Walter Cullen

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.

Prevalence of fatigue in general practice.

BackgroundFatigue is an important symptom in general practice due to its association with physical, psychological and social problems.AimTo determine the prevalence of fatigue as an unsolicited symptom during general practice consultations.MethodsA random sample of GPs practising in Ireland was invited to provide data on consultations held over one day. Data were recorded on the presence of fatigue as a main or supporting symptom, social and demographic characteristics.ResultsData were recorded by 89 GPs on 1,428 consultations. The prevalence of fatigue was 25%. It was the main reason for attending the dcctor in 6.5% and a secondary reason in 19%. Sixty-two per cent of patients were female and 48% were eligible for free GP services. The mean age was 47.1 years. The presence of fatigue was associated with: attending a female GP, being female, attending a GP who had been qualified for fewer years and attending the GP frequently.ConclusionThe prevalence of fatigue reported in this study is over three times higher than that reported in earlier work. Doctor characteristics appear to be as important as patient characteristics in determining fatigue.

Improving delirium care through early intervention: from bench to bedside to boardroom

Delirium is a complex neuropsychiatric syndrome that impacts adversely upon patient outcomes and healthcare outcomes. Delirium occurs in approximately one in five hospitalised patients and is especially common in the elderly and patients who are highly morbid and/or have pre-existing cognitive impairment. However, efforts to improve management of delirium are hindered by gaps in our knowledge and issues that reflect a disparity between existing knowledge and real-world practice. This review focuses on evidence that can assist in prevention, earlier detection and more timely and effective pharmacological and non-pharmacological management of emergent cases and their aftermath. It points towards a new approach to delirium care, encompassing laboratory and clinical aspects and health services realignment supported by health managers prioritising delirium on the healthcare change agenda. Key areas for future research and service organisation are outlined in a plan for improved delirium care across the range of healthcare settings and patient populations in which it occurs.

Transition from child and adolescent to adult mental health services in the Republic of Ireland: an investigation of process and operational practice

Ensuring a seamless transition from child to adult mental health services poses challenges for services worldwide. This is an important process in the ongoing care of young people with mental illness; therefore, it is incumbent on all countries to probe their individual structures to assess the quality of mental health service delivery to this vulnerable cohort. To date, there have been no published studies on the transition from Child to Adult Mental Health Services in the Republic of Ireland. To this end, a nationwide survey of transition policies of community mental health teams in both services was conducted in order to compare best practice guidelines for transition with current process and experience in clinical practice.

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.

Problem alcohol use among problem drug users in primary care: a qualitative study of what patients think about screening and treatment

BackgroundProblem alcohol use is common and associated with considerable adverse outcomes among patients who attend primary care in Ireland and other European countries for opiate substitution treatment. This paper aims to describe patients’ experience of, and attitude towards, screening and therapeutic interventions for problem alcohol use in primary care.MethodsThis qualitative study recruited problem drug users (N = 28) from primary care based methadone programmes in the Ireland’s Eastern region, using a stratified sampling matrix to include size of general practice and geographical area. Semi-structured interviews were conducted and analysed using thematic analysis, and audited by a third reviewer.ResultsWe identified three overarching themes relevant to the purpose of this paper: (1) patients’ experience of, and (2) attitude towards, screening and treatment for problem alcohol use in primary care, as well as their (3) views on service improvement. While most patients reported being screened for problem alcohol use at initial assessment, few recalled routine screening or treatment. Among the barriers and enablers to screening and treatment, patients highlighted the importance of the practitioner-patient relationship in helping them address the issue. Nevertheless, patients felt that healthcare professionals should be more proactive in the management of problem alcohol use at a primary care level and that primary care can play an important role in their treatment.ConclusionsProblem alcohol use is an important challenge in the care of problem drug users. While primary care is well placed to address this issue, little data has reported on this topic. The development of interventions which promote screening and brief interventions in practice are likely to benefit this at-risk group and further research and education, that help achieve this goal, are a priority. Strategies such as dissemination of clinical guidelines, educational videos, academic detailing and practice visits, should be explored.

Management of hepatitis C among drug users attending general practice in Ireland: Baseline data from the Dublin Area Hepatitis C in General Practice Initiative

Objective: In Ireland, general practice is increasingly providing long-term care for injecting drug users, 62–81% of whom are infected with hepatitis C (HCV). Clinical guidelines for the management of HCV among drug users have recently been developed in Ireland, and this study aimed to describe HCV care among drug users attending general practice in the greater Dublin area, prior to the implementation of the clinical practice guidelines. Methods: The clinical records of 196 patients attending 25 general practices in the Eastern Regional Health Authority area of Ireland for methadone maintenance treatment were examined on site and anonymized data collected on HCV care processes. Results: Patients had been attending general practice for methadone maintenance treatment for a mean of 30.7 months, 72% were male and 51% had provided a urine sample testing positive for metabolites of drugs of abuse other than methadone in the previous 3 months. There was evidence that 77%, 69% and 60% had been screened for HCV, human immunodeficiency virus (HIV) and hepatitis B (HBV), respectively. Among those who had been tested, the prevalence of HCV, HIV and HBV infection was 69%, 10% and 11%, respectively. Of those known to be HCV positive, 36 (35%) had been tested for HCV-RNA (29 testing positive), 31 (30%) had been referred to a hepatology clinic, 24 (23%) had attended a clinic, 13 (13%) had a liver biopsy performed and three (3%) had started treatment for HCV. Conclusion: While the majority of patients have been screened for blood-borne viruses, a minority of those infected with HCV have had subsequent investigations or treatment. New interventions to facilitate optimum care in this regard need to be considered.

