MESSAGE
| DATE | 2017-01-30 |
| FROM | Ruben Safir
|
| SUBJECT | Subject: [Hangout-NYLXS] [communications@pharmacistelink.com: Walgreens
|
----- Forwarded message from Pharmacist e-Link -----
Date: Mon, 30 Jan 2017 16:02:07 -0700
From: Pharmacist e-Link
To: ruben-at-mrbrklyn.com
Subject: Walgreens Faces U.S. Antitrust Concerns Over Rite Aid Fix | Pharmacist
eView | January 30, 2017
Click here to view an online version of this email ( http://sable.madmimi.com/c/29106?id=5644192.35684.1.d6eb6633973f385a7fec49e4fb2d4600 )
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\*\*Yes, Pharmacy Ownership is Within Reach!\*\*
Boost your ownership and management skills at NCPA's popular Ownership Workshop ( http://sable.madmimi.com/c/29106?id=5644192.35687.1.3744d35629f32a28447693611b3722c9 ), where you'll learn the ins and outs of buying an existing pharmacy or opening a new one. The workshop covers topics such as financing, marketing, and business management, as well as cover profitable merchandising ideas. Current owners especially will find this three-day program valuable for further developing business and merchandising skills. The program will be held over three different dates in 2017 ( http://sable.madmimi.com/c/29106?id=5644192.35688.1.f57ff5f4b55cc6f850ef8d160f4a261a ) so you can find a date and location that works for your schedule. Register today ( http://sable.madmimi.com/c/29106?id=5644192.35689.1.0364f4ff57e458b36a0c0134cfc68c17 ) and discover (or rediscover) the benefits of ownership.
\*\*»\*\* \*\*Industry News\*\*
-
Four States Join NABP PMP InterConnect
( #908082 )
-
Johnson & Johnson to Acquire Actelion in $30 Billion Deal
( #908367 )
-
PQA Endorses Two New Performance Measures
( #908081 )
-
Walgreens Faces U.S. Antitrust Concerns Over Rite Aid Fix
( #907504 )
-
Walgreens to Pay $200,000 Settlement for Lapses With Opioids
( #908079 )
\*\*»\*\* \*\*Drugs and Treatment\*\*
-
Are New Drugs for HCV Safe? A Report Raises Concerns ( #908073 )
-
Jackson, St. Louis Counties Team Up to Track Prescription Drug Abuse ( #908078 )
-
Poll: Two-Thirds of Michigan Voters Oppose Losing Access to PSE Cold Medicine ( #908633 )
\*\*»\*\* \*\*Health Care Legislation & Regulation and Medicaid/Medicare\*\*
-
Bill to Better Monitor Prescription Opioids Moves Forward in Idaho ( #908641 )
-
FDA Approves Plecanatide for Chronic Idiopathic Constipation ( #907248 )
-
Indiana Bill Would Allow Juveniles Involved in Non-Violent Pharmacy Robberies to Be Tried as Adults ( #908370 )
-
Maryland Governor Proposes Limits on Opioid Prescriptions to Tackle Heroin Crisis ( #908077 )
-
SD Senate Passes Prescription Bill That Would Tighten Monitoring ( #908368 )
-
Trump Considers an Entrepreneur With Sweeping Reform Plans to Run FDA ( #908084 )
\*\*Industry News\*\*
\*\*
Four States Join NABP PMP InterConnect\*\*
_NABP News Release (01/19/17)
_
Massachusetts, New Hampshire, New York, and Texas have joined the National Association of Boards of Pharmacy prescription monitoring program (PMP) InterConnect network. PMP InterConnect was designed to allow authorized health care professionals obtain multi-state information about their patients' controlled substance prescriptions and aims to help combat drug abuse nationwide. Thirty-seven states now share PMP data, with additional states expected to join the system soon. Each state is able to use the system, free of charge, in full compliance with their own laws. "The fight against prescription drug abuse is one of our top public health concerns," said Allison Vordenbaumen Benz, director of Professional Services, Texas State Board of Pharmacy. "We have joined the InterConnect program because it will ensure our public health professionals secure access to information that can have a positive impact on the health of our local communities."
