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AIMS: Dermatology treatments require adherence for safe and effective use. Real-world healthcare databases can reveal drug utilization patterns and uncover inappropriate or unexpected use. This study aimed to analyse dermatology drug utilization patterns using epidemiological and inequality measures, leveraging Danish nationwide registries. It also assessed the feasibility of this method for detecting aberrant drug use. METHODS: We formed a 2019 cohort of all patients treated for skin conditions through Danish healthcare registries. We calculated prevalence, incidence rates and treatment duration for dermatological drugs. Inequality in drug utilization was assessed using Lorenz curves, Gini coefficients and other measures. RESULTS: The study encompassed 1 021 255 patients using 94 dermatology drugs. Most usage aligned with 'expected clinical use', but we detected inequality, with some drugs having high Gini coefficients and disproportionate consumption by the top percentile of users. Notable findings included potential inappropriate antibiotic use, excessive topical corticosteroid use and unexpected drug use duration. CONCLUSIONS: In Denmark, dermatology drugs are used primarily as anticipated, with minimal unexpected patterns. Specific follow-up is required to draw conclusions about inappropriate use. This approach demonstrates broad applicability for screening aberrant drug utilization.
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Fármacos Dermatológicos , Sistema de Registros , Humanos , Dinamarca/epidemiologia , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Fármacos Dermatológicos/uso terapêutico , Idoso , Dermatopatias/tratamento farmacológico , Dermatopatias/epidemiologia , Dermatopatias/diagnóstico , Uso de Medicamentos/estatística & dados numéricos , Prescrição Inadequada/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Adulto Jovem , Adolescente , Idoso de 80 Anos ou maisRESUMO
INTRODUCTION: Safe and effective pharmacological treatment is of paramount importance for treating severe psoriasis. Brodalumab, a monoclonal antibody against interleukin (IL) 17 receptor A, was granted marketing authorisation in the EU in 2017. The European Medicines Agency requested a postauthorisation safety study of brodalumab to address potential safety issues raised during drug development regarding major adverse cardiovascular events, suicidal conduct, cancer and serious infections. METHODS AND ANALYSIS: BRodalumab Assessment of Hazards: A Multinational Safety is a multicentre observational safety study of brodalumab running from 2017 to 2029 using population-based healthcare databases from Denmark, Sweden, Norway, Netherlands, Germany and three different centres in Italy. A distributed database network approach is used, such that only aggregate data are exchanged between sites.Two types of designs are used: a case-time-control design to study acute effects of transient treatment and a variation of the new user active comparator design to study the effects of transient or chronic treatment. As comparators, inhibitors of TNF-α, inhibitors of IL-12 and IL-23, and other inhibitors of cytokine IL-17A are included.In the self-controlled case-time-control design, the risk of developing the outcome of interest during periods of brodalumab use is compared within individuals to the risk in periods without use.In the active comparator cohort design, new users of brodalumab are identified and matched to new users of active comparators. Potential baseline confounders are adjusted for by using propensity score modelling. For outcomes that potentially require large cumulative exposure, an adapted active comparator design has been developed. ETHICS AND DISSEMINATION: The study is approved by relevant authorities in Denmark, Norway, Sweden, the Netherlands, Germany and Italy in line with the relevant legislation at each site. Data confidentiality is secured by the distributed network approach. Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: EUPAS30280.
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Anticorpos Monoclonais Humanizados , Psoríase , Humanos , Anticorpos Monoclonais Humanizados/efeitos adversos , Anticorpos Monoclonais Humanizados/uso terapêutico , Psoríase/tratamento farmacológico , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
BACKGROUND: The use of a new medication (e.g., potassium supplementation) for managing a drug-induced adverse event (e.g., loop diuretic-induced hypokalemia) constitutes a prescribing cascade. However, loop diuretics are often stopped while potassium may be unnecessarily continued (i.e., relic). We aimed to quantify the occurrence of relics using older adults previously experiencing a loop diuretic-potassium prescribing cascade as an example. METHODS: We conducted a prescription sequence symmetry analysis using the population-based Medicare Fee-For-Service data (2011-2018) and partitioned the 150 days following potassium initiation by day to assess the daily treatment scenarios (i.e., loop diuretics alone, potassium alone, combination of loop diuretics and potassium, or neither). We calculated the proportion of patients developing the relic, proportion of person-days under potassium alone, the daily probability of the relic, and the proportion of patients filling potassium after loop diuretic discontinuation. We also identified the risk factors of the relic. RESULTS: We identified 284,369 loop diuretic initiators who were 8 times more likely to receive potassium supplementation simultaneously or after (i.e., the prescribing cascade), rather than before, loop diuretic initiation (aSR 8.0, 95% CI 7.9-8.2). Among the 66,451 loop diuretic initiators who subsequently (≤30 days) initiated potassium, 20,445 (30.8%) patients remained on potassium after loop diuretic discontinuation, and 9365 (14.1%) patients subsequently filled another potassium supplementation. Following loop diuretic initiation, 4.0% of person-days were for potassium alone, and daily probability of the relic was the highest after day 90 of loop diuretic initiation (5.6%). Older age, female sex, higher diuretic daily dose, and greater baseline comorbidities were risk factors for the relic, while patients having the same prescriber or pharmacy involved in the use of both medications were less likely to experience the relic. CONCLUSIONS: Our findings suggest the need for clinicians to be aware of the potential of relic to avoid unnecessary drug use.
