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Canada is set to begin deploying a national electronic prescribing platform, called PrescribeIT...Canada Health Infoway, a federally funded, nonprofit digital health organization, said...that it has reached agreements to enable PrescribeIT in six provinces: Alberta, Ontario, Manitoba, Nova Scotia, New Brunswick and Newfoundland/Labrador. Those provinces represent 61% of the Canadian population...PrescribeIT will allow prescribers to securely transmit an prescription from an electronic medical record to the pharmacy management system at a patient’s pharmacy of choice...PrescribeIT’s features will include the ability to securely send e-scripts for all medications, including controlled substances; deliver a prescription to a patient’s pharmacy; send prescription renewal requests from a pharmacist to a prescriber; and cancel a transaction by the prescriber or pharmacist...PrescribeIT is expected to decrease patient wait times for their prescriptions, enhance patient safety by reducing the possibility of medication errors, improve medication management and patient health outcomes, reduce fraud and abuse by eliminating handwritten prescriptions, ensure data integrity for monitoring of controlled substances, and create a commercial-free prescribing and dispensing environment...

The CEO of a herpes vaccine company at the center of a controversy over an offshore clinical trial,,,said that future testing of the drug will follow U.S. Food and Drug Administration oversight rules, as demanded by a new group of financial backers that includes venture capitalist Peter Thiel...In an impassioned interview, Rational Vaccines Chief Agustin Fernandez said he feared the great promise of the vaccine developed by the late university professor William Halford was being overshadowed by criticism over Halford's decision to test the drug using American patients on the West Indian nation of St. Kitts and Nevis without monitoring by the FDA or an institutional review board, as is traditional...Fernandez...said that he now understands it is necessary from now on to conduct further trials following FDA oversight standards if Rational Vaccines hopes to market the vaccine in the United States...

As early as January 1, Oregon pharmacists will be permitted to prescribe and dispense drugs and devices listed on a formulary to be established by the state board of pharmacy under a bill recently signed by Governor Katherine Brown...The formulary, according to the new law, may contain such "post-diagnostic" items as diabetic testing supplies, smoking-cessation aids, epinephrine autoinjectors, albuterol inhalers, rapid strep tests, and spacers for inhalers...Other possibilities mentioned in the law are discharge medications during transitions of care and emergency refills of insulin..."Nothing about this is new territory," said Michael E. Millard, cochair of the Oregon Society of Health-System Pharmacists...Legal and Regulatory Affairs Committee, in explaining why the prescribing bill passed the legislature on the first try...the bill builds on past legislation and advances pharmacy practice a step further...

The US Food and Drug Administration has stopped a California company from continuing to inject the smallpox vaccine into the tumors of cancer patients...US marshals seized five vials of the smallpox vaccine from San Diego-based StemImmune Inc, which was using them as part of an unproven method for treating tumors...he vaccine is not commercially available and is only reserved for people who are at very high risk for developing smallpox, so it’s not clear how StemImmune got the vials to begin with. Luckily, the vaccine is not made from the actual smallpox virus and cannot give anyone the disease...It was...not meant to be used the way StemImmune was doing so, which was by mixing it with stem cells that come from body fat and injecting it into the tumors of patients at California Stem Cell Treatment Centers in Beverly Hills and Rancho Mirage...The FDA is encouraging consumers who have tried the treatment and had bad effects to use its MedWatch Adverse Event Reporting program.

The plaintiff in a proposed class action lawsuit against CVS dropped her claims...After making a series of allegations that pharmacy giant CVS was gouging generic drug consumers who paid with insurance, the plaintiff in a proposed class action lawsuit dropped her claims...Megan Schulz alleged she paid more through insurance to get a generic drug than if she’d just paid cash. The suit also alleged pharmacy "copays" were really payments to pharmacy benefit managers, set up by confidential deals. CVS refuted the allegations and said in a statement...that it’s pleased the suit has been dismissed..."The complaint contained numerous demonstrably false assertions that a reasonable pre-filing investigation by the law firm would have discovered,"..."As such, we are pleased that the suit has been voluntarily dismissed.",,,"We plan to refile the lawsuit against CVS related to its generic drug pricing scheme promptly,"..."Our case against Walgreens was not dismissed and will remain on file until we achieve a just outcome for consumers."

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

FDA...announced the approval of tisagenlecleucel, a first-in-class chimeric antigen receptor (CAR) T-cell immunotherapy consisting of genetically modified autologous T cells, for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in children and young adults...After modification in the laboratory and infusion back into the patient, the CAR T cells target and eliminate both normal and malignant CD19-expressing B cells. The genetic modification enhances the initiation of T-cell activation and the persistence of the transformed T cells...Novartis will market tisagenlecleucel as Kymriah. Labeling for the product states that it is indicated in patients up to age 25 years with ALL that is refractory or in second or later relapse...Tisagenlecleucel has an FDA-required risk evaluation and mitigation strategy (REMS) program that includes elements to assure safe use. The labeling states that the immunotherapy is available "only through a restricted program."...

Arizona sued Insys Therapeutics Inc...accusing the drugmaker of engaging in a fraudulent marketing scheme aimed at increasing sales of a fentanyl-based cancer pain medicine called Subsys...The lawsuit by Arizona Attorney General Mark Brnovich in Maricopa County Superior Court in Phoenix comes during a series of federal and state investigations centered on Insys’ drug Subsys amid a national opioid addiction epidemic...The lawsuit accused Arizona-based Insys of paying doctors sham speaker fees in exchange for writing prescriptions of Subsys and of misleading insurers into believing patients who were prescribed the opioid had cancer when they actually did not...The lawsuit seeks an injunction, restitution for customers and the disgorgement of any illegally earned profits…

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The Food and Drug Administration is stepping up its enforcement of the existing rules covering stem cell therapies in order to protect patients from unproven or potentially dangerous treatments...Under "a comprehensive policy framework" that will be put into place next quarter, individual providers and companies will be able to gain approval for products and procedures through a lower-cost and more streamlined process...A new working group will pursue unscrupulous clinics through legally enforceable means in order to protect public health...Patients desperately seeking solutions for potentially fatal diseases can get to a point that they will clutch at any solution offered...FDA Commissioner Scott Gottlieb's statement shows an awareness of the potential for "unscrupulous actors" in the field, and their impact both on vulnerable people and on the reputation of sound researchers and companies..."These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This puts the entire field at risk. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science. To make sure the agency is separating the promise from the unscrupulous hype, we are stepping up our enforcement activity in this area," said Gottlieb...