Ambulatory Drug Research Articles

Pilot study with randomised control of dual site theta burst transcranial magnetic stimulation (TMS) for methamphetamine use disorder: a protocol for the TARTAN study

BackgroundTranscranial magnetic stimulation (TMS) (including the theta burst stimulation (TBS) form of TMS used in this study) is a non-invasive means to stimulate nerve cells in superficial areas of the brain. In recent years, there has been a growth in the application of TMS to investigate the modulation of neural networks involved in substance use disorders. This study examines the feasibility of novel TMS protocols for the treatment of methamphetamine (MA) use disorder in an ambulatory drug and alcohol treatment setting.MethodsThirty participants meeting the criteria for moderate to severe MA use disorder will be recruited in community drug and alcohol treatment settings and randomised to receive active TMS or sham (control) intervention. The treatment is intermittent TBS (iTBS) applied to the left dorsolateral prefrontal cortex (DLPFC), then continuous TBS (cTBS) to the left orbitofrontal cortex (OFC). Twelve sessions are administered over 4 weeks with opt-in weekly standardized cognitive behaviour therapy (CBT) counselling and a neuroimaging sub-study offered to participants. Primary outcomes are feasibility measures including recruitment, retention and acceptability of the intervention. Secondary outcomes include monitoring of safety and preliminary efficacy data including changes in substance use, cravings (cue reactivity) and cognition (response inhibition).DiscussionThis study examines shorter TBS protocols of TMS for MA use disorder in real-world drug and alcohol outpatient settings where withdrawal and abstinence from MA, or other substances, are not eligibility requirements. TMS is a relatively affordable treatment and staff of ambulatory health settings can be trained to administer TMS. It is a potentially scalable and translatable treatment for existing drug and alcohol clinical settings. TMS has the potential to provide a much-needed adjuvant treatment to existing psychosocial interventions for MA use disorder. A limitation of this protocol is that the feasibility of follow-up is only examined at the end of treatment (4 weeks).Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12622000762752. Registered on May 27, 2022, and retrospectively registered (first participant enrolled) on May 23, 2022, with protocol version 7 on February 24, 2023.

Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 2023.

Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 2023.

A Case report of a continuous ambulatory drug delivery (CADD) pump to deliver opioid agonist treatment in an acute care setting

BackgroundPeople with substance use disorder are at risk of complications of drug use and frequent hospitalization and may continue to use substances during admission to acute care. Acute care harm reduction strategies including oral or injectable prescription opioids may aid in care retention and improve health outcomes in this patient population.Case presentationA 58-year-old woman with refractory opioid use disorder was admitted to hospital for management of dysphagia secondary to esophageal stricture. She received injectable opioid agonist therapy using a continuous ambulatory drug delivery (CADD) pump in order to facilitate completion of her hospital admission.ConclusionsThe patient successfully received acute medical care with the use of a CADD pump for consistent, patient-controlled opioid administration, with the support of an interdisciplinary team and by respecting the patient’s own substance use goals.

Evaluation of the duration of supervised ambulatory drug provocation tests in children with mild non-immediate reactions to beta-lactams

Evaluation of the duration of supervised ambulatory drug provocation tests in children with mild non-immediate reactions to beta-lactams

