Exploring Challenges to COVID-19 Vaccination in the Darfur Region of Sudan.

The current COVID-19 pandemic has affected the ability of health systems to provide essential services globally. The Darfur region, located in the western part of Sudan, has been largely devastated by the war that began in 2003 and has been drawing considerable attention from the international community. The war, which erupted as a result of environmental, political, and economic factors, has led to tragic outcomes. Collapsing health-care infrastructures, health workforce shortages, lack of storage facilities for medicines and medical products, and inadequate access to health services are some of the effects of the war. After Sudan received the AstraZeneca COVID-19 vaccine through the COVID-19 Vaccines Global Access facility, significant challenges have been implicated in the delivery, storage, and use of the vaccine in the Darfur region. Lack of vaccine storage and transportation facilities, vaccination hesitancy, inequity in the distribution to health facilities, and shortage of health-care professionals resulting from insecurity and instability have added an extra layer of burden on local authorities and their ability to manage COVID-19 vaccinations in the region adequately. Addressing the impact of COVID-19 requires an effectively managed vaccination program. In the face of current challenges in Darfur, ensuring a fully vaccinated population might remain far-fetched and improbable if meaningful efforts are not put in place by all stakeholders and actors to address some of the challenges identified.

Potency of commonly retailed antibiotics in pharmacies found in Adama, Oromia regional state, Ethiopia.

INTRODUCTION: Antibiotics are commonly used for the treatment and prevention of bacterial infections. The potency of antibiotics can be affected by factors such as temperature, light, moisture, and storage conditions. Inappropriate storage and transportation of antibiotics may lead to loss of potency earlier than the expiry date. The aim of this study was to determine the potency and associated factors of commonly retailed antibiotics. METHOD: Institution-based cross-sectional study was conducted on commonly retailed antibiotics in pharmacies that are available in Adama, Ethiopia from March 2018 to June 2018. This study focused on commonly ordered antibiotics such as amoxicillin, azithromycin, ciprofloxacin, and ceftriaxone. Antibiotics to be tested were selected by using a simple random sampling technique. Socio-demographic and related data were collected using a semi-structured questionnaire. Antibiotic susceptibility testing was performed using the disc diffusion method as described in the Clinical Laboratory Standard Institute guideline. RESULTS: Mean inhibition zones of amoxicillin, ciprofloxacin, azithromycin, and ceftriaxone were 14.2 ± 4 mm, 30.9 ± 4.2 mm, 17.47 ± 3.83 mm, and 32.7±1.8 respectively. Out of 164 antibiotics tested, 61% passed the potency test. The potency of antibiotics varies across different countries in which 53.7% and 54.6 of antibiotics from India and Ethiopia passed the potency test. All ceftriaxone tested in this study passed the potency test. Factors such as air condition of pharmacy (X2 = 4.27; p = 0.039), source of all antibiotics (X2 = 5.41; p = 0.02), and source of amoxicillin (X2 = 4.73; p = 0.03) were significantly associated with potency of antibiotics. CONCLUSIONS: About 40% of antibiotics tested in the current study did not pass the potency test; this warrants further investigation to identify the magnitude of the problem and its causes at a large scale.

Storage of Medications: A Survey of Families in the Pediatric Emergency Department.

OBJECTIVES: To evaluate caregivers' practice of prescription medication storage, particularly of opioid medications, as well as to provide educational materials to families about the opioid crisis. METHODS: Caregivers of patients in a pediatric emergency department were asked to participate in a survey about medication storage practices and beliefs, focusing on opioid medications. Data were collected through a survey documenting demographic data along with knowledge and behaviors of medication storage. Brief education about the US opioid crisis and safe storage was provided. RESULTS: In total, 233 families participated; 3 families declined; 11.5% of caregivers reported storing prescribed medications in a locked or latched place, although most store them "out of reach." Most believed their child or children's friends could not easily access their medications (81.8%). Families who did not keep their medications in locked or latched places had never thought about it (39.7%). In total, 33% of respondents were unaware of the opioid crisis; 87.4% of caregivers said they would use a medication lock box if given one. CONCLUSIONS: Many caregivers are not aware of the opioid crisis and do not keep opioid medications locked up. Half of the caregivers surveyed stated they "never thought about" locking up medications. Most parents would use a lock box if given to them. This opens the door to further study, education, and interventions.