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Potássio , Inibidores de Simportadores de Cloreto de Sódio e Potássio , Humanos , Feminino , Idoso , Estados Unidos , Inibidores de Simportadores de Cloreto de Sódio e Potássio/efeitos adversos , Medicare , Diuréticos/efeitos adversos , Suplementos NutricionaisRESUMO
AIMS: To assess the gabapentinoid-oedema-loop diuretic prescribing cascade in adults using large administrative health care databases from the USA and Denmark. METHODS: This study used a sequence symmetry analysis to assess loop diuretic initiation before and after the initiation of gabapentinoids among patients aged 20 years or older without heart failure or chronic kidney disease. Data from MarketScan Commercial and Medicare Supplemental Claims databases (2005 to 2019) and Danish National Prescription Register (2005 to 2018) were analyzed. Use of loop diuretics associated with initiation of selective norepinephrine reuptake inhibitors (SNRI) was used as a negative control. We assessed the pooled temporality of loop diuretic initiation relative to gabapentinoid or SNRI initiation across the 2 countries. Secular trend-adjusted sequence ratios (aSRs) with 95% confidence intervals (CIs) were calculated using data from 90 days before and after initiation of gabapentinoids. Pooled ratio of aSRs were calculated by comparing gabapentinoids to SNRIs. RESULTS: Among the 1 511 493 gabapentinoid initiators (Denmark [n = 338 941]; USA [n = 1 172 552]), 20 139 patients had a new loop diuretic prescription 90 days before or after gabapentinoid initiation, resulting in a pooled aSR of 1.33 (95% CI 1.06-1.67). The pooled aSR for the negative control (i.e., SNRI) was 0.84 (95% CI 0.75-0.94), which resulted in a pooled ratio of aSRs of 1.58 (95% CI 1.23-2.04). Pooled estimated incidence of the gabapentinoid-loop diuretic prescribing cascade was 8.14 (95% CI, 1.92-34.49) events per 1000 patient-years. CONCLUSION: We identified evidence of the gabapentinoid-oedema-loop diuretic prescribing cascade in 2 countries.
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Inibidores da Recaptação de Serotonina e Norepinefrina , Inibidores de Simportadores de Cloreto de Sódio e Potássio , Humanos , Adulto , Estados Unidos/epidemiologia , Inibidores de Simportadores de Cloreto de Sódio e Potássio/efeitos adversos , Medicare , Edema , Dinamarca/epidemiologia , Diuréticos/efeitos adversosRESUMO
BACKGROUND: Hypertension is a leading cause of morbidity in Ghana. However, there is insufficient data on the prevalence and quality of antihypertensive therapy. OBJECTIVES: To describe the prevalence of use and quality of antihypertensive therapy. METHODS: A cross-sectional study design was used to analyze the 2015 Ghana National Health Insurance Scheme (NHIS) electronic claims data. Hypertension diagnosis was defined using ICD-10 codes. The primary outcomes assessed were the prevalence of use and quality of antihypertensive therapy. Quality of antihypertensive therapy was defined as the use of antihypertensive agents recommended for treating hypertension patients with comorbid heart failure, myocardial Infarction/Coronary Artery Disease, diabetes, chronic kidney disease or stroke. We used multivariable logistic regression models to identify predictors of antihypertensive use and quality of therapy. RESULTS: Antihypertensive medication use was very high (86%) among the 161 873 hypertension patients covered under the Ghana NHIS. Only a third (32%) of hypertension patients received guideline-concordant therapy. Angiotensin receptor blockers were consumed at the highest dosages of 120 (Interquartile Range [IQR]: 60, 180) daily defined doses over a year. Males (odds ratio [OR] = 0.60; 95% Confidence Interval [CI]:0.58, 0.61) and those with comorbid stroke (OR = 0.91, 95% CI:0.84, 0.99), diabetes (OR = 0.72; 95% CI:0.69, 0.74) and stroke (OR = 0.74, 95%CI:0.68, 0.80) were less likely to use antihypertensives, all other predictors were associated with higher use. CONCLUSION: Antihypertensive medication use was very high among hypertension patients covered under the Ghana NHIS. However, there was indication of suboptimal quality of the antihypertensive therapy provided.
