Introduction of Unit-Dose Care in the 1,125 Bed Teaching Hospital: Practical Experience and Time Saving on Wards.

Purpose: The shortage of nursing staff as well as the slow progress in the German health care system's digitalisation has gained much attention due to COVID-19. Patient-specific medication management using the unit-dose dispensing system (UDDS) has the potential for a lasting and positive influence on both digitalisation and the relief of nursing staff. Methods: Nursing staff UDDS-acceptance was determined via a validated online survey. For the evaluation of stock keeping on the wards, the delivery quantities were determined for a comparative period before and after the introduction of the UDDS. The time required for on-ward medication-related processes on ward before and after the introduction of UDDS was recorded based on a survey form and the nursing relief in full-time equivalent (FTE) was calculated using the data obtained. Results: We show that nurses appreciate the UDDS and confirm a significant reduction in drug stocks on the wards. The UDDS reduces the time needed to dispense medications from 4.52 ± 0.35 min to 1.67 ± 0.15 min/day/patient. In relation to the entire medication process, this corresponds to a reduction of 50% per day and per patient. Based on 40,000 patients/year and a supply of 1,125 beds with unit-dose blisters, 7.36 FTE nursing staff can be relieved per year. In contrast, 6.5 FTE in the hospital pharmacy are required for supplying the hospitals. Conclusion: UDDS is well accepted by nurses, reduces stock levels on ward, and fulfils criteria as a nursing-relief measure.

The Impact of Hospital Pharmacy Operation on the Quality of Patient Care.

This paper presents the role, tasks, and place of a hospital pharmacy in the structure of the entire facility. The role of hospital drug management and pharmacy seems to be extremely important in providing patients with high-quality care. Particular emphasis was placed on the distribution systems of medicinal products and medical devices in the hospital. The advantages and disadvantages of the classical distribution system and modern systems such as unit-dose and multi-dose-and the most important differences between them-are presented. Difficulties related to implementing modern distribution systems in hospitals were also discussed. The information provided is presented in the context of the legal regulations in Poland.

Automated unit dose dispensing systems producing individually packaged and labelled drugs for inpatients: a systematic review.

OBJECTIVES: Pharmacy automation is increasing in hospitals. The aim of this systematic review was to identify and evaluate the literature on automated unit dose dispensing systems (UDDS) producing individually packaged and labelled drugs for inpatients. METHODS: The search was conducted on eight electronic databases, including Scopus, Medline Ovid, and Cinahl, and limited to peer reviewed articles with English abstracts published 2000-2020. Studies were included in the review if drug dispensing was performed by an automated UDDS where individually packaged and labelled unit doses were subsequently assembled patient specifically for inpatients. All outcomes related to UDDS functionality were included with specific interest in medication safety, cost-efficiency and stock management. Outcomes were categorised and results synthesised qualitatively. RESULTS: 664 publications were screened, one article identified manually, resulting in eight included articles. Outcomes of the studies were categorised as medication administration errors (MAEs), dispensing errors, costs and cost-effectiveness. Studies showed that automated UDDS reduced significantly MAEs of inpatients compared with traditional ward stock system (WSS), especially when UDs were dispensed patient specifically by unit dose dispensing robot. Patient specific drug dispensing with automated UDDS was very accurate. Of three different automated medication systems (AMSs), patient specific AMS (psAMS) was the most cost-effective and complex AMS (cAMS) the most expensive system across all error types due to the higher additional investments and operation costs of automated dispensing cabinets (ADCs). None of the studies investigated the impact on the medication management process such as efficiency, costs and stock management as primary outcome. CONCLUSIONS: UDDS improved patient safety. However, automation is a costly investment and the implementation process is complex and time consuming. Further controlled studies are needed on the clinical and economical outcomes of automated UDDS to produce reliable knowledge for hospital decision makers on the cost-benefit of the investment and to support decision making.

Estimation of Topical Glaucoma Medication Over-Prescription and Its Associated Factors.

This study aims to report the disparity between the ideal and actual quantities of eyedrops prescribed to individual glaucoma patients. This retrospective observational study included 676 patients receiving treatment with antiglaucoma topical medication(s) in at least one eye. These patients had follow-up appointments scheduled at mean intervals of 3.4 ± 1.4 months and were actively using antiglaucoma medication. The mean age was 70.4 ± 11.9 years, with 372 (55%) being male. The over-prescription volume was 1.4 ± 1.7 bottles per month for each medication when prescribed for both eyes. Multiple regression analysis revealed that older age (p = 0.03), hyperopic refractive error (p < 0.0001), and the use of multiple medications (p = 0.03) were associated with a larger over-prescription volume, while the use of unit-dose medication only (p < 0.0001) was associated with a smaller over-prescription volume. Factors such as sex, Mini-Cog cognitive function score, best-corrected visual acuity, intraocular pressure, glaucoma type, and a history of cataract surgery were not significantly associated. This study revealed a significant over-prescription of eyedrops for glaucoma patients, with actual prescriptions often exceeding the theoretically ideal amount by 2.4 times, influenced by factors like age and the format of prescriptions, where unit-dose eyedrops show promise in reducing excess.

