Lachman CONSULTANTS - Bob Pollock先生 2014-06-18
校译：识林-柯 2014-06-21
Poll Produces Interesting Results on Generic Drug Labeling Rule
Written by Bob Pollock • June 18, 2014
The Generic Pharmaceutical Association (GPhA) commissioned a survey organization (PublicMind) to poll physicians, physician assistants and pharmacists about how much they knew about the proposed generic drug labeling rule, how it would impact their practice (if at all), and how they felt about the current system of how generic drug labeling is approved by the FDA. The survey had some interesting results, which are summarized below.
Again, “The intention of this study was to ascertain the awareness of physicians, pharmacists and physician's assistants of this proposed rule, and their perceptions of how it may impact them and/or their patients.” The survey polled 450 healthcare professionals in the groups identified above and included 150 participants from each group. Here are some of the conclusions reached from the study:
Among those surveyed, there is a strong belief (86%) that information presented in generic drug labeling relative to safety was adequate.
News of the proposed rule had not reached most physicians, physician assistants or pharmacists; as a matter of fact, 76% said they had heard nothing about the proposed rule.
Prescribers and dispensers both expressed concern that the proposed rule would lead to confusion in the marketplace. Most (76%) said that their patients would be at least somewhat confused, while more than half (53%) say that having multiple safety labels would be “very” confusing for themselves as practitioners.
Most believe the new rule would have a negative impact on their time.
71% anticipate the new rule would increase the amount they need to spend with their patients reviewing individual patient histories and the new labels;
74% percent believe it would have at least some impact on the time they will need to spend researching labeling differences;
Equally as important, most (68%) believe they would NOT have the time required to keep current with the labeling changes.
The majority (81%) believe FDA approval should be required prior to changing generic safety labels; while almost all (90%) believe access to safety data should be required prior to changing generic product safety labels.
Concerns regarding liabilities are also an issue, as 77% are at least somewhat concerned the proposed rule could impact their legal liabilities. This concern is even more pronounced among pharmacists (85%).
60% say that the proposed rule will have at least “some” influence on their decision to prescribe generic drugs in the future.
These somewhat chilling conclusions are an indication that many of the stakeholders were not properly included in the decision to issue the proposed rule, nor were many even aware of it. The results of this sample also validate many of the issues that have been raised in comments to the FDA's proposed rule. One issue that is of particular concern is that many prescribers indicate that they may think twice about prescribing a generic drug in the future if the rule is implemented in its current proposed form. In a time when patients and the government are all trying to reduce associated healthcare costs, such a result could actually work to increase the costs of drug therapy and reduce the substitution of high quality lower cost generics.
There is no need for us to repeat ourselves, other than to say that the FDA's proposed generic drug labeling rule is bad medicine! The detailed findings and methodology can be found on the GPhA web page, which can be found here.