COVID-19 vaccines: resolving deployment challenges.

After the record-breaking pace of vaccine development, vaccine roll-outs are getting off to a frustratingly slow start. Tatum Anderson reports.

A Randomized Controlled Trial Assessing the Impact of Opioid-Specific Patient Counseling on Opioid Consumption and Disposal After Reconstructive Pelvic Surgery.

OBJECTIVES: This study aims to determine the effect of opioid-specific counseling on postdischarge opioid consumption and opioid storage/disposal patterns after reconstructive pelvic surgery. METHODS: In this multicenter randomized-controlled trial, participants were randomized to standard generalized counseling or opioid-specific perioperative counseling. Opioid-specific counseling was provided at the preoperative and 2-week postoperative visits with educational handouts about the risks of opioids and U.S. Food and Drug Administration recommendations for appropriate opioid storage and disposal. The primary outcome was morphine milligram equivalent (MME) consumption between hospital discharge and 2 weeks postoperatively. Secondary outcomes included opioid storage 2 weeks postoperatively, opioid disposal 6 weeks postoperatively, and rate of opioid refills. RESULTS: Among 70 opioid-specific and 65 standard counseling participants, there were no significant differences in demographic characteristics, type of surgery, concomitant hysterectomy, or perioperative complications. For the primary outcome, there was no significant difference in median opioid consumption between the 2 arms. Median (interquartile range) postdischarge MME consumption for all participants was 15 mg (0-75). Forty percent of participants denied postdischarge MME consumption. For secondary outcomes, there were no significant differences in appropriate opioid storage between groups. The appropriate disposal rate of unused opioid tablets 6 weeks after surgery was higher among participants who received opioid-specific counseling. The rate of opioid refill was 7.4%. CONCLUSIONS: Opioid-specific counseling did not affect postdischarge consumption but increased the disposal rate of unused opioid tablets 6 weeks postoperatively. Opioid-specific counseling could minimize the potential for opioid misuse by reducing the number of unused opioid tablets in patients' possession after surgery.

Metodología Lean: diseño y evaluación de un modelo estandarizado de almacenaje de medicación / LEAN methodology: design and assessment of a standardized medication storage model

OBJETIVO: El objetivo del estudio es evaluar los resultados de la aplica-ción de la metodología Lean en el diseño de un modelo estandarizado de almacenaje de medicación en las unidades de hospitalización. MÉTODO: Estudio descriptivo y retrospectivo desarrollado entre septiembre de 2017 y enero de 2019 en un hospital de tercer nivel. Se creó un equipo multidisciplinar liderado por el Servicio de Farmacia. Se empleó la metodología Lean para establecer los elementos y criterios de organización e identificación que conformaron el modelo estandarizado de almacenaje de medicación. Se revisaron y cuantificaron los stocks de cada unidad de hospitalización, se consensuó la medicación con la supervisora de cada unidad y se estimó el impacto económico de la implantación del modelo estandarizado. Se diseñó y envió una encuesta para evaluar la satisfacción de enfermería con el nuevo modelo. RESULTADOS: El modelo estandarizado de almacenaje se aplicó en 20 unidades de enfermería y supuso una reducción global del 56,72% en el número de presentaciones de principios activos disponibles (5.688 versus2.462). Se disminuyó el número de presentaciones de principios activos de medicamentos de alto riesgo en un 40,73% (631 versus 374). La eliminación de este despilfarro supuso un ahorro económico de 25.357,98 (Euro). Se recibieron 58 respuestas a la encuesta de satisfacción del personal de enfermería (20,70% del total de encuestas enviadas), de las que un 22,40% correspondieron al turno fijo y 77,60% al turno rotativo. La media de la satisfacción global (valorada entre 1 y 10) fue de 5,79 ± 3,61. CONCLUSIONES: La aplicación de la metodología Lean es útil para la gestión de stocks de medicación de las unidades de hospitalización. La implantación del modelo estandarizado de almacenaje conlleva un ahorro económico y una reducción del número de presentaciones de principios activos y de medicamentos de alto riesgo. El personal de enfermería está conforme con la implantación del modelo, lo que nos plantea seguir en esta línea de mejora

