Medicines are fundamental components of treatment, management and control of various diseases. However, despite all their benefits, adverse reactions can be evoked by the use of medicines. Medicinal products achieve maximum advantage when they are appropriately used based on the sound understanding of their risks and benefits. To achieve this, evaluation and monitoring of the safety of medicines under real-life conditions, the appropriate pharmacovigilance systems, are essential. The World Health Organization (WHO) is a specialised agency of the United Nations which commits broad range of works to secure international public health. Pharmacovigilance is embraced as the WHO Programme for International Drug Monitoring (PIDM), which is led and organised by the Safety and Vigilance of Medicines group in the Department of Essential Medicines and Health Products in WHO. Pharmacovigilance is defined by the WHO as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” . Any other drug-related problems include such as substandard medicine, medication error, lack of efficacy, misuse, abuse, and Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit (SSFFC) products. Whilst the world has made significant progresses in accessing essential medicines through the global efforts such as the UN Millennium Development Goals (MDGs), pharmacovigilance system is not well enough developed. The access to new medicines or the use of medicines in new environments can bring issues to concern. This article outlines the WHO PIDM, the core programme of pharmacovigilance in WHO, on its development, overview and current status. In addition, Safety and Vigilance of Medicines group's activities in order to tackle above concerns are also introduced.

Vaccines are one of the most successful stories in public health in human history. Currently, immunisation averts about 2.5 million deaths every year in the world. To obtain appropriate vaccination is one of the fundamental elements of the human rights on health and is regarded as the responsibility for citizens, communities and governments. Vaccines used for the national immunisation programmes are generally safe and effective when appropriately used. However, vaccination is never zero-risk as any pharmaceuticals and effective vaccines may produce some undesirable side effects. The success of national immunisation programme needs the public's confidence in vaccines, by monitoring risk-benefit balance of vaccines and providing relevant information through pharmacovigilance activities. Pharmaceuticals including vaccines achieve maximum advantage when they are appropriately used based on the sound understanding of their risks and benefits. Pharmacovigilance is defined by the WHO as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” and essential for accurate evaluation of risk-benefit balance of pharmaceuticals. The WHO pursues actions to increase vaccination coverage and aims to spur research and development of Dengue and Malaria vaccines. In addition, the elapsed time between introduction of new vaccines in developed countries and in developing countries is being shortened, and technical cooperation facilitate local manufacture of vaccines in developing countries. This results in increasing immunisation rate and administration of various vaccines including relatively new vaccines on a global mass scale. Under such circumstances with increasing importance of vaccine pharmacovigilance more than ever, the article outlines the global movements on vaccine pharmacovigilance, mainly focus on the WHO's activities.

Objective：The objective of this study was to apply Least Absolute Shrinkage and Selection Operator （LASSO）logistic regression to detection of adverse drug reaction （ADR） signals using an electronic health records database as a comprehensive and quantitative method to supplement the current pharmacovigilance activities in Japan.

Design：case-control study

Methods：We analyzed data from 40767 inpatients using a single-institution hospital database and identified two ADRs, suspected pancreatitis and thrombocytopenia, using abnormal laboratory test results. LASSO logistic regression analysis was applied to detect ADR signals with adjustment for age, sex, comorbidities and medical procedures. The positive predictive value （PPV） was calculated using reference standard of known drug-ADR associations based on drug product labels.

Results：The number of case group was 6735 for suspected pancreatitis and 11561 for thrombocytopenia. The number of ADR signals detected using LASSO logistic regression was 27 for suspected pancreatitis and 40 for thrombocytopenia. The calculated PPV was 3.7% for suspected pancreatitis and 55.0% for thrombocytopenia.

Conclusion：LASSO logistic regression analysis efficiently detects ADR signals by adjusting for confounding factors such as comorbidities and medical procedures. The false positive signals may contain unknown signals and further signal assessment will be needed.

We, a group of four delegates from Japan, participated in the fifth Japan-UK Primary Care Exchange Programme and visited the UK in October of 2018. This report highlights some differences between the UK and Japanese healthcare systems, such as working conditions for GPs and requirements for GP trainers, and what the Japan Primary Care Association can learn from them. We propose that the Japan Primary Care Association create opportunities to discuss and exchange views with other healthcare professionals, strengthen training programs for future GP trainers and define competencies for GP trainers in Japan.

Medicines are fundamental components of treatment, management and control of various diseases. However, despite all their benefits, adverse reactions can be evoked by the use of medicines. Medicinal products achieve maximum advantage when they are appropriately used based on the sound understanding of their risks and benefits. To achieve this, evaluation and monitoring of the safety of medicines under real-life conditions, the appropriate pharmacovigilance systems, are essential. The World Health Organization (WHO) is a specialised agency of the United Nations which commits broad range of works to secure international public health. Pharmacovigilance is embraced as the WHO Programme for International Drug Monitoring (PIDM), which is led and organised by the Safety and Vigilance of Medicines group in the Department of Essential Medicines and Health Products in WHO. Pharmacovigilance is defined by the WHO as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” . Any other drug-related problems include such as substandard medicine, medication error, lack of efficacy, misuse, abuse, and Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit (SSFFC) products. Whilst the world has made significant progresses in accessing essential medicines through the global efforts such as the UN Millennium Development Goals (MDGs), pharmacovigilance system is not well enough developed. The access to new medicines or the use of medicines in new environments can bring issues to concern. This article outlines the WHO PIDM, the core programme of pharmacovigilance in WHO, on its development, overview and current status. In addition, Safety and Vigilance of Medicines group's activities in order to tackle above concerns are also introduced.

Tuberculous spondylitis, or so-called Pott's disease, seems to be overlooked because of a lack of severe inflammation in the insidious generating process and tends to cause non-specific symptoms, such as back pain, fever, weakness, and weight loss. Diagnostic delay is common and the results can be disastrous. Discriminating between Pott's disease and other diseases, such as malignancy and pyogenic infection, is difficult. However, the inflammatory process in Pott's disease tends to spare the disk space, while that of pyogenic infection typically affects the area. Herein, we present a patient with Pott's disease who showed the characteristic clinical and radiological findings.

Prospective clinical study.

Prospective clinical study.