Pre-Conference Workshop

How will our patients survive the next drug shortage?

Thursday, October 18th
8:30 am – 12:00 pm
$50 for all attendees

Drug shortages, recalls, or discontinuations of key human generic pharmaceuticals are occurring more and more often; impacting our ability to provide quality care for pets with cancer.   This pre-conference forum will provide insights into the root causes of the short supply issues, address some of the impact on patient care, and an evidence-based review of chemotherapy compounding.  Our speakers will be Dr. Butch Kukanich, Associate Director of Pharmacology, Kansas State University, Dr. Kevin Hahn, EVP of Tri-Source Pharma, and VCS Member panelists.


Presenter #1:  Dr. Kevin Hahn

Topic: Drug shortages in veterinary medicine– Causes, patient impact, practical solutions

Specialty human pharmaceutical injectable products used off-label by veterinarians to manage their companion animal patients are in critical short supply.   Some are all too common and familiar to veterinary oncologists such as doxorubicin and vincristine; and other products to mitigate treatment side effects or improve quality of life.   Reasons for the spike in drug shortages include a lack of materials to make the drugs, rising costs to maintain governmental approval, fewer domestic pharmaceutical companies making drugs, and increased scrutiny of overseas manufacturing quality control processes.   Shortages are pushing the costs of existing drugs ever higher resulting in a rationing or dwindling supply of lesser cost, lesser effective alternative drug products or the use of compounded versions.   This presentation will examine market forces, supply chain management, and regulatory expectations that influence the continuity of drug product availability in the veterinary practice.

 

Presenter #2:  Dr. Butch Kukanich

Topic:  The ins and outs of drug compounding in veterinary medicine

Compounding is the patient specific manipulation of an FDA approved medication, other than label directions. Some common examples are mixing two drugs in a syringe prior to administration (e.g. acepromazine and butorphanol), diluting a drug to achieve a lower concentration (e.g. making a 1 mg/mL acepromazine solution from a 10 mg/mL solution) or making an oral suspension from FDA approved tablets when an oral suspension is not available. “Compounding” a drug product from a bulk substance (i.e. active pharmaceutical ingredient or API) is considered drug manufacturing and is not legal in the United States for any compounding pharmacy to perform.

The purpose of this session is to address legal compounding, examples and benefits of legitimate compounding and problems that may occur with compounded products. Independent studies have demonstrated compounded chemotherapy products contained the incorrect (relative to stated) drug content in as low as 0% of the tested products (i.e. none of them were correct) up to 100% (i.e. all of them correct) of the tested products (e.g., chlorambucil, melphalan, lomustine).  Many of the tested compounds had less drug content than stated; however, some of the products exceeded the stated drug content. Some of the products were stable, but some degraded over time. In contrast, FDA approved products were within the stated limits for drug content and remained stable during the testing periods.

Since most chemotherapeutic drugs have a relatively low safety profile, accurate and safe dosing is needed in order to ensure desired effects while minimizing adverse effects. The lack of consistency in both the accuracy and precision of compounded chemotherapy drugs suggests they should only be used when no FDA approved products are available or appropriate. The limitations of compounded drug formulations (potency and stability) should be discussed with clients prior to administering or prescribing them.