Author: Peter

Two Indian states have put sales of...Roche's blockbuster drug Avastin on hold, officials said on Tuesday, after it hampered the vision of 15 patients who used it for a condition it is not officially meant to treat...Avastin (bevacizumab) is a cancer drug but is often used by doctors to treat vision loss even though it has not been approved by the U.S. Food and Drug Administration for that purpose. Studies have shown that eye injections of Avastin curb vision loss...Roche's India unit said the company does not promote the use of Avastin for treatments for which it is not approved, but has initiated an internal investigation...H.G. Koshia, the top drug controller in western Gujarat state, said he had directed distributors to recall one batch of the medicine given to the patients last week. Its samples were being tested following the incident at a hospital in Ahmedabad city...The hospital said all standard protocols were followed. Koshia, Gujarat's drug regulator, said they would need to ascertain whether the drug was a fake copy of Avastin.

Anthem CEO Joseph Swedish caused a bit of a stir at an otherwise tame JP Morgan Healthcare Conference this month when he essentially accused Express Scripts...of overcharging his managed care organisation by $3 billion per year...the public spat represents a serious headache for Express Scripts, and could result in an unexpected windfall for one of the company’s main competitors, but in a broader sense the episode highlights what one industry expert believes is an increasingly important market inefficiency that would – if exposed to and by payers – have massive implications for the PBM sector...Politicians (and plenty of others) have been raising hay lately about the need for...more transparency...this same thought process has not (yet) been extended into the PBM space, where companies’ primary role is that of a middleman...“I hope it erupts into more – this is serious and real. PBMs...make price transparency for pharmaceuticals impossible and it is the patient that suffers the most because of it,”...“The thing centres on the fact that the PBMs insist on large rebates from the manufacturers, and the amounts are ‘proprietary’ so they can conceal them from their clients. The discounts aren’t being passed along to their customer but the effect is to force list prices higher to maximise rebates,”...more transparency could be a big benefit for drugmakers, who are likely well aware of the situation but feel as though their hands are tied when it comes to fighting back. “I believe that the more this gets pushed, and the more others learn about it, they will have to have this extend further,”...“Pharma has to have this revealed by others – they can’t complain because the PBMs could retaliate” during the formulary negotiation process.

Food and Drug Administration on Friday issued draft guidelines to medical device makers on how to protect patients from cybersecurity vulnerabilities in the devices...Cybersecurity threats to medical devices are a growing concern...The exploitation of cybersecurity vulnerabilities presents a potential risk to the safety and effectiveness of medical devices...The draft guidance, which is not legally binding, recommends companies take a number of actions, including monitoring and assessing risk, adopting a coordinated vulnerability disclosure policy, and taking measures to address cybersecurity risk early.

To realise new ways of working means moving away from traditional professional boundaries and enabling the pharmacy workforce to take on different roles if it benefits patients...the demand for pharmacists’ clinical skills as medicines experts continues to grow. Medicines optimisation spans all pharmacy services....In order to deliver this, maximising the skills, knowledge and experience of the rest of the pharmacy team is an absolute necessity...As pharmacists’ clinician role continues to evolve and become embedded in new areas...pharmacy technician, can help to support them.

• Education and training...realigning functional tasks and providing confidence in delegating duties is to ensure there is a defined education and training pathway that assures the public and the profession of a competent practitioner at every level.
• Expanding roles...Pharmacy technicians, as registered and accountable professionals working across the same pharmacy environments as pharmacists, can be used to release pharmacists’ time to undertake additional clinical responsibilities.
• Blurred roles...The expanding responsibilities of pharmacy technicians may help give clarity to the role...However, there is no clear distinction between a newly registered pharmacy technician and a dispensing assistant...requires greater clarity around the role of the dispensing assistant...This must be resolved if pharmacy technicians are to further their practice and help release pharmacists to conduct more clinical work.
• Working together...Pharmacy technicians will not be substitutes for pharmacists but, as foundation practitioners, they can work closely together, exercising autonomy and judgement within limited parameters...Working together for the benefit of patients will allow pharmacy to embrace the changes that are needed to relieve pressure on the UK healthcare system.

