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A Super Bowl commercial paid for by AstraZeneca and Daiichi Sankyo to stimulate awareness of opioid-induced constipation continues to draw controversy...days after the big game. Since Sunday, a parade of politicians, physicians and pundits have criticized the ad, linking the campaign to the opioid prescription drug addiction problem...and forcing AZ and Daiichi, which market...Movantik (naloxegol), to defend it...Vermont Governor Peter Shumlin..."In the midst of America's opiate and heroin addiction crisis the advertisement was not only poorly timed, it was a shameful attempt to exploit that crisis to boost your companies' profits."...U.S. Pain Association..."In the current health care landscape, chronic pain patients are continually forced to 'prove' their pain. They face backlash and ridicule instead of compassion and help. U.S. Pain Foundation collaborated on this ad with other organizations to spread awareness and information...The goal--for all involved on this project--was to make sure people living with OIC do not feel embarrassed or alone...Did the pharmas get their money's worth, reported at $5 million per 30 seconds this year?...so far the ad has been mentioned more than 38,000 times on social media...in the past few days, according to real-time TV tracker iSpot.tv. It also had a 50% positive Tweet rating and has been viewed more than 2 million times online...

Express Scripts Holding Co. is carefully scrutinizing prescriptions for products made by Valeant Pharmaceuticals International Inc., making sure the pharmacy manager’s rules are being followed...We are looking at every single claim for their products...They are getting extra scrutiny...Valeant last year was accused of working with a network of pharmacies to boost sales of its drugs and get them reimbursed by health insurers and pharmacy benefit managers like Express Scripts, even when there were cheaper generics available...Express Scripts reviews prescription claims to ensure that the manufacturer and pharmacies are operating in a manner consistent with its contracts and in the best interests of its clients and patients...The reviews ensure that patients and payers aren’t spending more on the products than necessary...

The Pharmaceutical Research and Manufacturers of America, one of the top bodies representing American pharmaceutical and biotechnology companies, said in an annual report that India's intellectual property rights protection is weak and the group added India to its "priority watch list."...The country's legal and regulatory systems "pose procedural and substantive barriers at every step of the patents process,"..."Not only is this a concern in the Indian market, but also in other emerging markets that may see India as a model to be emulated,"...since 2012 about 25 products "have had their patent rights undermined in India" and that "in 2015 alone, at least six products have faced issues due to the continued denial of applications" under India's patents act...PhRMA also said high tarrifs (tariffs) and taxes in India on APIs and finished products were a huge challenge for the industry and that India "collects more in taxes on pharmaceuticals than it spends on medicines."

LinkedIn's professional social network appeals to business people, networkers and recruiters, but also to industries that tend to be more cautious on social media. Welcome, pharma...Healthcare, overall, and pharma is definitely on the developmental side of the LinkedIn spectrum...from an advertising perspective...But over the past three years, we've seen a huge growth in having these companies consider LinkedIn as a channel...Many drugmakers have taken a first step, usually by setting up a company page where drugmakers can build up followers and create an audience with employees, colleagues and associates. But pharmas are increasingly using LinkedIn for paid sponsorships and advertising. Sponsored updates and InMail campaigns are beginning to move from testing to a repeat marketing strategy among pharmas...InMail, in which sponsored messages are sent directly to targeted LinkedIn members inboxes, tends to be "safe" for pharma because email bypasses any open comment possibilities...I think there are a lot of opportunities for pharma companies to be the leader and the innovator across their competitive set...Professionals on LinkedIn are connected to peers, colleagues and managers so the platform allows for that much more engagement. You're not hiding behind a handle or showing pictures of family, this is your professional brand...

Eli Lilly suffered a crushing defeat in the U.K. over patents for its lung cancer blockbuster Alimta (pemetrexed) as the U.K. High Court ruled in favor of Actavis' plan to market copycat versions of the med...The High Court's decision also applies to Actavis' generics in France, Italy and Spain...The company has a separate compound patent for the drug that expires in 2017. But certain patents for Alimta expire in 2021, and the latest ruling could throw a wrench in Lilly's plans to hold on to sales...Lilly is not pleased with the High Court's decision. "We strongly disagree with the ruling by the U.K. High Court" and "we plan to seek permission to appeal this ruling,"…The company has fared better with Alimta in the U.S., though. In August, a federal court ruled in favor of Lilly and granted the company 5 more years of U.S. exclusivity for the med. The court found that generic meds proposed by Teva Pharmaceutical Industries would infringe on Lilly's method patent for Alimta in combination with vitamins, allowing Lilly to hold on to the patent until 2022...

The meteoric rise in the cost of specialty drugs has been well-documented and appropriately lambasted, at least in some circumstances...Two consequences of the growing cost for specialty medications percolated to the top of my list when considering its ability to impact the specialty pharmaceutical industry...First is the arrival of the pharmaceutical manufacturers’ day at-risk...the deal between Harvard Pilgrim and Amgen for the PCSK9 inhibitor...Harvard Pilgrim will recoup additional rebates from Amgen if various patient groups taking Repatha do not achieve specific cholesterol targets...Given the need for improved alignment within the industry as a whole, this development is a good thing. If manufacturers and payers would allow them to do so, specialty pharmacies could serve as the primary conduit...that enable both parties to generate value from at-risk agreements...we will explore how this can be achieved.

