Enforcement and Compliance with Price Ceilings on Essential Medicines

2018 ◽  
pp. 197-227
Author(s):  
Ajay Bhaskarabhatla
Keyword(s):  
Essential Medicines

Novel Drugs and Biologics of 2016: A Boom for Neurodrugs in the Pipelin

2017 ◽  
Vol 10 (5) ◽  
pp. 3809-3814
Author(s):  
D Samba Reddy
Keyword(s):  
Muscular Atrophy ◽  
Clinical Care ◽  
New Drugs ◽  
Essential Medicines ◽  
High Demand ◽  
The Past ◽  
Novel Drugs ◽  
Innovative Products ◽  
Cns Drugs ◽  
The U.S

This article provides a brief overview of novel drugs approved by the U.S. FDA in 2016.  It also focuses on the emerging boom in the development of neurodrugs for central nervous system (CNS) disorders. These new drugs are innovative products that often help advance clinical care worldwide, and in 2016, twenty-two such drugs were approved by the FDA. The list includes the first new drug for disorders such as spinal muscular atrophy, Duchenne muscular dystrophy or hallucinations and delusions of Parkinson’s disease, among several others. Notably, nine of twenty-two (40%) were novel CNS drugs, indicating the industry shifting to neurodrugs. Neurodrugs are the top selling pharmaceuticals worldwide, especially in America and Europe. Therapeutic neurodrugs have proven their significance many times in the past few decades, and the CNS drug portfolio represents some of the most valuable agents in the current pipeline. Many neuroproducts are vital or essential medicines in the current therapeutic armamentarium, including dozens of “blockbuster drugs” (drugs with $1 billion sales potential).  These drugs include antidepressants, antimigraine medications, and anti-epilepsy medications. The rise in neurodrugs’ sales is predominantly due to increased diagnoses of CNS conditions. The boom for neuromedicines is evident from the recent rise in investment, production, and introduction of new CNS drugs.  There are many promising neurodrugs still in the pipeline, which are developed based on the validated “mechanism-based” strategy. Overall, disease-modifying neurodrugs that can prevent or cure serious diseases, such as multiple sclerosis, epilepsy, and Alzheimer’s disease, are in high demand. 

Chemistry of Iodinated Contrast Media (ICM): A Minireview

2020 ◽  
Vol 17 ◽  
Author(s):  
Maithili Pramod Joshi ◽  
Ameya Chaudhari ◽  
Prashant S. Kharkar ◽  
Shreerang V. Joshi
Keyword(s):  
Adverse Effects ◽  
Contrast Media ◽  
Aqueous Solubility ◽  
Synthetic Methods ◽  
Essential Medicines ◽  
World Health ◽  
Iodinated Contrast Media ◽  
Environmental Aspects ◽  
Iodinated Contrast ◽  
Health Organization

: Historically, the use of Iodinated Contrast Media (ICM) for diagnostic purposes, particularly radiography and computed tomography (CT), is well-known. Many of the ICM are included in the World Health Organization (WHO)’s List of Essential Medicines. Depending on the chemotype and the presence of ionizable functional group(s), the ICM are categorized in the ionic/nonionic monomers/dimers. The lipophilicity, aqueous solubility, viscosity and osmolality are major characteristics dictating their use for one procedure versus the other. Over last several decades, substantial advancement occurred in the design and development of novel ICM, solely to reduce their propensity to cause adverse effects. Given the nature of their acute usage, some of the agents with appreciable toxicity are still used. Understanding their chemistry aspects is crucial to appreciate, acknowledge and justify the usage of these extremely important torch-bearers of diagnostic agent’s class. The present review article presents an in-depth overview of the synthetic methods, therapeutic indications, potential adverse effects along with the commercial and environmental aspects of ICM. The safety and tolerability of these agents is a field that has gained significant importance, which is given due importance in the discussion.

Evolution in Drug Access

2017 ◽  
Author(s):  
Joia S. Mukherjee
Keyword(s):  
Drug Development ◽  
Medical Care ◽  
Essential Medicines ◽  
Neglected Diseases ◽  
International Treaties ◽  
Drug Availability ◽  
For Profit ◽  
The Poor ◽  
Drug Access ◽  
Life Saving

Treatment and curative medical care often require medication. This chapter focuses on the provision of medications in impoverished settings and the challenges that inhibit access to life-saving drugs. It will review the failure of the for-profit market to increase drug access for the poor. The evolving concept of essential drugs will be explored by reviewing the history the WHO Essential Medicines List (EML) and the fight to expand the list to include new, and often patented medicines. The international treaties and policies that impact drug availability will be highlighted as will novel systems for drug development and distribution. Finally, the chapter will highlight the growing movement to decrease costs, increase supply, and advance development of drugs for neglected diseases affecting impoverished people.