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Anti-Hipertensivos , Hipertensão , Anti-Hipertensivos/uso terapêutico , Estudos Transversais , Gana/epidemiologia , Humanos , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Seguro Saúde , Masculino , Programas Nacionais de Saúde , PrevalênciaRESUMO
PURPOSE: Validating cases of acute liver injury (ALI) in health care data sources is challenging. Previous validation studies reported low positive predictive values (PPVs). METHODS: Case validation was undertaken in a study conducted from 2009 to 2014 assessing the risk of ALI in antidepressants users in databases in Spain (EpiChron and SIDIAP) and the Danish National Health Registers. Three ALI definitions were evaluated: primary (specific hospital discharge codes), secondary (specific and nonspecific hospital discharge codes), and tertiary (specific and nonspecific hospital and outpatient codes). The validation included review of patient profiles (EpiChron and SIDIAP) and of clinical data from medical records (EpiChron and Denmark). ALI cases were confirmed when liver enzyme values met a definition by an international working group. RESULTS: Overall PPVs (95% CIs) for the study ALI definitions were, for the primary ALI definition, 84% (60%-97%) (EpiChron), 60% (26%-88%) (SIDIAP), and 74% (60%-85%) (Denmark); for the secondary ALI definition, 65% (45%-81%) (EpiChron), 40% (19%-64%) (SIDIAP), and 70% (64%-77%) (Denmark); and for the tertiary ALI definition, 25% (18%-34%) (EpiChron), 8% (7%-9%) (SIDIAP), and 47% (42%-52%) (Denmark). The overall PPVs were higher for specific than for nonspecific codes and for hospital discharge than for outpatient codes. The nonspecific code "unspecified jaundice" had high PPVs in Denmark. CONCLUSIONS: PPVs obtained apply to patients using antidepressants without preexisting liver disease or ALI risk factors. To maximize validity, studies on ALI should prioritize hospital specific discharge codes and should include hospital codes for unspecified jaundice. Case validation is required when ALI outpatient cases are considered.
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Doença Hepática Induzida por Substâncias e Drogas/epidemiologia , Bases de Dados Factuais , Grupos Diagnósticos Relacionados/normas , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença Hepática Induzida por Substâncias e Drogas/diagnóstico , Dinamarca/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Farmacoepidemiologia , Reprodutibilidade dos Testes , Espanha/epidemiologia , Adulto JovemRESUMO
Register-based administrative data comprise the backbone of pharmacoepidemiological research. However, information from these registers lacks biochemical details. The aim of our study was to describe the creation, coverage and content of the Funen Laboratory Cohort (FLaC). FLaC is a database comprising all inhabitants of Funen, Denmark, who in the study period of January 2000 to December 2015 had their creatinine levels measured. Data were linked to the Danish nationwide registers with information on vital status, redeemed prescriptions, discharge diagnoses, and socio-economic status. A total of 693 843 individuals lived on Funen during the study period, and we included 460 365 (66.4%) individuals with a creatinine measurement. In total, 7 742 124 creatinine measurements were performed during the study period. The coverage increased with increasing age, reaching 90%-100% of all 65-90 + year-olds in 2015. We found that an overall coverage of individuals recorded in FLaC with at least one creatinine measured redeeming prescriptions from public pharmacies was 83% (interquartile range [IQR] 75%-89%) compared to the entire Funen population. In total, 94.1% of all individuals with a discharge diagnosis of chronic kidney disease (CKD) were covered in FLaC, but only 16.5% (n = 3136) of all individuals with a laboratory-confirmed CKD also had a discharge diagnosis of CKD. We described the creation and content of the FLaC - a haven and a valuable resource for pharmacoepidemiological research using Danish nationwide administrative registers enriched with individual-level biochemical information in a population-based setting.
