A discrete choice experiment to understand preferences of patients with type 2 diabetes treated with injectable non-insulinic agents.

OBJECTIVE: To identify and evaluate the Spanish diabetes mellitus type 2 patients' preferences on injection and medication frequency and complexity of the treatment of diabetes. Additionally, patients' willingness to pay is evaluated. METHODS: A total of 180 patients recruited from five health care centres in Spain completed a discrete choice experiment survey designed to evaluate patients' preferences over three attributes discriminating by age, sex and patients experience with previous treatment. The resulting model was analysed using a conditional (fixed-effects) logistic regression. RESULTS: Naïve and non-naïve patients were willing to pay 83.25€ for a 'no preparation required' dose. In addition, both groups of patients were willing to pay 44.30€ for a 'simple preparation' dose. In terms of treatment frequency, no-naïve patients preferred a daily injection with freedom of timing before a daily scheduled injection, willing to pay 22.20€. In addition, no-naïve patients were willing to pay 34.61€ for a weekly injection. Finally, the most valued treatment change in naïve patients was to exchange a daily scheduled injection for a weekly injection, willing to pay 14.35€ for that change. CONCLUSIONS: This study shows that patients highly value the avoidance of injections, with weekly dosing clearly preferred over daily dosing. Of the other attributes, a 'no preparation required' dose is clearly preferred over a 'simple preparation' dose. These findings may provide a better understanding of what patients prefer and value in their treatment and provide guidance for clinicians making therapeutic decisions regarding T2DM treatments.

Estimation of cost-based prices for injectable medicines in the WHO Essential Medicines List.

OBJECTIVES: Challenges remain in ensuring universal access to affordable essential medicines. We previously estimated the expected generic prices based on cost of production for medicines in solid oral formulations (ie, capsules or tablets) on the WHO Model List of Essential Medicines (EML). The objectives of this analysis were to estimate cost-based prices for injectable medicines on the EML and to compare these to lowest current prices in England, South Africa, and India. DESIGN: Data on the cost of active pharmaceutical ingredients (APIs) exported from India were extracted from an online database of customs declarations (www.infodriveindia.com). A formula was designed to use API price data to estimate a cost-based price, by adding the costs of converting API to a finished pharmaceutical product, including the cost of formulation in vials or ampoules, transportation and an average profit margin. RESULTS: For injectable formulations on the WHO EML, medicines had prices above the estimated cost-based price in 77% of comparisons in England (median ratio 2.54), and 62% in South Africa (median ratio 1.48), while 85% of medicines in India had prices below estimated cost-based price (median ratio 0.30). 19% of injectable medicines in England, 9% in South Africa, and 5% in India had prices more than 10 times the estimated cost-based price. Medicines that appeared in the top 20 by ratio of lowest current price to estimated cost-based price for more than one country included numerous oncology medicines-irinotecan, leuprorelin, ifosfamide, daunorubicin, filgrastim and mesna-as well as valproic acid and ciclosporin. CONCLUSIONS: Estimating manufacturing costs can identify cases in which profit margins for medicines may be set significantly higher than average.

A cost-effectiveness analysis of the use of safety-engineered syringes in reducing HBV, HCV, and HIV burden in Egypt.

INTRODUCTION: The objective of this study was to estimate the effects and costs of safety-engineered syringes (SS) as a prevention strategy from HBV, HCV, and HIV infections versus conventional syringes (CS). METHODS: A decision-analytic model with five health states was constructed. The clinical parameters and utilities were derived using published data. Direct medical costs from the health care system perspective were sourced from national data. All costs and effects were discounted at 3.5% annually. RESULTS: The estimate of total quality adjusted life years (QALYs) while using SS were 10.87 compared to 9.20 for the use of CS in the Egyptian population exposed to unsafe injection practices. The total costs for using SS and CS were EGP2,870 and EGP81,794 (I$1,130 and I$32,202), respectively, per 5.9 injections per person per year. Adopting SS resulted in better outcomes (difference; 1.66 QALYs) and total savings (EGP-78,924/I$-31,073) per person. CONCLUSION: Introducing SS in the Egyptian health care system might help in preventing transmission of blood-borne infections that are acquired through health care settings. The overall benefit of investing in this technology is far more than CS. These findings encourage the urgent adoption of SS by health care delivery institutions in similar resource-limited settings.