scholarly journals A Study on Service Availability and Readiness Assessment of Non-Communicable Diseases Using the WHO Tool for Gazipur District in Bangladesh

2016 ◽  
Vol 7 (2) ◽  
pp. 1-13 ◽  
Author(s):  
Mohammad Rashemdul Islam ◽  
Shamima Parvin Laskar ◽  
Darryl Macer
Keyword(s):  
Respiratory Disease ◽  
Chronic Respiratory Disease ◽  
Communicable Diseases ◽  
Health Facilities ◽  
Essential Medicines ◽  
Service Availability ◽  
Diabetes Diagnosis ◽  
Cross Sectional ◽  
Non Communicable Diseases ◽  
Service Readiness

Non-communicable diseases (NCDs) disproportionately affect low and middle-income countries where nearly three quarters of NCD deaths occur. Bangladesh is also in NCD burden. This cross-sectional study was done on 50 health facilities centres at Gazipur district in Bangladesh from July 2015 to December 2015 to introduce SARA for better monitoring and evaluation of non-communicable diseases health service delivery. The General Service readiness index score was 61.52% refers to the fact that about 62% of all the facilities were ready to provide general services like basic amenities, basic equipment, standard precautions for infection prevention, and diagnostic capacity and essential medicines to the patients. But in case of non-communicable diseases, among all the health facilities 40% had chronic respiratory disease and cardiovascular diseases diagnosis/ management and only 32% had availability of diabetes diagnosis/management. Overall readiness score was 52% in chronic respiratory disease, 73% in cardiovascular disease and 70% in diabetes. Therefore, service availability and readiness of the health facilities to provide NCD related health services were not up to the mark for facing future targets.  A full-scale census survey of all the facilities of the study area would give a better understanding of the availability and service readiness.

scholarly journals European List of Essential Medicines for Medical Education: a protocol for a modified Delphi study

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e045635
Author(s):  
Erik Donker ◽  
David Brinkman ◽  
Milan Richir ◽  
Paraskevi Papaioannidou ◽  
Robert Likic ◽  
...  
Keyword(s):  
Medical Education ◽  
Delphi Study ◽  
Medical Training ◽  
Medical Center ◽  
European Countries ◽  
Essential Medicines ◽  
Ethical Review ◽  
Junior Doctors ◽  
Direct Supervision ◽  
Modified Delphi

IntroductionJunior doctors are responsible for a substantial number of prescribing errors, and final-year medical students lack sufficient prescribing knowledge and skills just before they graduate. Various national and international projects have been initiated to reform the teaching of clinical pharmacology and therapeutics (CP&T) during undergraduate medical training. However, there is as yet no list of commonly prescribed and available medicines that European doctors should be able to independently prescribe safely and effectively without direct supervision. Such a list could form the basis for a European Prescribing Exam and would harmonise European CP&T education. Therefore, the aim of this study is to reach consensus on a list of widely prescribed medicines, available in most European countries, that European junior doctors should be able to independently prescribe safely and effectively without direct supervision: the European List of Essential Medicines for Medical Education.Methods and analysisThis modified Delphi study will recruit European CP&T teachers (expert group). Two Delphi rounds will be carried out to enable a list to be drawn up of medicines that are available in ≥80% of European countries, which are considered standard prescribing practice, and which junior doctors should be able to prescribe safely and effectively without supervision.Ethics and disseminationThe study has been approved by the Medical Ethics Review Committee of VU University Medical Center (no. 2020.335) and by the Ethical Review Board of the Netherlands Association for Medical Education (approved project no. NVMO‐ERB 2020.4.8). The European List of Essential Medicines for Medical Education will be presented at national and international conferences and will be submitted to international peer-reviewed journals. It will also be used to develop and implement the European Prescribing Exam.

scholarly journals Mapping the inequality of the global distribution of seasonal influenza vaccine

2021 ◽  
pp. 0308518X2199835
Author(s):  
Yen Ching Yau ◽  
Michael T Gastner
Keyword(s):  
Influenza Vaccine ◽  
Respiratory Diseases ◽  
Seasonal Influenza ◽  
Developed Countries ◽  
Essential Medicines ◽  
World Health ◽  
Equitable Access ◽  
Seasonal Influenza Vaccine ◽  
Choropleth Map ◽  
Vaccine Distribution

