- DNA4Life announces U.S. launch of its pharmacogenetics report (drugstorenews.com)
DNA4Life announced the…launch of its Pharmacogenetic Report, which will be available…to patients… DNA4Life’s test analyzes a person’s DNA to predict how they will respond to 120 commonly prescribed medication. One of the main goals of pharmacogenetics is avoiding adverse drug reaction…"Our differentiated and more comprehensive analysis will assist healthcare professionals in customizing a personalized treatment plan for their patients…particularly those being treated for chronic conditions, like high cholesterol, depression, ADHD or pain."
- F.D.A. Approval of OxyContin Use for Children Continues to Draw Scrutiny (nytimes.com)
Ever since the Food and Drug Administration approved the use of ...OxyContin for certain children…it has faced unabated criticism from lawmakers and public officials who are wrestling with devastating rates of prescription opioid abuse in their communities…. The crux of the issue is whether the agency’s approval will lead to more prescriptions for OxyContin in young patients. For years, the powerful long-acting drug has been prescribed off-label to…children in severe pain… agency’s approval means those doctors will finally have "information about how to do it appropriately," like dosage recommendations…"This approval allows Purdue Pharma to market and promote this product for use in children, and the obvious concern is this approval will change the pattern of use.".. postmarketing data could prove revelatory and useful..."It’s not a given, but it could help us better address the problem of prescription drug abuse in adolescents....
- Specialty Pharmaceuticals for Hyperlipidemia — Impact on Insurance Premiums (nejm.org)
PCSK9 inhibitors…offer the promise of reductions in blood cholesterol levels…This broad indication sets the practice of cardiology on a collision course with specialty pharmaceutical pricing models…reserved for drugs that benefited relatively limited patient populations…these therapies may also lead to savings down the road, by reducing rates of cardiovascular events…There will surely be formal economic evaluations of these data, and there are long-term outcome studies under way to elucidate the potential effect of these therapies on cardiovascular event rates…it is apparent that the prices for these drugs will result in net costs to the health care system, even if they may eventually be found to offer good value for the money…expected total annual costs in the billions, it's important to ask who will bear these costs...Pricing pressure on innovative products would drive a fundamental restructuring of the industry and further increase the financial challenges of bringing scientific innovations to the market. It is important that we manage these downside risks carefully as we work toward a more sustainable pricing model in this market..
- Alkermes’ schizophrenia drug Aristada gets FDA nod (reuters.com)
Food and Drug Administration…approved Alkermes Plc's longer-acting injectable version of … schizophrenia pill Abilify (Aristada,aripiprazole lauroxil), making the treatment available in two doses…Abilify, developed by Japanese drugmaker Otsuka Pharmaceuticals and sold…by Bristol-Myers Squibb Co, is already facing generic competition.
- Nevada State Board of Pharmacy – October 2015 Newsletter (bop.nv.gov)
- Counseling Revisited Omnibus Budget Reconciliation Act (OBRA) of 1990.
- FDA Issues Warning About Name Confusion for Brintellix and Brilinta
- Seven Persistent Safety Gaffes in Community/Ambulatory Settings That Need to Be Resolved! Institute for Safe Medication Practices
- FDA Advises Caution Against Codeine for Treating Colds in Young Patients
- Daytrana Patch May Cause Permanent Skin Color Changes, FDA Warns
- Baxter International, Inc, Recalls Three Lots of IV Solutions Due to Particulate Matter
- FDA Warns Against Unapproved Prescription Ear Drops
- Acino Products in New Jersey Ordered to Stop Selling Rectacort-HC and GRx HiCort 25
- President Basch!
