Joint pain treatment planning in osteoarthritis patients with chronic kidney disease

Treatment of osteoarthritis, as the most common pathology of the musculoskeletal system, presents certain clinical difficulties in comorbid patients. The frequent combination of osteoarthritis (OA) and cardiovascular diseases (CVD), diabetes mellitus type 2 and other cardiometabolic pathologies raises questions about the safety of pain relievers in the presence of chronic kidney disease (CKD). Safe treatment for chronic pain syndrome implies an informed decision about the risks / benefits of using any analgesic intervention. Particular attention should be paid to the decision on the appointment of non-steroidal anti-inflammatory drugs (NSAIDs). An alternative strategy for the treatment of joint pain in patients with CKD may be the use of chondroitin sulfate prescription form. Particular attention should be paid to the possibility of using the parenteral form of the drug, which has reliable evidence, faster onset of the clinical effect of analgesia, with a potential protective effect on the structure of joint tissues.

REDUCE-IT: outcomes by baseline statin type

Background REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial) randomized 8,179 statin-treated patients with elevated triglycerides and increased cardiovascular (CV) risk to either icosapent ethyl (IPE), a pure, stable prescription form of eicosapentaenoic acid, 4g/day or placebo. IPE significantly reduced time to first occurrence of the primary composite endpoint of major adverse CV events (CV death, nonfatal myocardial infarction [MI], nonfatal stroke, coronary revascularization, or hospitalization for unstable angina) (HR 0.75, CI 0.68–0.83) and key secondary endpoint events (composite of CV death, nonfatal MI, or nonfatal stroke) (HR 0.74, CI 0.65–0.83) versus placebo (all p<0.0001). A modest reduction in placebo-corrected LDL-C was observed (−6.6%; p<0.0001). The mechanisms for the CV benefit of icosapent ethyl are not fully understood. Purpose Explore the impact of statin type and lipophilic/lipophobic category on outcomes, and on LDL-C, to further consider the possible relevance of LDL-C pathways to the observed CV benefit of icosapent ethyl. Methods Primary and key secondary endpoint analyses and LDL-C changes from baseline were explored by individual statin type (atorvastatin, simvastatin, rosuvastatin, or pravastatin) at baseline, and then by categorizing these statins into lipophilic (i.e., hydrophobic: atorvastatin, simvastatin) and lipophobic (i.e., hydrophilic: rosuvastatin, pravastatin) statin groups; 96.1% of patients fell within these individual statin groups. Results CV outcomes were similar across statin types (interaction p=0.61) and lipophilic/lipophobic categories (interaction p=0.51) (Figure). Statin type and category had a similar lack of meaningful impact on the modest placebo-corrected median LDL-C changes from baseline to one year, which ranged from −5.8 to −8.4% (all p≤0.0003). Conclusion No meaningful treatment differences in the primary or key secondary endpoints across statin type or lipophilic/lipophobic category were observed. A similar lack of treatment difference was observed in LDL-C changes from baseline to one year. Therefore, the LDL-C changes and CV risk reduction in REDUCE-IT appear independent of the type of concomitant statin therapy. These data provide clinicians with additional insight regarding concomitant statin therapy considerations when prescribing icosapent ethyl and suggest there are important mechanisms of action for the substantial CV risk reduction observed with icosapent ethyl that are distinct from the LDL receptor pathway. Funding Acknowledgement Type of funding source: Other. Main funding source(s): The study was funded by Amarin Pharma, Inc.

REDUCE-IT: total ischemic events reduced across the full range of baseline LDL cholesterol and other key subgroups