OBJECTIVE: The objective of this study was to assess the results of applying Lean Methodology in the design of a standardized medication storage model in hospitalization departments. METHOD: Descriptive and retrospective study conducted between September 2017 and January 2019 in a tertiary level hospital. The Pharmacy Service led the creation of a multidisciplinary team. Lean Methodology was used to establish the components and organization and identification criteria that made up the standardized medication storage model. The stocks of each hospitalization department were reviewed and quantified, the final amount of stock needed was agreed with the supervisor of each department, and the economic impact of the implementation of the standardized medication model was assessed. A questionnaire was designed and sent to nursing staff to determine their level of satisfaction with the new model. RESULTS: The standardized medication storage model was scaled up to 20 nursing departments, leading to an overall reduction of 56.72% in the number of pharmaceutical dosage forms available (5,688 vs 2,462). The number of high-risk drugs was reduced by 40.73% (631 vs 374). This elimination of wastage achieved a saving of (Euro)25,357.98. A total of 58 nurses returned the questionnaires (20.70% of the total): 22.40% worked a fixed shift and 77.60% worked a rotating shift. The mean score on overall satisfaction was 5.79 ± 3.61 (scores ranged from 1 to 10). CONCLUSIONS: The application of Lean Methodology is very useful for the management of medication stocks in hospitalization departments. The implementation of a standardized medication storage model leads to economic savings and a marked reduction in the number of active ingredients and high-risk medications. The nursing staff were satisfied with the implementation of the model, suggesting that we should continue to pursue this effective line of action

Quality of oxytocin and misoprostol in health facilities of Rwanda.

Sustainable Development Goal 3.1 calls for a reduction of the maternal mortality ratio to less than 70 per 100,000 live births by 2030. The most important cause of maternal mortality is post-partum haemorrhage (PPH). Oxytocin injections and misoprostol tablets are medicines of first choice for the management of PPH in low- and middle-income countries (LMICs). Unfortunately, both substances are chemically unstable, and previous studies have revealed serious quality problems of these medicines in LMICs. The present study is the first report on their quality in Rwanda. From 40 randomly selected health facilities (hospitals, health centers, retail pharmacies and private clinics) in different parts of Rwanda, as well as from six wholesalers and government stores, oxytocin injections and misoprostol tablets were collected. Oxytocin storage temperatures in the health facilities were monitored for six months using temperature data loggers, and found to correctly follow the storage requirements stated by the manufacturers (2-8°C, or room temperature) with few minor deviations. Oxytocin injections (57 samples, representing seven batches of four brands) were tested for their oxytocin content and pH value according to the United States Pharmacopeia. Twenty-four samples from three European manufacturers passed all tests. However, all nine samples of one batch of a Chinese manufacturer showed an excessive content of oxytocin (range 117.2-121.5% of the declared amount). Another batch of the same manufacturer showed extreme variations of the concentration of the preservative benzyl alcohol. Misoprostol tablets (25 samples, representing ten batches of six brands) were tested for content and dissolution according to the International Pharmacopoeia. Fifteen samples passed, but all 10 samples of two brands from India failed with extreme deviations, containing only 42.5-48.7% of the stated amount of misoprostol. In conclusion, oxytocin quality in Rwanda was better than reported from other African countries. However, two extremely substandard brands of misoprostol tablets were found. The Rwandan authorities reacted quickly and efficiently, and recalled these substandard medicines from the market. For oxytocin and misoprostol, with their well-known problems of quality and stability, procurement should possibly be restricted to medicines which are WHO-prequalified or which have been manufactured in countries with stringent regulatory authorities.

Stability of Diazepam Solution for Injection Following Long-Term Storage in an Ambient Temperature of the Mediterranean Climate.

