Generic medicines: a holistic assessment of stakeholder perceptions and online information provision

Background: Generic medicines result from expired intellectual property protection and the ability of pharmaceutical producers, other than originator companies, to manufacture analogous medicines containing identical active ingredients and to distribute them in relevant markets. Cost reductions associated with procurement of generics by national agencies, and subsequent savings for patients buying generic medicines from pharmacies, result in policies regarding generic medicines and reference pricing being promoted by governments internationally. In Ireland, however, generic medicines usage has been poor historically and attitudes of stakeholders, other than the Irish Government, have been relatively negative. In June 2013 the Health (Pricing and Supply of Medical Goods) Act was signed into law, meaning that Irish patients are now more likely than ever before to receive a generic medicine. Objectives From 2013, general practitioners (GPs) and pharmacists alike are likely to encounter greater patient awareness, and discussion, of generic medicines, their potential benefits and disadvantages. This thesis focused initially on providing a comprehensive description of generic medicines and their development and, at a time immediately preceding introduction of the Irish Act, on gaining insight into current stakeholder attitudes and awareness towards generic medicines in Ireland. In parallel, a novel tool based on principles of understandability and readability of text was developed. This was utilised to assess websites most likely to be accessed by patients seeking information regarding generic medicines across a number of English speaking regions, with emphasis on Ireland. Methods Mixed methods studies (in the format of 1:1 interviews) with GPs, pharmacists and patients from rural and urban settings in Ireland. Analysis of interviews was both qualitative and quantitative using SPSS (version 20) and NVivo (version 9), as appropriate. Evaluation of websites was completed with a novel Website Quality Assessment (WQA) tool, developed as part of this thesis. Websites most likely to be used by searchers looking for online information about generic medicines in five Englishspeaking geographical regions (US, UK, Ireland, Canada and Australia) were assessed for quality and accessibility (in terms of readability and understandability) of information provided. Results Analysis of survey data showed that there was a hierarchy of understanding and acceptance of generic medicines in Ireland. In summary, pharmacists had the greatest understanding of generic medicines and the processes associated with their regulation and safety, followed by GPs and then patients. Notably, GPs had less confidence in generics than pharmacists; indeed 5/34 (15%) of GPs would prefer not to use a generic medicine if provided an originator alternative versus 3/44 (7%) of pharmacists. Patients expressed the lowest level of confidence with 9/38 (24%) stating a preference for the branded medication in addition to a belief that generics were of poorer quality than originator medicines. Use of the WQA tool, following peer review and validation of its design, demonstrated clearly that readability and understandability of healthcare information influenced the Google search ranking of generic medicine-related websites. In Ireland, analogous to other jurisdictions, none of the websites most likely to be seen by a searcher demonstrated the desired combination of scoring highly for both quality of information and readability. Conclusions: In summary, these investigations impart new insights regarding knowledge, attitudes and behaviours in Ireland towards generic medicines, determine and evaluate the Internet resources likely to be accessed by those seeking knowledge on this topic across a number of English-speaking regions, and provide a unique tool to enhance the promotion and provision of relevant information

What do people really think about generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic medicines.

Background: Considerable emphasis is presently being placed on usage of generic medicines by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generic medicines. The objective of this paper is to report the outcomes of a systematic search for peer-reviewed, published studies that focus on physician, pharmacist and patient/consumer perspectives of generic medicines. Methods: Literature published between January 2003 and November 2014, which is indexed in PubMed and Scopus, on the topic of opinions of physicians, pharmacists and patients with respect to generic medicines was searched, and articles within the scope of this review were appraised. Search keywords used included perception, opinion, attitude and view, along with keywords specific to each cohort. Results: Following review of titles and abstracts to identify publications relevant to the scope, 16 papers on physician opinions, 11 papers on pharmacist opinions and 31 papers on patient/consumer opinions were included in this review. Quantitative studies (n = 37) were the most common approach adopted by researchers, generally in the form of self-administered questionnaires/surveys. Qualitative methodologies (n = 15) were also reported, albeit in fewer cases. In all three cohorts, opinions of generic medicines have improved but some mistrust remains, most particularly in the patient group where there appears to be a strongly held belief that less expensive equals lower quality. Acceptance of generics appears to be higher in consumers with higher levels of education while patients from lower socioeconomic demographic groups, hence generally having lower levels of education, tend to have greater mistrust of generics. Conclusions: A key factor in improving confidence in generic products is the provision of information and education, particularly in the areas of equivalency, regulation and dispelling myths about generic medicines (such as the belief that they are counterfeits). Further, as patient trust in their physician often overrules their personal mistrust of generic medicines, enhancing the opinions of physicians regarding generics may have particular importance in strategies to promote usage and acceptance of generic medicines in the future

