Opportunities for pedagogical change in Turkish medical education revealed in the wake of the COVID-19 pandemic.

Phenomenon: As the first stage of a large-scale educational design research (EDR) study focused on the complex problem of providing authentic experiential "hands-on, minds-in" learning opportunities online during a pandemic or other exigency, we conducted a literature review and we interviewed Turkish academic staff and students about their experiences during the first year of the COVID-19 Pandemic. ApproachWe interviewed faculty members, faculty members of medical education departments, and medical students from both public and private medical schools in Türkiye between October 1 and December 31, 2020. Working in pairs, we analyzed the transcripts of 49 interviews using open qualitative coding methods with satisfactory levels of coefficients of agreement. FindingsWe defined six major themes from the qualitative analysis: 1) Fear and concern were the most common reactions when first encountering the pandemic; 2) Teaching methods during the pandemic were primarily unidirectional from faculty to students. This largely one way transmission of information occurred both synchronously and asynchronously; 3) Technological support during the pandemic shutdowns was found to be challenging for both faculties and students; 4) Evaluation of learning during the pandemic was opportunistic and had questionable rigor; 5) Healthy communication was valued by both faculty and students using an array of different tools including social media; and 6) The pandemic had both negative and positive impacts on the educational processes experienced by students and provided by faculty and resulted in recommendations for new approaches to teaching and learning in the future. Medical students were primarily concerned about the susceptibility to COVID-19 of themselves and others, and how the pandemic would affect their progress toward completing their studies. Faculty were primarily concerned about the capacity of online learning to provide clinical learning opportunities and the difficulties of assessing student clinical skills using online modalities. Medical education specialists were primarily concerned about the quality of educational opportunities offered online. InsightsOur findings were similar to other studies conducted in the USA, China, United Kingdom, and other countries. However, the interviews revealed interest among faculty and medical education specialists for further investigation of experiential or active learning models that could be applied in medical education regardless of whether the delivery mode is face-to-face, online, or most likely, blended. In the next stage of our larger scale EDR study, we will design and construct prototype learning environments that incorporate experiential, active, and authentic learning design principles.

Evaluation of COVID-19 pandemic management in Türkiye.

Three years since the first cases were identified and 2 years since an effective vaccine was developed, COVID-19 continues to claim lives and impact people's health and wellbeing, both socially and economically. While the world has been waiting for its leaders to come together to form a collective response to end the pandemic, we still have not seen a multisectoral response, nor any whole-of-society approach. Like many other countries around the globe, Türkiye was caught unprepared by the pandemic. This was exacerbated by the unsuccessful management of the pandemic by the authorities. The reasoning and/or scientific explanations for enforcing or lifting public health measures have never shared with the public. Throughout the pandemic, no epidemiological details have been released on cases and deaths, other than the numbers of these two measures. Civil society organizations, professional associations, and the public in general have been kept out from policy formulation and decision making. As a result, community engagement has never been properly put into practice. In this paper, we analyzed Türkiye's pandemic management response through the continuum of the response cycle to emergencies: prevention, preparedness, readiness, response, and recovery.

Ensuring quality and integrity of vaccines throughout the cold chain: the role of temperature monitoring.

INTRODUCTION: Vaccines have continually proven their inestimable value to the world through the eradication of smallpox, gains achieved toward a polio-free world, and controlling other vaccine-preventable diseases. Although vaccines require certain temperatures and conditions to maintain their potency, supply chain controls vary greatly at different legs of the global journey. Vaccine manufacture is closely managed, but inconsistencies plague the cold chain when vaccines are shipped and stored in variable conditions. Monitoring vaccine temperatures throughout the cold chain is of paramount importance to ensure quality. The emerging COVID-19 vaccines present the world with new challenges and additional opportunities to establish best practices for safeguarding human health. AREAS COVERED: We review the risks associated with the vaccine cold chain that require temperature monitoring throughout shipment and storage. Electronic and chemical monitoring devices are compared along with data needs. Regulatory oversight and guidance are also discussed. EXPERT OPINION: Regulatory oversight has contributed to the creation of a risk management and quality culture among private sector players in the vaccine field. Meanwhile, the public sector (the main player at the country level) remains largely untouched by regulatory oversight. Adherence to best practices shall only be possible with increased regulatory oversight of public sector operations.

