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Review of economic data on closed system transfer drug for preparation and administration of hazardous drugs.

OBJECTIVES: The objectives of this study were to review economic data on the use of closed system drug transfer devices (CSTDs) for preparing and administering hazardous drugs, and to evaluate the quality of data reporting as defined by the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). METHODS: All references from a recent Cochrane review about CSTDs were evaluated for inclusion. A literature review was also conducted. Articles containing economic data about the use of CSTDs were retained for analysis. Two researchers independently graded the articles according to the 24-item CHEERS checklist. RESULTS: Of the 138 articles identified initially, 12 were retained for analysis. Nine of these studies did not report acquisition costs or did not detail acquisition costs. Six studies reported economic benefits associated with the used of CSTDs, all related to extending the beyond-use date. The mean number of CHEERS criteria fulfilled by the included articles was 9.2 (SD 2.4). CONCLUSIONS: CSTDs are costly to acquire. However, few studies have examined the economic impact of these devices, and the existing studies are incomplete. As a result, hospitals planning to implement these devices will be unable to make a sound economic evaluation. Robust economic evaluation of CSTDs is needed.

Ministério da Saúde anuncia estratégias de reabastecimento de medicamentos de intubação - 25.08.2020

Use of controlled temperature chain and compact prefilled auto-disable devices to reach 2030 hepatitis B birth dose vaccination targets in LMICs: a modelling and cost-optimisation study.

BACKGROUND: Hepatitis B causes more than 800 000 deaths globally each year. Perinatal infections are a major driver of this burden but can be prevented by vaccination within 24 h of birth. Currently, only 44% of newborn babies in low-income and middle-income countries (LMICs) receive a timely birth dose. We investigated the effects and cost-effectiveness of implementing ambient storage of hepatitis B vaccines under a controlled temperature chain (CTC) protocol and the use of compact prefilled auto-disable (CPAD) devices for community births. METHODS: In this mathematical modelling study of perinatal hepatitis B transmission and disease progression, we estimated the coverage impact and cost-effectiveness of implementing CTC and CPAD interventions in the six Global Burden of Disease (GBD) regions containing LMICs. Combinations of four different scenarios of birth dose delivery strategies (cold chain, CTC) and interventions (needle and syringe, CPAD) were modelled across facility or community birth locations. We also estimated the minimum cost and most cost-effective strategy to achieve the WHO 90% hepatitis B birth dose coverage target in GBD regions and in 46 LMICs with a reported coverage of less than 90%. FINDINGS: Current delivery protocols achieved a maximum coverage of 65% (IQR 64-65) across GBD regions. Reaching 90% hepatitis B birth dose coverage across all GBD regions was estimated to cost a minimum of US$687·5 million per annum ($494·0 million more than the estimated current expenditure), of which $516·5 million (75%) was required for CTC and CPAD interventions. Reaching 90% coverage in this way was estimated to be cost saving in five of the six regions (and in 40 of 46 LMICs individually assessed) due to the disease costs averted, with the cost per disability-adjusted life-years averted being less than $83·27 otherwise. INTERPRETATION: Hepatitis B birth dose coverage of 90% is unlikely to be reached under current protocols. CTC and CPAD vaccine strategies present cost-effective solutions to overcome coverage barriers. FUNDING: The Burnet Institute.

Importance of reasons for stocking adult vaccines.