Building informed trust: developing an educational tool for injection practices and health insurance in Cambodia.

Unnecessary injections increase the risk of blood-borne infections as well as pose an avoidable financial burden on patients. Perceptions in rural Cambodia that medical drug injections provide the best quality medical care have resulted in a large proportion of the population seeking injections across medical conditions. As private providers have a higher propensity to offer injections, patients pursue more expensive care contributing to a greater financial burden. This study aimed to use an educational intervention to improve participant knowledge about injections and health insurance in order to build informed trust in safer injection practices and health insurance. Using an experimental study design, villages in rural Cambodia were randomly assigned to an intervention or control arm. Community educational workshops were implemented to improve participant knowledge about injections and health insurance. Pre-and post-intervention assessments were used to record the resulting changes in knowledge and trust in providers. Statistical analysis of survey results from the two study arms showed increases of 16.8% and 15.9% in study participant knowledge regarding injections and health insurance, respectively. Trust in health insurance increased by 12.9%. However, trust in healthcare providers proved to be resilient with small to no change. These results show that knowledge about injection safety and health insurance, as well as trust in health insurance, can be increased through information dissemination in rural Cambodia. However, health information campaigns may not easily influence people's trust in healthcare providers. Education of the general populace about safe injection practices and health insurance can contribute toward the country's efforts to reach universal health coverage.

Cost-Effective Management of Stenosing Tenosynovitis.

PURPOSE: Stenosing tenosynovitis (STS) is a common condition treated by hand surgeons. Limited evidence exists to support the nonsurgical management of STS. The purpose of this study was to prospectively evaluate a cohort of patients with STS, and to determine the strategy for treating patients with this condition that is most cost effective in terms of dollars reimbursed by payers. METHODS: Prospective data were collected on patients diagnosed with STS between March 2014 and September 2014. All patients were initially treated with a corticosteroid injection. Patients with persistent symptoms were given the option of injection or surgery. A maximum of 3 injections were offered. All patients were evaluated every 6 months through office appointments or phone calls. A cost analysis was performed in our cohort using actual reimbursement rates for injections, initial and established patient visits, and facility and physician fees for surgery, using the reimbursement rates from the 6 payers covering this patient cohort. Cost savings were calculated based on offering 1, 2, and 3 injections. RESULTS: Eighty-eight digits in 82 patients were followed for an average of 21.9 months (range, 18.7-22.7 mo) after an initial corticosteroid injection. Thirty-five digits went on to surgical release, whereas 53 digits were treated nonsurgically. Had all patients initially undergone surgery, the cost would have totaled $169,088.98 ($1,921 per digit). Offering up to 3 injections yielded a potential savings of $72,730 ($826 per digit) or 43% of the total cost. For the 33 patients who underwent more than 1 injection, offering a second injection yielded potential savings of $15,956 ($484 per digit, 22.7%), and for the 7 patients presenting a third time, a third injection saved $1,986 ($283 per digit, 14.5%). CONCLUSIONS: Based on the data from our cohort, the efficient way to treat STS in terms of health care dollars spent is to offer up to 3 injections before surgical release. The first injection had the highest component of cost savings, at $826 per digit. TYPE OF STUDY/LEVEL OF EVIDENCE: Economic/Decision Analysis III.

Cost analysis of injection laryngoplasty performed under local anaesthesia versus general anaesthesia: an Australian perspective.

OBJECTIVE: To conduct a cost analysis of injection laryngoplasty performed in the operating theatre under local anaesthesia and general anaesthesia. METHODS: The retrospective study included patients who had undergone injection laryngoplasty as day cases between July 2013 and March 2016. Cost data were obtained, along with patient demographics, anaesthetic details, type of injectant, American Society of Anesthesiologists score, length of stay, total operating theatre time and surgeon procedure time. RESULTS: A total of 20 cases (general anaesthesia = 6, local anaesthesia = 14) were included in the cost analysis. The mean total cost under general anaesthesia (AU$2865.96 ± 756.29) was significantly higher than that under local anaesthesia (AU$1731.61 ± 290.29) (p < 0.001). The mean operating theatre time, surgeon procedure time and length of stay were all significantly lower under local anaesthesia compared to general anaesthesia. Time variables such as operating theatre time and length of stay were the most significant predictors of the total costs. CONCLUSION: Procedures performed under local anaesthesia in the operating theatre are associated with shorter operating theatre time and length of stay in the hospital, and provide significant cost savings. Further savings could be achieved if local anaesthesia procedures were performed in the office setting.