Construction and optimization of automatic checking mode for unit dose dispensing system of oral drugs / 中国药房

OBJECTIVE To provide a reference for establishing an automatic checking mode and improving the checking efficiency of the unit dose dispensing system of oral drugs in hospital. METHODS The automatic checking process reengineering team was established in our hospital. ECRSI method was adopted to sort out the verification process and mode of drug bags for the unit dose formula of our hospital through five principles of eliminating， combining， rearranging， simplifying and increasing， and the hardware series problem and the problem of excessive system false-positive proportion were optimized. The drug bags for the unit dose formula were randomly selected from 10 wards， the efficiency and external error rates of manual check and automatic checking mode before and after optimization were compared， and the false-positive reporting failure in automatic checking mode was also compared before and after optimization. RESULTS After the establishment of the automatic checking mode of the unit dose formula for oral drugs， the average checking time of drug bags was significantly shorter than that of manual checking mode in the other 8 wards except for cardiovascular and renal departments （P＜0.05）. After the optimization of the automatic checking mode， the average checking time of drug bags in all wards was significantly shorter than that in manual checking mode （P＜0.05）. Compared with before optimization of the automatic checking mode， the average checking time of drug bags was shortened by 0.43 s， and the average checking time of drug bags in half of the wards was shortened significantly （P＜0.05）. At the same time， the false-positive proportion decreased from 96.83% before optimization to 92.76% after optimization （P＜0.05）. The external error rate dropped from 0.039‰ in manual checking mode to 0.019‰ before optimization and 0.015‰ after optimization （P＜0.05）. CONCLUSIONS Based on ECRSI method， the automatic checking mode for the unit dose dispensing system of oral drugs can effectively reduce the average checking time of drug bags， reduce external error and improve the work efficiency of pharmacists.

Your clinical pharmacist can save your life, the impact of pharmacists intervention

Objective: Patient safety and adverse event analysis are of paramount importance in the management of patient medication, given the significant economic burden they place on a country’s healthcare system. Medication errors fall into the category of preventable adverse drug therapy events and are therefore of key importance from a patient safety perspective. Our study aims to identify the types of medication errors associated with the medication dispensing process and to determine whether automated individual medication dispensing with pharmacist intervention significantly reduces medication errors, thereby increasing patient safety, compared to traditional, ward base medication dispensing (by a nurse). Method: A prospective, quantitative, doubleblind point prevalence study was conducted in three inpatient internal medicine wards of Komló Hospital in February 2018 and 2020. We analyzed data from comparisons of prescribed and non-prescribed oral medications in 83 and 90 patients per year aged 18 years or older with different diagnoses treated for internal medicine on the same day and in the same ward. In the 2018 cohort, medication was traditionally dispensed by a ward nurse, while in the 2020 cohort, it used automated individual medication dispensing with pharmacist intervention. Transdermally administered, parenteral and patient-introduced preparations were excluded from our study. Results: We identified the most common types of errors associated with drug dispensing. The overall error rate in the 2020 cohort was significantly lower (0.9%) than in the 2018 cohort (18.1%) (p < 0.05). Medication errors were observed in 51% of patients in the 2018 cohort, i.e. 42 patients, of which 23 had multiple errors simultaneously. In contrast, in the 2020 cohort, a medication error occurred in 2%, i.e. 2 patients (p < 0.05). (AU)

Bayesian statistical approaches to drug product variability assessment and release.