OBJECTIVES: To identify the most important reasons underlying decisions to stock or not stock adult vaccines. STUDY DESIGN: US physicians, nurses, pharmacists, and administrators of internal medicine, family medicine, obstetrics/gynecology, and multispecialty practices who were involved in vaccine stocking decisions (N = 125) completed a best-worst scaling survey online between February and April 2018. METHODS: Sixteen potential factors influencing stocking decisions were developed based on key informant interviews and focus groups. Respondents selected factors that were most and least important in vaccine stocking decisions. Relative importance scores for the best-worst scaling factors were calculated. Survey respondents described which vaccines their practice stocks and reasons for not stocking specific vaccines. Subgroup analyses were performed based on the respondent's involvement in vaccine decision making, role in the organization, specialty, and affiliation status, as well as practice characteristics such as practice size, insurance mix, and patient age mix. RESULTS: Relative importance scores for stocking vaccines were highest for "cost of purchasing vaccine stock," "expense of maintaining vaccine inventory," and "lack of adequate reimbursement for vaccine acquisition and administration." Most respondents (97%) stocked influenza vaccines, but stocking rates of other vaccines varied from 39% (meningococcal B) to 83% (tetanus-diphtheria-pertussis). Best-worst scaling results were consistent across respondent subgroups, although the range of vaccine types stocked differed by practice type. CONCLUSIONS: Economic factors associated with the purchase and maintenance of vaccine inventory and inadequate reimbursement for vaccination services were the most important to decision makers when considering whether to stock or not stock vaccines for adults.

Cost-reduction strategy for isoproterenol use in radiofrequency catheter ablation procedures.

PURPOSE: A cost-reduction strategy for isoproterenol use in radiofrequency catheter ablation procedures was evaluated. SUMMARY: A medication-use evaluation at a 454-bed tertiary medical center revealed that the cardiac catheterization laboratory was the highest user of isoproterenol. Isoproterenol was removed from all AcuDose-Rx machines Omnicell, Mountain View, CA, and compounding was performed by pharmacy personnel. It was initially provided to the cardiac catheterization laboratory as an 8-µg/mL concentration in 20-mL 0.9% sodium chloride injection syringes with a 24-hour beyond-use date. This resulted in an initial cost savings but with an unacceptably high rate of wastage. Isoproterenol was then compounded as a 4-µg/mL concentration in 30 mL 5% dextrose in water syringes with a 9-day beyond-use date after a thorough literature search supported longer stability with this admixture. After 12 months of our current process, isoproterenol use during radio frequency catheter ablations (RFCAs) in the cardiac catheterization laboratory was reduced by 85%, decreasing the number of ampules used from 11.15 to 1.66 per week. CONCLUSION: A pharmacy-initiated process to mitigate an extraordinary increase in isoproterenol acquisition cost resulted in a reduction in usage in a tertiary care community hospital. Isoproterenol usage was reduced 85% after two different interventions were implemented, which is estimated to save $1,839 per procedure.

Field-derived estimates of costs for Peste des Petits Ruminants vaccination in Ethiopia.

In 2015, the OIE and FAO launched a global eradication programme for Peste des Petits Ruminants (PPR). Vaccination is a major component of this strategy yet the costs of implementing a campaign are unknown or based on assumptions without field-based verification necessary for effective economic planning. This study used experiences of attending four PPR vaccination campaigns in Ethiopia to estimate various cost components in pastoral and mixed-crop livestock systems. These components included: cost of vaccine; vaccine transport from the producer to the local storage facility; storage of vaccine at the local facility; delivery and administration of vaccine in the field; opportunity cost of farmer's time to attend the vaccination; co-ordination of vaccination campaign; publicity and mobilisation costs; vaccine wastage from missed shots and vaccine discard. The overall cost of vaccination was approximately 6 Ethiopian birr (ETB) or US$0.2 per animal in the mixed-crop livestock system compared to approximately 3ETB or US$0.1 in pastoral areas. The relative importance of cost components varied in the two systems with farmer time being the largest contributor in the mixed-crop livestock system while field delivery was the main cost in pastoral areas. Notable vaccine wastage was observed particularly through missed shots that were typically between 0 and 10% but as high as 33%. At the national level, the output of the stochastic model showed the cost of vaccination to be highly variable particularly in the mixed-crop livestock system. These results highlight the importance of doing economic assessments of vaccination campaigns and issues that may be compromising efficiency of delivery and vaccine coverage. It is recommended that the framework be used for further economic evaluations of vaccination for PPR and other livestock diseases particularly when limited public or donor funds are being used, and that the approach be expanded to other countries and regions.

Impact of drug storage systems: a quasi-experimental study with and without an automated-drug dispensing cabinet.

OBJECTIVE: To compare the costs and benefits of an automated-drug dispensing cabinet (ADC) versus traditional floor stock storage (TFSS). DESIGN: A quasi-experimental multicenter study conducted during 2015. SETTING: A teaching hospital (814 beds) equipped with 43 ADCs and a not-for-profit teaching hospital (643 beds) equipped with 38 TFSS systems, in Paris, France. PARTICIPANTS: All the wards of the two hospitals were included in the study. INTERVENTION(S): ADC versus TFSS. MAIN OUTCOME MEASURE(S): A composite outcome composed of cost and benefits. RESULTS: The total cost with payback period was substantially higher for the ADCs (574 006€ for 41 ADCs) than TFSS (190 305€ for 30 TFSS systems). The mean number of costly drugs and units were significantly higher for ADCs (P < 0.001). There was no significant difference in the mean number of overall drugs and units. There were significantly fewer urgent global deliveries with ADCs than TFSS units. Nurses' satisfaction with ADCs was high and the prevalence of medication process errors related to ADCs was low. No event due to storage errors was reported for ADCs and nine events were reported for TFSS units. On the contrary, informatic-related events increased with the use of ADCs, as expected. CONCLUSIONS: Overall, ADCs are well-established in wards and are particularly appreciated by nurses. A significant difference in the initial investment cost was confirmed, but it must be adjusted over time. This difference is offset in the long-term by gains in preparation time and fewer medication process errors, securing the medication process.

Challenges of dispensing costly tablets with short shelf-life.

Afatinib, trametinib and regorafenib are three costly oral oncology drugs with a short shelf-life after the original container has been opened. Their short shelf-lives are due to degradation on exposure to moisture. Therefore, manufacturers recommend them to be dispensed in the original packaging with the desiccant. However, the prescribed quantities do not always match the quantities in the original packaging, usually because of dose modifications for toxicities. This leads to potentially significant drug wastage and financial losses. We describe some potential approaches to this issue.

Cost-effectiveness of the controlled temperature chain for the hepatitis B virus birth dose vaccine in various global settings: a modelling study.

BACKGROUND: The controlled temperature chain (CTC) strategy allows vaccines to be kept outside the cold chain for a short period of time. In remote rural areas, the CTC strategy for the hepatitis B virus (HBV) birth dose vaccination could improve its geographical coverage and timeliness of delivery, but with additional outreach costs. We assessed the cost-effectiveness of the CTC strategy for the HBV birth dose across six world regions and 72 countries according to their HBV prevalence, delivery costs, and birth dose coverage and timing. METHODS: By use of a mathematical model of perinatal HBV transmission and disease progression, we calculated per 1000 births the total HBV-related disability-adjusted life-years (DALYs) and costs, including vaccine delivery costs and costs associated with HBV-related disease, with and without the CTC strategy. FINDINGS: A CTC strategy produced health benefits in all regions and was cost-saving in the regions of east Asia and Pacific, Latin America and Caribbean, sub-Saharan Africa, and north Africa and Middle East. The CTC strategy cost US$0·15 (IQR -7·11 to 4·75) per DALY averted in the central and eastern Europe and central Asia region and $79·72 (66·47 to 94·47) in the south Asia region. Within individual countries, more savings were achieved and more DALYs averted in areas with above average HBV prevalence, below average birth dose coverage, or later than average birth dose delivery. INTERPRETATION: A CTC outreach strategy that improves the timing and coverage of the HBV birth dose vaccination is likely to be cost-saving and reduce the burden of HBV infection associated with perinatal transmission. FUNDING: Burnet Institute.

Evaluating scenarios of locations and capacities for vaccine storage in Nigeria.

