Open Access Research BMJ Open: first published as 10.1136/bmjopen-2017-017453 on 8 November 2017. Downloaded from Consensus validation of the POSAMINO (POtentially Serious Alcohol–Medication INteractions in Older adults) criteria Alice E Holton,1 Paul J Gallagher,1 Cristín Ryan,1 Tom Fahey,2 Gráinne Cousins1 To cite: Holton AE, Gallagher PJ, ABSTRACT Strengths and limitations of this study Ryan C, et al. Consensus Objectives Older adults are particularly vulnerable to validation of the POSAMINO adverse effects from concurrent alcohol and medication ► The POtentially Serious Alcohol–Medication (POtentially Serious Alcohol– use. However, there is limited evidence regarding the Medication INteractions in INteractions in Older adults criteria were developed prevalence of these adverse outcomes among older adults, Older adults) criteria. BMJ Open in a robust fashion, using a two-step process and there is a lack of consensus regarding what constitutes 2017;7:e017453. doi:10.1136/ involving a systematic review and two-round Delphi an alcohol-interactive medicine. The objective of this study bmjopen-2017-017453 process. was to develop an explicit list of potentially serious alcohol– ► The Delphi consensus technique used in this study is ► Prepublication history and medication interactions for use in older adults. flexible and enabled communication from a diverse additional material for this Design Following a systematic review, review of drug paper are available online. To group of healthcare professionals from both the UK compendia and clinical guidance documents, a two-round view these files, please visit and Ireland. Delphi consensus method was conducted. the journal online (http:// dx. doi. ► The final criteria will need to be further validated Setting Ireland and the United Kingdom (UK), primary care org/ 10. 1136/ bmjopen- 2017- prospectively to quantify the magnitude of risk and hospital setting. 017453). posed for each criterion for adverse outcomes in Participants The Project Steering Group developed a older adults. Received 23 April 2017 list of potentially serious alcohol–medication interactions. ► Once validated, these criteria have the potential Revised 6 September 2017 The Delphi panel consisted of 19 healthcare professionals to inform medical decision making and enable Accepted 11 September 2017 (general practitioners, geriatricians, hospital and healthcare professionals to risk stratify older adults community pharmacists, clinical pharmacologists and at the point of prescribing and prioritise alcohol pharmacists, and physicians specialising in substance http://bmjopen.bmj.com/ screening and brief interventions in high-risk groups. misuse). Results An inventory of 52 potentially serious alcohol– medication interactions was developed by the Project Steering 1 Group. British National Formulary black dot warnings (n=8) population continuing to increase. While were included in the final criteria as they represent ‘potentially alcohol consumption tends to decline with serious’ interactions. The remaining 44 criteria underwent a age, older adults are inclined to drink more 2 two-round Delphi process. In the first round, 13 criteria were frequently. Ageing is associated with a variety accepted into the POtentially Serious Alcohol–Medication of physiological changes, which may place INteractions in Older adults (POSAMINO) criteria. Consensus older adults at an increased risk of alcohol-re- on September 26, 2021 by guest. Protected copyright. was not reached on the remaining 31 criteria; 9 were lated health problems.3 4 In fact, compared removed and 8 additional criteria were included following a with younger adults, they encounter a dispro- review of panellist comments. The remaining 30 criteria went portionate burden of alcohol-related harm, to round 2, with 17 criteria reaching consensus, providing with reported alcohol-related deaths highest a final list of 38 potentially serious alcohol–medication among those aged 55 to 74 years in England interactions: central nervous system (n=15), cardiovascular 4 system (n=9), endocrine system (n=5), musculoskeletal in 2010. system (n=3), infections (n=3), malignant disease and Polypharmacy is also increasing in older 1 5 School of Pharmacy, Royal immunosuppression (n=2), and respiratory system (n=1). adults and certain medicines may interact College of Surgeons in Ireland Conclusions POSAMINO is the first set of explicit with alcohol, increasing the risk of adverse (RCSI), Dublin 2, Ireland 2Division of Population Health potentially serious alcohol–medication interactions for use events such as sedation, hypotension, gastro- Science, HRB Centre for Primary in older adults. Following future validation studies, these intestinal bleeds, hypoglycaemia and liver 6 7 Care