Anthony R. Cox

Adverse drug reaction teaching in UK undergraduate medical and pharmacy programmes.

Objectives:  To assess the extent of teaching about the Committee on Safety of Medicines Yellow Card scheme and adverse drug reactions within UK Schools of Medicine and Pharmacy.

Patient experiences of serious adverse drug reactions and their attitudes to medicines: a qualitative study of survivors of Stevens-Johnson syndrome and toxic epidermal necrolysis in the UK.

Background: Adverse drug reactions (ADRs) cause significant morbidity and mortality and account for around 6.5% of hospital admissions. Patient experiences of serious ADRs and their long-term impact on patients’ lives, including their influence on current attitudes towards medicines, have not been previously explored.Objective: The aim of the study was to explore the experiences, beliefs, and attitudes of survivors of serious ADRs, using drug-induced Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) as a paradigm.Methods: A retrospective, qualitative study was undertaken using detailed semi-structured interviews. Fourteen adult survivors of SJS and TEN, admitted to two teaching hospitals in the UK, one the location of a tertiary burns centre, were interviewed. Interview transcripts were independently analysed by three different researchers and themes emerging from the text identified.Results: All 14 patients were aware that their condition was drug induced, and all but one knew the specific drug(s) implicated. Several expressed surprise at the perceived lack of awareness of the ADR amongst healthcare professionals, and described how the ADR was mistaken for another condition.Survivors believed that causes of the ADR included (i) being given too high a dose of the drug; (ii) medical staff ignoring existing allergies; and (iii) failure to monitor blood tests. Only two believed that the reaction was unavoidable. Those who believed that the condition could have been avoided had less trust in healthcare professionals. The ADR had a persisting impact on their current lives physically and psychologically. Many now avoided medicines altogether and were fearful of becoming ill enough to need them.Conclusions: Life-threatening ADRs continued to affect patients’ lives long after the event. Patients’ beliefs regarding the cause of the ADR differed, and may have influenced their trust in healthcare professionals and medicines. We propose that clear communication during the acute phase of a serious ADR may therefore be important.

A patient’s perspective: the impact of adverse drug reactions on patients and their views on reporting

What is known and objective:  Adverse drug reactions to prescribed medication are relatively common events. However, the impact such reactions have on patients and their attitude to reporting such events have only been poorly explored. Previous studies relying on self‐reporting patients indicate that altruism is an important factor. In the United Kingdom, patient reporting started in 2005; though, numbers of serious reports remain low.Summary What is known and objective:  Adverse drug reactions to prescribed medication are relatively common events. However, the impact such reactions have on patients and their attitude to reporting such events have only been poorly explored. Previous studies relying on self-reporting patients indicate that altruism is an important factor. In the United Kingdom, patient reporting started in 2005; though, numbers of serious reports remain low. Method:  A purposive sample of fifteen patients who had been admitted to an inner city hospital with an adverse drug reaction were interviewed using a semi-structured questionnaire. Patients were asked to relate in their own words their experience of an adverse drug reaction. Patient’s reactions to the information leaflet, adherence to treatment and use of other sources of information on medication were assessed. Interviews were recorded, and a thematic analysis of patients’ responses was performed. Results and discussion:  Analysis of the patient interviews demonstrated the reality of being admitted to hospital is often a frightening process with a significant emotional cost. Anger, isolation, resentment and blame were common factors, particularly when medicines had been prescribed for acute conditions. For patients with chronic conditions, a more phlegmatic approach was seen especially with conditions with a strong support networks. Patients felt that communication and information should have been more readily available from the health care professional who prescribed the medication, although few had read the patient information leaflet. Only a minority of patients linked the medication they had taken to the adverse event, although some had received false reassurance that the drug was not related to their illness creating additional barriers. In contrast to previous studies, many patients felt that adverse drug reporting was not their concern, particularly as they obtained little direct benefit from it. The majority of patients were unaware of the Yellow Card Scheme in the UK for patient reporting. Even when explained, the scheme was felt too cold and impersonal and not a patient’s ‘job’. What is new and conclusion:  Patients having a severe adverse drug reaction following an acute illness felt negative emotions towards their health care provider. Those with a chronic condition rationalized the event and coped better with its impact. Neither group felt that reporting the adverse reaction was their responsibility. Encouraging patients to report remains important but expecting patients to report solely for altruistic purposes may be unrealistic.

Internet Accounts of Serious Adverse Drug Reactions

AbstractBackground: Life-threatening adverse drug reactions (ADRs) such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) continue to affect patient’ lives long after the event. Survivors and their relatives rely heavily on Internet sources for support and advice, but narratives of their experiences posted on patient websites have not been explored previously. Objectives: The aim of the study was to illuminate patient experience by analysing Internet narratives of drug-induced SJS and TEN and considering the reasons for postings on patient websites, and the concerns they reflect. We also aimed to compare these experiences with a previous study of survivors of SJS and TEN conducted by face-to-face interview. Methods: We searched for unsolicited personal narratives or descriptions of drug-induced SJS and TEN posted on the Internet between February 2009 and June 2010, and analysed them using a thematic qualitative approach. Results: We analysed 208 Internet descriptions. Motivation for posting on the Internet included a desire to share experiences and to seek advice from others. Patients and their relatives expressed concern that the ADR may be hereditary, worries about effects on fertility and a fear of recurrence. They also wished to increase awareness of the potential harms from medicines and to inform others of the suspected cause of the ADR. Conclusion: Individuals experiencing SJS or TEN had many unanswered questions and concerns long after the event. Our findings could guide health professionals in the management of survivors of the ADR, and in communicating more effectively with patients and their relatives. Internet forum postings of patient experiences of ADRs provide insight into patient concerns and supplement findings from detailed face-to-face interviews.

