Saturday, October 4, 2014
ACA Marketing-What's Happening? Workshop
Marketing – What’s Happening? Workshop
October 31 – November 1, 2014
Royal Sonesta Harbor Court Hotel
Baltimore, Maryland
Description:
Marketing, networking and roundtable discussions. This workshop is designed for the pharmacy marketer to hear from other marketers. Friday will have 7.5 hours of CE for pharmacists and pharmacy techs. Saturday there will be 4.5 hours of networking and roundtable discussions!
Friday Schedule:
- Specialty Pharmacy Marketing – Michelle Sherman, Lauren Onsa, Scherra Bartoli
- Communication – Lauren Onsa, Scot Maitland, Patti Storey, Scherra Bartol
- My Day Looks Like This – Scherra Bartoli, Lauren Onsa, Michelle Sherman
- Branding – Patti Storey, Scot Maitland
- HIPAA and the New Omnibus HITECH Rules – Patti Storey
- Legal Do’s and Don’ts of Marketing – David Miller
Saturday Schedule – No CE – 4.5 hrs of networking and roundtable discussions
- Your Ideal Customer Avatar Michelle Sherman, Lauren Onsa, Scherra Bartoli
- Building a Premium Brand Position – Patti Storey, Scot Maitland
- Marketing Round Table Discussions – All Speakers
ACA Compounding-What's happening? Conference October 31-November 1, 2014
Compounding – What’s Happening? Conference
October 31 – November 1, 2014
Royal Sonesta Harbor Court Hotel
Baltimore, Maryland
Description:
Educational and legislative updates for your compounding pharmacy. Education, resources and marketing that will help improve your patients’ outcome and your pharmacy’s success. 12 hours of continuing education for pharmacists and pharmacy technicians.
CE sessions will include:
Friday Schedule:
- Quality, Safety, and Workflow in the Compounding Pharmacy – Bryan Prince
- Compounding for Wound and Scar Treatment – Erik Tosh
- Penetrating Insight: An Update on Veterinary Transdermal Therapy – Gigi Davidson
- This Works for Me! – Panel
- What’s Hot and What’s Not in Veterinary Pharmacotherapy – Gigi Davidson
- USP Standards Setting Process — What’s going on with Compounding Standards? - Lisa Ashworth
Saturday Schedule:
- Pharmacy Law & Regulations – Staying Current in a Changing World – David Miller
- Specialty compounding for pediatrics and geriatrics, how similar are they? – Erik Tosh
- 503 B Update –
Texas Board of Pharmacy Hiring Inspector and License and Permit Specialist
Inspector V - West Texas
License and Permit Specialist III
More Information Available at http://www.pharmacy.texas.gov/
Friday, October 3, 2014
Third Question of the Day October 3, 2014 In recently seeing a comment posted by a compounder that said if the FDA insist that drugs made by the FDA-approved companies are safer why are we seeing so many FDA-approved recalls? Does this just destroy part of the compounder's arguments? The FDA has more authority and say over FDA approved products and thus has the ability to immediately notify consumers and get them pulled from the market. Compounders fight even an inch of over oversight so the question I would really like answered is if compounded medications are so much safer and better why are compounding pharmacists so afraid of oversight and having their compounds tested?
Breaking News!! Very Important Read FDA seeks permanent injunction against Pharmaceutical Innovations, Inc. Defendants charged with distributing adulterated and misbranded medical devices
FDA News Release
FDA seeks permanent injunction against Pharmaceutical Innovations, Inc.
Defendants charged with distributing adulterated and misbranded medical devices
For Immediate Release
October 3, 2014
Release
The U.S. Food and Drug Administration is seeking a permanent injunction to stop Pharmaceutical Innovations Inc., and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling, and distributing medical products until they come into compliance with all applicable FDA requirements.
The Newark, New Jersey company’s products include ultrasound, mammography, and electrocardiogram gels, and scanning pads. These products are medical devices used for diagnostic purposes in health care settings.
