{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,7]],"date-time":"2025-11-07T09:43:29Z","timestamp":1762508609234,"version":"build-2065373602"},"reference-count":35,"publisher":"MDPI AG","issue":"18","license":[{"start":{"date-parts":[[2021,9,8]],"date-time":"2021-09-08T00:00:00Z","timestamp":1631059200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Drug-related deaths (DRDs) are a common cause of hospital death. Pharmacovigilance, either as spontaneous reporting or active surveillance, plays a key role in the detection and reporting of suspected adverse drug reactions (ADRs). We conducted a retrospective analysis of all DRDs spontaneously reported to a pharmacovigilance program of a tertiary hospital, by health care professionals. We compared these results to those of a previous retrospective study conducted in the same hospital from the hospital\u2019s mortality registry. From 1460 spontaneous reported ADRs in a 10-year period, 73 (5%) were DRDs. The median age of DRD was 75 years (range 1 month\u201394) and 60.3% were men. The most frequent DRDs were hemorrhages (41.1%), followed by infections (17.8%). The most frequently involved drugs were anticoagulants and\/or antithrombotic (30%), and antineoplastics (26.3%). When comparing both studies, spontaneous reporting detected more type B reactions (p &lt; 0.001) and hospital-acquired DRD (p &lt; 0.001); the number of concomitant drugs was higher (p = 0.0035); and the kind of ADR were different. The combination of several methods is mandatory to detect, assess, understand, and design strategies to prevent ADRs in a hospital setting, to ensure patient safety.<\/jats:p>","DOI":"10.3390\/jcm10184053","type":"journal-article","created":{"date-parts":[[2021,9,8]],"date-time":"2021-09-08T10:12:03Z","timestamp":1631095923000},"page":"4053","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Drug-Related Deaths in a Tertiary Hospital: Characteristics of Spontaneously Reported Cases and Comparison to Cases Detected from a Retrospective Study"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8601-3504","authenticated-orcid":false,"given":"Ana Luc\u00eda","family":"Arellano","sequence":"first","affiliation":[{"name":"Department of Pharmacology, Therapeutics and Toxicology, Universitat Aut\u00f2noma de Barcelona, 08001 Bellaterra, Spain"},{"name":"Department of Clinical Pharmacology, Germans Trias i Pujol University Hospital, 08916 Badalona, Spain"},{"name":"Department of Clinical Pharmacology, Hospital Clinic of Barcelona, 08036 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pau","family":"Alcubilla","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Hospital Clinic of Barcelona, 08036 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8338-7543","authenticated-orcid":false,"given":"Mag\u00ed","family":"Farr\u00e9","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Therapeutics and Toxicology, Universitat Aut\u00f2noma de Barcelona, 08001 Bellaterra, Spain"},{"name":"Department of Clinical Pharmacology, Germans Trias i Pujol University Hospital, 08916 Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1691-7652","authenticated-orcid":false,"given":"Eva","family":"Montan\u00e9","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Therapeutics and Toxicology, Universitat Aut\u00f2noma de Barcelona, 08001 Bellaterra, Spain"},{"name":"Department of Clinical Pharmacology, Germans Trias i Pujol University Hospital, 08916 Badalona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2021,9,8]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1255","DOI":"10.1016\/S0140-6736(00)02799-9","article-title":"Adverse drug reactions: Definitions, diagnosis, and management","volume":"356","author":"Edwards","year":"2000","journal-title":"Lancet"},{"key":"ref_2","unstructured":"(2021, August 03). DIRECTIVE 2010\/84\/EU of The European Parliament and of the Council of 15 December 2010 Amending, as Regards Pharmacovigilance, Directive 2001\/83\/EC on the Community Code Relating to Medicinal Products for Human Use. Available online: https:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF."},{"key":"ref_3","unstructured":"World Health Organization (1973). Technical Report Series (1972, No 498). International Drug Monitoring. The Role of the National Centres, World Health Organization. Available online: http:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/40968\/WHO_TRS_498.pdf."