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..specialty pharmacy that fills prescriptions for Valeant Pharmaceuticals International Inc. has altered doctors’ orders to wring more reimbursements out of insurers, according to former employees and an internal document…Workers at the mail-order pharmacy, Philidor RX Services LLC, were given written instructions to change codes on prescriptions in some cases so it would appear that physicians required or patients desired Valeant’s brand-name drugs -- not less expensive generic versions -- be dispensed, the former employees said. Typically, pharmacists will sell a generic version if not precisely told to do otherwise by a “dispense as written” indication on a script. The more "dispense as written" orders, the more sales for the brand-name drugmaker.

FDA has once again delayed its enforcement of product tracing requirements for pharmacies under the Drug Supply Chain Security Act...Although these track-and-trace requirements took effect on July 1, 2015, the FDA said it would not enforce the product tracing obligations for pharmacies until November 1, 2015, which it has now extended to March (March 1,2016)…FDA granted this latest extension because “some dispensers—primarily smaller, independent pharmacies and health systems—have expressed that they need additional time,” …In the meantime, pharmacies that do not capture and maintain product tracing information, or accept prescription drugs without product tracing information prior to or during a transaction, will not be penalized…this compliance policy does not extend to other requirements for dispensers under the DSCSA, which include verification related to suspect and illegitimate product (including quarantine, investigation, notification, and record keeping) and engaging in transactions only with authorized trading partners.

Novartis agreed to pay about $390 million to wrap up federal kickback claims before the $3.3 billion case went to trial. The Justice Department and a number of U.S. states had sought up to $3.4 billion in damages in the case, which zeroed in on the Swiss drugmaker's relationships with specialty pharmacies…settlement, together with other one-time charges, knocked down Novartis' third-quarter net income, which declined to $1.8 billion…Novartis offered special deals to pharmacies to boost prescriptions of its transplant drug Myfortic (mycophenolic acid) in a head-to-head competition with Roche's CellCept (mycophenolate mofetil). The drugmaker set up another scheme to increase refills of its iron chelation drug Exjade (deferasirox)…

As part of its advocacy and community outreach efforts during American Pharmacists Month, the American Pharmacists Association is partnering with the co-chairs of the House Community Pharmacy Caucus, the National Association of Chain Drug Stores, the National Community Pharmacists Association, the American Society of Health-System Pharmacists, and Walgreens to host the 3rd Annual Capitol Hill Health Fair on October 28. Flu shots and health screenings, including bone density, glucose, cholesterol, blood pressure, and body composition will be available to members of Congress, staff, and the general public in the Rayburn Foyer in the Rayburn House Office Building from 10:00 am to 2:00 pm.

Pharmacists from Walgreens and student pharmacists from:

• University of Maryland Eastern Shore School of Pharmacy
• University of Maryland School of Pharmacy
• Notre Dame of Maryland University School of Pharmacy
• Howard University College of Pharmacy
• Shenandoah University Bernard J. Dunn School of Pharmacy
• Virginia Commonwealth University School of Pharmacy

Valeant Pharmaceuticals International Inc, seeking to allay investor concerns about its business practices, said Friday it is cutting ties with a specialty pharmacy called Philidor Rx Services accused of helping it inflate revenue…The news failed to stem Valeant's sliding share price, which lost another 12 percent on Friday even after Bill Ackman…told investors the shares were "tremendously undervalued."…three top U.S. drug benefit managers...said they would no longer work with the pharmacy (Philidor). Express Scripts, CVS Health and OptumRx…said they made the decision after conducting audits of the pharmacy…Valeant shares have lost more than half their value since September as the company has come under attack on several fronts. U.S. prosecutors are also investigating the company over drug pricing…

Some of the biggest customers of Philidor Rx, the consolidated specialty pharmacy tucked inside embattled drug giant Valeant Pharmaceuticals, are seeing red flags. Two of the nation’s biggest pharmacy benefits managers, CVS Health and Express Scripts, both said on Thursday they are cutting ties with Philidor Rx after finding the noncompliance with provider agreements…The terminations add a new headache to Valeant Pharmaceuticals as it tries to recover from an onslaught of scrutiny from lawmakers, regulators and investors into its business practices.

...Valeant Pharmaceuticals finally explained its complex interactions with Philidor RX Services, a so-called “specialty pharmacy” that has a previously-undisclosed financial relationship with Valeant...Valeant has been labeled the “Enron of the pharmaceutical industry,” although I don’t know if any of the alleged shenanigans are true…the controversy has tarred the entire specialty pharmacy industry along with manufacturers’ legitimate specialty pharmacy relationships…Philidor RX is not a specialty pharmacy. I also suggest what the Valeant-Philidor relationship could mean for payer surveillance of manufacturers’ copay offset programs…I believe (hope?) that over time, everyone will recognize the differences between a true specialty pharmacy and a company such as Philidor...expect greater scrutiny of manufacturers’ specialty channel strategies. Smaller independent specialty pharmacies should also expect greater oversight, as manufacturers and payers work to validate the business operations of their trading partners.

Ken Whittemore Jr, Surescript's senior vice president of professional and regulatory affairs, discusses some of the ways in which e-prescribing trumps traditional prescriptions. (video)

Mischaracterization of Specialty Pharmacies: NASP (National Association of Specialty Pharmacy) Corrects the Record….published recently in the New York Times mischaracterize specialty pharmacies. The fact that a company calls itself a specialty pharmacy does not make it so. Simply stated, charging high prices for medications does not define a specialty pharmacy…A specialty pharmacy is a state-licensed pharmacy that solely or largely provides only medications for people with serious health conditions such as cancer, hepatitis, rheumatoid arthritis, HIV/AIDs, multiple sclerosis, organ transplantation, or bleeding disorders…specialty pharmacies are often accredited by independent third parties such as URAC (Utilization Review Accreditation Commission) or the Accreditation Commission for Health Care…Specialty pharmacies provide medications and related high touch health care services to seriously ill people who need complex medications, assistance in using these medications properly and not infrequently, assistance with reimbursement. Specialty medications have a complex profile, often requiring intensive patient management as well as special handling and administration assistance…

Embattled Valeant Pharmaceuticals International…that its accounting related to its relationship with a specialty pharmacy was legal and appropriate, but added that its board was nonetheless forming a special committee to investigate the relationship…disclosed for the first time last week that it had acquired an option to buy the specialty pharmacy, Philidor Rx Services, which dispenses some of Valeant’s dermatology drugs… If doctors send prescriptions to Philidor, rather than having their patients go to a retail pharmacy, it makes it harder for the pharmacies or insurers to switch the patient to a cheaper generic alternative…Philidor negotiates for reimbursement with insurers, relieving doctors of the hurdles that might otherwise discourage them from prescribing a high-priced drug. Patient co-payments are also reduced or eliminated, removing another barrier to use of Valeant’s drugs.