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Gastric  bypass surgery can improve glycemic control in adults with type 2 diabetes, but  doesn’t cure diabetes, according to the largest community-based 

 of long-term diabetes outcomes after bariatric surgery,  published online in 

The  multisite study tracked 4,434 adults at Kaiser Permanente Northern California,  Kaiser Permanente Southern California and HealthPartners for 14 years from 1995  to 2008. The research arms of all 3 of these integrated healthcare delivery  systems-and Group Health Research Institute, where the study's results were  analyzed-belong to the HMO Research Network. The patients had type 2 diabetes  that was either controlled with medication or else uncontrolled, and they were  also obese enough to be candidates for gastric bypass surgery.

“We  found that for most of those people, diabetes either never remitted after  gastric surgery or relapsed within five years,” says principal investigator  David E. Arterburn, MD, MPH, a general internist and associate investigator at  Group Health Research Institute.

The  main impetus of the study is the growing numbers of Americans who are obese and  have type 2 diabetes, according to Dr. Arterburn. Researchers have been  disappointed with the results from attempts to treat diabetes with intensive  lifestyle changes and intensive medical management, he says.

Prior  research has shown that, in the short term, gastric bypass surgery can  profoundly improve glycemic control in adults with type 2 diabetes-often even  before they lose significant weight. 

“That  led some people to think that gastric bypass surgery might be a ‘cure’ for  diabetes,” says Dr. Arterburn. “We wanted to see what happened in the longer  term.”

It's  still not clear whether diabetes relapse happens because of gaining weight back  or because of the underlying progression of diabetes, but patients' weight  before and after surgery was not strongly correlated with remission or relapse  of diabetes in this population.

“Managed care and hospital decision-makers need to  find the best ways to care for their many patients who are obese and have  diabetes-ways that will serve those patients best in the long run,” says Dr.  Arterburn. “Of course prevention is the best medicine, and gastric bypass  surgery isn't for everyone, but for patients who are already obese and have  diabetes, our results suggest that it's never too early to start considering  the surgery.”

Articles

In the short term, gastric bypass surgery can profoundly improve glycemic control in adults with type 2 diabetes.

Bariatric surgery can help, but not cure, diabetes

The specialty pharmacy market is currently fragmented with extreme variation in knowledge and education, patient care management, service, and outcomes. This market fragmentation has fueled the formation of the National Association of Specialty Pharmacy (NASP). 

"Specialty will become the standard for pharmacy," says Gary M. Cohen, BSPharm, RPh, interim executive director of the Specialty Pharmacy Certification Board. 

NASP is a not-for-profit organization dedicated to represent all specialty pharmacy stakeholders.  

Deeper knowledge and educational programs are required for the drugs, complex therapies and the diseases they aim to treat, according to Nameth.  

"High-touch services are required for the handling, administration and care management of specialty drugs," he says. 

Only 3% to 5% of the population currently use specialty drugs and in some cases drugs are only available through a limited network of pharmacies. 

Specialty is the fastest growing segment in pharmacy today. Nameth also says payers are experiencing a 15% to 20% annual trend for specialty drugs and the management of specialty in the pharmacy and medical benefit will be a primary focus for payers going forward. 

Additionally, 50% of the top 100 drugs and eight of the top 10 will be specialty pharmaceuticals by 2016.  

"The future of pharmacy is specialty, and with technology and medical advancements, specialty will become the standard for pharmacy," Cohen says. 

NASP will provide accredited educational programming for all healthcare professionals servicing specialty patients, provide preparatory programs for the Certified Specialty Pharmacist (CSP) credential, provide organizational and business-to-business education and training for specialty pharmacy stakeholders to improve their operations and compliance to accreditation and licensure standards. The new organization will develop national and regional forums for networking among healthcare professionals and specialty pharmacy stakeholders. NASP also will develop committees and task forces committed to challenge the status quo in all areas of specialty pharmacy, and provide a foundation for development, and improvement through innovation and science. NASP will also help define or improve standards and practice parameters that will improve patient outcomes, both clinically and economically.  

The specialty pharmacy market is currently fragmented with extreme variation in knowledge and education, patient care management, service, and outcomes.

