scholarly journals Availability of Authorizations from EMA and FDA for Age-Appropriate Medicines Contained in the WHO Essential Medicines List for Children 2019

Pharmaceutics ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 316 ◽  
Author(s):  
Jose-Manuel delMoral-Sanchez ◽  
Isabel Gonzalez-Alvarez ◽  
Marta Gonzalez-Alvarez ◽  
Andres Navarro-Ruiz ◽  
Marival Bermejo
Keyword(s):  
Drug Product ◽  
Essential Medicines ◽  
World Health ◽  
European Medicines Agency ◽  
Drug Products ◽  
United States Food ◽  
Age Appropriate ◽  
States Food ◽  
Health Organization ◽  
Medicines For Children

Lack of age-appropriate commercially drug products availability is a common problem in pediatric therapeutics; this population needs improved and safer drug delivery. In addition, biopharmaceutic aspects, dosage requirements, and swallowing abilities demand pediatric forms different to adult formulations. The objective of this study was to evaluate the authorization availability from United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) of oral essential medicines for children and analyze its age-appropriateness for oral administration in children. All oral drugs from 7th List of Essential Medicines for Children by World Health Organization (WHO) were selected. Availability of commercial drug products was collected from OrangeBook, Spanish drug product catalogue, British electronic Medicines Compendium, and the International Vademecum. Tablets, effervescent tablets, and capsules were considered as not age-appropriate forms. Liquid forms, powder for oral suspension, mini tablets, granules, and soluble films were considered as age-appropriate forms due to their flexibility. More than 80% of the studied drugs possess a commercial authorization in oral forms in both EMA and FDA. Nevertheless, around 50% of these formulations are not age-appropriate for most pediatric groups. This study shows the lack of age-appropriate medicines for children. More efforts are needed to improve development and approval of pediatric medicines.

scholarly journals A critical comparison between the World Health Organization list of essential medicines for children and the Brazilian list of essential medicines (Rename)

2013 ◽  
Vol 89 (2) ◽  
pp. 171-178
Author(s):  
Helena Lutéscia L. Coelho ◽  
Luís Carlos Rey ◽  
Marina S.G. de Medeiros ◽  
Ronaldo A. Barbosa ◽  
Said G. da Cruz Fonseca ◽  
...  
Keyword(s):  
World Health Organization ◽  
Essential Medicines ◽  
World Health ◽  
Critical Comparison ◽  
The World ◽  
Health Organization ◽  
Medicines For Children

Persisting pain in childhood medical illness

2013 ◽  
pp. 319-327
Author(s):  
Martha Mherekumombe ◽  
John J. Collins
Keyword(s):  
Pain Management ◽  
World Health Organization ◽  
Essential Medicines ◽  
World Health ◽  
Medical Illness ◽  
Global Problem ◽  
The World ◽  
Health Organization ◽  
Medicines For Children

Persisting pain in the context of medical illness has been recognized recently as a global problem by the World Health Organization (WHO, 2012). Whilst the epidemiology of medical illness varies throughout the world, the general principles of pain management are applicable to most medical illnesses in children and are effective. Successful pain management for most children is contingent on the availability of the WHO model list of essential medicines for children (WHO, 2011), although regrettably not all medicines are available in every country in the world.

scholarly journals A critical comparison between the World Health Organization list of essential medicines for children and the Brazilian list of essential medicines (Rename)

2013 ◽  
Vol 89 (2) ◽  
pp. 171-178 ◽  
Author(s):  
Helena Lutéscia L. Coelho ◽  
Luís Carlos Rey ◽  
Marina S.G. de Medeiros ◽  
Ronaldo A. Barbosa ◽  
Said G. da Cruz Fonseca ◽  
...  
Keyword(s):  
World Health Organization ◽  
Essential Medicines ◽  
World Health ◽  
Critical Comparison ◽  
The World ◽  
Health Organization ◽  
Medicines For Children

scholarly journals Review of Quality Deficiencies Found in Active Pharmaceutical Ingredient Master Files Submitted to the WHO Prequalification of Medicines Programme

2014 ◽  
Vol 17 (2) ◽  
pp. 169 ◽  
Author(s):  
Isabel Ortega Diego ◽  
Antony Fake ◽  
Matthias Stahl ◽  
Lembit Rägo
Keyword(s):  
Technical Assistance ◽  
Active Pharmaceutical Ingredient ◽  
The United States ◽  
World Health ◽  
European Medicines Agency ◽  
United States Food ◽  
Materials Used ◽  
The Stability ◽  
Health Organization ◽  
Over Time

