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Nonmedical use of prescription opioids remains a critical public health issue; 8.5 million people in the United States misused opioids in 2022. Most people obtain prescription opioids for misuse from family or friends. Thus, facilitating secure storage and disposal of opioid medications during and after treatment is needed to prevent medication diversion and subsequent misuse. The primary objective of this study is to test the feasibility and efficacy of a novel intervention that uses a persuasive, informational SMS text message reminder system to enhance the impact of secure storage and disposal of unused opioid medications. We hypothesize that the SMS text message intervention will increase secure storage during treatment and disposal of prescription opioids after treatment. We will use a 2-arm randomized controlled trial to test the intervention for feasibility and efficacy. Participants (aged 18+ years who have received an opioid prescription in the past 2 weeks) will be randomly assigned to either receive the SMS text message intervention or standard-of-care educational materials. Participants in the intervention will receive 4 SMS text messages related to secure storage and 3 messages related to disposal. All participants will complete baseline, midpoint (day 25), and postintervention (day 45) evaluation surveys. We will test whether receipt of the intervention is associated with two primary outcomes, which are (1) secure storage of prescription opioid medication (locked vs unlocked) and (2) disposal of unused prescription opioid medication (disposed vs not disposed). We will use multiple logistic regression to test the main hypotheses that the intervention will be positively associated with secure storage (locked vs unlocked) and disposal (yes vs no) behaviors, which will allow us to control for demographic variables known to influence the outcomes. This protocol represents the entire structure of the randomized controlled trial. Recruitment for the randomized controlled trial was launched in April 2024, and data collection was completed in December 2024. The final sample size is 484. Data analyses for the main hypothesis will be completed by May 2025, and the main hypothesis manuscript will be submitted for publication by May 2025. Results from this study will indicate whether a text message reminder system can increase secure storage and disposal behaviors for individuals who receive opioid medication. This type of intervention has the potential to be integrated into currently used health care delivery systems, such as prescription pickup reminders at pharmacies. Thus, the intervention is scalable across systems of care, thus expanding the reach of secure storage and disposal programs to prevent prescription opioid misuse. ClinicalTrials.gov NCT05503186; https://clinicaltrials.gov/study/NCT05503186. DERR1-10.2196/60332.

In resource-poor settings, cold chain requirements present barriers for vaccine delivery. We evaluated the immunogenicity and safety of tetanus toxoid (TT) vaccine in “Controlled Temperature Chain” (CTC; up to 40°C for <30 days before administration), compared to standard cold chain (SCC; 2–8°C). Prior to the study, stability parameters of TT–CTC were shown to meet international requirements. A cluster randomized, non-inferiority trial was conducted in Moïssala district, Chad, December 2012–March 2013. Thirty-four included clusters were randomized to CTC or SCC. Women aged 14–49 years, eligible for TT vaccination and with a history of ≤1 TT dose, received two TT doses 4 weeks apart. Participants were blinded to allocation strategy. Tetanus antibody titers were measured using standard ELISA at inclusion and 4 weeks post-TT2. Primary outcome measures were post-vaccination seroconversion and fold-increase in geometric mean concentrations (GMC). Non-inferiority was by seroconversion difference (TTSCC−TTCTC) <5% and ratio of GMCs (TTSCC/TTCTC) <1.5. Adverse events were monitored at health centers and at next contact with participants. A total of 2128 women (CTC=1068; SCC=1060) were recruited. Primary intention to vaccinate analysis included 1830 participants; 272 of these were included in the seroconversion analysis. Seroconversion was reached by >95% of participants; upper 95%CI of the difference was 5.6%. Increases in GMC were over 4-fold; upper 95%CI of GMC ratio was 1.36 in the adjusted analysis. Few adverse events were recorded. This study demonstrates the immunogenicity and safety of TT in CTC at <40°C for <30 days. The high proportion of participants protected at baseline results in a reduction of power to detect a 5% non-inferiority margin. However, results at a 10% non-inferiority margin, the comparable GMC increases and vaccine's stability demonstrated in the preliminary phase indicate that CTC can be an alternative strategy for TT delivery in situations where cold chain cannot be maintained.

Background Immunization programs are among the most effective public health strategies worldwide. Adequate vaccine storage is a prerequisite to assure the vaccines’ effectiveness and safety. In a questionnaire survey among a random sample of German primary care physicians, we discovered vaccine storage deficits: 16 % of physicians had experience with cold chain breaches either as an error or near error, 49 % did not keep a temperature log, and 21 % did not use a separate refrigerator for vaccine storage. In a recent feasibility study of 21 practice refrigerators, we showed that these were outside the target range 10.2 % of the total time with some single refrigerators being outside the target range as much as 66.3 % of the time. These cooling-chain deficits are consistent with the international medical literature, yet an effective, easy to disseminate, practice-centered intervention to improve storage conditions is lacking. Methods/design This randomized intervention trial will be conducted in a random sample of primary care practices. Based on continuous temperature recordings over 7 days, all practices with readings outside the target range for vaccine storage (+2 °C to +8 °C) will be randomly allocated to a web-based education program or a waiting list control group. The practice physicians and their teams constitute the target population. Participants will be educated about best practices in vaccine storage and will receive a manual including storage checklists and templates for temperature documentation. In all practices, temperatures of the vaccine refrigerators will be monitored continuously using a data logger with a glycol probe as a surrogate for vaccine vial temperature. The effectiveness of the web-based education program will be determined after 6 months in terms of the proportion of refrigerators with vaccine vial temperatures within the target range (+2 °C to +8 °C) during 7-day temperature logging. Secondary outcome parameters include temperature monitoring, no critically low temperatures (≤ -0.5 °C), compliance with storage recommendations, knowledge of good vaccine storage conditions, and assignment of personnel as vaccine storage manager and backup. Discussion Keep Cool will develop and evaluate a web-based education program to improve vaccine storage conditions in primary care and thereby ensure immunization safety and effectiveness. Trial registration DRKS00006561 (date of registration: 20 February 2015)

Background Severe malarial anaemia requiring blood transfusion is a life-threatening condition affecting millions of children in sub-Saharan Africa. Up to 40% of children with severe malarial anaemia have associated lactic acidosis. Lactic acidosis in these children is strongly associated with fatal outcomes and is corrected by blood transfusion. However, it is not known whether the storage age of blood for transfusion affects resolution of lactic acidosis. The objective of this pilot study was to evaluate the effect of blood storage age on resolution of lactic acidosis in children with severe malarial anaemia and demonstrate feasibility of conducting a large trial. Methods Children aged six to 59 months admitted to Acute Care Unit of Mulago Hospital (Kampala, Uganda) with severe malarial anaemia (haemoglobin ≤ 5 g/dL) and lactic acidosis (blood lactate ≥5 mmol/L), were randomly assigned to receive either blood of short storage age (one to 10 days) or long storage age (21–35 days) by gravity infusion. Seventy-four patients were enrolled and randomized to two equal-sized study arms. Physiological measurements, including blood lactate, oxygen saturation, haemoglobin, and vital signs, were taken at baseline, during and after transfusion. The primary outcome variable was the proportion of children whose lactic acidosis resolved by four hours after transfusion. Results Thirty-four of 37 (92%) of the children in the short storage treatment arm compared to 30/37 (81%) in the long storage arm achieved a blood lactate <5 mmol/L by four hours post transfusion (p value = 0.308). The mean time to lactic acidosis resolution was 2.65 hours (95% CI; 2.25–3.05) in the short storage arm, compared to 3.35 hours (95% CI; 2.60–4.10) in the long storage arm (p value = 0.264). Conclusion Pilot data suggest that among children with severe malarial anaemia and lactic acidosis transfused with packed red blood cells, the storage age of blood does not affect resolution of lactic acidosis. The results support a larger and well-powered study which is under way. Trial registration clinicaltrials.gov NCT01580111