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Creatinina/sangue , Insuficiência Renal Crônica/sangue , Insuficiência Renal Crônica/induzido quimicamente , Adolescente , Adulto , Idoso , Estudos de Coortes , Bases de Dados Factuais , Dinamarca/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/sangue , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Farmacoepidemiologia , Insuficiência Renal Crônica/epidemiologia , Adulto JovemRESUMO
BACKGROUND: There are inadequate data on prescribed drug utilization in Sub-Saharan Africa (SSA). Drug utilization research (DUR) in this region is hampered by lack of access to databases that capture prescribed drug utilization such as health insurance claims, electronic medical records and disease registries. The primary objective of this MiniReview was to describe the content of the NHIS claims database in the context of the health care system in Ghana. We will also review the possibilities and limitations of analysing this novel database for drug utilization research (DUR) in Ghana. METHODS: We reviewed the history, composition of the database, coverage and health systems in Ghana. To demonstrate the application of the NHIS claims database for DUR, we reviewed the NHIS' drug formulary (NHIS medicines' list), assessed and quantified the utilization of the top 25 most commonly prescribed medicines and their distributions by age, sex, region of residence and by MDCs. RESULTS: As of December 2014, about 40% (~10.5 million) of the Ghanaian population were active beneficiaries of NHIS. There were 1.43 million unique patients in the NHIS claims database who received services from about 81 providers located in 9 out of the 10 regions in Ghana. The mean age of this sample of beneficiaries was 31 (standard deviation, 22) years, a third of whom were aged <18 years old. Nearly, 2 out of every 3 beneficiaries were females. On average, there were approximately 3 outpatient visits per beneficiary in 2015. There were about 522 unique drugs on the NHIS medicine list. Overall, analgesic was the most prescribed class of medicine (mostly paracetamol and diclofenac). Antimalarials, artemether-lumefantrine, were observed as the second most prescribed medicines followed by anti-infectives (metronidazole) and antihypertensives (amlodipine). CONCLUSION: The Ghana NHIS claims database is a great resource for DUR. This database could also be extended to facilitate pharmacoepidemiological and other health services' research especially if transformed into one of the existing standardized common data models.
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Bases de Dados Factuais/estatística & dados numéricos , Revisão de Uso de Medicamentos/métodos , Revisão da Utilização de Seguros/estatística & dados numéricos , Programas Nacionais de Saúde/estatística & dados numéricos , Prescrições de Medicamentos/estatística & dados numéricos , Revisão de Uso de Medicamentos/estatística & dados numéricos , Gana , HumanosRESUMO
AIM: To quantify the contribution of changes in different risk factors population levels and treatment uptake on the decline in CHD mortality in Denmark from 1991 to 2007 in different socioeconomic groups. DESIGN: We used IMPACTSEC, a previously validated policy model using data from different population registries. PARTICIPANTS: All adults aged 25-84 years living in Denmark in 1991 and 2007. MAIN OUTCOME MEASURE: Deaths prevented or postponed (DPP). RESULTS: There were approximately 11,000 fewer CHD deaths in Denmark in 2007 than would be expected if the 1991 mortality rates had persisted. Higher mortality rates were observed in the lowest socioeconomic quintile. The highest absolute reduction in CHD mortality was seen in this group but the highest relative reduction was in the most affluent socioeconomic quintile. Overall, the IMPACTSEC model explained nearly two thirds of the decline in. Improved treatments accounted for approximately 25% with the least relative mortality reduction in the most deprived quintile. Risk factor improvements accounted for approximately 40% of the mortality decrease with similar gains across all socio-economic groups. The 36% gap in explaining all DPPs may reflect inaccurate data or risk factors not quantified in the current model. CONCLUSIONS: According to the IMPACTSEC model, the largest contribution to the CHD mortality decline in Denmark from 1991 to 2007 was from improvements in risk factors, with similar gains across all socio-economic groups. However, we found a clear socioeconomic trend for the treatment contribution favouring the most affluent groups.
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Doença das Coronárias/mortalidade , Classe Social , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença das Coronárias/epidemiologia , Doença das Coronárias/história , Dinamarca/epidemiologia , Feminino , História do Século XX , História do Século XXI , Humanos , Masculino , Pessoa de Meia-Idade , Vigilância em Saúde Pública , Fatores de Risco , Fatores SocioeconômicosRESUMO
Phthalates are known endocrine disruptors. Not commonly recognized, phthalates are used as excipients in a number of drug formulations. We aimed to describe the sale of phthalate-containing drugs in Denmark from 2004 to 2015. National data on annual sale of medications (tablets only) were accessed from medstat.dk. Data from the Danish Medicines Agency on phthalate content per tablet were merged with data on total sale for each active substance and drug formulation. We used the 'defined daily dose' (DDD) as the unit of sale and calculated the total amount of phthalate (mg) dispensed per 1000 inhabitants. Specific tablet content was compared with the maximum daily exposure limits defined by regulatory agencies for diethyl phthalate (DEP) and dibutyl phthalate (DBP) of 4.0 and 0.01 mg/kg/day, respectively. Use of phthalate-containing drugs in Denmark was common. We found 154 drug products containing five different phthalates. Two low-molecular-weight phthalates and three high-molecular-weight phthalates were identified, with a total sale of 59.4 and 112 DDD per 1000 inhabitants per day during the study period, respectively. The highest amount of DBP was found in multi-enzymes (24.6-32.8 mg per DDD) and mesalazine (12.5-26.4 mg per DDD). Budesonide, lithium and bisacodyl also exceeded the DBP exposure limit of 0.01 mg/kg/day. Other drugs had high levels of DEP, although not exceeding the exposure limit. Sales of phthalate-containing drugs in Denmark from 2004 to 2015 were substantial, and phthalate exposure from several products exceeded the regulatory exposure limit introduced in 2014.