1733. Stability of Imipenem/Cilastatin/Relebactam under Different Temperature and Administration Conditions

Abstract Background Imipenem/Cilastatin/Relebactam is an FDA-approved combination antibiotic indicated for resistant infections. There is a practical need to extend the shelf life of parenterals given to patients with such life-threatening infections in the hospital setting. The reconstituted drug's shelf life can be extended by storing at subzero temperatures to slow the degradation kinetics. Package insert indicate stability is 2 hrs at room temperature and refrigeration up to 24 hr. The study aims to determine the stability of the combination in polyvinyl chloride (PVC) infusion (IV) bags when stored at room temperature, refrigerated in addition to continuous infusion CADD pumps. Methods Drug vials (Merck & Co) were reconstituted to 5mg/mL (imipenem) in a 100mL normal saline. To avoid further degradation, samples were collected and mixed 1:1 with stabilizing buffer, then frozen at -80 °C within 5 minutes. For room temperature stability, 6 bags were prepared and stored at (24°C). 0.5ml samples were collected at 0, 2, 4, 6, 8, 12, 24 h from each bag at each time point. For refrigeration stability, 6 bags were prepared and refrigerated at 4 °C. At each time point (24, 36, 48, 60, 72, 84, 96,108, 120h), a sample of 0.5-mL is taken from each bag and frozen at −80 °C. For continuous ambulatory drug delivery (CADD) infusion devices stability, the reconstituted drug is loaded to 2g/200 mL cassettes (for 24-hr infusion) continuous infusion and 1g/100mL (for 12-hr infusion). The cassettes are immediately attached to the infusion pump and placed in a cold pouch with gel packs. After the initial 0.5 mL, 0-h samples from each pump, the pumps are sampled at 4, 8,12, 16, 20, and 24 hours for 2g/ 200mL cassettes and 2, 4, 8, 12 h for 1g/100 mL. Cut off for stability was set at 90% of the original concentration. Chemical assay was performed by a validated HPLC method. Results See tables Table 1:CADD pumps, concentrations are in mg/mL. Imi; imipenem, Rel; relebactam, Cil; Cilastatin, CADD; continuous ambulatory delivery device, SD; standard deviationTable 2:PCV bags, concentrations are in mg/mL. Imi; imipenem, Rel; relebactam, Cil; Cilastatin, PVC; polyvinyl chloride, SD; standard deviation Conclusion Imipenem/relebactam/cilastatin drug product was stable for 12 hrs in CADD pumps 100mL, 16 hrs in 200 mL, 108 hours in refrigerated PVC bags and 12 hrs at room temperature. The extended stability data will assistant pharmacy departments in optimizing drug preparation and storage, nursing time and minimize drug waste improving overall cost and efficiency of drug administration. Disclosures Islam Ghazi, PharmD, Merck And Co Inc: Grant/Research Support David Nicolau, PharmD, Marck and Co Inc: Advisor/Consultant|Marck and Co Inc: Grant/Research Support.

893-P: Incremental Health Care Utilizations and Medical Expenditures Associated with Cognitive Impairment among Older Adults with Diabetes

Cognitive impairment (CI) poses a large economic burden on the US health care system, but little is known about how CI impacts health care (HC) utilization and medical expenditures among people with diabetes. Using data from the 2016-20Medical Expenditure Panel Survey, we quantified the incremental HC utilization and medical expenditures associated with CI among adults aged ≥ 60 years with diabetes. Diabetes status was based on self-report. Participants who reported having difficulty concentrating, remembering, or making decisions were defined as having CI. We used negative binomial regressions to model the number of ambulatory visits, prescriptions, and home health care days; logistic regressions to model the probabilities of ER visits and hospital admissions; and gamma regressions to model medical expenditures in total and by category. All models were adjusted for age, sex, race and ethnicity, income, education, and comorbidities. We included 6,714 adults ≥ 60 years with diabetes, of which 1,025 (15.27%) had CI. CI was associated with additional ambulatory visits (+4.7 [95% CI, 3.5-5.8]) , drug prescriptions (+10.6 [8.1-13.1]) , and home health care days (+32.6 [19.2-52.2]) ; and higher odds of ER visits (Odds Ratio (OR) : 1.55 [95% CI, 1.27-1.89]) and hospital admissions (OR: 1.27 [1.02-1.58]) . CI was also associated with additional expenditures for outpatient care (+$12[$731-$1720], or 28% higher than those without CI [17%-40%]) , prescription drugs (+$17[$1103-$2372], or 31% higher [20%-43%]) , and home health care (+$25[$445-$7060], or 197% higher [35%-555%]) . Overall, those with CI spent $70[$5168-$8835], or 42% [31%-53%] more than those without CI. All p < 0.05. CI is associated with higher HC utilization and medical expenditures among older adults with diabetes. Early detection of CI and additional assistance to those with CI may lower CI-related HC utilization and expenditure in this population. Disclosure D.Guan: None. P.Zhang: None. S.Tang: None. J.D.Brown: None. R.R.Fang: None. J.Guo: None. Y.Zhang: None. H.Shao: Board Member; BRAVO4HEALTH, LLC.

Palliative pain: putting the patient back in control of their analgesia.

