This guidance should be followed if an unlicensed medicine is prepared in
a registered pharmacy. The preparation of an unlicensed medicine (for
...
example unlicensed methadone, or menthol in aqueous cream) in a pharmacy is called ‘extemporaneous preparation’.
The guidance should be read alongside the standards for registered pharmacies. These aim to create and maintain the right
environment, both organizational and physical, for the safe and effective practice of pharmacy.
By following this guidance, the pharmacy will:
• demonstrate that it meets our standards, and
• provide assurances that the health, safetyand wellbeing of patients and the public are safeguarded
Responsibility for making sure this guidance is followed lies with the pharmacy owner. If the registered pharmacy is owned by a ‘body
corporate’, the directors have responsibility.
Those responsible for the overall safe running of the pharmacy need to take into account the nature of the pharmacy and the range of services
already provided and, most importantly, the needs of patients and members of the public.
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5th revised edition.
This document provides a ranking of medically important antimicrobials for risk management of antimicrobial resistance due to non-human use. The current revision took place at ...the seventh meeting of the AGISAR held in Raleigh, United States of America in 2016.
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Full eHandbook under: http://www.msh.org/resources/health-systems-in-action-an-ehandbook-for-leaders-and-managers
Effective supply management has the potential to make a powerful contribution to the reliable availability of essential ...ttribute-to-highlight medbox">medicines, which are a crucial part of the delivery of highquality health care services. Because medicines are costly and poor management so often results in waste, good supply management is also crucial to the cost-effectiveness of providing medicines.
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For the first time in almost 50 years there are two new drugs for the treatment of drug-resistant TB (DR-TB): bedaquiline and delamanid. There has also been increased attention given to the safety and effi...cacy of “re-purposed” drugs that have been widely used to treat other infections but are also showing promise in the treatment of DR-TB, including linezolid and clofazimine. This special supplemental guide has been developed for nurses, because it is essential that nurses be provided with material that maximizes their ability to provide optimal support to patients who are receiving new and re-purposed drugs
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Improving the quality of hospital antibiotic use is a major goal of WHO’s global action plan to combat antimicrobial resistance. The WHO Essential Medic...ines List Access, Watch, and Reserve (AWaRe) classification could facilitate simple stewardship interventions that are widely applicable globally. We aimed to present data on patterns of paediatric AWaRe antibiotic use that could be used for local and national stewardship interventions.
www.thelancet.com/lancetgh Vol 7 July 2019
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In this edition, medicines used in ICU, haemodialysis and chemotherapy unit has also been added under NEML. The medicines under disinfectants and antiseptics, intrauterine devices and barrier met...hods under contraceptives has been deleted and moved to medical supplies and equipment list. A section on traditional essential medicines list is also included at the end of the NEML
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The reports bring together the latest findings and conclusions about the state of resistance to artemisinins and artemisinin-based combination therapy (ACT), summarize WHO’s current policy and treatment recommendations, and highlight areas ...lass="attribute-to-highlight medbox">of concern.
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The coronavirus disease (COVID-19) pandemic exacerbated pre-existing inequalities in the treatment and care of noncommunicable diseases (NCDs). This report examines the effect of the COVID-19 pandem...ic on access to NCD medicines, and the policies and strategies implemented by countries and health systems to anticipate and mitigate stresses across NCD medicine supply chains. The full range of upstream and downstream impacts are investigated, including: manufacturing; procurement, importation and last mile delivery; patient-level effects through affordability and availability; and the effects on NCD medicine availability by category of disease. The report culminates in recommended actions and interventions for key stakeholders in the NCD pharmaceutical supply chain, including governments, regulatory authorities, manufacturers and the private sector; as well as directions for future research for improving access and supply chain access resilience.
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The coronavirus disease (COVID-19) pandemic exacerbated pre-existing inequalities in the treatment and care of noncommunicable diseases (NCDs). This report examines the effect of the COVID-19 pandem...ic on access to NCD medicines, and the policies and strategies implemented by countries and health systems to anticipate and mitigate stresses across NCD medicine supply chains. The full range of upstream and downstream impacts are investigated, including: manufacturing; procurement, importation and last mile delivery; patient-level effects through affordability and availability; and the effects on NCD medicine availability by category of disease. The report culminates in recommended actions and interventions for key stakeholders in the NCD pharmaceutical supply chain, including governments, regulatory authorities, manufacturers and the private sector; as well as directions for future research for improving access and supply chain access resilience.
