Opportunities for Pedagogical Change in Turkish Medical Education Revealed in the Wake of the COVID-19 Pandemic.

: 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. We 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.

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.

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.

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.

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.

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)]xnHO, aluminum hydroxide, hydrated for adsorption) stored under recommended conditions, and exposed to freezing temperature until solid-frozen.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.