A common reason for admission to palliative care wards is severe cancer-related pain. The delivery of therapy, an essential component in combating pain, is complicated by boundaries imposed by the law and quality use of medicines standards, which patients do not necessarily face in their own homes. These boundaries significantly delay the time until the patient is relieved of pain. Subcutaneous patient-controlled analgesia (PCA), delivered via a continuous ambulatory drug device, offers a potential method of mitigating these boundaries. This case series describes the experiences of the first four patients treated when subcutaneous PCA was introduced to an Australian palliative care ward and offers comments for consideration for future studies and wider implementation of use. It is noted that although PCA was generally effective overall, considerations about the patient's mental state and pain behaviours should be made before deciding to initiate PCA in lieu of nurse-administered breakthroughs.

Utilization of drugs with reports on potential efficacy or harm on COVID-19 before, during, and after the first pandemic wave.

PurposeConflicting information on potential benefits of drugs as well as reports on hypothetical harm of commonly used drugs in COVID‐19 treatment have challenged clinicians and healthcare systems. We analyzed the change in ambulatory drug utilization before, during, and after the first wave of the pandemic in 2020.MethodsWe explored dispensing data of nearly 19 000 pharmacies at the expense of the statutory health insurance funds covering 88% of Germany's population. We analyzed utilization of publicly discussed drugs with conflicting information. Drug utilization as number of packages dispensed per week from January to June 2020, reflecting 314 million claims, was compared with 2019.ResultsUtilization of hydroxychloroquine increased +110% during March 2020 and then slightly decreased until week April 13–19. Renin–angiotensin–aldosterone system inhibitors and simvastatin/atorvastatin increased, +78% and +74%, respectively, and subsequently decreased below 2019 levels. Utilization of azithromycin and all systemic antibiotics decreased continuously from March 2–8 until June to levels considerably lower compared to 2019 (June 22–28: azithromycin: −55%, all systemic antibiotics: −27%). Pneumococcal vaccines utilization initially increased +373%, followed by supply shortages. Paracetamol utilization showed an initial increase of +111%, mainly caused by an increase of over‐the‐counter dispensings.ConclusionsApart from the pandemic itself, the data suggest that dissemination of misinformation and unsound speculations as well as supply shortages influenced drug prescribing, utilization, and purchasing behavior. The findings can inform post‐pandemic policy to prevent unfounded over‐ and underprescribing and off‐label use as well as drug shortages during a public health crisis.

FC 070USE OF POTENTIALLY NEPHROTOXIC MEDICATIONS IN PERSONS WITH CHRONIC KIDNEY DISEASE: PARALLEL COHORT STUDIES IN SWEDISH AND U.S ROUTINE CARE

Abstract Background and Aims Many adverse drug events are preventable, such as those potentially resulting from the prescription of nephrotoxic drugs to persons with chronic kidney disease (CKD). We here quantify the extent of contemporary nephrotoxic medication use in patients with CKD. Method In two observational cohorts of Swedish (Stockholm CREAtinine Measurements [SCREAM] project, Stockholm, Sweden) and U.S. (Geisinger Health System, Pennsylvania) adults with confirmed CKD stages G3-G5 undergoing routine care during 2016-2018, we explored the prescription (in U.S.) and dispensation (in Sweden) of 115 different ambulatory drugs with proven or purported nephrotoxicity during the 12 months following study inclusion. We evaluated the proportion of participants receiving nephrotoxic drugs, ranked main contributors and identified clinical predictors. Results In the Swedish cohort, there were 57880 patients (54.6% women) with median age of 80.00 (inter-quartile range [IQR]: 73.0-86.0) years and eGFR 48.9 ([IQR]: 39.9-55.0) mL/min/1.73 m2. In the U.S. cohort, there were 16255 patients (59% women) with median age of 76 years and eGFR 44 mL/min/1.73 m2. During observation, 20% (Sweden) and 17% (U.S.) of patients received at least one nephrotoxic drug. The top 3 potentially inappropriate nephrotoxic drugs identified were NSAIDs (9% and 11% of participants in U.S. and Sweden received it), antivirals (2.0% and 2.5%) and immunosuppressants (1.5% and 2.7%). Bisphosphonate use was common in Sweden (3.3% of participants), but not in U.S. (0.5%). Conversely, fenofibrates were common in U.S. (3.6%), but not in Sweden (0.13%). In adjusted analyses, patients with young age (<65 years old), women, or with CKD G3 were at higher risk of receiving nephrotoxic medications in both cohorts (P>0.05 for all). Notably, patients aware of their CKD (identified either by issued diagnosis or recent visit to a nephrologist), were at lower risk of nephrotoxic drug use (OR 0.87, 95% CI 0.82-0.92 in Sweden and 0.89, 95% CI 0.81-1.01 in U.S.). Conclusion In two geographically distinct health systems, one in five patients with CKD received potentially inappropriate nephrotoxic medications, mainly NSAIDs. Strategies to increase CKD awareness and physician’s knowledge of drug nephrotoxicity may reduce inappropriate ambulatory prescriptions and prevent iatrogenic kidney injury.

