Review of purchases of unapproved medications by the Veterans Health Administration.

PURPOSE: Many medications that were marketed prior to 1962 but lack Food and Drug Administration (FDA) approval are prescribed in the United States. Usage patterns of these "unapproved medications" are poorly elucidated, which is concerning due to potential lack of data on safety and efficacy. The purpose of this project was to characterize purchases of unapproved medications within the Veterans Health Administration (VHA) by type, frequency, and cost. METHODS: VHA purchasing databases were used to create a list of all products with National Drug Codes (NDCs) purchased nationwide in fiscal year 2016 (FY16). This list was compared to FDA databases to identify unapproved prescription medications. For each identified combination of active pharmaceutical ingredient (API) and route of administration ("API/route combination"), numbers of packages purchased and associated costs were added. RESULTS: VHA pharmacy purchasing records contained 3,299 unapproved products with NDCs in FY16. After excluding equipment, nutrition products, compounding ingredients, nonmedication products, and duplicate NDCs, there were 600 unique NDCs associated with 130 distinct API/route combinations. The most commonly acquired product was prescription sodium fluoride dental paste (350,775 packages). The greatest pharmaceutical expenditure was for sodium hyaluronate injection ($24.5 million). Unapproved products accounted for less than 1% of overall VHA pharmacy purchasing in FY16. CONCLUSION: VHA purchased many unapproved prescription products in FY16 but is taking action to address use of such products in consideration of safety and efficacy data and available alternatives.

[Surveillance of antibiotic agents according to § 23 of the German Infection Protection Act-data and results from hospitals in Frankfurt am Main, Germany, 2012-2017]. / Antibiotika-Verbrauchs-Surveillance nach § 23 Infektionsschutzgesetz ­ Daten und Erfahrungen aus den Krankenhäusern in Frankfurt am Main, 2012­2017.

BACKGROUND: Since 2011, German hospitals have been requested to record and evaluate antibiotic use in their institution. In this publication, the use of antibiotics in hospitals belonging to the administrative district Frankfurt/Main between 2012 and 2017 is presented and discussed with regards to the targets set in 2014. These targets are to improve the perioperative prophylaxis, reduce the use of cefuroxime, and increase the penicillin/cephalosporin ratio. METHODS: Since 2012, hospitals in Frankfurt/Main have been transmitting the defined daily doses (DDD) of all antibiotics used, the absolute number of patients, and their days of treatment. Since 2013, the data have also distinguished between intensive care and other units. The Frankfurt health authority calculated the total number of antibiotics and the DDD/100 patient days for all hospitals combined as well as for every hospital compared to each other. RESULTS: From 2012 to 2017, the number of absolute annual patient days increased from 1,592,161 to 1,615,180. Antibiotic use decreased from 1,073,975 DDD to 953,349 DDD, leading to a decrease from 67.5 DDD per 100 patient days to 59.0 DDD per 100 patient days. Cefuroxime was the most frequently used antibiotic in all hospitals. The use of cefuroxime showed a significant decrease between 2012 and 2017 (from 250,398 in 2012 to 165,160 DDD in 2017, a decrease of 34%). The use of ceftriaxone was reduced by 27%, ciprofloxacin by 9%, and levofloxacin by 16%. DISCUSSION: The targets set in 2014 were reached in the entirety of Frankfurt hospitals. However, there were significant differences between the hospitals taking part. The results were given as feedback to the hospitals in order to support their efforts in further improving antibiotic stewardship.

[Antibiotic consumption surveillance - state of implementation in Munich hospitals : Latest survey by the Munich public health department on the implementation of § 23 Infection protection act]. / Antibiotika-Verbrauchs-Surveillance und Antibiotic Stewardship ­ Stand der Umsetzung in Münchner Kliniken : Aktuelle Abfrage des Gesundheitsamtes München zur Umsetzung des § 23 des Infektionsschutzgesetzes (IfSG).

