Managed Healthcare Executive - January 2009 - (Page 24)

{ PHARMACY BEST PRACTICES } ture and the post-market risk identi cation and analysis system. The post-market risk system is mandated under the FDAAA to improve FDA’s ability to track products that are already on the market. FDA expects to link data among 100 million patients by 2012. When a safety issue is discovered, the agency determines if a drug’s bene ts still outweigh its risks. If so, a manufacturer may be required to add certain side e ects to the drug label or develop a Medication Guide—part of REMS, the risk mitigation strategy—for patients, families and caregivers when drugs are dispensed. FOUR LABEL CHANGES IN 2008 included in FDAAA are: 1) prescribers must be specially trained and certi ed to prescribe; 2) pharmacies, practitioners and healthcare settings that dispense those drugs must be certi ed; 3) drugs must be dispensed with evidence of safe use conditions, such as lab test results; or 4) drugs must be dispensed in speci ed healthcare settings. Those submitted proposals are in the process of formal review and approval. As of November 20, 2008, FDA had approved 21 REMS, while 28 other REMS await review. “They can be made safer by ensuring that the right people get the right drug, and that a diagnosis supports use of a speci c medication.” That is why Pitts prefers to use the terminology “safe use of drugs” rather than “drug safety.” SAFETY ALERTS ARRIVE BY EMAIL Between March 25 and September 9, 2008, FDA issued 21 letters calling for post-marketing studies or clinical trials to address safety issues. The letters resulted in four label changes, including a boxed warning on conventional antipsychotic medications because of a risk of mortality in elderly patients treated for dementiarelated psychosis. “There needs to be a paradigm change in the way clinical trials are conducted to discover risks earlier on,” says Annette Stemhagen, vice president, epidemiology and risk management for United BioSource Corp. in Bethesda, Md. “Once a drug hits the market, there are many more people taking a drug with more opportunity to nd safety problems.” Under section 909 of FDAAA, drugs that already were associated with speci cally identi ed elements to assure safe use, as enumerated in the Act, were “deemed to have REMS,” but those risk mitigation strategies required formal review and approval. In March 2008, FDA published a Federal Register Notice identifying those drugs “deemed to have REMS.” FDA required that those REMS reports be submitted for approval by September 21, 2008. Some of the elements to assure safe use 24 JANUARY 2009 The traditional “Dear Doctor” letter notifying physicians about patient safety information through the U.S. mail may be a thing of the past. The Health Care Noti cation Network (HCNN) is an online service that delivers patient safety alerts to physicians and other healthcare EXECUTIVE VIEW professionals via email. Between March 25 and “HCNN provides safety information September 9, 2008, the FDA immediately without the delay of regular issued 21 letters calling for mail and the interference of junk mail post-marketing studies or clinithat physicians often receive,” says Edcal trials for drugs and biologward Fotsch, MD, CEO of San Franics to address safety issues. cisco-based Medem Inc., which provides network operations for HCNN under FDA receives 450,000 contract with iHealth Alliance. drug-reaction reports per year, Dr. Fotsch adds that the network mitand one-third are considered igates the problem of liability for manuserious. facturers, sends alerts based on medical HCNN online service delivers specialties and decreases alert “weariness” patient safety alerts to physibecause physicians receive the electronic cians and other clinicians via alert from only one source rather than email. from many health plan sources. This rst HCNN alert went out in SERIOUS REACTIONS October for the uoroquinolone class of Dr. Seligman says FDA receives about antibiotics, as the FDA recently stated 450,000 reports of drug reactions a that this class is associated with an inyear with about one-third of those creased risk of tendonitis and tendon considered serious, resulting in hospi- rupture. Manufacturers have updated talization or death. their warning labels to include this inThe agency evaluates whether the formation. Bayer (Cipro, Avelox) was safety issue was discovered during pre- the rst manufacturer to issue a Patient and post-marketing trials, whether the Safety Alert via the HCNN, which inissue can be prevented and if drug’s ben- cluded a Box Warning for tendonitis and e ts outweigh risks. About 900 of the tendon rupture and a plan to develop a 450,000 reports result in safety-related REMS. MHE label changes. “All drugs are inherently risky,” says PeFOR MORE INSIGHT ter Pitts, president and cofounder of the See more Pharmacy Best Practices on Center for Medicines in the Public Interest. managedhealthcareexecutive.com http://www.managedhealthcareexecutive.com

Table of Contents Feed for the Digital Edition of Managed Healthcare Executive - January 2009

Managed Healthcare Executive - January 2009 Contents Editorial Advisors For Your Benefit News Analysis Politics & Policy Letter of the Law Managed Care Outlook New Day 5 New Realities of Disease Management Pharmacy Best Practices Health Management Technology State Report: Hawaii MHE Resource Ad/Edit Index

Managed Healthcare Executive - January 2009

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