Parent and healthcare provider views of live varicella vaccination of pediatric solid organ transplant recipients.

BACKGROUND: Live attenuated varicella vaccine (LAVV) has historically been contraindicated in children who are immunocompromised due to solid organ transplant (SOT) because of safety concerns. Recently, clinical guidelines were developed that support post-transplant varicella vaccination in selected SOT recipients based on emerging evidence of LAVV safety. This qualitative study sought to explore barriers and facilitators to implementing the new guidelines, as well as acceptability of LAVV among healthcare providers (HCPs) and parents. METHODS: HCPs and parents of transplant recipients were recruited from four sites using purposive sampling. Data from semi-structured interviews were analyzed using an Interpretive Description approach that incorporated data from the interviews, academic knowledge and clinical experience, and drew from Grounded Theory and Thematic Analysis. The theoretical framework used was Adaptive Leadership. RESULTS: Thirty-four participants (16 HCPs and 18 parents) were included in the analysis. Parents developed skills in adaptive leadership that included strategies to protect their child against infectious diseases. Foundational information that live vaccines were absolutely contraindicated post-transplant "stuck" with parents and led them to develop strategies other than vaccination to keep their child safe. Some parents struggled to understand that information previously presented as a certainty (contraindication of LAVV) could change. Their approach to adaptive leadership informed their appraisal of the new vaccination guidelines and willingness to accept vaccination. CONCLUSIONS: HCPs should adopt a family-centered approach to communicating changing guidelines that considers parents' approach to adaptive leadership and discusses the changing nature of medical evidence. Trust between HCPs and parents can facilitate these conversations.

Healthcare provider awareness, attitudes, beliefs, and behaviors regarding the role of pharmacists as immunizers.

We explored perceptions of healthcare providers in Nova Scotia and New Brunswick about pharmacists as immunizers. Pharmacists' scopes of practice are increasingly broadening to include immunization, and providers and policymakers may find meaning in the lessons we learned. Invitations to participate in our online survey were circulated by professional associations, health authorities, and in social media posts. A total of 204 healthcare providers completed our survey, of whom 59.3% were pharmacists, 17.6% were nurses, and 23.0% were physicians. Nurses (30.6%) and physicians (34.0%) experienced fewer logistical barriers to immunizing compared to pharmacists, 71.1% of whom identified practice logistics as a determinant in offering vaccines to patients (p < .001). Pharmacists were most supportive of the expansion of their own scope of practice to include the provision of vaccines to adults (95.9%) and children as young as five years (92.6%) compared to nurses (72.2% and 69.4%) and physicians (61.7% and 40.4%) (p < .001). Diversity of opinion was evident even among pharmacists about whether they should be permitted to vaccinate children younger than five years. Nurse and physician respondents had lower odds of thinking pharmacists have enough training to vaccinate (p < .001), that vaccines should be given in a pharmacy (p < .001), and of supporting the expansion of pharmacists' scope of practice (p < .001) than pharmacists did in the multivariable analyses. Pharmacists are well-positioned and willing to vaccinate and generally have support from their nurse and physician peers, but logistical challenges and interprofessional complexities persist as barriers to optimizing immunization by pharmacists.

In most Canadian provinces and territories, pharmacists are trained and able to give vaccines alongside traditional immunizers like doctors and nurses. In this study, we surveyed the views of immunizing professionals (pharmacists, doctors, and nurses) in Nova Scotia and New Brunswick about pharmacists giving vaccines. Healthcare providers were invited to do our online survey by their professional associations, provincial health authorities, and through posts on social media. Healthcare providers generally supported pharmacists giving vaccines, but not without some conditions from nurses, doctors, and some pharmacists themselves. We found all three professions to be very vaccine positive but learned that pharmacists experience barriers to giving vaccines that their nurse and doctor colleagues do not such as working by themselves, volume of work, time, compensation, and record-keeping. We highlight the importance of collaboration between immunizing professionals, acknowledgment of pharmacists' training as immunizers, a uniform funding model for all immunization providers, and a central and accessible vaccine registry. We also suggest that until power dynamics and complexities between professions are addressed in meaningful and structural ways, we might not enjoy the full benefits of pharmacists as immunizers. We hope these findings are useful in places where pharmacists cannot yet vaccinate and where pharmacists' scopes of practice are in the process of widening to include immunization.

Governing off-label vaccine use: An environmental scan of the Global National Immunization Technical Advisory Group Network.

BACKGROUND: National Regulatory Authorities approve the indications for vaccine use in the product information. Occasionally, National Immunization Technical Advisory Groups (NITAGs) make off-label recommendations for use in different age groups, populations, and dosing schedules from the product information. We sought to determine the rationale, policies and procedures for NITAG off-label recommendations. METHODS: We conducted an environmental scan of Global NITAG Network members, immunization program managers and regulators in 38 high-, middle- and low-income countries. Participants completed an online survey regarding policies, procedures, and legislation governing development of off-label recommendations. A sub-sample of respondents met for a focus group and interviews which were analyzed qualitatively. RESULTS: Thirty-four people responded from 26/38 (68%) countries surveyed; 76% of respondents were NITAG members or immunization program managers. Recommendations for off-label vaccine use were made in 14/26 (54%) countries; the NITAG made those recommendations in 8/14 (57%) countries. Reasons for off-label vaccine recommendations included response to disease outbreaks or vaccine shortages. Only one country had standard operating procedures for developing off-label recommendations while 6/14 (43%) countries had policies for implementing off-label recommendations. Nine respondents from 8 countries agreed to participate in a focus group (n = 6) or individual interviews (n = 3). Barriers to off-label recommendations included legal concerns, lack of standard definition for off-label use, and manufacturer reluctance to update product information. Facilitators included confidence in the decision-making process, and transparency of open communication among stakeholders. CONCLUSIONS: Best practice guidelines are needed that define off-label use and outline a transparent, evidence-based approach to develop off-label recommendations.

Developing product label information to support evidence-informed use of vaccines in pregnancy.

BACKGROUND: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy. PURPOSE: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels. METHODS: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus. PRINCIPAL RESULTS: Stakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific pre-clinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada. CONCLUSIONS: The revised statements for IIV and Tdap aligned with workshop participants' goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy.