Background. Globally, pharmacovigilance activities were affected by COVID-19. Therefore, several competent health authorities around the world, including several countries in the Middle East, have issued guidelines and practices to ensure that pharmacovigilance activities are maintained and continued during the pandemic. Objective. The aim of this study was to assess the impact of COVID-19, preparedness and performance of national pharmacovigilance systems in participating countries during COVID-19 pandemic. Methods. This was a cross- sectional study that was conducted between July and October 2020. National pharmacovigilance centres in 18 Arab countries in the Middle East were invited to participate in this study. Descriptive analysis was used to summarize and present the results of this study. Results. Responses were obtained from 14 (77.8%) Arab countries. Ten of participating countries (71.4%) have either specific national PV guidelines or local PV practices during the COVID-19 pandemic. Adverse events reporting was the main PV activity that was covered by PV guidelines and practices. National guidelines and practices covered other PV activities in 8 (57.14%) of the participating countries. Performance and practices of national PV centres vary considerably among participating countries during the pandemic. Conclusion. The findings highlight the differences in preparedness and performance of different national PV centres in participating Middle Eastern countries. Improving digital infrastructure among participating countries could serve as a useful tool to minimize the impact of the pandemic on PV activities.

Purpose: Studies suggested that drug pricing might be a risk factor for drug shortage; however, a few provided a quantitative assessment of this possible causal association. This study aimed to assess whether drug prices are associated with drug shortage incidents. Methods: This was a retrospective database analysis study. Drugs with shortage notifications (one drug per notification) that were sent to the Saudi Food and Drug Authority (SFDA) from Jan/2017 to Dec/2020 by different stakeholders were included in the study. For each drug, the foreign-to-Saudi-price ratio (FTSPR) was calculated (FTSPR= mean international price/Saudi price). Accordingly, drugs were split into three groups: Group 1 (FTSPR >1]), Group 2 (FTSPR =1]), and Group 3 (FTSPR <1]). The primary outcomes were the ratio of mean counts (mCR) between the three groups with Group 3 chosen as a control group. The study outcomes were analyzed using a negative binomial regression model adjusting for the measured confounders. All study analyses were conducted using RSudio Version 1.2.5033. Results: A total of 900 drugs were included (Group 1=348, Group 2=345, Group 3=209). The mean count of Group 1 higher was higher than Group 3 (mCR: 1.88; 95% confidence interval [CI] 1.24 to 2.83), while and mean counts of Group 2 vs. Group 3 were comparable (mCR: 1.39; 95%CI 0.92 to 2.09). Conclusions: The results of our study showed that shortage was associated with drugs that are more expensive outside Saudi Arabia. Additional international studies are needed to explore this causal association.

Aims: Studies suggested that drug pricing might be a risk factor for drug shortage; however, a few provided a quantitative assessment of this possible causal association. This study aimed to assess whether drug prices are associated with drug shortage incidents. Methods: This was a retrospective database analysis study. Drugs with shortage notifications (one drug per notification) that were sent to the Saudi Food and Drug Authority (SFDA) from Jan/2017 to Dec/2020 by different stakeholders were included in the study. For each drug, the foreign-to-Saudi-price ratio (FTSPR) was calculated (FTSPR= mean international price/Saudi price). Accordingly, drugs were split into three groups: Group 1 (FTSPR >1]), Group 2 (FTSPR =1]), and Group 3 (FTSPR <1]). The primary outcomes were the ratio of mean counts (mCR) between the three groups with Group 3 chosen as a control group. The study outcomes were analyzed using a negative binomial regression model adjusting for the measured confounders. All study analyses were conducted using RSudio Version 1.2.5033. Results: A total of 900 drugs were included (Group 1=348, Group 2=345, Group 3=209). The mean count of Group 1 higher was higher than Group 3 (mCR: 1.88; 95% confidence interval [CI] 1.24 to 2.83), while and mean counts of Group 2 vs. Group 3 were comparable (mCR: 1.39; 95%CI 0.92 to 2.09). Discussion: The results of our study showed that shortage was associated with drugs that are more expensive outside Saudi Arabia. Additional international studies are needed to explore this causal association.