Out of the boxes,out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain

In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.     

Investigating the association of receipt of seasonal influenza vaccine with occurrence of anesthesia/paresthesia and severe headaches,Canada 2012/13–2016/17, the Canadian Vaccine Safety Network

BackgroundConcern about adverse events following immunization is frequently cited by both those who receive or decline vaccines. Neurological adverse events are especially concerning.ObjectivesOur aim was to detect associations between seasonal influenza vaccination and the occurrence of severe anesthesia/paresthesia or severe headaches.MethodsData were analyzed from the Canadian National Vaccine Safety network. Events occuring on days 0–7 were self-reported and prevented daily activity, led to school or work absenteeism, or required medical attention. Controls were the previous year’s vaccinees; events in controls were collected prior to the start of the influenza vaccination program of each year (2012/13 through 2016/17). Multivariable logistic regression was used to determine the association between seasonal influenza vaccination and the occurrence of anesthesia/paresthesia or severe headaches.ResultsThe total sample was 107,565 for investigating anesthesia/paresthesia and 97,420 for investigating severe headaches. Anesthesia/paresthesia was reported by 104/107,565 (0.10%) participants; 63/69,129 (0.09%) vaccinees and 41/38,436 (0.11%) controls (adjusted odds ratio (aOR) = 0.89; 95% CI = 0.60, 1.32). Severe headaches were reported by 1361/97,420 (1.40%) participants; 907/61,463 (1.48%) vaccinees and 454/35,957 (1.26%) controls (aOR = 1.21; 95% CI = 1.08, 1.36). No specific vaccine product was associated with severe headaches.ConclusionsOur study found no association between severe anesthesia/paresthesia and seasonal influenza vaccination. While there was an association with severe headaches as an adverse event following influenza vaccination, the rates of these events are similar to rates reported from clinical trials and are not a cause for additional concern.     

Enhanced surveillance of tetanus toxoid,reduced diphtheria toxoid,and acellular pertussis (Tdap) vaccines in pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2011–2015

BackgroundIn October 2011, the Advisory Committee on Immunization Practices (ACIP) issued updated recommendations that all pregnant women routinely receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine.ObjectivesWe characterized reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received Tdap after this updated recommendation (2011–2015) and compared the pattern of adverse events (AEs) with the period before the updated recommendation (2005–2010).MethodsWe searched the VAERS database for reports of AEs in pregnant women who received Tdap vaccine after the routine recommendation (11/01/2011–6/30/2015) and compared it to published data before the routine Tdap recommendation (01/01/2005–06/30/2010). We conducted clinical review of reports and available medical records. The clinical pattern of reports in the post-recommendation period was compared with the pattern before the routine Tdap recommendation.ResultsWe found 392 reports of Tdap vaccination after the routine recommendation. One neonatal death but no maternal deaths were reported. No maternal or neonatal deaths were reported before the recommendation. We observed an increase in proportion of reports for stillbirths (1.5–2.8%) and injection site reactions/arm pain (4.5–11.9%) after the recommendation compared to the period before the routine recommendation for Tdap during pregnancy. We noted a decrease in reports of spontaneous abortion (16.7–1%). After the 2011 Tdap recommendation, in most reports, vaccination (79%) occurred during the third trimester compared to 4% before the 2011 Tdap recommendation. Twenty-six reports of repeat Tdap were received in VAERS; 13 did not report an AE. One medical facility accounted for 27% of all submitted reports.ConclusionsNo new or unexpected vaccine AEs were noted among pregnant women who received Tdap after routine recommendations for maternal Tdap vaccination. Changes in reporting patterns would be expected, given the broader use of Tdap in pregnant women in the third trimester.     

