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Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Ins
...
pection Cooperation Scheme (jointly known as PIC/S). PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
more
N Engl J Med 2022; 386:911-922, DOI: 10.1056/NEJMoa2104535
Four months of antituberculosis treatment was noninferior to 6 months of treatment in children with drug-susceptible, nonsevere, smear-negative tuberculosis (SHINE Study)
The Updated guidelines on Management of tuberculosis in children and adolescents include new recommendations that cover diagnostic approaches for TB, shorter treatment for children with non-severe drug-susceptible TB, a new option for the treatment
...
of TB meningitis, the use of bedaquiline and delamanid in young children with multidrug- and rifampicin-resistant TB and decentralized and family-centred, integrated models of care for TB case detection and prevention in children and adolescents.
more
It outlines key achievements, needs and opportunities for intervention in the field of rehabilitation in Ukraine. The content of this document is a snapshot in time – not an in-depth analysis of the entire rehabilitation sector. The analysis focuses on rehabilitation policy and governance, service
...
provision, financing, information management and human resources, with the aim of improving access to high-quality rehabilitation services in Ukraine.
more
The Department of Health (DOH) has developed a National Integrated Sexual and Reproductive Health and Rights (SRHR) Policy.1 This policy addresses the many cross-cutting issues relating to SRH service provision, drawing together the principles, rights, and guidance for planning and implementation th
...
at underpin the provision of quality, comprehensive, and integrated SRHR services in South Africa. The National Integrated SRHR Policy is supported by several clinical and service delivery guidelines covering related programmatic
areas, including the National Contraception Clinical Guidelines.
more
Obesity is a global health problem. Its worldwide prevalence has tripled between 1975 and 2016, reaching a prevalence in Chile of 34.4%, according to the National Health Survey 2016-2017. If this condition corresponds to a risk factor or primary disease is a widely discussed issue. It is recognized
...
as a disease by the American Medical Association and World Health Organization,
based on its metabolic and hormonal features, such as dysregulation of appetite, abnormal energy balance and endocrine dysfunction, among others. Its main environmental risk factors are the consumption of ultra-processed foods and sedentariness. Preventive measures at the population level are fundamental, emphasizing promotion and prevention using a transdisciplinary approach. The individual approach in the management of obesity should improve the quality of life, avoid early mortality, reduce cardiovascular risk, and reduce the progression to type 2 diabetes and incidence of cancer. Thus, an adequate management and
control of obesity would have a great impact in our society.
more
Infectious disease outbreaks and epidemics are increasing in frequency, scale and impact. Health care facilities can amplify the transmission of emerging infectious diseases or multidrug-resistant organisms (MDRO) within their settings and communities. Therefore, evidence-based infection prevention
...
and control (IPC) measures in health care facilities are critical for preventing and containing outbreaks, while still delivering safe, effective and quality health care. This toolkit is intended to support IPC improvements for outbreak management in all such facilities, both public and private throughout the health system. Specifically, this document systematically describes a framework of overarching principles to approach the preparedness, readiness and response outbreak management phases. The document also provides a toolkit of resource links to guide specific actions for each infectious disease and/or MDRO outbreak management phase at any health facility. This document is specifically tailored to an audience of stakeholders who establish and monitor health care facility-level IPC programs including: IPC focal points, epidemiologists, public health experts, outbreak response incident managers, facility-level IPC committee(s), safety and quality leads and managers, and other facility level IPC stakeholders.
more
Lymphatic filariasis is a neglected tropical disease that can cause permanent disability through disruption of the lymphatic system. This disease is caused by parasitic filarial worms that are transmitted by mosquitos. Mass drug administration (MDA)
...
of antihelmintics is recommended by WHO to eliminate lymphatic filariasis as a public health problem. This study aims to produce the first geospatial estimates of the global prevalence of lymphatic filariasis infection over time, to quantify progress towards elimination, and to identify geographical variation in distribution of infection.
more
Arsenical monotherapies were previously very successful for treating human African trypanosomiasis (HAT).