A vaccine cold chain temperature monitoring study in the United Mexican States.

Vacine cold chain assessments conducted in various parts of the world indicate that maintaining equipment at the temperature range recommended by the World Health Organization (WHO) is not always observed. It has been also the case that staff rather prioritize protecting vaccine from heat damage, thus often exposing vaccines to freezing temperatures. As a result, inadvertent freezing of vaccines is a largely overlooked problem all over the world. In a recent systematic review, comparison of the occurrence of freezing temperatures during storage and transport were found to be a global problem occurring both in the resource-rich as well as the resource-limited settings. A vaccine cold chain temperature monitoring study was conducted using standard WHO study protocol with the objective to document potential problems and to identify appropriate control measures. Multiple temperature monitoring devices were used in the study to evaluate user friendliness of these devices and staff attitudes towards them. In general, majority of the time, temperatures were kept between recommended temperature range of 2-8 °C. Temperature variation got wider when products moved from 3PL Laboratory to service points. The wider variation is found at the service points. High temperature excursions were observed or short periods of time while exposures to freezing temperatures were more both higher in number and duration, however, shake test with these vaccines indicated no freeze damage. 91% of staff believed that they did not have the necessary tools to detect if a vaccine had been damaged by a temperature excursion outside the 2-8 °C range, and all staff believed that inclusion of such devices (e.g. vaccine vial monitor) in the system would improve cold chain operations as they have became aware of problematic areas through this study.

Creating a "Good Clinical Practices Inspection" Authentic Online Learning Environment through Educational Design Research.

Educational design research (EDR) was applied to address the challenge of providing more public health professionals with opportunities to develop their knowledge and skills related to Good Clinical Practices (GCP) inspections. The conduct of clinical research in accordance with the principles of GCP is necessary to ensure that clinical research participants are not exposed to undue risk, and that data generated from the research are valid and accurate. The safety and efficacy of pharmaceuticals, medical devices, and other healthcare products depend upon the application of GCP. The World Health Organization has been providing a global face-to-face GCP Inspection course in Indonesia for a decade, but budget constraints only allow this course to be offered once a year to 15 participants. This paper describes how the move from a face-to-face course to an online authentic learning environment was accomplished through EDR and concludes with a discussion of design principles derived from the research. The results of a beta test of the new online course with 12 participants are also described in the paper.

Physical and chemical changes in Alhydrogel™ damaged by freezing.

Accidental freezing of aluminum-based vaccines occurs during their storage and transportation, in both developed and developing countries. Freezing damages the freeze-sensitive aluminum adjuvanted vaccines, through separation of lattice between aluminum adjuvant and antigen, leading to formation of aluminum aggregates, and loss of potency. In this study, we examined Alhydrogel™ ([AlO(OH)]xnH2O, aluminum hydroxide, hydrated for adsorption) stored under recommended conditions, and exposed to freezing temperature until solid-frozen. The main purpose of our research was to determine the destruction areas of the solid-frozen Alhydrogel™ using selected methods of scanning electron microscopy, energy dispersive X-ray spectroscopy, Raman spectroscopy, Fourier-transform infrared spectroscopy and transmission electron microscopy working in diffraction mode. The Zeta potential evaluation, measurements of albumin adsorption power, thermogravimetric analysis and estimation of the mass loss after drying indicated significant structural (physical) and chemical differences between the freeze-damaged and non-frozen vaccine adjuvant. The presented results are important to better understand the type and nature of damages occurring in freeze-damaged aluminum-based vaccines. These results can be used in future studies to improve the temperature stability of aluminum adjuvanted vaccines.