The determination of the variability of critical dosage form attributes has been a challenge in establishing the quality of pharmaceutical products. During the development process knowledge is minimal. Consequently, ad hoc statistical tools such as hypothesis or significance tests, with calibrated decision error rates are often used in an effort to vet CQAs (Critical Quality Attributes) and keep their levels "between the curbs". As progress moves towards product launch, process and mechanistic understanding grows considerably and there are opportunities to leverage that knowledge for predictive modeling. Bayesian models offer a coherent strategy for integrating prior knowledge into both experimental design as well as predictive analysis for optimal risk-based decision making. This is because the Bayesian paradigm, unlike the frequentist paradigm, can assign probabilities to underlying states of nature that directly impact safety and efficacy such as the population distribution of tablet potencies or dissolution profiles in a batch. However, there are challenges and reluctance in switching to a predictive modeling quality framework once regulatory approval has been attained. This paper offers encouragement to make this switch. In this paper, we review a joint Long Island University - Purdue University (LIU-PU) FDA funded project whose purpose was to further integrate the concepts of this adaptive approach to lot release with the rationale and methods for data generation and curation and to extend the testing of this approach. We discuss the utility of the approach in product development. We consider the regulatory compliance implications, with examples, and establish a potential way forward toward implementation of this approach for both industry and regulatory stake-holders.

Your clinical pharmacist can save your life, the impact of pharmacist's intervention.

Objective: Patient safety and adverse event analysis are of paramount importance in the management of patient medication, given the significant economic burden they place on a country's healthcare system. Medication errors fall into the category of preventable adverse drug therapy events and are therefore of key importance from a patient safety perspective. Our study aims to identify the types of medication errors associated with the medication dispensing process and to determine whether automated individual medication dispensing with pharmacist intervention significantly reduces medication errors, thereby increasing patient safety, compared to traditional, ward base medication dispensing (by a nurse). Method: A prospective, quantitative, double-blind point prevalence study was conducted in three inpatient internal medicine wards of Komló Hospital in February 2018 and 2020. We analyzed data from comparisons of prescribed and non-prescribed oral medications in 83 and 90 patients per year aged 18 years or older with different diagnoses treated for internal medicine on the same day and in the same ward. In the 2018 cohort, medication was traditionally dispensed by a ward nurse, while in the 2020 cohort, it used automated individual medication dispensing with pharmacist intervention. Transdermally administered, parenteral and patient-introduced preparations were excluded from our study. Results: We identified the most common types of errors associated with drug dispensing. The overall error rate in the 2020 cohort was significantly lower (0.9%) than in the 2018 cohort (18.1%) (p < 0.05). Medication errors were observed in 51% of patients in the 2018 cohort, i.e. 42 patients, of which 23 had multiple errors simultaneously. In contrast, in the 2020 cohort, a medication error occurred in 2%, i.e. 2 patients (p < 0.05). When evaluating the potential clinical consequences of medication errors, in the 2018 cohort, the proportion of potentially significant errors was 76.2% and potentially serious errors 21.4%, whereas in the 2020 cohort, only three medication errors were identified in the potentially significant category due to pharmacist intervention, which was significantly lower (p < 0.05). Polypharmacy was detected in 42.2% of patients in the first study and in 12.2% (p < 0.05) in the second study. Conclusion: Automated individual medication dispensing with pharmacist intervention is a suitable method to increase the safety of hospital medication, reduce medication errors, and thus improve patient safety.

Cost-saving medication therapy management for outpatients.

OBJECTIVE: Medication costs comprise the majority of health system budgets and continue to increase faster than other health-care expenditures. The objective of this study is to evaluate the causes and monetary value of cost-saving prescription interventions made by clinical pharmacists in outpatient pharmacy. MATERIALS AND METHODS: Outpatient prescriptions were randomly audited for a period of 11 months (August 2017-June 2018) using a customized outpatient prescription audit tool integrated with computerized physician order entry. Drug-related problems were communicated to respective prescribers, and their response to each intervention was documented in accordance with PCNE classification. Both unit dose cost and anticipated dose cost savings were calculated to evaluate the monetary benefit for patients. RESULTS: Unit dose cost of INR 4875.73 and anticipated dose cost of INR 26890.8 were saved from outpatients. Majority of the prescribing errors were associated with therapeutic duplication (43.4%) and drug interaction (25.7%) that account for anticipated dose cost savings of INR 17812.65 for patients. Major contributory drug classes that reduced the cost of therapy were antibiotics (24.23%), proton-pump inhibitors (13.27%), and analgesics (12.34%). Prescribers' response to pharmacist intervention varied, 53% responded to stop the drug, 21% responded to change the brand, and 20% changed the frequency of administration. Necessary instructions were verbally given to patients without making any modification in the prescription for 3.2% (n = 10) of cost-saving interventions. DISCUSSION AND CONCLUSION: As clinical pharmacist has the expertise to detect, resolve, and prevent medication errors, the development of clinical pharmacy practice in a hospital outpatient pharmacy will have a significant impact on reducing prescription errors and health-care cost also.