The complaint alleges that the defendants did not manufacture their devices in conformity with the current good manufacturing practice requirements of the Federal Food, Drug, and Cosmetic Act, and that they distributed their products nationwide without required premarket approval or clearance.
The complaint also details that U.S. marshals, acting at the request of the FDA, seized certain lots of Other-Sonic Generic Ultrasound Transmission Gel from the company in April 2012. The seizure took place after FDA laboratories found in those lots significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca – bacteria that pose serious risks of infection, such as pneumonia, to people exposed to the product. The FDA is aware of people who were infected with Pseudomonas aeruginosa after having undergone a surgical procedure at a Michigan hospital involving Other Sonic Generic Ultrasound Transmission Gel. On April 18, 2012, FDA issued a safety alert to health care professionals and facilities to stop using the contaminated product.
“Despite multiple warnings by the FDA over the past three years, and promises to correct the numerous ongoing violations, the defendants continued to violate the law,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “This presents serious health risks to patients who used and continue to use the company’s products. By taking this action, the FDA is demonstrating its commitment to protecting the public from the dangers of adulterated and misbranded medical products.”
The complaint for permanent injunction was filed by the U.S. Department of Justice on behalf of the FDA on Oct. 2, 2014, in the U.S. District Court for the District of New Jersey.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Inquiries
Related Information
- Justice Department Files Suit Against New Jersey Company for Adulterated and Misbranded Medical Devices
- Safety Communication: FDA Safety Communication: Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection
- Class 1 Recall: Other-Sonic Generic Ultrasound Transmission Gel (Posted May 30, 2012)
Page Last Updated: 10/03/2014
Second Question of the Day October 3, 2014 Wouldn't it be interesting to know which compounding pharmacies benefited or profited most from Tricare reimbursement of compounded medications? Isn't this another reason there should be full disclosure or open records of all compounding pharmacies or pharmacists who gain from government related resources?
The Gators are Snapping as Hospira Gets Another FDA Warning Letter by Ed Silverman
Seven months ago, Hospira executives were celebrating an FDA upgrade of a key manufacturing plant in North Carolina, a development they suggested was a sign that troubling quality-control issues at various facilities were starting to recede. And as Hospira chief executive Michael Ball told analysts in a conference callabout the agency move, “I think we’ve got the swamp drained” of alligators.
continue to read here
continue to read here
North Carolina Board of Pharmacy October 2014 Newsletter-Answers question about Outsourcing Facilities
october 2014 newsletter - North Carolina Board of Pharmacy 
www.ncbop.org/Newsletters/Oct2014.pdf
Question off the Day October 3, 2014 Is the recent GAO Report on Tricare Table 1: Top 25 High-Cost Compounded Drugs Containing Bulk Drug Substances Dispensed to TRICARE Beneficiaries in Retail Pharmacies, Fiscal Year 2013 evidence that patient-specific drugs are not being used but instead drugs are being mass produced by compounding pharmacies? Isn't it odd that or 700 and 800 or 1000 plus people need the same formula of a compounded medication? What, if anything, does it prove that PCCA products were used and paid for in a number of these prescriptions
Compounded drug prescriptions paid for through TRICARE’s pharmacy benefit cost about $259 million in fiscal year 2013—representing about 3 percent of the total cost of prescription drugs paid for through its pharmacy benefit—up from about $5 million in fiscal year 2004.34 Compounded drug prescriptions containing at least 1 bulk drug substance accounted for about 98 percent of the $259 million cost.35 The average cost of a compounded drug that included at least 1 bulk drug substance was $557 per prescription compared to an average cost of $53 per prescription for a compounded drug that contained only FDA-approved products.3
quoted from here
In fiscal year 2013, TRICARE paid for about 465,000 compounded drug prescriptions through its pharmacy benefit, representing 0.3 percent of all prescription drugs paid for through its pharmacy benefit in that year. Over 395,000, or 85 percent, of these compounded drug prescriptions were dispensed in retail pharmacies.