Stability of oxytocin along the supply chain: A WHO observational study.

Postpartum haemorrhage is the leading cause of maternal mortality in low-income countries and oxytocin is the drug recommended by WHO for preventing and treating it. There are concerns about the quality of oxytocin available at the service level provider. The study aimed to document how temperature variations along the supply chain affect quality of oxytocin. The study was run from March to June 2015 in four regions of Ghana. 130 ampoules of oxytocin were shipped from the manufacturer to service level following Ghanaian public sector supply chain. Along the supply chain, temperatures were recorded continuously. After one month storage at central, regional and service level, ampoules were sent to laboratory for testing. Quality of the initial oxytocin sample from the manufacturer and the 130 oxytocin samples received from study points were tested according to International Pharmacopeia monograph. Samples fully complied with specifications. Temperature profile showed that the lowest and highest temperatures experienced were -9.9 °C and +30.1 °C. The results of this study indicate that the activity of oxytocin was not affected by these temperature excursions which occurred along the supply chain. The quality of the oxytocin from the manufacturer as well as from the service level was within the required specifications.

Experiential and authentic learning approaches in vaccine management.

A high level of concern is placed on the storage, handling, transportation, and distribution of vaccines and other pharmaceutical products, particularly those that are time and temperature sensitive. While active and passive cooling equipment and monitoring devices are important, it is the various personnel responsible for executing and writing procedures, designing and operating systems, and investigating problems and helping prevent them who are paramount in establishing and maintaining a "cold chain" for time and temperature sensitive pharmaceutical products (TTSPPs). These professionals must possess the required competencies, knowledge, skills and abilities so they can effectively perform these activities with appropriate levels of expertise. These are complex tasks that require the development of higher cognitive skills that cannot be adequately addressed through professional development opportunities based on simple information delivery and content acquisition. This paper describes two unique learning solutions (one on a bus called the "wheels course" and the other online called "e-learning") that have been developed by WHO Global Learning Opportunities (WHO/GLO) to provide participants with opportunities not just to learn about cold chain systems or vaccine management, but, rather, to develop high levels of expertise in their respective fields through experiential and authentic learning activities. In these interactive learning environments, participants have opportunities to address real-life situations in contexts similar to what they may face in their own work environments and develop solutions and critical thinking skills they can apply when they return to their jobs. This paper further delineates the managerial and operational vaccine management functions encompassed in these two unique learning environments. The paper also describes the alignment of the objectives addressed in the "wheels course" and the e-learning version with effective vaccine management (EVM) criteria as prescribed by WHO. The paper concludes with an example of a real world product developed by course graduates (specifically a decision tree that is now used by some national programmes). These types of products, valuable in their own right, often emerge when learning environments based on authentic learning principles are designed and implemented as they were by WHO/GLO.

Tools and approaches to ensure quality of vaccines throughout the cold chain.

The Expanded Program on Immunization was designed 40 years ago for two types of vaccines: those that are heat stable but freeze sensitive and those that are stable to freezing but heat labile. A cold chain was developed for transport and storage of such vaccines and established in all countries, despite limited access to resources and electricity in the poorest areas. However, cold chain problems occur in all countries. Recent changes to vaccines and vaccine handling include development and introduction of new vaccines with a wide range of characteristics, improvement of heat stability of several basic vaccines, observation of vaccine freezing as a real threat, development of regulatory pathways for both vaccine development and the supply chain, and emergence of new temperature monitoring devices that can pinpoint and avoid problems. With such tools, public health groups have now encouraged development of vaccines labeled for use in flexible cold chains and these tools should be considered for future systems.

Structural damages in adsorbed vaccines affected by freezing.

