Suzanne S. Dunne

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.

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

BackgroundConsiderable 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.MethodsLiterature 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.ResultsFollowing 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.ConclusionsA 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.

A Method for the Design and Development of Medical or Health Care Information Websites to Optimize Search Engine Results Page Rankings on Google

Background The Internet is a widely used source of information for patients searching for medical/health care information. While many studies have assessed existing medical/health care information on the Internet, relatively few have examined methods for design and delivery of such websites, particularly those aimed at the general public. Objective This study describes a method of evaluating material for new medical/health care websites, or for assessing those already in existence, which is correlated with higher rankings on Googles Search Engine Results Pages (SERPs). Methods A website quality assessment (WQA) tool was developed using criteria related to the quality of the information to be contained in the website in addition to an assessment of the readability of the text. This was retrospectively applied to assess existing websites that provide information about generic medicines. The reproducibility of the WQA tool and its predictive validity were assessed in this study. Results The WQA tool demonstrated very high reproducibility (intraclass correlation coefficient=0.95) between 2 independent users. A moderate to strong correlation was found between WQA scores and rankings on Google SERPs. Analogous correlations were seen between rankings and readability of websites as determined by Flesch Reading Ease and Flesch-Kincaid Grade Level scores. Conclusions The use of the WQA tool developed in this study is recommended as part of the design phase of a medical or health care information provision website, along with assessment of readability of the material to be used. This may ensure that the website performs better on Google searches. The tool can also be used retrospectively to make improvements to existing websites, thus, potentially enabling better Google search result positions without incurring the costs associated with Search Engine Optimization (SEO) professionals or paid promotion.

Generic medicines: an evaluation of the accuracy and accessibility of information available on the internet

BackgroundInternationally, generic medicines are increasingly seen as a key strategy to reduce healthcare expenditure, therefore awareness and knowledge transfer regarding generic medicines are valid areas of research. Although the Internet is a frequently used source of medical information, the accuracy of material found online is variable. The aim of this study was to evaluate information provided on the Internet regarding generic medicines in terms of quality of information and readability.MethodsInternet searches for information regarding generic medicine were completed, with a pre-defined search term, using the Google search engine, in five English-speaking geographical regions (US, UK, Ireland, Canada and Australia). Search results likely to be looked at by a searcher were collated and assessed for the quality of generic medicine-related information in the websites, using a novel customised Website Quality Assessment (WQA) tool; and for readability, using existing methods. The reproducibility of the tools between two independent reviewers was evaluated and correlations between WQA score, readability statistics and Google search engine results page ranking were assessed.ResultsWikipedia was the highest-ranking search result in 100% of searches performed. Considerable variability of search results returned between different geographical regions was observed, including that websites identified in the Australian search generated the highest number of country specific websites; searches performed using computers with Irish, British, American and Canadian IP addresses appear to be more similar to each other than the google.com search performed in Australia; and the Canadian google.ca results show a notable difference from any of the other searches. Of the 24 websites assessed, none scored a perfect WQA score. Notably, strong correlation was seen between WQA and readability scores and ranking on google.com search results.ConclusionsThis novel evaluation of websites providing information on generic medicines showed that, of the websites likely to be seen by a searcher, none demonstrated a combination of scoring highly on quality of information (as evinced by WQA score) and readability. Therefore, there is a gap in online knowledge provision on this topic which, if filled by a website designed using the WQA tool developed in this study, has an improved likelihood of ranking highly in google.com search results.

The first survey of attitudes of medical students in Ireland towards termination of pregnancy

Background Since the UK Abortion Act (1967), women have travelled from Ireland to the UK for legal abortion. In 2011 >4000 women did so. Knowledge and attitudes of medical students towards abortion have been published, however, this is the first such report from Ireland. Objective To investigate medical students’ attitudes towards abortion in Ireland. Methods All medical students at the University of Limerick, and physicians who graduated from the university within the previous 12 months, were invited via email to complete an anonymous online survey. The questionnaire comprised 17 questions. Quantitative and qualitative analyses were performed. Results Response rate was 45% (n=169; 55% women; 88.2% <30 years of age; 66.7% Irish; 29.2% North American). Outcomes were: abortion should not be legally available (7.1%), abortion should be allowed in limited circumstances only (35.5%), abortion should be legally available upon request (55%). 72.8% of respondents were moderately/strongly prochoice (74% of women/71% of men/72% and 76% of Irish and North American respondents, respectively). Students aged >30 years were less likely to be prochoice (55%). While 95.2% believed that education on abortion should be offered within medical school curricula, 28.8% stated that they would decline to terminate pregnancies even if legally permitted. While 58.8% indicated that they might perform legal abortions once qualified, 25.7% would do so under limited circumstances only. Conclusions The majority of participants wanted education regarding abortion. Despite being predominantly prochoice, considerably fewer students, irrespective of nationality, indicated that they would perform abortions.