Background REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial), a study of 8,179 randomized statin-treated patients with elevated triglycerides (TG) and increased cardiovascular (CV) risk followed for a median of 4.9 years, demonstrated robust results. Icosapent ethyl (IPE), a pure and stable prescription form of eicosapentaenoic acid, 4g/day reduced both time-to-first and total primary endpoint ischemic events (CV death, nonfatal myocardial infarction [MI], nonfatal stroke, coronary revascularization, or hospitalization for unstable angina) by 25% (HR 0.75; 95% CI 0.68–0.83; p<0.0001) and 30% (rate ratio 0.70; 95% CI 0.62–0.78; p<0.0001), respectively. Similar substantial reductions in first and total key secondary endpoint ischemic events (composite of CV death, nonfatal MI, or nonfatal stroke) were also observed. Demographic and baseline disease characteristics were generally balanced across treatment groups. Time-to-first event analyses showed robust and generally consistent benefit across subgroups. Previous total event analyses by baseline TG demonstrated large, consistent, statistically significant reductions across tertiles, suggesting the CV benefit of IPE is tied primarily to non-TG factors. Purpose Further explore the extent to which IPE reduced total primary and key secondary events across prespecified baseline demographic, disease, treatment, and lipid/lipoprotein/inflammatory biomarker subgroups. Methods Total events across subgroups were assessed with the prespecified negative binomial regression method. Main outcomes were total (first and subsequent) primary and key secondary composite endpoint events. Results Median baseline LDL-C levels in ascending tertiles were 58, 76, and 96 mg/dL; there were large, significant relative reductions in total primary endpoint events with IPE across tertiles (35%, 28%, and 27%, respectively; interaction p=0.62), with parallel substantial absolute risk reductions. Similar, significant relative reductions of 33%, 28%, and 24% in total key secondary endpoint events were observed, along with substantial absolute risk reductions. Total events analyses of prespecified subgroups also demonstrated robust and generally consistent findings for the primary and key secondary composite endpoints. Conclusion REDUCE-IT demonstrated substantial reductions in first and total primary and key secondary endpoint ischemic events, with robust and generally consistent results across baseline TG and LDL-C levels, as well as other prespecified baseline biomarker, demographic, disease, and treatment subgroups. These analyses provide useful insights for clinicians considering the range of patients who may benefit from IPE therapy and suggest that mechanisms beyond the lipid/lipoprotein/inflammatory pathways tested, including mechanisms beyond the LDL receptor pathways, may contribute to the observed substantial reductions in total ischemic burden with IPE therapy. Funding Acknowledgement Type of funding source: Other. Main funding source(s): The study was funded by Amarin Pharma, Inc.

P35 Paediatric rheumatology virtual biologic clinic (VBC)

AimTo improve the overall process for the prescribing of biologics within the paediatric rheumatology service. The VBC would help achieve the following:Successful implementation within the service.Streamlined process for cost effective prescribing of biologics in line with national guidance.Ensuring all patients receive the appropriate pre–biologic checks and documentation of core set criteria (where possible) to ensure safe prescribing.Ascertaining other funding mechanisms for patients who do not meet national guidance or commissioning criteria.MethodsThe VBC was modelled on the adult service and the process comprises of the following:Patients starting or switching biologic therapy are highlighted in clinic.Patients who require continuation in therapy are highlighted by the pharmacy homecare team.For new patients, pre–biologic checks are ordered and routine bloods are requested for those continuing therapy.VBC comprises of a 2 hour multidisciplinary team (MDT) meeting between a consultant paediatric rheumatologist or senior fellow, specialist nurse and pharmacist.Patients referred to VBC are reviewed against our biologics clerking sheet. Ensuring pre–biologic checks have been completed, routine bloods have been checked, core set criteria has been recorded, patient is compliant with national guidance and that the appropriate Blueteq form has been completed.A homecare registration (if required) and prescription form are completed.A telephone consultation with the parent/patients is provided by the pharmacist explaining the homecare process and answering any clinical questions.The specialist nurse completes output documentation for GP and arranges next follow up.A real–time biologics database records core quality data for auditing purposes.VBC list is sent to the service manager for reimbursement.Patients who do not meet national guidance are referred to the weekly MDT.ResultsThe service has 120 patients being treated on biologics. Since November 2018, 112 patients of these patients have been reviewed. 1.7% have been non-compliant with national guidance and 5% did not have Blueteq numbers.The VBC has enabled the MDT to assess response to biologic therapies by ensuring core set criteria is being recorded. A snapshot audit showed that documentation had increased from 25% to 50%.Prescription turnaround time has reduced from 7 days to 3 days preventing treatment delay.DiscussionVBC has enabled the majority of patients to be reviewed, whilst showing we are compliant with national guidance. Routine and pre-biologic bloods had been requested for all patients and the recording of core set criteria had shown some improvement. Although not achieving the required level of documentation. Telephone consults have been perceived well by patients/parents. Having a pharmacist prescriber has had a positive outcome within the MDT and both the workflow and workload has improved.ConclusionThe VBC has been pivotal in improving patient care within the service. The MDT have collaboratively been able to ensure cost-effective prescribing, improve data collection, and reduce treatment delay whilst enhancing the pharmacist’s role. The process has highlighted the documentation of core set criteria is still low and requires further improvement. Ensuring compliance with NHS England commissioning criteria, Blueteq forms should be completed prior to prescriptions being written.