A Novel Restraint Device for Injection of Galleria mellonella Larvae that Minimizes the Risk of Accidental Operator Needle Stick Injury.

Larvae of the insect Galleria mellonella are increasingly being used for studying pathogenic microbes and their virulence mechanisms, and as a rapid model for screening novel antimicrobial agents. The larvae (waxworms) are most frequently infected by injection of pathogenic organisms into the haemocoel through the insect's prolegs. The mostly widely used method for restraining the waxworms for injection is by grasping them between the operator's fingers, which puts the operator at risk of needle stick injury, an important consideration when working with highly pathogenic and/or drug-resistant microorganisms. While use of a stab proof glove can reduce this risk of injury, it does so at the loss of manual dexterity and speed, resulting in a more labor-intensive, and cumbersome assay. We describe a simple cost effective device (the so-called "Galleria Grabber") for restraining waxworms for injection that keeps the operator's fingers clear of the needle thus reducing the risk of injury.

Epinephrine entrepreneur.

A Minnesota allergist continues his quest to build a better--and cheaper--drug injection device for people with severe food allergies.

Midyear Commentary on Trends in Drug Delivery and Clinical Translational Medicine: Growth in Biosimilar (Complex Injectable Drug Formulation) Products Within Evolving Collaborative Regulatory Interagency (FDA, FTC, and DOJ) Practices and Enforcement.

Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14.2 B/y), Enbrel (etanercept; $8.7 B/y), and Remicade (infliximab; $6.5 B/y). With well-established product market capitalization of these and other top income producers-such as Rituxan (rituximab; $6.8 B/y), Herceptin (trastuzumab; $6.5 B/y), and Avastin (bevacizumab; $5.8 B/y), and a price differential of 15%-30% compared to branded products, there is an intense interest in development of biosimilars by established pharmaceutical companies. Currently, there are 160 biosimilar candidates in clinical studies, many of which are sponsored by large pharmaceutical companies known for product innovation. This trend will likely continue. Additional information on a biomolecule platform is presented in the Journal of Pharmaceutical Sciences Drug Delivery Clinical Trials Database (jpharmscidatabase.org). There are 44,789, 18,456, and 12,897 clinical trials registered to evaluate (1) drug delivery technology, (2) biomolecule platform, and (3) drug metabolism and pharmacokinetic-pharmacodynamic interactions; representing 19%-60% increase over the last 3 years.

[The Safety of Using Long-acting Injections : From an Opposing Position-Is It Better to Administer Long-acting Injections?].

While long-acting injections (LAI) have arrived in Japan as a second-generation antipsy- chotic drug and LAI therapy for the symptom-stabilization phase is garnering attention, deaths associated with paliperidone (PAL) -LAI were sensationally reported, attracting interest regarding the safety of LAIs. In writing this report, an opportunity to oppose LAI usage was provided, so we raise the following three issues concerning the usage of the second-generation antipsychotic LAI for the symptom-stabilization phase. 1) Particularly notable adverse reactions of LAI are those acutely developed and in some cases fatal, including malignant syndrome, diabetic ketoacidosis, torsade de pointes due to pro- longed electrocardiogram QT, and leukopenia. All antipsychotic drugs come with the risk of such adverse reactions, and since the occurrence of adverse reactions cannot be predicted prior to administration, once they have developed, the offending drugs should be immediately reduced or discontinued to remove the drug from the body ; however, since this process can- not be followed with LAIs, such fatal adverse reactions may be protracted. Moreover, in the US, adverse reactions from post injection delirium/sedation syndrome (PDSS) have been reported in relation with olanzapine (OLZ) -LAI. This is a disease state in which the drug rap- idly flows into the blood following LAI intramuscular administration along with an acute increase in blood level, leading to significant sedation (lethargy in some cases) and/or serious symptoms accompanied by delirium ; therefore, in order to minimize these risks, the US FDA has made it mandatory to use a monitoring system referred to as REMS (Risk Evaluation and Mitigation Strategy)for OLZ-LAI. Whether or not the phenomenon occurs only with OLZ-LAI remains to be seen, so careful attention must be paid. 2) In Japanese psychiatric clinical sites, the current situation is that monitoring of adverse reactions for antipsychotic drugs, particularly with outpatients, is not sufficiently carried out Under such circumstances, there remain doubts when it comes to advocating -looking to replace oral drugs with LAI in the symptom-stabilization phase. 3) Replacing oral drugs with LAI in the symptom-stabilization phase significantly increases treatment costs as well as increasing the number of hospital visits. This increase in treatment cost and number of visits may have a large impact on the adherence of the patients to the drugs.