Purpose. The aim of this work was to determine the number and type of active pharmaceutical ingredient (API) quality deficiencies in API Master Files (APIMFs) as submitted to the World Health Organization (WHO) Prequalification of Medicines Programme (PQP). Methods. We conducted a retrospective review of API quality deficiencies identified following the assessment of new APIMFs for non-sterile APIs during a 6-year period from 1 January 2007 to 31 December 2012. All deficiencies were collected, classified and quantified according to the Common Technical Document (CTD) sections and subsections and as groups of commonly raised questions. Results. There were 5446 deficiencies collected from 159 APIMF deficiency letters by CTD section, by selected CTD subsections and by selected CTD subsections and year. More than 50% of the total number of deficiencies related to the manufacturing sections of the CTD, followed by deficiencies concerning the impurities, the API specification and the stability sections of the CTD.  A pattern of API deficiencies across the different CTD subsections and over time was identified. Conclusions. The most frequent critical deficiencies were related to how the specific manufacturing process and the key materials used, in particular the API starting material, impact the API impurities content. The number and pattern of APIMF deficiencies did not change over time. The results are compared to the findings in similar studies as reported by the United States Food and Drug Administration (USFDA), the European Directorate for the Quality of Medicines (EDQM) and the European Medicines Agency (EMA) and similarities and differences are discussed. Our findings highlight the need for greater guidance and technical assistance for API manufacturers submitting APIMFs to the PQP. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

Chemistry of Iodinated Contrast Media (ICM): A Minireview

2020 ◽  
Vol 17 ◽  
Author(s):  
Maithili Pramod Joshi ◽  
Ameya Chaudhari ◽  
Prashant S. Kharkar ◽  
Shreerang V. Joshi
Keyword(s):  
Adverse Effects ◽  
Contrast Media ◽  
Aqueous Solubility ◽  
Synthetic Methods ◽  
Essential Medicines ◽  
World Health ◽  
Iodinated Contrast Media ◽  
Environmental Aspects ◽  
Iodinated Contrast ◽  
Health Organization

: Historically, the use of Iodinated Contrast Media (ICM) for diagnostic purposes, particularly radiography and computed tomography (CT), is well-known. Many of the ICM are included in the World Health Organization (WHO)’s List of Essential Medicines. Depending on the chemotype and the presence of ionizable functional group(s), the ICM are categorized in the ionic/nonionic monomers/dimers. The lipophilicity, aqueous solubility, viscosity and osmolality are major characteristics dictating their use for one procedure versus the other. Over last several decades, substantial advancement occurred in the design and development of novel ICM, solely to reduce their propensity to cause adverse effects. Given the nature of their acute usage, some of the agents with appreciable toxicity are still used. Understanding their chemistry aspects is crucial to appreciate, acknowledge and justify the usage of these extremely important torch-bearers of diagnostic agent’s class. The present review article presents an in-depth overview of the synthetic methods, therapeutic indications, potential adverse effects along with the commercial and environmental aspects of ICM. The safety and tolerability of these agents is a field that has gained significant importance, which is given due importance in the discussion.

scholarly journals D-Penicillamine: The State of the Art in Humans and in Dogs from a Pharmacological and Regulatory Perspective

Antibiotics ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 648
Author(s):  
Michela Pugliese ◽  
Vito Biondi ◽  
Enrico Gugliandolo ◽  
Patrizia Licata ◽  
Alessio Filippo Peritore ◽  
...  
Keyword(s):  
Veterinary Medicine ◽  
State Of The Art ◽  
European Medicines Agency ◽  
Therapeutic Goals ◽  
First Choice ◽  
Regulatory Perspective ◽  
The World ◽  
United States Food ◽  
States Food ◽  
Food And Drugs Administration

