Author: Peter

More than half of Nevada occupational licensing boards aren’t following a 2010 directive to keep their salaries in line with state employees, and another 12 percent are paying salaries above caps set in state law...A report presented...to members of the state’s executive audit committee — composed of the governor, lieutenant governor, attorney general, secretary of state, treasurer and controller — detailed various oversight issues with the state’s nearly three dozen occupational licensing boards on everything from executive compensation to inconsistencies in how boards manage their finances...The audit — and the somewhat testy responses from several licensing boards — underlined a consistent pressure between the semi-autonomous regulatory bodies and the governor’s office, which is nominally in charge of regulating them...The audit reported that at least four of the boards — Pharmacy, Medical, Contractors and Accountancy — paid out salaries above the limit set in state law, which caps most salaries for state employees at 95 percent of the governor’s annual $149,753 salary...The boards presented a variety of reasons for paying their executive directors above the limit set in law. The State Board of Pharmacy wrote in a response to the audit that the salary figure included contributions to the state’s retirement fund and pointed to conflicting language in state law that gave the board the ability to determine the executive director’s salary...The audit suggested that boards were overpaying executive directors between $28,000 and $59,000 on average compared to similar positions for state employees...

The company plans to open a 200,000-square-foot space in Chicago's Old Post Office Building...Walgreens expects about 1,300 employees will relocate from its Deerfield, Illinois, headquarters...Walgreens is the latest of a slew of companies shifting operations out of the suburbs and into the city. Some companies, including food giants McDonald's and Kraft Heinz, have even relocated their headquarters to Chicago...It's one way to attract employees, particularly millennials, in a competitive labor market. In announcing the move, Walgreens said it will help the company "meet the needs of its current and future workforce while continuing to attract and retain the best talent."

A woman in Arizona made the brave choice this week, to make a very private loss — a miscarriage — into a public discussion, in the hopes that her story can save other women from what she went through at her local Walgreens. The pharmacist there refused to fill the prescription required to help her end her pregnancy, citing moral objections, even though her fetus no longer had a heartbeat...Pharmacists have been known to refuse to give women this medication, as well as prescriptions for over-the-counter emergency contraception pills, because of their anti-abortion beliefs...

Online black-market sales of opioid painkillers more than doubled in the United States during the two years after these drugs were “rescheduled,” putting tighter restrictions on legal prescriptions and sales, according to a recent study...In October 2014, hydrocodone combination products...were reclassified from...schedule III to schedule II, imposing stricter controls on prescriptions written by doctors and on patients’ ability to refill them...Almost immediately, the proportion of all drugs illicitly purchased in the U.S. from sellers on the “dark net” that were in the opioid category began rising, reaching 13.7 percent in 2016. Stronger, more dangerous opioids also gained in popularity in these so-called cryptomarkets...cutting off supply leads to people sourcing their drugs from illegal and uncontrolled sources, and they buy products of higher strength - with all the dangers that this type of supply carries...A better approach would be harm reduction, therapeutic intervention, reliable treatment options, dealing with over-prescription early on, and providing information on the danger of opioid use to reduce stigmas...policy measures like up-scheduling, an introduction of abuse-deterrent formulations, prescribing limits, and prosecuting health care providers created a powerful push that precipitated the changes in the overdose dynamics we are contending with today...

Two in five Nevada physicians lobbied by pharmaceutical sales representatives in the last three months of 2017 received monetary compensation, according to a report released earlier this month by the Department of Health and Human Services...The department found that 42 percent of doctors, or 396 physicians, identified in reports made to the state received some amount of monetary compensation from pharmaceutical reps between October and December, while 58 percent only received samples. But the report is also telling in what it is unable to say, with only about half of the states’ 2,572 active pharmaceutical reps detailing their doctor lobbying activities and only 13 percent of submitted reports containing enough information to tie the data back to licensed Nevada physicians...Of the small percentage of data it was able to collect and analyze, the state identified a total of 954 doctors that either received direct compensation, samples or both from pharmaceutical sales representatives, with 396 of them receiving direct compensation. (Nevada had a little under 6,000 active physicians as of March 2018.)...The report is the first formal product released as a result of Nevada’s new drug pricing transparency law. The state will be required to compile another report after it receives certain data related to the costs and profits associated with manufacturing and selling so-called essential diabetes drugs from drug manufacturers and pharmacy benefit managers, who are the middlemen in the drug pricing process...The drug lobby is continuing to challenge the constitutionality of those reporting requirements in U.S. District Court after final regulations were approved last month.