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"481","DOI":"10.7861\/clinmedicine.16-5-481","article-title":"Adverse drug reactions","volume":"16","author":"Coleman","year":"2016","journal-title":"Clin. Med."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1111\/bcp.13098","article-title":"The value of patient reporting to the pharmacovigilance system: A systematic review","volume":"83","author":"Cavaco","year":"2017","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"73","DOI":"10.4103\/0976-500X.120957","article-title":"Clinical and economic burden of adverse drug reactions","volume":"4","author":"Sultana","year":"2013","journal-title":"J. Pharmacol. Pharmacother."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1539","DOI":"10.1007\/s00228-017-2330-3","article-title":"The prevalence of medication-related adverse events in inpatients\u2014A systematic review and meta-analysis","volume":"73","author":"Laatikainen","year":"2017","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"ref_8","first-page":"977","article-title":"La prevalencia de eventos adversos de f\u00e1rmacos en el cuidado ambulatorio: Un repaso sistem\u00e1tico","volume":"45","author":"Ashcroft","year":"2011","journal-title":"Ann. Pharmacother."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1295","DOI":"10.1136\/bmj.316.7140.1295","article-title":"Fortnightly review: Adverse drug reactions","volume":"316","author":"Pirmohamed","year":"1998","journal-title":"BMJ"},{"key":"ref_10","unstructured":"European Comission (2021, August 02). Strengthening Pharmacovigilance to Reduce Adverse Effects of Medicines. Memo\/08\/782, Available online: https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/de\/MEMO_08_782."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1200","DOI":"10.1001\/jama.279.15.1200","article-title":"Incidence of Adverse Drug Reactions in Hospitalized Patients","volume":"279","author":"Lazarou","year":"1998","journal-title":"JAMA"},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Montan\u00e9, E., and Castells, X. (2021). Epidemiology of drug-related deaths in European hospitals: A systematic review and meta-analysis of observational studies. Br. J. Clin. Pharmacol.","DOI":"10.1111\/bcp.14799"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"819","DOI":"10.1007\/s00228-018-2441-5","article-title":"Mortality among patients due to adverse drug reactions that lead to hospitalization: A meta-analysis","volume":"74","author":"Patel","year":"2018","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1293","DOI":"10.1007\/s00228-019-02702-4","article-title":"Mortality among patients due to adverse drug reactions that occur following hospitalisation: A meta-analysis","volume":"75","author":"Patel","year":"2019","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"ref_15","unstructured":"WHO (2006). WHO: Safety Medicines in Public Health Programmes: Pharmcovigilance, an Essential Tool, World Health Organization. Available online: https:\/\/www.who.int\/medicines\/areas\/quality_safety\/safety_efficacy\/Pharmacovigilance_B.pdf."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1007\/s40264-018-0766-8","article-title":"Towards Drug Safety Surveillance and Pharmacovigilance: Current Progress in Detecting Medication and Adverse Drug Events from Electronic Health Records","volume":"42","author":"Liu","year":"2019","journal-title":"Drug Saf."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"443","DOI":"10.3904\/kjim.2012.27.4.443","article-title":"A Comparison of Active Surveillance Programs Including a Spontaneous Reporting Model for Phamacovigilance of Adverse Drug Events in a Hospital","volume":"27","author":"Yun","year":"2012","journal-title":"Korean J. Intern. Med."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"385","DOI":"10.2165\/00002018-200629050-00003","article-title":"Under-Reporting of Adverse Drug Reactions: A systematic review","volume":"29","author":"Hazell","year":"2006","journal-title":"Drug Saf."},{"key":"ref_19","unstructured":"WHO Collaborating Centre for Drug Statistics Methodology (2021, August 02). The Anatomical Therapeutico Chemical (ATC) Classification System. Available online: http:\/\/www.whocc.no\/atc_ddd_index\/."},{"key":"ref_20","unstructured":"Cascorbi, I. (2021, August 02). Drug Interactions. Dtsch Aerzteblatt Online. Available online: https:\/\/www.aerzteblatt.de\/10.3238\/arztebl.2012.0546."