Exploratory analysis of requests for authorization to dispense high-cost medication to COPD patients: the São Paulo "protocol".

OBJECTIVE: A resolution passed by the government of the Brazilian state of São Paulo established a protocol for requesting free COPD medications, including tiotropium bromide, creating regional authorization centers to evaluate and approve such requests, given the high cost of those medications. Our objective was to analyze the requests received by an authorization center that serves cities in the greater metropolitan area of (the city of) São Paulo between 2011 and 2016. METHODS: Data regarding the authorization, return, or rejection of the requests were compiled and analyzed in order to explain those outcomes. Subsequently, the clinical and functional data related to the patients were evaluated. RESULTS: A total of 7,762 requests for dispensing COPD medication were analyzed. Requests related to male patients predominated. Among the corresponding patients, the mean age was 66 years, 12% were smokers, 88% had frequent exacerbations, and 84% had severe/very severe dyspnea. The mean FEV1 was 37.2% of the predicted value. The total number of requests decreased by 24.5% from 2012 to 2013 and was lowest in 2015. Most (65%) of the requests were accepted. The main reasons for the rejection/return of a request were a post-bronchodilator FEV1/FVC ratio > 0.7, a post-bronchodilator FEV1 > 50% of the predicted value, and failure to provide information regarding previous use of a long-acting ß2 agonist. During the study period, the total number of requests returned/rejected decreased slightly, and there was improvement in the quality of the data included on the forms. CONCLUSIONS: Here, we have identified the characteristics of the requests for COPD medications and of the corresponding patients per region served by the authorization center analyzed, thus contributing to the improvement of local public health care measures.

Frequency of comorbidities in chronic obstructive pulmonary disease, and impact on all-cause mortality: A population-based cohort study.

BACKGROUND: In chronic obstructive pulmonary disease (COPD), the role of specific comorbidities on all-cause mortality is of major interest particularly with a database representative of the beneficiaries covered by the French health system. We investigated the frequency and the role of major comorbidities on all-cause mortality in a population-based cohort of COPD patients, and whether this impact was modulated by gender. METHODS: A historical cohort was identified in the French claims data. Patients aged ≥45 years were selected in 2006 from the French national claims data (1/97(th) random sample) by at least one of the following criteria: (a) COPD-related hospitalisations, (b) long-term disease status for COPD, (c) dispensations of bronchodilators. Cardiovascular diseases, diabetes, depression and cancer were defined by specific therapy and/or long-term disease status. The impact of comorbidities on mortality was investigated during a seven-year follow-up period (2007-2013), using Cox models. RESULTS: In 4,237 patients (mean age 68 years, 55% males, mean annual death-rate 4.9%), cardiovascular diseases, diabetes, depression and cancers were identified in 68.7%, 15.2%, 14.2% and 10.6% of patients, respectively. Associations with mortality were significant for cardiovascular diseases (HR = 1.2, 95%CI = [1.0-1.4]), diabetes (HR = 1.2, 95%CI = [1.0-1.4]), depression (HR = 1.4, 95%CI = [1.2-1.6]) and cancers (HR = 1.6, 95%CI = [1.4-1.9]), with no difference between genders. CONCLUSIONS: In the French population, major comorbidities are common in COPD, particularly cardiovascular diseases that occur in over two thirds of patients. The impact of comorbidities on mortality was not related to their prevalence, with cancer having the largest impact.

Epinephrine Policies and Protocols Guidance for Schools: Equipping School Nurses to Save Lives.

In response to limited direction given by legislative bodies to school nurses about how to implement state-mandated or recommended stock epinephrine programs in their schools, NASN convened a workgroup of invested stakeholders. This workgroup was challenged to equip school nurses with the necessary tools to develop policies and protocols regarding stock epinephrine in their school districts. The dynamic workgroup subcommittees focused on policies, procedures, and reporting tools. This article reviews the results of the subcommittees' work and the overall collaboration within the workgroup. This article provides clear, nationally recognized guidance on the best practice for establishing stock epinephrine policies and protocols with reporting tools at the local school district level.

Improvement of the Prediction of Drugs Demand Using Spatial Data Mining Tools.