Oxytocin in Uniject Disposable Auto-Disable Injection System versus Standard Use for the Prevention of Postpartum Hemorrhage in Latin America and the Caribbean: A Cost-Effectiveness Analysis.

Postpartum hemorrhage (PPH) is a leading cause of maternal death. Despite strong evidence showing the efficacy of routine oxytocin in preventing PPH, the proportion of women receiving it after delivery is still below 100%. The Uniject injection system prefilled with oxytocin (Uniject) has the potential advantage, due to its ease of use, to increase oxytocin utilization rates. We aimed to assess its cost-effectiveness in Latin America and the Caribbean (LAC). We used an epidemiological model to estimate: a) the impact of replacing oxytocin in ampoules with Uniject on the incidence of PPH, quality-adjusted life years (QALYs) and costs from a health care system perspective, and b) the minimum increment in oxytocin utilization rates required to make Uniject a cost-effective strategy. A consensus panel of LAC experts was convened to quantify the expected increase in oxytocin rates as a consequence of making Uniject available. Deterministic and probabilistic sensitivity analyses were performed. In the base case, the incremental cost of Uniject with respect to oxytocin in ampoules was estimated to be USD 1.00 (2013 US dollars). In the cost-effectiveness analysis, Uniject ranged from being cost-saving (in 8 out of 30 countries) to having an incremental cost-effectiveness ratio (ICER) of USD 8,990 per QALY gained. In most countries these ICERs were below one GDP per capita. The minimum required increment in oxytocin rates to make Uniject a cost-effective strategy ranged from 1.3% in Suriname to 16.2% in Haiti. Switching to Uniject could prevent more than 40,000 PPH events annually in LAC. Uniject was cost-saving or very cost-effective in almost all countries. Even if countries can achieve only small increases in oxytocin rates by incorporating Uniject, this strategy could be considered a highly efficient use of resources. These results were robust in the sensitivity analysis under a wide range of assumptions.

A study on the factors affecting the prescription of injection medicines in Iran: a policy making approach.

BACKGROUND & AIM: Inappropriate prescribing injection medicines can reduce the quality of medical care, patient safety, and leads to a waste of resources. Sufficient evidence is not available in developing countries to persuade policy-makers to promote rational drug prescription. The objective of this study is to assess some factors affecting the prescription of the injection medicines in Iran. METHODS: In this descriptive-analytic study, the data of 91,994,667 selected prescription letters were collected by the Ministry of the Health and Medical Education (MOHME) throughout the country at the year 2011 which were analyzed through a logarithmic regression model. RESULTS: Results of the study show that the percentage of the prescription letters containing injection items varied from 27 percent (in Yazd) to 57 percent (in Ilam). Also the impact of price on the prescription of the injection medicines was not significant (P=0.55). But the impact of the prescription of antibiotics and corticosteroid on injections were significant (P>0.05) and equal 0.44 and 0.65 respectively. CONCLUSION: Increasing price of injection medicines as a policy towards reducing consumptions cannot be a successful policy. But reducing the use of antibiotics and corticosteroids can be a more effective policy to reduce the use of injection medicines.

