What is required during the dispensing of Clozaril, Avandia, or Tikosyn?

When dispensing medications such as Clozaril (clozapine), Avandia (rosiglitazone), or Tikosyn (dofetilide), it is essential to adhere to the Risk Evaluation and Mitigation Strategy (REMS) requirements associated with these products. REMS programs are designed to manage specific risks linked to certain medications to ensure that their benefits outweigh potential harms.

Clozaril has a REMS in place primarily due to the risk of agranulocytosis, a potentially life-threatening side effect. The REMS for Clozaril requires regular monitoring of a patient's white blood cell counts to ensure they remain within safe limits before each refill. Similarly, Tikosyn's REMS relates to its potential to cause serious arrhythmias, necessitating specific patient monitoring and education to prevent these adverse effects.

Although patient package inserts, consumer medication information, and medication guides can play important roles in providing information to patients, they do not encapsulate the comprehensive risk management and monitoring program that REMS requires for these specific drugs. The essential aspect of the dispensing process for Clozaril, Avandia, and Tikosyn is the documentation and adherence to these REMS protocols to ensure patient safety.