Public Health & Community Medicine, Tufts University School of Medicine, Boston, Massachusetts.
Pfizer Inc, Collegeville, Pennsylvania.
Clin Ther. 2022 Sep;44(9):1225-1236. doi: 10.1016/j.clinthera.2022.07.007. Epub 2022 Jul 25.
The COVID-19 pandemic poses an unprecedented threat to global business relationships and dynamics. The pharmacovigilance function of pharmaceutical companies is particularly susceptible to changing external pressures because of its highly structured compliance activities. We conducted an industry-wide survey to provide insights on how the pharmacovigilance function responded to the challenges posed by the pandemic. We compared smaller companies and larger companies regarding impact on portfolios and operational activity metrics.
We conducted a survey through the Navitas Life Science annual benchmark of pvnet, a network of large enterprise (LE) companies, and pvconnect, a network of small and medium enterprise (SME) companies, using an online surveying tool during the first quarter of 2021. We collected information on pharmacovigilance activities, including quantitative measures of workload, costs, and key performance indicators, and qualitative data on the effects of the pandemic on product portfolios and operations.
Survey questions were posed to LE (pvnet) network members (n = 12) and SME (pvconnect) network members (n = 18) for the period from January 1 through December 31, 2020. The date of data collection was March 26, 2021. Descriptive median values of parameter metrics included the following: revenue ($28.4 billion for LE companies and $1.6 billion for SME companies), number of products (127 for LE companies and 19 for SME companies), and volume of individual case safety reports (391,000 for LE companies and 13,000 for SME companies). SME companies reported a greater impact on 2 survey categories, remote working and employee well-being, than did LE companies. However, LE companies reported a greater impact than did SME companies on all other survey categories: effect on strategic priorities, shift in product focus, workload changes, changes in sourcing model, effect on case reporting compliance, effect on business continuity, changes in pharmacovigilance technology strategy, impact of interactions with health authorities, effect on resource capacity, and impact on recruitment.
Four major themes emerge from this survey: (1) shift to remote working, (2) recognition of the impact on employee well-being, (3) shift in strategic priorities, and (4) newly recognized aspects of risk mitigation. The COVID-19 pandemic has had a marked effect on every aspect of pharmaceutical companies' pharmacovigilance functions, although the effects appear to be different for LE companies than for SME companies.
新冠疫情对全球商业关系和动态构成了前所未有的威胁。由于其高度结构化的合规活动，制药公司的药物警戒功能特别容易受到外部压力变化的影响。我们进行了一项全行业调查，以了解药物警戒功能如何应对疫情带来的挑战。我们比较了小公司和大公司在投资组合和运营活动指标方面的影响。
我们通过 Navitas Life Science 对 pvnet（大型企业网络）和 pvconnect（中小企业网络）进行的年度基准调查进行了调查，该调查使用在线调查工具在 2021 年第一季度进行。我们收集了药物警戒活动的信息，包括工作量、成本和关键绩效指标的定量措施，以及疫情对产品组合和运营影响的定性数据。
我们向大型企业（pvnet）网络成员（n=12）和中小企业（pvconnect）网络成员（n=18）提出了 2020 年 1 月 1 日至 12 月 31 日期间的调查问题。数据收集日期为 2021 年 3 月 26 日。参数指标的描述性中位数值包括以下内容：收入（大型企业公司为 284 亿美元，中小企业公司为 16 亿美元）、产品数量（大型企业公司为 127 个，中小企业公司为 19 个）和个例安全报告量（大型企业公司为 391000 份，中小企业公司为 13000 份）。中小企业公司报告说，远程办公和员工福利这两个调查类别受到的影响比大型企业公司更大。然而，与中小企业公司相比，大型企业公司在所有其他调查类别中报告的影响更大：对战略重点的影响、产品重点转移、工作量变化、采购模式变化、对病例报告合规性的影响、对业务连续性的影响、药物警戒技术战略变化、与卫生当局互动的影响、资源能力的影响以及招聘的影响。
从这项调查中出现了四个主要主题：（1）向远程办公转变，（2）认识到对员工福利的影响，（3）战略重点转移，以及（4）新认识到的风险缓解方面。新冠疫情对制药公司药物警戒功能的各个方面都产生了显著影响，尽管对大型企业公司和中小企业公司的影响似乎不同。
