Essential medicines for universal health coverage

Drug regulatory agencies should ensure that the benefits of drugs outweigh their risks, but licensed medicines sometimes do not perform as expected in everyday clinical practice. Failure may relate to lower than anticipated efficacy or a higher than anticipated incidence or severity of adverse effects. Here we show that the problem of benefit-risk is to a considerable degree a problem of variability in drug response. We describe biological and behavioural sources of variability and how these contribute to the long-known efficacy-effectiveness gap. In this context, efficacy describes how a drug performs under conditions of clinical trials, whereas effectiveness describes how it performs under conditions of everyday clinical practice. We argue that a broad range of pre- and post-licensing technologies will need to be harnessed to bridge the efficacy-effectiveness gap. Successful approaches will not be limited to the current notion of pharmacogenomics-based personalized medicines, but will also entail the wider use of electronic health-care tools to improve drug prescribing and patient adherence.

Bridging the efficacy–effectiveness gap: a regulator's perspective on addressing variability of drug response

Introduction: South Africa has an appreciable burden of both communicable and non-communicable diseases as well as high maternal, neonatal and child morbidity. There have been significant strides with improving the public health system, and addressing current inequalities, in recent years with the right to health a constitutional provision in South Africa. Initiatives include the introduction of National Health Insurance (NHI), programmes to enhance access to medicines for patients with chronic diseases, as well as activities to improve care in hospitals including improving pharmacovigilance. Consequently, the objective of this paper is to review ongoing initiatives within the public healthcare sector in South Africa and their influence to provide future direction. Method: Principally a structured review of current and planned activities. Results: There have been a number of major activities and initiatives surrounding the availability and access to medicines in the public system in recent years in South Africa. This includes a National Surveillance Centre and an innovative early warning system for the supply of medicines as well as the development of a National Health Care Pricing Authority and initiatives to improve contracting. There have also been developments to improve the supply chain including instigating Medicine Procurement Units in the provinces and enhancing forecasting capabilities. Access to medicines is improving though the instigation of stable chronic disease management initiatives to increase the number of external pick-up points for medicines. There are also ongoing programmes to enhance adherence to medicines as well as enhance adherence to Standard Treatment Guidelines and Essential Medicines Lists with their increasing availability. In addition, there is a movement to enhance the role of health technology assessment in future decision making. Hospital initiatives include increased focus on reducing antimicrobial resistance through instigating stewardship programmes as well as improving adverse drug reaction reporting and associated activities. Conclusion: Overall, there are an appreciable number of ongoing activities within the public health system in South Africa to try and ensure and sustain universal healthcare. It is too early to assess their impact, which will be the subject of future research.

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Ongoing Initiatives to Improve the Quality and Efficiency of Medicine Use within the Public Healthcare System in South Africa; A Preliminary Study.

Medicines play an integral part of healthcare delivery However, they are expensive commodities and account for a significant proportion of overall health expenditure in most countries Irrational use of medicines is a major challenge facing many health systems across the world Such practices are likely to lead to poor health delivery that may put patients at risk and result in wastage of scarce resources that could have been used to tackle other pressing health needs The concept of "rational use of medicine" can at times be confusing and not easily appreciated by patients, healthcare providers, policy makers, or the public, all of whom need to collaborate effectively to address this challenge In this article, we summarize basic concepts such as rational medicine use, good prescribing and dispensing, and explore some of the factors that contribute to irrational use of medicines as well as potential impacts of such practices This article has been written with the intention of offering a clear, concise, and easy to understand explanation of basic medicine use concepts for health professionals, patients, policy makers, and the public

Irrational Use of Medicines-A Summary of Key Concepts.

Background: Knowledge, perceptions and prescribing behaviour are key to antibiotic prescribing. The aim of this paper is to systematically review this. Method: An extensive literature search from 1990 to 2014. Results: Nineteen articles were included; eight in ambulatory care, seven in hospital settings and four in both, across all countries. Physicians still have inadequate knowledge and misconceptions about antibiotic prescribing. Moreover, some physicians, although aware that antibiotics are of limited benefit in some conditions, still prescribed them. Several factors influenced prescribing, including patients’ expectations, severity and duration of infections, uncertainty over diagnosis, potentially losing patients and influence of pharmaceutical companies. Pocket-sized guidelines seen as an important source of information for physicians. Conclusion: Inadequate knowledge of prescribing is prevalent among physicians. However, many physicians were interested in improving their antibiotic prescribing. Mu...