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\*\*
Johnson & Johnson to Acquire Actelion in $30 Billion Deal\*\*
_Wall Street Journal (01/26/17) Blackstone, Brian; Dummett, Ben
_
Johnson & Johnson is buying Actelion Pharmaceuticals Ltd. for $30 billion. Under the agreement, J&J will retain Actelion's commercially available treatments for rare diseases such as pulmonary arterial hypertension. Actelion will spin off its drug-discovery operations into a separate company, currently designated as R&D NewCo; J&J will initially hold 16 percent of the shares in the new company, with an option to buy another 16 percent. "We believe this transaction offers compelling value to both Johnson & Johnson and Actelion shareholders," said J&J Chairman and CEO Alex Gorsky in a statement. The companies first revealed they were in talks about a possible deal last November, and then in December, J&J said it had bowed out of the talks, and Actelion said it had "engaged in discussions with another party."
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\*\*
PQA Endorses Two New Performance Measures\*\*
_Pharmacy Quality Alliance (01/16/2017)
_
The Pharmacy Quality Alliance (PQA) has backed two new performance measures: one addressing opioid misuse and another addressing adherence to therapies to treat multiple sclerosis (MS). The first measure, Concurrent Use of Opioids and Benzodiazepines, assesses the percentage of adults receiving both prescription opioids and benzodiazepines for 30 or more cumulative days. "As the toll in deaths and serious injuries from opioid use and abuse continues to rise, including that due to abuse of prescription opioids and benzodiazepines, it is anticipated that this measure will provide an important tool for health plans and CMS to manage this epidemic," said Woody Eisenberg, MD, senior vice president for PQA. The second measure, Adherence to Non-Infused Disease Modifying Agents Used to Treat Multiple Sclerosis, examines the percentage of adults who are adherent at least 80 percent of the time to their medications used to treat MS. Eisenberg noted, "While there is no cure for MS, disease-modifying agents clearly decrease the incidence of exacerbations and may slow disease progression. If the patient is non-adherent to their medications, the medication's effectiveness may be compromised." PQA collaborated with Humana Pharmacy Solutions and the University of Mississippi Center for Pharmaceutical Marketing and Management to test the first measure and with Humana's Comprehensive Insights to test the second measure.
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Return to Headlines ( #top )
\*\*
Walgreens Faces U.S. Antitrust Concerns Over Rite Aid Fix\*\*
_Bloomberg (01/20/17) McLaughlin, David; Langreth, Robert; Forden, Sara
_
Walgreens Boots Alliance's effort to win U.S. antitrust clearance for its acquisition of Rite Aid reportedly has not satisfied officials at the Federal Trade Commission (FTC). With just a week left before the companies' deadline to complete the deal, FTC lawyers are said not to be sold on Walgreens's proposal to sell 865 drugstores to Fred's Inc. to get approval to take over Rite Aid. The officials are reportedly concerned the sale does not go far enough to preserve competition that would be lost in the merger. The commission is considered unlikely to complete its review by the companies' January 27 deadline to close the deal. If the merger does not win antitrust clearance, Walgreens would have to pay Rite Aid a termination fee of $325 million or $650 million "in certain circumstances," according to a company filing.
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\*\*
Walgreens to Pay $200,000 Settlement for Lapses With Opioids\*\*
_Boston Globe (01/19/17) Freyer, Felice J.
_
Some Walgreens pharmacies failed to monitor patients' drug use patterns and did not use adequate professional judgment when dispensing opioids and other controlled substances, according to an investigation by Attorney General Maura Healey of Massachusetts. Under an agreement filed January 18 in Suffolk Superior Court, Walgreens agreed to pay $200,000 and follow certain procedures for dispensing opioids. A company spokesperson said in an email, "Our records show that the prescriptions in question were dispensed to patients for a legitimate medical purpose and issued by licensed practitioners." But the AG's Medicaid Fraud Division reported that, from 2010 through most of 2015, several Walgreens pharmacies across Massachusetts failed to monitor the opioid use of some Medicaid patients who were deemed high-risk. These individuals are supposed to fill all of their prescriptions from only one pharmacy, and that pharmacy must track the patient's pattern of prescription use. In addition, some of the state's 160 Walgreens accepted cash for controlled substances from patients in the state's MassHealth Medicaid program, rather than seeking approval from the agency. MassHealth rejected the prescriptions in some cases, but other times, it was never billed. "We're pleased to see Walgreens joining as a partner with the payment with this agreement," Healey said in a phone interview. "It's great to see them stepping up to put in place best practices."
