Hospital pharmacist challenges in evaluation of scientific evidence and its incorporation to pharmacotherapeutic protocols through therapeutic committees in COVID-19 times.

Type 2 coronavirus pandemics that is plaguing almost all the world has caused  qualitative and quantitative strains in health systems that have had to be responded to. The lack of known vaccines and effective treatments has generated the need to  use drugs with very little evidence for their incorporation into pharmacotherapeutic  protocols agreed by the clinical team. The hospital pharmacist, within the  multidisciplinary team, has been responsible for critically evaluating the alternatives and positioning them in these protocols. Finally, some ethical and legal questions  that should be considered in this scenario are analyzed in this article.

La pandemia por coronavirus tipo 2 que está azotando prácticamente todo el mundo ha provocado en los sistemas sanitarios tensiones cualitativas y cuantitativas a las  que ha habido que dar respuesta. La inexistencia de vacunas y de tratamientos  eficaces conocidos ha generado la necesidad de utilizar fármacos con muy escasa  evidencia para su incorporación en protocolos farmacoterapéuticos consensuados  por el equipo clínico. El farmacéutico de hospital, dentro del equipo multidisciplinar,  ha sido en muchas ocasiones el responsable de evaluar críticamente las alternativas para su posicionamiento en estos protocolos. Se analizan en el presente artículo algunas cuestiones éticas y legales que deben ser consideradas en este  escenario.

Ifema hospital model. Implementation and start-up of the Pharmacy Department.

On the 20th of March 2020, triggered by the public health emergency declared,  the Health Authorities in Madrid reported a legal instruction (Orden 371/2020)  indicating the organization of a provisional hospital to admit patients with  COVID-19 at the Trade Fair Institution (IFEMA). Several pharmacists working in  the Pharmacy and Medical Devices Department of the Madrid Regional Health  Service were called to manage the Pharmacy Department of the  abovementioned hospital. Required permissions to set up a PD were here  authorized urgently. Tackling human and material resources, and computer  systems for drug purchase and electronic prescription, were some of the initial  issues that hindered the pharmaceutical provision required for patients from the  very day one. Once the purchase was assured, mainly by direct purchase from suppliers, drug dispensing up to 1,250 hospitalized patients (25 nursing units) and 8 ICU patients was taken on. Dispensing was carried out  through either drug stocks in the nursing units or individual patient dispensing  for certain drugs. Moreover, safety issues related to prescription were  considered, and as the electronic prescription was implemented we attained  100% prescriptions review and validation. The constitution of a multidisciplinary  Pharmacy and Therapeutics Committee let agree to a pharmacotherapy guide,  pres cription protocols, therapeutic equivalences, interactions, and drug  dispensing circuits. The Pharmacy Department strategy was to ensure a very  quick response to basic tasks keeping the aim to offer a pharmaceutical care of  the highest quality whenever possible. Working under a health emergency  situation, with many uncertainties and continuous pressure was a plight.  However, the spirit of collaboration in and out of the Pharmacy Department was  aligned with the whole hospital motivation to offer the highest quality of  healthcare. These were possibly the keys to allow caring for almost 4,000  patients during the 42 days that the hospital lasted.

El día 20 de marzo de 2020 la Consejería de Sanidad publicó una Orden  (371/2020) para la apertura de un centro hospitalario provisional para atender a  pacientes COVID-19 en la Institución Ferial de Madrid (IFEMA), por razón de  emergencia sanitaria. Se dispuso un equipo de farmacéuticos de la Subdirección  General de Farmacia y Productos Sanitarios para la apertura de un Servicio de  Farmacia, que obtuvo la autorización correspondiente por el órgano competente, con carácter de urgencia. La gestión de recursos humanos,  materiales y de herramientas informáticas para la adquisición y prescripción  electrónica fueron unas de las primeras dificultades que se solaparon con el  primer reto de garantizar la prestación farmacéutica a los pacientes que atendía  el hospital desde el mismo día uno. Asegurada la adquisición, fundamentalmente  mediante la compra directa a proveedores, se planteó la  dispensación para un máximo de 1.250 pacientes de hospitalización (25  controles de enfermería) y una Unidad de Cuidados Intensivos de 8 pacientes;  se establecieron botiquines en las unidades de enfermería y circuitos  individualizados de dispensación para determinados medicamentos. A su vez,  desde el primer momento se trabajó en la seguridad en la prescripción, llegando  a la revisión y validación del 100% de los tratamientos, una vez instaurada la  prescripción electrónica. La creación de una  Comisión de Farmacia y Terapéutica multidisciplinar permitió consensuar la guía farmacoterapéutica, protocolos de  prescripción, equivalencias terapéuticas, interacciones y circuitos de  dispensación de medicamentos. La estrategia del Servicio de Farmacia se basó  en asegurar una respuesta rápida en las funciones básicas, sin perder la visión  de incorporar una atención farmacéutica de la máxima calidad posible a medida  que iba siendo factible. A pesar de un escenario adverso, de incertidumbre y  presión continuas por la emergencia sanitaria, se ha mantenido un espíritu de  colaboración y contribución dentro y fuera del Servicio de Farmacia, alineado con un objetivo común de trabajo en equipo para brindar una atención sanitaria rápida y de la mayor calidad posible. Posiblemente éstas han sido las claves del  éxito que han permitido atender a casi 4.000 pacientes en los 42 días de vida  del hospital.

[Evolution of the legal and normative framework surrounding the practice of hospital pharmacy and the correct use of drugs in Quebec]. / Évolution du cadre juridique et normatif entourant l'exercice de la pharmacie hospitalière et le bon usage des médicaments au Québec.

OBJECTIVES: The objective was to identify the main texts applicable to the practice of pharmacy in Quebec, then count the specific number of recommendations and criteria and describe the evolution of the legal and normative framework. METHODS: This is a descriptive and retrospective study of the main texts applicable to the legal and normative framework for the practice of pharmacy on January 1st, 2019. RESULTS: A total of 107 texts relating to the practice of pharmacy in Quebec were identified. They come from the legislator (53.1 %), the Order of pharmacists (26.1 %) or other organizations (20.8 %). These were laws/regulations (n=59), contributing to the optimal use of drugs (n=18), relating to hospital pharmacy management (n=18), the provision of pharmaceutical care (n=11), drug preparation (n=3), oncology practice (n=2) or health and safety at work (n=1). Thirty-three texts were considered for enumeration of recommendations and explicit criteria, for a total of 235 recommendations and 3703 explicit criteria applicable to the practice of hospital pharmacy in Quebec. CONCLUSION: There is a significant increase in the number of texts, recommendations and criteria applicable to the practice of hospital pharmacy in Quebec. Compliance with this legal and normative framework appears to be a considerable challenge for hospital pharmacists. It seems worthwhile to further promote discussion with text-issuing agencies in order to keep the search for compliance realistic.

Implementation of hyperlinks to medication management policies and guidelines in the electronic health record.

PURPOSE: The implementation and maintenance of a process for adding and removing hyperlinks to medication management policies and guidelines approved by a pharmacy and therapeutics (P&T) committee into the electronic health record (EHR) are described. SUMMARY: Medication management policies and guidelines approved by the P&T committee are published on the University of Utah Health intranet, making it possible to add hyperlinks to this information within the EHR. Adding these hyperlinks allows policy and guideline information to be available to clinicians on the medication ordering, verification, and administration screens without requiring a separate search of the intranet. In a quality-improvement project, all medication management policies and guidelines posted on the intranet were reviewed for relevance to the medication ordering, verification, and administration processes. Hyperlinks to relevant policies and guidelines were implemented into the EHR for specific medications. At the beginning of the review, 100 unique drugs associated with 1 or more hyperlinks were identified. The hyperlinks referenced a total of 33 Web documents: 8 policies and 25 guidelines. There are 74 medication management policies and 78 medication management guidelines approved by the P&T committee at University of Utah Health. After investigator review, 12 of 74 policies (16%) and 41 of 78 guidelines (53%) were deemed relevant during the medication ordering, verification, and administration processes. The review and hyperlink implementation process took a total of 101 hours. A continual review process was developed to enable addition and removal of hyperlinks as appropriate. CONCLUSION: Providing direct access to relevant medication management policies and guidelines approved by the P&T committee during the medication ordering, verification, and administration processes via hyperlinks in the EHR makes formulary information readily accessible by appropriate staff. These hyperlinks may also improve adherence to formulary information, reduce medication expenditure, and improve safety and therapeutic outcomes of medication therapy.

Pharmacy Technicians Are People, Too! Let's Consider Their Personal Outcomes Along With Other Pharmacy Outcomes.

Studies have found that expanded pharmacy technician roles can help "free up" pharmacist time, leading to role optimization. However, these studies and the positions taken by many are quite pharmacist-centric. We seem to have underestimated the importance of support staff in pharmacy operations. If research demonstrates that technicians can perform a function safely and effectively, that alone should compel the function's allowance in practice. Freeing up pharmacist time for higher-order care is a positive corollary to technician advancement, but it need not be a precondition for it.

