tag:blogger.com,1999:blog-8550428.post114113181112862308..comments2024-03-27T01:34:23.434-04:00Comments on Pharma Marketing Blog: Off-label Marketing: Next State IssueVladhttp://www.blogger.com/profile/04114063498108633047noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-8550428.post-1141335665963025532006-03-02T16:41:00.000-05:002006-03-02T16:41:00.000-05:00The "Prescription Medication Off-Label Use Informe...The "Prescription Medication Off-Label Use Informed Consent" is an example of why today's doctors are bogged down with massive paperwork and sludging through inefficiencies in their medical practice. Last year, I wrote an article in Pharmaceutical Representative magazine about adverse events reporting, and how doctors become discouraged with the reporting process because FDA's adverse event reporting is so inefficient. I interviewed a doctor who said he used to report adverse events, but was so disgusted with time hogged that he would no longer report adverse events unless compensated for his time. After listening to his experience, I can't say I blame him.<BR/><BR/>Having physicians require patients to sign off-label use informed consent "sounds like a good idea" but in reality, will only create confusion from patients and demand additional resources doctors don't have. You'll need someone to translate the consent form if the patient have poor understanding of English (in addition to making sure they understand how to take the drug). You'll need additional staff members to administer these informed consent forms and make sure these comply with whatever rules and regulations that come with such forms. You'll need to document proper storage and protection of such paperwork.... to start. Maybe this will create novel business opportunities, much like Sarb-Ox created for a slew of 'compliance services.' But what AB 2856 will NOT do is to keep doctors from disillusionment and a sense of powerlessness from practicing medicine the way they'd presume after going through decade(s) of medical training.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-1141235861785145712006-03-01T12:57:00.000-05:002006-03-01T12:57:00.000-05:00The problem with voluntary guidelines is (a) they'...The problem with voluntary guidelines is (a) they're voluntary and (b) they're guidelines. Compliance without enforcement is always illusory - the proverbial fox guarding the henhouse.Anonymousnoreply@blogger.com