BACKGROUND: On 4 August 2011 a modification of the infection protection act became law, meaning that antibiotic consumption surveillance and evaluation of data on the local resistance situation became obligatory for hospitals. Four years after the modification of the infection protection act became law, the Munich public health department aimed to evaluate the state of implementation of antibiotic consumption surveillance in Munich hospitals and to ascertain which antibiotic stewardship (ABS) structures have already been established. METHODS: A questionnaire was sent to Munich hospitals about their antibiotic management structural data and state of implementation of legal requirements. RESULTS: Only 32 % of the hospitals have qualified ABS-experts available. In 76 % of the hospitals persons responsible for antibiotic consumption surveillance are appointed, while in 12 % persons responsible for antibiotic consumption surveillance are at least partly released from their normal work for this activity. Twenty-one hospitals (21 %) conduct antibiotic consumption surveillance taking into account all antiinfective agents mentioned in the Robert Koch-Institute (RKI) guidelines. Of these, 19 (76 %) did this on basis of World Health Organizations ATC/DDD-system (anatomical therapeutic chemical [ATC] classification system which uses defined daily doses [DDD]). The data on antibiotic consumption is evaluated in 72 % of the hospitals, 68 % take account of the local resistance situation. In 96 %, in-house lists of antiinfectives are available; in 80 %, in-house guidelines for antibiotic treatment are available. Fourty-four percent of the hospitals take part in a national surveillance. CONCLUSIONS: For the first time data were collected on implementation of antibiotic consumption surveillance in hospitals, which has been required by law since 2011. An incomplete implementation of legal requirements was demonstrated. It was found that structural and personnel prerequisites are often missing, that release from normal work for this additional duty is rarely granted and that the evaluation of data is often either missing or does not correspond to the legal requirements by omitting to take account of the local resistance situation. The hygienic control of hospitals by the public health service was extended by an additional subject. To carry out this very specialized task in a competent way, an ABS-qualification for public health staff is essential from the perspective of the authors.

Comentarios a la segunda versión en castellano de los criterios STOPP-START. Réplica / Comments on the second Spanish version of the STOPP-START criteria: reply

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Sequence analysis of the 5′ third of glycoprotein C gene of South American bovine herpesviruses 1 and 5

Bovine herpesviruses 1 (BoHV-1) and 5 (BoHV-5) share high genetic and antigenic similarities, but exhibit marked differences in tissue tropism and neurovirulence. The amino-terminal region of glycoprotein C (gC), which is markedly different in each of the viruses, is involved in virus binding to cellular receptors and in interactions with the immune system. This study investigated the genetic and antigenic differences of the 5′ region of the gC (5′ gC) gene (amino-terminal) of South American BoHV-1 (n=19) and BoHV-5 (n=25) isolates. Sequence alignments of 374 nucleotides (104 amino acids) revealed mean similarity levels of 97.3 and 94.2% among BoHV-1 gC (gC1), respectively, 96.8 and 95.6% among BoHV-5 gC (gC5), and 62 and 53.3% between gC1 and gC5. Differences included the absence of 40 amino acid residues (27 encompassing predicted linear epitopes) scattered throughout 5′ gC1 compared to 5′ gC5. Virus neutralizing assays testing BoHV-1 and BoHV-5 antisera against each isolate revealed a high degree of cross-neutralization between the viruses, yet some isolates were neutralized at very low titers by heterologous sera, and a few BoHV-5 isolates reacted weakly with either sera. The virus neutralization differences observed within the same viral species, and more pronounced between BoHV-1 and BoHV-5, likely reflect sequence differences in neutralizing epitopes. These results demonstrate that the 5′ gC region is well conserved within each viral species but is divergent between BoHV-1 and BoHV-5, likely contributing to their biological and antigenic differences.

Efecto del Real Decreto-Ley 16/2012 sobre el consumo de fármacos excluidos de la financiación pública en Navarra / Effect of Royal Decree-Law 16/2012 on consumption of drugs excluded from public coverage in Navarre (Spain)

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A comprehensive approach to address the prescription opioid epidemic in Washington State: milestones and lessons learned.

