Posts tagged veterinarymedicine
Custom Compounded Prescriptions and The Patient Care Program

Health Matters is a weekly radio show sponsored by the Medicine Center Pharmacy on WHBC 1480 AM in Canton, Ohio. This episode pharmacists Brad White and Paul White discuss custom compounded prescriptions and the Medicine Center Pharmacy Patient Care Program today with Pharmacists Janice Marciniak and Austin Hopkins.

The role of the pharmacist has broadened, and The Medicine Center Pharmacy has become a destination for patient care.  Medicine Center Pharmacy continues to be an ideal place for health care advice, recommendations for over the counter treatments and point of care testing. But did you know that we have an accredited lab that allows us to formulate custom medications designed specifically for you or your pet.  This morning we will talk with Janice and discuss pharmacy compounding at Medicine Center Pharmacy along with opportunities to develop a relationship with your pharmacist, a valuable member of your health care team.

Topics covered in todays program:

  1. How are pharmacies and compounding pharmacies regulated in Ohio?

  2. How does a pharmacy earn PCAB Accreditation?

  3. How does compounding benefit a patient?

  4. What kind of prescriptions can be compounded?

  5. What is a bioidentical hormone replacement specialist?

  6. What is BHRT?

  7. Who can benefit from hormone replacement therapy?

  8. What is the Medicine Center Pharmacy Patient Care Program?

  9. What vaccines are administered at the Medicine Center?

  10. What type of Vitamin D should I be taking?

  11. How much sunscreen should I apply to be safe?

Caring for our Favorite Pets!

Health Matters is a weekly radio show sponsored by the Medicine Center Pharmacy on WHBC 1480 AM in Canton, Ohio. This episode pharmacists Brad White and Paul White discuss caring for our furry friends with Dr. Mandy Pullekins from For Paws Animal Hospital.

If you are listening to this show, you are probably a pet owner and in the United States, 70% of us are pet owners, up from 56% in 1988.  You may have heard that pet adoption spiked during the pandemic and the statistics show that was true, but primarily among households who already had a least one pet.  More of us are dog lovers than cat lovers.  The average annual spending on a pet dog is $1,200 with a little over $400 of that going towards food.  We spend significantly less on our cats for an average annual spend of $687 with $329 of that for food.

Regardless of the statistics, our pets are members of our family.  Our spending, concern and devotion to our pets is a reflection of that bond.  This morning we will talk with Dr. Pullekins about showing our pets some love and learning some tips to keep them happy and healthy!

In this edition of Health Matters with the Medicine Center Pharmacy we cover:

  1. Is it safe for my dog to eat chocolate and candy?

  2. What should we avoid giving our pets for treats?

  3. What are some good examples of healthy treats for dogs and cats?

  4. If you want to treat your pet to a spa day, what are some activities you can do at home?

  5. Are there any types of toys to avoid giving our pets?

  6. Do you recommend puzzle feeders?

  7. Can pets get car sick?

  8. What are common conditions you see in your veterinary practice?

  9. How are compounded medications used in your practice?

  10. What are signs that my dog or cat could use a little less attention?

  11. What tips can you offer for leaving pets in the care of a kennel?

  12. What special precautions should pet owners take during tick season?

Listen to the episode on Apple Podcasts, Spotify, Castro, Stitcher, Amazon Music, or on your favorite podcast platform.

Thanks for listening today! We’d like to remind our listeners, if you suspect you have a medical issue, please contact your healthcare provider. Thanks to our sponsors Studio Arts & Glass and Jenior Appraisals and LIquidations. As always, we thank our listeners for joining us on Health Matters with the Medicine Center Pharmacy. Have a healthy week and we’ll see you again next Friday right here on News Talk 1480 WHBC.

Animal Compounding At Risk

**Updated: the New Closing Date for public comments is October 15th, 2020.

Protect your access to customized compounded medications for your pets.

The FDA has released a Guidance for Industry #256 that if approved as is and enforced will directly affect how your veterinarian can provide care for your favorite pet or animal. Below we have outlined some facts with the assistance of PCCA and Alliance for Pharmacy Compounding that are listed to demonstrate the far reaching scope of this prepared to submit to the FDA so that we can share what challenges this will cause for veterinarians, pharmacists, owners, and animals if this guidance document is enforced in its current form.

The policy requires compounded animal medications to be prepared from FDA-approved products with the idea that these deliver better quality active ingredients and better quality to the final compound. FDA currently regulates manufacturers of active ingredients, making the reliance on approved products an unnecessary burden. Further, no evidence is available that compounds made from approved products are of higher quality. In fact, USP has shown failures of compounds using approved products. The end-result is a more expensive compound that is not proven to have higher quality. This unnecessary stipulation will lead to fewer animals being able to receive their needed medications, or sadly, euthanized.  

The Draft Guidance fails to recognize that pharmacists generally lack access to approved animal products to be able to compound with them. Further, the Guidance does not recognize the need for compounds to be made in cases of shortages of animal drugs.  Human drug shortages are no secret in the marketplace.  Products as simple as sodium bicarbonate and cyanocobalamin were in short supply for a considerable amount of time, there is no reason to assume that this is not possible in the animal space.

The Draft Guidance attempts to enter into the practice of veterinary medicine and single out these animal health professionals as the only ones required to document their rationale for their prescription, as opposed to the prescription itself being the expression of their best choice for that individual patient based on their education, training and experience.

The Agency has previously registered its concerns with splitting tablets for the purpose of creating fractional doses; yet, somehow recommends this practice for animal patients rather than compound an appropriate dose. 

The policy on patient specific animal compounds requires that the medication be prepared in compliance with applicable “USP monographs for a compounded finished product.” These formulations are not appropriate for all species and force some animals to be exposed to ingredients that can be detrimental to their health.

USP monographs for compounded formulations do not consistently use FDA-approved products as a source of active ingredients, instead, favoring bulk pharmaceutical ingredients. This directly contradicts the FDA’s other requirement to use approved products as the source of active ingredients.   

The FDA does not have statutory authority to regulate animal compounding from bulk ingredients. Federal law discusses the application of the Agency’s extralabel use provisions to drugs with an approved application as an animal drug. Further, the scope of the Agency’s own regulations state that they apply to “the extralabel use in an animal of any approved new animal drug or approved new human drug” (emphasis added).  

The FDA has no ability to create a positive or negative list of bulk ingredients related to office use of compounded medications for animals. Further, this appears that FDA is once again attempting to apply provisions from DQSA to animal compounding. Congress has chosen for compounding from bulk ingredients to be available for human patients and it is illogical to conclude that they would prohibit or limit this for animal patients in the ways that the Draft Guidance proposes.

Animal owners, Veterinary providers, and pharmacy staff members are encouraged to submit comments to the FDA during this draft period before June 17th, 2020**. You can download a template here and customize it to share your views and make it unique.

**Updated: the New Closing Date is October 15th, 2020.

Submissions can be made on the FDA website at” https://www.regulations.gov/