Systematic review : a cornerstone to promote the uptake of research findings for evidence-based practice

Review of existing research findings from the literature is essential to inform evidence-based practice, decision making, academia and policy. In the medical field, systematic review is considered as standard practice, while in other fields there are different levels of uptake. As compared to traditional literature review, the methodology of systematic review adopts a number of steps and is systematic and transparent. This leads to increased rigour, less bias and allows reproducibility and update. There are still a number of difficulties with the conduct of systematic reviews. The utilisation of systematic review to support different areas of practice is highly recommendable.peer-reviewe

A National Adverse Drug Reaction Reporting System for Malta

The mission of the Medicines Authority (MA) in Malta is to contribute to protection of public health through regulation of the safety, quality and efficacy of medicines for human use on the local market and to ensure that healthcare professionals and patients have access to accurate and up to date information about medicines. In order to disseminate information regarding safety of medicines, the MA publishes guidance notes for healthcare professionals and the pharmaceutical industry. The MA also publishes information on its website: http://www.health.gov.mt/mru/ On the 4th of May, 2004 the MA held a seminar to launch a national adverse drug reaction (ADR) reporting system involving the co-operation of doctors, dentists and pharmacists, as well as the pharmaceutical industry. The ADR reporting system will form part of an overall pharmacovigilance system within the Authority and this will be the primary means of collecting information useful in the surveillance of medicinal products.peer-reviewe

Towards a framework for the continual improvement of healthcare

Quality improvement has become an integral part of healthcare systems. Substantial improvements can only be expected through the creation of new systems. Transforming a healthcare organisation so that it is capable of continual improvement requires a specific framework. This framework includes the linking of professional knowledge (subject, discipline and values) and improvement knowledge (system, variation, psychology and theory of knowledge) to daily work. Improvement knowledge enables linking of the knowledge and interrelationships of the elements of a system, consideration of the type of variation, teamwork and motivation of participants and the use of prediction and measurement to link theory and action.peer-reviewe

Enhancing the choice and use of medicines : an overview of the Medicines Authority’s strategy to empower patients and consumers and support healthcare professionals

Public health authorities regulate in the public interest to protect health, ensure patient access to safe medicines, stimulate innovation and encourage a competitive market.1 Pharmaceutical regulation supports various components of a national pharmaceutical policy, including research and development (through regulation of clinical trials and provision of scientific advice), authorisation of medicinal products, regulation of the supply chain (manufacturers, wholesale dealers and pharmacies), pharmacovigilance and the rational use of medicinal products (through information about medicinal products and the use of medicines). The tangible public health outcomes of these processes are access, availability and affordability of medicinal products which are of good quality, and safe and efficacious when used rationally.peer-reviewe

Medicines management in the palliative care of cancer patients

Cancer is one of the leading causes of death in Malta. Palliative care is a mainstay in the care of such patients. Commonly encountered symptoms include pain, nausea and vomiting, constipation and oropharyngeal complications. All of these bear an impact on the quality of life of the patient and also of the carers. Drug treatment is an integral part of the management of these symptoms. Patients and their carers may have concerns regarding their medication. The community pharmacist is well positioned and competent to support the needs of these patients as part of their holistic care.peer-reviewe

The managed entry of new drugs into a National Health Service: a case study for Malta.

The research question was to determine if it is possible to develop a systematic approach to the managed entry of new drugs into a National Health Service( NHS), using Malta as a case study. In early 1999, Malta had major problems with the managed entry of new drugs into the NHS. Some essential processes such as medicines registration did not exist, and the processes that existed were not systematic. The policy for the introduction of new drugs resulted in a large number of non-formulary requests for individual patients, with such applications rising to 14,129 by 1998. There were no set criteria for assessing these applications and this together with internal and external influences led to inequity of access to drugs within the NHS. A case study was conducted. A descriptive evaluation was undertaken and a logic model was used to represent the case as in June 1999 (baseline). Areas for change were planned and prioritised. An action evaluation was undertaken and action research was implemented as an intervention for change. A second descriptive model was developed to represent the processes at the end of the action evaluation (December 2001). An outcome evaluation described the changes that took place during the action evaluation. A number of improvements supporting a more systematic approach were achieved. Several policies were revised and new policies developed where appropriate. The outcome was that new drugs were to be approved on the formulary for groups of patients (rather than individuals) that met specific criteria. Due to limited NHS resources inequity remains. However, the approach is now systematic which has made the processes more transparent. Recommendations for further development of the systematic approach were made with the aim of further reducing inequity

