Saudi Vigilance Program: Challenges and lessons learned.

Pharmacovigilance is vital to public health. Adopting a robust spontaneous reporting system for adverse drug events can counteract most hazards that arise from utilizing medicinal products. Prior to the establishment of the Saudi Food and Drug Authority (SFDA), the number of pharmacovigilance-related activities in Saudi Arabia was limited. In 2009, the SFDA established the National Pharmacovigilance and Drug Safety Center (Saudi Vigilance). The pharmacovigilance system has remarkably improved during the past few years. Several initiatives have been taken to improve the program's performance. These initiatives include initiation of pharmacovigilance guidelines, enhancement of communication and reporting tools, training sessions for concerned staff and healthcare providers, and compliance from stakeholders. This review article provides an overview of what the Saudi Vigilance program is, focusing on the scope, mission and vision, hierarchy, operational themes, and overall work processes. Additionally, we will shed light on the challenges we encountered during the early phase and on our future plans.

Pharmaceutical policies used by private health insurance companies in Saudi Arabia.

BACKGROUND: Currently, the Council of Cooperative Health Insurance (CCHI) is the body responsible for regulating health insurance in the KSA. While the cooperative health insurance schedule (i.e., model policy for health insurance) is available on the CCHI web site, policies related to pharmaceuticals are ambiguous. AIMS: The primary objective of this study was to assess the impact of health insurance policies provided by health insurance companies in KSA on access to medication and its use. SETTINGS AND DESIGN: This study was descriptive in design and used a survey, which was conducted through face-to-face interviews with the medical managers of health insurance companies. METHODS AND MATERIAL: The survey took place between March and June, 2011. All 25 insurance companies accredited by CCHI were eligible to be included in the study. Out of these 25 companies, three were excluded from this survey as no response was received. RESULTS: All the 16 companies responded "Yes" that they had a prior authorization policy; however, their reasons varied. Eight (50%) of the companies were concerned about the duration of treatment. While 10 (62.5%) did not offer additional coverage over the CCHI model policy, the other 6 (37.5%) reported that they could reconcile certain conditions. The survey also demonstrated that 10 insurance companies allowed refilling of medication but with certain limitations. Six out of the 10 permitted refilling within a maximum time of three months, whereas the other four companies did not have any time-based limits for refilling. The other six companies did not allow refilling without prescription. CONCLUSIONS: Although this paper was primarily descriptive, the findings revealed a substantial scope for improvement in terms of pharmaceutical policy standards and regulation in the health insurance companies in KSA. Additionally, the study highlighted such areas to augment the overall quality use of medication, over-prescribing and irrational use of medication. Further research, thus, is definitely needed.

Regional group purchasing of vaccines: review of the Pan American Health Organization EPI revolving fund and the Gulf Cooperation Council group purchasing program.

This paper reviews the key design features, accomplishments of and lessons learned from two regional group procurement mechanisms dealing with vaccines that have been in operation for more than 25 years. The Pan American Health Organization (PAHO) EPI Revolving Fund purchases vaccines and immunization supplies on behalf of more than 35 countries in the Latin American and Caribbean region. Based on a 'central contracting' model, the program handles most aspects of procurement-from tendering to contracting with and paying producers--using a common fund to pay producers before being reimbursed by countries once goods are received in-country. The Gulf Cooperation Council (GCC) Group Purchasing Program among seven Persian Gulf States issues joint tenders for vaccines, as well as drugs and other medical goods. Through this 'group contracting' program, countries are responsible for contracting with and paying producers on their own, once the group has selected winning bids. Both programs have experienced substantial growth in the past two decades and are considered to have contributed to or accelerated achievements of immunization programs in both regions, including the introduction of new vaccines. The paper identifies several features of both programs--both those designed to attract country participation and those designed to ensure the programs' financial viability--which help explain their success and longevity.