Off-Label Promotion Analyzed, Fixes Involve Docs
From the April 6 2011 MedPage Today article
By Cole Petrochko, Staff Writer, MedPage Today |
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Healthcare professionals are the best defense against illegal off-label*** marketing of drugs, researchers found.
“Our findings suggest that no regulatory strategy will be complete and effective without physicians themselves serving as a bulwark against off-label promotion,” Aaron S. Kesselheim, MD, MPH, of Harvard, and colleagues wrote in the April issue of PLoS Medicine.
Despite regulations against off-label marketing, the practice appears to have fluorished in the last several years, the researchers noted. To get a better understanding of the problem, they analyzed whistleblower-initiated legal complaints filed in off-label marketing cases over the last 15 years….
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Prescriber-related practice complaints included:
- Encouraging healthcare professionals to prescribe for off-label use through false or unbalanced study data (76% of all prescriber-related practice complaints)
- Distributing free samples as a convenient source of off-label promotion (20%)
- Providing “lavish gifts” or honoraria to healthcare professionals (85%)
- Creating CME activity with speakers known to promote off-label use or through shell corporations (54%)
Payer-related practice complaints included:
- Discussions with prescribers to ensure insurance reimbursement for off-label prescriptions (78% of all payer-related practice complaints)
- Discussions with payers to ensure insurance reimbursement for off-label prescriptions (35%)
- Advice on ways to bypass an insurer’s restrictions on a drug’s prescription (53%)
- Falsification of billing codes (48%)
***Off-label use: In the United States, the regulations of the Food and Drug Administration (FDA) permit physicians to prescribe approved medications for other than their intended indications. This practice is known as off-label use [MedicineNet.com definition]
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April 11, 2011 -
Posted by Janice Flahiff |
Consumer Health, Public Health | doctor_patient_relations, off-label_use, pharmaceutical_industry, physician_patient_relations
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