1. Leverage programs proven to improve adherence - Pharmacists and patient care coordinators employed by medication management providers and specialty pharmacies are perfectly suited for this task.
2. Agree on data and outcomes - In order for manufacturers to accept some risk, there should be upfront agreement on financial and health outcomes. Top health outcomes should be close to the clinical trial results manufacturers tout themselves.
3. Assign a near-neutral third-party for health outcomes metrics arbitration - Neither payers nor manufacturers can be the arbiters of the data by which at-risk agreements are adjudicated...In the world of specialty medications, the entity best suited to this task is the specialty pharmacy with validation from a clinical pharmacist.

Barriers to Access are not Good and Must be Broken Down...The second consequence applies to health care on a national level, but the pharmaceutical industry, inclusive of pharmacy benefit managers and payers, has the ability to do something about it...The barriers to treatment access, even preventative treatment, created by increasingly complex prior authorization processes and state budgets stretched to the breaking point, are causing patients to defer treatment...Investing in Access Solutions...new personnel specifically tasked with prior authorization assistance...will carry an arsenal of knowledge and experience that makes them the most suitable resource given the increasingly complex requirements for successful completion of prior authorization forms...

Drugmakers, long reliant on using DTC ads to drive patients into doctor's offices, should rethink that strategy...The marketing model used to be big and bold out of the gate on day one...the industry is starting to challenge that model...The consumerization of healthcare is king, not the consumer...if a patient today requests a new drug or tries to refill an old one, that request may face more resistance from physicians with differing views about a specific medication or from payers that give certain medications preferred status on their formularies than it would have in the past...This raises questions about the effectiveness of traditional branded pharmaceutical advertising campaigns, which perform best in a market where the drug is broadly available...About 47% of Americans ask their doctor questions about a drug, while 30% ask the pharmacist. Nearly half of respondents—43%—say that their pharmacist always or frequently recommends an alternative brand or type of medication in order to reduce out-of-pocket costs...The role of the pharmacist in a formulary driven world is becoming far more dominant...The pharmacist is becoming as good a choice for health counsel...Marketers are seeing a need to better communicate with the pharmacist...

In the latest government effort to penalize unfair competition among drug makers, the United Kingdom fined GlaxoSmithKline $54.5 million for illegally colluding with generic rivals to delay marketing lower-cost versions of the Paxil antidepressant...the UK Competitions and Market Authority found that between 2001 and 2004, Glaxo made payments totaling about $72 million to several generic companies. The deals were reached as part of a settlement to end patent litigation that was filed by Glaxo against the generic drug makers...Such settlements are known as pay-to-delay, since a brand-name drug company pays cash or transfers something else of value to a generic rival, which agrees to delay launching a copycat medicine. In 2001, Paxil was a blockbuster with sales in the UK exceeding $130 million...In this instance, the agreement deferred competition and potentially deprived the UK’s National Health Service of a lower-cost generic Paxil. UK authorities noted that when a generic version of Paxil eventually became available at the end of 2003, average prices fell by more than 70 percent in two years...Cracking down on these practices is essential to protect consumers, to encourage legitimate business activity that such practices stifle, and to stimulate innovation and growth...

Health-system pharmacists can play a critical role in managing drug shortages to prevent medical errors and adverse events...[Pharmacists] can often prevent shortages from impacting their institution by proactively managing inventory...When a shortage situation impacts hospital inventory, pharmacists should inform providers early...Pharmacists can also develop protocols for emergency department staff on what to do if a drug is not available. These protocols should include information about the best alternative medication, dosing recommendations, proper administration of the drug, and contraindications...Pharmacists can also take the following steps:

• To prevent errors, place specific labeling on a medication if a different concentration than what is normally stocked is being used.
• Help develop protocols for the ethical distribution of medications on shortage.
• Minimize waste of medications while compounding.
• Assist emergency medical services providers and directors with out-of-hospital protocols during shortages.
• Monitor and report adverse outcomes and medication errors.

...researchers examined data from the University of Utah Drug Information Service...Here are 7 things pharmacists should know about these findings:

1. Of the 1789 drug shortages, about one-third (610) were within the scope of emergency medicine practice.
2. From January 2008 to March 2014, emergency medicine drug shortages rose by 435%, from 23 to 123.
3. The reason behind shortages remains unknown for around half of the 1789 cases.
4. Infectious disease medications were hit hardest.
5. Around 40% of drug shortages affect emergency care, according to a report from the Health and Human Services’ Emergency Care Coordination Center.
6. The median shortage time for emergency medicine drugs was 9 months.
7. The most common reasons for a drug shortage were related to manufacturing delays or problems.

Walgreens...announced the launch of a new effort to combat drug abuse, introducing two programs that address contributors to the crisis.

1. ...Walgreens will install safe medication disposal kiosks in more than 500 drug stores in 39 states and Washington, D.C., primarily at locations open 24 hours. The program will make the disposal of medications — including opioids and other controlled substances — easier and more convenient while helping to reduce the misuse of medications and the rise in overdose deaths.
2. Walgreens also will make naloxone...available without a prescription at its pharmacies in 35 states and Washington, D.C., rolling out the program state-by-state throughout this year.