New nonprofit advocates models to manage specialty pharmacy

Approximately half of drug labels don’t have  information on the medication’s safety and proper dosing in children, according  to a study from FDA researchers.

In the study, researchers looked at 560  medications listed in the 2009 electronic Physicians' Desk Reference, some not  relevant for pediatric use, and they found only 46% referred to children's  usage. When they looked only at drugs used in children, they found  "adequate" labeling information for 231 of 461 drugs.  "Adequate" meant they included information on drug effectiveness,  safety in kids and teens, and guidance on dosing.

Although this finding is an improvement in  pediatric labeling, Debbie Avant, RPh, from the Office of Pediatric  Therapeutics, Office of the Commissioner, FDA, says that the study reminds care  providers and parents that many products still remain to be studied in  children.

“Historically, drugs were not studied in  children and studies in 1975 and 1999 found that about 22% of drug labeling had  information on use in children,” Avant says. “Legislation in the past 10 years  has led to an increase in pediatric studies and labeling. This study was done  to estimate the progress made over the last decade and approximate the  percentage of drugs with information on use in children.”

Some very vulnerable populations such as  neonates remain almost untouched as far as developing adequate information on  how best to use therapies in this population, Avant says. 

“Obviously doctors need to use these therapies  and would not withhold treatment, but it does emphasize that one should think  about this aspect if a child is not responding or having unexpected adverse  effects from a therapy,” she says.

Managed Healthcare Executive         eNews

Approximately half of drug labels donâ€™t have information on the medicationâ€™s safety and proper dosing in children, revealing an overall lack of study of childrenâ€™s drug therapies, according to a study from FDA researchers.

Safety information for children missing on many drug labels

Practice patterns of medication initiation in  newly diagnosed diabetes mellitus have implications for healthcare spending,  according to a study published in the 

“A substantial proportion of patients  initiating an oral hypoglycemic drug do not receive guideline recommended therapy,”  says Niteesh K. Choudhry, MD, PhD, one of the study authors. “We found  substantial variability in contemporary clinical practice for patients  initiating drug therapy for diabetes.”

The study included a large group of managed  care enrollees starting oral diabetes treatment and found that 35% of patients  did not receive the recommended first-line drug. Further, the medication costs  for this subgroup of patients comprised 66.3% of the total expenditures for  hypoglycemic drugs in the entire cohort. 

Nationally, with approximately 2 million new  cases of diabetes each year, an excess expenditure of $1,120 per patient per  year would translate to more than $420 million in additional direct medication  costs for diabetes therapy outside established consensus recommendations,  according to the researchers.

However, the prevalence of diabetes is  increasing dramatically, so the potential savings from improved adherence to  the recommendations could exceed the estimates.

Dr. Choudhry, who is also associate professor,  Harvard Medical School, and associate physician, Division of  Pharmacoepidemiology and Pharmacoeconomics and the Hospitalist Service, Brigham  and Women's Hospital in Boston, says the results highlight a situation where  recommended care, clinical efficacy, and cost-conscious prescribing are all  aligned.

“Pharmacotherapy for diabetes presents a  significant opportunity for quality and performance improvement initiatives and  holds the potential to realize significant savings for patients, payers and the  entire healthcare system.”

In the United States, more than 20 million  individuals have diabetes, and an additional 6 million have undiagnosed  disease. The number of Americans with diabetes is projected to increase 165% by  2050. In the United States, this disease alone accounts for nearly $200 billion  in direct and indirect medical costs each year. Six different oral medication  classes have been approved by FDA for the treatment of type 2 diabetes but only  metformin and sulfonylurea are recommended as first-line therapy.

“Despite the widespread dissemination of  professional society recommendations, little is known about current clinical  practice patterns for patients who initiate an oral hypoglycemic agent,” Dr.  Choudhry says. 

A substantial proportion of patients initiating an oral hypoglycemic drug do not receive the recommended therapy. The potential savings from improved adherence to the recommendations could top $420 million annually.

Tracey Walker

Articles

Bariatric surgery can help, but not cure, diabetes

New nonprofit advocates models to manage specialty pharmacy

Safety information for children missing on many drug labels

Confusion over oral diabetes treatments increases costs