This study was planned to evaluate structural damages in adsorbed vaccines affected by freezing using scanning electron microscopy and X-ray analysis of the elements. Randomly selected 42 vials of eight different types of WHO pre-qualified adsorbed freeze-sensitive vaccines from 10 manufacturers were included in the study. Vaccines were kept at 5 °C. Selected numbers of vials from each type were then exposed to -25 °C for 24 h periods. All samples were evaluated for their structure using scanning electron microscopy, X-ray analysis of the elements and precipitation time. Scanning electron microscopy of vaccines affected by freezing showed either smooth or rough surfaced conglomerates associated with phosphate content of the precipitate. These vaccines precipitated 2-15 times faster compared to non-frozen samples. Non-frozen samples showed uniform flocculent structure either dense or dispersed. X-ray analysis of precipitates in frozen samples confirmed that the precipitate is mainly aluminium clutters. Scanning electron microscopy confirmed that the lattice structure of bonds between adsorbent and the antigen is broken and aluminium forms conglomerates that grow in size and weight. The precipitation time of vaccines affected by freezing is 4.5 times faster on average compared to non-frozen samples. These facts form the basis of the "shake test".

Assessing the potency of oral polio vaccine kept outside of the cold chain during a national immunization campaign in Chad.

This study is the first systematic documentation of the potency of monovalent oral polio vaccine type 3 (mOPV3) kept at ambient temperatures during a polio immunization campaign in Chad. During the study test vials were exposed to temperatures of up to 47.1 °C, and kept outside of the 2-8 °C range for a maximum of 86.9 hours. Post-campaign laboratory testing confirmed that the test vials were still potent, and in conformity with the defined release specifications. Further, the Vaccine Vial Monitors performed as expected, giving an early warning indication of when cumulative exposure to heat reached levels that may have negatively affected the vaccine's potency. This study provides proof-of-concept evidence that certain types of OPV remain potent and thus can be kept, for limited periods of time, as well as administered at ambient temperatures.

A case study in experiential learning: pharmaceutical cold chain management on wheels.

INTRODUCTION: People who handle and regulate temperature-sensitive pharmaceutical products require the knowledge and skills to ensure those products maintain quality, integrity, safety, and efficacy throughout their shelf life. People best acquire such knowledge and skills through "experiential learning" that involves working with other learners and experts. METHODS: The World Health Organization developed a weeklong experiential learning event for participants so they could gain experience in how temperature-sensitive products are handled, stored, and distributed throughout the length of the distribution supply chain system. This experiential learning method enabled participants to visit, critically observe, discuss and report on the various components of the cold chain process. An emphasis was placed on team members working together to learn from one another and on several global expert mentors who were available to guide the learning, share their experiences, and respond to questions. RESULTS: The learning event, Pharmaceutical Cold Chain Management on Wheels, has been conducted once each year since 2008 in Turkey with participants from the global pharmaceutical industry, health care providers, national regulatory authorities, and suppliers/vendors. Observations made during the course showed that it was consistent with the principles of experiential and social learning theories. Questionnaires and focus groups provided evidence of the value of the learning event and ways to improve it. DISCUSSION: Reflecting the critical elements derived from experiential and social learning theories, five factors contributed to the success of this unique experiential learning event. These factors may also have relevance in other experiential learning courses and, potentially, for experiential e-learning events.

Validation of the shake test for detecting freeze damage to adsorbed vaccines.