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Contaminação de Medicamentos , Disruptores Endócrinos/toxicidade , Exposição Ambiental/efeitos adversos , Excipientes/toxicidade , Ácidos Ftálicos/toxicidade , Plastificantes/toxicidade , Adulto , Bases de Dados Factuais , Dinamarca , Dibutilftalato/química , Dibutilftalato/toxicidade , Contaminação de Medicamentos/legislação & jurisprudência , Contaminação de Medicamentos/prevenção & controle , Disruptores Endócrinos/química , Excipientes/química , Humanos , Legislação de Medicamentos , Peso Molecular , Preparações Farmacêuticas/economia , Preparações Farmacêuticas/normas , Ácidos Ftálicos/química , Plastificantes/química , ComprimidosAssuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Monitoramento de Medicamentos/métodos , Prescrições de Medicamentos/estatística & dados numéricos , Farmacoepidemiologia , Sistema de Registros , Dinamarca , Humanos , Medicamentos sob Prescrição , Sistema de Registros/normas , PesquisaRESUMO
The Danish Society of Clinical Pharmacology was founded in 1976, and mainly thanks to the persistent efforts of the society, clinical pharmacology became an independent medical speciality in Denmark in 1996. Since then, clinical pharmacology has gone from strength to strength. In the Danish healthcare system, clinical pharmacology has established itself as an indispensible part of the efforts to promote the rational, safe and economic use of drugs. Clinical pharmacologists are active in drug committees both in hospitals and in the primary sector. All clinical pharmacology centres offer a local medicines information service. Some centres have established an adverse drug effect manager function. Only one centre offers a therapeutic drug monitoring service. Clinical pharmacologists are responsible for the toxicological advice at the Danish Poison Information Centre at Bispebjerg University Hospital in the Capital Region. The Department of Clinical Pharmacology at Aarhus University Hospital works closely together with forensic toxicologists and pathologists, covering issues regarding illicit substances, forensic pharmacology, post-mortem toxicology, expert testimony and research. Therapeutic geriatric and psychiatric teach-inns for specialist and junior doctors are among the newest initiatives organized by clinical pharmacologists. Clinical pharmacologists work also in the Danish Medicines Agency and in the Danish pharmaceutical industry, and the latter has in particular a great growth potential for creating new jobs and career opportunities for clinical pharmacologists. As of July 2016, the Danish Society of Clinical Pharmacology has 175 members, and 70 of these are specialists in clinical pharmacology corresponding to approximately 2.5 specialists per 1000 doctors (Denmark has in total 28,000 doctors) or approximately 12 specialists per one million inhabitants.
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Farmacologia Clínica/história , Sociedades Científicas/história , Especialização/história , Mobilidade Ocupacional , Dinamarca , Indústria Farmacêutica , Monitoramento de Medicamentos , Controle de Medicamentos e Entorpecentes , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/terapia , Toxicologia Forense/educação , Toxicologia Forense/história , Toxicologia Forense/tendências , História do Século XX , História do Século XXI , Humanos , Serviços de Informação , Agências Internacionais , Internacionalidade , Farmacologia Clínica/educação , Farmacologia Clínica/tendências , Sociedades Científicas/tendências , Especialização/tendências , Recursos HumanosRESUMO
BACKGROUND: The significant increase in the average life expectancy has increased the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease. DESIGN: Population-based randomized clinically controlled screening trial. PARTICIPANTS: 45,000 Danish men aged 65-74 years living on the Island of Funen, or in the surrounding communities of Vejle and Silkeborg. No exclusion criteria are used. INTERVENTIONS: One-third will be invited to cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive findings. OBJECTIVE: To investigate whether advanced cardiovascular screening will prevent death and cardiovascular events, and whether the possible health benefits are cost effective. OUTCOME: Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome). RANDOMIZATION: Each of the 45,000 individuals is, by EPIDATA, given a random number from 1-100. Those numbered 67+ will be offered screening; the others will act as a control group. BLINDING: Only those randomized to the screening will be invited to the examination;the remaining participants will not. Numbers randomized: A total of 45,000 men will be randomized 1:2. Recruitment: Enrollment started October 2014. OUTCOME: A 5% reduction in overall mortality (HR=0.95), with the risk for a type 1 error=5% and the risk for a type II error=80%, is expected. We expect a 2-year enrollment, a 10-year follow-up, and a median survival of 15 years among the controls. The attendance to screening is assumed to be 70%. DISCUSSION: The primary aim of this so far stand-alone population-based, randomized trial will be to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic/iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for CVD in men aged 65-74. Attendance rate and compliance to initiated preventive actions must be expected to become of major importance. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN12157806 (21 March 2015).
