Identification and Quantitation Classifications for Extractables and Leachables.

Extractables and leachables (E&L) are identified and quantified so that their impact on patient safety can be established and assessed. The uncertainty in the impact assessment is affected by the uncertainty in the substance's experimentally determined identity and concentration. Thus, these experimentally determined quantities must be reported not only in terms of their absolute result but also in terms of the uncertainty in the result, which is based on the amount and rigor of the information on which the result is based. In this way, the impact assessment can be tempered to account for the uncertainty in its input data. To facilitate the assignment and reporting of uncertainty, classification hierarchies are proposed and discussed for both identification and quantitation. Both hierarchies establish levels or degrees of identification and quantitation based on the uncertainty of the result and contain descriptions of the quality and quantity of information required to achieve a certain level within the hierarchy. The minimal levels that must be achieved to support impact assessment are also established.

Comparison of traditional methods versus SAFEcount for filling prescriptions: A pilot study of an innovative pill counting solution in eSwatini.

BACKGROUND: Packaging medications is a crucial component of health system efficiency and quality. In developing countries, medications often arrive in bulk containers that need to be counted by hand. Traditional counting is time-consuming, inaccurate and tedious. SAFEcount is a novel and inexpensive handheld device that may improve the accuracy and speed of pill-counting in resource limited settings. We designed a head-to-head trial to compare traditional and SAFEcount prescription filling in eSwatini. METHODS: We recruited 31 participants from 13 health facilities throughout eSwatini. Speed and accuracy for each prescription was recorded while each participant filled prescriptions of various quantities using both the traditional and SAFEcount methods. RESULTS: Traditional pill counting resulted in an error rate of 12.6% inaccurate prescriptions compared to 4.8% for SAFEcount (p<0.0001). SAFEcount was 42.3% faster than traditional counting (99.9 pills per minute versus 70.2; p<0.0001). Using SAFEcount was preferred over traditional pill counting by 97% (29/30) of participants. CONCLUSIONS: The SAFEcount device is a preferred alternative by counting personnel and is significantly faster and more accurate compared to traditional counting methods. SAFEcount could help improve the efficiency and quality of health care delivery in place of traditional hand counting.

Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study / Bulas dos medicamentos mais consumidos em Portugal: aspectos de segurança e de adequação regulamentar. Um estudo descritivo

CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines. .

CONTEXTO E OBJETIVO: As bulas dos medicamentos são necessárias para a sua utilização segura. Os objetivos do presente estudo foram: 1) avaliar a adequação entre o conteúdo das bulas e as especificações da regulação farmacêutica e 2) identificar os aspectos que potencialmente possam comprometer a utilização segura dos medicamentos pelos doentes. TIPO DE ESTUDO E LOCAL: Estudo descritivo qualitativo com a inclusão de todas as bulas dos medicamentos de marca dos três grupos terapêuticos mais consumidos em Portugal, analisados no Departamento de Farmacoepidemiologia da Faculdade de Farmácia da Universidade de Lisboa. MÉTODOS: Utilização de uma checklist para recolher os dados. A checklist foi validada por um processo de consenso entre peritos. O conteúdo de cada uma das bulas da amostra foi classificado em relação à adequação aos aspectos regulatórios obrigatórios, como a descrição das reações adversas, dose e frequência de administração, e à adequação dos aspectos regulatórios facultativos, como a frequência das reações adversas e sintomas e procedimentos em caso de sobredosagem. RESULTADOS: Foram identificadas 651 bulas. Em termos gerais, todas as bulas foram consideradas conformes em relação aos aspectos regulatórios obrigatórios. No entanto, os aspectos regulatórios opcionais foram descritos em apenas cerca de metade da amostra de bulas, o que permite a identificação de situações susceptíveis de comprometer a utilização segura dos medicamentos. CONCLUSÃO: Idealmente as metodologias de aprovação das bulas devem ser revistas e otimizadas de forma a assegurar um mínimo de informação essencial para a utilização segura dos medicamentos. .

Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study.

CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.

Globalización de los requisitos para la comercialización de medicamentos: importancia de la humedad ambiental en el diseño de los estudios de estabilidad / International requirements for drug marketing: relevance of environmental humidity in the design studies

Se revisan y analizan las condiciones de almacenamiento de las muestras para los estudios de estabilidad recogidas en la normativa elaborada por el ICH, y se propone incorporar un estudio a diferentes humedades relativas (una superior y otra inferior a la propuesta en las "condiciones de almacenamiento de las muestras") en el caso de medicamentos sólidos en envases semipermeables

The sstorage conditions of the samples in the stability studies according to ICH normative are revised and analysed. An additional study at different relative humidities (higher and lower than that proposed in "storage conditions of the samples") incase of drug products in semi permeable containers is proposed

Glass classification by linear discriminant analysis of LA-ICP-MS data.

The classification of pharmaceutical and common glasses (ampoules, infusion bottles, cylinders, lead crystal and bottle glass) has been performed means by of chemometric methods. For this purpose intensity data of glass examinations received by laser ablation inductively coupled plasma mass spectrometry (LA-ICP-MS) were applied. A Nd:YAG laser with 10 Hz repetition rate in the Q-switch mode at its 4th harmonic (266 nm) was used to get mass spectrometric data of the glasses. 13 isotopes (= variables) were used for measurements (7Li, 11B, 23Na, 24Mg, 27Al, 28Si, 39K, 42Ca, 47Ti, 57Fe, 123Sb, 137Ba, 207Pb). The glass samples represented four types of glasses: 1. borosilicate glass (type "Duran") 2. borosilicate glass (type "Fiolax") 3. soda-lime glass 4. lead glass. Calculations were made by using the SAS statistical software. All results were obtained on the assumption that the underlying data are normally distributed. By applying linear discriminant data analysis a classification of all types of the glasses was possible (13 variables included). The use of the method of "stepwise discriminant analysis" reduced the minimal required number of variables to eight. All types of glasses could be distinguished faultlessly. Besides a graphic system consisting of the isotopes 24Mg-47Ti-137Ba was developed. By means of this system optical distinction of glass classes was possible. The developed method allows to distinguish several types of pharmaceutical and common glasses on the basis of intensity data of mass spectrometric measurement without calibration experiments and linear regression.

Línea de control de calidad en el reenvasado de medicamentos. Bases metodológicas. Diseño. Utilidad / Quality control line in drug repackaging. Methodological grounds. Design. Usefulness

El Sistema de Distribución de Medicamentos en Dosis Unitarias está establecido en el 100 por ciento de nuestras camas (410), y anualmente, alrededor de 490.000 unidades sólidas son reenvasadas en el servicio de farmacia. El objetivo del presente trabajo es exponer el concepto y la metodología seguida en el diseño de la Línea de Control de Calidad y valorar su repercusión sobre la calidad del producto final reenvasado. Utilizamos los resultados de un estudio descriptivo de 284 especialidades farmacéuticas reenvasadas, para diseñar una línea de información para cada una de ellas. Esta información, permite detectar errores durante la elaboración del reenvasado, la dispensación de la dosis unitaria reenvasada, en la administración del medicamento por la enfermera, e incluso por el propio paciente. Por ello, nos parece un sistema que mejora la calidad del proceso de reenvasado de medicamentos y contribuye a disminuir los errores de administración de medicamentos en los hospitales (AU)

Medicamentos huérfanos: propuesta para el establecimiento de un valor de prioridad para su clasificación / Orphan drugs: a proposal for the institution of a priority value for her classification

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