U.S. patent officials...denied petitions by Amgen to review two formulation patents on AbbVie's Humira, a potential setback in Amgen efforts to market a biosimilar version of the world's top-selling prescription medicine...In June, Amgen...asked the U.S. Patent and Trademark Office for the review, arguing that the patents in question should not have been granted in the first place for Humira, an injected rheumatoid arthritis treatment with annual sales approaching $14 billion...In declining to review the patents, the agency said "we determine, based on the petition and the accompanying evidence, that Amgen has not shown a reasonable likelihood of prevailing on any of its challenges."...Amgen said it still plans to challenge the legality of the patents.

A longtime Elko obstetrician whose medical privileges have been revoked has filed a lawsuit against Northeastern Nevada Regional Hospital...Dr. George A. Winch Jr. and the Elko Women’s Health Center filed the complaint...The complaint alleges that “NNRH began a campaign to suspend and revoke Dr. Winch’s privileges from NNRH based upon pre-textual, wrongful and false grounds.”...Furthermore, it says the “defendants’ bad faith breaches of the implied covenant were done maliciously, fraudulently, and oppressively, with the wrongful intention of injuring plaintiffs, and acted with an improper and evil motive amounting to malice, and in conscious disregard of the plaintiff’s rights.”

Community pharmacy negotiators are refusing to negotiate with the government over its planned 6% cut in community pharmacy funding in England until it has seen details of the government’s long-term plans and the evidence behind them...The move comes as the Pharmaceutical Services Negotiating Committee voiced its fears that the government is deliberately keeping it in the dark about deeper cuts to come...We cannot agree to commence negotiations before we have had an opportunity to understand fully your plans and the analysis underpinning them…We believe we are entitled to this material but it has not been forthcoming. The government appears to have a settled intention to proceed on a course of action that will run counter to its stated ambition to develop a clinically focused pharmacy service, and be damaging to patient care...the 6% cut will force pharmacies to cut staff and damage patient confidence in the profession; the PSNC is also suspicious of government plans to create more online pharmacy services.

...2016 will see a number of drugs going off patent...most notable are the patent expiries for two major LDL-cholesterol lowering drugs: the statin, Crestor...and the cholesterol absorption inhibitor, Zetia...However, the availability of generic ezetimibe and rosuvastatin could have other impacts. There are a number of people who cannot tolerate statins because of side-effects such as muscle pain. Statin intolerance, in fact, is a driver for companies seeking novel LDL-c lowering drugs in order to provide patients with alternatives. But that road has gotten harder...the most compelling new LDL-c drugs are the PCSK-9 inhibitors...These medicines have the ability to lower LDL-c to levels unattainable by statins alone...PCSK-9 inhibitors are expensive drugs listing at more than $14,000/year/patient...There is no doubt that the loss of exclusivity for Crestor and Zetia will impact the bottom lines of AstraZeneca and Merck, respectively...the availability of the generic forms of these drugs will also have an impact on physician prescribing habits and even drugs not yet on the market. Containing prescription drug costs is a major priority these days, and the use of generics is a key lever in accomplishing this, particularly in the face of high costs alternatives...

Wal-Mart Supercenter customers expressed shock, frustration and dismay Sunday night in the final hours before closure of the Nellis Boulevard store, one of the few grocery shopping venues for Nellis Air Force Base families and others who live nearby...Shock that the store was closing so suddenly — just two days after...Wal-Mart Stores Inc., announced that the store at 4350 N. Nellis Blvd. was one of the 269 stores slated for closure globally and the only one in the Las Vegas Valley...Frustration that they now would have to travel farther to buy groceries, fill prescriptions and pick up other goods.

Community pharmacies focus on providing value through convenience, service, and price. Value, that is, for the customer and the customer alone...Traditionally, community pharmacists haven’t had to worry much about them beyond deciphering prescriptions and asking for reimbursement...a pharmacy is a pharmacy is a pharmacy, right? Not anymore...alert independent pharmacies realize that to survive, they’ll have to do more than dispense drugs...They’ll also have to show that they have more to offer than the competition does, and that comes down to serving as much more than sophisticated pill dispensers...The new mantra...“I’m an investment, not a cost center.” In other words, by helping patients get better, the independent pharmacist can offer value to a health plan or a provider. That means taking advantage of opportunities to improve patient health in areas such as chronic illness...New payment models are the big drivers of this revolution...as healthcare reform forces a massive rethinking of how doctors are paid...What happens outside pharmacy will affect pharmacy...This is where creativity and business savvy enter the picture. As billions of dollars move toward models that emphasize results, independent pharmacies will need to show health plans and physicians that they can save them money.