Hand hygiene practices for prevention of health care‑associated infections associated with admitted infectious patients in the emergency department: a systematic review

BackgroundIn most high-income countries, emergency departments (ED) represent the principal point of access forcer by critically ill or injured patients. Unlike inpatient units, ED healthcare workers (ED HCWs) have demonstrated relative lack of adherence to hand hygiene (HH) guidelines, commonly citing frequency of intervention and high rates of admission, which reflect severity of cases encountered.AimAssessment of studies on hand hygiene compliance (HHC) by ED HCWs conducted between 2010 and 2020, seeking to estimate HHC rates and intervention strategies utilised to improve HHC in EDs.MethodsSearches conducted in Web of Science, EBSCO HOST (CINHAL & Medline), PubMed, Embase, and Cochrane for full studies published between 2010 and 2020 on the topic of HHC in the ED.ResultsOne hundred twenty-nine eligible articles were identified of which 79 were excluded. Fifty-one underwent full-text screening before 20 studies were deemed relevant. Of the eligible studies, fifteen (75%) had, as the primary outcome, HHC according to the WHO-recommended 5-moments. Twelve studies (60%) implemented multimodal or single intervention strategies. Eight studies were ambiguous regarding the nature of the approach adopted. In the nine observational studies where HHC was documented, an overall post-intervention median HHC rate of 45% (range 8–89.7%).ConclusionMultimodal approaches appear to have enhanced HHC moderately among ED HCWs. Elevated complexity associated with critically ill patients, and ED overcrowding, are contributing factors to relatively low compliance rates observed. Strategies to improve HHC rates may need to acknowledge, and cater for, the context of an unpredictable environment.</p

Patient perceptions of generic medicines a mixed-methods study.

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Beliefs, perceptions and behaviours of GPs towards generic medicines.

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A qualitative assessment of practitioner perspectives post-introduction of the first continuous professional competence (CPC) guidelines for emergency medical technicians in Ireland.

Background: In November 2013, the Irish Regulator for emergency medical technicians (EMTs) introduced the first mandatory requirement for registrants to demonstrate evidence of continuous professional development (CPD)/ continuous professional competence (CPC). This qualitative study assessed the experience of practitioners with CPC-related materials provided to them by the Regulator in addition to identifying perceived or encountered practical challenges and suggested improvements six months following introduction of the requirement. Methods: Five fora were utilised, comprising two distinct groupings: a group of student EMTs (n = 62) and four discrete groups of qualified EMTs (total n = 131) all of whom had commenced the newly-introduced CPC process. All 193 volunteers were members of the Civil Defence (an auxiliary/voluntary organisation) and represented a nationwide distribution of personnel. Responses were categorised as ‘perceived’ challenges to CPC, relating to student EMTs, and ‘experienced’ challenges to CPC, relating to qualified EMTs. Responses also included suggestions from both groups of EMTs on how to improve the current system and guidance material. Audio/visual recordings were made, transcribed and then analysed using NVivo (version 10). A coding framework was developed which identified unifying themes. Results: All participants agreed that CPC for pre-hospital practitioners was a welcomed initiative believing that CPC activities would help ensure that EMTs maintain or enhance their skills and be better enabled to provide quality care to the patients they might encounter. Two specific areas were identified by both groups as being challenging: 1) the practicalities of completing CPC and 2) the governance and administration of the CPC process. Challenging practicalities included: ability of voluntary EMTs to gain access to operational placements with paramedics and advanced paramedics; the ability to experience the number of patient contacts required and the definition of what constitutes a ‘patient contact’. With regard to the governance and administration of CPC, it was suggested that in order to enhance the process, the Regulator should provide: an outline of the CPC audit process; examples of cases studies and reflective practice; templates for portfolios; and should establish a central hub for CPC information. Conclusion: These groups of Irish EMTs appeared keen to participate in continuous professional competence activities. In addition, these EMTs identified areas that, in their opinion, required clarification by the Regulator related to the practicalities of CPC and the governance and administration of CPC. More information, dissemination of sample requirements and further effective engagement with the Regulator could be used to refine the current CPC requirements for EMTs

