FDA accepts application for extended-release Janumet
WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug to treat Type 2 diabetes made by Merck, the drug maker said Tuesday.
Merck announced the acceptance of its application for extended-release Janumet, which combines in a single pill the active ingredient sitagliptin with extended-release metformin, a drug commonly prescribed for Type 2 diabetes.
Janumet belongs to the class known as DPP-4 inhibitors, which also includes Onglyza (saxagliptin), made by Bristol-Myers Squibb and AstraZeneca. Merck also makes an immediate-release formulation of the drug.
Bayer: Betaseron not affected by prep pads recall
WAYNE, N.J. — Bayer HealthCare Pharmaceuticals sought to reassure healthcare professionals and their patients that a recall of alcohol prep pads distributed with its multiple sclerosis drug did not affect the drug itself.
The drug maker’s MS treatment Betaseron (interferon beta-1b) is distributed with prep pads made by Triad Group, which recently staged a recall of prep products due to potential contamination with Bacillus cereus bacteria, which would lead to life-threatening infections.
Bayer said the contamination was confined to the prep pads and that the Betaseron itself was still safe to use. The company is urging patients to use alternative prep pads not subject to the recall.
‘Pharmacy home’ can help organize medication management
WOONSOCKET, R.I. — The healthcare system needs to find ways to help patients with such complex therapies as chronic heart disease to simplify and centralize their medication management and create a "pharmacy home" to improve medication adherence, according to a new study conducted by researchers from Harvard Medical School, Brigham and Women’s Hospital and CVS Caremark.
Why is this important? Because, according to researchers, patients with chronic heart disease are likely to have multiple doctors and take nearly a dozen medications that are filled in at least two different pharmacies. This results in many patients struggling to keep their medications straight.
The study, published Monday in the Archives of Internal Medicine, concluded that the healthcare system needs to find ways to help patients simplify, synchronize, centralize and organize their medication management. Among the potential solutions: Create a "pharmacy home" to coordinate pharmacy care from a single point of contact. "Consolidating prescriptions in a single ‘pharmacy home’ may help improve healthcare quality similar to the intended effects of a patient-centered medical home," researchers stated.
In addition, the researchers said there is a need to synchronize medication regimens for patients because "those who make numerous trips to the pharmacy to pick up their medications, or fill prescriptions at different pharmacies, may have difficulty taking their medications as prescribed."
"Some people might look at these results and say it is not surprising that patients who have multiple doctors and take medications purchased from multiple pharmacies are less likely to be adherent," stated Larry Merlo, president and COO of CVS Caremark. "But these findings show that the healthcare system needs to do a much better job helping these patients consolidate and manage their pharmacy care if we are intent on improving their health outcomes."
The study reviewed pharmacy claims from the CVS Caremark PBM book of business for 1.83 million patients taking statins, and 1.48 million patients taking angiotensen converting enzyme inhibitors (ACE inhibitors) or rennin angiotensen receptor blockers (ARBs) between June 1, 2006, and May 30, 2007. According to CVS Caremark, the researchers selected these medicines for review because they are the most widely sold medications for the treatment of cardiovascular disease, which is the condition that imposes the greatest clinical and economic burden in the United States and abroad. During a three-month period, patients filled prescriptions for an average of 11 medications representing an average of six different drug classes, according to researchers.
"More striking, during this 90-day time frame, 10% of these patients filled prescriptions for 23 or more medications … and 11 or more different drug classes, had prescriptions written by four or more prescribers, filled these prescriptions at two pharmacies and made 11 or more visits to those pharmacies," researchers stated.
Among solutions discussed in the study:
Creating a centralized pharmacy home, which is similar to the concept of a medical home, where a patient’s pharmacy care is evaluated and renewals and refills are better synchronized and managed. This could include providing financial incentives for patients to fill prescriptions at a single pharmacy so that a single healthcare professional has a full view of the patient’s needs and care;
Encouraging programs that reduce complexity of both filling and taking medications by streamlining the number of trips it takes to fill patients’ prescriptions through such programs as 90-day versus 30-day prescriptions and coordination through mail-order pharmacies; and
Experimenting with programs and technologies that may make it easier for patients to better organize their medications.
The study is the work of CVS Caremark’s previously announced three-year collaboration with Harvard University and Brigham and Women’s Hospital to research pharmacy claims data to better understand patient behavior around medication adherence.