Reducing hospitalizations: Implementation of CADD pumps in infusion clinic at a Los Angeles safety net hospital.

e18648 Background: Computerized ambulatory drug delivery (CADD) pumps introduced in the 1980s made it possible to move infusion delivery from the hospital to the home. At Harbor-UCLA Medical Center, hundreds of scheduled chemotherapy admissions occur annually. The procurement and implementation of CADD pumps was a collaborative effort with members of pharmacy, nursing, physicians and administration. The implementation of CADD pumps for home chemotherapy demonstrated a cost-savings by decreasing the number of inpatient hospital days required for scheduled chemotherapy admissions. Methods: The first outpatient chemotherapy infusion by CADD pump began on 12/5/2017. Records from 12/5/2017 through 12/4/2018 (365 days) were reviewed to assess the benefit of CADD pumps, defined by inpatient hospital days avoided. Eight chemotherapy regimens were administered through outpatient CADD pumps; the equivalent number of inpatient hospital days were estimated based on inpatient hospital records between 2015 and 2017. The average number of hospital days that would have occurred inpatient per chemotherapy regimen was multiplied by the number of outpatient CADD pump chemotherapy infusions to estimate the number of inpatient hospital days avoided. Based on information provided by our hospital’s finance department, including reimbursement for inpatient and similar outpatient care, each hospital day avoided was estimated to provide $1,695 in cost-savings. On average, a typical hospitalization for infusional 5-FU chemotherapy was three days in length. Results: Over one year, 35 patients received a total of 178 outpatient CADD infusions. The average number of CADD infusions per patient was five. We estimated that 642 hospital bed days were saved over a 1-year period following the implementation of outpatient CADD pumps. With the estimate that each hospital bed day saved was valued at $1,695, we concluded a savings of $1.1 million dollars at our hospital through the implementation of CADD pumps within the first year. Conclusions: The implementation of CADD pumps for home chemotherapy demonstrated cost-savings by decreasing the number of inpatient hospital days required for scheduled chemotherapy admissions. This shift provides a superior value for the patient with equivalent treatment outpatient, spending less time in the healthcare setting, and reduced health care costs. [Table: see text]

Ambulatory drug changes in the elderly after hospital discharge: A cohort study

To describe the ambulatory changes in drug prescriptions 3 months after hospital discharge among elderly patients aged 75 and over, and to identify the reasons for these changes. A prospective cohort study was conducted on subjects, discharged between 09/2016 and 01/2017 from the Bordeaux University Hospital. Prescription forms were collected from patients' pharmacists. The main outcome was the occurrence of at least one significant change (SC) defined as an initiation, a discontinuation, a switch or change in drug daily dosage as regards the drugs prescribed upon hospital discharge and those prescribed 3 months after. Whenever drug SC occurred, general practitioners were requested to elicit reasons for such changes. Among the 126 patients included in our study, 73 underwent a 3-month follow-up period, without death or being re-hospitalised. 87.7% of them had at least one SC 3 months after discharge, with an average of 3.1±2.5 SC per patient. Main changes involved: discontinuation or dose decrease of anxiolytics, hypnotics, antalgics, betablockers and calcium channel blockers; start or dose increase of diuretics, ACE inhibitors and angiotensin receptor blockers. In patients with a 3-month follow-up period, 27.4% underwent at least one ADR-induced SC. Most elderly patients experience drug prescription changes after discharge. Some, according to drug iatrogenic, could be avoided through better cooperation between hospital and ambulatory prescribers.