Impacto en la producción de material contaminante y eficiencia del reetiquetado respecto al reenvasado de medicamentos / The environmental impact of relabeling process compared with the unitary dose repackaging

Objetivo: Analizar el impacto en la producción de material contaminante y la eficiencia del reetiquetado con el programa Dale color a tu dosis unitaria respecto al reenvasado. Método: Se analizó la cantidad de material empleado en la elaboración de 100.000 dosis unitarias mediante reetiquetado y reenvasado para calcular el ahorro de material obtenido con el proceso de reeetiquetado. Además, se midió el espacio ocupado por el material contaminante generado en ambos procesos y se realizó una estimación de la producción en función de la capacidad del hospital. Se calculó el coste asociado al material empleado en ambos procesos para el acondicionamiento de 100.000 dosis unitarias, así como el de la maquinaria necesaria para reetiquetar y reenvasar durante 20 años. Resultados: Se generaron 2,11-4,54 kg de plástico en el reetiquetado de 100.000 dosis unitarias (según el formato de etiqueta), y 67,82 kg de material contaminante para la misma cantidad de reenvasados, siendo el reetiquetado 15-32 veces menos contaminante en peso. Además, el reetiquetado supuso un ahorro de 620,64-702,43 m2 de material contaminante (6-13 veces menos contaminante en espacio). Un hospital de tercer nivel que elabore 1-2 millones de reenvasados al año, produciría anualmente hasta 1.356,40 kg de material contaminante. En cuanto a los costes, el reetiquetado supuso un ahorro de material del 89% (1.580 €), y del 98,2% (17.830 €) en cuanto a la amortización de la maquinaria durante 20 años. Conclusiones: El reetiquetado parece ser una alternativa más eficiente y respetuosa con el medio ambiente en materia de generación de residuos contaminantes respecto al reenvasado. (AU)

Objective: To analyze the environmental impact of relabeling process with “Color your unitary dose” program and the efficiency compared to the traditional repackaging. Method: The contaminating material used in the relabeling and repackaging of 100,000 unitary dose was calculated. In addition, the area occupied by the contaminating material produced in both processes was measured to determinate the saving of material with the relabeling process, and an approximate estimation of material production was made according to the hospital capacity. The cost associated to the material required in both processes and the machinery needed to relabeling and repackaging during 20 years was evaluated. Results: The contaminating material used in the relabeling of 100,000 unitary dose was 2.11 kg and 4.54 kg of plastic (depending on the label model used), and 67.82 kg (plastic, aluminum and tracing) in the traditional repackaging process. The area occupied by the contaminating material produced in both processes was 56.81 m2 and 138.60 m2 (relabeling), and 759.24 m2 (repackaging), which means a saving of 620.64 m2 and 702.43 m2 of contaminating material (15-32 times less polluting in weight and 6-13 times, in space). A third level hospital that repackages 2 million unitary dose would annually produce around 1,356.40 kg. A saving of 89% (1,580 €) of material used was obtained with the relabeling, and 98.2% (17,830 €) in terms of the cost of amortization of the machinery necessary for 20 years. Conclusions: The relabeling was an efficient and less polluting process than the traditional repackaging system, so we should only use it for medications that can not be relabelled. (AU)

A Comparative Ocular Pharmacokinetics Study of Preservative-Free Latanoprost Unit-Dose Eye Drops and a Benzalkonium Chloride-Preserved Branded Product Following Topical Application to Rabbits.

Purpose: To evaluate the aqueous humor pharmacokinetics of a preservative-free 0.005% latanoprost unit-dose eye drop (test drug) compared with that of a benzalkonium chloride (BAK)-preserved 0.005% latanoprost branded product (control drug) following topical application to rabbits. Methods: A total of 120 healthy New Zealand albino rabbits were administrated test eye drops (T group) or control eye drops (C group) for a comparative pharmacokinetics study. The aqueous humor was collected at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 h after a single dose or multiple doses. Ultraperformance liquid chromatography-tandem quadrupole mass spectrometry was employed to detect latanoprost free acid (LTA, the active metabolite of latanoprost) in the aqueous humor. Results: For the single-dose study, there was no significant difference (t-test, P > 0.05) in the peak concentration (Cmax) of LTA in aqueous humor between the T group (69.0 ± 23.4 ng/mL) and C group (73.8 ± 28.7 ng/mL). The area under the curve values over 12 h (AUC0-12h) of LTA for the 2 groups were 254.4 (ng/mL) × h and 219.5 (ng/mL) × h, respectively. For the multidose study, there was also no significant difference (t-test, P > 0.05) in the Cmax of LTA in the aqueous humor between the T group (86.8 ± 21.2 ng/mL) and C group (70.5 ± 25.9 ng/mL). The AUC0-12h values of LTA for the 2 groups were 274.5 (ng/mL) × h and 256.3 (ng/mL) × h, respectively. Conclusions: The preservative-free 0.005% latanoprost unit-dose eye drops demonstrated similar pharmacokinetic properties to the BAK-preserved branded product following topical application to rabbits.

