A Global Call to Action on Antimicrobial Resistance at the UN General Assembly.

As the United Nations General Assembly prepares to convene its second high-level meeting on antimicrobial resistance (AMR) in September 2024, it is crucial to reflect on the progress made since the first meeting in 2016 and the urgent need for immediate action [...

Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use-A Narrative Review.

The spread of antimicrobial resistance (AMR) is a global challenge. Close and continuous surveillance for quick detection of AMR can be difficult, especially in remote places. This narrative review focuses on the contributions of pharmacovigilance (PV) as an auxiliary tool for identifying and monitoring the ineffectiveness, resistance, and inappropriate use of antibiotics (ABs).

Tackling potentially inappropriate prescriptions in older adults: development of deprescribing criteria by consensus from experts in Colombia, Argentina, and Spain.

Background: Potentially inappropriate medication use is prevalent among older adults in primary care, leading to increased morbidity, adverse drug reactions, hospitalizations, and mortality. This study aimed to develop and validate a tool for identifying PIMs in older adults within the primary care setting. The tool is composed of a list of criteria and was created based on consensus among experts from three Spanish-speaking countries, including two from Latin America.

Safety Profile of Medicines Used for the Treatment of Drug-Resistant Tuberculosis: A Descriptive Study Based on the WHO Database (VigiBase).

Background: The introduction of new drugs that increase the usage of repurposed medicines for managing drug-resistant tuberculosis (DR-TB) comes with challenges of understanding, properly managing, and predicting adverse drug reactions (ADRs). In addition to the health consequences of ADRs for the individual, ADRs can reduce treatment adherence, thus contributing to resistance. This study aimed to describe the magnitude and characteristics of DR-TB-related ADRs through an analysis of ADRs reported to the WHO database (VigiBase) in the period from January 2018 to December 2020.

Impact of a system to assist in clinical decision-making in primary healthcare in Catalonia: prescription Self Audit.

Background: In 2008, in the context of a complete computerisation of medical records, the Institut Català de la Salut (ICS, Catalan Health Institute) implemented a system in its electronic clinical workstation (ECW) to assist decision-making at the prescription level. This system is known as Self Audit, and it supports physicians in reviewing the medication of their patients. Self Audit provides lists of patients presenting medication-related problems (MRPs) that have potential for improvement, and provides therapeutic recommendations that are easy to apply from the system itself.

Pharmacovigilance Data as a Trigger to Identify Antimicrobial Resistance and Inappropriate Use of Antibiotics: A Study Using Reports from The Netherlands Pharmacovigilance Centre.

(1) Background: Antimicrobial resistance (AMR) requires urgent multidisciplinary solutions, and pharmacovigilance has the potential to strengthen current antimicrobial stewardship strategies. This study aimed to characterize AMR-relevant adverse drug reaction (ADR) reports submitted to The Netherlands Pharmacovigilance Centre; (2) Methods: We carried out a descriptive analysis of ADR reports submitted to Lareb, coded with AMR-relevant MedDRA Preferred Terms (PTs); (3) Results: Between 1998 and January 2019, 252 AMR-relevant ADR reports were submitted to Lareb. The most frequent antibiotics were tobramycin ( = 89; 35%), colistin ( = 30; 11.

Safer prescription of drugs: impact of the PREFASEG system to aid clinical decision-making in primary care in Catalonia.

Background: In 2008, the Institut Català de la Salut (ICS, Catalan Health Institute) implemented a prescription decision support system in its electronic clinical workstation (ECW), which automatically generates online alerts for general practitioners when a possible medication-related problem (MRP) is detected. This tool is known as PREFASEG, and at the time of beginning a new treatment, it automatically assesses the suitability of the treatment for the individual patient. This analysis is based on ongoing treatments, demographic characteristics, existing pathologies, and patient biochemical variables.

Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database.

The U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events.

Pharmacovigilance network as an additional tool for the surveillance of antimicrobial resistance.

Background: The WHO Programme for International Drug Monitoring (PIDM) is a large Pharmacovigilance network of countries sharing Adverse Drug Reaction (ADR) reports. Pharmacovigilance Experts have suggested that antimicrobial resistance (AMR) is an overlooked adverse event. We undertook this study to investigate the potential role of Pharmacovigilance databases in the surveillance of AMR.

Development of a stepwise tool to aide primary health care professionals in the process of deprescribing in older persons.

Objective: The aim of this study was to develop and validate a stepwise tool to aid primary health care professionals in the process of deprescribing potentially inappropriate medication in older persons.

Methods: We carried out a systematic review to identify previously published tools. A composite proposal of algorithm was made by following the steps from clinical experience to deprescribe medications.

Antimicrobial stewardship: can we add pharmacovigilance networks to the toolbox?

Background: Antimicrobial resistance (AMR) is no longer an expected upcoming threat; it has become a real public health concern, challenging all existing control tools, requiring multidisciplinary innovative solutions. Antimicrobial stewardship (AMS) programs require a set of tools and skills which can be put to service by health systems. However, there is an immense capacity gap between health systems in developed countries compared to developing ones.

The "Square Box": Therapeutic Equivalence as a Foundation of the WHO Model List of Essential Medicines.

Every two years, the World Health Organization (WHO) updates its Model List of Essential Medicines, intended as a guide for countries to adopt or adapt in accordance with local priorities and treatment guidelines, for the development of national essential medicines lists. When more than one therapeutic option is available for a given indication, the WHO Model List often includes a single medicine as representative of a group of equivalent and interchangeable medicines. The representative medicine of that group is listed with an accompanying 'square box' symbol.

Prescription of Levofloxacin and Moxifloxacin in Select Hospitals in Uganda: A Pilot Study to Assess Guideline Concordance.