Additive Manufacturing with 3D Printing: Progress from Bench to Bedside.

Three-dimensional (3D) printing was discovered in the 1980s, and many industries have embraced it, but the pharmaceutical industry is slow or reluctant to adopt it. Spiritam® is the first and only 3D-printed drug product approved by FDA in 2015. Since then, the FDA has not approved any 3D-printed drug product due to technical and regulatory issues. The 3D printing process cannot compete with well-established and understood conventional processes for making solid dosage forms. However, pharmaceutical companies can utilize it where mass production is not required; rather, consistency, precision, and accuracy in quality are paramount. There are many 3D printing technologies available, and not all of them are amenable to pharmaceutical manufacturing. Each 3D technology has certain prerequisites in terms of material that it can handle. Some of the pertinent technical and regulatory issues are as follows: Current Good Manufacturing Practice, in-process tests and process control, and cleaning validation. Other promising area of 3D printing use is printing medications for patients with special needs in a hospital and/or pharmacy setting with minimum regulatory oversight. This technology provides a novel opportunity for in-hospital compounding of necessary medicines to support patient-specific medications. However, aspects of the manufacturing challenges and quality control considerations associated with the varying formulation and processing methods need to be fully understood before 3D printing can emerge as a therapeutic tool. With these points in mind, this review paper focuses on 3D technologies amenable for pharmaceutical manufacturing, excipient requirement, process understanding, and technical and regulatory challenges.

Impact of Antibiotic Policy on Antibiotic Consumption in a Neonatal Intensive Care Unit in India.

OBJECTIVE: To study the impact of initiating antibiotic policy on antibiotic consumption in a neonatal intensive care unit (NICU). METHODS: This retrospective study was conducted between January, 2013 and December, 2014 in a 30 bed NICU. The antibiotic policy for neonatal sepsis was initiated on January 1st, 2014. The overall antibiotic consumption (Daily Defined Dose [DDD] per 100 patient-days), one year before and one year after the initiation of antibiotic policy was evaluated using interrupted time-series analysis. RESULTS: There was no significant change (12.47 vs. 11.47 DDD/100 patient-days; P = 0.57) in overall antibiotic consumption. A significant increase in the proportion of patients on first-line agents (ampicillin and gentamicin) (66% (n=449) vs. 84% (n=491); P <0.001) and significant decrease in consumption of third generation cephalosporins (1.45 vs. 0.45 DDD/100 patient-days; P =0.002) was observed. CONCLUSION: Antibiotic policy increased the use of first-line agents and decreased the consumption of third generation cephalosporins.

On-label and off-label prescribing patterns of erythropoiesis-stimulating agents in inpatient hospital settings in the US during the period of major regulatory changes.

BACKGROUND: A number of policy and labeling interventions aimed at reducing inappropriate prescribing of erythropoiesis-stimulating agents (ESAs) were implemented in the U.S. between 2006 and 2010. These interventions included the addition of an FDA Black Box Warning to ESA labeling, the implementation of a Risk Evaluation and Mitigation Strategy program, and the adoption of payment restrictions by the Centers for Medicare and Medicaid Services (CMS). The impact of these safety interventions on different types of ESA prescribing (on-label, off-label; evidence-based, not evidence-based) has not been investigated in a single study. OBJECTIVES: The objective of this study was to explore the prescribing patterns of ESAs for on- and off-label indications in the U.S. hospital inpatients during the period of major policy and labeling changes. METHODS: A retrospective analysis of ESAs utilization patterns was conducted using Cerner Health Facts® database from January 1, 2005 to June 30, 2011. The study population consisted of adult patients admitted to hospitals during the study period who received at least one ESAs order. Indications for ESA use were assigned based on ICD-9 CM diagnosis codes, procedure codes, and medication records. ESA use was then classified based on FDA-approval and the strength of scientific evidence supporting its use. Indication categories included (1) on-label use (ONS); (2) off-label use, supported (OFS); and (3) off-label use, unsupported (OFU). Descriptive statistics were used to examine ESA use by patient, hospital, and physician characteristics and over time. RESULTS: ESAs were most frequently prescribed for ONS (48.7%), followed by OFU (42.7%) and OFS indications (8.6%). Of all off-label use, 83.2% were for unsupported indications. Between 2005 and 2010, the percent of inpatient visits with ESA use decreased for supported indications, both on-label (-63.2%) and off-label (-78.2%), but increased for unsupported indications (80%). OFU use surpassed ONS use as the most common type of ESA use in 2009. CONCLUSIONS: Total and ONS ESA use decreased markedly, while OFU ESA use continued to increase during the period of major policy and labeling changes.