Opioid-based analgesic therapy represents a cornerstone of pain management after surgery. The recent rise in opioid sales and opioid overdoses suggests it is important to maximize the safety of opioid prescribing after surgery. Given that patients may live with other family members in the home, safe storage and appropriate disposal of excess opioids after hospital discharge are necessary to prevent unintended secondary exposures. Identifying characteristics of patients who are likely to be prescribed excess opioids after surgery may enable more targeted prescription practices and safety interventions. Our study aimed to elucidate patient-reported opioid use patterns and modes of home storage of opioids among patients discharged home after Cesarean section (C-section) and thoracic surgery. Specifically, we sought to identify characteristics of patients who reported using about half or more versus less of the opioids prescribed to them for use after hospital discharge. For this cohort study, we developed a survey on quality of analgesia following hospital discharge, amounts of opioids taken relative to the amount prescribed, reasons for not taking all prescribed medications, and storage and disposal methods for leftover opioids. Adult patients, who had C-section or thoracic surgery at a tertiary academic medical center, were given a web-based self-administered survey after discharge. Descriptive statistics (means and standard deviations, proportions) were used to describe the study sample and survey results. Comparisons between patients who reported taking about half or more versus less of the opioids prescribed to them for use after hospital discharge were made using unpaired t-tests, Mann-Whitney tests, and Chi-square tests as appropriate. The majority (53%) of respondents after C-section (N = 30) reported taking either no or very few (less than 5) prescribed opioid pills; 83% reported taking half or less; and 17% of women, reported taking all or nearly all (5 or fewer pills left over) of their opioid prescription. In a cohort of patients after thoracic surgery (n = 31) 45% reported taking either no or very few (5 or less) prescribed opioid pills; 71% reported taking half or less; and 29% of patients reported taking all or nearly all (5 or fewer pills left over) of their opioid prescription. In both cohorts, use of opioids while hospitalized was higher in the group reporting using about half or more of prescribed opioids after discharge. Leftover opioids were stored in an unlocked location in 77% and 73% of cases following C-section and thoracic surgery, respectively. Our findings from surveys in two distinct patient populations at a single academic medical center suggest that current opioid prescribing practices for pain management at hospital discharge following Cesarean section and thoracic surgery may not account for individual patients' analgesic requirements. Excess opioid pills are commonly stored in unsecured locations and represent a potential source for non-medical opioid use and associated morbidity and mortality in patients and their families. Research to develop goal-directed and patient-centered post-discharge opioid prescription practices and encourage opioid safety practices after surgery is needed.

Administration of a birth dose of hepatitis B vaccine (HepB vaccine) to neonates is recommended to prevent mother-to-infant transmission and chronic infection with the hepatitis B virus (HBV). Although manufacturers recommend HepB vaccine distribution and storage at 2-8 degrees C, recognition of the heat stability of hepatitis B surface antigen stimulated research into its use after storage at, or exposure to, ambient or high temperatures. Storage of HepB vaccine at ambient temperatures would enable birth dosing for neonates delivered at home in remote areas or at health posts lacking refrigeration. This article reviews the current evidence on the thermostability of HepB vaccine when stored outside the cold chain (OCC). The reports reviewed show that the vaccines studied were safe and effective whether stored cold or OCC. Field and laboratory data also verifies the retained potency of the vaccine after exposure to heat. The attachment of a highly stable variety of a vaccine vial monitor (measuring cumulative exposure to heat) on many HepB vaccines strongly supports policies allowing their storage OCC, when this will benefit birth dose coverage. We recommend that this strategy be introduced to improve birth dose coverage, especially in rural and remote areas. Concurrent monitoring and evaluation should be undertaken to affirm the safe implementation of this strategy, and assess its cost, feasibility and effect on reducing HBV infection rates. Meanwhile, release of manufacturer data verifying the potency of currently available HepB vaccines after exposure to heat will increase confidence in the use of vaccine vial monitors as a managerial tool during storage of HepB vaccine OCC.

To document and characterize freezing temperatures in the Indonesian vaccine cold chain and to evaluate the feasibility of changes designed to reduce the occurrence of freezing. Data loggers were used to measure temperatures of shipments of hepatitis B vaccine from manufacturer to point of use. Baseline conditions and three intervention phases were monitored. During each of the intervention phases, vaccines were removed progressively from the standard 2-8 degrees C cold chain. Freezing temperatures were recorded in 75% of baseline shipments. The highest rates of freezing occurred during transport from province to district, storage in district-level ice-lined refrigerators, and storage in refrigerators in health centres. Interventions reduced freezing, without excessive heat exposure. Inadvertent freezing of freeze-sensitive vaccines is widespread in Indonesia. Simple strategies exist to reduce freezing - for example, selective transport and storage of vaccines at ambient temperatures. The use of vaccine vial monitors reduces the risk associated with heat-damaged vaccines in these scenarios. Policy changes that allow limited storage of freeze-sensitive vaccines at temperatures >2-8 degrees C would enable flexible vaccine distribution strategies that could reduce vaccine freezing, reduce costs, and increase capacity.

