Category:

• Reappointment of Jason Penrod
• A New Era for Compounding Inspections
• Senate Bill 59 Makes Changes in Reporting to the Nevada PMP
• PMP Data Submission Accuracy Data

National Pharmacy Compliance News First Quarter 2018

• FDA Draft Guidance Addresses Delayed Enforcement of DSCSA Requirements for Product Identifiers
• Amount of Prescribed Opioids Remains High, Reports CDC
• AMA Opioid Task Force Encourages Co-Prescribing Naloxone to At-Risk Patients
• Opioid Addiction Medications Should Not Be Withheld From Patients Taking Benzodiazepines or CNS Depressants
• New Study Shows Substantial Variation in the Availability of Pharmacies Across the Country
• Consent Decree Entered Against Outsourcing Facility Isomeric Pharmacy Solutions
• FDA Issues Warning on Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes Made by Foshan

The federal government...approved a device made by a private company...that will allow the first domestic production of a medical imaging isotope...a move the government said would enhance national security by reducing the need to transport weapons-grade uranium...The Food and Drug Administration granted the approval to NorthStar Medical Radioisotopes, which said it would begin delivering systems to make technetium-99...the most common isotope in medicine and is used in 40,000 procedures a day in the United States...consumers have long had to depend on a complicated and risky supply chain for the materials...The current process involves shipping weapons-grade, or highly enriched, uranium from the United States to research reactors in Australia, South Africa and Europe where it is irradiated to make molybdenum-99, which decays into technetium-99..."This is a win for our national security," said Peter Hanlon, an official with the National Nuclear Security Administration office of material management and minimization...

The Food & Drug Administration has released a 2018 Compounding Policy Priorities Plan...FDA also issued a final guidance on mixing, diluting, or repackaging biological products, which describes the conditions under which the agency does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. According to FDA, "These policies are intended to minimize public health risks, while preserving access to these products for patients who have a medical need for them."

Under-served patients haven’t benefited...The 340B Drug Pricing Program, a 25-year-old discount plan aimed at boosting resources for hospitals treating low-income patients, has not delivered on its promise to enhance care for the needy, according to research from Harvard Medical School and the NYU School of Medicine...The federal program was designed to provide discounted drugs to hospitals that treat many low-income patients under the premise that generating surplus revenue would give these hospitals the financial resources to improve care for their most vulnerable. However, eligible hospitals have not used the financial windfalls from the program in ways that have clearly benefited under-served patients, according to results of the study published January 24 in The New England Journal of Medicine...Researchers say their findings paint a picture of good intentions handicapped by poor policy design and lack of oversight.

Diverging penalties in EU Member States for the falsification of medicines raise concerns for organised crime, says Medicines for Europe...The European Commission has submitted a report detailing the application of penalties for those involved in the production and circulation of falsified medicines to the European Parliament on the request of the Falsified Medicines Directive (2011/62/EU)​...While the Commission said measures taken by Member States are “satisfactory”​, it has called for their strict enforcement...“…penalties are only effective if they are well-enforced,”...“I urge all EU countries to make sure that criminals falsifying medicines are punished.”...A lack of data regarding illegal activity in Member States makes it challenging to determine the effectiveness of national penalties...According to the report, all Member States deem at least some activities relating to the falsification of medicinal products a criminal offence. However just 21 EU countries enforce criminal penalties for the manufacture, distribution, brokering, import, export and sale at a distance of falsified medicines...

...some dispute...findings on the controversial cuts...Increased reimbursements under Medicare Part B overall could offset potential losses for hospitals under changes to the 340B discount program, according to a new analysis...consulting firm Avalere Health analyzed hospital-level data from the Centers for Medicare and Medicaid Services on reimbursements in 2017 and 2018 and found that 85% of hospitals would receive higher Part B payouts that would minimize the reductions from cuts to 340B discounts...CMS finalized changes to 340B in November, changing its payment rate to 22.5% less than the list price for medication. Previously, it had paid up to 6% more than the list price under the program, and the cuts could equal $1.6 billion in lost payments...Rural hospitals would especially benefit from CMS’ increased Part B payouts, according to Avalere, as those facilities will net an average increase of 2.7%. Urban hospitals will see a 1.4% net increase...The 340B program wasn’t always controversial, but in recent years lawmakers and pharmaceutical companies have expressed concern that too many hospitals have enrolled, taking advantage of the program’s discounts. A study...suggests that hospitals have snapped up physician practices in areas like oncology to boost their 340B discounts but don’t often invest those savings in improving care for low-income patients.

A risk-based approach to inspection regulations could result in increased audits of more complex manufacturing sites, the FDA says...The final rule...revises time of inspection requirements and removes the duties of inspector requirements, both contained in section 600​ of the Code of Federal Regulations (entitled ‘Biological Products: General’)...It will affect how often the Food and Drug Administration is inspecting certain facilities and implement a risk-based schedule replacing...the biennial inspection requirement for drug and biological product establishments required in the Federal Food Drug and Cosmetic Act ​ and aligning the requirements with 2012’s Food and Drug Administration Safety and Innovation Act ...“This change clarifies the FDA’s flexibility under FDASIA to inspect facilities either more or less frequently, according to the potential risk the establishment’s operations present, without diminishing public health protections,”...According to Commissioner Scott Gottlieb, the ruling is part of efforts to modernise the FDA’s regulations, remove inefficient policies and reduce costs.

As Nevada’s suicide rate has jumped to No. 5 in the nation and to its highest level since the late 1990s, the state’s doctors are being asked to be the frontline in recognizing suicidal tendencies of their patients and get them help before they take their lives...The effort is part of a state law passed in 2017 requiring physicians in all specialties to receive two hours of training on suicide prevention as a way to deal with the epidemic. The training for Southern Nevada started on Jan. 23 when Dr. Lesley Dickson, executive director of the Nevada Psychiatric Association addressed more than 90 doctors, medical residents and medical students in a presentation called “Suicide Prevention: How to Save a Life.”...“Interventions by mental health professionals are very important, but many suicidal individuals never see a therapist,”...“It’s important that all people who interact with a suicidal person know how to help.”...Nevada had 650 suicides — just under two a day — and a suicide rate of 22.1 per 100,000, in the latest numbers from the American Association of Suicidology. That’s up from 2015’s 558 deaths and 19.3 rate per 100,000 when Nevada was ranked 11th. The state is typically in the top 10...

...Food and Drug Administration is asking manufacturers of a common opioid medicine to change the way the drug is packaged, as part of efforts to deter its abuse amid an opioid epidemic...The FDA said...it sent letters to manufacturers of diarrhea medicine loperamide, asking them to ensure that packages contain only a limited amount of the drug that is appropriate for use for short-term diarrhea...The agency wants to eliminate the large bottles in which loperamide is often sold because the abuse of the drug requires such large quantities.

Republican Governor Doug Ducey...signed into law legislation intended to crack down on opioid abuse, calling it vital to combat an epidemic felt statewide and across the nation...The legislation includes new regulations that will limit initial opioid prescriptions to five days and set a maximum of 30 days for certain patients receiving highly addictive painkillers...Other measures call for $10 million to be spent treating opioid abusers who are underinsured and ineligible for Medicaid. A controversial provision holds harmless those reporting potential overdoses...Despite the unanimous final vote, some lawmakers raised concerns about the unintended consequences of the state becoming more involved in doctor-patient issues, fearing it may hurt individuals needing opioids...