Medicines and Healthcare products Regulatory Agency

PFD Addressee
Reports: 71 Earliest: Dec 2013 Latest: 1 Apr 2026

62% 2-year response rate (below 83% average). 28% of classified responses show concrete action taken.

Response Status (last 2 years, 16 reports)
Responded 10 No Response 3
AI Classification
Action Taken 28%
Action Planned 38%
Noted 31%
Disputed 3%
Based on 129 classified responses
PFD Reports Received by Quarter
PFD Reports
71 results
Aaron McCaffrey
Historic (No Identified Response)
2017-0195 16 Jun 2017 Manchester (South)
Product related deaths
Concerns summary (AI summary) The lack of purchase limits for loperamide medication at retail stores enables bulk buying, increasing the risk of addiction and overdose.
Maurice Macdonnell
All Responded
2017-0188 14 Jun 2017 London Inner (South)
Product related deaths
Concerns summary (AI summary) A potential conflict of interest arose when a doctor, also a research investigator, administered a second drug dose despite adverse effects, raising concerns about patient safety safeguards in clinical trials.
Noted (AI summary) The MHRA reviewed the SUSAR report and determined that the symptoms were in line with the known safety profile for nivolumab, and no further action is required for participants in nivolumab clinical trials. They also stated that conflict of interest lies outside the remit of MHRA for clinical trials.
Marjorie Bassendine
Partially Responded
2016-0424 30 Nov 2016 Surrey
Care Home Health related deaths
Concerns summary (AI summary) Failure to recognise the cardiac risks of multiple psychotropic medications led to a lack of pre-treatment and regular ECGs to monitor for potential QT interval prolongation.
Noted (AI summary) The Royal College of Psychiatrists will publicize the coroner's concerns to its members, review continuing medical education initiatives, and inform the Presidents of the Royal Colleges of Physicians and General Practitioners of their plans. The MHRA reviewed product information for olanzapine, mirtazapine, and indapamide and considers the existing warnings regarding QT prolongation to be appropriate. They are not proposing any regulatory action to change these warnings but will keep the issue under review.
Raymond Woodward
All Responded
2016-wp25391 26 Aug 2016 Birmingham and Solihull
Alcohol, drug and medication related deaths
Concerns summary (AI summary) The risk of adverse cardiovascular reactions to Buscopan, especially in patients with ischaemic heart disease, is not widely known, and the Summary of Product Characteristics (SPC) for intravenous Buscopan could be more specific regarding this risk.
Action Taken (AI summary) The Summary of Product Characteristics (SmPC) for Buscopan Ampoules has been updated to more clearly communicate and minimise the risk of serious adverse reactions in patients with underlying cardiac disease. These recommendations have also been communicated to healthcare professionals through an article in the MHRA newsletter, Drug Safety Update.
James Hedge
All Responded
2016-wp25334 27 Jul 2016 South Wales Central
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Insulin pump guidance inadequately highlights misuse dangers from incorrect cartridge insertion, and patient education fails to emphasize the rapid life-threatening nature of hyperglycaemia.
4 responses from Medicine and Healthcare Products Regulatory Agency, Welsh Government, Roche Diabetes Care Limited
Leslie Matthews
All Responded
2016-0276 26 Jul 2016 County Durham and Darlington
Hospital Death (Clinical Procedures and medical management) related deaths Other related deaths
Noted (AI summary) The MHRA has brought the Coroner's concerns to the attention of the manufacturer and requested that they evaluate whether additional clarity in information could be incorporated at the next Instructions for Use review. They have not identified a systemic problem with cracks associated to Oxylitre flowmeters. All oxygen flowmeters across the Trust have been checked and faults logged. Equipment Controllers/Department Managers are now performing weekly checks of all flowmeters, using a checklist devised by the Medical Devices Nurse.
Daniel Paylor
Historic (No Identified Response)
2016-0353 1 Jul 2016 Wiltshire and Swindon
Community health care and emergency services related deaths Product related deaths
Concerns summary (AI summary) Ambulance services exhibit inadequate regulatory control, safeguards, and auditing for drugs compared to hospitals, lacking sufficient peer supervision and requiring only single-person authority for drug access.
Christine Stevenson
All Responded
2016-0123 10 Mar 2016 Manchester (South)
Alcohol, drug and medication related deaths
Concerns summary (AI summary) Large volumes of Oramorph solution, despite containing less than 0.2% morphine, are prescribed without sufficient control. This poses a serious and potentially fatal risk to naive users due to the high total dosage.
Action Planned (AI summary) Greater Manchester will raise concerns about volumes/strengths of prescribed controlled drugs and provide guidance to prescribers, as well as examine its reporting system to identify high-volume prescribers. They will highlight prescribing volumes in the national Care Quality Commission "Controlled Drugs Vigilance Newsletter" and use local newsletters, with some CCGs already working with practices to reduce high doses. The Home Office notes the concerns and states information from the investigation has been added to the Yellow Card Scheme to monitor substances suspected of being misused. The Home Secretary has commissioned the ACMD to explore potential medical and social harms arising from the illicit supply of medicines.
Lynn Poyser
Historic (No Identified Response)
2015-0295 23 Jul 2015 South Lincolnshire
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Existing guidance for co-prescribing Lisinopril and Spironolactone may not sufficiently highlight the risks of renal deterioration and hyperkalaemia, indicating a need for more caution and a holistic patient view.
Andre Mickley
Historic (No Identified Response)
2015-0231 17 Jun 2015 Lincolnshire (Central)
Alcohol, drug and medication related deaths
Concerns summary (AI summary) Product information for SSRI drugs fails to adequately inform prescribers about potential adverse pharmacokinetic interactions with cocaine and other illicit substances, or to advise patients to seek caution.
Annette Charlton
Partially Responded
2015-0009 9 Jan 2015 Birmingham & Solihull
