Genzyme drug shows improvement in MS patients
CAMBRIDGE, Mass. — Disease relapse rates and worsening of disability were low among patients taking a drug made by Genzyme for multiple sclerosis, the company said.
Genzyme, a division of French drug maker Sanofi, announced results of an extension study of the drug Lemtrada (alemtuzumab). The study was a follow-up to two other late-stage clinical studies of the drug, finding that relapse rates and sustained accumulation of disability remained low among patients who had previously received the drug.
"These findings are important because they suggest that the benefits of Lemtrada as observed in the phase-3 studies are maintained, even though most patients did not receive further dosing," Multiple Sclerosis Clinic of Central Texas director Edward Fox said, presenting the results at the annual meeting of the American Academy of Neurology in San Diego.
Ga. compounding pharmacy recalls all lots of sterile products
SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.
The agency said the Clinical Specialties Compounding Pharmacy of Augusta, Ga., was recalling all lots of sterile products it had produced and distributed following reports of five patients diagnosed with serious eye infections after using Genentech’s drug Avastin (bevacizumab) that the pharmacy had repackaged into syringes from vials labeled as sterile. The infections, known as endophthalmitis, occur inside the eyeball and can lead to permanent loss of vision; the Centers for Disease Control and Prevention reported the infections to the FDA.
"A compromised sterile product puts patients at risk of serious infections," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "Healthcare professionals should ensure that any medicines they administer to patients are obtained from appropriate, reliable sources and are properly administered."
The products were distributed between Oct. 19, 2012 and Tuesday this week, and the FDA said healthcare providers should stop using all products that the company had produced through sterile compounding and return them.
The recall comes in the wake of a nationwide scandal involving the New England Compounding Center in which hundreds of patients contracted serious fungal meningitis after receiving injections of compounded steroids from the pharmacy, leading to dozens of deaths. An investigation of the NECC found widespread contamination and lack of attention to sanitation. The case has brought increased scrutiny among the public and policymakers to the practice of compounding, particularly sterile compounding.
University of Nebraska Medical Center implements outcome-oriented treatment model with Walgreens
KEARNEY, Neb. — In collaboration with Walgreens, the University of Nebraska Medical Center on Wednesday unveiled a new treatment model to help positively impact clinical outcomes for hypertension and Type 2 diabetes patients through a program made possible by a National Association of Chain Drug Stores Foundation grant.
“This collaboration takes the clinical and practical relationship to a whole new level by helping to create a key communication stream,” stated Donald Klepser, assistant professor of pharmacy practice at UNMC, and the study’s primary investigator. “It’s a more economical utilization of healthcare resources — and takes better advantage of a pharmacist’s expertise.”
UNMC approached Kearney Clinic because of its innovative approach to care with electronic medical record technology and a patient-centered medical home model. Typically, patients are seen once every six months. To help gain a better understanding of what happens after seeing a doctor or being prescribed medication, the pilot will track select patients’ activity and progress. “It’s research like this that will inform and shape how we practice,” commented Ken Shaffer, pediatrician at Kearney Clinic.
Walgreens pharmacists will fill participants’ prescriptions, and provide a comprehensive medication review to address any patient questions or concerns, identify possible interactions and help improve adherence. In addition, pharmacists will offer free blood pressure testing each time medications are picked up, tracking results for each patient. If refills are late or never picked up, that information will be shared with the clinic for follow-up by a physician. The project will utilize the Nebraska Health Information Initiative, a statewide bilateral information sharing portal, which will allow physicians and community pharmacists to safely and easily share data across clinical settings.
The two-year initiative begins April 1 and is focused on increasing communication between community pharmacists and physicians to help improve patient care and medication adherence. Potential candidates for the program are currently being enrolled.
Walgreens is working with UNMC, Kearney Clinic, Blue Cross and Blue Shield of Nebraska and Nebraska Health Information Initiative, Nebraska’s statewide health information exchange, on introducing the program.
The NACDS Foundation awarded UNMC a $369,000 grant to study the potential impact on patient health by incorporating community pharmacy-provided medication management strategies into existing patient-centered care teams, such as medical homes and accountable care organizations.