Prescribing Errors in Diabetes

Prescribing errors in diabetes have the potential to cause serious adverse effects. Antidiabetic agents are a significant cause of admission to hospital. Prescribing errors can be caused by poor ha...

Restoring Confidence in Vaccines by Explaining Vaccine Safety Monitoring Is a Targeted Approach Needed

Public trust in childhood vaccines is crucial to achieving adequate immunisation coverage to ensure population-level immunity. However, in the UK, immunisation uptake has been adversely affected by vaccine safety scares, such as those surrounding whooping cough and measles, mumps and rubella (MMR). It is our belief that greater public awareness of safety surveillance schemes may play a key role in improving trust in vaccine safety.Many parents of vaccination-age children are unaware of the procedures in place for postmarketing surveillance of vaccines. Thus, we propose specific steps for generating such awareness, such as assisting parents to report suspected adverse reactions directly to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card scheme, providing information about adverse reaction reporting with vaccination information packs, and displaying posters and leaflets to convey the message that patient concerns and experiences are taken seriously by the MHRA and to generate further awareness about the scheme. In addition, healthcare staff should be encouraged to report suspected adverse reactions relating to vaccine products.Unresolved issues about the scientific usefulness of data reported by parents and the potential for these steps to increase parental concern and expectations require further investigation.

An analysis and comparison of commonly available United Kingdom prescribing resources

Background and objective:  Safe prescribing requires accurate and practical information about drugs. Our objective was to measure the utility of current sources of prescribing guidance when used to inform practical prescribing decisions, and to compare current sources of prescribing guidance in the UK with idealized prescribing guidance.

Improving follow-up rates in spontaneous adverse drug reaction reporting: effectiveness of a targeted letter used by a regional centre in the UK.

AbstractBackground: Spontaneous reports of suspected adverse drug reactions to regulatory bodies and market authorization holders are important in pharmacovigilance. Follow-up information, which can be difficult to obtain, is often required from reporters; therefore, we developed targeted follow-up letters that we hoped would make replying easier. Objective: To examine the effects of introducing targeted letters on responses to follow-up requests from a regional pharmacovigilance centre in the UK. Method: In January 2001 we redesigned our follow-up request letter to include tick-boxes targeted to obtain the appropriate information from reporters. Response rates and the requirement for a second follow-up letter were examined for the 5-year period before introduction of the targeted follow-up letter (1996–2000) and the 5 years after the change to the targeted follow-up system (2001–5). In an 18-month sub-study examining data from 2001–2, time from the production of the first targeted follow-up letter to receipt of a response from reporters was also measured. Results: The introduction of targeted follow-up letters was associated with an increase in the mean annual response rate for follow-up from 36.4% in the 5 years pre-targeted follow-up to 60.5% in the 5 years post-targeted follow-up (p < 0.0001). Fifty percent of all successful follow-up responses were obtained within 70 days. Conclusion: Targeted follow-up letters were associated with increased follow-up success rates. Results also indicate that closing cases to follow-up information at 70 days would allow collection of 78% of all follow-up that would ever arrive.

Internet networking for pharmacists: an evaluation of a mailing list for UK pharmacists

Objective To analyse the content of messages to an internet mailing list for UK pharmacists and to ascertain if the list was performing a continuing professional development (CPD) function.

Deaths from Medicines: A Systematic Analysis of Coroners’ Reports to Prevent Future Deaths

IntroductionSince legislation in 2009, coroners in England and Wales must make reports in cases where they believe it is possible to prevent future deaths. We categorised the reports and examined whether they could reveal preventable medication errors or novel adverse drug reactions.MethodsWe examined 500 coroners’ reports by pre-defined criteria to identify those in which medicines played a part, and to collect information on coroners’ concerns.ResultsWe identified 99 reports (100 deaths) in which medicines or a part of the medication process or both were mentioned. Reports mentioned anticoagulants (22 reports), opioids (17), antidepressants (17), drugs of abuse excluding opioids (12 deaths) and other drugs. The most important concerns related to adverse reactions to prescribed medicines (22), omission of necessary treatment (21), failure to monitor treatment (17) and poor systems (17). These were related to defects in education or training, lack of clear guidelines or protocols and failure to implement existing guidelines, among other reasons. Most reports went either to NHS Hospital Trusts or to local trusts. The responses of addressees were rarely published. We identified four safety warnings from the Medicines and Healthcare Products Regulatory Agency that were based on coroners’ warnings.ConclusionCoroners’ reports to prevent future deaths provide some information on medication errors and adverse reactions. They rarely identify new hazards. At present they are often addressed to local bodies, but this could mean that wider lessons are lost.