An epidemic of morbidity and mortality has swept across the United States related to the use of prescription opioids for chronic noncancer pain. More than 100,000 people have died from unintentional overdose, making this one of the worst manmade epidemics in history. Much of health care delivery in the United States is regulated at the state level; therefore, both the cause and much of the cure for the opioid epidemic will come from state action. We detail the strong collaborations across executive health care agencies, and between those public agencies and practicing leaders in the pain field that have led to a substantial reversal of the epidemic in Washington State.

Policy statement on antimicrobial stewardship by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society (PIDS).

Antimicrobial resistance has emerged as a significant healthcare quality and patient safety issue in the twenty-first century that, combined with a rapidly dwindling antimicrobial armamentarium, has resulted in a critical threat to the public health of the United States. Antimicrobial stewardship programs optimize antimicrobial use to achieve the best clinical outcomes while minimizing adverse events and limiting selective pressures that drive the emergence of resistance and may also reduce excessive costs attributable to suboptimal antimicrobial use. Therefore, antimicrobial stewardship must be a fiduciary responsibility for all healthcare institutions across the continuum of care. This position statement of the Society for Healthcare Epidemiology of America, the Infectious Diseases Society of America, and the Pediatric Infectious Diseases Society of America outlines recommendations for the mandatory implementation of antimicrobial stewardship throughout health care, suggests process and outcome measures to monitor these interventions, and addresses deficiencies in education and research in this field as well as the lack of accurate data on antimicrobial use in the United States.

The impact of federal warnings on publically funded desmopressin utilization among children in Ontario.

OBJECTIVE: To determine whether safety warnings issued by health regulatory agencies regarding desmopressin treatment influenced treatment rates among children. PATIENT POPULATION AND METHODS: We conducted a time-series analysis using health administrative data from Ontario, Canada, between January 1, 2003 and March 31, 2010. We examined desmopressin prescribing rates among children (<13 years) and investigated the impact of a United States Food and Drug Administration warning (December 2007) and a subsequent Health Canada warning (July 2008) on these rates. A secondary analysis stratified rates according to route of administration. RESULTS: On average, quarterly desmopressin treatment rates were 29.8% lower following the two warnings (4.7 per 1000 population) compared with the period prior to warnings being issued (6.7 per 1000 population). Structural break analyses identified a significant decrease in overall desmopressin prescribing rates in Q3 2008, with the 95% confidence interval (CI) spanning both safety warnings (Q4 2007 to Q1 2009). A secondary analysis of prescribing rates for oral formulations found consistent results (structural break Q4 2008, 95% CI Q2 2007 to Q2 2009). The average quarterly prescribing rate of intranasal formulations declined by 73.1% following the warnings compared with the period preceding the warnings. CONCLUSION: Safety warnings issued by regulatory agencies dramatically influenced desmopressin use among Ontario's children.

Generic drug approval: a US perspective.

OBJECTIVE: Generic drugs are identical or bioequivalent versions of the brand name drugs. They are the economic alternative of the costlier brand name drugs. This article presents a general overview of the procedure and regulatory aspects relating to generic drug approval in the US. METHODS: A computerized search was conducted to find literature on generic drug approval in the US. The literature was searched using the following key words: generic drug, brand name drug, Hatch-Waxman Act, Medicare Act, NDA, ANDA, CTD and exclusivity. FINDINGS: The search results were filtered for the literature describing and analyzing the procedure and regulatory provisions for generic drug approval in the US. After the screening total 19 applicable literature remained. CONCLUSION: In the US standardized procedures for the recognition of generic drugs have been laid down under the Drug Price Competition and Patent Term Restoration Act, 1984 (the Hatch-Waxman Act). Provisions of this Act such as patent challenge, patent term extension and data exclusivity have created profound effects on the approval, sale and distribution of the pharmaceuticals in the US. The Hatch-Waxman Act is an excellent piece of legislation that takes care of the rights of both the brand name and generic drug companies. This article presents only an overview of generic drug approvals and for all practical purposes official resources should be referred.