Circumstances Involved in Unsupervised Solid Dose Medication Exposures among Young Children.

OBJECTIVE: To identify types of containers from which young children accessed solid dose medications (SDMs) during unsupervised medication exposures and the intended recipients of the medications to advance prevention. STUDY DESIGN: From February to September 2017, 5 US poison centers enrolled individuals calling about unsupervised solid dose medication exposures by children ≤5 years. Study participants answered contextually directed questions about exposure circumstances. RESULTS: Sixty-two percent of eligible callers participated. Among 4496 participants, 71.6% of SDM exposures involved children aged ≤2 years; 33.8% involved only prescription medications, 32.8% involved only over-the-counter (OTC) products that require child-resistant packaging, and 29.9% involved ≥1 OTC product that does not require child-resistant packaging. More than one-half of exposures (51.5%) involving prescription medications involved children accessing medications that had previously been removed from original packaging, compared with 20.8% of exposures involving OTC products (aOR, 3.39; 95% CI, 2.87-4.00). Attention deficit hyperactivity disorder medications (49.3%) and opioids (42.6%) were often not in any container when accessed; anticonvulsants (41.1%), hypoglycemic agents (33.8%), and cardiovascular/antithrombotic agents (30.8%) were often transferred to alternate containers. Grandparents' medications were involved in 30.7% of prescription medication exposures, but only 7.8% of OTC product exposures (aOR, 3.99; 95% CI, 3.26-4.87). CONCLUSIONS: Efforts to reduce pediatric SDM exposures should also address exposures in which adults, rather than children, remove medications from child-resistant packaging. Packaging/storage innovations designed to encourage adults to keep products within child-resistant packaging and specific educational messages could be targeted based on common exposure circumstances, medication classes, and medication intended recipients.

Risk-Based Approach to Lot Release.

In this work, a novel risk-based methodology for lot release is proposed. Its objective is to assess the risk that a lot declared to have passed truly meets product specifications. The methodology consists of 3 parts: adaptive sample size determination, estimation of the probability that the product was within specifications, and the lot-release decision. The methodology provides a probabilistic statement about the true quality of the batch. Having a probability estimate is the essential condition of risk-based decision-making. We demonstrate the proposed methodology on experimental data generated from 17 immediate-release solid oral drug products from a number of different manufacturers with 5 to 10 lots per manufacturer.

In vitro comparison of unit dose vs infusion pump administration of albuterol via high-flow nasal cannula in toddlers.

OBJECTIVES: Transnasal pulmonary aerosol delivery using high-flow nasal cannula (HFNC) devices has become a popular route of aerosol administration in toddlers. Clinically, albuterol is administered using an infusion pump or unit doses. However, little evidence is available to compare the two administration strategies. METHODS: A toddler manikin (15 kg) with appropriate anatomic airway was connected with collecting filter to a simulator of distressed breathing. HFNC device with mesh nebulizer placed at the inlet of a humidifier at 37°C, with the gas flow set at 25 and 3.75 L/min. Five milligrams of albuterol was delivered in all experiments. With infusion pump administration, albuterol concentrations of 5 and 1 mg/mL were delivered at 4 and 20 mL/hr for 15 minutes. With unit dose administration, 1 mL (5 mg/mL) and 2 mL (2.5 mg/mL) of albuterol were nebulized. Additional tests with mouth open and nebulizers via mask were using 5 mg/1 mL for mesh nebulizer and 5 mg/3 mL for jet nebulizer (n = 3). The drug was eluted from the filter and assayed with UV spectrophotometry (276 nm). RESULTS: The inhaled dose was higher with unit dose than infusion pump administration with gas flows of 25 L/min (2.66 ± 0.38 vs 1.16 ± 0.28%; P = .004) and 3.75 L/min (10.51 ± 1.29 vs 8.58 ± 0.68%; P = .025). During unit dose administration, compared with closed-mouth breathing, open-mouth breathing generated a higher inhaled dose at 3.75 L/min and lower inhaled dose at 25 L/min. Compared to the nebulizers via mask with both open and closed-mouth breathing, nebulization via HFNC at 3.75 L/min generated greater inhaled dose, while HFNC at 25 L/min generated lower inhaled dose. CONCLUSIONS: During transnasal aerosol delivery, the inhaled dose was higher with medication administrated using unit dose than using an infusion pump.

