INITIATIVE SHOULD EXTEND TO CVM
The FDA should be applauded for the Safe Use Initiative, but it should not be limited to human medicine alone. The initiative should cover products regulated by the Center for Veterinary Medicine.
There is a continuing problem with the safety of veterinary non-steroidal anti-inflammatories and case after case highlights problems which could have been avoided had caregivers received the FDA-mandated Client Information Sheets for these drugs.
CVM itself has documented that caregivers are NOT receiving the Client Information Sheets, yet other than publishing a few articles on the subject, the agency has taken no action to change this situation which is bad today as it was 5 years ago when CVM showed some concern for the problem by studying it.
By definition, when caregivers do not receive vital safety information, the drug they are giving to their companions is unsafe because the owners do not have the necessary information to safely administer it.
One solution to this problem is obvious: do NOT allow manufacturers of drugs requiring Client Information Sheets to ship these drugs in bulk. Require that they be sold in unit-of-use packaging complete with required safety information.
To summarize:
1.CVM has documented that caregivers are NOT receiving vital safety information with veterinary drugs requiring Client Information Sheets.
2.The lack of vital safety information renders the drugs unsafe.
3.FDA could ensure that caregivers receive mandatory safety information by mandating that all drugs requiring such documentation be available only in unit-of-use packaging which includes the safety information.
A second, related safe use issue stems from the decision of the CVM to stop publishing numerical data on adverse reactions. While numerical data can be misleading, the lack of any numbers makes the data almost useless.
Consumers were mislead for more than a year about this change which now appears permanent.