Method of quality improvement and economic efficiency of pharmacotherapy for community-acquired pneumonia and its utility in Ukraine health-care facilities

Aim. Development of a method quality improvement and economic efficiency of pharmacotherapy for community-acquired pneumonia with the possibility of its further use in Ukraine health care facilities. Material and Methods. The object of the study was medical documentation of patients (n=370) diagnosed with community-acquired pneumonia (1st group - patients treated in 2017 on a regular prescription (n=270); 2nd group - patients treated in 2018 according to the "Standardized prescription form" developed by the authors (n=100)). According to the presence of complications or concomitant pathology, patients of both groups were divided into 4 subgroups: subgroup 1 - patients with the main diagnosis - community-acquired pneumonia without complications and concomitant pathology; 2 - patients with community-acquired pneumonia and its complications; 3 - patients with community-acquired pneumonia and concomitant pathology; 4 - patients with community-acquired pneumonia, its complications and concomitant pathology. The following methods were applied: system analysis, analytical and comparative, systematic literature searching, clinical, pharmacological, pharmaceutical, statistical, structural and logical, economic. Results and Discussion. The "Standardized prescription form" was developed and implemented in the therapeutic department of one of inpatient health care establishments of Lviv, which treated 100 patients at the time of the study. Quality assessment of pharmacotherapy revealed a decrease in the number of medication-related problems in patients of group 2 (17 medication-related problems per 100 patients) compared to patients of group 1 (4364 medication-related problems in 270 patients). The results of the study of differences in the average cost of one prescription form of patients of the 1st and 2nd groups revealed a possiblility ofa significant reduction of the average cost of pharmacotherapy per patient (p <0.0001) with the application of our invention: in subgroup 1 - by 1426. 23 UAH [47.81 $] (from 2418.325 UAH [84. 47 $] in 2017 to 992. 10 UAH [36.66 $] in 2018); in subgroup 2 - by 1527.72 UAH [50.94 $] (from 2724.40 UAH [95.16 $] to 1196.68 UAH [44.22 $]); in subgroup 3 - by 1267.87 UAH [42.11 $] (from 2338.31 UAH [81.67 $] to 1070.44 UAH [39.56]) and in subgroup 4 - by 908.39 UAH [28.96 $] (from 2272.755 UAH [79.38 $] in 2017 to 1364.37 UAH [50.42 $] in 2018). Thus, the new form of regular prescription form used by us allowed rationalizing pharmacotherapy of community-acquired pneumonia, saving 128 255. 25 UAH [4245.5 $] on averagefor 100 treated patients. Conclusions. By applying the "Standardized prescription form", we not only managed to reduce the number of medication-related problems resulting from irrational use of medications, but also significantly reduced economic costs of treating patients with community-acquired pneumonia. The total cost savings as a result of the patients' pharmacotherapy rationalization was 128,255.25 UAH ($ 4,245.50) per 100 treated patients. Keywords: community-acquired pneumonia, medication-related problems, cost of pharmacotherapy, rational pharmacotherapy

Drug Utilization Pattern by Using WHO Core Prescribing Indicators in Orthopedics and Obstetrics / Gynecology Departments of a Tertiary Care Hospital

Introduction: Drug utilization research is an important tool to facilitate rational use of drugs. In low income countries irrational use of drugs is a common problem like overuse of drugs and inappropriate use of antibiotics, leading to poor treatment outcome and increased burden of treatment. This study was conducted to provide understanding of drug utilization pattern by using WHO Core Prescribing Indicator. Methods: This study was conducted in Orthopedics and Obstetrics / Gynecology departments. Patients visiting these Out Patient Departments with at least one drug on prescription form were included in the study. Further, information related to WHO Core Prescribing Indicators were collected in pre-designed proforma. Results: Average number of drugs prescribed per prescription was 2.6. Means of number of drugs prescribed in Orthopedics and Obstetrics / Gynecology departments were 2.9 and 2.3 respectively (p < 0.001). Drugs prescribed in generic name and from essential drug list was 41.4% and 34.3% respectively. Prescription forms with generic name in Orthopedics department were significantly more compared to Obstetrics / Gynecology department (p = 0.00002). However, there was an increased tendency to prescribe drugs from essential drug list in Obstetrics / Gynecology department compared to Orthopedics department (p < 0.001). Conclusion: Drugs were prescribed by generic name and from essential drug list, but this was not sufficient to meet the ideal values of WHO Core Prescribing Indicator. Therefore, prioritization on prescribing drugs by generic name and from essential drug list by respective departments to achieve the standards of WHO needs to be encouraged.