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\*\*Drugs and Treatment\*\*
\*\*Are New Drugs for HCV Safe? A Report Raises Concerns\*\*
_New York Times (01/25/17) Grady, Denise
_
A new report from the Institute for Safe Medication Practices suggest that drugs approved in recent years that can cure hepatitis C may have severe adverse effects, including liver failure. The number of adverse events appears relatively small, and the findings are not conclusive, but observers say the report is a warning that should not be ignored. It involves nine widely used antiviral drugs that were heralded as a huge advance because they greatly increased cure rates, seemingly with few adverse events. The report's findings are based on an analysis of the Food and Drug Administration's database of reports from doctors around the world of adverse events that might be related to medications. About 250,000 people took the newer drugs in 2015, the report said. In those treated during the year ending June 30, 2016, the report identified 524 with liver failure, 165 of whom died. Of those with liver failure, 386 were from outside the United States. An additional 1,058 had severe liver injury, and in 761 the drugs appeared not to work. But whether the drugs were to blame is not known. The problems were observed by doctors who suspected drugs were the cause, but that does not prove cause and effect. Details about the patients' medical histories were not available.
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\*\*
Jackson, St. Louis Counties Team Up to Track Prescription Drug Abuse\*\*
_Kansas City Star (01/24/17) Hendricks, Mike
_
Missouri's Jackson County and St. Louis County are joining forces in a prescription drug monitoring program as a way to fight abuse of opioid analgesics. Missouri is the only state in the nation without a system to track the sales of prescription drugs. Despite repeated attempts over the past decade and wide support from health advocates, law enforcement and others, the General Assembly has been unable to pass legislation that would set up a statewide program. A small number of opponents have blocked those bills, citing privacy concerns. The Jackson County Legislature authorized establishment of its monitoring system late last year. Both Kansas City and Independence have said they will join in when it is set up. St. Louis County’s system, which includes the city of St. Louis, is already up and running, making it cheaper for Jackson County to activate its own. The Jackson County program is estimated to cost $150,000 or less. Recently at the urging of U.S. Sen. Claire McCaskill (D-Mo.), the federal government agreed to help counties pay for monitoring programs. Previously the grants were available only to states. Once the program has been activated this spring, pharmacists would have 7 days to provide information on each purchase of schedule II, III and IV controlled substances, or face up to a $500 fine and 90 days in jail on each violation.
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\*\*
Poll: Two-Thirds of Michigan Voters Oppose Losing Access to PSE Cold Medicine\*\*
_Drug Store News (01/19/17) Johnsen, Michael
_
Nearly 70 percent of registered voters in Michigan oppose legislation that would require a prescription for OTC cold and allergy medicines containing pseudoephedrine (PSE), according to poll results released by the Consumer Healthcare Products Association (CHPA). Almost two-thirds of respondents treat colds, congestion, and allergies with medication, and more than three-quarters of them use non-prescription medication. "This poll of Michigan consumers … makes clear that there is widespread rejection of unnecessary restrictions on these types of medicine," said Carlos Gutiérrez, vice president for state and local government affairs at CHPA. There are already numerous laws to help fight the meth problem in Michigan, he said, and "punishing Michigan families with unfair restrictions has proven to be an ineffective way to combat the meth scourge." Larry Wagenknecht, CEO of the Michigan Pharmacists Association, added: "The results of this poll demonstrate that patients expect access to medication from pharmacists to improve their quality of care. Patients do not want to have to jump through extra hoops or incur additional expenses to acquire medications that they have been accustomed to using to treat their minor colds and allergies."
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\*\*Health Care Legislation & Regulation and Medicaid/Medicare\*\*
\*\*
Bill to Better Monitor Prescription Opioids Moves Forward in Idaho
\*\*
_Idaho Press-Tribune (01/25/17) Brown, Ruth
_
House lawmakers in Idaho have approved a bill that would require pharmacists to register with the Prescription Monitoring Program, a database which monitors all controlled substances prescribed by doctors across the state. The proposed legislation now heads to the Senate for consideration. The program serves as a tool to help identify abuse by allowing prescribers and pharmacists to review how often a patient fills a prescription for a controlled substance, for example. Since 2014, the monitoring program has required physicians and others with authority to prescribe medications to register, but not pharmacists. The legislation would also require that any data collected on patients be kept for 5 years, based upon the state statute of limitations for when a person may be charged with a drug crime. "It sends the message about pharmacists having a corresponding responsibility for prescriptions that they dispense," Alex Adams, executive director of the Idaho Board of Pharmacy, told the House Health and Welfare Committee. As of mid-January, 89 percent of Idaho pharmacists were already registered, Adams said, up from 60 percent a year ago.