Cost-Effectiveness of Injectable Extended-Release Naltrexone Compared With Methadone Maintenance and Buprenorphine Maintenance Treatment for Opioid Dependence.

BACKGROUND: The aim of this study was to estimate the cost-effectiveness of injectable extended-release naltrexone (XR-NTX) compared with methadone maintenance and buprenorphine maintenance treatment (MMT and BMT, respectively) for adult males enrolled in treatment for opioid dependence in the United States from the perspective of state-level addiction treatment payers. METHODS: A Markov model with daily time cycles was used to estimate the incremental cost per opioid-free day in a simulated cohort of adult males aged 18-65 over a 6-month period from the state health program perspective. RESULTS: XR-NTX is predicted to be more effective and more costly than methadone or buprenorphine in our target population, with an incremental cost per opioid-free day gained relative to the next-most effective treatment (MMT) of $72. The cost-effectiveness of XR-NTX relative to MMT was driven by its effectiveness in deterring opioid use while receiving treatment. CONCLUSIONS: XR-NTX is a cost-effective medication for treating opioid dependence if state addiction treatment payers are willing to pay at least $72 per opioid-free day.

American Medical Society for Sports Medicine (AMSSM) position statement: interventional musculoskeletal ultrasound in sports medicine.

BACKGROUND: The use of diagnostic and interventional ultrasound has significantly increased over the past decade. A majority of the increased utilisation is by non-radiologists. In sports medicine, ultrasound is often used to guide interventions such as aspirations, diagnostic or therapeutic injections, tenotomies, releases and hydrodissections. OBJECTIVE: Critically review the literature related to the accuracy, efficacy and cost-effectiveness of ultrasound-guided injections (USGIs) in major, intermediate and small joints; and soft tissues. DESIGN: Systematic review of the literature. RESULTS: USGIs are more accurate than landmark-guided injections (LMGIs; strength of recommendation taxonomy (SORT) Evidence Rating=A). USGIs are more efficacious than LMGIs (SORT Evidence Rating=B). USGIs are more cost-effective than LMGIs (SORT Evidence Rating=B). Ultrasound guidance is required to perform many new procedures (SORT Evidence Rating=C). CONCLUSIONS: The findings of this position statement indicate there is strong evidence that USGIs are more accurate than LMGI, moderate evidence that they are more efficacious and preliminary evidence that they are more cost-effective. Furthermore, ultrasound-guided (USG) is required to perform many new, advanced procedures and will likely enable the development of innovative USG surgical techniques in the future.

Economic impact of converting from 10-mL insulin vials to 3-mL vials and pens in a hospital setting.

PURPOSE: The economic impact associated with the conversion from 10-mL vials of insulin to 3-mL vials and pens at a community hospital was assessed. METHODS: Pharmacy purchasing and administrative data from Providence St. Vincent Hospital in Portland, Oregon, were used in this analysis. The hospital converted floor-stock 10-mL vials of insulin in October 2010 to individual patient supply (IPS) 3-mL vials and pens. Insulin acquisition costs from the nine-month preconversion period were compared with those during the nine-month postconversion period. RESULTS: Before the conversion, total acquisition costs were $168,783 for 5,086,500 units of insulin. After the conversion, total acquisition costs were reduced by 8.6% (to $154,303) and units purchased were reduced by 33.1% (to 3,404,900 units of insulin). The analyses also examined the results of converting to 3-mL vials of rapid-, short-, or intermediate-acting insulin to 3-mL pens of long-acting insulin analog. Conversion from 10- to 3-mL vials was associated with a 37.6% reduction in units of insulin and a 23.5% reduction in acquisition costs. In contrast, switching from 10-mL vials to 3-mL pens was associated with a 10.1% increase in costs, despite the fact that there was a 11.5% reduction in units purchased. CONCLUSION: Conversion from floor-stock 10-mL insulin vials to IPS 3-mL insulin vials or pens reduced the number of units of insulin purchased and expenditures for insulin. The overall cost savings was driven by the conversion from 10- to 3-mL vials, whereas cost increased for the conversion of 10-mL vials to 3-mL pens for long-acting insulin analogs.