Melarsoprol resistance emerged as early as the 1970s and was widespread by the late 1990s.
Melarsoprol resistance represents the only example of widespread
...
drug resistance in HAT patients where the genetic mechanism has been established.
The current goal of elimination of HAT as a public health problem by 2020 may be undermined by the emergence and spread of resistance to current or new drugs.
Insights into potential resistance mechanisms for current and new drugs will facilitate predictions of the likelihood of resistance and will also facilitate rational approaches to minimizing, monitoring, and tackling the future emergence of resistance.
more
The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities around the world.
In addition, this edition includes summary and recommendations from the virtual meeting of the members of the WHO Programme f
...
or International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
more
A lot has happened this year. While we continued to tackle the COVID-19 pandemic, we were hit by disease outbreaks and
humanitarian crises. Yet, despite these challenges, we marched on, resolute in resolving critical health systems issues to increase
access to
...
quality healthcare services. To further our vision and bring concrete actions to reality, under
the leadership of the Government of South Sudan, we developed the Health Sector Strategic Plan to define the strategic
approaches, key interventions, mapping resource needs, and the implementation framework to strengthen the health system
to deliver essential quality health services equitably for 2023 to 2027. For WHO, this Plan will usher in a new reality -- access
to lifesaving or health-promoting interventions is doable and possible, making the health sector fairer, especially for those
unable to pay
more
The availability of controlled medicines is crucial for patients requiring palliative care, pain relief and symptom management. Many individuals worldwide, especially in low- and middle-income countries, continue to experience limited access to these essential medicines. Enhancing access to controll
...
ed medicines is paramount in promoting universal health coverage. This report offers a detailed situational analysis of policies and programmes aimed at improving access to affordable, high-quality controlled medicines for pain management in the WHO South-East Asia Region. The report identifies the existing barriers, challenges and possible solutions to facilitate access to such medicines across all Member States.
more
The WHO standard: Universal access to rapid tuberculosis diagnostics sets benchmarks to achieve universal access to WHO-recommended rapid diagnostics (WRDs), increase bacteriologically confirmed tuberculosis and drug resistance detection, and reduce
...
the time to diagnosis. WHO-recommended rapid diagnostics are highly accurate, cost-effective, reduce the time to treatment initiation, and impact patient-important outcomes.
more
This brief update on tuberculosis (TB) in the African region covers the state of TB in the WHO African region, strategic priorities and targets and the impact of COVID-19 on essential services. This is followed by key figures for the region, the role of WHO in country support and, recognizing the im
...
portance of diagnosis and drug susceptibility testing, a focus onstrengthening laboratory networks and the regional laboratory and diagnostic objectives. A brief update of the state of the science and how this is funded across the African region is provided, before closing with challenges and opportunities,strategic directions and a brief discussion of funding concerns. Discussions around the drivers of the disease, and issues of the poverty, inequality and stigma that continue to plague those living with TB are fully recognized, but are outside the scope of this report.
more
People affected by impairments and disabilities associated with TB are even more likely to belong to marginalized segments of society and are more likely to have their human rights unprotected. The challenges faced by people affected by TB include the consequences of impairment and disability associ
...
ated with the disease, its treatment as well as with the stigma and discrimination applied to people affected by TB. There is now compelling evidence that the disease and its treatment affect quality of life and life expectancy even after successful treatment.
The WHO Global Tuberculosis Programme has produced the first policy brief on TB-associated disability, building on the increasing evidence in recent years on the unaddressed needs of people with TB who experience impairment and disability while on TB treatment and after completing TB treatment.
more
The Democratic Republic of Timor-Leste has the highest TB incidence rate in the South East Asian Region - 498 per 100,000, which is the seventh highest in the world. In Timor-Leste TB is the eighth most common cause of death.
The salient observations are as follows:
In 2018, 487 (12.5%) of the
...
