FDA advisory committee recommends approval for Bristol-Myers Squibb’s, AstraZeneca’s metreleptin in generalized lipodystrophy
PRINCETON, N.J. — A panel of experts at the Food and Drug Administration has recommended approval for an experimental biotech drug under development by Bristol-Myers Squibb and AstraZeneca for a group of rare metabolic disorders.
The drug makers said the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 11-1 to recommend that the agency approve metreleptin for treating children and adults with generalized lipodystrophy, also known as LD. LD disorders cause severe metabolic abnormalities and significant morbidity and death. The FDA is not required to follow the votes of advisory committees when considering whether to approve a drug, but it usually does.
However, the committee did not vote in favor of recommending the drug for patients with metabolic disorders associated with partial LD, though the companies said they would continue to push for approval for that usage.
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Shoppers Drug Mart report: Allowing pharmacists in Canada to immunize could save lives, money
TORONTO — Pharmacists have the ability to significantly increase vaccination rates in Canada and save the healthcare system money by reducing the number of hospitalizations due to complications from the flu, according to a new report developed by Shoppers Drug Mart.
The Ontario Pharmacists Association, the Pharmacists’ Association of Newfoundland and Labrador, the New Brunswick Pharmacists’ Association and the Prince Edward Island Pharmacists Association have endorsed the new report, The Sustainable Solutions Report: A Focus on Immunizations.
"We know when pharmacists offer immunization services more people get vaccinated," said Perry Eisenschmid, CEO of the Canadian Pharmacists Association, in support of the report’s recommendations. "It’s already happening with great success in many provinces; however, to really make an impact, pharmacists in all provinces should be granted the authority to administer common vaccinations like influenza and tetanus, but we need provincial governments’ help to make it happen."
Allowing pharmacists to vaccinate, in addition to physicians and public health, will increase system capacity and immunization rates. According to a report issued by the broader pharmacy community called 9,000 Points of Care: Improving Access to Improving Access to Affordable Healthcare, it is estimated that if pharmacists administered common vaccinations including flu shots, immunization rates for vaccinations like flu shots would increase by 1% to 3% in Canada. This could help to reduce the 75,000 hospital admissions attributed to the flu each year.
Already this flu season in Ontario alone, 446,000 people have received flu vaccinations from pharmacists. These types of activities can result in a 52% reduction in healthcare service costs, helping to avoid hospitalizations for the flu. The average cost for an influenza-related hospital stay of six days is more than C$6,400 and it costs C$220 for an emergency room visit.
"Pharmacists are trusted health care professionals that are easy to access making them a much more convenient choice for many Canadians," stated Domenic Pilla, president and CEO of Shoppers Drug Mart. "Canadians in Saskatchewan, Manitoba, Quebec, Prince Edward Island, Newfoundland and Labrador, Nunavut, Yukon and the Northwest Territories deserve access to this same type of preventative care as those in the rest of the country."
Physicians and Canadians agree. A recent study by the Canadian Pharmacists Association found 48% of Canadians said they would likely choose to get their flu shot at a pharmacy if the service was available in their province; a further 45% said the same of vaccinations overall. A recent survey of physicians showed 61% felt pharmacists in all provinces should be given the authority to vaccinate for flu. Convenience was cited by both groups as the biggest benefit to seeing a pharmacist for vaccinations.
Currently, only pharmacists in British Columbia, Alberta and New Brunswick have the ability to administer a broad range of injections, including influenza, human papillomavirus, hepatitis A or B, tetanus, pneumococcal and diphtheria, while pharmacists in Ontario and Nova Scotia can vaccinate for flu only.
Expanding pharmacists’ scope of practice, according to the Sustainable Solutions Report, has other benefits too, including reducing physician workload and wait times. The average family physician wait time is 1.35 days for urgent care and more than three weeks for non-urgent care. Pharmacists can play a key role in relieving pressure on family physicians, helping to free up time for patients with more complex care needs.
There is also a benefit to workplace productivity. The average flu season causes an estimated loss of 1.5 million working days in Canada, resulting in healthcare costs and lost productivity equaling C$1 billion. By ensuring more people remain healthy, pharmacists can help ease the burden if illness on corporate Canada too, the pharmacy retailer stated.
I've been a Phm for 25 yrs of which 13 of my last 15 as a relief Phm & a very large percentage was in the SDM system. SDM is NOT interested in advancing the Phm profession, if there is any doubt ask the staff Phm that has no overlap (coverage), lunch break & how about the many, many associates they've locked-out in recent years for not bowing to corporate pressure. SDM is very concerned with what it appears to be doing for the public; it used to be fluff call backs, now the revenue generator is med-checks & how many flu shots you can do in a shift; once again no lunch break, no over-lap & how many Rx's you can check. I have NO interest in performing injections, I prefer to leave that skill to RN's such as my wife. I feel sad for the 1000's of young Phm trying to begin their careers in the corporate jungle of SDM/Recall all the while being told what's good for the public. John Fontaine RPh, Phm.
Novo Nordisk provides funding for diabetes initiatives
NEW YORK — Diabetes organizations in several cities are getting a boost in funding from a Danish drug maker that specializes in developing treatments for the disease.
Novo Nordisk said it would provide funding to groups in Seattle; Portland, Ore.; and Rochester, Minn., as part of the Novo Nordisk Community Care initiative. The initiative provides funding to nonprofits that support educational programs for people with Type 2 diabetes.
Groups in Seattle receiving funding include the Center for MultiCultural Health, the EvergreenHealth Foundation, Senior Services and the University of Washington Foundation. In Portland, recipients include the African American Health Coalition, the Harold Schnitzer Diabetes Health Center at Oregon Health and Science University, Legacy Health and the Wallace Medical Concern. The Mayo Clinic and Migrant Health Service are the groups in Rochester receiving funding.
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