Fins & Tails, Bits & Bobbers ... Vol 4-2
American Fisheries Society (AFS) and AADAP to publish an aquaculture drug use poster: The AFS’s Fish Culture (FCS) and Fish Health Sections (FHS) have partnered with the AADAP program to produce a Quick Reference Guide poster titled “Approved Drugs for Use in Aquaculture.” The poster is intended to serve as a useful outreach product that will hopefully minimize some of the confusion that typically arises regarding what approved drugs are available to fisheries biologists, as well as how and when they may be used.
The poster is currently being made available to all FCS and FHS members. It is also being made available to non-FCS/FHS folks on a first-come/first-served basis. Anyone who is interested in receiving a copy of the poster should contact Jim Bowker at 406-994-9910 or firstname.lastname@example.org. Supply is limited so don’t delay! The poster is constructed of a laminated heavy-weight paper and designed to be used in, or in close proximity to, fish-rearing environments.
Automation of INAD reporting being planned: AADAP has begun the process of moving our INAD reporting procedures into the Web-age. Currently, each of the 200+ co-investigators working under INADs held by the U.S. Fish & Wildlife Service (FWS) are responsible for submitting (in hard-copy paper form) 4-6 forms for each treatment event…for each INAD in which they are enrolled. AADAP in turn, as required by FDA’s Center for Veterinary Medicine (CVM), must compile the information contained on these forms, and then summarize and report this information to CVM.
To facilitate these activities, all the collected information is currently hand-entered into an AADAP-designed database. Inherently, the transcription of information from paper forms to a computer database is extremely labor-intensive. This process also has the inherent potential for transcription errors.
AADAP is currently in the early stages of developing a web-based system for INAD reporting. As envisioned, when the new system is up-and-running, co-investigators under FWS INADs will no longer need to fill out paper forms, but will complete the required “paper-work” totally on-line. As planned, the system will additionally remind (via email) co-investigators of their obligations (i.e., reporting requirements) and will contain built-in features to eliminate co-investigator entry errors.
Given the regulatory hurdles to accomplish this change-over, not to mention the development and testing per se of the user interface and web database, implementation of the new INAD reporting system will probably not occur until 2009. So those FWS INAD co-investigators with a web-phobia have probably a year or so to prepare. Stay tuned; we’ll keep you informed as we progress, and may even call on a few of you to “test-drive” a prototype version.
National INAD Program (NIP) update: The NIP continues to be an extremely successful program for the USFWS and partner facilities/agencies.
To date in FY 08 there are over 200 federal, state, private, and tribal facilities participating in 43 different states and one U.S. territory. Currently 13 different INADs are available for use, with several additional INADs “in the works.”
Calendar Year 2007 NIP study submission statistics: NIP participants - please do not feel like the “Lone Ranger” out there when you are filling out your required INAD paperwork. Last year was another busy year for conducting INAD studies, and with your help, we were able to collect a wealth of very useful real-world data. Here are some of the summary statistics from 2007 studies:
- Number of completed study reports submitted to the AADAP Office – 700
- Number of reporting facilities - 136
- Number of INADs used - 12
- Number of treated fish – 72.7 million fish
- Species of fish treated – 18 salmonid species; 29 non-salmonid species;
7 marine species; 1 aquarium species; and 2 shellfish species
- Number of Quarterly Reports submitted to FDA/CVM – 52
- Number of Annual Reports submitted to FDA/CVM – 12
Thank you to everyone for your hard work in contributing data to the AADAP Office, and please be aware that this data is being used to support new and/or expanded drug labels.
Oxytetracycline (OTC) medicated feed INAD #9332 OTC formulation update: OTC INAD participants should please note that the OTC formulation for INAD #9332 has changed from Terramycin® 100 for Fish (TM 100) to Terramycin® 200 for Fish (TM 200). It is also important to note that TM 100 contains 100g of oxytetracycline per pound of Type A Medicated Article, and TM 200 contains 200g of oxytetracycline per pound of Type A Medicated Article. While INAD investigators are encouraged to use TM 200 for all future studies, stocks of TM 100 are still available in some locations (e.g., feed manufacturers) and may continue to be used until they are no longer available. Hence, the “take home message” is to please be sure to be aware of which Terramycin® product is being used in your studies, and to determine your dose calculations accordingly.
Additional information for OTC medicated feed INAD #9332 co-investigators: Given today’s (9July 2008) news regarding the new OTC supplemental approval, INAD #9332 co-investigators will need to be aware that very shortly AADAP will be notifying all INAD #9332 participants of changes in the “conditions for use” under the INAD. In essence, those uses now newly approved will no longer be permitted under INAD #9332 authorization. Watch your mail or email for detailed information from AADAP.