- Pharmacy education and provider status – Validating the 60-year debate (drugtopics.modernmedicine.com)
The knowledge, skills, and attitudes pharmacists must have in order to meet the needs of Medicare beneficiaries are exactly those that graduates acquire in our colleges and schools of pharmacy today. It might be said that practice will finally catch up with education...Why were pharmacists not included among the list of professionals when Medicare was enacted 50 years ago?...there was no vision for pharmacists' patient-care services in this era...In the decades following the introduction of Medicare, medication use has become increasingly complex. Pharmacists in every practice setting have demonstrated their ability to collaborate with prescribers to identify patients' drug-related needs...Pharmacy organizations lobbied successfully to include a modest provision for patient-care services in Medicare Part D, and medication therapy management services are currently provided on a limited basis...The profession has the potential to offer much greater value, especially to those in medically underserved communities...Are we prepared to deliver such services when Congress amends the Medicare law and adds pharmacists to the list of providers? I believe the majority of pharmacists stand ready to expand their patient-care services...As pharmacy is recognized for its vital contribution to healthcare and wellness, pharmacy education will adapt to meet the needs of the pharmacists of today and tomorrow...
- Dr Aimee Tharaldson Expects the Biosimilar Approval Process to Pick Up Speed (ajmc.com)
The process for approving biosimilars has been moving slowly, but Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapies at Express Scripts, foresees them as having the potential to lower costs for the industry and hopes the approval process will pick up speed.
- FDA seeks suspension of 4,402 illegal prescription drug websites (reuters.com)
The U.S. Food and Drug Administration said...along with international authorities, has formally sought to suspend 4,402 websites that illegally sell potentially dangerous, counterfeit or unapproved prescription drugs to U.S. consumers...The move is part of a global effort being led by the INTERPOL...to identify the makers and distributors of illegal prescription drugs...the FDA said it has also issued warning letters to operators of 53 websites that illegally sell unapproved and misbranded prescription drug products to U.S. consumers...Preliminary findings...showed U.S. consumers had purchased certain unapproved drug products from abroad to treat depression, narcolepsy, high cholesterol, glaucoma, and asthma, among other conditions...
- Troubled Teva plant in Hungary faces an FDA crackdown (statnews.com)
The latest broken link in the pharmaceutical supply chain has appeared in Hungary, where Teva Pharmaceuticals has suspended production at a plant following a crackdown by the US Food and Drug Administration...The drug maker voluntarily halted work at its Godollo facility, which makes sterile injectable medicines, as "a precautionary measure" shortly after FDA inspectors visited last January...The company is "working around the clock to restart manufacturing operations as soon as possible,"...The shutdown only came to light after Hungarian regulators late last week issued a notice in an attempt to address concerns about drug shortages...The disclosure by Hungary’s National Institute of Pharmacy...came several days after the FDA also issued a so-called import alert, which is a notice about products that are banned from entering the United States. The FDA alert cites issues with good manufacturing practices, a regulatory term for minimum standards, but specific problems were not disclosed...the episode underscores the ongoing challenges that even the largest drug makers face in maintaining their plants...
- Fake vaccination papers let yellow fever spread in Angola (reuters.com)
The world's worst yellow fever outbreak in decades took hold in an Angolan slum because its early victims were Eritrean migrants whose false vaccination papers sent doctors off on the wrong path for weeks...The flare-up of the mosquito-borne disease has killed 325 people in Angola, spread as far as China - which has close commercial links with oil-rich Angola - and raised fears of the world running out of vaccine, but it might have been stopped in its tracks if it had been identified quickly in Luanda...Nearly the whole of Luanda has now been vaccinated, but the mass campaign across the rest of the country has depleted the world's emergency vaccine stockpile and there is no quick way to boost production...Manufacturers, including the Institut Pasteur, government factories in Brazil and Russia, and French drugmaker Sanofi, use a time-consuming method involving sterile chicken eggs...
