Practical experiences of risk minimisation
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1 Practical experiences of risk minimisation Ciara Kirke Health Services Executive Quality Improvement Division Ireland 16 th September, 2015
2 Sources of harm with medicines Drug, medicinal product, packaging etc Healthcare processes, systems & professionals Patients interaction with their medicines
3 Burden of medication-related harm Adverse reactions (including preventable ADRs) in % of hospital patients Prolonged hospitalisation days/ adverse reaction/ patient Serious adverse reactions in 4%; older patients 11.9% Number of drugs (polypharmacy), renal impairment, high-risk medication most predictive of risk of harm Saedder et al. Br J Clin Pharmacol 2015 Hakkarainen KM et al. PLoS One 2012; 7: e33236 de Vries EN, et al. Qual Saf Health Care 2008; 17: Kongkaew C et al. Ann Pharmacother 2008; 42: Krahenbuhl-Melcher A et al. Drug Saf 2007; 30: Lazarou J, Pomeranz BH, Corey PN. JAMA 1998; 279: Muehlberger N et al. Pharmacoepidemiol Drug Saf 1997; 6 Suppl 3: S71-7 Rodriguez-Monguio R et al Pharmacoeconomics 2003; 21: Tegeder I et al. Br J Clin Pharmacol 1999; 47: Beijer HJ et al. Pharm World Sci 2002; 24: 46-54
4 High-risk medication/classes Most drug-related harm with, e.g., anticoagulants, opioids, NSAIDs, antimicrobials, insulin, diuretics 70% of preventable death or serious adverse drug reactions (ADRs) due to nine drugs or classes Saedder EA et al. Eur J Clin Pharmacol :
5 Prevention is better than cure Minimising potential risks and avoiding error Understand drug, product, device AND processes, psychology, human factors Healthcare professional participation in EMA Consultations Naming Review Group Packaging, labelling Patient/ HCP information Restrictions
6 Hierarchy of effectiveness Remove the hazard Forcing functions and constraints Automation and computerisation Standardisation, simplification Checklists and double-checking Rules and policies Education and information Try harder Veteran s Health Administration Center for Patient Safety
7 Patient needs 5,000 unit bolus, what do you give?
8 Total content eliminated error
9 Minimising risk in hospitals Risk identification Local reporting, national and international alerts, research... Risk analysis Systems analysis of serious incidents and trends Screening alerts Prioritising for action Potential for patient harm, potential improvements Minimising risk Information, alerting appropriate staff Process improvement, systems improvement
10 Local alert Acute kidney injury with aciclovir IV Report to pharmacovigilance and indemnifiers Open communication with patients Incident review - ideal body weight, hydration Review evidence, expert opinion nephrology/ neurology/ microbiology/ pharmacy Local prescribing guidance and IV monographs changed, memo/alert circulated Vigilance and reporting
11 International alert
12 Local implementation Recommendations patient group, ADR or risk, potential severity Improvement Awareness who needs to know? Patients? Which specialties, professions? Urgency, type of communication? Embed into processes, reference sources Change systems, behaviour Measure to ensure implemented Outcome measures to ensure effective
13 Actions to outcome Mock data
14 Healthcare professionals and EMA Working together to combine regulatory and pharmacovigilance knowledge with understanding of processes, psychology and human factors Prevention better than cure
15 Contact Ciara Kirke Clinical Lead, Medication Safety Programme HSE Quality Improvement Division
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