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
Wednesday, February 27, 2013
February 27, 2013 FDA Strategic Plan to Address Drug Shortages, Solicitation for Comment - See more at: http://www.policymed.com/2013/02/fda-strategic-plan-to-address-drug-shortages-solicitation-for-comment.html#sthash.RZdGQEmp.dpuf
Earlier this month, the Food and Drug Administration (FDA) released a notice for public comment in the Federal Register regarding ideas stakeholders and the public may have for combating drug shortages. As noted on FDA’s own blog, the agency believes that despite the progress made over the last year, even more can be done and is therefore turning to the American public for advice.
Comments due by Thursday, March 14, 2013. The Docket Number is FDA-2013-N-0124.
Background
As we previously wrote this summer, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) on July 9, 2012. Section 1003 of FDASIA adds section 506D to the Federal Food, Drug, and Cosmetic Act (the FDCA) to require the formation of a task force to develop and implement a strategic plan for enhancing the Agency's response to preventing and mitigating drug shortages. Section 506D of the
PCMA: The Drugstore Lobby (Again) Looks to Avoid Fraud and Abuse Detection February 27, 2013
Legislative Proposals Backed by Drugstores Undermine the Bipartisan National Fight against Fraud and Abuse
WASHINGTON, Feb. 27, 2013 /PRNewswire-USNewswire/ — As the U.S. House of Representatives Energy and Commerce Subcommittee on Health examines preventing waste, fraud, and abuse in the health care system during a Congressional hearing today, the independent drugstore lobby is continuing to promote an agenda that seeks to ban tools that detect pharmacy fraud, waste, and abuse. This special interest agenda runs counter to the goals of payers, unions, and a bipartisan chorus of policymakers who want to reduce wasteful spending by demanding more accountability in the health care system.
Independent Drugstores vs. the Anti-Fraud Community. In the last Congress, independent drugstores were the driving force behind legislation (H.R. 1971/S. 1058 and H.R. 4125) which would have limited the use of audits and other tools used to uncover fraud in the pharmacy setting.
Fraud and abuse costs Americans up to $234 billion a year, according to the National Health Care Anti-Fraud Association (NHCAA). A recent report examined how recent Congressional hearings and government investigations have raised serious questions about opaque business practices and pricing strategies within the independent drugstore industry, which now generates $93 billion in annual sales from 23,000 stores nationwide and ranks among America’s most profitable small business sectors.
At independent drugstores, the owner, cashier, and book keeper are often one and the same. These factors make independent drugstores more susceptible to irregularities and make oversight more challenging. The report highlighted three basic questions policymakers are asking of independent drugstores:
- Why are independent drugstores eight times more likely than other pharmacies to submit questionable bills to Medicare?
- Are independent drugstores exploiting the drug shortage crisis?
- Why are independent drugstores fighting bipartisan efforts to reduce drug diversion?
A white paper published by NHCAA also raised serious questions about the kind of legislative proposals promoted by the independent drugstore lobby. The policies and specific NHCAA concerns include:
- Policies that undermine payers’ ability to audit independent pharmacies suspected of fraud (“Audit Reform” policies). NHCAA supports measures that would “protect the integrity of health care audits by giving auditors more discretion and flexibility to perform their duties” and notes that “on-site audits have revealed indications of fraud such as nonexistent pharmacies, unexplained stockpiles of controlled substances, mismatches between inventories and prescriptions and other discrepancies.” NHCAA also warns that “proposed federal and state legislation that would require payers to provide providers advance warning of an audit – even in cases when fraud is suspected – would give suspects time to tamper with evidence and evade authorities altogether.”
- Policies that undermine authority across Medicare to suspend payments when there is suspicion of fraud.The ability to stop fraud before paying a claim is more effective and more efficient than relying on paying first and then chasing after claims that are later found to be fraudulent. Congress should extend to Medicare Part D the recently enacted statutory authority Congress provided in Medicare Parts A and B to suspend payment to health care providers upon a credible allegation of fraud, waste, or abuse.
- Policies that reduce payers’ time to verify pharmacy claims before payment (“Prompt Pay” policies). NHCAA states: ‘if claims are not rushed through the payment process, auditors and investigators will have more opportunities to detect attempts at fraud before they come to fruition.” So-called “prompt pay” laws in Medicare Part D that mandate rapid payment to independent pharmacies reduce the time available to detect pharmacy fraud, waste, and abuse.
- Policies that make payers partner with pharmacies that are banned from federal programs (“Any Willing Pharmacy” policies). Legislation that would force plans to include in their networks pharmacies that have been banned from federal programs “runs counter” to preventing fraud, according to NHCAA. This “low standard of admission could allow for the participation in employer networks of pharmacists who have been suspended from government programs. Even if they have records of harmful prescription errors or a high number of consumer complaints, they would still be potentially eligible in the absence of a criminal conviction.”