Using evidence-based management in practice : a case study on the pricing and reimbursements of medicines

In the last twenty-five years, there were several initiatives for European Member State (MS) collaboration for pricing and reimbursement. Initially, these were driven by the MSs, were voluntary, lacked coordination between them, and were not systematic (World Health Organisation [WHO] 2015). Council Conclusions of different Presidencies of the Council of the European Union supported MS-driven voluntary cooperation on health technology assessment (HTA) (Council of the European Union, 2016; Council of the European Union, 2017). Pricing and reimbursement authorities of most MSs collaborated within the ‘European Network for Health Technology Assessment’ (EUnetHTA) (EUnetHTA, 2018); however, difficulties were experienced with implementation (European Commission, 2016). In 2018, the European Commission came up with a legislative proposal: ‘Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/ EU’ (European Commission, 2018). In parallel, initiatives for the development of ‘regional cooperations’ within groups of MSs had started, and Malta was signatory of the Valletta Declaration.peer-reviewe

Patients' lived experiences of cytotoxic medications prescribed for the management of malignant solid tumours: a systematic review.

The aim of the systematic review is to critically appraise, synthesise and present the available evidence of patients' lived experiences of cytotoxic medications prescribed for the management of malignant solid tumours. In relation to the patients pharmacological treatment journey for the management of malignant solid tumours: What are the patients' lived experience? What is the medication related burden? What are the medication related beliefs? What is the medication taking practice? What is the relationship between the lived experience and medication related burden, medication related beliefs and medication taking practice

Patients' lived experiences with antineoplastic medicines for the management of malignant solid tumours: a systematic review.

Background: Antineoplastic medicines affect the patients’ physical and psychosocial well-being posing challenges for patients, caregivers and healthcare professionals. However, little is known about the patients’ lived experience with medicines (PLEM) for antineoplastic treatment. It is the lived experience that gives meaning to each individual’s perception of a particular phenomenon which is influenced by internal and external factors relevant to the individual. Objectives: To critically appraise, synthesise and present the available evidence of patients’ lived experience with antineoplastic medicines prescribed for the management of malignant solid tumours. Method: A systematic literature search was conducted in six electronic databases for articles published in English with no date restrictions. The search terms were related to beliefs, practice and burden in relation to patient, antineoplastic medicines, tumours and lived experience. Study selection, quality assessment and data extraction were performed independently by 2 reviewers. Research findings were analysed using narrative and meta-synthesis approaches. Results: The search retrieved 31,004 articles with only 10 studies satisfying the inclusion and exclusion criteria. These studies were published between 2005 and 2016 in Europe (n=6), America (n=3) and Asia (n=1). Nine themes were identified to contribute to the patients’ lived experience with antineoplastic medicines. These were (a) influence from family members, healthcare professionals, media and culture, (b) general attitude towards medicine, (c) accepting medicine, (d) modifying or altering medicine regimen or dose, (e) medicine characteristics, (f) medicine routine, (g) medicine adverse events, (h) medicine and social burden and (i) healthcare associated medicine burden. Patients tend to undergo a continuous process of reinterpretations of their experience with medicines throughout their treatment journey. Conclusion: The use of antineoplastic medicines has a profound effect on the patients’ lives. Further longitudinal in-depth studies are required to provide deeper insight into PLEM and support patients in their treatment journey