The continued availability of products at any store is the major issue in order to provide good customer service. If the store is a drugstore this matter reaches a greater importance, as out of stock of a drug when there is high demand causes problems and tensions in the healthcare system. There are numerous studies of the impact this issue has on patients. The lack of any drug in a pharmacy in certain seasons is very common, especially when some external factors proliferate favoring the occurrence of certain diseases. This study focuses on a particular drug consumed in the city of Jaen, southern Andalucia, Spain. Our goal is to determine in advance the Salbutamol demand. Advanced data mining techniques have been used with spatial variables. These last have a key role to generate an effective model. In this research we have used the attributes that are associated with Salbutamol demand and it has been generated a very accurate prediction model of 5.78% of mean absolute error. This is a very encouraging data considering that the consumption of this drug in Jaen varies 500% from one period to another.

Continuing to confront COPD International Surveys: comparison of patient and physician perceptions about COPD risk and management.

PURPOSE: Using data from the Continuing to Confront COPD International Physician and Patient Surveys, this paper describes physicians' attitudes and beliefs regarding chronic obstructive pulmonary disease (COPD) prognosis, and compares physician and patient perceptions with respect to COPD. METHODS: In 12 countries worldwide, 4,343 patients with COPD were identified through systematic screening of population samples, and 1,307 physicians who regularly saw patients with COPD were sampled from in-country professional databases. Both patients and physicians completed surveys about their COPD knowledge, beliefs, and perceptions; physicians answered further questions about diagnostic methods and treatment choices for COPD. RESULTS: Most physicians (79%) responded that the long-term health outlook for patients with COPD has improved over the past decade, largely attributed to the introduction of better medications. However, patient access to medication remains an issue in many countries, and some physicians (39%) and patients (46%) agreed/strongly agreed with the statement "there are no truly effective treatments for COPD". There was strong concordance between physicians and patients regarding COPD management practices, including the use of spirometry (86% of physicians and 76% of patients reporting they used/had undergone a spirometry test) and smoking cessation counseling (76% of physicians reported they counseled their smoking patients at every clinic visit, and 71% of smoking patients stated that they had received counseling in the past year). However, the groups differed in their perception about the role of smoking in COPD, with 78% of physicians versus 38% of patients strongly agreeing with the statement "smoking is the cause of most cases of COPD". CONCLUSION: The Continuing to Confront COPD International Surveys demonstrate that while physicians and patients largely agreed about COPD management practices and the need for more effective treatments for COPD, a gap exists about the causal role of smoking in COPD.

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

OBJECTIVE: To perform a critical comparison between the Brazilian national essential medicines list (Rename, 2012) with the list of essential medicines for children (LEMC, 2011) of the World Health Organization (WHO), regarding the differences among drugs and formulations listed for children. METHODS: The LEMC drugs were classified into four categories: 1) absent in Rename; 2) included in Rename but without any formulation suitable for children; 3) listed in Rename only in some formulations; 4) present in Rename in all formulations. The missing formulations were analyzed by therapeutic group. Alternatives present in Rename were searched. RESULTS: From the 261 drugs of interest on the LEMC, 30.3% are absent from Rename, 11.1% are in Rename but without any pediatric formulation, and 32.2% are present in some but not all formulations listed in LEMC. Considering all formulations items listed in the LEMC (n = 577), 349 are missing from Rename, of these 19.6% due to their strength, and 18.5% due to the the dosage form. Useful formulations specific for neonatal care, respiratory tract, central nervous system, and anti-infectives, among other groups, are missing. CONCLUSION: The lack of age-appropriate formulations of essential medicines for children in Brazil includes important therapeutic groups and indispensable drugs for severe clinical conditions. Some of these products exist in the Brazilian pharmaceutical market, but not in public facilities; others could be produced by national laboratories with commercial interest or stimulated by a specific governmental policy, as in other countries.

Uma comparação crítica entre a Lista de Medicamentos Essenciais para Crianças da Organização Mundial de Saúde e a Relação Nacional de Medicamentos Essenciais (Rename) / A critical comparison between the World Health Organization list of essential medicines for children and the Brazilian list of essential medicines (Rename)

