Activity Content
Botulinum toxin is well known for its cosmetic uses, but the current clinical literature is also replete with studies of the therapeutic use of botulinum toxins type A and type B for a variety of indications, usually characterized by excessive neuromuscular activity or chronic pain, only some of which are FDA approved. It has been challenging for health professionals to draw conclusions from the accumulated studies because of small sample sizes and limitations in study design. Further, since botulinum toxin products are not interchangeable, it is difficult to compare study results. Recently published evidence-based clinical guidelines from the American Academy of Neurology (AAN) provide much needed evidence-based reviews of the efficacy and safety of botulinum neurotoxin for spasticity, movement disorders, and autonomic disorders and pain.
As the medication-use experts in health systems, pharmacists have the responsibility of ensuring the safe and effective use of botulinum toxin. In order to fulfill this responsibility, they must keep abreast of current clinical guidelines, evolving clinical evidence, and medication safety issues. This program will provide an overview of current and emerging therapeutic uses of botulinum toxin in light of evidence-based guidelines, after first reviewing the pharmacology of botulinum toxin and comparing characteristics of botulinum toxin products that are currently available. Safety considerations related to botulinum toxin will be reviewed, as well as the need to educate patients, their caregivers, and follow-up health care providers about potential systemic effects of botulinum toxin and instructions for seeking immediate medical care, if necessary. Reimbursement issues related to biosimilars and the status of policy and regulatory initiatives related to follow-on biologics that may influence formulary decisions in the future will also be described.