RISK MANAGEMENT OF THALIDOMIDE IN JORDAN: AN APPLICATION OF THE WORLD HEALTH ORGANIZATION'S HEALTH SYSTEMS FRAMEWORK

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Abstract

Thalidomide is a highly teratogenic medicine and an effective frontline treatment for multiple myeloma when used in combination with other therapeutic agents. The global burden of multiple myeloma has been steadily increasing over the last decade, with the most significant rise being in middle and low sociodemographic index countries. The increasing burden of multiple myeloma poses particular concerns regarding the safe use of thalidomide and the need for risk management programmes to prevent foetal exposure. Evidence suggests that the effectiveness of risk management programmes for thalidomide has not been extensively investigated in spite of the serious risks of the medicine. Such lack of research on the risk management of thalidomide is of particular significance in countries where the incidence of multiple myeloma is increasing. Consequently, the programme of research presented in this thesis focuses on understanding the risk management of thalidomide in Jordan, a middle income country in which the burden of multiple myeloma has shown a recent increase. Two empirical studies were carried out in this programme of research to address the aim of understanding the risk management of thalidomide in Jordan and identify affecting factors within the Jordanian health system. The first study was informed by findings from a systematic review of the literature on teratogenic risk management that was carried out as the initial step in this programme of research. The systematic review found a lack of research on risk management of thalidomide, particularly in countries of the Middle East. It also found variation in the reported use of teratogenic risk management measures which included reporting low levels of adherence to these measures. While this might constitute a significant medicine safety concern, it may be the result of using data sources that might have been unable to generate complete data. Therefore, the review concluded by highlighting the need for future research to investigate multiple sources to confirm consistency of the obtained findings on the use of teratogenic risk management. Therefore, the first study of this programme of research utilised primary data reported by patients through filling a questionnaire and secondary data extracted from medical records to investigate risk management of thalidomide in Jordan. The cross-sectional study aimed to profile the characteristics of patients using thalidomide in Jordan and describe patients' use of teratogenic risk management measures using quantitative methods. Subsequently, the second study sought to contextualise findings by exploring those factors within the health system that have an effect on risk management using qualitative methods. This was achieved by applying the World Health Organization's (WHO) health systems framework to explore the experiences and views of patients, industry, drug regulators, and health care professionals of risk management of thalidomide in Jordan. Findings of this programme of research show that that implementing the risk management programme of thalidomide in Jordan is failing to consider the sociodemographic characteristics of patients using the medicine. Although few exceptions exist, the programme generally does not fit the profile of patients using thalidomide due to their old age. In addition, the programme overlooks the cultural dimension of family members' involvement in handling thalidomide which might constitute a significant safety concern among those caregivers. Moreover, by applying the WHO health systems framework, this research identifies which of the health system components have the most significant impact on the risk management of thalidomide and therefore, need to be improved. Consequently, it can be concluded that there is a real need for the patient voice in preventing foetal exposure to thalidomide, and this has to be at the centre of a well-functioning health system.

Keyword(s)

Risk management; Thalidomide

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