Precaution, governance and the failure of medical implants: the ASR(TM) hip in the UK

Hip implants have provided life-changing treatment, reducing pain and improving the mobility and independence of patients. Success has encouraged manufacturers to innovate and amend designs, engendering patient hopes in these devices. However, failures of medical implants do occur. The failure rate of the Articular Surface Replacement metal-on-metal hip system, implanted almost 100,000 times world-wide, has re-opened debate about appropriate and timely implant governance. As commercial interests, patient hopes, and devices’ governance converge in a socio-technical crisis, we analyse the responses of relevant governance stakeholders in the United Kingdom between 2007 and 2014. We argue that there has been a systemic failure of the governance system entrusted with the safety of patients fitted with medical implants. Commercial considerations of medical implants and the status quo of medical implant governance have been given priority over patient safety despite the availability of significant failure data in an example of uncertainty about what constitutes appropriate precautionary action

Development and initial validation of a postal survey evaluation of community pharmacists' opinion regarding falsified (counterfeit) medicines in Hampshire (UK)

Context: Falsified-medicines pose a worldwide problem to patients, healthcare professionals, pharmaceutical companies, and governments. Community pharmacists are usually the last points of contact with patients and can protect them by quarantining falsified medicines. Hence, their opinions are valuable in exploring how the profession can combat this. Aims: To explore the opinion of pharmacists with respect to falsified medicines. Methods: A postal survey was developed and distributed to 359 pharmacies via the local pharmaceutical committee in Hampshire, UK. Descriptive statistics and hypothesis testing was conducted. Hypothesis testing (95% CI, α = 0.05) will be conducted to identify any gender differences, differences based on years of experience and differences based on number of working hours per week. Results: A 14% response rate was achieved. Pharmacists surveyed believe that falsified-medicines pose a significant problem to the profession on a five-point Likert scale (4.02 ± 1.078). A pharmacist’s intervention can prevent or disrupt the supply to patients (4.12 ± 0.824) and training courses can improve pharmacist’s knowledge (4.06 ± 0.843). Pharmacists are not confident and capable in identifying falsified-medicines (2.62 ± 1.105). This is surprising and unexpected because pharmacists are medicines-expert. A 10-item scale is validated (72.2% Cronbach alpha). Conclusions: Falsified-medicines pose a small but significant and growing challenge to the profession. There is underutilization of the high street community pharmacist in identifying falsified-medicines. Healthcare professionals should report suspect counterfeits to the MHRA

Gaining approval for clinical research

Set-up and delivery of a clinical research project can be complicated and difficult. This article introduces the regulatory processes involved in gaining approval for clinical research and discusses the obstacles that may be encountered

Pathway map development for medical device event reporting in operating theatres: a human factors approach to improving the existing system

OBJECTIVES: This study aimed to develop the actual pathway to reporting and information transfer in operating theatres in relation to medical technology malfunction/failure. This with the aim of understanding the differences with the pathway published by NHS Improvement and identification of points for improvement. DESIGN: This is a qualitative study involving stakeholder interviews with doctors, nurses, manufacturers, medical device safety officer and Medicines and Healthcare products Regulatory Agency. SETTING: Data were collected on reporting pathway used in operating theatres. Clinical staff who took part worked in different trusts throughout UK while manufacturers provided devices in UK and EU/USA. PARTICIPANTS: Semistructured interviews were completed with 15 clinicians and 13 manufacturers. Surveys were completed by 38 clinicians and 5 manufacturers. Recognised methods of pathway development were used. The Lean Six Sigma principles adapted to healthcare were used to develop suggestions for improvement. MAIN OUTCOME MEASURES: To identify the differences between the set pathway to reporting and information transfer to what is occurring on a day-to-day basis as reported by staff. Identify points in the pathway where improvements could be applied. RESULTS: The developed pathway demonstrated great complexity of the current reporting system for medical devices. It identified numerous areas that give rise to problems and multiple biases in decision making. This highlighted the core issues leading to under-reporting and lack of knowledge on device performance and patient risk. Suggestions for improvement were deduced based on end user requirements and identified problems. CONCLUSIONS: This study has provided a detailed understanding of the key problem areas that exist within the current reporting system for medical devices and technology. The developed pathway sets to address the key problems to improve reporting outcomes. The identification of pathway differences between 'work as done' and 'work as imagined' can lead to development of quality improvements that could be systematically applied

GCP inspections in Germany and Europe following the implementation of the Directive 2001/20/EC

Background: The implementation of the Clinical Trials Directive 2001/20/EC and the Good Clinical Practice Directive 2005/28/EC fundamentally restructured and harmonized the conduct of clinical trials in Europe. GCP inspections – which affect study sites, laboratories, sponsors and contract research organizations (CRO) alike – make up an important part of these regulations. A common understanding of how these regulations apply in daily life is however not always ensured

