Author: Peter

A British vote to leave the European Union would threaten some prescription medicines with regulatory limbo, posing a legal headache for drugmakers, according to lawyers and industry officials...The highly regulated pharmaceutical sector has more at stake than most from a so-called Brexit, prompting top manufacturers GlaxoSmithKline and AstraZeneca, both of which oppose exit, to draw up detailed contingency plans...Currently, under EU rules, drugmakers launching a medicine get a single marketing approval that allows them to tap the entire European market of 500 million potential patients...In the event of a British exit, UK firms could no longer apply for or hold EU marketing authorizations, unless or until the UK negotiated to be part of the EEA. Licences would have to be transferred to businesses inside remaining member states..."The potential complexities around such issues as marketing authorization simply highlight the problems that could be faced by companies and patients alike in the event of exiting the EU,"...GlaxoSmithKline said leaving the EU would create uncertainty, add complexity and making some short-term disruption likely...

ASHP has released the ASHP Specialty Pharmacy Resource Guide, a new publication that outlines ways for hospitals and health systems to address the challenges and opportunities presented by specialty pharmacy, the fastest growing segment of the pharmaceutical industry... It is projected that by 2020, specialty pharmaceuticals will represent half of all drug expenditures, driving pharmacy directors to seek out strategies to address the impact of the products on pharmacy services. The resource guide discusses the financial, legal, administrative, and patient care aspects of four specialty pharmacy business models and helps users determine which model best matches their needs.

Three years ago, doctors in Europe displayed grave doubts about using biosimilars instead of branded biologics on their patients. But after a couple of years of experience with a biosimilar of Merck's Remicade (infliximab) from Hospira and Celltrion, a new report finds doctors are much more responsive to the biologic copies...The survey of European Crohn's and Colitis Organization members was released Friday at ECCO's 11th Congress in Amsterdam. It found that 44.4% of physicians taking the survey considered the Remicade biosimilar, a mAb, interchangeable with the original product...The key advantage of using biosimilars is to save money...while...their key concern with using them is immunogenicity...The survey results are potentially promising for drugmakers taking biosimilars to the U.S. market which is just now opening up but offers the biggest payoff. Citigroup analysts estimate innovative biologics will lose $110 billion in sales to copycats by 2025.

America's love affair with prescription drugs began in the 90s when narcotic pain killers left the hospital and headed home in the form of a pill..."Pain killers began being prescribed at such a high rate, and the folks who were prescribing them didn't necessarily have any training," said Jennifer Delette-Snyder...of Join Together Northern Nevada..."Think of Heroin. An opioid in a pill is the synthetic form of that type of a drug,"..."A surge in painkiller prescribing has been the main driving force over this epidemic and of the heroin epidemic," said Dr. Tom Frieden, Director of the CDC...This week the agency started to combat the problem by issuing new guidelines (for) the prescriptions of opioids. The guidelines say opioids should not be the default solution for pain care..."People don't realize that these opioids are lethal. No one ever takes a pill thinking that it is going to kill them and this is the type of awareness that we are trying to build," said Teresa Benitez-Thompson, Nevada Assemblywoman from District 27...Doctors in Nevada now have to log opioid prescriptions in a database. The practice prevents patients from doctor shopping as well as prevents doctors from accidentally over prescribing...Delette-Snyder says both the CDC actions and the legislature actions have the potential to save lives, but she says we need to stay the course and only look to opioids for only the most extreme situations...Physicians could go back to prescribing only Ibuprofen, but only time will tell if they will. The CDC guidelines are only guidelines. They are not a mandate.

The National Association of Chain Drug Stores...announced the expansion of its get-out-the-vote initiative for 2016, with new video ads to encourage pharmacy personnel to volunteer and vote for the candidates of their choice...The new ads are part of the larger NACDS RxIMPACT Votes get-out-the-vote effort, one aspect of NACDS’ suite of grassroots advocacy resources under the NACDS RxIMPACT name. The ads will bear the "hashtag" #PharmacyVoter that will be used in social media to foster a community-wide focus on voter engagement. NACDS also launched PharmacyVoter.org – a website targeted to the pharmacy community to showcase the effort... The first 30-second ad — called "Effective" — debuted...during the launch of NACDS RxIMPACT Day on Capitol Hill, when nearly 400 pharmacy advocates will meet with 90% of the U.S. Congress to discuss key patient care issues.

World Health Organization has suspended the approval of tuberculosis drugs made by India's Svizera Labs, a major supplier to developing countries, following an investigation into standards...The United Nations agency, which acts as a drug watchdog in markets lacking robust local regulation, said on Friday it had suspended all TB products made at Svizera's Mumbai site because manufacturing standards and quality management were unreliable...It also said independent experts should retest batches of medicine already on the market and it might be necessary to recall supplies, depending on the outcome of those tests...The move is a fresh blow for India's pharmaceuticals industry, which supplies cheap generic medicines to countries worldwide but has been tarnished by a series of quality problems in recent years, denting confidence in its products...The WHO plays a critical role in monitoring drug quality in poorer countries through its Prequalification of Medicines Program, which ensures that treatments supplied by U.N. agencies such as UNICEF are of acceptable quality.

Dan Steiber, Editor in Chief for Specialty Pharmacy Times, speaks to True North P.S. President, Ron Lanton. What is limited distribution and its effect on specialty? What are the risks in arrangements between specialty pharmacies and manufacturers? (podcast 44:12 min)

Medicine Shoppe Canada and its parent company, McKesson Canada, on Friday announced a partnership with Quality Foods, a Canadian grocery chain, to drive better patient experience in retail pharmacy...This partnership will see the opening of a new, state-of-the-art pharmacy within a leading grocery store – designed with evolving patient centric care models in mind. Long-time community pharmacist, Larry Johannessen...will operate the new location within the Port Alberni Quality Foods..."As pharmacists, patient and customer care is at the heart of what we do, each and every day", Johannessen said. "I’m excited to partner with Quality Foods to welcome patients into our new facility as we expand access to patient care."

Daniel T. Abazia, PharmD, BCPS, discusses some of the non-pharmacologic treatment options that pharmacists can recommend to patients experiencing opioid-induced constipation.

Patients with pancreatic cancer living in Wales will no doubt welcome news that Celgene’s Abraxane will continue to be available on the National Health Service in the country, despite a decision by the National Institute for Health and Care Excellence to reject its use...NICE confirmed back in November that Celgene’s Abraxane (nab-paclitaxel) will not be routinely funded for use in combination with gemcitabine for treating pancreatic cancer on the NHS in England and Wales, claiming that the drug’s cost does not justify its benefit to patients...the Institute said while the Abraxane/gemcitabine combination was more effective than the latter drug alone, it resulted in more serious side effects, and also caused more adverse events than a gemcitabine/capecitabine regimen despite having similar effectiveness...in a rare move, the Welsh government (All Wales Medicines Strategy Group) has now stepped in to ensure continued access for metastatic pancreatic cancer patients in Wales, on the back of data from the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, which showed an increase in median overall survival of 1.8 months with Abraxane in combination with gemcitabine, when compared to gemcitabine alone.