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Doenças Cardiovasculares/diagnóstico , Serviços Preventivos de Saúde , Fatores Etários , Idoso , Algoritmos , Índice Tornozelo-Braço , Biomarcadores/sangue , Análise Química do Sangue , Glicemia/análise , Pressão Sanguínea , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Colesterol/sangue , Protocolos Clínicos , Angiografia Coronária , Análise Custo-Benefício , Dinamarca/epidemiologia , Custos de Cuidados de Saúde , Frequência Cardíaca , Humanos , Masculino , Programas de Rastreamento/economia , Programas de Rastreamento/métodos , Valor Preditivo dos Testes , Serviços Preventivos de Saúde/economia , Serviços Preventivos de Saúde/métodos , Prognóstico , Sistema de Registros , Projetos de Pesquisa , Medição de Risco , Fatores de Risco , Fatores Sexuais , Telemetria , Fatores de Tempo , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: While Denmark is well known for its plethora of registers. Many studies are conducted on research databases that only cover parts of Denmark, and regional differences could potentially threaten these studies' external validity. The aim of this study was to assess sociodemographic and health related homogeneity of the five Danish regions. METHODS: We obtained descriptive data for the five Danish regions, using publicly available data sources: Statbank Denmark, the Danish Ministry of Economic Affairs, and Medstat.dk. These data sources comprise aggregate data from four different nationwide registers: The Danish National Patient Register, The Danish Civil Registration System, The Danish Register of Medicinal Product Statistics, and The Danish National Health Service Register for Primary Care. We compared the Danish regions regarding demographic and socioeconomic characteristics, health care utilization, and use of medication. For each characteristic, one-year prevalence was obtained and analyses were performed for 2013 and 2008 to account for possible change over time. RESULTS: In 2013, 5,602,628 persons were living in Denmark. The mean age was 40.7 years in the entire Danish population and ranged between 39.6 to 42.4 years in the five regions (coefficient of variation between regions [CV] = 0.028). The proportion of women in Denmark was 50.4% (CV = 0.009). The proportion of residents with low education level was 28.7% (CV = 0.051). The annual number of GP contacts was 7.1 (range: 6.7-7.4, CV = 0.040), and 114 per 1,000 residents were admitted to the hospital (range: 101-131, CV = 0.107). The annual number of persons redeeming a prescription of any medication was 723 per 1,000 residents (range: 718-743, CV = 0.016). Analyses for 2008 showed comparable levels of homogeneity as for 2013. CONCLUSIONS: We found substantial homogeneity between all of the five Danish regions with regard to sociodemographic and health related characteristics. Epidemiologic studies conducted on regional subsets of Danish citizens have a high degree of generalizability.
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Serviços de Saúde/estatística & dados numéricos , Programas Nacionais de Saúde , Aceitação pelo Paciente de Cuidados de Saúde , Atenção Primária à Saúde , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Estudos Transversais , Dinamarca , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Prescrições , Sistema de Registros , Fatores Socioeconômicos , Adulto JovemRESUMO
PURPOSE: We present a database of prescription drugs and international normalized ratio (INR) data and the applied methodology for its use to assess drug-drug interactions with vitamin K antagonists (VKAs). We use the putative interaction between VKAs and tramadol as a case study. METHODS: We used a self-controlled case series to estimate the incidence rate ratio (IRR) comparing the rate of INR measurements of ≥4.0 in concomitant tramadol and VKA-exposed periods to VKA-only-exposed periods. Secondary analyses considered specific subgroups, alternative exposure criteria, alternative outcome definitions, and other drugs. RESULTS: We identified 513 VKA users with at least 1 INR measurement ≥4.0 and concomitant tramadol and VKA exposure during the observation period. The overall IRR was 1.80 (95% confidence interval [CI], 1.53-2.10), with a stronger association among users of phenprocoumon compared to warfarin (IRR, 3.37; 95%CI, 2.50-4.53 and IRR, 1.46; 95%CI, 1.20-1.76, respectively). We observed larger IRRs with stricter outcome definitions. Concomitant tramadol and VKA exposure was also associated with an increased rate of low INR measurements (i.e., <1.5; IRR, 1.70; 95%CI, 1.37-2.13). Morphine and, to some extent, oxycodone, penicillin, beta-blockers, and inhaled beta-agonists were associated with high INR. CONCLUSIONS: The approach successfully identified an interaction between tramadol and VKA. However, associations observed for other drugs with no known VKA interaction suggest that the current approach may have too low specificity to be useful as a screening tool, at least for drugs for which time-varying confounding may be present.