Safety and cost effectiveness of direct supervised ambulatory drug provocation tests in children with mild non-immediate reactions to beta-lactams

Safety and cost effectiveness of direct supervised ambulatory drug provocation tests in children with mild non-immediate reactions to beta-lactams

Impact of socioeconomic status on end-of-life costs: a systematic review and meta-analysis

BackgroundSocioeconomic inequalities in access to, and utilization of medical care have been shown in many jurisdictions. However, the extent to which they exist at end-of-life (EOL) remains unclear.MethodsStudies in MEDLINE, EMBASE, CINAHL, ProQuest, Web of Science, Web of Knowledge, and OpenGrey databases were searched through December 2019 with hand-searching of in-text citations. No publication date or language limitations were set. Studies assessing SES (e.g. income) in adults, correlated to EOL costs in last year(s) or month(s) of life were selected. Two independent reviewers performed data abstraction and quality assessment, with inconsistencies resolved by consensus.ResultsA total of twenty articles met eligibility criteria. Two meta-analyses were performed on studies that examined total costs in last year of life – the first examined costs without adjustments for confounders (n = 4), the second examined costs that adjusted for confounders, including comorbidities (n = 2). Among studies which did not adjust for comorbidities, SES was positively correlated with EOL costs (standardized mean difference, 0.13 [95% confidence interval, 0.03 to 0.24]). However, among studies adjusting for comorbidities, SES was inversely correlated with EOL expenditures (regression coefficient, −$150.94 [95% confidence interval, −$177.69 to -$124.19], 2015 United States Dollars (USD)). Higher ambulatory care and drug expenditure were consistently found among higher SES patients irrespective of whether or not comorbidity adjustment was employed.ConclusionOverall, an inequality leading to higher end-of-life expenditure for higher SES patients existed to varying extents, even within countries providing universal health care, with greatest differences seen for outpatient and prescription drug costs. The magnitude and directionality of the relationship in part depended on whether comorbidity risk-adjustment methodology was employed.

Cannabis in the Emergency Department: The impact of cannabis legalization on cannabis and opioid-related presentations

Background: On October 17th, 2018, non-medical cannabis became legal to adults for the first time in Canada. This has created a previously unseen opportunity to investigate the effects of recreational cannabis legalization in a developed country, particularly on strained Emergency Departments (EDs). Secondly, reports within the United States have suggested state-level legalization of cannabis, both recreationally and medically, has resulted in a decrease of opiate-related presentations. Given the pressure of the opiate crisis on healthcare resources, we sought to examine if this trend was present in Alberta.
 Objectives: The current study aims to identify if presentation patterns in adult and pediatric populations have changed when comparing pre- and post-legalization periods, and if rural-urban disparities exist. We also aim to identify if the legalization of cannabis is correlated with a reduction in opiate-related ED presentations. Lastly, we aimed to address the aforementioned objectives in the context of telehealth by examining calls to poison control and HealthLink within Alberta. 
 Methods: Retrospective data was collected from the National Ambulatory Care Reporting System, HealthLink, and Poison and Drug Information Service. Extraction is currently in progress, and we expect to include 20 000 records and 12 000 calls. An interrupted time-series analysis will be completed, allowing for a comparison of trends pre- and post-legalization. Participants have been identified based on International Disease Classifications for cannabis and opiate-related injury. Commonly reported injuries will be clustered to identify changes in injury patterns. Data was collected from October 1st 2013 up to May 31st, 2019 for all EDs within Alberta. 
 Results: Preliminary results suggest the legalization of cannabis initially led to a dramatic increase in ED presentations, followed by a return to pre-legalization volume. HealthLink data suggests a different trend, with steadily increasing calls in the months prior to legalization, followed by stabilization. Cannabis legalization is also correlated with a decrease in post-legalization opiate-related calls (r=-0.51, p=0.01). 
 Conclusion: Overall, national legalization of cannabis appears to be responsible for a short period of increased ED usage, but does not appear to have long-lasting effects on healthcare resource utilization. Differences are apparent between telehealth service and ED use.