quoted from here
Handling Hazardous Drugs: USP in Pharmacy Practice Fred M. Eckel, RPh, MS, ScD (Hon), Pharmacy Times Editor-in-Chief Published Online: Thursday, October 2, 2014 - See more at: http://www.pharmacytimes.com/publications/issue/2014/October2014/Handling-Hazardous-Drugs-USP-in-Pharmacy-Practice#sthash.aODd1Fjp.dpuf
Thursday, October 2, 2014
Horse trainer Doug O'Neill suspended by New York Oct. 2, 2014 3:14 PM EDT
NEW YORK (AP) — Southern California-based trainer Doug O'Neill has been suspended 45 days and fined $10,000 by the New York State Gaming Commission after one of his horses tested positive for a banned substance after a race at Belmont Park in June 2013.
Under a settlement with the gaming commission, O'Neill's suspension begins Nov. 3 — two days after the Breeders' Cup is run at Santa Anita — and ends Dec. 18. The deal also calls for O'Neill to serve an additional 45 days if he incurs another violation involving a Class 1, 2 or 3 medication between now and Dec. 18, 2015, at any racetrack.
The Daily Racing Form first reported the settlement.
O'Neill said in a statement issued Wednesday night through his publicist that he wasn't in New York when the alleged infraction took place and he's confident that none of his employees or staff administered the substance. O'Neill says that as the trainer of record, he's taking responsibility for the positive test and he cares deeply for the horses under his supervision.
The drug Oxazepam, considered a Class 2 sedative with muscle-relaxing properties, was found in the post-race sample of Wind of Bosphorus, who won a $35,000 claiming race at Belmont on June 2, 2013.
continue to read here
US trainer Doug O'Neill suspended for doped horse
US trainer Doug O'Neill suspended for doped horse - World ...
article.wn.com/.../us_trainer_doug_o_aposneill_suspended_for_doped_h...46 mins ago - NEW YORK (AP) Kentucky Derby-winning trainer Doug O'Neill has been suspended for 45 days and fined $10000 by the New York State Gaming Commission ...
Compounded Drugs Prior Authorization - Blue Cross Blue Shield of Massachusetts
Prior Authorization - Blue Cross Blue Shield of Massachusetts
https://www.bluecrossma.com/.../...Blue Cross Blue Shield of Massachusetts15 hours ago - Diclofenac (Compounded Medication) · Dulera · Dysport ... Erectile Dysfunction (Compounded Medication) ... Narcotic Analgesics (CompoundedMedication).
Ohio prosecutors demand immunity for execution drug makers
Ohio prosecutors demand immunity for execution drug makers
States have moved to compounded drugs – small, specialty batches that don't face the same kind of ...
The Guardian - 4 hours ago
IACP submitts comments to FDA Regarding Bulk Ingredients Regarding 503A, 503B and Traditional Compounders
The International Academy of Compounding Pharmacists (IACP) has submitted comments and Active Pharmaceutical Ingredient (API) lists to the Food & Drug Administration (FDA) for both 503A and 503B.
As covered in IACP's submission letter, the Academy is extremely concerned that the FDA is intentionally setting an "impossible to meet" standard by requiring descriptions and justification for the use of APIs in lieu of commercially available products. That is especially troubling given that the agency has yet to vet and begin the appointment process for the Pharmacy Compounding Advisory Committee (PCAC).
Please click here to view IACP's letter to FDA re: Nominations on Bulk Ingredients 503A Non-USP, Non-FDA Approved
Please click here to view IACP's letter to FDA re: Nominations on Bulk Ingredients 503B Non-USP, Non-FDA Approved
Please click here to view IACP's Bulk Drug Submission List for 503A Traditional Compounders (Please note this API list also was submitted for 503B.)
