PHARMACY

Mylan resolves defamation suit against Pittsburgh Post-Gazette, two reporters

BY Allison Cerra

PITTSBURGH — Mylan on Friday announced that the company and its subsidiary, Mylan Pharmaceuticals, have resolved the defamation and other related litigation filed by Mylan against the Pittsburgh Post-Gazette and two of its reporters.

"The litigation has been resolved to the satisfaction of both parties," the parties said in a joint statement. "The Post-Gazette did not find and did not intend to report that Mylan had manufactured or distributed any defective drugs. The Post-Gazette regrets if any reader of the article thought otherwise."

Back in 2009, Mylan filed suit against the newspaper for publishing articles that alleged the drug maker conducted pervasive manufacturing misconduct at the company’s plant in Morgantown, W.Va.

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Putting some teeth into MTM

BY Jim Frederick

Message to Congress: You’ve got to spend a little money to save a lot of it. Paying $100 million to the nation’s community pharmacists to provide comprehensive medication therapy management to more American seniors would save Medicare $1 billion or more. Spend $200 million and save $2 billion … you get the picture.

It’s time for the feds to take the larger view of pharmacy-driven preventive health costs and benefits and put some teeth into drug therapy management for older Americans. The concept of MTM services delivered by pharmacists was woven into the Medicare Modernization Act that created the Medicare Part D prescription drug benefit program, but it’s been limited to seniors with multiple chronic conditions, and its language was vague regarding such things as frequency of seniors’ drug utilization reviews, measurement of patients’ long-term outcomes with MTM and standardized payments for pharmacists.

Two members of Congress have been trying for the past year to fix those shortcomings through a piece of legislation called the Medication Therapy Management Benefits Act. The bipartisan bill, introduced last year by Reps. Mike Ross, D-Ala., and Cathy McMorris Rodgers, R-Wash., would allow Part D beneficiaries access to pharmacist-delivered MTM, even if they have only one chronic condition. It also would provide funds for creation of a personal medication record and quarterly, face-to-face medication reviews by a licensed pharmacist.

(For a description of the bill, go to the Library of Congress).

In a written appeal for support and co-sponsorships for their bill, Ross and Rodgers told their congressional colleagues that every dollar spent on MTM saves $10 or more in avoided healthcare costs (see Reps. seek sponsors for MTM bill). "There is significant evidence that MTM improves care and saves money," the two wrote in late January.

An independent audit of North Carolina’s ChecKmeds NC program — a five-year-old MTM initiative open to all senior residents of the state who are members of a Medicare Part D drug benefit plan — turned up an even more striking result. According to Mark Gregory, VP pharmacy and government relations for Raleigh, N.C.-based Kerr Drug, that outside survey found that for every dollar invested in MTM provided by pharmacists through the ChecKmeds NC program, Medicare saved an average of $13.55 in reduced hospitalizations and other acute care costs for seniors.

That’s saving North Carolina’s Medicare program $34 million each year, Ross and Rodgers told Congress.

Another study of 186 patients covered by Blue Cross/Blue Shield of Minnesota found that the steady intervention of pharmacists with patients through a regularly applied MTM program cut those patients’ health costs 31.5%, or $12.15 per dollar invested in MTM services.

The long and short of it: Pharmacists potentially can save the nation’s overwrought, stretched-thin healthcare system huge amounts of money by working with patients to identify potential medication problems, improve their adherence to their drug regimens and monitor their progress.

"The drug distribution system is broken and fragmented,” Gregory told Pharmacist Society in mid-February. “One element of drug distribution we need is comprehensive medication management. And of course, pharmacy needs to get reimbursed for those services. Having an outcomes-based pharmaceutical model that can measure results gives you documentation that almost guarantees a savings. If you measure it, there’s significant value to it, and that’s what we’re doing now: measuring it.”

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FDA moves to address cancer drug shortages

BY Alaric DeArment

SILVER SPRING, Md. — An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

The FDA announced that it would address a shortage of the injectable Doxil (doxorubicin hydrochloride liposome) by allowing importation of Lipodox, an identical drug, by India-based Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Labs. The FDA said the measure was temporary and that such temporary importation of unapproved foreign drugs was considered in rare cases when there was a shortage of a critical drug. The shortage resulted from the closing of a manufacturing plant in Bedford, Ohio, owned by drug maker Ben Venue.

The FDA also gave expedited review to APP Pharmaceuticals’ preservative-free methotrexate, which it expects to become available in March. The drug is used to treat leukemia in children and osteosarcoma, as well as autoimmune disorders. In addition to the approval of APP’s version, Hospira is releasing 31,000 vials of the drug, enough to last a month, and the agency said it was working with Mylan, Sandoz and other companies to increase production.

Doxil is used in several treatment regimens, such as for ovarian cancer after treatment with platinum-based chemotherapy has failed, and also in patients with AIDS-related Kaposi’s sarcoma and multiple myeloma.

"A drug shortage can be a frightening prospect for patients, and President Obama made it clear that preventing these shortages from happening is a top priority of his administration," FDA commissioner Margaret Hamburg said. "Through the collaborative work of [the] FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need."

The FDA’s action is based on an executive order that President Obama made on Oct. 31, 2011, designed to address shortages of critical drugs. The FDA said the order and its own letter to manufacturers resulted in a six-fold increase in voluntary notifications of potential shortages by drug companies, with 114 shortages prevented since the order.

In addition to Tuesday’s approvals, the agency released draft guidance to the industry on detailed requirements for mandatory and voluntary notifications to the FDA on issues that could result in shortages and supply disruptions.

 


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