Research, Royal College criteria may allow for the risk stratification of older adults damage. In a previous observational study, of Surgeons in Ireland (RCSI), at the point of prescribing. moderate alcohol consumption increased Dublin 2, Ireland the risk of adverse drug reactions by 24% 8 Correspondence to BACKGROUND among older adults. Alcohol interactive Alice E Holton; Population demographics are changing glob- (AI) medicines may interact with alcohol by aliceholton@ rcsi. ie ally, with the proportion and age of the older altering the effects (pharmacodynamic) or Holton AE, et al. BMJ Open 2017;7:e017453. doi:10.1136/bmjopen-2017-017453 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2017-017453 on 8 November 2017. Downloaded from metabolism (pharmacokinetic) of the medication and/ Furthermore, the British National Formulary (BNF), or alcohol.7 The interactions may occur with any alcohol Stockley’s Drug Interactions and Martindale Complete or may follow a dose response, with the severity and risk Drug Reference drug compendia were also searched.11–13 of interactions increasing with increasing levels of alcohol Additional documents such as clinical guidance docu- consumption.6 ments14 and previous reviews6 7 were also accessed. While a number of studies have investigated the Information extracted included medication name/class, concurrent use of alcohol and AI medicines among older potential adverse outcome(s), whether an interaction is adults,9 there is still a lack of agreement regarding the likely to occur with any alcohol consumption or with heavy inclusion of AI medicines across studies. Several studies consumption using national low risk drinking guide- have reported on a broad range of medication classes, lines15 16 and, if reported, evidence supporting the inter- using different drug reference sources and software to action. The list of medications was organised according identify medications as AI, thus leading to a lack of consis- to the BNF physiological classification system. There was tency in the inclusion of these medicines.9 Other studies considerable heterogeneity across reference sources in focused on psychotropic medications alone.9 terms of identifying medications as having potential to Despite the findings of our previous systematic review, interact with alcohol, with no age-specific information for highlighting a high prevalence of concurrent use among interactions. Furthermore, there were inconsistencies in older adults, no study to date has examined longitudinal relation to the quantity of concurrent alcohol consump- associations of concurrent use with adverse outcomes.9 An tion that should be avoided. For example, the Martindale evidence-based list of potentially serious alcohol–medi- mentioned that alcohol combined with non-steroidal cine interactions for older adults has potential in a clin- anti-inflammatory drugs (NSAIDs) may increase the risk ical setting, once validated, allowing for the identification of gastrointestinal bleeds with no mention of alcohol of older adults whose alcohol consumption places them consumption patterns, Stockley’s described that both at increased risk and who would benefit from a preven- NSAIDs and excessive alcohol use carry the risk of gastro- tative intervention. Therefore, the aim of this study is to intestinal adverse effects, while NSAIDs and alcohol were derive the first set of explicit potentially serious alcohol– not included as an interaction in the BNF. For the next medication interactions in older adults. step, the Project Steering Group reviewed and assessed each medication or drug class. Using the definition of ‘necessary to avoid’ previously described by Dreischulte METHODS et al,17 it was considered necessary to avoid concurrent Study design alcohol with a specific medication if, in an average older A Delphi consensus technique was used to develop the adult, concurrent use of alcohol with this medication list of potentially serious alcohol–medication interactions would be considered unsafe because (a) there is suffi- in older adults. The Delphi method allows a consensus cient evidence that the patient is likely to be harmed and http://bmjopen.bmj.com/ opinion to be reached among a panel of experts through (b) the likely harm to the patient is large enough to be an iterative process of questionnaires.10 Ethics approval clinically significant. for this study was obtained from the Royal College Drugs were excluded for the following reasons: their of Surgeons in Ireland (RCSI) (reference number interaction with alcohol was not considered serious, that REC 1097). A Project Steering Group comprising is, unlikely to cause significant harm to the patient (eg, 13 academic and clinical pharmacists, a general practitioner selective serotonin