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The U.S. Food and Drug Administration said...it will allow regulators in eight European countries to determine whether drug manufacturing facilities there meet FDA requirements, freeing up American inspectors to spend more time in higher-risk countries like India and China...The FDA said it will begin relying on inspection data from the regulators in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom as of Nov. 1...in some situations the United States could still do inspections in those countries...The move is the first step by the FDA to implement an agreement the United States and the EU finalized in March. The European Commission already determined in June that the FDA could carry out inspections for it in the United States...FDA Commissioner Scott Gottlieb said in a statement that partnering with European regulators would allow the agencies to get “the greatest bang for our collective inspectional buck.”

Throughout the past year, and without much fanfare, Amazon.com Inc. has gained approval to become a wholesale distributor from a number of state pharmaceutical boards...It’s unclear, though, whether the regulatory filings support speculation that the e-commerce giant is planning a move into the prescription drug delivery business, territory currently dominated by a handful of companies...Industry analysts in recent weeks have raised the possibility that Amazon was eyeing this lucrative new business, posing a potential threat to such companies as north St. Louis County-based Express Scripts Holding Co...According to a review of records by the St. Louis Post-Dispatch, Amazon has received approval for wholesale pharmacy licenses in at least 12 states, including Nevada, Arizona, North Dakota, Louisiana, Alabama, New Jersey, Michigan, Connecticut, Idaho, New Hampshire, Oregon and Tennessee....

Message From the Executive Secretary, Larry Pinson - It is with mixed emotions that I announce my decision to retire, effective sometime within the next year, after over 22 years of being associated in one way or another with the Nevada State Board of Pharmacy.

New Executive Secretary Announced (The Ultimate Bearcat!) - J. David (“Dave”) Wuest, a graduate of the University of Cincinnati in Ohio and hence an avid Bearcat fan, has been selected to succeed Executive Secretary Larry Pinson upon Larry’s pending retirement in 2018.

Regulatory Update

SB 59 requires the uploading of Schedule V opioid medications into the state’s prescription monitoring database.
SB 337 authorizes a registered pharmacist to manipulate a person for the collection of specimens.
SB 131 requires each retail community pharmacy in the state to provide a prescription reader upon the request of a person to whom a drug is dispensed or advice on obtaining a prescription reader.
SB 260 authorizes a pharmacist who has entered into a valid collaborative practice agreement (CPA) to engage in the collaborative practice of pharmacy and collaborative drug therapy management in the retail setting.
SB 171 requires retail pharmacies in Nevada to post instructions for the safe disposal of unused drugs.   Assembly Bill 474 - many requirements on practitioners using CS to treat patients...

Bowl of Hygeia Recipient 2017 - Congratulations to Mark C. Decerbo

Friendly Reminder - Technicians-in-training must have a separate registration for each individual pharmacy in which they receive their training.

Is Your Pharmacy Helping or Hindering the Health of Nevadans? - Adults may grow up, but they never outgrow the need for vaccines.

.Pharmacy Domain Signals Safety on the Web - With only 4% of websites selling pre­scription drugs online following United States pharmacy laws and practice stan­dards, consumers seeking medications online are faced with the daunting task of finding a safe site. To assist consumers and those legitimate pharmacies with an online presence, NABP has streamlined its website verification programs.

Quality Processes, Risk Management, and Culture: HR-Related Policies That Conflict With a Just Culture

AMA Task Force to Reduce Opioid Abuse Promotes Safe Storage, Disposal of Opioids

CDC Guide Shows Importance of Physicians, Pharmacists Working Together

FIP Report Shows Value of Pharmacists’ Role in Consumers’ Self-Care

FDA Restricts Use of Codeine and Tramadol Medicines in Children; Recommends Against Use in Breastfeeding Women

AVMA Warns Pharmacists and Pet Owners About Xylitol Pharmaceutical Products

CDC Publishes Guide to Help Pharmacists Initiate CPAs With Prescribers

DEA Releases New Edition of Drugs of Abuse Resource Guide - 2017 edition of Drugs of Abuse, A DEA Resource Guide

Business will continue as usual for Nevada’s Silver State Health Insurance Exchange during the upcoming open enrollment period despite uncertainty over its future in Congress...Insurance exchange officials, joined by Democratic state Sen. Yvanna Cancela, addressed advisers who will help with the enrollment process ...emphasizing the need for aggressive outreach to Nevada’s estimated 43,000 eligible but non-enrolled residents...They also said planning will continue ahead of the Nov. 1 beginning of the enrollment period despite the potential that Congress could eliminate the exchange by repealing the Affordable Care Act...

...the FDA is overstepping its authority and jeopardizing patient access to compounded medications...The pharmacies say the Food and Drug Administration has misinterpreted Congress’s intent when it enacted the Drug Quality and Security Act (DQSA)...by not allowing office-use compounding...The pharmacies also are concerned that the FDA has issued no rules for compounding but only guidance documents, which aren’t legally enforceable...‘Mass confusion has resulted from the usage of guidance documents, and the FDA is definitely circumventing the Administrative Procedure Act (APA) in our opinion,’’ Cynthia Blankenship, executive vice president of the International Academy of Compounding Pharmacists (IACP)...The APA governs how federal agencies propose and establish regulations. IACP wants Congress to pass a bill (H.R. 2871) they say will fix these issues...Since the DQSA was enacted, the FDA has significantly..increased its inspections of drug compounding...facilities...The FDA has conducted more than 350 inspections of compounding pharmacies as of Nov. 27, 2016, and nearly 120 of those inspections were due to reports of serious adverse events or product quality issues...

