PHARMACY

Amazon.com gets FAA clearance to test Prime Air

BY Michael Johnsen

WASHINGTON — The Federal Aviation Administration on Thursday issued an experimental airworthiness certificate to an Amazon Logistics unmanned aircraft design that the company will use for research and development and crew training. 
 
The ruling breathes new life into Amazon.com's proposed 30-minute Prime Air drone delivery option that had been grounded in February following an FAA proposed framework of regulations governing small unmanned aircraft systems. 
 
Under the provisions of the certificate, all flight operations must be conducted at 400 feet or below during daylight hours in visual meteorological conditions. The UAS must always remain within visual line-of-sight of the pilot and observer. The pilot actually flying the aircraft must have at least a private pilot’s certificate and current medical certification.
 
These provisions fall within FAA's proposed framework of regulations issued earlier this year. 
 
The certificate also requires Amazon to provide monthly data to the FAA. The company must report the number of flights conducted, pilot duty time per flight, unusual hardware or software malfunctions, any deviations from air traffic controllers’ instructions and any unintended loss of communication links. 
 
The FAA includes these reporting requirements in all UAS experimental airworthiness certificates, the FAA stated.
 

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Research project aims to bring personalized medicine to British Columbia patients through community pharmacists

BY Antoinette Alexander

 

VANCOUVER — Twenty-two pharmacies in rural and urban locations across British Columbia have been selected to participate in a research project that aims to help bring personalized medicine to patients through community pharmacists.

The "Genomics for Precision Drug Therapy in the Community Pharmacy" project is the first of its kind in North America. It is funded by the BC Pharmacy Association and Genome BC, with research done by a team at the University of British Columbia's Faculty of Pharmaceutical Sciences.

The research project focuses on using community pharmacists to collect saliva samples to test how an individual's DNA can impact medication selection and dosage. The project will develop standard operating procedures for the collection of patient saliva samples by community pharmacists as well as procedures for the processing and sequencing of the DNA in these samples by UBC researchers.

Across the province, the 22 pharmacies will recruit 200 volunteer patients, who are currently taking the anticoagulation drug warfarin, to be part of the study. Researchers will do a retrospective analysis of DNA information to learn how genetics would have altered the drug dosage patients were prescribed.

Pharmacy locations include Burnaby, Courtenay, Cranbrook, Enderby, Fort St John, Hope, Houston, Kamloops, Kelowna, Penticton, Port Coquitlam, Port McNeill, Prince George, Surrey, Vancouver, Victoria and Williams Lake.

"Pharmacists, who are experts in medication, are the health-care practitioners best positioned to collect and use patient genetic information to help make medication selection and dosing decisions," stated Geraldine Vance, CEO of the BC Pharmacy Association. "Over time, the aim is to use DNA to make decisions about the most commonly-prescribed medications, making personalized medicine accessible for all patients in the province."

There are more than 1,200 community pharmacies across the province, meaning any British Columbian could ultimately have access to this testing regardless of where they live.

"With the modern genome technology used in this project, the idea of personalized medicine can become a reality," stated UBC lead researcher Corey Nislow. "We know there are more than 150 medications that are impacted by an individual's DNA. This project is about using that genetic information to make decisions about which medications are right for a patient – the right drug, in the right dosage at the right time."

The British Columbia Pharmacy Association is a not-for-profit professional association that represents more than 3,000 pharmacists and more than 850 pharmacies throughout British Columbia.
 

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Bipartisan Senate bill aims to enhance MTM services for seniors

BY Antoinette Alexander

 

ARLINGTON, Va. — The Senate has introduced legislation to improve medication therapy management services for senior citizens enrolled in the Medicare program.

S.776, the Medication Therapy Management Empowerment Act of 2015, was introduced by Sens. Pat Roberts, R-Kansas, a senior member of the Senate Finance Committee; Jeanne Shaheen, D-N.H., co-chair of the Senate Diabetes Caucus; Sherrod Brown, D-Ohio, member of the Senate Finance Committee; and Mark Kirk, R-Ill., member of the Senate Health, Education, Labor and Pensions Committee.  

The bipartisan legislation received a nod from the National Association of Chain Drug Stores. 

The legislation would amend the Social Security Act to allow Medicare Part D beneficiaries to become eligible for MTM services if they suffer from a single chronic condition that has been shown to respond well to improved medication adherence, resulting in better health outcomes and reduced overall medical costs. Specifically, the bill would provide access to MTM services for beneficiaries with diabetes, cardiovascular disease, chronic obstructive pulmonary disease and high cholesterol.

Health policy research group NEHI cites that only 50% of patients take their medications properly as prescribed by their doctor, which costs the nation more than $290 billion annually in avoidable health spending annually. 

There is overwhelming support showing that MTM improves medication adherence, including specific research showing the benefits for patients with diabetes, cardiovascular disease, COPD and high cholesterol.
 
In 2014, the Medicare Payment Advisory Committee (MedPAC) studied the effects of medication adherence on the Medicare program and found that patients newly diagnosed with congestive heart failure showed significant medical side savings.

In addition, a 2013 study by the Centers for Medicare & Medicaid Services found that in comparison to Medicare beneficiaries with COPD or congestive heart failure who did not receive any MTM services in 2010, those who were enrolled in MTM programs  experienced significant improvements in the quality of their drug regimens and costs were saved. The results were particularly impressive for those who received annual comprehensive medication reviews.

A 2013 study of published research on medication adherence, conducted by Avalere, concluded that patients who are adherent to their medications have more favorable health outcomes such as reduced mortality and use fewer healthcare services, especially hospital readmissions and emergency room visits.  

The Congressional Budget Office found “estimates that a 1% increase in the number of prescriptions filled by beneficiaries would cause Medicare’s spending on medical services to fall by roughly one-fifth of 1%.”  In real world terms, CBO's analysis means that, nationwide, a one percent increase in overall prescription drug utilization would lead to an overall decrease of $1.7 billion in overall healthcare costs, or a savings of $5.76 for every person in the United States.

“The evidence is mounting of the positive impact of MTM on patient health. Innovative pharmacist-provided services such as MTM are important tools in improving medication adherence, patient health and healthcare affordability,” stated NACDS president and CEO Steve Anderson.  “We commend the leadership of Senators Roberts, Shaheen, Brown and Kirk for their leadership in proposing this commonsense, bipartisan legislation that can help Medicare patients with chronic conditions understand the importance of taking their medications as prescribed, and help manage and improve their health.”

“We have recognized the value of pharmacists in the health system for many years. They are especially valuable for our Kansas communities and are sometimes the only health provider in our rural towns.” stated Roberts. “MTM is an important tool in the pharmacists’ tool box for many patients but especially for those suffering from chronic conditions. The Medication Therapy Management Empowerment Act gives patients access to valuable counseling and management for their conditions, and takes the essential steps to guarantee what we already know: that MTM will save the system money while providing higher quality care for patients. I urge my colleagues to support this bipartisan legislation.”

“Our bipartisan bill has the potential to improve care for seniors who need it the most while also reducing healthcare costs for our system as a whole,” Shaheen stated. “Providing seniors with better access to counseling when it comes to the safe and proper use of their medication should be a matter of commonsense. It will make sure seniors are not only taking their medications properly but does so in a way that lowers healthcare costs.”

 

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