Please email IACP with questions. iacpinfo@iacprx.org
Animal Drug Approvals October 2014 Update (Green Book) –
Animal Drug Approvals October 2014 Update (Green Book) – http://www.fda.gov/downloads/
Wellness Store Compounding Pharmacy Robin Terrero had two civil penalties ($2,700.00 and $2,000) assessed by Tennessee Board of Pharmacy in 2013
https://drive.google.com/file/d/0B5XoIEP2XgASaXhHWTQ1STNMZzZvWFFpZlJnclFsWl92RzJv/edit?usp=sharing
Second Question of the Day October 2, 2014: Recent filing in NECC suggest that Medisca, the firm that supplied NECC with the bulk materials for its products should have known NECC was not in compliance with the law simply because of the high volume of base chemicals it was purchasing. How many other cases can this theory be used in? How many other suppliers could be liable in other cases where death or injury resulted?
meningitis-etc: Clinic Lawyers Say Any Blame for Outbreak Should B...
meningitis-etc: Clinic Lawyers Say Any Blame for Outbreak Should B...: By Walter F. Roche Jr. Lawyers for the Saint Thomas Outpatient Neurosurgical Center have named nearly a dozen other parties, including thr...
Here are some great examples of where preprinted prescription pads were used by compounding pharmacies that ended up in trouble!!
During the inspection, you stated approximately [redacted] of all finished drug products are distributed outside of Alabama, to the following states: [redacted] Your firm is engaged in the commercial-level distribution of standardized drug products. You employ a team of [redacted]sales representatives and contract the services of several other sales representatives to visit physician's offices, provide preprinted prescription pads and promotional material to physicians, and obtain "orders" from physicians for your transdermal, prescription drug products. Furthermore, your firm markets its transdermal products by providing physicians with drug product samples on their request.
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Pre-printed script forms were used by NECC and the reason for a 1999 complaint to the board of pharmacy:
.tiff)
complete testimony found here
Question of the Day October 2, 2014 Since 503A requires traditional compounded prescriptions to be patient-specific doesn't this mean no pre-printed script forms should be used by traditional compounding pharmacies despite the fact some state laws may allow pre-printed script forms? Shouldn't all state legislators and/or state boards of pharmacy revisit this issue and bring any contrary or unclear laws or regulations in compliance so that pre-preprinted, check-the-box type forms are illegal for traditional, patient-specific compounded prescriptions?
Operation Gym Candy! UPDATED: AG’s office busts alleged steroid, prescription pill rings Suspects include prison guards, pharmacist technician Last updated: October 01. 2014 7:17PM - 2042 Views
WILKES-BARRE — Correctional officers, a pharmacist technician and a recently-released Dallas Cowboys guard were among the Luzerne County residents charged Wednesday in connection with two alleged anabolic steroid rings.
A state Attorney General’s Office investigation dubbed “Operation Gym Candy” led to the arrest of 13 suspects from five Northeast Pennsylvania counties who are alleged to have participated in the distribution of steroids and prescription drugs.
All suspects were released on varying amounts of bail, ranging from $1,000 to $50,000.
According to court papers, Brian Laubach, 36, of Berwick, and Richard Piccarreta, 49, of Plymouth, each ran respective anabolic steroid manufacturing and sales operations, working alongside others to distribute the Schedule III substances to customers locally and through the Internet.
continue to read here
NABP: FDA Warns of Growing Network of Rogue Wholesale Drug Distributors
http://www.nabp.net/news/fda-warns-of-growing-network-of-rogue-wholesale-drug-distributors
New Albany-area outsourcing labs to sell drugs to hospitals Lab sees potential for big growth as FDA source of rare drugs By Claire Hughes Published 9:19 pm, Wednesday, October 1, 2014
http://www.timesunion.com/business/article/New-Albany-area-outsourcing-labs-to-sell-drugs-to-5795249.php
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