Assuntos
Analgésicos Opioides/farmacologia , Anticoagulantes/farmacologia , Coeficiente Internacional Normatizado , Medicamentos sob Prescrição/farmacologia , Vitamina K/antagonistas & inibidores , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares , Codeína/farmacologia , Dinamarca , Interações Medicamentosas , Feminino , Humanos , Revisão da Utilização de Seguros , Masculino , Farmacoepidemiologia , Femprocumona/farmacologia , Fatores Sexuais , Tramadol/farmacologia , Varfarina/farmacologiaRESUMO
PURPOSE: This study aims to investigate the possible association between patients' concerns about their medicine and generic switch. METHODS: Cross-sectional survey was carried out comprising responses from 2217 randomly selected persons aged 20 years or older and living in the Region of Southern Denmark, who had redeemed generically substitutable drugs in September 2008. For each patient, we focused on the purchase of one generically substitutable drug (index drug). We applied the specific concerns subscale from the Beliefs about Medicine Questionnaire (BMQ) to analyse lack of confidence in treatment. We also included general beliefs about medicine (BMQ), views on generic medicine and confidence in the health-care system. The information about the patients' generic switch was obtained from a prescription database and not provided by the patients. Data were analysed using linear regression. RESULTS: No statistically significant associations were found between concerns about the index medicine and the generic switch (-0.02 95% CI: -0.10; 0.05). Viewing medicines as harmful in general was associated with increased concerns (BMQ general harm: 0.39 95% CI: 0.30; 0.47 and BMQ general overuse: 0.28 95% CI: 0.20; 0.35). Patients having high confidence in the health-care system showed less concern (-0.16 95% CI: -0.27; -0.06). CONCLUSION: This study showed that for all three drug categories investigated, the patients who experienced a generic switch did not have more concerns about their index medicine than patients who did not switch.
Assuntos
Substituição de Medicamentos/psicologia , Medicamentos Genéricos/uso terapêutico , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Conhecimento do Paciente sobre a Medicação/estatística & dados numéricos , Adulto , Idoso , Estudos Transversais , Bases de Dados de Produtos Farmacêuticos , Dinamarca , Feminino , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Inquéritos e QuestionáriosRESUMO
AIM: This study had two aims: Firstly, to describe how prescriptions for proton pump inhibitor (PPI) in primary care were influenced by a change of the hospital drug policy, and secondly, to describe if a large discount on an expensive PPI (esomeprazole) to a hospital would influence prescribing patterns after discharge. METHODS: This register study was conducted at Odense University Hospital, Denmark, and by use of pharmacy dispensing data and a hospital-based pharmacoepidemiological database, the medication regimens of patients were followed across hospitalisation. The influence of hospital drug policy on prescribings in primary care was measured by the likelihood of having a high-cost PPI prescribed before and after change of drug policy. RESULTS: In total, 9,341 hospital stays in 2009 and 2010 were included. The probability of a patient to be prescribed an expensive PPI after discharge decreased from 33.5 to 9.4%, corresponding to a risk ratio of 0.28. In primary care after discharge, 13.4% of esomeprazole use was initiated in the hospital, and this was 8.4% for PPIs in general. After the change of hospital drug policy, this decreased to 6.5% for esomeprazole and increased for the recommended PPIs pantoprazole and lansoprazole to 14.6 and 26.1%, respectively. The effect of a large discount on expensive PPI to hospital was 14.7%, and this decreased to 2.6% when coordinating drug policy in hospital and primary care. CONCLUSION: The likelihood of having an expensive PPI prescribed after hospital stay decreased when coordinating drug policy and the influence of a large discount to hospital could be minimised.
