Do pregnant persons want influenza vaccines? Knowledge, attitudes, perceptions, and practices toward influenza vaccines in 8 low- and middle-income countries.

BACKGROUND: While vaccination is the most effective way to prevent influenza infection and adverse outcomes, and despite WHO recommendations to vaccinate pregnant persons, access to seasonal influenza vaccines remains low. We explored knowledge, attitudes, and practices of pregnant persons about seasonal influenza vaccines to inform actions to improve vaccine uptake among this priority population. METHODS: We pooled individual-level data from cross-sectional surveys assessing pregnant persons' attitudes toward seasonal influenza vaccines in eight low- and middle-income countries during 2018-2019. The eight countries used a standard protocol and questionnaire to measure attitudes and intents toward influenza vaccination. We stratified by country-level (presence/absence of a national influenza vaccination program, country income group, geographic region) and individual-level factors. FINDINGS: Our analysis included 8,556 pregnant persons from eight low- and middle-income countries with and without seasonal influenza vaccination programs. Most pregnant persons (6,323, 74%) were willing to receive influenza vaccine if it was offered for free. Willingness differed by presence of an existing influenza vaccination program; acceptance was higher in countries without influenza vaccination programs (2,383, 89%) than in those with such programs (3,940, 67%, p < 0.001). INTERPRETATION: Most pregnant persons in middle-income countries, regardless of influenza vaccination program status, were willing to be vaccinated against influenza if the vaccine was provided free of charge. National investments in influenza vaccination programs may be well-received by pregnant persons, leading to averted illness both in pregnant persons themselves and in their newborn babies. FUNDING: US Centers for Disease Control and Prevention.

Lessons learned from a cluster of immunization errors in newborns.

Background: Vaccines are safe and effective, but adverse reactions can occur. Immunization errors (IEs) are one of the types of adverse events following immunization. The Moroccan Pharmacovigilance Centre (MPC) received a cluster of IEs from a maternity university hospital (MUH) regarding six newborns who were inadvertently administered rocuronium instead of hepatitis B (HepB) vaccine. The newborns experienced respiratory distress and one had a fatal outcome. Objectives: The study aimed to describe the investigation findings, the underlying causes, and contributing factors of the IEs cluster, and proposed risk minimization actions. Design: We carried out a descriptive analysis of the cluster of IEs related to the HepB vaccine reported to the MPC. Methods: An investigation was conducted by the Ministry of Health according to the World Health Organization guidance. The root cause analysis was performed to identify underlying causes and contributing factors that lead to IE occurrence. Results: The cluster analysis showed that the main contributing factors were the look-alike rocuronium and HepB vaccine packaging, the first-time running HepB vaccination for newborns in the MUH, the lack of a full-time pharmacist, and the unsafe storage of rocuronium and vaccines. The administration of Sugammadex to the newborns followed by their transfer to the neonatal care unit resulted in the recovery of five of the six newborns. Proposed recommendations included (1) raising awareness of healthcare professionals to the risk related to look-alike medications, (2) training nurses to ensure vaccination to implement procedures related to immunization practices, (3) nomination of a full-time pharmacist, (4) reassessment of the safety of drug storage and dispensing at the hospital pharmacy, particularly for high-alert medications. Conclusion: Reporting IEs, particularly serious ones, allows us to identify causes and contributing factors that led to their occurrence. Lessons learned from errors are key to take risk minimization actions to improve vaccine safety worldwide.

Adverse drug reactions to chloroquine/hydroxychloroquine in combination with azithromycin in COVID-19 in-patients: data from intensive pharmacovigilance in Morocco, 2020.

In Morocco, chloroquine/hydroxychloroquine + azithromycin have been used off-label for COVID-19 treatment. This study aimed to describe the distribution, nature and seriousness of the adverse drug reactions (ADRs) associated with the two drug combinations in COVID-19 in-patients. We conducted a prospective observational study based on intensive pharmacovigilance in national COVID-19 patients' management facilities from April 1 to June 12, 2020. Hospitalized patients treated with chloroquine/hydroxychloroquine + azithromycin and who experienced ADRs during their hospital stay were included in the study. The causality and seriousness of the ADRs were assessed using the World Health Organization-Uppsala Monitoring Centre method and the agreed criteria in the ICH guideline (E2A) respectively. A total of 237 (51.7%) and 221 (48.3%) COVID-19 in-patients treated respectively with chloroquine + azithromycin and hydroxychloroquine + azithromycin experienced 946 ADRs. Serious ADRs occurred in 54 patients (11.8%). Gastrointestinal system was most affected both in patients taking chloroquine + azithromycin (49.8%) or hydroxychloroquine + azithromycin (54.2%), followed by nervous system and psychiatric. Eye disorders were more frequent in patients receiving chloroquine + azithromycin (10.3%) than those receiving hydroxychloroquine + azithromycin (1.2%). Cardiac ADRs accounted for 6.4% and 5.1% respectively. Chloroquine + azithromycin caused more ADRs by patients than hydroxychloroquine + azithromycin (2.6 versus 1.5 ADRs/patient). Causality assessment was possible for 75.7% of the ADRs. Diabetes was identified as a risk factor for serious ADRs (ORa 3.56; IC: 95% 1.5-8.6). The off-label use of the two drug combinations in COVID-19 in-patients according to the national therapeutic protocol seems to be safe and tolerable. ADRs were mainly expected. However, precaution should be taken in using the drugs in diabetic patients to prevent the risk of serious ADRs.