Hepatitis C infection among drug users attending general practice

Background The prevalence of hepatitis C (HCV) infection among injection drug users is high and addiction-related care is increasingly being provided by GPs in Ireland.Aims To determine the prevalence and associated factors of HCV infection among injecting drug users attending general practice.Methods The records of 571 patients attending 42 general practices in the Eastern Regional Health Authority (ERHA) area for methadone maintenance treatment were reviewed.Results The HCV status was recorded in 380 cases (67%). Of these, 193 had a test performed by their GP, 74 had been tested by another service and 113 had no evidence of being tested, but HCV status was recorded based on information provided by the patient himself. A total of 276 cases were identified as being HCV positive (prevalence 73%), with no difference in prevalence between the three sources of information (p=0.12). A history of injecting drug use was the major determinant of testing for HCV.Conclusions While a large proportion of drug users attending GPs for methadone maintenance treatment are known to be HCV positive, a considerable number have not been tested. Barriers to testing need to be explored to facilitate comprehensive screening.

Psychosocial Interventions for Alcohol Use Among Problem Drug Users: Protocol for a Feasibility Study in Primary Care

Background Alcohol use is an important issue among problem drug users. Although screening and brief intervention (SBI) are effective in reducing problem alcohol use in primary care, no research has examined this issue among problem drug users. Objective The objective of this study is to determine if a complex intervention including SBI for problem alcohol use among problem drug users is feasible and acceptable in practice. This study also aims to evaluate the effectiveness of the intervention in reducing the proportion of patients with problem alcohol use. Methods Psychosocial intervention for alcohol use among problem drug users (PINTA) is a pilot feasibility study of a complex intervention comprising SBI for problem alcohol use among problem drug users with cluster randomization at the level of general practice, integrated qualitative process evaluation, and involving general practices in two socioeconomically deprived regions. Practices (N=16) will be eligible to participate if they are registered to prescribe methadone and/or at least 10 patients of the practice are currently receiving addiction treatment. Patient must meet the following inclusion criteria to participate in this study: 18 years of age or older, receiving addiction treatment/care (eg, methadone), or known to be a problem drug user. This study is based on a complex intervention supporting SBI for problem alcohol use among problem drug users (experimental group) compared to an “assessment-only” control group. Control practices will be provided with a delayed intervention after follow-up. Primary outcomes of the study are feasibility and acceptability of the intervention to patients and practitioners. Secondary outcome includes the effectiveness of the intervention on care process (documented rates of SBI) and outcome (proportion of patients with problem alcohol use at the follow-up). A stratified random sampling method will be used to select general practices based on the level of training for providing addiction-related care and geographical area. In this study, general practitioners and practice staff, researchers, and trainers will not be blinded to treatment, but patients and remote randomizers will be unaware of the treatment. Results This study is ongoing and a protocol system is being developed for the study. This study may inform future research among the high-risk population of problem drug users by providing initial indications as to whether psychosocial interventions for problem alcohol use are feasible, acceptable, and also effective among problem drug users attending primary care. Conclusions This is the first study to examine the feasibility and acceptability of complex intervention in primary care to enhance alcohol SBI among problem drug users. Results of this study will inform future research among this high-risk population and guide policy and service development locally and internationally.

Undergraduate medical education in substance use in Ireland: a review of the literature and discussion paper

BackgroundMedical complications of substance use are a considerable cause of morbidity and the role of the physician in the care of such problems has consistently been demonstrated. Appropriate knowledge and skills are necessary to carry out this role.AimsTo review the literature on training undergraduate medical students in identifying and managing substance misuse and to discuss the implications of this literature for Irish medical education.MethodsA search of the literature was performed using keywords; “substance-related disorders”, “undergraduate” and “curriculum”. All abstracts were reviewed and the full text of relevant abstracts was studied and references reviewed for further articles.ResultsDespite an increase in prevalence of the problem of drug and alcohol use in Ireland and the UK, this has not been reflected in undergraduate medical curricula. In the UK, minimal time is devoted to formal teaching of medical undergraduates in the area of substance misuse and many doctors do not have the appropriate knowledge, skills, attitudes and confidence to treat patients with such problems. In Ireland, no data has reported formal undergraduate teaching hours in the area of drug and alcohol misuse. Internationally, substance abuse curricula have been developed and implemented in medical schools in the United States and Australia.ConclusionWhile substance misuse is increasing in prevalence, this is not reflected in the composition of medical curricula, especially in Ireland. International best practice whereby undergraduate curricula that adequately address substance misuse and related issues are systematically developed and implemented, is recommended for adoption by Irish medical schools.