The Development of Risk Management of Medicines in Thailan: A Case Study of Paracetamol

Abstract

Knowledge on drug safety and efficacy increases throughout product life cycle, thus benefit-risk balance of medicines may change overtime. Therefore Thailand has recently begun to introduce risk management plan as a condition for approval and re-evaluation of certain groups of high risk medicines. However it may be difficult to apply in the case of registered product  with high number of registration and widely used. Therefore we conducted the action research on the development of risk management of medicines in Thailand  by testing  the  concept and process of risk management plan using paracetamol as a case study. We found that  oral and intramuscular dosage form of paracetamol have different safety specifications. Paracetamol intramuscular injection has no clinical and pharmacokinetic evidence to support claims for reducing pain and fever. Thus benefit-risk assessment was used as the basis for proposed risk management measures. While oral form has clear benefit over risk for pain and fever, we therefore identifed risk factors of important identified risks in order to propose appropriate measures to reduce the risks.  We analyzed the case study and relevant literatures and proposed to develop risk management of medicines for both pre- and post- approval. Risk management plan should be used as a condition for registration of new drugs and high risk products instead of safety monitoring program. For registered products, pharmacovigilance system should be used for  risk detection and assessment to identify appropriate measures for risk management and communication. In case risk tends to over benefit, re-evaluation should be introduced to assess the balance to benefit and risk of  medicines and appropriate measures identified.