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Physicians' knowledge, perceptions and behaviour towards antibiotic prescribing: a systematic review of the literature

The aim was to present and evaluate the impact of a comprehensive strategy over 10 years to select, communicate and achieve adherence to essential drug recommendations (EDR) in ambulatory care in a metropolitan healthcare region. EDRs were issued and launched as a 'Wise List' by the regional Drug and Therapeutics Committee in Stockholm. This study presents the concept by: (i) documenting the process for selecting, communicating and monitoring the impact of the 'Wise List'; (ii) analysing the variation in the number of drug substances recommended between 2000 and 2010; (iii) assessing the attitudes to the 'Wise List' among prescribers and the public; (iv) evaluating the adherence to recommendations between 2003 and 2009. The 'Wise List' consistently contained 200 drug substances for treating common diseases. The drugs were selected based on their efficacy, safety, suitability and cost-effectiveness. The 'Wise List' was known among one-third of a surveyed sample of the public in 2002 after initial marketing campaigns. All surveyed prescribers knew about the concept and 81% found the recommendations trustworthy in 2005. Adherence to recommendations increased from 69% in 1999 to 77% in 2009. In primary care, adherence increased from 83% to 87% from 2003 to 2009. The coefficient of variation (CV%) decreased from 6.1% to 3.8% for 156 healthcare centres between these years. The acceptance of the 'Wise List' in terms of trust among physicians and among the public and increased adherence may be explained by clear criteria for drug recommendations, a comprehensive communication strategy, electronic access to recommendations, continuous medical education and involvement of professional networks and patients.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1742-7843.2011.00682.x

The 'Wise List' - A Comprehensive Concept to Select, Communicate and Achieve Adherence to Recommendations of Essential Drugs in Ambulatory Care in Stockholm

A health record integrated clinical decision support system to support prescriptions of pharmaceutical drugs in patients with reduced renal function: design, development and proof of concept.

Because of the many new drugs available and the vast information on the appropriate usage of newly approved drugs, improved methods are needed to teach medical students clinical pharmacology. We developed a case based course in clinical pharmacology on the web for advanced medical students. Twenty cases outlining several key learning objectives centered on two goals: learning key clinical pharmacological principles and learning how to find the relevant medical information using the web. During this intensive two-week course, students spent the day solving simulated patient cases on the web using the PharmapaC tool (www.pharmapac.org). The course improved students' knowledge of clinical pharmacology and their ability to search the web for evidence-based medical literature. This method of teaching advanced clinical pharmacology serves as a model for ongoing self-directed learning and is an appealing way to learn clinical pharmacology. Introduction With the cost of drugs rapidly rising and the proliferation of newly approved pharmacotherapies it is imperative that medical students be educated on the most up-to-date drug treatments. Furthermore, the students need to strengthen their critical thinking so their proficiency in critical drug evaluation can match strong marketing efforts by drug companies. [1,2] To accomplish this, new approaches are needed in medical school curriculums to teach clinical pharmacology. [3-5] We have designed a course in clinical pharmacology for advanced medical students using the world-wide-web. Advances in technology have enabled instruction on the web to be highly effective. [6-8] Advantages to using the web for medical education include, but are not limited to: 1. Distance learning 2. Access to up-to-date literature 3. Access to digital images, videos, and sound 4. Self paced and self directed learning 5. Around-the-clock access. The teaching of clinical pharmacology is particularly suited for utilizing the Internet for education since traditional pharmacology textbooks often have outdated material as soon as they are published. [9,10] However, liberal use of the Internet as a source of information can also be a disadvantage for learning since there are many false advertisements and misinformation published through the Internet. [11,12] Since drug companies also use the Internet to advertise their medications to influence both physicians and patients, students need to be trained in how to critically evaluate the literature and the information in order to identify misleading information. This paper presents a two-week intensive course that utilizes the world-wide-web and advanced computer applications to teach the principles of pharmacotherapy by having medical students search for answers using the Internet. Objectives The two main goals of the course were to: increase the student's knowledge of clinical pharmacology principles, which include the assessment of adverse drug reactions and the anticipation of interactions and personalized medicine according to the principles of evidence based medicine. In addition, this course was aimed at teaching how to search and critically evaluate the medical literature. Traditional teaching of basic pharmacology is focused on the mechanisms of action and pharmacokinetic properties of drugs. However, the students are not trained how to apply what they know about medications to patient care. They learn how to apply drug therapy to patients during third and fourth year clerkships under the guidance of their interns, residents and attending physicians. In these situations (on the wards or in the clinics) the students themselves, however, are not making the decisions, but are usually following the recommendations of their supervisors. In order to learn effectively, students should be given opportunities to participate in the decision making for the optimal pharmacological treatment and work out patient cases on their own. …

Elisabeth Törnqvist

Papers

The 'Wise List' - A Comprehensive Concept to Select, Communicate and Achieve Adherence to Recommendations of Essential Drugs in Ambulatory Care in Stockholm

A health record integrated clinical decision support system to support prescriptions of pharmaceutical drugs in patients with reduced renal function: design, development and proof of concept.

A Web Based Course in Clinical Pharmacology