Model of Current Practice Regarding Prescriptions of Controlled Substances and the Perceived Benefits of E-Prescribing in an Academic Medical Center.

To review current practices regarding prescribing controlled substances at an academic medical center and describe possible advantages of electronic prescribing of controlled substances (EPCS). A 10-question multiple choice survey was sent electronically to all house staff at an academic medical center. Aggregated data was analyzed for trends. 193 surveys (18.8 %) were completed. Of all respondents, 46.6 % were not able to write their own prescriptions. 70.0 % have used another provider's prescription pad to write prescriptions. 53.4 % have had prescriptions rejected or not filled by a pharmacy for being written incorrectly. 59.6 % kept a patient as an inpatient for a longer period of time due to the inability to obtain a prescription, costing an estimated $3.28 million per year. 58.0 % needed to have a patient return to the hospital to pick up prescriptions for an estimated 1583 return trips to the hospital yearly. 35.1 % had a patient return to the emergency department due to uncontrolled pain, estimated at $139,000 in yearly emergency department patient charges. The authors' survey highlights some of the financial, legal, efficiency, and satisfaction disadvantages due to the inability to use EPCS. Implementing EPCS and making it ubiquitous may limit some inefficiencies in academic hospital systems.

Obtaining i.v. fosfomycin through an expanded-access protocol.

PURPOSE: One hospital's experience with procuring i.v. fosfomycin via an expanded-access protocol to treat a panresistant infection is described. SUMMARY: In mid-2014, a patient at a tertiary care institution had an infection caused by a gram-negative pathogen expressing notable drug resistance. Once it was determined by the infectious diseases (ID) attending physician that i.v. fosfomycin was a possible treatment for this patient, the ID pharmacist began the process of drug procurement. The research and ID pharmacists completed an investigational new drug (IND) application, which required patient-specific details and contributions from the ID physician. After obtaining approval of the IND, an Internet search identified a product vendor in the United Kingdom, who was then contacted to begin the drug purchasing and acquisition processes. Authorization of the transaction required signatures from key senior hospital administrators, including the chief financial officer and the chief operating officer. Approximately 6 days after beginning the acquisition process, the research pharmacist arranged for the wholesaler to expedite product delivery. The ID pharmacist contacted the wholesaler's shipping company at the U.S. Customs Office, providing relevant contact information to ensure that any unexpected circumstances could be quickly addressed. The product arrived at the U.S. Customs Office 8 days after beginning the acquisition process and was held in the U.S. Customs Office for 2 days. The patient received the first dose of i.v. fosfomycin 13 days after starting the expanded-access protocol process. CONCLUSION: I.V. fosfomycin was successfully procured through an FDA expanded-access protocol by coordinating efforts among ID physicians, pharmacists, and hospital executives.

[The criminal liability of the hospital pharmacist vs the liability of the hospital]. / La responsabilità penale del farmacista ospedaliero vs la responsabilità dell'ente ospedaliero.

This study proposes an analysis of the boundaries of liability of the negligent hospital pharmacist, in relation with the liability of the hospital. The conditions of departure are: the knowledge that the pharmacist works within the limits of compliance programs adopted by the hospital; the finding that, in recent times, there has been an expansion in the objective sense of liability of the pharmacist. The laudable aim of protecting the patient is well accompanied by the violation of the principle of individual criminal liability (Art. 27 of the Constitution) and practical reason for discouraging the risky assets even useful. Through the analysis of the d. lgs. n. 231/2001 regarding the corporate liability for the crime and law n. 158/2012 regarding criminal liability limited to the gross negligence of the health care, it will arrive at the conclusion about the need to recognize a liability for the organization to hospitals, limiting the liability of the hospital pharmacist to cases of chargeability/criminal liability of negligent conduct.

Compounding practices in Iran.

This article has been presented by pharmacists of the Razi Hospital Pharmacy, which is located within the Dermatology Center of Tehran University of Medical Sciences in Tehran, Iran, and by members of the staff at the Tehran University of Medical Sciences. Discussed within this article are the legalization and regulation of pharmaceutical compounding in Iran, the restrictions on pharmaceutical compounding, the general equipment used in Iran pharmacies, beyond-use dating/expiration dating, the required pharmacy education, as well as information related specifically to Razi Hospital Pharmacy.