Sunday, July 7, 2013

Sample Letter to Legislature Suggested by Roadrunner Pharmacy


SAMPLE LETTER TO LEGISLATURE
7/1/2013 - 8/1/2013


Sir/Madam:
In the face of the misadventures surrounding compounding facilities like New England Compounding Center, I know that statutes regarding pharmacy compounding are being addressed and likely revised. As a veterinary practitioner who depends on compounding pharmacy to meet the health care demands of a population not well serviced by pharmaceutical companies, I’m very concerned that the special needs of the veterinary profession will not be considered in this review process.

Due to the lack of commercial drug availability in the companion pet sector, the consistent source of veterinary therapeutics is dependent, to a large degree, on veterinary compounding pharmacies. The most preferred approach would be an exemption from these issues for a new class of specially licensed veterinary pharmacies. This approach would allow for the continued care of this large segment of pets with special needs that do not fall into the scope of proposed legislation. At the bare minimum, the following concerns should be addressed:

1) It is essential that veterinary practitioners have the ability to utilize compounded medication within a clinic environment for office use for multiple pets. Very often, especially in these times of back-ordered and hard-to-find products, commercial drugs are simply not available and
practitioners are forced to use less-than-effective alternates.

2) It is frequently essential that veterinary clinicians be able to dispense small amounts (24-96 hours) of compounded medications to pets, affording a few days worth of medication (as a therapy start until pet owners secure larger supplies of complex medications from other sources) and to provide a few days of coverage for drugs like post-operative analgesics and antibacterials. Often,a 48 hour supply will provide an entire antiparasitical treatment.

3) Compounding with properly tested bulk powders is essential to the veterinary world. Many animal drugs are not easily sourced from human medications and even when they are, their excipients are often untested for safety in animals. Further, there is a range in strength that manufacturers are afforded and still adhere to the labeled potency. Compounders who utilize manufacturer’s products frankly do not know the ultimate strength of the beginning product. These ranges are not of consequence in humans but I assure you, they can be of great consequence in small animals. Lastly, there exists very innovative therapeutics that are never going to be addressed by human medicine manufacturers. Being able to obtain and compound with bulk powders enables the veterinary community to provide cutting-edge care to our patients.

4) “Compounding” should be defined as service to a specific animal and to items limited for administration within a clinic. Compounding should not be restricted by state lines; there are some out-of-state state facilities that are preferential due to quality assurances standards and product availability; practitioners should be able to freely utilize them.

5) As a practitioner, I consider it to be an issue wholly between me and the pet owner as to what dosage form is best for the presenting clinical picture. If the pet can not/will not be dosed with conventional dosage forms, and the owner agrees, compounding pharmacies can often deliver efficacious therapeutic in untested dosage forms.

While I recognize that the overlying problem was specific to medications compounded for humans, the changes you are likely considering will affect all practice formats. All-too-often, high quality veterinary care is dependent on the presence of pharmacy compounding.

Regards,

No comments: