Author: Peter

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program highlights the latest in pharmacy news, product news, and more. (video)

National Association of Specialty Pharmacy Executive Director James E. Smeeding, RPh, MBA, discusses the trend of larger entities absorbing independent specialty pharmacies.

Imagine if simply typing “password123” into a computer did not open your email account, but an internet-connected medical device responsible for feeding you drugs or monitoring your blood oxygen or insulin levels...It may sound like the nightmare stuff of fiction, but the lack of basic cyber security on hospital equipment is attracting hackers who want to use them as a way to enter medical networks...Experts say that while they have not yet seen someone die as a result of hacking, the risks are growing...Motives for attacks could range from wanting to harvest patient information or stealing intellectual property from medical trials to simply wanting to create chaos...Devices with default passwords that are left unchanged, and outdated operating systems that are connected to the network, such as medical databases, are all too common in healthcare...Each provider needs to carefully examine for themselves what types of risk are being brought in by new devices. They will have to give careful consideration to making sure they are kept up to date, behind firewalls and in networks segmented off from key medical and personnel data…

Systech International and Servicepoint recently joined forces to provide serialization and automation solutions to the pharmaceutical manufacturing industry...Internationalization, outsourcing, e-tailing and the expansion of international trade zones have created enormous complexities throughout the supply chain and product life cycle...This has resulted in a rapid escalation of global counterfeiting issues, threatening consumer safety like never before...Systech is known to have pioneered serialization and is becoming a model for the future of authentication. It unifies and protects the supply chain through...authentication and track and trace technologies that ensure regulatory compliance and reduce risks. These technologies have been used not only in the pharmaceutical industry, but also in industries, such as life science and consumer packaged goods...As part of a regulation adopted by the European Commission in October, the serialization of prescription medicine packages will be mandatory in all European Union countries by 2019. There are currently 15,000 prescription medicine production lines in Europe, and some may have to be either replaced or automated in order to put serialization into effect.

After deliberating for most of the year, Isis Pharmaceuticals Inc said on Friday it would change its name to avoid being confused with the Islamist militant group known as ISIS...The biotechnology company said it would be called Ionis Pharmaceuticals Inc from Dec. 22 and also changed its stock exchange ticker symbol to "IONS" from "ISIS"...When you talk about the company you want people to immediately think about the incredible work you're doing to deliver transformational drugs to patients ... not as an unfortunate namesake...The...company's stock dropped about 4 percent on the first trading day after the Paris attacks, for which ISIS claimed responsibility.

China's drug regulator said on Thursday it will strengthen oversight of clinical trials of new drugs, where it said regulation was falling short despite a recent push to improve the quality of local drugs and compete better with international rivals...China Food and Drug Administration has rejected dozens of drug applications over the past few months due to false or incomplete trial data. A further 82 firms withdrew applications earlier this month...The drug regulator said in a statement...that while some regions had made progress in cracking down on poor drug trial data, many regions were still falling behind...The inspection work in some regions is not being taken seriously enough and the quality of inspection is too low...Global drugmakers in China are facing a tough challenge as local firms get increasingly competitive and as the central government looks to rein in drug prices to help curtail a wider medical bill expected to hit $1.3 trillion by around 2020...

U.S. regulators have backed off an attempt to limit Pacira Pharmaceuticals Inc.’s promotion of its pain drug, striking an agreement that’s likely to fan the flames of debate over free speech and drug marketing...After the drugmaker filed suit citing its constitutional rights to free speech, the Food and Drug Administration agreed to let Pacira broadly promote the medication Exparel (bupivacaine), rather than limiting its sales team to talking only about its use after bunion and hemorrhoid surgeries...The painkiller, a non-narcotic shot, hadn’t been studied for use with other surgeries, such as dental or orthopedic procedures. While its FDA-approved label notes that fact, it doesn’t explicitly say the medication can only be used for surgeries that have been studied. Pacira argued that meant it could market the treatment for broader use...FDA has faced difficulty in its efforts to police drug marketing. In August, a court ruled the agency couldn’t bar Amarin Corp. from talking to doctors about unapproved uses of its fish-oil pill. While doctors are already allowed to prescribe drugs off-label, drugmakers have been restricted on promoting such uses...Drugmakers are able to give doctors information about unapproved uses if doctors specifically request it. The Amarin ruling allows pharmaceutical companies to hand out the information more widely without a request…

...more physician groups are making the case that stringent regulations and suboptimal technology have left physicians spending too much time grappling with their electronic health records...It's not that physicians are against health IT. In fact, most have adopted technology "at a blistering pace,"...But unrealistic and uncoordinated requirements are overburdening physicians' time and affecting the quality of patient care...AMA published a list titled "How EHRs tied up physician time in 2015."...EHR technology continues to underwhelm...Meaningful use is outliving its usefulness...Physicians are talking back -- and being heard...the Association of American Physicians and Surgeons also put out a strongly worded complaint this week, charging that EHRs could "crash" the U.S. healthcare system..."EHRs are supposed to be a cure-all for inefficiency and medical errors,"..."But the costly, clunky systems the government demands are worsening the problems and even driving some software experts back to paper."..."It's a major distraction from face-to-face patient care and interaction, thereby increasing the chance of missing important information, and in the end, increasing the probability of clinical and treatment errors,"..."The federal government should have no role in telling how physicians how to keep their records,"...

Biological medicines often represent the cutting-edge of biomedical research and have revolutionized the treatment of a variety of medical illnesses and conditions that presently have no other treatments available. A biosimilar product is exactly what its name implies — it is a biologic that is "similar" to another biologic drug already approved by the FDA. To help increase awareness and understanding of the important scientific, regulatory and reimbursement policies for these medicines, PhRMA is excited to launch a new section of our website today that provides educational resources on these topics.

• How biologics and biosimilars work;
• What data protection measures are in place to promote research and development of these medicines; and,
• How science-based regulatory policies protect patient safety and facilitate health care provider and patient choice.

Our goal is to create a comprehensive source of information on biologics and biosimilars, so that we can help improve awareness, science and evidence-based decision-making and patient choice. To access the new biologics and biosimilars web page, go to: Biologics and Biosimilars

Pharmacists should learn how to properly diagnose foreign-acquired diseases in order to optimize outcomes for infected patients...these diseases are rarely seen in US emergency departments, health-system pharmacists might nevertheless encounter them during their careers...It’s important to recognize these diseases and know what you need to help them, [but] you don’t need to be an expert...Pharmacists can also play a role in preventing these diseases by reminding patients that they must follow their entire prescribed regimen when taking drugs prior to travel...The following are some exotic diseases primarily coming from Southeast Asia that pharmacists should know:

• Malaria
• Dengue Fever
• Typhoid Fever