Current and future direct healthcare cost burden of chronic obstructive pulmonary disease in Alberta, Canada

OBJECTIVES: To examine the resource use and healthcare costs for chronic obstructive pulmonary disease (COPD) in Alberta, Canada between 2008 and 2016 and model the future costs to 2030.METHODS: Interlinked hospitalization, ambulatory care, practitioner claims and drug databases in Alberta were used to identify COPD healthcare encounters and medications. Canadian Institution for Health Information Cost of a Standard Hospital Stay was used to calculate hospitalization and ambulatory costs and Alberta Drug Benefit List was used to provide drug unit costs. Linear regression and generalized linear model were used to project future COPD healthcare costs.RESULTS: The study included 68,812 hospitalizations, 159,750 ambulatory care visits, 1,239,801 practitioner claims and 3,103,408 drug dispensing events of 70,585 unique patients with COPD. The prevalence of health services use decreased (2008: 1,831 per 100,000 population; 2016: 1,683; p < 0.001), while the patient age increased over time (mean age, 2008: 67.6 years; 2016: 69.9 years; p < 0.001). Number of hospitalizations increased but hospital length of stay decreased over time. A hospitalization with COPD costs CAN$12,994 while an ambulatory care visit costs CAN$602. Annual healthcare costs increased from CAN$115.5 in 2008 to CAN$170.5 million in 2016 (p < 0.001). Hospitalization and drug costs accounted for 65.5% and 19.7%, respectively. Annual healthcare costs for COPD were projected to reach CAN$412.5 million in 2030.CONCLUSION: The healthcare cost burden of COPD for health systems is substantial and is projected to increase further. Interventions to shift COPD management from inpatient to less costly outpatient and home settings to alleviate the cost burden are needed.

Patterns of the initiation of disease-modifying antirheumatic drugs in incident rheumatoid arthritis: a German perspective based on nationwide ambulatory drug prescription data

This study aimed at providing a current and nearly complete picture of the patterns of the initiation of disease-modifying antirheumatic drugs (DMARDs) in patients with newly diagnosed RA. Based on ambulatory drug prescription data and physician billing claims data covering 87% of the German population, we assembled a cohort of incident RA patients aged 15–79 years (n = 54,896) and assessed the prescription frequency of total DMARDs, conventional synthetic (csDMARDs) and biologic DMARDs (bDMARDs) within the first year of disease. Using multiple logistic regression, we estimated the chance of early DMARD receipt based on age, sex, serotype and specialty of prescribing physician while controlling for region of residence. In total, 44% of incident RA patients received a DMARD prescription within the first year of disease. In multiple regression, younger patients (< 35 years) had 1.7-fold higher chances of receiving a csDMARD than patients aged ≥ 65 years [odds ratio (OR): 1.65 with 95% confidence interval (CI) 1.51–1.80] and almost tenfold higher chances to receive a bDMARD [OR (95% CI) 9.5 (8.0–11.3)]. Seropositivity and a visit to a rheumatologist were positively associated with DMARD initiation [OR (95% CI) 2.8 (2.6–2.9) and 5.9 (5.6–6.2) for csDMARDs, respectively]. Based on data covering 87% of the German population, the present study revealed that less than half of incident RA patients receive DMARDs within the first year of disease and that marked differences exist according to age. The study highlights the importance of involving a rheumatologist early in the management of RA.

Utilisation du dossier pharmaceutique en rétrocession : analyse de 5 mois d’expérimentation

The pharmaceutical record integrated in the health insurance card is now exploitable by hospital pharmacists. The aim of this study is to assess the impact of pharmaceutical record's use in hospital drugs sales service and the relevance of this tool to secure the ambulatory dispensing of drugs. All patients admitted in hospital drugs sales service between June and October 2016 were included. With the patient's consent, pharmaceutical record was created and/or consulted and implemented. When it included the city pharmacy's treatment, a pharmaceutical analysis was carried out to research drug interaction with hospital drugs sales service's treatment. If a contraindicated or not recommended association was detected, a pharmaceutical intervention was sent to the general practitioner, by secured mail. Each stage was timed. For the 183 included patients, 40 pharmaceutical records have been created and 74 completed. For the 69 remaining patients, pharmaceutical record could not be used. At the end of these 5 months, 86 pharmaceutical records included city pharmacy's and hospital treatments. The pharmaceutical analysis performed have shown 24 drugs interactions related to hospital treatment; seven inappropriate associations were transmitted to the general practitioner. Five minutes were required for both the use and the analysis of pharmaceutical record. Now, the pharmaceutical record is systematically used in the hospital drugs sales service, and its content is systematically analyzed. It represents one of the tool improving communication between town-hospital networks, and helps secure the ambulatory drugs dispensation.