OBJECTIVE: To determine the validity of the shake test for detecting freeze damage in aluminium-based, adsorbed, freeze-sensitive vaccines. METHODS: A double-blind crossover design was used to compare the performance of the shake test conducted by trained health-care workers (HCWs) with that of phase contrast microscopy as a "gold standard". A total of 475 vials of 8 different types of World Health Organization prequalified freeze-sensitive vaccines from 10 different manufacturers were used. Vaccines were kept at 5 degrees C. Selected numbers of vials from each type were then exposed to -25 degrees C and -2 degrees C for 24-hour periods. FINDINGS: There was complete concordance between HCWs and phase-contrast microscopy in identifying freeze-damaged vials and non-frozen samples. Non-frozen samples showed a fine-grain structure under phase contrast microscopy, but freeze-damaged samples showed large conglomerates of massed precipitates with amorphous, crystalline, solid and needle-like structures. Particles in the non-frozen samples measured from 1 microm (vaccines against diphtheria-tetanus-pertussis; Haemophilus influenzae type b; hepatitis B; diphtheria-tetanus-pertussis-hepatitis B) to 20 microm (diphtheria and tetanus vaccines, alone or in combination). By contrast, aggregates in the freeze-damaged samples measured up to 700 microm (diphtheria-tetanus-pertussis) and 350 microm on average. CONCLUSION: The shake test had 100% sensitivity, 100% specificity and 100% positive predictive value in this study, which confirms its validity for detecting freeze damage to aluminium-based freeze-sensitive vaccines.

Improving temperature monitoring in the vaccine cold chain at the periphery: an intervention study using a 30-day electronic refrigerator temperature logger (Fridge-tag).

This intervention study was conducted in Albania to establish the superiority of the Fridge-tag (30-day electronic refrigerator temperature logger) against thermometers. Intervention sites used Fridge-tag and a modified temperature control record sheet, while control sites continued with their routine operation with thermometers. All refrigerators in both groups were equipped with downloadable electronic data loggers to record temperatures for reference. Focus group sessions were conducted with involved staff to discuss temperature monitoring, Fridge-tag use and its user-friendliness. Significant discrepancies were observed between thermometer readings and the electronic data loggers in control sites, while all alarms from Fridge-tag were confirmed in the intervention group. Thermometers are not sufficient to monitor temperatures in refrigerators since they miss the great majority of low and high alarms. Fridge-tag has proven to be an effective tool in providing health workers with the information they need to take the necessary actions when there are refrigerator temperature variations.

Using oral polio vaccine beyond the cold chain: a feasibility study conducted during the national immunization campaign in Mali.

We conducted the first systematic documentation of using oral polio vaccine (OPV) out of the cold chain during national immunization day (NID) campaigns in Mali. Using a crossover intervention design, vaccinators compared the transport of OPV in vaccine carriers with or without ice packs. Vaccine integrity was assured through monitoring vaccine vial monitor (VVM) status. Despite ambient temperatures up to 40 degrees C, none of the VVMs on any of the vials used (n=956) reached their discard point. Over 90% of vaccinators and supervisors preferred conducting NIDs without ice packs. In addition, using OPV out of the cold chain reduced vaccine wastage resulting from melting ice packs causing labels to detach from the vial.

Use of cool water packs to prevent freezing during vaccine transportation at the country level.

OBJECTIVES: To study the impact of the use of cool water packs (water packs refrigerated at 2 to 8 degrees C) on the cold life of vaccine transport boxes and the shelf life of the vaccines. METHODS: Data loggers were used to measure the temperatures of vaccine shipments with cool water packs in laboratory studies and country evaluations. The temperature recordings were mathematically translated into reduction of vaccines shelf life, which are illustrated through degrees of color changes of Vaccine Vial Monitors. FINDINGS: Laboratory studies at extreme ambient temperatures (43 degrees C) showed that, with the use of cool water packs, temperatures inside the cold box rise to around 20 degrees C within 48 h. When this exposure scenario was repeated four times, the impact of the temperature history on the different heat stability categories of vaccines varied between 2.4 and 36.0% shelf life loss. Oral polio vaccine was found to be the most affected vaccine. All other vaccines were affected with 2.4 to 10.4% life loss. Country assessments (real life situation with temperature variations between day and night) showed between 0.4% to 4.6% life loss when the boxes were exposed to ambient temperatures ranging from 11.7 to 39.8 degrees C over the 98 h 15 min test period. CONCLUSIONS: The use of cool water packs is found to be a legitimate and safe practice for vaccines other than oral polio vaccine, so that cool water packs can safely replace frozen icepacks without any serious consequences on the ability of vaccines to confer protection against disease.