Liquid laundry detergent capsules (PODS): a review of their composition and mechanisms of toxicity, and of the circumstances, routes, features, and management of exposure.

Introduction: Liquid laundry detergent capsules (also called single-use detergent sacs; laundry pods; laundry packets) have become an increasingly popular household product worldwide. Objectives: To review the composition and mechanisms of toxicity of liquid laundry detergent, capsules, and the circumstances, routes, clinical features (and impact of packaging changes) and management of exposure. Methods: The databases PubMed and EMBASE were searched using the terms: "detergent" and "capsule", "pod", "pac" or "sac" combined with "poison", "ingest", "expos" but not "animal" or "in vitro" or "bacteria". The searches yielded 289 articles, of which 186 were excluded: 38 duplicates, 133 not relevant, 10 abstracts which had been published as a paper and 5 non-English language articles. The bibliographies of relevant articles were hand-searched which yielded 14 additional citations. Searching of abstracts from scientific meetings produced five additional citations. A total of 122 publications were relevant to the objectives of the review. Capsules and composition: Capsules typically contain anionic surfactants (20-35%), non-ionic surfactants (10-20%), propylene glycol (8-20%) and ethanol (2-5%) within a water-soluble polyvinyl alcohol membrane. Mechanisms of toxicity: Non-ionic surfactants are the primary mechanism, though anionic surfactants, ethanol and propylene glycol may also contribute. Circumstances of exposure: The majority (60%) of children are exposed when the capsule is removed from its original container. Routes of exposure: Ingestion is the most common (>85%); ocular (<15%) and dermal (<8%) exposure account for the remainder. Features following ingestion: Features develop in around half of all exposures, though >90% are minor. In those with features, vomiting occurs in some 50%; coughing and drowsiness are reported in <5%. Respiratory depression (<0.5%), central nervous system depression (<0.1%) esophageal or gastric injury (<0.5%), metabolic acidosis and hyperlactatemia (<0.05%) have been reported rarely. Of 17 deaths reported, 13 were adults and nine were suffering from cognitive impairment. Features following ocular exposure: Conjunctivitis, eye irritation and/or eye pain are commonly experienced; corneal injury is less common but complete recovery typically occurs within one week. Features following dermal exposure: Clinically important dermal toxicity seldom occurs, though skin burns can develop in <5% of cases when skin contact is prolonged. Impact of packaging changes on features: The implementation of packaging changes resulted in a fall in the number of exposures and their severity in the United States and in the number in Italy. Management-ingestion: Gut decontamination is not recommended, though small amounts of fluid can be administered orally to rinse out the mouth. Symptomatic and supportive care should be offered to all patients that develop features of toxicity. Supplemental oxygen should be administered for hypoxemia, and bronchodilators for laryngospasm/bronchospasm. Intubation and assisted ventilation may be required if CNS and respiratory depression develop. A chest radiograph should be performed if respiratory features develop. In patients with swallowing difficulties, drooling or oropharyngeal burns, endoscopy should be performed; if substantial mucosal damage is present MRI should be considered. In addition, intravenous fluids will be required if prolonged vomiting or diarrhea occur and acid-base disturbances should be corrected. Management-eye exposure: Thorough irrigation of the eye with sodium chloride 0.9% is required. Instillation of a local anesthetic will reduce discomfort and help more thorough decontamination. Due to the potential for corneal injury, fluorescein should be instilled. If ocular injury is present, the patient should be referred to an ophthalmologist. Management-skin exposure: Skin should be irrigated thoroughly with soap and water, and burns should be treated as a thermal burn. Conclusions: Accidental ingestion usually produces no or only minor features. Very rarely respiratory depression, central nervous system depression, esophageal or gastric injury, hyperlactatemia and metabolic acidosis occur. Ocular exposure results in corneal injury infrequently and skin burns can develop uncommonly following prolonged dermal contact. Of 17 deaths reported, 13 were adults and nine were suffering from cognitive impairment.

[Securing the distribution of patient-specific unit dose medication following the installation of a unit dose dispensing system: Cartography of risks a priori within a hospital pharmacy]. / Sécurisation de la dispensation individuelle et nominative suite à l'implantation d'un automate de dispensation nominative : cartographie des risques a priori au sein d'une pharmacie à usage intérieur.