PURPOSE: Diazepam is utilized as a convulsion antidote following nerve gas attacks. As an emergency medicine, it requires storage at ambient temperatures which often doesn't meet manufacturers' requirements, leading to an early invalidation of the product. Current work investigated this issue. METHODS: Long-term stability of diazepam ampoules for injection stored in an ambient temperature of the Mediterranean climate for ~10 years vs storage at room temperature was studied. RESULTS: Diazepam assay and pH remained within pharmacopeial specifications irrespective of storage conditions. A major degradation product 2-methylamino-5-chlorobenzophenone (MACB) showed a clear trend of accumulation as a function of storage time, exceeding the permitted limit at ~2 years, irrespective of storage conditions. A strong correlation between the discoloration of the solutions and the concentration of MACB was obtained. Intravenous administration of MACB to rats at doses ~2200-fold higher than permissible specification levels caused neither mortality nor any toxicological nor post-mortem findings. CONCLUSIONS: Regarding the parameters tested: diazepam assay, MACB assay, and pH, storing ampoules of diazepam solution for injection in field conditions of high temperatures of the Mediterranean climate did not cause accelerated degradation as compared to room temperature. These findings open an option for the usage of expired ampoules in special scenarios.

Intelligent non-colorimetric indicators for the perishable supply chain by non-wovens with photo-programmed thermal response.

Spoiled perishable products, such as food and drugs exposed to inappropriate temperature, cause million illnesses every year. Risks range from intoxication due to pathogen-contaminated edibles, to suboptimal potency of temperature-sensitive vaccines. High-performance and low-cost indicators are needed, based on conformable materials whose properties change continuously and irreversibly depending on the experienced time-temperature profile. However, these systems can be limited by unclear reading, especially for colour-blind people, and are often difficult to be encoded with a tailored response to detect excess temperature over varying temporal profiles. Here we report on optically-programmed, non-colorimetric indicators based on nano-textured non-wovens encoded by their cross-linking degree. This combination allows a desired time-temperature response to be achieved, to address different perishable products. The devices operate by visual contrast with ambient light, which is explained by backscattering calculations for the complex fibrous material. Optical nanomaterials with photo-encoded thermal properties might establish new design rules for intelligent labels.

Webconferência: atualização do Calendário Nacional de Vacinação - Telessaúde ES 15/03/2016

Screening for expired medications in automated dispensing cabinets.

PURPOSE: Results of a study to quantify rates of identification of expired medications in automated dispensing cabinets (ADCs) are reported. METHODS: A pre-post analysis was conducted to determine the effect of various types of ADC audits on rates of finding expired medications in ADCs. For the experimental phase of the study, 4 ADCs at the main campus of an academic medical center were randomly assigned to receive one of 4 interventions: (1) monthly audits of all ADC pockets, (2) monthly audits of matrix (open pocket) drawers only, (3) monthly audits of unassigned pockets only, and (4) no additional intervention. RESULTS: At baseline, rates of finding expired medication doses in the 4 ADCs ranged from 0.4% to 0.7%. During the 3-month experimental period, rates of finding expired medication doses ranged from 0.1% to 0.3%. During a final audit 1 month later, the ADC targeted for monthly audits of all pockets was found to contain no expired doses, with an overall improvement in expired-dose rates for all audited ADCs observed over the course of the 4-month study. The average time to perform a full audit for an ADC with about 340 pockets was 1 hour, or 15 seconds per pocket. The average time to perform matrix drawer-only audits averaged around 45 minutes, or 11 seconds per pocket. The average time to perform audits of unassigned matrix drawers averaged 30 minutes, or 10 seconds per pocket. CONCLUSION: Auditing of all ADC pockets on a monthly basis appears to be an effective method of reducing the rate of identification of expired medications in ADC pockets.

Prefilled Cyclic Olefin Sterilized Syringes of Norepinephrine Injection Solution Do Not Need to Be Stabilized by Antioxidants.