Monitoring the safety of influenza A/H1N1 pandemic and seasonal vaccines in Morocco.

Background: A vaccination campaign against pandemic influenza A/H1N1 was implemented in Morocco between November 2009 and April 2010. Overall, 705,883 subjects were vaccinated by Pandemrix, Arepanrix, and Panenza. The adverse events following immunization (AEFIs) data comparison was made with the 2014/2015 seasonal influenza vaccination campaign that was specifically investigated. Aim: To evaluate the safety of the 2009 pandemic influenza A/H1N1 vaccine and to compare it to that of 2014 seasonal influenza vaccine. Methods: During the pandemic vaccination campaign, the Morocco Pharmacovigilance Centre reinforced passive AEFI surveillance with an active and prospective monitoring programme of 1000 immunized people over 6 months at 10 randomly selected vaccination centres. For the 2014/2015 seasonal vaccination campaign, AEFI data were collected from spontaneous notifications. Results: Active monitoring of 2009 pandemic collected 771 AEFI reports, corresponding to an AEFI incidence rate of 77.1% with vaccination by either Pandemrix or Arepanrix vaccine in 95% of cases. Reported AEFI were most frequently local (37.7%), general (29.5%), and neurological reactions (20.3%). Most of the AEFI (95.5%) were observed during the first 48 hours after vaccination, and the remainder within 2 weeks. None of the reported AEFI were serious case. The highest rate of notification was documented for health professionals, followed by patients with diabetes or chronic respiratory diseases. Concerning passive surveillance, the AEFI notification rate was significantly higher for the 2009/2010 pandemic vaccine (3.1 vs 1.2 per 10,000). However, there was no significant difference between pandemic and seasonal vaccination with regards to the serious adverse events (SAE) notification rate (0.3 vs 0.2 per 10,000). Conclusion: Data analysis indicates that the vaccines used against 2009 pandemic influenza in Morocco have a satisfactory safety profile, similar to the seasonal influenza vaccine with the exception of local reactions as observed previously in other countries.

Construction and analysis of a database for medication errors in a pharmacovigilance centre-the Moroccan experience.

PURPOSE: The study aimed to describe the epidemiological profile of medication errors (MEs) reported to the Moroccan Pharmacovigilance Center (MPVC), to determine factors associated with serious MEs, and to describe signals related to them. METHODS: We carried out a retrospective descriptive analysis of MEs reported to the MPVC from 2006 to 2016 and a secondary analysis of the seriousness of MEs with adverse drug reactions (ADRs). The reports were sorted by demographic profile and by ME and ADR characteristics. For signal detection, a quantitative approach was adopted, and the root cause analysis was completed. Epi info 7 software was used to perform descriptive and analytical statistics. The statistical significance level was set at p < 0.05. RESULTS: A total of 1618 ME reports were retrieved. The proportion of MEs associated with serious ADRs was 23.9%. The factors statistically associated with serious MEs were as follows: (i) the age group 16 years old and less (p < 0.001), (ii) the gender (p = 0.01), (iii) the administration and the prescription stages (p < 0.001), and (iv) the ME types related to inappropriate schedule of drug administration, drug prescribing error (p < 0.001), and incorrect drug administration dosage form (p = 0.04). Fourteen signals related to MEs were detected, for which risk minimization actions were implemented. CONCLUSION: The establishment of a ME unit within the MPVC was an opportunity to further improve the pharmacovigilance centre performance and consequently its contribution to medication safety. The lessons learned from MEs should be shared through pharmacovigilance networks and with institutions involved in medication safety for synergistic results to achieve patient safety worldwide.

Assessment of a new instrument for detecting preventable adverse drug reactions.

BACKGROUND: Pharmacovigilance centres (PVCs) in the World Health Organization (WHO) Programme for International Drug Monitoring have demonstrated their ability to detect preventable adverse drug reactions (ADRs) in their databases. In this field, there is no gold-standard method for detecting medication errors and evaluating ADR preventability. Therefore, we developed, from existing tools, a preventability assessment method: the 'P Method' (PM). OBJECTIVE: To present the PM and to evaluate its inter-rater reliability. METHODS: The PM includes 20 explicit criteria for assessing ADR preventability. This approach is based on identification of any potentially preventable risk factor that increases the likelihood of ADR occurrence. The outcome of the preventability assessment results in one of three possible scores: 'preventable', 'non-preventable' or 'not assessable'. The PM was tested in a multicentre study involving nine national PVCs. Two experienced reviewers at each participating PVC independently analysed the preventability of 183 ADRs, applying the PM. RESULTS: The overall agreement between all reviewers for assessment of ADR preventability was 'fair', with a kappa value of 0.27 [95 % confidence interval (CI) 0.21-0.40]. The level of agreement between reviewer pairs ranged from 'slight', with a kappa value of 0.12 (95 % CI -0.03 to 0.27), to 'substantial', with a kappa value of 0.69 (95 % CI 0.48-0.89). CONCLUSION: The analysis of the agreements and disagreements between reviewers highlighted where improvements might be made. Given that no standard assessment tool exists in the WHO Programme, the transparency of the assessment process in this method provides a substantial basis for further development and for support in signalling possible preventability.