The U.S. Food and Drug Administration plans to encourage widespread use among opioid addicts of less harmful opioid drugs such as methadone and buprenorphine, a radical shift in policy that could draw opposition from those in the addiction field who believe abstinence is the only effective treatment...FDA Commissioner Scott Gottlieb outlined a proposal under which every addict who suffers a non-fatal overdose would be treated with an opioid substitute, for long periods if necessary, or even for life...“I know this may make some people uncomfortable,” Gottlieb said...“FDA will join efforts to break the stigma associated with medications used for addiction treatment.”...The FDA, Gottlieb said, will issue guidance for drugmakers to promote the development of new addiction treatments and lay out the agency’s interest in “novel, non-abstinence-based” products...

Australia provides half of the world’s legal supply of raw opiate, but demand and prices are tumbling...With the U.S. imposing stricter rules on the use of painkillers, demand for the raw material has tumbled. Poppy growers in Tasmania have responded by scaling back or giving up on the crop altogether. The state is the source of about half of global supply, thanks to a 1971 agreement with the Commonwealth of Australia that granted it a decades-long monopoly on poppy cultivation...Tasmanian farmers...are reeling from the impact of government and corporate efforts to stem the abuse of prescription painkillers and their illegal knockoffs. The volume of opioid-based medicines prescribed in the U.S. has dropped 28 percent since 2012 following moves by the Drug Enforcement Agency to tighten access...The prescription branded-opioid market is at its lowest point in almost a decade...Tasmania is facing more competition: Three states on the Australian mainland have eased restrictions on poppy growing in recent years...As they wait for a rebound in demand, Tasmania’s poppy farmers need to focus on becoming more efficient...Some growers have managed to boost their yields to an average of about 40 kilograms of active raw material per hectare, up from 25 kilograms five years ago...It is a really, really tough marketplace out there, and it doesn’t look like it’s improving...The only thing at the present time to make it viable is increasing productivity...

...numerous rural health insurance markets have teetered on the brink of collapse. Rural areas have long posed a special challenge to health care policymakers, but a poorly-designed system of subsidies for rural hospital care has turned this into a crisis. It has fostered a rural hospital market structure that has crippled the ability of private insurers to negotiate reasonable payment rates, without fully securing the provision of essential care. By refocusing federal assistance on emergency care, it should be possible to restore rural insurance markets to health, while improving the affordability and access to care available to residents...MedPAC (Medicare Payment Advisory Commission)...has argued that CAHs (Critical Access Hospitals) are “not the best solution”, as “many small towns do not have the population to support efficient, high-quality inpatient services.” MedPAC has proposed...lump-sum payments to cover the overheads needed to provide 24/7 emergency care at geographically isolated outpatient-only facilities and suggested that Medicare reimbursement be extended to care provided by standalone emergency departments...This would focus subsidies to secure emergency services, which must be delivered locally, while leaving elective care to be located efficiently according to market demand. Such a reform would give emergency rural hospital care a firmer financial foundation while restoring payment rules for elective care that would make it possible for insurers to re-enter the rural marketplace.

In light of recent guidance from the FDA on appropriate communications between payers and drug manufacturers prior to a drug’s approval, a panel of stakeholders at the Academy of Managed Care Pharmacy 2017 Nexus meeting...discussed how these new guidelines can raise as many questions as they answer.

Soumi Saha...background on the implications of the guidance...Payers and other healthcare decision makers need thorough healthcare economic information (HCEI) on a potential new drug’s budgetary impact and treatment population in order to plan and budget their resources...Saha pointed to surveys that found that 64% of payers perceived a gap between the information they needed and what they received, and 91% of manufacturers said it was difficult to have their HCEI materials approved under FDAM (Food and Drug Administration Modernization Act)...

Mark Gaydos...was not aware of any enforcement letters that had been sent by the FDA regarding formulary communications, and that it would have been difficult for the FDA’s Office of Prescription Drug Promotion to write such letters anyway, considering the lack of clarity in the rules...

Jay Jackson...provided more insight on how manufacturers are using the updated guidance to change how they generate HCEI. It is important for companies to establish standards on the scope of the data they will present, the scientific evidence supporting it, and how it should be presented, in a process he called “beginning with the end in mind.”...“I think we’re moving in the right direction,” Jackson said. “We’re not even 1 year into this, but I do think there’s increased knowledge of how to handle” HCEI both proactively and reactively....

Kat Wolf Khatchatourian...discussed her experiences with HCEI communications...Because formularies and rate filings are locked in by June for the next year, they cannot be adjusted to account for any additional products that are approved later on in the year. As such, plans are “perpetually playing catch-up with the innovation that’s coming to market.”...She called for additional legislation that “would improve both the timing and the quality of information that’s able to be exchanged and enable a safe harbor where people are not fearful” of sharing information...

Chicago has moved a step closer to placing major restrictions on pharmacist workloads in a bid to improve consumer safety...The City Council Finance Committee on Tuesday approved a measure that would allow Chicago pharmacists to fill prescription orders for no more than 10 patients per hour, as well as guaranteeing meal and washroom breaks. It also would require pharmacies to post a list in plain sight showing which pharmacists and technicians have worked shifts longer than eight hours...The proposal's sponsor, Ald. Edward Burke, the committee's chairman, said he hoped to bring the plan up for a vote in the full City Council...The...alderman has argued that the proposal would reduce the "undue levels of stress" on pharmacists caused by pressure from retailers to fill hundreds of prescriptions a day. Pharmacists working constantly for as long as 12 hours a day have said they worry about losing focus during busy shifts and potentially putting their customers in jeopardy...Along with the 10-patient-per-hour limit, Burke's Chicago proposal would give pharmacists who work at least seven hours in a shift two 15-minute breaks and one 30-minute meal break. A pharmacy also would need to schedule at least 10 pharmacy technician hours per 100 prescriptions filled.