Norepinephrine is a potent α-sympathomimetic drug which plays an important role in the acute treatment of hypotension and shock. Commercially available norepinephrine solutions contain sodium metabisulfite (Na2S2O5) as an antioxidant. However, prefilled cyclic olefin polymer syringes are not compatible with sodium metabisulfite. The aim of this study was to develop a new formulation of 0.1-mg/mL norepinephrine solution without sodium metabisulfite which is chemically stable and sterile and can be stored in prefilled polymer syringes. Formulation studies were performed with 0.1-mg/mL norepinephrine solution with 0, 0.05, or 0.1% ascorbic acid added as antioxidant. The syringes were filled under nitrogen gassing, stored at 20 ± 5°C, and protected from daylight. Based on the formulation test results, the final formulation was defined and stability testing at 20 ± 5°C was performed measuring norepinephrine concentration, pH, clarity, color of the solution, subvisible particles, and sterility at time intervals up to 12 months. The norepinephrine concentrations at t = 22 weeks were 100.4%, 95.4%, and 92.2% for the formulations with no ascorbic acid and with 0.05% and 0.10% ascorbic acid, respectively. Three batches for the stability study were produced containing norepinephrine, sodium edetate, sodium chloride, and water for injections filled under nitrogen gassing and stored at 20 ± 5°C. Norepinephrine concentrations were respectively 98.8%, 98.6%, and 99.3% for batches 1, 2, and 3 at t = 12 months. It can be concluded that norepinephrine (0.1 mg/mL) solution without metabisulfite is stable for at least 12 months at room temperature when protected from daylight.

Chemical Evaluation of the Effects of Storage Conditions on the Botanical Goldenseal using Marker-based and Metabolomics Approaches.

Hydrastis canadensis, commonly known as goldenseal, is a botanical native to the southeastern United States that has been used for the treatment of infection. The activity of goldenseal is often attributed to the presence of alkaloids (cyclic, nitrogen-containing compounds) present within its roots. Chemical components of botanical supplements like goldenseal may face degradation if not stored properly. The purpose of the research was to analyze the stability of known and unknown metabolites of H. canadensis during exposure to different storage conditions using mass spectrometry. Three abundant metabolites of H. canadensis, berberine, canadine, and hydrastine, were chosen for targeted analysis, and the stability of unknown metabolites was evaluated using untargeted metabolomics. The analysis and evaluation of H. canadensis samples were performed utilizing LC-MS and Principal Component Analysis (PCA). The research project focused on identifying the chemical changes in the metabolite content of H. canadensis under different temperature conditions (40°C ± 5°C, 20°C ± 5°C , and 4°C ± 5°C), different light:dark (hr:hr) cycles (16:8, 12:12, and 0:24), and different sample conditions (powdered roots versus whole roots) over a six month period. The results of this 6-month study revealed that the storage conditions evaluated had no significant effects on the chemical composition of H. canadensis roots. Hence, as long as H. canadensis roots are stored within the storage conditions tested in the study, no significant changes in chemical compositions of metabolites are expected.

Creating a Sustainable Vaccine Delivery Practice.

Providing vaccines places a significant logistical and financial burden on an office but is important in providing care to patients. Start the process by finding a vaccine champion, choosing a primary and backup vaccine coordinator, and creating a team in the office to promote and administer vaccines. Follow best practices when storing and monitoring vaccines. Create office policies for ordering vaccines in a fiscally sound manner, accepting deliveries, and managing inventory. Have backup processes in place to avoid preventable errors when administering vaccines. In addition, bill vaccine administration codes appropriately to collect the full reimbursement that is due.

Ultrasound-responsive lipid microbubbles for drug delivery: A review of preparation techniques to optimise formulation size, stability and drug loading.

Lipid-shelled microbubbles have received extensive interest to enhance ultrasound-responsive drug delivery outcomes due to their high biocompatibility. While therapeutic effectiveness of microbubbles is well established, there remain limitations in sample homogeneity, stability profile and drug loading properties which restrict these formulations from seeing widespread use in the clinical setting. In this review, we evaluate and discuss the most encouraging leads in lipid microbubble design and optimisation. We examine current applications in drug delivery for the systems and subsequently detail shell compositions and preparation strategies that improve monodispersity while retaining ultrasound responsiveness. We review how excipients and storage techniques help maximise stability and introduce different characterisation and drug loading techniques and evaluate their impact on formulation performance. The review concludes with current quality control measures in place to ensure lipid microbubbles can be reproducibly used in drug delivery.