Esophageal Surveillance Practices in Esophageal Atresia Patients: A Survey by the Eastern Pediatric Surgery Network

IntroductionEndoscopic surveillance guidelines for patients with repaired esophageal atresia (EA) rely primarily on expert opinion. Prior to embarking on a prospective EA surveillance registry, we sought to understand EA surveillance practices within the Eastern Pediatric Surgery Network (EPSN).MethodsAn anonymous, 23-question Qualtrics survey was emailed to 181 physicians (surgeons and gastroenterologists) at 19 member institutions. Likert scale questions gauged agreement with international EA surveillance guideline-derived statements. Multiple-choice questions assessed individual and institutional practices.ResultsThe response rate was 77%. Most respondents (80%) strongly agree or agree that EA surveillance endoscopy should follow a set schedule, while only 36% claimed to perform routine upper GI endoscopy regardless of symptoms. Many institutions (77%) have an aerodigestive clinic, even if some lack a multi-disciplinary EA team. Most physicians (72%) expressed strong interest in helping develop evidence-based guidelines.ConclusionsOur survey reveals physician agreement with current guidelines but weak adherence. Surveillance methods vary greatly, underscoring the lack of evidence-based data to guide EA care. Aerodigestive clinics may help implement surveillance schedules. Respondents support evidence-based protocols, which bodes well for care standardization. Results will inform the first multi-institutional EA databases in the United States (US), which will be essential for evidence-based care.Level of EvidenceThis is a prognosis study with level 4 evidence.     

深圳市南山区医疗机构消毒效果分析

目的:了解南山区各医院及个体诊所卫生消毒状况。方法:对2002~2003年间区属各医院及个体诊所消毒效果的监测结果进行统计分析。结果:2002年与2003年区镇医院消毒效果平均合格率分别为94.4%和97.1%,个体诊所平均合格率分别为87.6%和89.8%。结论:区(镇)医院消毒效果优于个体诊所,空气合格率普遍较低,卫生防疫机构要加大力度进行监督检测,同时加强对医务人员进行消毒知识培训。     

2005～2006年江西省血吸虫病疫情监测点螺情调查结果分析

目的分析2005～2006年江西省12个国家级血吸虫病疫情监测点螺情调查结果,掌握各监测点钉螺消长情况。方法依据《全国血吸虫病疫情监测点方案》,对各监测点钉螺孳生环境与可疑环境进行调查,比较两年的各项螺情指标。结果2006年12个监测点的有螺面积较2005年下降17.27%,但各监测点有螺面积下降幅度不相一致,有10个监测点查出有阳性钉螺分布;另外各监测点活螺密度、阳性螺密度也有较大波动。结论各监测点螺情依然严重,应加强控制钉螺的防治力度。     

上海市流动人口血吸虫病、疟疾、丝虫病监测结果分析

目的：评价外来流动人口对上海市人群传播血吸虫病、疟疾、丝虫病(简称“三病”)的潜在危害，从而预防和控制外源性“三病”在本市传播。方法：对外省市来沪居留3个月以上人员，进行“三病”血清免疫学检测，达到规定的阳性滴度时进行病原学追踪及治疗。结果：2001—2003年共监测外来流动人口909960人次，血吸虫病、疟疾、丝虫病抗体阳性率分别为0．55％、0.28％和0．02％；质量抽检符合率分别为98、42％、94．21％和99．84％。结论:必须加强外来流动人口“三病”监测和防治管理，以有效预防和控制外源性“三病”在本市传播。     

甘肃省1995年急性弛缓性麻痹病例病毒学监测

甘肃省１９９５年共报告１５岁以下儿童急性弛缓性麻痹（ＡＦＰ）病例９０例，发病率为１．３２／１０万。省脊髓灰质炎（脊灰）实验室收到ＡＦＰ病例的粪便标本共７９例，占８８％；双份合格粪便标本采集率为６８％（６１／９０）；粪便标本７天内送省脊灰实验室的占６５％（５２／７９）收到粪便标本后７天内分离培养的占８９％（７０／７９）；分离培养结果及时报告率为８７％（６９／７９）。病毒分离阳性率１３．９２％（１１／７９），其中脊灰病毒（ＰＶ）Ⅱ型５株，Ⅲ型１株，非脊灰肠道病毒（ＮＰＥＶ）５株。收到ＡＦＰ病例密切接触者粪便标本３ｌ８份，病毒分离阳性率５．６６％（１８／３１８），其中ＰＶⅡ型８株，ＮＰＥＶ１０株。全部送检粪便标本ＮＰＥＶ分离率３．７８％（１５／３９７）。所分离的ＰＶ均为疫苗株，且Ⅱ型居多。