OBJECTIVE: To perform a critical comparison between the Brazilian national essential medicines list (Rename, 2012) with the list of essential medicines for children (LEMC, 2011) of the World Health Organization (WHO), regarding the differences among drugs and formulations listed for children. METHODS: The LEMC drugs were classified into four categories: 1) absent in Rename; 2) included in Rename but without any formulation suitable for children; 3) listed in Rename only in some formulations; 4) present in Rename in all formulations. The missing formulations were analyzed by therapeutic group. Alternatives present in Rename were searched. RESULTS: From the 261 drugs of interest on the LEMC, 30.3% are absent from Rename, 11.1% are in Rename but without any pediatric formulation, and 32.2% are present in some but not all formulations listed in LEMC. Considering all formulations items listed in the LEMC (n = 577), 349 are missing from Rename, of these 19.6% due to their strength, and 18.5% due to the the dosage form. Useful formulations specific for neonatal care, respiratory tract, central nervous system, and anti-infectives, among other groups, are missing. CONCLUSIONS: The lack of age-appropriate formulations of essential medicines for children in Brazil includes important therapeutic groups and indispensable drugs for severe clinical conditions. Some of these products exist in the Brazilian pharmaceutical market, but not in public facilities; others could be produced by national laboratories with commercial interest or stimulated by a specific governmental policy, as in other countries.

OBJETIVO: Realizar uma comparação crítica entre a Relação Nacional de Medicamentos Essenciais (Rename, 2012) e a Lista de Medicamentos Essenciais para Crianças (LMEC, 2011) da Organização Mundial de Saúde (OMS), com relação às diferenças entre os medicamentos e as formulações listadas para crianças. MÉTODOS: Os medicamentos da LMEC foram classificados em quatro grupos: 1) não constam na Rename; 2) constam na Rename, porém sem qualquer formulação adequada para crianças; 3) listados na Rename apenas com algumas formulações; 4) constam na Rename em todas as formulações. As formulações que faltam foram analisadas por grupos terapêuticos. As alternativas presentes na Rename foram pesquisadas. RESULTADOS: Dos 261 medicamentos de interesse listados na LMEC, 30,3% não estão presentes na Rename, 11,1% estão na Rename, mas sem qualquer formulação pediátrica, e 32,3% estão presentes em algumas, mas não todas as formulações listadas na LMEC. Considerando todos os itens de formulações listados na LMEC (n = 577), 349 não constam na Rename, desses, 19,6% devido à intensidade de dosagem, e 18,5% devido à forma farmacêutica. Faltam formulações úteis específicas para cuidado neonatal, trato respiratório e sistema nervoso central, anti-infecciosos, entre outros grupos. CONCLUSÃO: A ausência de formulações adequadas à idade de medicamentos essenciais para crianças no Brasil inclui importantes grupos terapêuticos e medicamentos indispensáveis para quadros clínicos graves. Alguns desses produtos são encontrados no mercado farmacêutico brasileiro, porém não existem em unidades públicas; outros poderiam ser produzidos por laboratórios nacionais com interesse comercial ou estimulados por uma política governamental específica, como é feito em outros países.

Anaphylaxis. How often patients carry epinephrine in real life?

BACKGROUND: Epinephrine is an important life-saving treatment in patients with anaphylaxis. OBJECTIVE: To evaluate how many patients with a history of anaphylaxis, carry epinephrine with them during medical consultation. MATERIAL AND METHODS: A prospective study was done in the Allergy Unit of the University of Antioquia (Medellin, Colombia), we recruited patients, of all ages, from August 2012 to June 2013, who were referred with suspected anaphylactic reaction for the last 18 months, and were asked about carrying epinephrine with them. RESULTS: Among 120 patients with a history of anaphylaxis, only 69 (57.5%) had epinephrine in their house or office, and 33 (27.5%) carried it in the medical consultation after 6 months of being prescribed. CONCLUSIONS: Most patients with a history of anaphylaxis do not carry epinephrine with them all the time, and it is necessary to advise the patients, to improve their compliance to treatment.

ANTECEDENTES: la epinefrina es un tratamiento importante en los pacientes con anafilaxia. OBJETIVO: evaluar cuántos pacientes con antecedentes de anafilaxia portaban la epinefrina durante la consulta médica. MATERIAL Y MÉTODOS: estudio observacional efectuado en la Unidad de Alergología de la Universidad de Antioquia, Medellín, Colombia, entre agosto de 2012 y junio de 2013. Preguntamos a los pacientes con antecedente de reacción anafiláctica en los últimos 18 meses si portaban, o tenían en su casa, epinefrina para autoaplicación en caso de sufrir anafilaxia. RESULTADOS: de 120 pacientes con antecedente de anafilaxia, sólo 69 (57.5%) tenían adrenalina en la casa o en el lugar de trabajo, y 33 (27.5%) portaban la adrenalina durante la consulta, luego de seis meses de haber sido prescrita. CONCLUSIONES: la mayoría de los pacientes con antecedente de anafilaxia no portan epinefrina para autoinyección, y consideramos necesario mejorar el apego al tratamiento en este grupo de pacientes.

