Monday, April 18
13:00-14:30
Satellite Symposium - Roche Chile
Biological and Biosimilars: Pharmacovigilance, Interchangeability and Extrapolation of Indications
Biológicos y Biosimilars: farmacovigilancia, intercambiabilidad y extrapolación de indicaciones
Renato Murillo, Profesor Caedrático, Universidad de Costa Rica, Costa Rica
This session will be presented in Spanish with Simultaneous Interpretation into English.
Biological drugs produced by recombinant DNA technologies have the peculiarity that the final structure is dependent on the production process and its development; among other things, its complexity exceeds thousand times the complexity of small molecules. Create a copy of these drugs is, according to current technologies, impossible. That is why non-innovative versions of these drugs may be similar to their reference products, but not equal. These versions are called biosimilars.
This has led that the development of biosimilars is regulated differently from generics and there are several factors to consider: not being equal to innovative versions, pharmacovigilance programs should be more stringent in order to assess adverse drug reactions that can occur and have not been presented in the innovator product, and even the percentage of incidence of the known adverse reactions; In view of this, interchangeability between an innovative product and a biosimilar can interrupt the pharmacovigilance program and an erroneous adjudication of adverse reactions; moreover, as recently reported, this interchangeability could induce increased one of the most important adverse reactions of such products: immunogenicity.
Taking in consideration that many biological products have more than one therapeutic indication, international guidelines allow clinically evaluate an indication and the other are extrapolated if several conditions are met (the studied indication should have the most sensitive population and mechanism action must be the same, for example). When these conditions are not met, extrapolation of indications is not recommended and this leads to other consequences. Such as the case of the medical indication by the use of the International Non-Proprietary Name (INN), this could lead to confusion to know which drug (the innovator or biosimilar) should be administered to the patient, if the indication is not approved for the biosimilar. In addition to the consequences that this would lead to the pharmacovigilance program.
Tuesday, April 19
13:00-14:00
Satellite Symposium - Merck
Hospital Pharmacists Taking the Lead - How Can Guideline Based Standing Orders / Pathways Enhance Effective CINV Patient Care
Dr. David Warr, Princess Margaret Hospital, Toronto, Ontario, Canada
Annemeri Livinalli, Sociedade Brasileira de Farmacêuticos em Oncologia, Sao Paulo, Brazil
Agenda
13:00 – 13:05 Welcome and Introductions David Warr
13:05 – 13:25 CINV Pathways and Global CINV Guidelines - David Warr
13:25 – 13:45 The Pharmacist’s Role Establishing CINV Protocols/Formularies - Annemeri Livinalli
13:45 – 14:00 Q&A and Closing Remarks - Faculty
Wednesday, April 20
13:00-14:30
Satellite Symposium - BD Medical
Johan Vandenbroucke, University Hospital Ghent, Ghent, Belgium
A growing amount of evidence points to the dangers of hazardous drug exposure for healthcare workers during preparation and administration. Many institutions struggle to maximize their safety precautions for a variety of reasons: lack of awareness of the risks of exposure, the need for more information on engineering controls, lack of international guidelines or enforcement of those guidelines. We anticipate that profound changes on how institutions mitigate hazardous drug exposure will rapidly evolve as individuals become better informed.
This session will review the dangers of hazardous drug exposure, and help to clarify what a closed system drug transfer device (CSTD) is, what organizations have clearly defined as a CSTD, explore the differences in CSTD’s on the market and the important criteria you should consider when selecting one for your institution