M 27: Evaluation of Public Awareness and Impact of the Turkish Regulatory and Reimbursement Processes on Patients’ Access to Medicines
Emel Mashaki Ceyhan
Cardiff University Turkey
The objective of this study is to identify the public awareness and knowledge about the regulatory environment in Turkey with respect to patients’ access to medicines and to evaluate the impact of the current regulatory and reimbursement process on patients’ access to innovative medicines.
This study included designing a comprehensive paper-based questionnaire piloted and then distributed through associations, pharmacies and clinics to 350 outpatients receiving chronic disease treatment mainly in cardiovascular and diabetes. Face to face interviews were conducted with 22 patients.
Two hundred and ten patients (60%) completed the questionnaire (50% males). Most patients (84%) knew that medicines had to be approved by the government. Yet, 81% of patients were not aware of the regulatory review process with 73% unaware of approval timelines. Furthermore, 37% described the Turkish approval process to be of a lower standard compared to US and EU. However, 70% of patients believed that there are novel alternative medicines for their disease available in other developed countries. Similarly, 60% of patients thought that new medicines only become available in Turkey after the developed countries.
In contrast, responses demonstrated that patients know more about the reimbursement system in Turkey where the majority expressed their satisfaction and 34% described access to new medicines to be adequate. Additionally the majority of patients (75%) recognised that the government is the main payer, even though insufficient information is provided about new medicines.
Patients stated that they do not have any role in the decision-making process for approving or reimbursing new medicines and therefore most of them indicated that they need to be more involved in reimbursement (60%) as well as in the approval process (58%).
This study identified that patients on chronic disease treatment attempt to learn about their medicines and 70% believe they get sufficient useful information from various sources about their medicines’ benefits and harms. Additionally patients recognise the importance of treatment compliance (85%) and are keen to report adverse drug reactions directly to their physician (91%). Therefore, it is suggested to encourage a culture among physicians to enhance the reporting of adverse drug reactions to the Turkish Pharmacovigilance Centre which is the related unit at the Turkish Medicine and Medical Device Agency (TITCK).
This study has demonstrated the importance of the patients’ awareness, knowledge and role with regards to the regulatory review and reimbursement procedures in Turkey. When patients were asked to describe the three most important improvements in obtaining the medicines they need, they indicated access to medicines, improved health and pharmaceutical care as well as price were considered the priorities. This was despite the major challenges they perceived facing the government namely; the cost of innovative medicines is still too high as well as lack of government resources and scientific expertise.
Patients were willing to offer four principle solutions to address these concerns such as
1. “There should be more collaboration between the academic experts and government to enhance pharmaceutical policies and shorten the registration process”,
2. “Encourage involvement through patients’ questionnaires and online forms”,
3. “The government has been successful to transform the primary health care services, therefore a similar effort must be carried out to enhance patients’ timely access to medicines with lower costs”,
4. “Doctors and pharmacists must contribute to raise the awareness of patients regarding access to medicines”
The role of patients in the decision-making process of approving and reimbursing new medicines by the government should be encouraged. Patients suggested that to ensure that their needs are met in a timely way that patients’ associations become more involved in decision-making and ensuring that there is a fair representation in the process. It is concluded that the use of patient questionnaires online or via doctors & pharmacists together with the use of social media could raise the awareness of patients to regulatory changes and access procedures.