With an estimated annual worldwide death toll of between 290 000 and 650 000, seasonal influenza remains one of the deadliest respiratory diseases. Influenza vaccines provide moderate to high protection and have been on the World Health Organization’s Model List of Essential Medicines since 1979. Approximately 490 million doses of influenza vaccine are produced per year, but an investigation of geographic allocation reveals enormous disparities. Here, we present two maps that visualise the inequality of the distribution across 195 countries: a conventional choropleth map and a cartogram. In combination, these two maps highlight the widespread lack of coverage in Africa and many parts of Asia. As COVID-19 vaccines are now being distributed in developed countries, data for seasonal influenza vaccine distribution emphasises the need for policymakers to ensure equitable access to COVID-19 vaccines.

scholarly journals Empty shelves: selected essential medicines stockouts in South Africa

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
L Wolvaardt ◽  
R Nemuntandani ◽  
I Kamungoma-Dada
Keyword(s):  
South Africa ◽  
Urban Areas ◽  
Descriptive Analysis ◽  
Secondary Data ◽  
Treatment Interruption ◽  
Cross Sectional Study ◽  
Essential Medicines ◽  
Chi Square ◽  
Cross Sectional ◽  
Antiretroviral Medication

Abstract Background Access to essential medicines in South Africa has been compromised by stockouts in health facilities. This study describes the occurrence of stockouts for a selection of essential medicines. Methods This cross-sectional study used secondary data retrieved from the Stop Stock Outs Project (SSP). A descriptive analysis was conducted on data from the 2013-2015 SSP case management database of routinely reported stockouts. Chi square tests of independence was conducted on data from the SSP 2015 annual telephonic survey to investigate associations between the occurrence of stockouts, the level of health facility and the type of health professional. Results 231 facilities reported 609 stockouts. Antiretroviral medication had the most stockout reports (78%; n = 475/609), followed by anti-infectives (17.1%; n = 104/609) and tuberculosis medication (4.9%; n = 30/609). The highest number of stockout reports were received from Gauteng province and the majority (71.09%; n = 150/211) of facilities reporting stockouts were in urban areas. There were more stockouts at ambulatory, rather than inpatient care, facilities however, this was not statistically significant. Conclusions This study confirms that South Africa experiences medicine stockouts for many of the essential medicines, with antiretroviral medication being the category most affected. The stockouts vary between provinces and the urban-rural divide but are an equal threat to both ambulatory and inpatient facilities. Key messages The pattern of stockouts experienced over a three-year period suggest that stockouts are ‘normal’ despite the substantive effects of treatment interruption – especially patients with HIV and/or TB. Antiretroviral therapy is at risk as a result of stockouts.

scholarly journals Insufficient Stability of Clavulanic Acid in Widely Used Child-Appropriate Formulations

Antibiotics ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 225
Author(s):  
Ines Mack ◽  
Mike Sharland ◽  
Janneke M. Brussee ◽  
Sophia Rehm ◽  
Katharina Rentsch ◽  
...  
Keyword(s):  
Ambient Temperature ◽  
Clavulanic Acid ◽  
Storage Conditions ◽  
Essential Medicines ◽  
Active Components ◽  
Middle Income ◽  
Ambient Temperatures ◽  
Essential Medicines List ◽  
Dispersible Tablets ◽  
The Stability

Amoxicillin-clavulanic acid (AMC) belongs to the WHO Essential Medicines List for children, but for optimal antimicrobial effectiveness, reconstituted dry powder suspensions need to be stored in a refrigerated environment. Many patients in low- and middle-income countries who are sold AMC suspensions would be expected not to keep to the specified storage conditions. We aimed to assess the stability of both ingredients in liquid formulations and dispersible tablets, combined with nationally representative data on access to appropriate storage. Degradation of amoxicillin (AMX) and clavulanic-acid (CLA) was measured in suspensions and dispersible tablets commercially available in Switzerland at different ambient temperatures (8 °C vs. 28 °C over 7 days, and 23 °C vs. 28 °C over 24 h, respectively). Data on access to refrigeration and electricity were assessed from the USAID-funded Demographic and Health Survey program. In suspensions, CLA degraded to a maximum of 12.9% (95% CI −55.7%, +29.9%) at 8°C and 72.3% (95% CI −82.8%, −61.8%) at a 28 °C ambient temperature during an observation period of 7 days. Dispersible tablets were observed during 24 h and CLA degraded to 15.4% (95% CI −51.9%, +21.2%) at 23 °C and 21.7% (−28.2%, −15.1%) at a 28 °C ambient temperature. There is relevant degradation of CLA in suspensions during a 7-day course. To overcome the stability challenges for all active components, durable child-appropriate formulations are needed. Until then, prescribers of AMC suspensions or pharmacists who sell the drug need to create awareness for the importance of proper storage conditions regarding effectiveness of both antibiotics and this recommendation should be reflected in the WHO Essential Medicines List for children.

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