Chelant agents are the mainstay of treatment in copper-associated hepatitis in humans, where D-penicillamine is the chelant agent of first choice. In veterinary medicine, the use of D-penicillamine has increased with the recent recognition of copper-associated hepatopathies that occur in several breeds of dogs. Although the different regulatory authorities in the world (United States Food and Drugs Administration—U.S. FDA, European Medicines Agency—EMEA, etc.) do not approve D-penicillamine for use in dogs, it has been used to treat copper-associated hepatitis in dogs since the 1970s, and is prescribed legally by veterinarians as an extra-label drug to treat this disease and alleviate suffering. The present study aims to: (a) address the pharmacological features; (b) outline the clinical scenario underlying the increased interest in D-penicillamine by overviewing the evolution of its main therapeutic goals in humans and dogs; and finally, (c) provide a discussion on its use and prescription in veterinary medicine from a regulatory perspective.

scholarly journals Evaluation of Prescribing Indicators in a Paediatric Population Seen in an Outpatient Consultation at the Gaspard Kamara Health Centre in 2019 (Senegal)

Pharmacy ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 113
Author(s):  
Oumar Bassoum ◽  
Mouhamadou Faly Ba ◽  
Ndèye Marème Sougou ◽  
Djibril Fall ◽  
Adama Faye
Keyword(s):  
Descriptive Analysis ◽  
Health Centre ◽  
Paediatric Population ◽  
Essential Medicines ◽  
World Health ◽  
Bivariate Analysis ◽  
Prescribing Indicators ◽  
Outpatient Consultation ◽  
International Nonproprietary Name ◽  
Health Organization

Introduction: Data on drug use in paediatrics are scarce in Senegal. The objective of this study was to assess the prescribing indicators in a paediatric population seen in an outpatient consultation at a Health Centre in Dakar, Senegal. Methods: A retrospective and analytical study was conducted. The study population consisted of prescriptions for children aged 0 to 14 years who were seen in ambulatory consultation between 1 June and 30 November 2019. The sample size was 600 prescriptions. The systematic survey was then conducted. Five prescription indicators recommended by the World Health Organization were calculated. The R software was used for descriptive analysis, bivariate analysis and binomial logistic regression. Results: The average number of drugs per prescription was 2.56. The proportion of drugs prescribed under the International Nonproprietary Name (INN) was 18.9%, while the proportion of drugs on the National Essential Medicines List (NEML) was 41.3%. The proportions of prescriptions with at least one antibiotic and one injectable product were 41.5% and 1.3%, respectively. Conclusions: This study showed that prescribing habits were inadequate. Thus, it would be necessary to move towards continuing training of prescribers in the wise use of medicines.

scholarly journals Analysis of Crowdsourced Metformin Tablets from Individuals Reveals Widespread Contamination with N-Nitrosodimethylamine (NDMA) in the United States

2020 ◽  
Author(s):  
Qian Wu ◽  
Evgenia Kvitko ◽  
Amber Jessop ◽  
Shannon Williams ◽  
Ryan C. Costantino ◽  
...  
Keyword(s):  
United States ◽  
High Resolution Mass Spectrometry ◽  
Daily Intake ◽  
The United States ◽  
Product Recalls ◽  
Acceptable Daily Intake ◽  
Drug Products ◽  
Post Market ◽  
United States Food ◽  
States Food

AbstractRecent reports of metformin drug products contaminated with unacceptable levels of the probable human carcinogen N-Nitrosodimethylamine (NDMA) prompted a national sampling of post-market metformin drug products. To most broadly sample the market and minimize supply chain bias, metformin medication samples were crowdsourced directly from individuals across many states in the United States. 128 samples were received, and liquid chromatography-high resolution mass spectrometry tests for a panel of nitrosamines revealed significant levels of NDMA that trend with labeling company. 42% of all medication samples contained detectable levels of NDMA and, when scaled to maximum daily tablet dose, 36% of all medication samples contained NDMA levels exceeding the FDA daily acceptable intake limit. The highest NDMA detection from the tested samples was 1565 ng per tablet, which, when commonly taken four times a day, is 65 times the United States Food and Drug Administration (FDA) acceptable daily intake limit. Results underscore the need for immediate product recalls of tainted medications and an overall investigation of metformin manufacturing practices.

scholarly journals Examination of WHO/INRUD Core Drug Use Indicators at Public Primary Healthcare Centers in Kisii County, Kenya

2020 ◽  
Author(s):  
Faith A. Okalebo ◽  
Eric M. Guantai ◽  
Aggrey O. Nyabuti
Keyword(s):  
Drug Use ◽  
Low Income ◽  
Primary Healthcare ◽  
Essential Medicines ◽  
World Health ◽  
Low Income Countries ◽  
Rational Use ◽  
Health Organization ◽  
Consultation Time ◽  
Primary Healthcare Centers