Many developing countries still face the prevalence of preventable childhood diseases because their vaccine supply chain systems are inadequate by design or structure to meet the needs of their populations. Currently, Nigeria is evaluating options in the redesign of the country's vaccine supply chain. Using Nigeria as a case study, the objective is to evaluate different regional supply chain scenarios to identify the cost minimizing optimal hub locations and storage capacities for doses of different vaccines to achieve a 100% fill rate. First, we employ a shortest-path optimization routine to determine hub locations. Second, we develop a total cost minimizing routine based on stochastic optimization to determine the optimal capacities at the hubs. This model uses vaccine supply data between 2011 and 2014 provided by Nigeria's National Primary Health Care Development Agency (NPHCDA) on Tuberculosis, Polio, Yellow Fever, Tetanus Toxoid, and Hepatitis B. We find that a two-regional system with no central hub (NC2) cut costs by 23% to achieve a 100% fill rate when compared to optimizing the existing chain of six regions with a central hub (EC6). While the government's leading redesign alternative - no central three-hub system (Gov NC3) - reduces costs by 21% compared with the current EC6, it is more expensive than our NC2 system by 3%. In terms of capacity increases, optimizing the current system requires 42% more capacity than our NC2 system. Although the proposed Gov NC3 system requires the least increase in storage capacity, it requires the most distance to achieve a 100% coverage and about 15% more than our NC2. Overall, we find that improving the current system with a central hub and all its variants, even with optimal regional hub locations, require more storage capacities and are costlier than systems without a central hub. While this analysis prescribes the no central hub with two regions (NC2) as the least cost scenario, it is imperative to note that other configurations have benefits and comparative tradeoffs. Our approach and results offer some guidance for future vaccine supply chain redesigns in countries with similar layouts to Nigeria's.

Demonstration of the Use of Remote Temperature Monitoring Devices in Vaccine Refrigerators in Haiti.

After the 2010 earthquake, Haiti committed to introducing 4 new antigens into its routine immunization schedule, which required improving its cold chain (ie, temperature-controlled supply chain) and increasing vaccine storage capacity by installing new refrigerators. We tested the feasibility of using remote temperature monitoring devices (RTMDs) in Haiti in a sample of vaccine refrigerators fueled by solar panels, propane gas, or electricity. We analyzed data from 16 RTMDs monitoring 24 refrigerators in 15 sites from March through August 2014. Although 5 of the 16 RTMDs exhibited intermittent data gaps, we identified typical temperature patterns consistent with refrigerator door opening and closing, propane depletion, thermostat insufficiency, and overstocking. Actual start-up, annual maintenance, and annual electricity costs for using RTMDs were $686, $179, and $9 per refrigerator, respectively. In Haiti, RTMD use was feasible. RTMDs could be prioritized for use with existing refrigerators with high volumes of vaccines and new refrigerators to certify their functionality before use. Vaccine vial monitors could provide additional useful information about cumulative heat exposure and possible vaccine denaturation.

Costing analysis and anthropological assessment of the vaccine supply chain system redesign in the Comé District (Benin).

OBJECTIVE: At the end of 2013, a pilot experiment was carried out in Comé health zone (HZ) in an attempt to optimize the vaccine supply chain. Four commune vaccine storage facilities were replaced by one central HZ facility. This study evaluated the incremental financial needs for the establishment of the new system; compared the economic cost of the supply chain in the Comé HZ before and after the system redesign; and analyzed the changes induced by the pilot project in immunization logistics management. METHOD: The purposive sampling method was used to draw a sample from 37 health facilities in the zone for costing evaluation. Data on inputs and prices were collected retrospectively for 2013 and 2014. The analysis used an ingredient-based approach. In addition, 44 semi-structured interviews with health workers for anthropological analysis were completed in 2014. RESULTS: The incremental financial costs amounted to US$55,148, including US$50,605 for upfront capital investment and US$4543 for ongoing recurrent costs. Annual economic cost per dose administered (including all vaccines distributed through the Expanded Program on Immunization (EPI)) in the Comé HZ increased from US$0.09 before system redesign to US$0.15 after implementation, mainly due to a high initial investment and the operational cost of HZ mobile warehouse. Interviews with health workers suggested that the redesigned system was associated with improvements in motivation and professional awareness due to training, supportive supervision, and improved work conditions. CONCLUSIONS: The system redesign involved a considerable investment at HZ level. Benefits were found in the reduction of transportation costs to health posts (HP) and commune health center (CHC) levels, and the strengthening of health workers professional skills at all levels in Comé. The redesigned system contributed to a decrease in funding needs at HP and CHC levels. The benefits of the investment need to be examined after the introduction of new vaccines and after a longer period.