Reduced anterior cingulate grey matter volume in painful hand osteoarthritis

Objective Increasing evidence supports the role of central sensitisation in osteoarthritis (OA) pain. In this study, we used neuroimaging to compare pain-processing regions of the brain in participants with and without hand OA. We then assessed for volumetric changes in these brain regions following treatment with centrally acting analgesics. Methods Participants with hand OA (n = 28) underwent T1-weighted MRI of the brain before and after 12 weeks of treatment with pregabalin, duloxetine or placebo. Grey matter volume in the anterior cingulate cortex (ACC), insular cortex and thalamus was compared to non-OA control subjects (n = 11) using FreeSurfer regional volumetric analysis and voxel-based morphometry, and evaluated for differences pre- and post-treatment. Results Relative to non-OA controls, hand OA participants had areas of reduced grey matter volume in the ACC at baseline (p = 0.007). Regional volumetric differences in the ACC persisted after 13 weeks’ treatment with pregabalin or duloxetine (p = 0.004) with no significant differences between treatment cohorts, despite improvements in NRS pain scores for pregabalin (p = 0.005) and duloxetine (p = 0.050). The ACC grey matter changes persisted despite a significant improvement in pain in the pregabalin and duloxetine groups vs. placebo. No structural differences were observed in the insular cortex or thalamus at baseline or following treatment. Conclusion Our study found evidence of reduced ACC grey matter volume in participants with hand arthritis that persisted after treatment with centrally acting analgesics pregabalin and duloxetine, respectively. The sustained changes observed in the ACC in our study could reflect the relatively short duration of treatment, or that the differences observed are irreversible volume changes due to chronic pain that are established over time

Preventing and lessening exacerbations of asthma in school-age children associated with a new term (PLEASANT) : Study protocol for a cluster randomised control trial

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly citedBackground: Within the UK, during September, there is a pronounced increase in the number of unscheduled medical contacts by school-aged children (4-16 years) with asthma. It is thought that that this might be caused by the return back to school after the summer holidays, suddenly mixing with other children again and picking up viruses which could affect their asthma. There is also a drop in the number of prescriptions administered in August. It is possible therefore that children might not be taking their medication as they should during the summer contributing to them becoming ill when they return to school. It is hoped that a simple intervention from the GP to parents of children with asthma at the start of the summer holiday period, highlighting the importance of maintaining asthma medication can help prevent increased asthma exacerbation, and unscheduled NHS appointments, following return to school in September.Methods/design: PLEASANT is a cluster randomised trial. A total of 140 General Practices (GPs) will be recruited into the trial; 70 GPs randomised to the intervention and 70 control practices of "usual care" An average practice is expected to have approximately 100 children (aged 4-16 with a diagnosis of asthma) hence observational data will be collected on around 14000 children over a 24-month period. The Clinical Practice Research Datalink will collect all data required for the study which includes diagnostic, prescription and referral data.Discussion: The trial will assess whether the intervention can reduce exacerbation of asthma and unscheduled medical contacts in school-aged children associated with the return to school after the summer holidays. It has the potential to benefit the health and quality of life of children with asthma while also improving the effectiveness of NHS services by reducing NHS use in one of the busiest months of the year. An exploratory health economic analysis will gauge any cost saving associated with the intervention and subsequent impacts on quality of life. If results for the intervention are positive it is hoped that this could be adopted as part of routine care management of childhood asthma in general practice. Trial registration: Current controlled trials: ISRCTN03000938 (assigned 19/10/12) http://www.controlled-trials.com/ISRCTN03000938/.UKCRN ID: 13572.Peer reviewe

Evaluating the communication within fire and rescue services and the NHS on the fire risk of emollients in accordance of the MHRA safety update

The Medicines and Healthcare products Regulatory Agency update in 2018 reported 50 fatal fires linked with emollient use. It detailed the fire risk and new advice aimed at fire service and health care professionals in reporting of such fire incidents and educating the public on safer use of emollients. This study investigates how this has been communicated internally and publicly, with 52 Fire and Rescue Services (FRSs) websites and, 191 Clinical Commissioning Groups (CCGs), and 21 Local Health Boards (LHBs) formularies accessed. A Freedom of Information Request (FOIR) was also made, giving further details of implementations. Our study revealed that 63% of FRSs, 32% of CCGs and, 72% of LHBs gave no safety advice within their website or formularies. Of the 37% of FRSs and 68% of CCGs that did, only 5% and 4% were sufficiently up to date. 27% of FRSs and 28% of CCGs/LHBs revealed that they had no warning/advice internally in their FOIR responses and 25% of FRSs and, 35% of CCG/LHBs had not disseminated advice on using emollient safely to the public. We suggest improvements in safety campaigns using a multiagency and national approach and recommend organizations to educate professionals to improve reporting and effective dissemination

Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in acute lung injury to reduce pulmonary dysfunction (HARP-2) trial : study protocol for a randomized controlled trial

Acute lung injury (ALI) is a common devastating clinical syndrome characterized by life-threatening respiratory failure requiring mechanical ventilation and multiple organ failure. There are in vitro, animal studies and pre-clinical data suggesting that statins may be beneficial in ALI. The Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial is a multicenter, prospective, randomized, allocation concealed, double-blind, placebo-controlled clinical trial which aims to test the hypothesis that treatment with simvastatin will improve clinical outcomes in patients with ALI