INTRODUCTION: With a view to reinforcing the security of the drug distribution process, the hospital pharmacy has decided to automate the patient-specific unit dose distribution system which, up to now was performed manually, through the acquisition of a unit dose dispensing system: the ACCED S 300 (ECODEX®). The aim of this work is to realize a cartography of risks, focused on the dispensing stage, prior to the implementation of the automated system. MATERIALS AND METHOD: A multidisciplinary group applied the preliminary risk analysis (PRA) technique. The study was limited to the dispensing stage of unit doses within the hospital pharmacy. RESULTS: This analysis revealed 122 accident scenarii, including 18 with an initial unacceptable criticality (14.8 % of scenarii). In total, 140 risk management actions were proposed. These actions include: acquisition of equipment, communication and training of pharmacy staff, communication with services, human resources management and organization of working hours, writing and updating quality documents, programming the software and interfaces linked with the robot. CONCLUSION: The implementation of risk management actions should reduce the risk and contribute to avoiding the most critical scenarii. This will require the availability of human and financial resources and the implication of management.

[Medication safety in hospitals : Integration of clinical pharmacists to reduce drug-related problems in the inpatient setting]. / Arzneimitteltherapiesicherheit im Krankenhaus : Einbindung von Stationsapothekern zur Reduktion von arzneimittelbezogenen Problemen im stationären Medikationsprozess.

Drug-related problems (DRPs) are a significant and often preventable cause for morbidity and mortality. Hospitalization is associated with a high risk for DRPs, especially due to a lack of information transfer at transitions of care. At the same time, interventions during inpatient treatment usually require a change in drug therapy and additionally increase the risk of DRPs. Thereby, DRPs can occur at all levels of the medication process and can be caused by different groups of professionals. One way to improve medication safety in hospitals is to integrate clinical pharmacists into the medication process.According to available data, the integration of a clinical pharmacist in multi-professional teams during admission, hospitalization and discharge can significantly reduce DRPs, costs and increases efficacy of drug therapy. In addition, drug supply with unit-dose systems in combination with digitalization of the medication process can achieve an improvement in medication safety. Improvement in continuity of medical care through a structured medication review and seamless transmission of medically relevant information upon discharge contribute to a significant reduction of hospital readmissions and emergency admissions due to ABPs, as well as health costs. With a university education, the hospital pharmacist specialized in clinical pharmacy is the only professional group that can comprehensively support the physician in the field of drug therapy.

Factores asociados para el procedimiento de administración de medicamentos mediante el sistema de dosis unitaria / Associated factors for the procedure of administration of medicines through the system of unitary dose

El sistema de distribución de medicamentos en dosis unitarias es un método de dispensación y control de la medicación en servicios de salud,es organizado y coordinado por la farmacia institucional. Objetivo.Analizar los factores asociados para el procedimiento de administración de medicamentos mediante el sistema de dosis unitaria en el hospital de Instituto Ecuatoriano Seguridad Social de la ciudad de Babahoyo. Metodología. Diseño observacional, descriptivo de corte transversal. Institución: Hospital del IESS. Revisión sistemática documental nacional e internacional sobre SDUM y la aplicación de una encuesta a la población objetivo del estudio: 92 médicos, 118 enfermeras, 2 químicos farmacéuticos. Resultados.Confirmaron que el sistema tradicional afecta la racionalización de medicamentos; existiendoescasez de recursos humanos, espacio físico inadecuado, incumplimiento de normas vigentes.Serequiere la capacitación del recurso humano en el 100%. Existiendo la necesidad imperiosa de implementar el sistema de dosis unitaria en el 100% de los servicios de hospitalización del IESS Babahoyo. Conclusión.Los factores que mayor incidencia tienen en la implementación del nuevo sistema son conocimiento del sistema, las normas legales y reglamentación farmacéutica y el número insuficiente de profesionales químicos farmacéuticos especializados, a esto se une el factor presupuesto a nivel central que influye en la adquisición de equipamiento e implementación de las áreas funcionales según el Acuerdo Ministerial 00000569 del 6 de julio de 2011 Norma para la Aplicación del Sistema de Dispensación/Distribución de Medicamentos por Dosis Unitaria -Ministerio de Salud Pública, enero 2013.