Perceptions and attitudes of community pharmacists towards generic medicines.

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Timely publishing of experiences and sharing of knowledge.

Sir, Philip Larkin wrote “man hands on misery to man”. The poet was born in 1922 at the birth of the modern “antibiotic era” and, while he was not referring to infection, the phrase reflects the microbiological phenomenon. Early career doctors, nurses and IPC professionals should feel empowered to report their work and not be over-awed by perceived restrictions or hierarchical clinical and management structures. However, their early career focus is likely to be dominated by ambition for professional success. Controversy, “rocking of boats” and association with incidents of emerging drug resistance may, perhaps, be viewed as best avoided. And such was the case, in 2005, when a 15 year old male cystic fibrosis patient presented with a linezolid-resistant methicillin-sensitive Staphylococcus aureus G2576T mutation secondary to the prolonged use of linezolid by his attending physican in the absence of any specialist advice. Although now superceded by reports in 2006 and 2010 1,2 of similar incidences, at that time we did not publish our learning regarding risks associated with prolonged monotherapy in this setting, ineffective dosing and subsequent bacteriostatic activity

A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study

Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of medicines in the world’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing. This article refers to this situation as an exemplar of a national system on the cusp of significant health policy change, and specifically details Ireland’s history with usage of generic medicines and how the proposed changes could affect healthcare provision

Regulation and registration as drivers of continuous professional competence for Irish pre-hospital practitioners: a discussion paper.

Background The Regulatory Body responsible for the registration of Irish pre-hospital practitioners, the Pre-Hospital Emergency Care Council (PHECC), identified the need to implement a continuing professional competence (CPC) framework. The first cycle of CPC (focused on Emergency Medical Technicians) commenced in November 2013 creating for the first time a formal relationship between continuing competence and registration to practice. Aims To review current literature and to describe benefits and challenges relevant to CPC, regulation, registration and their respective contributions to professionalism of pre-hospital practitioners: advanced paramedics, paramedics and emergency medical technicians. Methods Online search of Cumulative Index to Nursing and Allied Health Literature (CINAHL Plus with Full Text), Allied and Complementary Medicine (AMED) and ‘Pubmed’ databases using: ‘Continuous Professional Development’; ‘Continuous Professional Development’; ‘emergency medical technician’; ‘paramedic’; ‘registration’; ‘regulation’; and “profession’ for relevant articles published since 2004. Additional policy documents, discussion papers, and guidance documents were identified from bibliographies of papers found. Results Reports, governmental policies for other healthcare professions, and professional developments internationally for allied professions (e.g., nursing, physiotherapy and medicine) link maintenance of competence with requirements for registration to practice. Conclusion We suggest that evolving professionalisation of Irish paramedics should be affirmed through behaviours and competencies that incorporate adherence to professional codes of conduct, reflective practice, and commitment to continuing professional development. While the need for ambulance practitioner CPD was identified in Ireland almost a decade ago, PHECC now has the opportunity to introduce a model of CPD for paramedics linking competence and professionalism to annual registratio