In Taiwan, new H1N1 monovalent vaccines without adjuvant and with MF59® adjuvant were used in the nationwide vaccination campaign beginning on November 1, 2009. From November 2009 through February 2010, the authors identified recipients of H1N1 vaccines who were diagnosed with adverse events of special interest (AESIs) in a large-linked safety database, and used the self-controlled case series (SCCS) method to examine the risk of each AESI in the 0–42 days after H1N1 vaccination. Of the 3.5 million doses of H1N1 vaccines administered and captured in the linked database, the SCCS analysis of Guillain-Barré syndrome (GBS) found an incidence rate ratio of 3.81 (95% confidence interval 0.43–33.85) within 0–42 days after nonadjuvanted H1N1 vaccination and no cases after MF59®-adjuvanted H1N1 vaccination. The risks of other AESIs were, in general, not increased in any of the predefined postvaccination risk periods and age groups. The databases and infrastructure created for H1N1 vaccine safety evaluation may serve as a model for safety, effectiveness and coverage studies of licensed vaccines in Taiwan.
The Taiwan Centers for Disease Control (Taiwan CDC) has established a 3-tier personal protective equipment (PPE) stockpiling framework that could maintain a minimum stockpile for the surge demand of PPE in the early stage of a pandemic. However, PPE stockpiling efforts must contend with increasing storage fees and expiration problems. In 2011, the Taiwan CDC initiated a stockpile replacement model in order to optimize the PPE stockpiling efficiency, ensure a minimum stockpile, use the government's limited funds more effectively, and achieve the goal of sustainable management. This stockpile replacement model employs a first-in-first-out principle in which the oldest stock in the central government stockpile is regularly replaced and replenished with the same amount of new and qualified products, ensuring the availability and maintenance of the minimum stockpiles. In addition, a joint electronic procurement platform has been established for merchandising the replaced PPE to local health authorities and medical and other institutions for their routine or epidemic use. In this article, we describe the PPE stockpile model in Taiwan, including the 3-tier stockpiling framework, the operational model, the components of the replacement system, implementation outcomes, epidemic supports, and the challenges and prospects of this model.
Background: Less storage space and longer shelf life have made Oseltamivir API a good choice for stockpiling as countermeasure against influenza pandemic. However dispensing before use is needed. To examine the efficiency of the processes from activation, packaging, dispensing to distribution, we conducted functional exercise and drill on August 2006 and November 2007 respectively.Methods: The central government establishes the stockpiles of antivirals. During the pandemic, the Taiwan association of clinical pharmacy (TACP) together with 105 dispensing sites nationwide will dispense and distribute API. The scenario for functional exercise assumed 4 clusters of A/H5N1 infection were detected and 400,000 doses of antivirals dispensed at 5 sites were indicated. We examined the time needed for each processes. Drill was conducted to test the accuracy and efficiency of dispensing and management through Material Information System (MIS) for 50 sites randomly selected. Dispensing skill and time was evaluated with a checklist by committee. The performance of operating MIS was recorded automatically by the system Results: TACP needed 6 to 8 hours to mobilized the personnel and activate the dispensing operation on receiving order. Simultaneously, the central government needed 11 hhours to transport the antiviral to GMP factory for packaging and then to dispensing sites. All the dispensing sites completed the dispensing within 6 hours and antiviral was sent to designated place within 3 hours. The dispensing skill was evaluated at 5 dispensing sites with 100% accuracy and mean dispensing time was 60 minutes. Seventy-six percent (38/50) of the hospitals feedback the information through MIS, and 79% of them completed in time.Conclusion: The mechanism in place can distribute the antiviral to designated place within 24 hours which will be in time for cases to use. Most of the units can use the MIS successfully indicates that this system effectively facilitate the management, though more training may be needed.
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