Introduction.The system of distribution of medications in unit doses is a method of dispensing and control of medication in health services is organized and coordinated by the institutional pharmacy. Objective.To analyze the factors associated with the benefits of the medication administration procedure through the unit dose system at the Instituto Ecuatoriano Seguridad Social in the city of Babahoyo. Methodology. Observational design, descriptive cross-section. Institution: IESS Hospital. Systematic national and international documentaryreview on SDUM and the application of a survey to the target population of the study: 92 doctors, 118 nurses, 2 pharmaceutical chemists. Results They confirmed that the traditional system affects the rationalization of medicines; There is a shortage of human resources, inadequate physical space, non-compliance with current regulations. 100% human resource training is required. There is a pressing need to implement the unit dose system in 100% of the IESS hospitalization services. Babahoyo.Conclusion: The factors that have the greatest impact on the implementation of the new system are knowledge of the system, legal regulations and pharmaceutical regulation and the insufficient number of specialized pharmaceutical chemists, to this is added the budget factor at the central level that influences the acquisition of equipment and implementation of the functional areas according to the Ministerial Agreement 00000569 of July 6, 2011 Standard for the Application of the Dispensing System / Distribution of Drugs by Unit Dose -Ministry of Public Health, January 2013.

A novel unit-dose approach for the pharmaceutical compounding of an orodispersible film.

Orodispersible films (ODF) have clinical potential as extemporaneous pharmacy preparations for individualized pharmacotherapy. However, the conventional method of ODF preparation using a film applicator may limit its application, due to content uniformity challenges arising from viscosity changes of the casting solution and varied operator manipulation. This study proposes the unit-dose (UD) plate as an alternative to the film applicator for compounding individual ODFs. Using a design-of-experiments approach, we developed an extemporaneous ODF formulation for an antiemetic drug, ondansetron hydrochloride dihydrate (OND), at a clinically relevant dose. ODFs cast with the UD plate showed excellent content uniformity independent of the viscosity of the casting solution and drug concentration. Formulations were evaluated for performance with respect to patient acceptability and product quality. The effects of critical process parameters on critical quality attributes of the ODF were studied. HPMC concentration and volume of casting solution were the main factors affecting disintegration time and mechanical properties of the film, while drug concentration had no significant effect. However, further studies incorporating different drugs in larger concentration ranges are needed to investigate the impact of drug concentration and to establish a design space. Nevertheless, our results indicate the potential of using the UD plate to prepare ODFs with customized drug doses from a generic casting solution. Results from this study provide a framework for an extemporaneous ODF platform.

Pharmacokinetic Comparison of a Unit Dose Dry Powder Inhaler with a Multidose Dry Powder Inhaler for Delivery of Fluticasone Furoate.

BACKGROUND: The unit dose dry powder inhaler (UD-DPI) is being considered as an alternative inhaler platform that, if developed, has the potential to improve access to inhaled respiratory medicines in developing countries. AIM: This study compared the systemic exposure of fluticasone furoate after delivery from the UD-DPI with that from the ELLIPTA® inhaler. METHODS: This open-label, five-way cross-over, randomized, single-dose study in healthy subjects evaluated fluticasone furoate systemic exposure of three dose strengths (using four inhalations), 4 × 80 µg [320 µg], 4 × 100 µg [400 µg], and 4 × 140 µg [560 µg]), and two percentages of drug in lactose blends (0.6% and 0.8% by weight) after delivery from the UD-DPI compared with systemic exposures from the ELLIPTA inhaler (4 × 100 µg [400 µg] dose, 0.8% lactose blend). The primary treatment comparisons were area under the concentration-time curve from time 0 to 6 hours [AUC0-6] and maximum plasma concentration [Cmax]. RESULTS: After single-dose administration of fluticasone furoate, systemic exposure was lower from all UD-DPI formulations versus the ELLIPTA inhaler in terms of both AUC0-6 [AUC0-6 geometric least squares mean (GLM) ratios confidence interval (90% CI) for: UD-DPI (400 µg 0.8% blend)/ELLIPTA: 0.61 (0.55-0.67) and Cmax GLM (90% CI) for: UD-DPI (400 µg 0.8% blend)/ELLIPTA: 0.56 (0.49-0.64)]. Systemic exposures were ∼10% lower for fluticasone furoate UD-DPI for the 0.8% blend versus the 0.6% blend [GLM ratio (90% CI); 0.90 (0.81-1.00) for AUC0-6 and 0.89 (0.77-1.01) for Cmax], and increasing doses of fluticasone furoate from the UD-DPI showed systemic exposures that were approximately dose proportional. All treatments were well tolerated. CONCLUSIONS: Fluticasone furoate systemic exposure was lower from the UD-DPI than from the ELLIPTA inhaler, but the UD-DPI formulations did demonstrate detectable systemic levels and approximate dose proportionality. Together with the good tolerability shown, these data support further evaluation of the UD-DPI as a potential device for delivering inhaled respiratory drugs.