La tenencia de estupefacientes en el ámbito intra familiar: (análisis dogmático jurídico sobre su penalización) / The possession of drugs in the field intra-family: (analysis legal dogmatic about his penalty)

Con el presente trabajo pretendemos desentrañar si, en los supuestos de delitos de tenencia de estupefacientes para consumo personal, la existencia de intereses jurídicamente relevantes, cuyos titulares son personas distintatas al tenedro de la droga - en lo que hace a nuestra investigación nos refierimos a los menores de edad. importa un dato a tener en cuanta que permita justificar la penalización del delito de referencia y en su caso su agravamiento.

With this work we aim to unravel if, in cases of crimes of drug prossession for personal consumption, the existencie of legally relevant interests whose holders are persons other than the holder of the drug-in regard to our investigation we refer to the minor, matter a fact to keep in mind that justifies the punishment of the crime of reference and, if it accurs, its aggravation.

Assessment of changes in utilization of health-care services after implementation of a prior authorization policy for atypical antipsychotic agents.

BACKGROUND: In 2004, the Georgia Medicaid program implemented a prior authorization (PA) policy for certain atypical antipsychotic agents, resulting in an average savings of $2.7 million per year. OBJECTIVE: To determine whether implementation of a PA policy for atypical antipsychotic drugs increased health-care utilization in the Georgia Medicaid program from July 2003 to April 2006. METHODS: A single cohort observational study employing segmented regression and time series analysis was conducted to determine health-care services utilization, including emergency department (ED) visits, outpatient office visits, hospital admissions, and length of stay (LOS). Study subjects included continuously eligible adult Georgia Medicaid recipients with a schizophrenia-related diagnosis and documented use of an atypical antipsychotic medication (N = 12,120). Where applicable, analysis of a noncontinuously eligible population was also performed to investigate disenrollment bias in study results. RESULTS: A significant decline in post-policy trend for the average number of ED visits (absolute difference -0.042 per member per month (PMPM); relative difference -20.92%) and average number of hospital admissions PMPM (absolute difference -0.010 PMPM; relative difference -22.27%) was observed at the end of the study period. Baseline and pre-policy trends were found to be significant predictors for both endpoints. Significant models were not identified for average outpatient office visits PMPM or average LOS per admission. CONCLUSIONS: In contrast to other published studies on PA for atypical antipsychotics, patient outcomes improved after the initiation of the policy. To the extent that medical utilization reflects patient health outcomes and health status, the results of this study indicate that the PA program has potentially improved the health of schizophrenic patients in Georgia and lowered program costs.

Guidelines for medication therapy management services in long-term care facilities.

Included in the Medicare prescription drug benefit (Medicare Part D) was a provision that sponsors of Medicare Part D prescription drug plans (PDP) provide a medication therapy management (MTM) program for "targeted beneficiaries." Medicare beneficiaries who reside in long-term care facilities also are eligible for Medicare Part D and these MTM services. Long-term care facilities encompass skilled nursing facilities and any medical institution or nursing facility for which payment is made for institutionalized individuals under Medicaid, as defined in section 1902(q)(1)(B) of the Social Security Act, and other payer sources. The design and implementation of MTM services for Medicare beneficiaries who reside in long-term care facilities is complicated because of the Centers for Medicare and Medicaid Services' (CMS) requirement of medication regimen review (MRR) for nursing facility residents. MRR is a broader, yet similar, competing clinical requirement. Moreover, it is newly defined, recently updated, and expanded in Appendix PP of the State Operations Manual (SOM) under "Guidance to Surveyors of Long Term Care Facilities." Changes to Appendix PP were effective December 18, 2006. The American Society of Consultant Pharmacists (ASCP) considers MRR and MTM to be distinct processes even though they share common goals regarding quality, safety, and cost-effectiveness. This document differentiates MTM services from MRR services and establishes guidelines by which MTM can be performed in the long-term care setting.