SWEDESBORO, N.J.--(BUSINESS WIRE)—A
new nationwide poll of veterinary practices shows that 69% of veterinary
practices are not confident they are prepared to comply with provisions of the
Food & Drug Administration (FDA) Guidance for Industry #256, Compounding Animal
Drugs from Bulk Drug Substances, which was finalized on April 13, 2022. The
Guidance is slated to be “enforced” beginning October 1, 2022. [Extended by FDA to April 2023.]
The survey, sponsored by Wedgewood Pharmacy, was fielded August 15 – 17,
2022. The survey reports on the responses of 1,574 veterinary professionals in
the U.S, all of whom work in practices that prescribe compounded medications for
animal health. The company conducted the research to learn how knowledgeable its
professional customers are about the FDA’s Guidance and the changes it
will require to ordering and prescribing procedures.
Marcy A. Bliss, CEO of Wedgewood Pharmacy, said: "We are working in a very
focused way across our organization and industry not only to comply with the
letter and spirit of this Guidance but to help our more than 60,000 veterinary
prescribers to interact with us so that they, too, are in compliance when they
order compounded medications, which are specially formulated for animal
patients. FDA's new Guidance will change the way medication is obtained by
veterinary practices for difficult-to-treat patients, those whose needs cannot
be met by FDA-approved alternatives.”
The Guidance details significant changes to the practices of pharmacy
compounding and veterinary medicine. Yet 83% of those surveyed, just weeks
before the Guidance is slated to be enforced, say they are not aware that the
Guidance had been finalized; 90% said they were not aware that it will be
enforced beginning October 1.
The survey tested how knowledgeable the respondents are with four key
provisions of the Guidance:
- 74% are not at all knowledgeable (56%) or not very knowledgeable (18%)
that medications for office use may be compounded from bulk drug substances
only if those substances appear on one of two so-called “positive lists” and
do not appear on a “negative list” published by FDA. (FDA calls drugs on
these lists “listed” and “not listed.”)
- 72% are not at all knowledgeable (52%) or not very knowledgeable (20%)
that if a drug they want to prescribe as a compounded medication for an
individual patient is made from a bulk drug substance, they must provide and
a pharmacy must maintain documentation of the medical rationale for why they
believe there is a “clinical difference” between the compounded medication
and a commercially manufactured drug.
- 70% are not at all knowledgeable (55%) or not very knowledgeable
(14%) that they will be required to report to FDA any adverse effects from
compounded medications prescribed using FDA form 1932A.
- 81% are not at all knowledgeable (63%) or not very knowledgeable
(19%) that FDA has defined a process through which anyone may nominate
substances for inclusion on one of the three “positive lists.” 63% say they
are not likely (25%) or not at all likely (38%) to nominate a drug to FDA.
Meghann Abbott, assistant product manager for Wedgewood Pharmacy, noted,
“Wedgewood Pharmacy is taking an aggressive lead in nominating Bulk Drug
Substances to FDA for approval for office-use compounding. So far, we have
nominated more than 50 families of medication. We have devoted significant
resources to this nomination process because we strongly believe that
veterinarians should be able to stock the medications they believe are critical
to immediate patient care.”
The most current FDA lists of nominated, under review, approved, and “not
listed” bulk pharmaceutical ingredients are
published by FDA.
With a majority of practices not aware that the Guidance has been finalized
and soon will be enforced, the survey also showed that most practices have not
taken steps necessary to understand or comply with its provisions:
- 65% of respondents have not and 20% don’t know if “someone in your
practice has reviewed the compounded medications you stock and frequently
prescribe to determine if and how you will need to change treatment
protocols related to requirements of the GFI.”
- 72% of respondents have not and 18% don’t know if their practice
“has developed policies and procedures for how you will document your
clinical rationales for prescribing a compounded medication as specified in
the GFI.”
- 70% of respondents have not and 17% don’t know if their practice
has ”developed policies and procedures for how you will report adverse
events as specified in the GFI.”
- Respondents are not aware (16%) or not at all aware (70%) that
they “will be expected to comply with both the GFI and conflicting state
regulations.”
The survey sample was not randomized and therefore the results cannot not be
projected statistically to any other group. The results represent the opinions
of the 1,574 veterinary professionals who responded to the survey.
Contact
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