- Update From Medicaid Pharmacy Dispensing Fee Increase and Pricing Methodology Using NADAC Files
- Reminder – October 2015 Is Renewal Time for Pharmacists
- No Syringe Is Approved as a Standalone Storage Container, FDA Says (ashp.org)
The…practice at pharmacies and outsourcing facilities of storing sterile compounded preparations or repackaging sterile pharmaceuticals in drug-administration syringes is actually an unapproved use of these medical devices…"FDA has not cleared or approved any syringes for stand-alone use as ‘closed container systems,’"…Syringe maker Becton, Dickinson and Company…stated that it does not test the performance of its general purpose syringes as storage containers for compounded pharmaceuticals….pharmacies that want to store their own compounded or repackaged sterile preparations in general purpose syringes have two choices:
- "Test every drug at every concentration that you use and in every size syringe that you use" or
- rely on the results of published stability studies "if you have the exact same syringe, the exact same concentration, and the exact same drug and you…handle it and store it just like the drug in the study was stored."
- Reducing LDL with PCSK9 Inhibitors — The Clinical Benefit of Lipid Drugs (nejm.org)
…Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration…met to consider marketing applications for the new molecular entities alirocumab (Praluent) and evolocumab (Repatha)on the basis of their ability to lower low-density lipoprotein cholesterol levels…These first-in-class medications are fully humanized monoclonal antibodies that inactivate proprotein convertase subtilisin–kexin type 9…consequent lowering of LDL cholesterol levels…has led to optimism regarding the potential — but as yet unproven — cardiovascular benefits…LDL cholesterol reduction as the surrogate measure of clinical benefit. No efficacy data on cardiovascular outcomes were provided…Establishing evidence of improved cardiovascular outcomes is key to evaluating medications from any new drug class intended to reduce such risk….definitive evidence of reduced cardiovascular event rates is essential…to provide such evidence should elucidate the medications' true clinical benefits and possible risks.
- Ohio prisons officials challenge FDA stand on execution drug (washingtonpost.com)
With two dozen scheduled executions in limbo, Ohio sent a forceful letter to Washington… asserting that the state believes it can obtain a lethal-injection drug from overseas without violating any laws…stopped short of suggesting Ohio is moving forward to obtain the powerful sedative sodium thiopental…the state asked to begin discussing with federal officials about acquiring the substance legally…FDA had warned Ohio in June that importing the restricted drug could be illegal…setting up the latest roadblock that Ohio and several other states have faced in carrying out the death penalty…States have struggled to obtain lethal injection drugs since pharmaceutical companies discontinued the medications they traditionally used or put them off limits for executions…"My sense is that the Food and Drug Administration…was never designed to create an additional impediment to states trying to carry out lawful sentences,"…
- Pfizer turns aside yet another case alleging Zoloft caused birth defects (fiercepharma.com)
In what has turned into a legal trifecta for Pfizer, it has won the dismissal of a lawsuit that claimed the use of the antidepressant Zoloft (sertraline) during pregnancy caused birth defects in a child. The decision comes after Pfizer has won two jury verdicts in recent months over the same claims… Philadelphia state court Judge Mark Bernstein…granted a summary judgment…to Pfizer and dismissed the case…The dismissal came as…Bernstein also denied a request by the plaintiffs to add to the testimony of their expert…there is insufficient epidemiological evidence to link the drug to birth defects...FDA recently asked Pfizer to add information about possible links to birth defects to the Zoloft label.
- Express Scripts to cover pricey new cholesterol treatments (washingtonpost.com)Pricey new cholesterol Rx covered by big drug plan, but... (cnbc.com)
..nation’s biggest pharmacy benefits manager has decided to cover two new drugs that lower…cholesterol but raise concern over prices that can top $14,000 a year…Express Scripts said…that it will pay for prescriptions of…Repatha as well as Praluent…under a few conditions designed to control costs…It will require prior approval…before any prescriptions are filled…will need to see a patient’s cholesterol levels first as well as proof that the older statins failed…is requiring the drugmakers to provide rebates if prices climb more than a set amount each year…Express Scripts also has agreed to cover any costs that exceed a certain amount per person, annually.