PCMA represents the nation’s pharmacy benefit managers (PBMs), which improve affordability and quality of care through the use of electronic prescribing (e-prescribing), generic alternatives, mail-service pharmacies, and other innovative tools for 215 million Americans.
SOURCE Pharmaceutical Care Management Association
Waltham Compounding Pharmacy Reopens OncoMed was previously cited for issues regarding chemotherapy medications.
A Waltham compounding pharmacy has reopened after recently suspending operations.
OncoMed ceased operations in November 2012 after state inspectors found “issues with chemotherapy” medications at the site.
As a result, the company has updated its operations to comply with recently imposed Massachusetts Board of Pharmacy regulations, according to an OncoMed press release. The changes related to how oral medications are stored. The Massachusetts Pharmacy Board has approved OncoMed reopening, according to the company.
Continue reading here
Cafepharma Message Board
Cafepharma Message Board has a ton of information. Although I cannot vouch for the accuracy of the information, it is all very interesting from the discussions about which companies are the best to work for to which bosses are having inappropriate relationships with employees. But more importantly, it contains a lot of information about compounding.
Click here to view discussion board index
Click here to view discussion board index
ISMP warns of potential errors when emergency compounding Tamiflu
Formulary , 02/26/2013
Because Tamiflu has been in short supply recently, pharmacists and other healthcare providers are being warned about confusion over emergency compounding of the drug. Tamiflu’s manufacturer, Genentech, has Tamiflu 6 mg/mL oral suspension in 60 mL bottles on intermittent back order. The company is releasing product as it becomes available, but also provides instructions for compounding an extemporaneous 6 mg/mL oral suspension from 75–mg capsules, if required, according to The Institute for Safe Medication Practices (ISMP)
Read more: http://www.mdlinx.com/pharma-news/news-article.cfm/4442548/#ixzz2M6sPthlA
South Carolina Proposed Legislation Relating to Pharmacy Practice Act and Compounding
VERSIONS OF THIS BILL
12/18/2012
2/20/2013
Indicates New Matter
COMMITTEE REPORT
February 20, 2013
H. 3161
Read the first time January 8, 2013.
Amend the bill, as and if amended, by deleting all after the enacting words and inserting:
/ SECTION 1. Section 40-43-30 of the 1976 Code is amended to read:
"Section 40-43-30. For purposes of this chapter:
(1) 'Administer' means the direct application of a drug or device pursuant to a lawful order of a practitioner to the body of a patient by injection, inhalation, ingestion, topical application, or any other means.
(2) 'Ante area' means an ISO 8 or greater area where personnel perform hand hygiene, garbing, and stage components. An ante area precedes a buffer area, provided:
(a) a buffer area must be separated by a wall from an ante area if high-risk preparations are compounded; and
(b) if only low-risk and medium-risk preparations are compounded, separating an ante room from a buffer area is recommended.
Florida Shuts Down N.W. Pharmacy, Inc.--parenteral/enteral compounding pharmacy
This ESO (Emergency Suspension Order) where pharmacy has been shut down. Thank you to Kenneth N. Woliner, M.D., A.B.F.M.,Holistic Family Medicine, LLC, www.holisticfamilymed.com for bringing to my attention
http://ww2.doh.state.fl.us/
http://ww2.doh.state.fl.us/
Tuesday, February 26, 2013
Pharmacy Practice Issues and Facility Qualifications in Sterile Product Compounding
2013 AAPS National Biotechnology Conference
Hot Topic
Pharmacy Practice Issues and Facility Qualifications in Sterile Product Compounding
10:30 am–noon
May 20, 2013
Sheraton San Diego Hotel and Marina, San Diego
May 20, 2013
Sheraton San Diego Hotel and Marina, San Diego
Overview
The fungal meningitis outbreak associated with tainted steroid injections from the New England Compounding Center has highlighted questions about the product needs of hospitals and clinics, as well as the qualifications of pharmacies that produce sterile products. This session will discuss sterile drug product distribution issues from the clinic or field perspective (e.g., a hospital pharmacy), including sterile product challenges facing a patient care organizations and why services from a group such as the New England Compounding Center may be needed. This session will also discuss technical issues of sterile product fabrication, with an emphasis on an approach to qualify pharmacies to produce sterile products.
Hotel/Travel
Sheraton San Diego Hotel and Marina
1380 Harbor Island Dr.
San Diego, CA 92101
1380 Harbor Island Dr.
San Diego, CA 92101
For more information click here
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