: In Uganda, national tuberculosis (TB) treatment guidelines were revised to include the newer generation fluoroquinolones among the second-line treatment options for multidrug-resistant TB. This study was designed to analyze if the prescription of these quinolones is compliant with country recommendations. : This was an observational retrospective study of consumption data for 2017 and 2018 across four selected regional referral hospitals.

Substandard Quality of the Antimicrobials Sold in the Street Markets in Haiti.

This pilot study was conducted to analyze the quality of the antimicrobials sold in the street markets in Port-au-Prince, Haiti. A total of 258 packs containing antimicrobials were bought in 28 street markets in Port-au-Prince (Haiti). Tablets and contents of capsules included in 196 packs were analyzed using a Raman handheld spectrometer (NanoRAM of BWTEK, Model: BWS456-785) during the first quarter of 2019.

Patterns of Antibiotic Prescription in Colombia: Are There Differences between Capital Cities and Municipalities?

The use of antibiotics is the most important modifiable risk factor for the development of microorganism resistance. A cross-sectional study of outpatients receiving antibiotic prescriptions registered in a population database in Colombia was conducted. The characteristics of the consumption in capital cities and small municipalities was studied and the AWaRe classification was used.

Adverse drug reactions to anti-diabetic drugs are commonest in patients whose treatment do not adhere to diabetes management clinical guidelines: cross-sectional study in a tertiary care service in sub-Saharan Africa.

Aims: The study aimed to identify and describe adverse drug reactions and adherence to clinical guidelines in patients receiving treatment for type 2 diabetes mellitus (T2DM) in Cameroon.

Methods: The method used was a cross-sectional study at a tertiary diabetes care service in Yaoundé, Cameroon. Adult T2DM patients attending the diabetes clinic were interviewed using a pre-structured data collection form.

Medicines in Western Sahara Refugee Camps in Tindouf: Prescriptions and self-medication mixing in the drawer.

Problems with access to medicines, either by shortage or excess can be especially relevant in refugee camps. In the present study, we describe the medicines found in a sample of the Western Sahara refugee households, with special emphasis on antimicrobials and their use. All households of the 2nd district of Mahbes , in the Smara of the Sahrawi Refugee Camps in Tindouf (Algeria) were visited during 10 days in April 2019 in order to know which medicines are kept at home.

Adverse Drug Reactions in Selected Wards of the Yangon General Hospital and Yangon Specialty Hospital During the First Quarter of 2019: An Active Pharmacovigilance Study in Myanmar.

Background: Previous studies in Europe and the USA have reported a high prevalence of adverse drug reactions (ADRs), but data on local ADRs in Myanmar are sparse.

Objective: Our objective was to study ADRs in patients admitted to selected wards of Yangon General Hospital (YGH) and Yangon Specialty Hospital (YSH), Myanmar.

Methods: This was a prospective observational study in three hospital wards during the first quarter of 2019.

Continuous rise in cephalosporin and fluoroquinolone consumption in Pakistan: a 5 year analysis (2014-18).

Background: Pakistan was third on the list of the highest antibiotic-consuming countries among low- and middle-income countries in 2015. Studies have suggested that areas with higher consumption of antibiotics are likely to have higher antibiotic resistance rates.

Objectives: With limited surveillance data on consumption and resistance in Pakistan, this study investigated the 5 year trends (April 2014 to March 2019) in consumption of the two highest-sold antibiotic classes, cephalosporins [Anatomical Therapeutic Chemical (ATC) group J01D] and fluoroquinolones (ATC group J01MA).

Analysis of the Antimicrobial Market in Pakistan: Is It Really Necessary Such a Vast Offering of "Watch" Antimicrobials?

Understanding antimicrobials (AM) on offer in a pharmaceutical market, with a particular reference to drugs categorized as "Watch" active ingredients, is one of the important first steps to prevent their potentially inappropriate use. The March 2019 data of all AM containing registered brands and presentations currently being sold in the country for the J01 Anatomical Therapeutic Chemical (ATC) subgroup from IQVIA Pakistan was used. Each AM was categorized as "Access," "Watch," or "Reserve," according to the WHO AWaRe classification.

Drug-induced gambling disorder: A not so rare but underreported condition.

The widespread use of dopaminergic agents for the treatment of Parkinson's disease has revealed the presence of gambling disorder (GD) as an uncommon, but serious, adverse reaction to these agents. We describe the main characteristics of drug-induced GD reports received by the Spanish Pharmacovigilance System during the period from 1983 to 2016. Fifteen reports of GD have been identified.

Inappropriately prescribed and over-the-counter antimicrobials in the Brazilian Amazon Basin: We need to promote more rational use even in remote places.

Background: Being aware of consumption patterns of antimicrobials is the first step in designing and implementing strategies to change behaviors and, thus, to reduce the occurrence of antimicrobial resistance. The present survey was carried out to identify and describe the use of antimicrobials without prescription in riverside dwellers of the Brazilian Amazon Basin.

Methods: A cross-sectional study was carried out from a conglomerate stratified sample in the rural municipality of Coari, Amazonas State, Brazil, between April and July 2016.

Towards preventive pharmacovigilance through medicine misuse identification: an example with recombinant human growth hormone for aesthetic purposes.

Purpose: Historically, somatropin has been used for conditions related with ageing, but since the marketing of recombinant human growth hormone (rhGH), increasing promotional pressure has prompted aesthetic uses, despite lack of evidences about its efficacy and safety for those purposes.

Methods: A routine analysis of the Pharmacovigilance Center of São Paulo (Brazil) showed reports of suspected adverse reactions in young adults and mature patients receiving rhGH. After presuming an off-label use of this expensive product, a drug utilisation study within the pharmacovigilance database has been carried out.