The US Food and Drug Administration's Center for Biologics Evaluation and Research...announced it is launching a new program for early meetings with biologics developers...The new program, called INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER ProducTs), replaces CBER's existing pre-investigational new drug meeting program...We know that academic investigators, small and medium enterprises, and sometimes even large companies can have questions regarding the path from preclinical to clinical development for biological products—particularly those that raise new regulatory questions," said CBER Director Peter Marks...the new program will be better tailored to providing input to biologics developers at early stages of development and will help sponsors plan their development programs to gather evidence needed for FDA approval more effectively.

A more difficult question is raised if a pharmacist refuses to fill based upon his or her religious beliefs...a University of Wisconsin student requested a refill on her birth control prescription at her local pharmacy. The pharmacist on duty, Neil Noesen, RPh, refused to fill it, citing his religious beliefs. He also would not transfer the prescription or tell her where she could get it filled...The student filed a complaint with the Wisconsin Board of Pharmacy.The board’s administrative law judge restricted Noesen’s license, finding that a pharmacist with a conscientious objection to dispensing a prescription must ensure there is an alternative mechanism for the patient to receive the medication, including informing the patient of their options to obtain their prescription.”...The Court on appeal ruled, “Noesen had a right to refuse to provide birth control pills but not to refuse to transfer a valid prescription to another pharmacy.”...The Trump administration is making it easier for medical providers to object to procedures on religious grounds...an HHS proposed rule...would allow HHS to enforce protections for religious medical providers...Pharmacists must be familiar with their state regulations and new federal guidelines...

The Australian government has endorsed several regulatory activities aimed at reducing the Therapeutic Goods Administration’s oversight on a range of low risk pharmaceuticals and medical devices...The consultation was released as part of the government’s response to TGA’s Review of Medicines and Medical Devices Regulation, identifying ways in which to improve patient access by reducing unnecessary costs associated with entering the Australian market...the government called on TGA to examine whether the regulatory oversight applied to a range of products that represent a very low safety risk too consumers was consistent with the principles of best practice regulation, and further whether there were any opportunities for streamlining or simplifying current regulatory requirements for these products...TGA...also implemented specific criteria last week to aid industry in identifying comparable overseas regulators and a process for work-sharing on drug applications using COR reports.

The relentless rise in prescription drug prices is prompting pharmacists to become more proactive in helping patients save money. Community pharmacists have had a front row seat for the tsunami of prescription price hikes that has been building for decades...What has really caused it to bubble up above the surface are the high deductible plans, and also the changes in insurance plan designs [that] are shifting more of the cost burden to consumers…

• Customer Relations Take a Hit
  Naturally, pharmacies are bearing the brunt of patient frustrations...J.D. Power 2017 U.S. Pharmacy Study reports “notable declines” in overall customer satisfaction that are driven by cost...
• One National Chain Reacts
  CVS Pharmacy Rx Savings Finder to help patients save money...tools to patients, prescribers, and pharmacists so they can evaluate prescription drug coverage in real-time and identify lower-cost alternatives...the right drug at the lowest possible cost for patients to ensure they are able to access and stay on the medications they need...
• Business Implications
  ...escalating prescription prices are also causing revenue problems for pharmacies...Zero reimbursements for many generics is common...retroactive DIR fees undermine patients’ access to prescriptions and hinder their own ability to manage their businesses.
• Revenue Boosting Options
  exploring alternative revenue streams—including chronic care management—and efficiency improvements...
• Alternative Revenue Streams
  expanding over-the-counter medications and products...offering immunizations, diabetes and cardiovascular education, smoking cessation, and nutrition classes...

Health Canada this week said it intends to restrict the marketing and advertising of opioid drugs...Evidence suggests that the marketing and advertising of opioids has contributed to increased prescription sales and availability of opioids...From presentations sponsored by opioid manufacturers at conferences to advertisements published in medical journals, these practices “can take many forms of direct and indirect activities and incentives.”...Manufacturers of opioids with a presence in the Canadian market are “strictly prohibited” from advertising to the public, but not to healthcare professionals...Health Canada...set forth additional authority for the Minister of Health to require implemented risk management plans from opioid manufacturers. These plans must include the preclearance of all materials related to opioids and provided to healthcare professionals to safeguard the compliance of their marketing clearances.