},{"key":"ref_21","unstructured":"European Medicines Agency (EMA) (2021, August 02). Medicines under Additional Monitoring. Available online: https:\/\/www.ema.europa.eu\/en\/human-regulatory\/post-authorisation\/pharmacovigilance\/medicines-under-additional-monitoring."},{"key":"ref_22","unstructured":"European Medicines Agency (EMA) (2021, August 29). List of Medicines under Additional Monitoring. Available online: https:\/\/www.ema.europa.eu\/en\/human-regulatory\/post-authorisation\/pharmacovigilance\/medicines-under-additional-monitoring\/list-medicines-under-additional-monitoring."},{"key":"ref_23","unstructured":"Davies, D.M. (1991). Textbook of Adverse Drug Reactions, Oxford University Press. [4th ed.]. Available online: https:\/\/academic.oup.com\/jpp\/article\/44\/3\/282\/6164228."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1038\/clpt.1981.154","article-title":"A method for estimating the probability of adverse drug reactions","volume":"30","author":"Naranjo","year":"1981","journal-title":"Clin. Pharmacol. Ther."},{"key":"ref_25","first-page":"538","article-title":"Focusing on the preventability of adverse drug reactions","volume":"27","author":"Schumock","year":"1992","journal-title":"Hosp. Pharm."},{"key":"ref_26","first-page":"542","article-title":"Drug-related deaths in hospital inpatients: A retrospective cohort study","volume":"84","author":"Arellano","year":"2017","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"290","DOI":"10.1038\/clpt.1987.149","article-title":"Interaction of amiodarone with racemic warfarin and its separated enantiomorphs in humans","volume":"42","author":"Trager","year":"1987","journal-title":"Clin. Pharmacol. Ther."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1136\/bmj.329.7456.15","article-title":"Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18 820 patients","volume":"329","author":"Pirmohamed","year":"2004","journal-title":"BMJ"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1036","DOI":"10.1136\/bmj.320.7241.1036","article-title":"Admissions to hospital caused by adverse drug reactions: Cross sectional incidence study","volume":"320","author":"Pouyanne","year":"2000","journal-title":"BMJ"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"653","DOI":"10.1111\/j.1365-2125.2005.02504.x","article-title":"Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital","volume":"60","author":"Vallano","year":"2005","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_31","doi-asserted-by":"crossref","unstructured":"Montastruc, J., Lafaurie, M., de Canecaude, C., Durrieu, G., Sommet, A., Montastruc, F., and Bagheri, H. (2021). Fatal adverse drug reactions: A worldwide perspective in the World Health Organization pharmacovigilance database. Br. J. Clin. Pharmacol.","DOI":"10.1111\/bcp.14851"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"703","DOI":"10.2165\/00002018-200831080-00007","article-title":"Drug-Related Deaths","volume":"31","author":"Leone","year":"2008","journal-title":"Drug Saf."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1016\/j.rmedc.2009.01.004","article-title":"Algorithms for assessing the probability of an Adverse Drug Reaction","volume":"2","author":"Doherty","year":"2009","journal-title":"Respir. Med. CME"},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"1071","DOI":"10.1038\/bjc.2013.48","article-title":"Prevalence of potential drug\u2013drug interactions in cancer patients treated with oral anticancer drugs","volume":"108","author":"Brundel","year":"2013","journal-title":"Br. J. Cancer"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"2234","DOI":"10.1097\/PRS.0b013e3181f44abc","article-title":"Observational Studies: Cohort and Case-Control Studies","volume":"126","author":"Song","year":"2010","journal-title":"Plast. Reconstr. Surg."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/18\/4053\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T06:58:29Z","timestamp":1760165909000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/18\/4053"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9,8]]},"references-count":35,"journal-issue":{"issue":"18","published-online":{"date-parts":[[2021,9]]}},"alternative-id":["jcm10184053"],"URL":"https:\/\/doi.org\/10.3390\/jcm10184053","relation":{},"ISSN":["2077-0383"],"issn-type":[{"type":"electronic","value":"2077-0383"}],"subject":[],"published":{"date-parts":[[2021,9,8]]}}}