General practitioners’ concepts on issuing out-of-pocket prescriptions for hypnotics and sedatives in Germany

Background In Germany, almost 50% of prescriptions for benzodiazepines and drugs as Zolpidem and Zopiclone are as out-of-pocket (OOP) prescriptions—requiring patients to buy the drug at their own expense—although almost 90% of the population has statutory health insurance covering medication costs. Objective To understand why general practitioners (GPs) choose this prescribing method since needed medications are insurance covered, and unnecessary drugs should not be prescribed at all. Methods In this qualitative study, 17 semi-structured interviews with GPs were conducted, audio recorded and transcribed verbatim. Transcripts were analysed with grounded theory to extract a model explaining the described behaviour. Results Knowing the significant medical risks and insecurity about regulations makes GPs wish to avoid hypnotics and sedatives. They achieve this by ‘Creating a barrier’ (central phenomenon) and employing the strategy ‘Using an out-of-pocket prescription’, which not only generates costs for the patient but also reduces the physicians´ legal and financial accountability. The perceived patient type, expected problem duration and diagnosis influence the decision about the prescription form: patients with an alcohol or drug addiction or those with ‘uncomplicated’ insomnia are more likely to receive an OOP prescription. Patients with any psychiatric diagnosis will likely receive a statutory health insurance prescription. Discussion Current regulations do not provide guidance to GPs regarding hypnotics and sedatives. A clear regulatory framework and guidelines could possibly reduce physicians’ defensive attitudes about these drugs and their use of OOP prescriptions. The approach to use OOP prescriptions as a barrier to reduce patients’ medication use lacks evidence regarding effectiveness.

Opioids in the treatment of non-specific acute and chronic pain

After reading this article, the reader will be familiar with the general classes of opioid agonists and partial agonists, the basics of the pharmacokinetics and pharmacodynamics of opioids, the risks of opioid therapy and the requirements for the safe and effective use of opioids in acute and chronic pain. The use of opioids during surgical procedures or anesthesia is not discussed. Also, there is no discussion about various available opioid antagonists that are used to treat overdose and the various disorders associated with their use (including naloxone and naltrexone). Opioids are available, the most powerful and effective analgesics, and have become acceptable drugs for the treatment of acute and cancerous pain. However, there is concern about their use in case of chronic pain, if there is no cancer, because they are long-range ineffective but best suited for stopping this pain. Opioid prescription must be monitored for better use. Chronic pain creates discomfort for these patients, reducing their productivity and efficiency, which, in turn, can lead to economic problems in the country. The choice of Nalbuphine is due to the following reasons: the opioid, which is comparable to morphine by its analgesic potential, but has a better safety profile for nausea, vomiting and respiratory depression; not subject to strict quantitative accounting (extract on prescription form 1); the choice of opioid analgesics is significantly limited in Ukraine.

Treatment by untrained providers among sick infants in rural Odisha, India

Aim: This study assessed the diagnosis, treatment and referral service provided by untrained providers for sick infants. Background: In rural India, lack of trained providers causes inopportune treatment of sick infants and results in increase in child morbidity and mortality. The untrained providers deliver a significant proportion of health care for rural infants; however, there is a paucity of information on their treatment practice. Method: A cross-sectional study was conducted in three rural blocks of Odisha. A total of 337 prescriptions recommended for sick infants were collected from the 15 untrained providers using pre-designed prescription form – designed as per the Integrated Management of Neonatal and Childhood Illness (IMNCI) guideline. The forms were collected through the periodic visit and regular follow-up to the providers. Findings: A total of 68% of infants were diagnosed with the possible serious bacterial infection, 56% fever, 10% feeding problems, 9% dysentery and 9% local bacterial infection. A total of 61% of sick infants prescribed antibiotics – cephalosporin was commonly prescribed (56%). Among severe persistent diarrhea-diagnosed infants, 76% prescribed oral rehydration salt (ORS), 48% zinc and 62% of them received various antibiotics. The untrained providers referred 23% of sick infants to trained providers/facilities. In rural settings, most of the sick infants sought care from untrained providers; however, none of them followed any standard treatment protocol. This study suggests there is a need for training on common disease algorithm and treatment using a standard guideline for untrained providers to reduce inopportuneness in the treatment of sick infants, promoting early diagnosis and referral services to public health systems.