Recent examples of medication errors arising from confusion between drug names (generic or brand) that look or sound similar have been highlighted by the Medicines and Healthcare products Regulatory Agency (MHRA).1 In 2010 and 2013, the MHRA issued safety alerts to remind healthcare professionals ...
Posted at 12:45 PM inDrug Safety Alerts,Medicines and Healthcare Products Regulatory Agency (MHRA),Side Effect: Cardiovascular (heart attack, stroke, heart failure, PE, DVT),Side Effect: Infections (necrotizing fasciitis, sepsis)|Permalink|Comments (0) Tags: blood clots, drug injury, drug safe...
Doctors are advised that they must inform the MHRA about “serious suspected adverse reactions to all medicines and all reactions to products marked with a Black Triangle in the BNF and elsewhere using the Yellow Card Scheme”. Healthcare staff must also report any adverse incident involving medica...
Available: http://www.mhra.gov.uk/Safetyinformation/ Reportingsafetyproblems/Reportingsuspectedadversedrugreactions/index.htm. Accessed 2010 Jun 28. 8. Hazell L, Shakir SA (2006) Under-reporting of adverse drug reactions : a systematic review. Drug Safety 29: 385–396. PLOS ONE...
The April 2010 MHRA Drug Safety Update article above, however, suggest that the drug company will not be permitted to essentially tell doctors and patients that those two medical articles -- which are among the most recent additions to the medical literature about the safety of YAZ and Yasmin ...
Physiologically based models in regulatory submissions: Output from the ABPI/MHRA forum on physiologically based modeling and simulation. CPT Pharmacometrics Syst Pharmacol. 2015;4:221–5. Article PubMed Central CAS PubMed Google Scholar Jones HM, Chen Y, Gibson C, et al. Physiologically based ...
drug information in children was verified with the Anvisa electronic package insert list and complemented by the Summary of Product Characteristics (SPC) and patient information leaflet (PIL) on the electronic Medicines Compendium (eMC) and Medicines and Healthcare products Regulatory Agency (MHRA). Bo...
In addition, all suspected serious adverse reactions will be collated annually and submitted to theresearch ethics committee and the MHRA, in accordance with the guidance on annual safety reporting. The data-monitoring committee will regularly assess the safety data collected for the trial and will ...
We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found 30 systematic reviews, RCTs or observational studies that met our inclusion criteria. We performed a ...
include FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, MHRA annual summaries of inspection deficiencies, and EUreports of GMDP noncompliance. This article presents themost recent publication of GMP drug inspection data,which address dr...