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above... publication and has been prepared to specifically assist national medicines regulatory authorities to understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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The first important change is a new priority ranking of the available medicines for MDR-TB treatment, based on a careful balance between expected benefits and harms. Treatment success for MDR-TB is ...currently low in many countries. This could be increased by improving access to the highest-ranked medicines for all patients with MDR-TB.
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Severe Acute Malnutrition (SAM) is one of the greatest child survival challenges in the world today and
reportedly affects more than 16.2 million children each year1. High impact, proven treatment interventions exist
yet sadly approximately only 3....2 million children with SAM have access to treatment each year2. Thus, there
is a need to scale up interventions to improve coverage and access across high burden countries. While efforts
are currently underway to expand services in many countries, obstacles remain.
One critical barrier to expanding SAM treatment services is the acceptance, accessibility and utilisation of
ready-to-use therapeutic food (RUTF). In some countries and contexts, RUTF is still not fully accepted by
community members; while other countries face problems with procurement, storage and supply chain
management which impact on availability and use3. Reports from Ghana and Zambia highlighted that stock-
outs and logistical challenges are often noted as key contributors to high default rates in outpatient treatment
centres4.
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Direct acting antivirals (DAAs) have revolutionized treatment for hepatitis C. Combi-
nations of DAAs can cure infection with HCV in 12 weeks, are highly effective and
have limited side-effects. Affordability ...ute-to-highlight medbox">of DAAs has improved significantly, but access remains lim-
ited. Initially, due to their high prices, affordability of DAAs was limited in high-, middle- and low-
income countries alike. Now there is a divide between those countries where, because of intellectual
property barriers, prices have remained (very) high and other countries where generics are, or can be,
available at much lower prices. The result is a dual market
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The recommendations cover the level of blood pressure to start medication, what type of medicine or combination ... medbox">of medicines to use, the target blood pressure level, and how often to have follow-up checks on blood pressure. In addition, the guideline provides the basis for how physicians and other health workers can contribute to improving hypertension detection and management.
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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effec...tive consumer reporting system within their pharmacovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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Replacement of Annex 2 of WHO Technical Report Series, No. 964...reverse most of the snakebite envenomings effects, and play a crucial role in minimizing mortality and morbidity. These preparations are included in the WHO List of Essential Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
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The WHO CIA List should be used as a reference to help formulate and prioritize risk assessment and risk management strategies for containing antimicrobial resistance. The WHO CIA List supports strategies to mitigate the human health risks associated with antimicrobial use in ...food-producing animals and has been used by both public and private sector organizations. The list helps regulators and stakeholders know which types of antimicrobials used in animals present potentially higher risks to human populations and how use of antimicrobials might be managed to minimize antimicrobial resistance of medical importance. The use of the WHO CIA List, in conjunction with the OIE list of antimicrobials of veterinary importance (1) and the WHO Model Lists of Essential Medicines (2) , will allow for prioritization of risk management strategies in the human sector, the food animal sector, inagriculture (crops) and horticulture, through a coordinated multisectoral One Health approach.
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Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vac...cine was developed during the West Africa Ebola epidemic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO will expedite prequalification and licensing of the vaccine for use in countries at risk of Ebola outbreaks and will coordinate work between those countries’ regulatory authorities and the European Medicines Agency and the US Food and Drug Administration.
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Cases of human monkeypox are rarely seen outside of west and central Africa. There are few data regarding viral kinetics or the duration of viral s...hedding and no licensed treatments. Two oral drugs, brincidofovir and tecovirimat, have been approved for treatment of smallpox and have demonstrated efficacy against monkeypox in animals. Our aim was to describe the longitudinal clinical course of monkeypox in a high-income setting, coupled with viral dynamics, and any adverse events related to novel antiviral therapies.
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Diabetes mellitus is one of the most common noncommunicable diseases worldwide. In the Eastern Mediterranean Region there has been a rapid increase in the incidence of diabetes mellitus and it is no...w the fourth leading cause of death. The increasing prevalence of diabetes mellitus, the emergence of diabetes complications as a cause of early morbidity and mortality, and the enormous and mounting burden on health care systems make diabetes a priority health concern. These guidelines provide up-to-date, reliable and balanced information for the prevention and care of diabetes mellitus in the Region. The information is evidence-based and clearly stated to facilitate the use of the guidelines in daily practice. They are intended to benefit physicians at primary, secondary and tertiary level, general practitioners, internists and family medicine specialists, clinical dieticians and nurses as well as policy-makers at ministries of health. They provide the information necessary for decision-making by health care providers and patients themselves about disease management in the most commonly encountered situations.
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