Assessment of the Current State of Pharmacovigilance System in Pakistan Using Indicator-Based Assessment Tool

Objectives: Pakistan felt the need for an effective and robust pharmacovigilance (PV) system after one of the deadliest drug-related tragedies causing more than 300 deaths in 2012. The country set up its national PV center in 2015 and joined WHO’s Program for International Drug Monitoring (PIDM) in 2018 as a full member. The current study was aimed to evaluate the PV system’s functionality, identify the gaps, areas of improvement, and a strategy to lead a functional PV system in Pakistan.Methods: The descriptive cross-sectional study was conducted by providing an interviewer-administered questionnaire of the PV system across Pakistan by utilizing the Indicator based Pharmacovigilance assessment tool (IPAT). By a convenience sampling method 36 study participants were selected from the Drug Regulatory Authority of Pakistan (DRAP), drug administration of provincial health departments of 4 provinces and federally affiliated areas, 5 national public health programs, and 23 public and private hospitals. The assessment includes document review, interviews of the key informants by structured open-ended questions, and a review of websites of relevant organizations.Results: Drug Regulatory Authority of Pakistan (DRAP) with a national PV center received a 75% overall performance score on IPAT. To be regarded as “minimally functioning,” a country’s PV and drug safety system must meet all core indicators. DRAP scored 80.76% on the core indicators so cannot be deemed functional at this time. The only province with a regional PV center, Punjab, had scored 72.13% on relevant parameters. Despite receiving funding from the Global Fund, none of the National Public Health Programs (PHPs) have PV centers or associated activities. All hospitals except two private hospitals could not qualify the minimum requirements for functional PV. The absence of a legal framework for mandatory ADR reporting, lack of drug information center, budgetary constraints, no active surveillance activities, the nonexistence of pharmacovigilance risk assessment expert committee, and insufficient coordination among stakeholders were identified as major gaps.Conclusion: The results of the study reveal that Pakistan’s PV system is not fully functional at all levels. A two-phased strategy encompassing the non-financial and financial interventions is proposed to improve the PV systems at the national, provincial, PHPs, and hospitals levels.

Validation of the revised Diabetes Self-Management Questionnaire (DSMQ-R) in the primary care setting

Background Available tools measuring self-management in diabetes are often improperly validated or do not correlate with glucose metabolism. The Diabetes Self-Management Questionnaire (DSMQ-R) is a valid tool, that showed strong relationship with glucose metabolism in tertiary care among people with mostly type 1 diabetes. Aim of the study To validate the translated DSMQ-R questionnaire in a Hungarian sample of people with predominantly type 2 diabetes in primary care. Methods We enrolled 492 adults from 38 practices in this cross-sectional cohort study, who filled out the self-administered questionnaire, consisting of DSMQ-R and the Summary of Diabetes Self-Care Activities (SDSCA) questionnaires. Family doctors provided clinical data. The translation process was performed in six steps, reaching the expert committee appraisal. The validity of the questionnaire was evaluated by assessing reliability and construct validity. Results Cronbach’s alpha showed the questionnaire to reach good reliability (α = 0.845), although subscales had lower alphas. Contrary to the SDSCA questionnaire, the DSMQ-R sum scale differed significantly between persons on target vs not on target (median (interquartile range): 7.23 (6.17–8.44) vs 6.91 (5.91–8.02), and the DSMQ-R sum scale correlated significantly with BMI, HbA1c and SDSCA sum scale. In multivariate analysis higher DSMQ-R scores were significant predictor of achieving glycemic target goal. Conclusion The Hungarian translation of the DSMQ-R is a comprehensible tool to assess self-management of persons with diabetes. The questionnaire is valid and reliable in family practice, although its association with achievement of diabetes HbA1c target is weaker in primary than in tertiary care.