3906 notified TB patients were tested for RR-TB and only 12 lab confirmed RR-TB patients were initiated on standard MDR-TB treatment of 20-months duration, (a 3-fold increase in RR-TB detection compared with 2017). This amounts to treatment coverage of only 17% of 72 estimated MDR/RR-TB among notified TB patients (3906) and 5% of 240 estimated incident MDR-TB patients as compared to 62% treatment coverage of 6300 incident drug sensitive TB patients estimated in TLS. The treatment success in the 2016 annual cohort of 6 MDR-TB patients has been reported at 83%. 80% of TB patients know their HIV Status with around 1% TB-HIV co-infection, 37/ 77 (48%) TB-HIV Co-infection Detected. Of the 387 PLHIV currently alive on ART, exact status on TB screening and testing is unknown. % of PLHIV newly enrolled in HIV care who received IPT is not known.
In 2018, the mortality rate for TB was 94 deaths per 100,000 people (1200 per annum) in TL with an increasing mortality trend (Figure 1), despite TB services being available for nearly two decades.
A survey of catastrophic costs due to TB (2016) highlights that 83% of TB patients are reported to be facing catastrophic costs due to the disease. This is the highest rate in the world.
more
The evolving epidemic of type 2 diabetes mellitus has challenged health-care professionals. It stands among the leading causes of mortality in the present world. It warrants new and versatile approaches to improve mortality and the associated huge quality
...
-adjusted life years lost to it once diagnosed. A possible venue to lower the incidence is to assess the safety and efficacy of various diabetes prevention strategies. Diet and exercise have a well-developed role in the prevention of weight gain and, ultimately, diabetes mellitus type II in high-risk individuals. However, high-risk individuals can also benefit from adjunct pharmacotherapy. In light of this information, we decided to conduct a systematic review of randomized controlled trials. This article summarizes the evidence in the literature on the pharmacological prevention of diabetes in high-risk individuals.
more
Long Acting Muscarinic Antagonists (LAMA) such as tiotropium and glycopyrronium are used in the management of COPD1. They have been shown to improve lung function, quality of life and exercise tolerance. They have also been associated with reduced C
...
OPD-related exacerbations, associated hospitalisations and duration of hospital stay. Both the South African Thoracic Society (SATS) and Global Initiative for Chronic Obstructive Lung Disease (GOLD), guidelines recommend the use of long acting anticholinergic drugs (or long acting beta agonists) in moderate to very severe disease as defined by lung function (FEV1). The most up to date guideline, utilizing the GRADE methodology (European Respiratory Society guidelines of 2017), confirms their superiority over long acting β agonists (LABA) as monotherapy for COPD in that LAMA's have demonstrated greater efficacy in terms of exacerbation reduction, with similar safety profile.2 These recommnedations are supported by published peer-reviewed
evidence including individual papers and Cochrane reviews.
more
Asthma is the most common chronic condition in children worldwide. It affects daytime activities, sleep and school attendance and causes anxiety to parents, families and other carers. The quality of asthma diagnosis and management globally still nee
...
ds substantial improvement. From infancy to the teenage years, there are age-specific challenges, including both underdiagnosis and overdiagnosis with stigma-related barriers to treatment in some cultures and in adolescents. The Paediatric Asthma Project Plan has been initiated to strengthen diagnosis and management of asthma. This encompasses a vision for the next 10–15 years, building on the knowledge and experience from previous educational projects. It will take into account the educational needs of patients, carers and healthcare professionals as well as the accessibility and affordability of medication, particularly in low and middle-income countries where the prevalence of asthma is rising more rapidly. This overview presents a first step for those involved in the diagnosis and management of childhood asthma to strengthen care for children globally.
more
Antimicrobial resistance (AMR) is occurring everywhere in the world, compromising the ability to treat infectious diseases, as well as undermining many other advances in health and medicine. Underlying factors that drive AMR include; weak or absent surveillance and monitoring systems, inadequate sys
...
tems to ensure quality and uninterrupted supply of medicines, inappropriate and irrational use of medicines including in animal husbandry, poor infection prevention and control practices, and depleted arsenals of diagnostics, medicines and vaccines as well as insufficient research and development of new products.
more
