance at the AWP (often $2,000 - $3,000 for a month's supply of transdermal cream), but get reimbursed by the insurance company at about 80% of billed charges. The insurance company may think they "negotiated a good deal", but in reality, they got scammed.
- The compounding pharmacy makes so much profit ($1,000 - $1,500 per prescription per month) that they can afford to pay outrageous commissions tomtheir sales reps (and sometimes, kickbacks to the prescriber).
Kenneth N. Woliner, M.D.
www.holisticfamilymed.com
Yes. The compounded pain creams may be useful for patients (or not), and are EXTREMELY LUCRATIVE FOR COMPOUNDING PHARMACIES and the sales reps they employ to get prescriptions from doctors all around the country (not just locally). Sometimes they are also lucrative to the prescribing physician through illegal kickbacks and split-fee relationships (e.g. Florida Board of Medicine v. David R. Balding, M.D. DOH 93-02958 - where the doctor was getting a 25% kickback on all compounded ketoprofen creme prescriptions - ALL IN CASH, as to not have a paper trail - http://ww2.doh.state.fl.us/FinalOrderNet/folistbrowse.aspx?LicId=42705&ProCde=1501&discpln=DISCPLN)
The way the SCAM part of this works is that:
- Active Pharmaceutical Ingredient (API) suppliers "artificially inflate" the "Average Wholesale Price (AWP) of the raw material drugs used in these creams by 1,000%, but will sell the API's to compounding pharmacies for a tenth of the AWP.
- Compounding Pharmacies bill insurance at the AWP (often $2,000 - $3,000 for a month's supply of transdermal cream), but get reimbursed by the insurance company at about 80% of billed charges. The insurance company may think they "negotiated a good deal", but in reality, they got scammed.
- The compounding pharmacy makes so much profit ($1,000 - $1,500 per prescription per month) that they can afford to pay outrageous commissions tomtheir sales reps (and sometimes, kickbacks to the prescriber).
Kenneth N. Woliner, M.D.
www.holisticfamilymed.com
AVMA announces that American Association of Bovine Practitioners have developed guide for proper oversight of drugs use in cattle
Cattle veterinarians develop guide on drug oversight
The AABP published in November 2013 the two-page guide on veterinarian-client-patient relationship practices that the organization endorses and that exceed regulatory requirements.
For example, the guide indicates veterinarians or veterinary practices should have written agreements that identify the veterinarian who is accountable for drug administration on a farm as well as who is responsible for duties such as drug inventory maintenance.
The guide, “Establishing and Maintaining the Veterinarian-Client-Patient Relationship in Bovine Practice,” is available here.
The document also describes AABP-endorsed practices of establishing a veterinarian of record, clarifying relationships among veterinarians and consultants on farms, providing treatment protocols, maintaining treatment records, and prescribing drugs.
The guide is intended to help veterinarians ensure they and their clients communicate and keep records in ways that ensure pharmaceuticals are used in a responsible manner, Dr. Keith Sterner of Ionia, Mich., said in an AABP announcement. Dr. Sterner was chair of the AABP task force that created the guidelines.
The AABP also is developing cattle well-being guidelines, the announcement states.
Posted Dec. 30, 2013
A guide from the American Association of Bovine Practitioners is intended
to help veterinarians ensure they establish proper oversight for drug use in
cattle.
The AABP published in November 2013 the two-page guide on veterinarian-client-patient relationship practices that the organization endorses and that exceed regulatory requirements.
For example, the guide indicates veterinarians or veterinary practices should have written agreements that identify the veterinarian who is accountable for drug administration on a farm as well as who is responsible for duties such as drug inventory maintenance.
The guide, “Establishing and Maintaining the Veterinarian-Client-Patient Relationship in Bovine Practice,” is available here.
The document also describes AABP-endorsed practices of establishing a veterinarian of record, clarifying relationships among veterinarians and consultants on farms, providing treatment protocols, maintaining treatment records, and prescribing drugs.
The guide is intended to help veterinarians ensure they and their clients communicate and keep records in ways that ensure pharmaceuticals are used in a responsible manner, Dr. Keith Sterner of Ionia, Mich., said in an AABP announcement. Dr. Sterner was chair of the AABP task force that created the guidelines.
The AABP also is developing cattle well-being guidelines, the announcement states.
quoted from here
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