Assuntos
Formulários de Hospitais como Assunto , Hospitais Universitários/tendências , Padrões de Prática Médica/tendências , Atenção Primária à Saúde/tendências , Inibidores da Bomba de Prótons/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Redução de Custos , Dinamarca , Custos de Medicamentos , Prescrições de Medicamentos , Revisão de Uso de Medicamentos , Feminino , Custos Hospitalares , Hospitais Universitários/economia , Hospitais Universitários/organização & administração , Humanos , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Formulação de Políticas , Padrões de Prática Médica/economia , Atenção Primária à Saúde/economia , Inibidores da Bomba de Prótons/economia , Sistema de RegistrosRESUMO
BACKGROUND: Comprehensive geriatric assessment of hospitalised patients implies optimising patients' medical treatment, and good coordination between hospital and general practice is essential for the quality of the drug treatment. Only a few studies have investigated the continuation of patients' medication from primary care to hospital and back again to primary care. OBJECTIVES: To describe changes of drug therapy during hospital stay in a geriatric ward and the following acceptance of these changes in primary cares after discharge. METHODS: An observational register study following 1,550 geriatric patients' pharmacological treatment longitudinally across hospital stay, by linkage of a primary care prescription database and hospital medical records. The medication regimens for the individual patients were compared at three cross sections: primary care before hospitalisation, during hospital stay and primary care after hospitalisation, analysed according to drug therapy, co-morbidity, functionality and outpatient follow-up. RESULTS: Patients were using an average of 8.2 drugs before hospital admission, of which an average of 0.9 drugs per patient was discontinued or switched during hospitalisation. An average of 1.7 new drugs per patient was initiated by the hospital physicians. After discharge, 63.9 % of the changes initiated by hospital physicians were continued in primary care. Of new drugs initiated in hospital 42.7 % were accepted in primary care. CONCLUSIONS: A relatively small proportion of drugs was switched or discontinued and the average number of drugs increased during hospital stay. Of these changes, two thirds were accepted in primary care after discharge and less than half of newly initiated drugs were continued in primary.
Assuntos
Uso de Medicamentos/estatística & dados numéricos , Avaliação Geriátrica , Hospitalização/estatística & dados numéricos , Alta do Paciente/estatística & dados numéricos , Atenção Primária à Saúde/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Dinamarca , Tratamento Farmacológico/estatística & dados numéricos , Feminino , Hospitais Universitários , Humanos , MasculinoRESUMO
PURPOSE: To investigate adherence rates to hospital drug formularies (HDFs) and cost of drugs in hospitals. METHODS: Data on drugs used during 2010 were analyzed for ten hospitals (two hospitals from each of the five regions), constituting 30 % of hospitals and 45 % of hospital beds in Denmark. Drug use data from individual hospitals were retrieved from the hospital pharmacies. Adherence to the HDFs was analyzed for selected substances characterised by extensive use both in primary and secondary sectors (ATC codes A10, B03, C03, C07, C08, C09, C10, J01, N02, N05 and R03). Within each group, we also identified the drugs constituting 90 % of the volume (= DU90%) and the adherence to the HDF in this segment (Index of Adherence). RESULTS: Substances used by hospitals varied between 598 and 1,093. The proportion of used substances that were on the HDF varied between 14 % and 44 %. University hospitals used a significantly higher total number of substances (median 165 vs. 139, p = 0.019) and cost/DDD [(median 5 vs. 2 Euros, p = 0.033), p = 0.033] in the DU90% segment than the regional hospitals. Index of adherence varied between 43 % and 91 %. For the selected ATC codes, the index of adherence was between 76 % and 100 %. CONCLUSIONS: Adherence to the selected ATC groups was high, which means that the most commonly used substances are included in the HDFs, even though a variation existed. A large variation existed between the hospitals in the number of substances at HDFs.
Assuntos
Custos de Medicamentos , Uso de Medicamentos/estatística & dados numéricos , Formulários de Hospitais como Assunto/normas , Fidelidade a Diretrizes , Farmacopeias como Assunto/normas , Estudos Transversais , Dinamarca , Uso de Medicamentos/economiaRESUMO
The majority of pharmacoepidemiological data resources are based on data generated in primary health care. Although inpatient data resources have existed since the 1960s, inpatient pharmacoepidemiological studies are relatively scarce. The objectives of this MiniReview were to describe pharmacoepidemiological studies in hospital settings and the underlying databases to provide an overview of research questions addressed by such databases. The studies were retrieved by chain searching. We included pharmacoepidemiological studies in hospital settings containing data on inpatient drug use. Twelve inpatient databases in Asia, the United States and Europe were found. Most databases were automatically collected from claims data or generated from electronic medical records. The contents of the databases varied as well as the potential for linkage with other data sources such as laboratory and outpatient data. Twenty studies were selected and discussed to illustrate the diversity of inpatient pharmacoepidemiological studies. Hospital-based databases had mainly been used for drug utilization studies and research in adverse drug reactions. Five studies within comparative effectiveness were found. The number of pharmacoepidemiological studies in inpatient settings was low compared with studies from primary healthcare settings. These resources may be under-utilized.