Traducción y adaptación transcultural del cuestionario para niños “Barriers and facilitators of sports in children with physical disabilities (BaFSCH)” para su uso al español en Chile (Transcultural translation and adaptation of the questionnaire for chi

El objetivo de este estudio fue realizar una adecuación transcultural del cuestionario “Barriers and facilitators of sports in children with physical disabilities” al idioma español hablado en Chile. Para el proceso de traducción y adaptación transcultural se siguieron los pasos de traducción directa, síntesis de traducciones, traducción inversa, consolidación de comité de expertos y pre-test. En cuanto a los resultados se realizaron los pasos según la metodología desarrollando las adaptaciones necesarias que se consideraron desde la opinión de los expertos y traductores que participaron de la adaptación del escrito. Participaron 93 sujetos con un promedio de edad de 13,95 años ± 4,84 donde hubo 42 niñas (45,16%) y 51 niños (54,84%). La mayoría de las y los participantes asisten a educación básica (62,36%), con condiciones no definidas (34,40%) seguido de quienes tiene dificultades para movilizarse (12,90%) y quienes no comprenden bien las indicaciones (12,90%). Se considera que este cuestionario puede ser una herramienta adecuada para conocer la percepción de los participantes lo que puede finalmente impactar en diversas acciones y políticas que permitan la participación efectiva en actividad física y deporte bajo un enfoque de derecho social. Abstract. The objective of this study was to carry out a cross-cultural adaptation of the questionnaire “Barriers and facilitators of sports in children with physical disabilities” into the Spanish language spoken in Chile. For the translation and cross-cultural adaptation process, the steps of direct translation, translation synthesis, reverse translation, consolidation of the expert committee and pre-test were followed. Regarding the results, the steps were carried out according to the methodology developing the necessary adaptations that were considered from the opinion of the experts and translators who participated in the adaptation of the writing. 93 subjects participated with an average age of 13,95 ± 4,84 years, where there were 42 girls (45,16%) and 51 boys (54,84%). Most of the participants attend basic education (62,36%), with undefined conditions (34,40%) followed by those who have difficulties to move around (12,90%) and those who do not understand the indications well (12,90%). It is considered that this questionnaire can be an adequate tool to know the perception of the participants, which can ultimately impact on various actions and policies that allow effective participation in physical activity and sport under a social law approach.

International collaborative study to evaluate and calibrate two recombinant L chain Ferritin preparations for use as a WHO International Standard

Objectives To evaluate and calibrate two candidate preparations for the 4th International Standard for Ferritin (Human, Recombinant) (codes: 19/118 and 19/162) against the 3rd International Standard for Ferritin (Human, Recombinant) (code: 94/572), and three serum commutability samples in an international collaborative study involving 12 laboratories in nine countries. Methods Eleven of the 12 participating laboratories performed Ferritin quantitation using automated assay platforms and one laboratory used a manual ELISA kit. Results There was better overall agreement between all laboratories and between assay methods for the potency of preparation 19/118 than for preparation 19/162. The overall geometric mean potency (from all methods) of the candidate 4th International Standard, 19/118, was 10.5 µg/ampoule, with inter-laboratory variability, expressed as % geometric coefficient of variation (GCV), of 4.7%. Accelerated stability studies have predicted both 19/118 and 19/162 to be very stable for long term storage at −20 °C. Conclusions The candidate 4th International Standard for Ferritin (Human, Recombinant) (19/118) has been shown to be immunologically similar to the 3rd International Standard for Ferritin (Human, Recombinant) (94/572). It was recommended to and accepted by the WHO Expert Committee on Biological Standardization that 19/118 be established as the 4th International Standard for Ferritin (Human, Recombinant) with an assigned potency of 10.5 µg/ampoule and expanded uncertainty limits 10.2–10.8 µg/ampoule (95% confidence; k=2.23).

12. Retinopathy, Neuropathy, and Foot Care: Standards of Medical Care in Diabetes—2022

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee (https://doi.org/10.2337/dc22-SPPC), are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc22-SINT). Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

1. Improving Care and Promoting Health in Populations: Standards of Medical Care in Diabetes—2022

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee (https://doi.org/10.2337/dc22-SPPC), are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc22-SINT). Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

6. Glycemic Targets: Standards of Medical Care in Diabetes—2022

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee (https://doi.org/10.2337/dc22-SPPC), are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc22-SINT). Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

13. Older Adults: Standards of Medical Care in Diabetes—2022

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee (https://doi.org/10.2337/dc22-SPPC), are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc22-SINT). Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2022

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee (https://doi.org/10.2337/dc22-SPPC), are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc22-SINT). Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.