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\*\*
FDA Approves Plecanatide for Chronic Idiopathic Constipation\*\*
_FDA News Release (01/19/17)
_
The Food and Drug Administration (FDA) approved on Thursday plecanatide (Trulance—Synergy Pharmaceuticals) to treat chronic idiopathic constipation (CIC) in adults. The drug, taken once daily, works locally in the upper gastrointestinal tract to stimulate secretion of intestinal fluid and support regular bowel function. Plecanatide's safety and efficacy were demonstrated in two 12-week, placebo-controlled trials involving 1,775 adults. In the studies, participants who received plecanatide were more likely to see improvement in the frequency of complete spontaneous bowel movements compared with those receiving placebo, and they also had improvements in stool frequency and consistency and straining. The FDA noted that plecanatide should not be used in children younger than aged 6 years due to the risk of serious dehydration, and use of the drug should be avoided in patients aged 6–18 years. The safety and effectiveness of plecanatide have not been established in those younger than aged 18 years. In addition, plecanatide should not be used in individuals with known or suspected mechanical gastrointestinal obstruction. Diarrhea is the most common and serious adverse effect of plecanatide. Patients who experience severe diarrhea should discontinue use of the drug and contact their health care provider.
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Indiana Bill Would Allow Juveniles Involved in Non-Violent Pharmacy Robberies to Be Tried as Adults
\*\*
_The Indy Channel (01/24/17) Cox, Katie; Thomas, Derrik
_
In Indiana, state Sen. Michael Young has introduced a bill that would allow teens to be tried as adults for robbing pharmacies. At present, juveniles who rob pharmacies in the state cannot be waived to adult court unless they use a gun or commit bodily harm during the incident. Indiana Black Expo president Tanya Bell argues that juveniles should be tried as juveniles, as long as there was no extreme violence. Bell asserts that juvenile courts "are better equipped to handle it. Let them treat them and let them handle it." Indiana ranked first in the nation for pharmacy robberies in 2015 and dropped to second place last year, after California, as major pharmacy chains began installing time-released safes.
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Maryland Governor Proposes Limits on Opioid Prescriptions to Tackle Heroin Crisis
\*\*
_Baltimore Sun (01/25/17) Duncan, Ian
_
Gov. Larry Hogan of Maryland outlined a package of anti-heroin proposals Tuesday, including strict limits on doctors' ability to write prescriptions for the opioid analgesics that can turn patients into addicts. The prescription proposal would limit doctors to providing an initial week's supply of opiates, with some exceptions for patients in hospice care and undergoing cancer treatment or treatment for substance abuse. House Speaker Michael Busch said that the governor's ideas would fall short of stopping the crisis and that any answer to the problem has to begin with treatment. "That means an investment of money," Busch said, suggesting that contractors could be hired to treat addicts. He did not offer specifics of how that would be paid for.
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SD Senate Passes Prescription Bill That Would Tighten Monitoring
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_Rapid City Journal (SD) (01/25/17) Mercer, Bob
_
In an effort to combat opioid abuse, senators in South Dakota voted this week in favor of stronger monitoring of prescription drugs. State senators voted unanimously to require pharmacists to participate in a digital monitoring system and decided 34-1 that state Board of Pharmacy must submit annual reports to the Legislature through 2022. The measures were developed by a task force that met during the interim. They now go to the House of Representatives for further consideration. According to state Sen. Jim White (R-Huron), who chaired the interim committee, S.B. 1 would require all dispensers to register with the prescription monitoring program; 87% of pharmacists participate at present. In addition, each prescription a pharmacist fills would be posted to the website within 24 hours, instead of weekly. "It's really important for the safety of our people," said Sen. Deb Soholt (R-Sioux Falls), who noted that some patients doctor-shop to obtain more prescriptions. S.B. 4, meanwhile, calls for annual reports from the state board of pharmacy.
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Trump Considers an Entrepreneur With Sweeping Reform Plans to Run FDA
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_STAT News (01/23/17) Kaplan, Sheila
_
Joseph Gulfo, MD, reportedly has talked with presidential transition team officials about the job of Food and Drug Administration (FDA) commissioner. Gulfo is currently executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University. While he declined to comment on his candidacy, Gulfo has made his positions clear in a number of publications. In one recent piece, for example, he wrote that the FDA should adopt four categories of drug approval, a system he says would follow the intent of the law better than the existing system. Other possible candidates for the FDA commissioner post are Jim O'Neill and Scott Gottlieb, a former FDA deputy director.
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\*\*January 30, 2017\*\*
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