What Do Users of Generic Medicines Think of Them? A Systematic Review of Consumers’ and Patients’ Perceptions of, and Experiences with, Generic Medicines

Background and ObjectiveConsiderable emphasis is placed on the use of generic medicines because of the potential economic benefits associated with their use. The objective of this systematic review is to compile and collate published research regarding patient/consumer perceptions and attitudes in relation to generic medicines, aiming to describe such views and detail patient experiences with generic medicines.MethodsLiterature published between 2005 and July 2015, indexed in PubMed, Scopus and EMBASE, on the topic of consumer or patient opinions of generic medicines were collated, using systematic searches, and appraised.ResultsA total of 59 papers were reviewed. Familiarity and trust in brand names appears to be a substantial barrier to the increased use of generics, with patients also appearing to hold the view that if a product is cheaper, then it must not be as good. Some publications report positive views of generics, with positively inclined consumers stating that they did not perceive any difference between a generic and the proprietary medicine. Acceptance of generics appears to be higher in consumers with higher levels of education while patients from lower socioeconomic demographic groups tend to have greater mistrust of generics.ConclusionsThe provision of information to consumers that dispels myths about generics may improve confidence in generic medicines. As patients demonstrate a high degree of trust in physicians, their opinions can impact on patient/consumer opinions. Therefore, enhancing the perceptions of generics held by physicians is likely to have a positive impact on patient/consumer opinions of, and trust in, generic medications.

Specialized cleaning associated with antimicrobial coatings for reduction of hospital-acquired infection: opinion of the COST Action Network AMiCI (CA15114)

Recognized issues with poor hand hygiene compliance among healthcare workers and reports of recontamination of previously chemically disinfected surfaces through hand contact emphasize the need for novel hygiene methods in addition to those currently available. One such approach involves antimicrobial (nano) coatings (AMCs), whereby integrated active ingredients are responsible for elimination of micro-organisms that come into contact with treated surfaces. While widely studied under laboratory conditions with promising results, studies under real-life healthcare conditions are scarce. The views of 75 contributors from 30 European countries were collated regarding specialized cleaning associated with AMCs for reduction of healthcare-associated infection. There was unanimous agreement that generation of scientific guidelines for cleaning of AMCs, using traditional or new processes, is needed. Specific topics included: understanding mechanisms of action of cleaning materials and their physical interactions with conventional coatings and AMCs; that assessments mimic the life cycle of coatings to determine the impact of repetitive cleaning and other aspects of ageing (e.g. exposure to sunlight); determining concentrations of AMC-derived biocides in effluents; and development of effective de-activation and sterilization treatments for cleaning effluents. Further, the consensus opinion was that, prior to widespread implementation of AMCs, there is a need for clarification of the varying responsibilities of involved clinical, healthcare management, cleaning services and environmental safety stakeholders.

Clustered interventions to reduce inappropriate duplicate laboratory tests in an Irish tertiary hospital

BACKGROUND There is increasing emphasis on understanding the rate, and avoidable costs, of inappropriate laboratory testing in hospitals, especially associated with duplication of tests following transfer of patients from one hospital to another. While studies of inappropriate testing have been reported previously, there are no published data relevant to Ireland. AIMS To determine the baseline rate of inappropriate testing for a subset of clinical parameters, specifically, full blood counts (FBC), biochemistry profiles (Bio) and coagulation (Coag) screens for geriatric patients transferring to and from University Hospital Limerick (UHL). Prospective pilot-scale implementation of five clustered interventions, and assessment of their effect. METHODS Baseline testing levels were determined between October 2013 and January 2014. A patient survey was conducted to evaluate patient awareness of the blood tests they underwent. Five interventions were trialed sequentially each month between January and May 2014. These included: educational poster, intern training, presentations and communication to consultants; automated prompt in the Lab Information Technology system; highlighting of patient survey results to medical staff; inclusion of laboratory test details on patient transfer document; patient booklet promoting empowerment. Impact was assessed by determining rates of inappropriate laboratory testing monthly, and associated actual cost reductions were calculated. RESULTS Approximately two-thirds of geriatric inpatients were unaware of why they underwent blood tests. Baseline numbers of inappropriate duplicate FBCs, Bio profiles and Coag tests were 758, 749 and 268 respectively for patients transferring to and from UHL. Following the interventions, these numbers dropped to 85, 84 and 0, respectively. CONCLUSION The interventions resulted in sustained reduction in rates of inappropriate testing by May 2014. Extrapolated cost reductions exceed two million Euro annually. The most effective intervention involved staff education.

A qualitative assessment of practitioner perspectives post-introduction of the first Continuous Professional Competence (CPC) guidelines for emergency medical technicians in Ireland

BackgroundIn 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.MethodsFive 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.ResultsAll 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.ConclusionThese 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.

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

BackgroundThe 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.AimsTo 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.MethodsOnline 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.ResultsReports, 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.ConclusionWe 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 registration.