When are solar refrigerators less costly than on-grid refrigerators: A simulation modeling study.

BACKGROUND: Gavi recommends solar refrigerators for vaccine storage in areas with less than eight hours of electricity per day, and WHO guidelines are more conservative. The question remains: Can solar refrigerators provide value where electrical outages are less frequent? METHODS: Using a HERMES-generated computational model of the Mozambique routine immunization supply chain, we simulated the use of solar versus electric mains-powered refrigerators (hereafter referred to as "electric refrigerators") at different locations in the supply chain under various circumstances. RESULTS: At their current price premium, the annual cost of each solar refrigerator is 132% more than each electric refrigerator at the district level and 241% more at health facilities. Solar refrigerators provided savings over electric refrigerators when one-day electrical outages occurred more than five times per year at either the district level or the health facilities, even when the electric refrigerator holdover time exceeded the duration of the outage. Two-day outages occurring more than three times per year at the district level or more than twice per year at the health facilities also caused solar refrigerators to be cost saving. Lowering the annual cost of a solar refrigerator to 75% more than an electric refrigerator allowed solar refrigerators to be cost saving at either level when one-day outages occurred more than once per year, or when two-day outages occurred more than once per year at the district level or even once per year at the health facilities. CONCLUSION: Our study supports WHO and Gavi guidelines. In fact, solar refrigerators may provide savings in total cost per dose administered over electrical refrigerators when electrical outages are less frequent. Our study identified the frequency and duration at which electrical outages need to occur for solar refrigerators to provide savings in total cost per dose administered over electric refrigerators at different solar refrigerator prices.

The real-life number of neonatal doses of Bacille Calmette-Guérin vaccine in a 20-dose vial.

BACKGROUND: Reducing vaccine wastage is important. Bacille Calmette-Guérin (BCG) vaccine is produced in vials of 20 infant doses. The reconstituted vaccine is discarded after 4-6 hours. Therefore, to reduce vaccine wastage, a 20-dose vial of BCG is often only opened if at least 10-12 infants are present, jeopardising BCG vaccination coverage and timely vaccination. We observed that nurses were not able to withdraw 20 doses from the vials and aimed to quantify how many doses could be obtained from these vials by experienced nurses under real-life circumstances. METHODS: At the maternity ward of the national hospital in Guinea-Bissau, since 2002 the same two nurses have been vaccinating all eligible children with BCG before discharge. During a month in 2015, within a randomised trial comparing BCG-Denmark and BCG-Russia, we registered how many doses the nurses were able to withdraw from the two types of vaccine vials. RESULTS: The median number of doses which it was possible to withdraw from the vials was 13 (range 11-17): 13 (11-16) for BCG-Denmark (based on 39 vials) and 15 (12-17) for BCG-Russia (based on 29 vials). CONCLUSIONS: In real life, experienced nurses could only obtain 13-15 doses from the 20-dose vials. Thus, vaccine wastage is much lower than assumed. Adjusting practice to the real-life number of doses would immediately suggest vials should be opened if 7 rather than 10 infants are present. As other studies have indicated that BCG may have beneficial non-specific effects on overall mortality, the potential gain by opening a 20-dose vial even for one child may be considerable.

Is insulin diluted when stored in water?