•Current cold chain systems unable to ensure availability of safe and potent vaccines.•Key performance gaps identified based on CHAI country experience.•Insufficient and suboptimal cold chain capacity hampers availability of safe vaccines.•Vaccines at risk due to inadequate temperature monitoring and maintenance systems.•Recommended interventions focus on addressing the root causes of performance gaps. While a number of new vaccines have been rolled out across the developing world (with more vaccines in the pipeline), cold chain systems are struggling to efficiently support national immunization programs in ensuring the availability of safe and potent vaccines. This article reflects on the Clinton Health Access Initiative, Inc. (CHAI) experience working since 2010 with national immunization programs and partners to improve vaccines cold chains in 10 countries—Ethiopia, Nigeria, Kenya, Malawi, Tanzania, Uganda, Cameroon, Mozambique, Lesotho and India – to identify the root causes and solutions for three common issues limiting cold chain performance. Key recommendations include: (1)To address cold chain capacity:•developing an accurate picture of cold chain capacity gaps based on current and future needs;•resource mobilization, and;•effective monitoring during implementation.(2)To encourage upgrade of cold chain with latest technology suitable in country:•in-country piloting of new equipment;•utilization of tools to better understand equipment trade-offs, and;•guide equipment selection and regular engagement with suppliers.(3)To control temperature excursions and equipment breakdowns•introduction of temperature monitoring and control (TMC) devices and practices;•improve competence and availability of existing and future technicians, and;•ensure availability of spare parts. Collectively, the solutions detailed in this article chart a path to substantially improving the performance of the cold chain. Combined with an enabling global and in-country environment, it is possible to eliminate cold chain issues as a substantial barrier to effective and full immunization coverage over the next few years.

The capture and safe storage of radioactive iodine ( 129 I or 131 I) are of a compelling significance in the generation of nuclear energy and waste storage. Because of their physiochemical properties, Porous Organic Polymers (POPs) are considered to be one of the most sought classes of materials for iodine capture and storage. Herein, we report on the preparation and characterization of two triazine-based, nitrogen-rich, porous organic polymers, NRPOP-1 (SA BET  = 519 m 2  g −1 ) and NRPOP-2 (SA BET  = 456 m 2  g −1 ), by reacting 1,3,5-triazine-2,4,6-triamine or 1,4-bis-(2,4-diamino-1,3,5-triazine)-benzene with thieno[2,3-b]thiophene-2,5-dicarboxaldehyde, respectively, and their use in the capture of volatile iodine. NRPOP-1 and NRPOP-2 showed a high adsorption capacity of iodine vapor with an uptake of up to 317 wt % at 80 °C and 1 bar and adequate recyclability. The NRPOPs were also capable of removing up to 87% of iodine from 300 mg L −1 iodine-cyclohexane solution. Furthermore, the iodine-loaded polymers, I 2 @NRPOP-1 and I 2 @NRPOP-2, displayed good antibacterial activity against Micrococcus luteus (ML), Escherichia coli (EC), and Pseudomonas aeruginosa (PSA). The synergic functionality of these novel polymers makes them promising materials to the environment and public health.

It is of particular interest for biopharmaceutical companies developing and distributing fragile biomolecules to warrant the stability and activity of their products during long-term storage and shipment. In accordance with quality by design principles, advanced kinetic modeling (AKM) has been successfully used to predict long-term product shelf-life and relies on data from short-term accelerated stability studies that are used to generate Arrhenius-based kinetic models that can, in turn, be exploited for stability forecasts. The AKM methodology was evaluated through a cross-company perspective on stability modeling for key stability indicating attributes of different types of biotherapeutics, vaccines and biomolecules combined in in vitro diagnostic kits. It is demonstrated that stability predictions up to 3 years for products maintained under recommended storage conditions (2–8 °C) or for products that have experienced temperature excursions outside the cold-chain show excellent agreement with experimental real-time data, thus confirming AKM as a universal and reliable tool for stability predictions for a wide range of product types.