Economic Impact of Leading Prosperity Diseases: COPD in South East Europe

ECONOMIC BURDEN OF COPD Chronic obstructive pulmonary disease is one of the leading “prosperity diseases” worldwide. Pooled global prevalence rates based on clinical assessments and spirometry ranged from 7.6 to 8.9%, reported in a sound meta-analytical study design (1). It has far reaching consequences, not only for an affected patient’s health but also for the entire national health systems (2). These refer to the substantial work load for the medical facilities due to chronic clinical course of illness and modest success of available treatment approaches. COPD attributable resource utilization patterns are particularly substantial if large university tertiary care hospitals, specialist clinics, and intensive care units are observed (3). According to most of published evidence the key cost driver are periodic exacerbations followed by intensive care unit admissions and episodes of infectious complications (4). Among major cost domains, physician consultations and surgery dominate in high-income settings. Unlike in the West, within the most of South Eastern European region, COPD medical care is still dominated with acquisition costs of pharmaceuticals and oxygen (5) and imaging diagnostics (6). Outpacing of indirect productivity-related opportunity costs by the direct costs of inand outpatient medical care is common to this region due to substantially lower wages of physicians and nursing staff (7). Apart from direct costs of COPD, mainly constituted from the resources consumed in the health care process, including costs of ambulatory care, drug treatment, hospital care, rehabilitation, and long-term home care, there are substantial indirect costs of COPD, which are incurred by productivity losses, premature retirement, and premature mortality from this disease. The indirect costs for premature mortality are being calculated through human capital approach, with the life years lost up to the age of 65 multiplied by the gross annual income. An insight into the economic reality of SEE region, particularly Serbia, with average wages significantly lower than in countries of the Western Europe, but at the same time with high unemployment rates in younger age groups, where some 50% of the working population is currently outside of the workforce (8), being in their most productive decades of life but at the same time most prevalent tobacco users, makes indirect cost of COPD in SEE region very difficult to calculate or even predict, but clearly shows significant magnitude of this burden in present years, and probable rise of these costs in the future. Intangible costs are not convertible into monetary terms and units, they are specifically related to the distress and suffering, which is caused by the disease. General lack of insight into patients’ perception of the disease and limitation and incapability, which it imposes, while healthcare workers are being focused mainly on physical burden of the disease, with very few patients being provided with structurised psychosocial aid in the attempt to overcome significant yet underestimated mental and emotional burden of the disease, makes these costs impossible to predict and foresee.

Patient-Controlled Analgesia for Children at Home

ContextPain is a common and significant symptom experienced by children with advanced malignant disease. There is limited research on pain management of these children at home. ObjectivesTo describe and review the indications for using patient-controlled analgesia (PCA) in the form of a Computerized Ambulatory Drug Delivery device (CADD®) in the home setting. MethodsA retrospective chart review was conducted in children discharged home with opioid infusions using a CADD. Charts from January 2008 to February 2012 were surveyed. ResultsThirty-seven CADDs were dispensed during the study period, and of these, 33 were prescribed for patients with cancer-related pain. A third of the CADDs were commenced at home and almost all PCA CADDs were used for end-of-life care. Hydromorphone was the most commonly prescribed opioid. Patients remained at home and pain control was achieved by either increasing the opioid dose or switching the opioid and using adjuvant therapy. Sixteen patients were readmitted to hospital from home and three admissions were related to pain. The median duration on a PCA CADD at home was 33.7 days (range, 1–150 days), and the mean morphine equivalent dose was 2.13 mg/kg/day. ConclusionPCA with a CADD can be used to manage pain in the home setting. Dose adjustments and opioid switches were performed with no adverse incidents.

Methods for measuring, enhancing, and accounting for medication adherence in clinical trials.

Adherence to rationally prescribed medications is essential for effective pharmacotherapy. However, widely variable adherence to protocol-specified dosing regimens is prevalent among participants in ambulatory drug trials, mostly manifested in the form of underdosing. Drug actions are inherently dose and time dependent, and as a result, variable underdosing diminishes the actions of trial medications by various degrees. The ensuing combination of increased variability and decreased magnitude of trial drug actions reduces statistical power to discern between-group differences in drug actions. Variable underdosing has many adverse consequences, some of which can be mitigated by the combination of reliable measurements of ambulatory patients' adherence to trial and nontrial medications, measurement-guided management of adherence, statistically and pharmacometrically sound analyses, and modifications in trial design. Although nonadherence is prevalent across all therapeutic areas in which the patients are responsible for treatment administration, the significance of the adverse consequences depends on the characteristics of both the disease and the medications.