BACKGROUND: Insulin storage is a challenge in resource-poor countries. In Uganda, patients were noted to store insulin vials by submerging them in water. OBJECTIVE: To examine whether withdrawing insulin from a vial without adding air back causes a vacuum which allows water to enter the vial, resulting in insulin dilution. METHODS: Seven hundred units of insulin were withdrawn from forty 10 mL vials of 100 units/mL insulin [20 neutral protamine hagedorn (NPH), 20 regular]. In half, air was added back. The vials were weighed (baseline). Half of the vials (10 with added air, 10 without) were submerged in water for 24 h and then air-dried for 24 h. Vials that were not submerged sat at room temperature for 48 h. All vials were weighed 48 h from baseline. RESULTS: Addition of air did not impact the change in weight after submersion (air added: -0.002 ± 0.001 g or -0.2 ± 0.1 unit; no air added: -0.003 ± 0.000 g or -0.3 ± 0 unit, p = 0.57). In a subset of vials in which an additional 240 units were withdrawn before submersion for another 24 h, there was still no difference in weight change in those vials with air added (p = 0.2). CONCLUSION: Withdrawing insulin from a vial without adding air did not result in uptake of water or dilution of insulin in the submerged vial, although it made drawing up the insulin easier. This study did not address the larger concern of bacterial contamination of the rubber stopper during water storage.

An economic evaluation of the controlled temperature chain approach for vaccine logistics: evidence from a study conducted during a meningitis A vaccine campaign in Togo.

INTRODUCTION: A recent innovation in support of the final segment of the immunization supply chain is licensing certain vaccines for use in a controlled temperature chain (CTC), which allows excursions into ambient temperatures up to 40°C for a specific number of days immediately prior to administration. However, limited evidence exists on CTC economics to inform investments for labeling other eligible vaccines for CTC use. Using data collected during a MenAfriVac™ campaign in Togo, we estimated economic costs for vaccine logistics when using the CTC approach compared to full cold chain logistics (CCL) approach. METHODS: We conducted the study in Togo's Central Region, where two districts were using the CTC approach and two relied on a fullCCL approach during the MenAfriVac™ campaign. Data to estimate vaccine logistics costs were obtained from primary data collected using costing questionnaires and from financial cost data from campaign microplans. Costs are presented in 2014 US dollars. RESULTS: Average logistics costs per dose were estimated at $0.026±0.032 for facilities using a CTC and $0.029±0.054 for facilities using the fullCCL approach, but the two estimates were not statistically different. However, if the facilities without refrigerators had not used a CTC but had received daily deliveries of vaccines, the average cost per dose would have increased to $0.063 (range $0.007 to $0.33), with larger logistics cost increases occurring for facilities that were far from the district. CONCLUSION: Using the CTC approach can reduce logistics costs for remote facilities without cold chain infrastructure, which is where CTC is designed to reduce logistical challenges of vaccine distribution.

The impact of implementing a demand forecasting system into a low-income country's supply chain.

OBJECTIVE: To evaluate the potential impact and value of applications (e.g. adjusting ordering levels, storage capacity, transportation capacity, distribution frequency) of data from demand forecasting systems implemented in a lower-income country's vaccine supply chain with different levels of population change to urban areas. MATERIALS AND METHODS: Using our software, HERMES, we generated a detailed discrete event simulation model of Niger's entire vaccine supply chain, including every refrigerator, freezer, transport, personnel, vaccine, cost, and location. We represented the introduction of a demand forecasting system to adjust vaccine ordering that could be implemented with increasing delivery frequencies and/or additions of cold chain equipment (storage and/or transportation) across the supply chain during varying degrees of population movement. RESULTS: Implementing demand forecasting system with increased storage and transport frequency increased the number of successfully administered vaccine doses and lowered the logistics cost per dose up to 34%. Implementing demand forecasting system without storage/transport increases actually decreased vaccine availability in certain circumstances. DISCUSSION: The potential maximum gains of a demand forecasting system may only be realized if the system is implemented to both augment the supply chain cold storage and transportation. Implementation may have some impact but, in certain circumstances, may hurt delivery. Therefore, implementation of demand forecasting systems with additional storage and transport may be the better approach. Significant decreases in the logistics cost per dose with more administered vaccines support investment in these forecasting systems. CONCLUSION: Demand forecasting systems have the potential to greatly improve vaccine demand fulfilment, and decrease logistics cost/dose when implemented with storage and transportation increases. Simulation modeling can demonstrate the potential health and economic benefits of supply chain improvements.