[Thesis]. Manchester, UK: The University of Manchester; 2020.
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
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.