Preparedness for students and staff with anaphylaxis.

BACKGROUND: Schools are responsible for handling life-threatening events due to a variety of conditions, including anaphylaxis. California is one of a few states that permits school districts to stock emergency epinephrine auto-injectors and to train unlicensed assistive personnel to administer epinephrine for a life-threatening event. We surveyed school nurses in California to explore their experience with life-threatening anaphylaxis, implementation of allowable stock epinephrine auto-injector programs, and the barriers to program implementation. METHODS: An exploratory, cross-sectional, descriptive design was used for this study. Data was obtained from a convenience sample of 171 credentialed California school nurses via an online survey service. Descriptive statistics and Pearson's chi-square were used to analyze the data. RESULTS: Thirty percent of school nurses reported using 1 student's prescribed medication to rescue another student in distress. Despite the frequency of using another student's rescue medication and California's permissive policy, only 13% of nurses reported having stock epinephrine programs. Barriers to stock epinephrine programs included: (a) limited availability of school nursing services, (b) lack of policies or guidelines, (c) inadequate funding for training and medication, and (d) lack of education. Limited awareness of susceptibility and the immediate life-threatening nature of anaphylaxis were also contributing factors. CONCLUSIONS: Legislative initiatives are sufficient to develop safe, effective policies and protocols to manage life-threatening allergic reaction in schools. The findings indicate that more education is needed for school personnel and research is needed to determine an effective mechanism to remove barriers for emergency care during school hours.

Evaluation of diagnostic criteria for severe asthma described in a public health directive regulating the free distribution of medications for the maintenance treatment of asthma.

OBJECTIVE: To evaluate the capacity of the criteria described in Complementary Directive SAS/MS 12, issued on November 12, 2002, to identify patients with severe asthma, describing and comparing clinical, functional and treatment data of such patients. METHODS: This was a nested case-control study using a structured database for adult asthma outpatients. We defined cases as asthma patients who met the inclusion criteria described in the directive, defining controls as those who did not. We collected and compared data related to the following: demographic characteristics; history of asthma; medications in use; comorbidities; history of tobacco use; number of exacerbations within the last 12 months, asthma-related hospitalizations and intensive care unit admissions within the last 12 months; spirometry; and sputum cytology. RESULTS: The case and control groups consisted of 29 and 31 patients, respectively. The number of asthma exacerbations and emergence room visits within the last 12 months, as well as the number of patients that received at least one pulse of oral corticosteroids, was significantly higher in the case group than in the control group. In addition, prebronchodilator FVC was lower among the cases than among the controls. Furthermore, cytology revealed that eosinophil counts were significantly higher in the induced sputum of cases than in that of controls. CONCLUSIONS: The criteria described in the directive are suited to stratifying patients with severe asthma.

Avaliação dos descritores de asma grave em pacientes incluídos na portaria de saúde pública que regulamenta a distribuição gratuita de medicamentos para o tratamento de manutenção da asma / Evaluation of diagnostic criteria for severe asthma described in a public health directive regulating the free distribution of medications for the maintenance treatment of asthma

OBJETIVO: Avaliar a capacidade dos critérios descritos na Portaria Complementar SAS/MS nº12, de 12 de novembro de 2002, em identificar pacientes asmáticos graves, bem como descrever e comparar dados clínicos, funcionais e de tratamento destes pacientes. MÉTODOS: Estudo caso-controle aninhado em um banco de dados estruturado de atendimento ambulatorial de asmáticos. Foram considerados casos os pacientes asmáticos que preencheram os critérios de inclusão determinados na portaria e considerados controles os que não preencheram os mesmos critérios. Foram coletados e comparados dados demográficos; história pregressa da asma; medicamentos em uso; presença de comorbidades; história de tabagismo; presença, no último ano, de exacerbações, de hospitalizações e de admissões em unidades de terapia intensiva devido à asma; e resultados de espirometria e de citologia de escarro. RESULTADOS: Foram incluídos 29 e 31 pacientes, respectivamente, nos grupos caso e controle. O grupo caso apresentou maior número de exacerbações e maior número de visitas ao pronto-socorro no último ano, maior porcentagem de pacientes que receberam pelo menos um pulso de corticosteroide oral, assim como menores valores de CVF pré-broncodilatador em relação ao grupo controle. O grupo caso também apresentou um aumento significante de eosinófilos na citologia do escarro induzido. CONCLUSÕES: Os critérios de inclusão descritos na portaria são adequados para estratificar pacientes com asma grave.