ABSTRACTBackgroundIrrational drug use is a global problem. However, the extent of the problem is higher in low-income countries. This study set out to assess and characterize drug use at the public primary healthcare centers (PPHCCs) in a rural county in Kenya, using the World Health Organization/ International Network for the Rational Use of Drugs (WHO/INRUD) core drug use indicators methodology.MethodsTen PPHCCs were randomly selected. From each PPHCC, ninety prescriptions from October to December 2018 were sampled and data extracted. Three-hundred (30 per PPHCC) patients and ten (1 per PPHCC) dispensers were also observed and interviewed. The WHO/INRUD core drug use indicators were used to assess the patterns of drug use.ResultsThe average number of drugs per prescription was 2.9 (SD 0.5) (recommended: 1.6– 1.8), percentage of drugs prescribed by generic names was 27.7% (recommended: 100%); the percentage of prescriptions with an antibiotic was 84.8% (recommended: 20.0–26.8%), and with an injection prescribed was 24.9% (recommended: 13.4–24.1%). The percentage of prescribed drugs from the Kenya Essential Medicines List was 96.7% (recommended: 100%). The average consultation time was 4.1 min (SD 1.7) (recommended: ≥10 min), the average dispensing time was 131.5 sec (SD 41.5) (recommended: ≥90 sec), the percentage of drugs actually dispensed was 76.3% (recommended: 100%), the percentage of drugs adequately labeled was 22.6% (recommended: 100%) and percentage of patients with correct knowledge of dispensed drugs was 54.7% (recommended: 100%). Only 20% of the PPHCCs had a copy of KEML available, and 80% of the selected essential drugs assessed were available.ConclusionThe survey shows irrational drug use practices, particularly polypharmacy, non-generic prescribing, overuse of antibiotics, short consultation time and inadequacy of drug labeling. Effective programs and activities promoting the rational use of drugs are the key interventions suggested at all the health facilities.

scholarly journals High global consumption of potentially inappropriate fixed dose combination antibiotics: Analysis of data from 75 countries

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0241899
Author(s):  
Barbara Bortone ◽  
Charlotte Jackson ◽  
Yingfen Hsia ◽  
Julia Bielicki ◽  
Nicola Magrini ◽  
...  
Keyword(s):  
The United States ◽  
Antibiotic Consumption ◽  
Essential Medicines ◽  
World Health ◽  
Fixed Dose ◽  
Middle Income ◽  
Us Fda ◽  
Analysis System ◽  
Health Organization ◽  
Data Analysis System

Antibiotic fixed dose combinations (FDCs) can have clinical advantages such as improving effectiveness and adherence to therapy. However, high use of potentially inappropriate FDCs has been reported, with implications for antimicrobial resistance (AMR) and toxicity. We used a pharmaceutical database, IQVIA-Multinational Integrated Data Analysis System (IQVIA-MIDAS®), to estimate sales of antibiotic FDCs from 75 countries in 2015. Antibiotic consumption was estimated using standard units (SU), defined by IQVIA as a single tablet, capsule, ampoule, vial or 5ml oral suspension. For each FDC antibiotic, the approval status was assessed by either registration with the United States Food and Drug Administration (US FDA) or inclusion on the World Health Organization (WHO) Essential Medicines List (EML). A total of 119 antibiotic FDCs were identified, contributing 16.7 x 109 SU, equalling 22% of total antibiotic consumption in 2015. The most sold antibiotic FDCs were amoxicillin-clavulanic acid followed by trimethoprim/sulfamethoxazole and ampicillin/cloxacillin. The category with the highest consumption volume was aminopenicillin/β-lactamase inhibitor +/- other agents. The majority of antibiotic FDCs (92%; 110/119) were not approved by the US FDA. Of these, the most sold were ampicillin/cloxacillin, cefixime/ofloxacin and metronidazole/spiramycin. More than 80% (98/119) of FDC antibiotics were not compatible with the 2017 WHO EML. The countries with the highest numbers of FDC antibiotics were India (80/119), China (25/119) and Vietnam (19/119). There is high consumption of FDC antibiotics globally, particularly in middle-income countries. The majority of FDC antibiotic were not approved by either US FDA or WHO EML. International initiatives such as clear guidance from the WHO EML on which FDCs are not appropriate may help to regulate the manufacturing and sales of these antibiotics.

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