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Pharmaceutical manufacturers are producing medications in almost identical packaging, which significantly increases the risk of dispensing errors and poses a serious threat to patient safety.
Action Planned (AI summary) Crescent Pharma has scheduled a meeting with the MHRA to discuss packaging redesign and the use of colour to differentiate products and strengths, after their request to do so in May 2014. Agreement of design and product range colour chart will lead to the creation of new artwork for all Crescent products, submission for MHRA approval and co-ordination of new artwork introduction after MHRA approval.
James Fyfe
All Responded
2015-0099 5 Jan 2015 Berkshire
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) The cot side on a trolley could remain in an unlocked position due to design and maintenance issues, which were not clearly highlighted. The MHRA failed to escalate this known hazard to other hospital trusts.
Disputed (AI summary) MHRA has discussed the QA3 instructions for use with the manufacturer, advising them to review them again to ensure that they are still accurate and appropriate. MHRA contacted four other Hospital Trusts via our Medical Device Safety Officer (MDSO) network, each of which have over one hundred QA3 trolleys in use, to establish whether they have had this problem but had not reported it to MHRA. AneticAid defends the design and safety record of its QA3 trolley, arguing that no retrospective changes are needed. They suggest the issue is localised to Royal Berkshire Hospital and will continue to provide training and support to the hospital staff. Royal Berkshire NHS Trust has contracted with Anetic Aid (AA) to undertake periodic inspection and maintenance on all of its QA3 trolleys. The Trust has further updated its Clinical Engineering Checklist for AA QA3 trolleys to expressly detail the checks that must be undertaken during every inspection of a QA3 trolley.
Patricia Mellor
Historic (No Identified Response)
2014-0491 12 Nov 2014 Nottinghamshire
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Despite detailed recommendations from a hospital regarding Long QT Syndrome and drug-related cardiac arrest risks during anaesthesia, regulatory bodies (MHRA, NICE) have failed to update guidelines and product warnings.
Shayla Walmsley
Historic (No Identified Response)
2014-0323 14 Jul 2014 London Inner (North)
Other related deaths
Concerns summary (AI summary) Delays in obtaining medical device data from manufacturers, inconsistent distribution of safety notices, and a lack of post-mortem analysis of medical devices hinder investigations and timely safety interventions.
Maria Lopes
Partially Responded
2014-0325 11 Jul 2014 Surrey
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) The report identifies multiple concerns, including consultant urologist on-call arrangements, supervision of out-of-hours urology trainees, recognition and treatment of sepsis, and the assessment of renal stones. There was also a lack of clarity and supervision regarding propofol infusion in ITU and a lack of understanding of Propofol-related infusion syndrome.
Noted (AI summary) Frimley Park Hospital acknowledges the coroner's concerns regarding urology on-call arrangements but states there are no specific national on-call guidelines for urology. They explain current practices and supervision of trainees, and note the Keogh recommendations will require a review of on-call services and development of an action plan.
Akua Anokye-Boateng
All Responded
2014-0211 9 May 2014 London (Inner South)
Alcohol, drug and medication related deaths
Concerns summary (AI summary) The report raises concerns about the use of NSAIDs in children with sickle cell disease, specifically regarding the potential for a single dose to cause GI damage and the lack of clear guidance on gastro-intestinal protection measures.
Action Planned (AI summary) The MHRA will publish an article in the September 2014 Drug Safety Update to remind healthcare professionals of existing SPC information regarding GI side-effects of NSAIDs. They will also strengthen the patient information for all NSAIDs regarding GI risk, with changes implemented within 12 months.
Paul Ashton
Partially Responded
2014-0170 14 Apr 2014 Manchester (West)
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) There was a lack of consultation with the cardiac transplant team and no established protocol for managing heart transplant patients undergoing non-cardiac surgery, leading to insufficient awareness of specific risks.
Action Planned (AI summary) NHS England will task its Rare Disease Advisory Group to prepare recommendations within six months for practical steps to improve care for heart transplant patients. NHS England will also ensure, immediately, through Area Medical Directors, that all hospitals are made aware of the ISHLT guidelines for heart transplant patients.
Victoria Meppen-Walter
Historic (No Identified Response)
2014-0083 27 Feb 2014 Manchester (North)
Product related deaths
Concerns summary (AI summary) Concerns were raised regarding the easy online availability and regulation of chloroquine, along with the associated risks of its misuse.
William Kent
Historic (No Identified Response)
2014-0056 31 Jan 2014 Surrey
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Staff lacked awareness and received insufficient training on the harmful side-effects of Haz-Tab granules when used with urine, compounded by unclear usage instructions.
Craig White
Historic (No Identified Response)
2014-0017 14 Jan 2014 South Lincolnshire
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Concerns include insufficient TB screening protocols before Infliximab treatment, inadequate prescriber awareness of increased TB risk, and the need for better patient education and prompt treatment for suspected tuberculous meningitis.
Kenneth Smalley
Partially Responded
2013-0367 19 Dec 2013 Manchester (West)
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) A malfunctioning operating table and emergency stop, potentially linked to a damaged, improperly positioned handset, highlight inadequate pre-operation checks and a lack of training or hospital-wide review for similar equipment.
Action Taken (AI summary) The Trust has reviewed operating tables and handsets, changed pre-operative checks and inspections, implemented a more robust system and matrix for training theatre staff, and expanded the data base within theatres to cover all medical devices. The Trust has also contacted the MHRA to request a discussion to strengthen communication and sharing of information.