OBJECTIVE: To evaluate the capacity of the criteria described in Complementary Directive SAS/MS 12, issued on November 12, 2002, to identify patients with severe asthma, describing and comparing clinical, functional and treatment data of such patients. METHODS: This was a nested case-control study using a structured database for adult asthma outpatients. We defined cases as asthma patients who met the inclusion criteria described in the directive, defining controls as those who did not. We collected and compared data related to the following: demographic characteristics; history of asthma; medications in use; comorbidities; history of tobacco use; number of exacerbations within the last 12 months, asthma-related hospitalizations and intensive care unit admissions within the last 12 months; spirometry; and sputum cytology. RESULTS: The case and control groups consisted of 29 and 31 patients, respectively. The number of asthma exacerbations and emergence room visits within the last 12 months, as well as the number of patients that received at least one pulse of oral corticosteroids, was significantly higher in the case group than in the control group. In addition, prebronchodilator FVC was lower among the cases than among the controls. Furthermore, cytology revealed that eosinophil counts were significantly higher in the induced sputum of cases than in that of controls. CONCLUSIONS: The criteria described in the directive are suited to stratifying patients with severe asthma.

Severe persistent pulmonary hypertension of the newborn in a setting where limited resources exclude the use of inhaled nitric oxide: successful treatment with sildenafil.

UNLABELLED: We present the case of a full term neonate with severe persistent pulmonary hypertension of the newborn (PPHN) after birth asphyxia cared for at the St. Elizabeth Hospital in Curacao, Netherlands Antilles. Although the child was ventilated with high pressures and was given high doses of cardiovascular pressors, the arterial oxygen levels remained low with an alveolar-arterial O2 gradient of 651 mmHg. As a last resort, sildenafil (1.5 mg/kg) was given via a nasogastric tube. This resulted in an immediate and sustained elevation of arterial oxygenation and subsequent complete recovery. After administration of sildenafil there was a transient hypotension which was corrected by a single bolus of saline. CONCLUSION: We discuss the current treatment modalities of persistent pulmonary hypertension of the newborn and the potential use of phosphodiesterase 5 inhibitors such as sildenafil in a situation where the standard of practice with inhaled nitric oxide and extracorporeal membrane oxygenation is not available.

Inner-city availability of preservative-containing albuterol.

Benzalkonium chloride (BAC) added to nebulized albuterol may induce bronchospasm. The objective of this study was to determine the availability of BAC-containing nebulized albuterol in the Bronx, New York pharmacies. A cross-sectional telephone survey of pharmacies was conducted. Overall, 158 (80%) pharmacies participated in the survey; 133 (84%) carried BAC-containing albuterol; 25 (16%) dispensed BAC-containing albuterol solution when presented with a prescription written for generic albuterol. Only 14 (9%) pharmacists had seen a prescription for nebulized albuterol where a physician specified "without BAC." Despite availability of BAC-free albuterol, pharmacies in the Bronx still carried and dispensed BAC-containing product.

Generic substitution: issues for problematic drugs.

The methodology and criteria for bioequivalence testing have been firmly established by the Food and Drug Administration (FDA). For certain drugs with a narrow therapeutic index (e.g., digoxin, levothyroxine, warfarin), generic substitution may not be advisable or even allowable, depending on the substitution laws of individual states. Digoxin and levothyroxine tablets are examples of drugs for which no New Drug Applications (NDAs) currently exist. However, commercially available generic products for both of these drugs have not been determined by the FDA to be therapeutically equivalent to the innovator products. Generic versions of warfarin have been approved by the FDA as being therapeutically equivalent to the innovator products, as have generic versions of the rescue inhaler albuterol. Yet, misinformation and myths persist regarding the adequacy and proven reliability of the FDA's determination of bioequivalence for these products.