- Pharmacy Week in Review: June 10, 2016 (pharmacytimes.com)
Brian Haug, President of Pharmacy and Managed Markets, Pharmacy Times (PTNN) This weekly video program highlights the latest in pharmacy news, product news, and more.
- Drug co-pay assistance programs facing increasing state, federal scrutiny (cnbc.com)
Charity-run funds to help patients pay high co-payments face new scrutiny by prosecutors in two states and increased federal oversight, amid increasing questions about how they mask high drug prices...Three drugmakers — Gilead Sciences, Jazz Pharmaceuticals and Biogen — disclosed subpoenas this spring related to their funding of co-pay assistance programs...The Department of Health and Human Services' office of the inspector general stepped up its oversight of patient groups' relationships with pharmaceutical companies beginning late last year by alerting patient groups to possible violations of Medicare's anti-kickback rules... patients not getting their drugs would drag down (pharmaceutical companies') entire pricing approach...So it's easily worth it to them to donate to a charity, even if it costs them a few million dollars...Drugmakers aren't allowed to directly cover patients' prescription co-payments for Medicare or Medicaid, but they can donate to patient charities as long as they are independent of the pharmaceutical companies...One of the issues some find troubling about both co-pay assistance and coupons is that neither are for the uninsured. Insurers say they use co-payments to steer patients to less expensive drugs that are equally effective. So when co-payments are subsidized, patients are insulated from the high cost of a drug and insurers and employers bear the brunt of the drug price, which then gets built into premiums paid by consumers...
- Dr Steven Pearson Explains the Growth in Specialty Medications (ajmc.com)
As the name and meaning of specialty medications have grown over time, so too has the importance of these pharmaceuticals, said Steven D. Pearson, MD, MSc, president of the Institute for Clinical and Economic Review.
- Vermont Pharmacists Cheer Provider Status Portions of New State Opioid Law (ashp.org)
Tucked inside a new Vermont law to combat opioid abuse are provisions that define clinical pharmacy services and indirectly confer healthcare provider status on pharmacists in the state...The legislation, formerly known as Vermont Senate Bill 243, defines a healthcare provider as "a person, partnership, or corporation, other than a facility or institution, that is licensed, certified, or otherwise authorized by law to provide professional health care service in this State to an individual during that individual's medical care, treatment, or confinement."...Separately, the law defines clinical pharmacy, in part, as the health science discipline through which a pharmacist "provides patient care to optimize medication therapy and to promote disease prevention and the patient's health and wellness."...The new law also states that insurers "may" pay or reimburse pharmacists for providing clinical services within their scope of practice...The next goal, he (VtSHP President Jeffrey Schnoor) said, is to secure reimbursement for services that pharmacists, as recognized healthcare providers, provide to Medicaid beneficiaries—and to be ready for future federal-level recognition as healthcare providers under Medicare.
- Valeant scrambles to restructure Walgreens deal (cnbc.com)
Valeant is attempting to restructure a deal with Walgreens after warning it is losing money on a large chunk of medicines sold through the chain of U.S. drugstores...The Canadian drugmaker will consider terminating the agreement within months unless the situation improves...Valeant...slashed its annual profit forecasts for the third time in six months, a move it blamed in part on its deal with Walgreens, which dispenses many of its best-selling medicines...Walgreens is filling prescriptions for some of the company's top drugs without first ensuring that the patient's health insurer will pay for them, resulting in losses for Valeant...Stefano Pessina...who runs Walgreens...negotiated a very favourable deal for Walgreens in exchange for supporting the drugmaker, which was reeling from the accounting irregularities, as well as a political outcry over the high price of its medicines...about a quarter of Valeant drugs sold through Walgreens are being dispensed without securing this "prior authorisation"...(Valeant)...would consider terminating the agreement with Walgreens unless things improve quickly, and believes that a "material adverse change" clause in the contract would provide legal cover...










