UntitledAge and Ageing 2015; 44: 213–218 The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Published electronically 16 October 2014 Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact [email protected] STOPP/START criteria for potentiallyinappropriate prescribing in older people:version 2 DENIS O'MAHONY1,2, DAVID O'SULLIVAN3, STEPHEN BYRNE3, MARIE NOELLE O'CONNOR2, CRISTIN RYAN4, 1Geriatric Medicine, University College Cork, Cork, Munster, Ireland2Geriatric Medicine, Cork University Hospital, Cork, Munster, Ireland3School of Pharmacy, University College Cork, Cork, Munster, Ireland 4School of Pharmacy, Queen's University, Belfast, Northern Ireland, UK Address correspondence to: D. O'Mahony. Tel: (+353) 214922396; Fax: (+353) 214922829. Email: [email protected] Purpose: screening tool of older people's prescriptions (STOPP) and screening tool to alert to right treatment (START) cri-teria were ﬁrst published in 2008. Due to an expanding therapeutics evidence base, updating of the criteria was required.
Methods: we reviewed the 2008 STOPP/START criteria to add new evidence-based criteria and remove any obsolete criteria.
A thorough literature review was performed to reassess the evidence base of the 2008 criteria and the proposed new criteria.
Nineteen experts from 13 European countries reviewed a new draft of STOPP & START criteria including proposed new cri-teria. These experts were also asked to propose additional criteria they considered important to include in the revised STOPP& START criteria and to highlight any criteria from the 2008 list they considered less important or lacking an evidence base.
The revised list of criteria was then validated using the Delphi consensus methodology.
Results: the expert panel agreed a ﬁnal list of 114 criteria after two Delphi validation rounds, i.e. 80 STOPP criteria and 34START criteria. This represents an overall 31% increase in STOPP/START criteria compared with version 1. Several newSTOPP categories were created in version 2, namely antiplatelet/anticoagulant drugs, drugs affecting, or affected by, renalfunction and drugs that increase anticholinergic burden; new START categories include urogenital system drugs, analgesicsand vaccines.
Conclusion: STOPP/START version 2 criteria have been expanded and updated for the purpose of minimizing inappropriateprescribing in older people. These criteria are based on an up-to-date literature review and consensus validation among aEuropean panel of experts.
Keywords: inappropriate prescribing, older people, STOPP/START criteria potential IP in older people recognise the dual nature of IP byincluding a list of PIMs (STOPP criteria) and PPOs (START Adverse drug reactions (ADRs) in older people currently re- criteria). Since the ﬁrst iteration of STOPP/START criteria in present a serious and growing public health problem ].
2008 ], our research group has shown a number of import- Polypharmacy and inappropriate prescribing (IP) are well- ant properties of STOPP/START criteria, namely: known risk factors for ADRs, which commonly cause adverseclinical outcomes in older people , ]. IP encompasses po- • STOPP criteria medications are signiﬁcantly associated tentially inappropriate medications (PIMs) and potential pre- with adverse drug events (ADEs), unlike Beers 2003 cri- scribing omissions (PPOs) ]. STOPP/START criteria for teria medications .
D. O'Mahony et al.
• STOPP/START criteria as an intervention applied at a and relevance. We asked the expert panel members to single time point during hospitalisation for acute illness in propose additional STOPP and START criteria and ways to older people signiﬁcantly improve medication appropriate- improve the structure and content of the existing criteria.
ness ], an effect that is maintained 6 months post- We evaluated all new criteria proposed by the expert panel in terms of their clinical importance, accuracy and evidence • STOPP/START criteria as an intervention applied within 72 h of admission signiﬁcantly reduce ADRs (with an abso- We then undertook a process of establishment of the lute risk reduction of 9.3%; number needed to treat = 11) evidence base to support all proposed criteria, including and average length of stay by 3 days in older people hospita- both the criteria to be retained from STOPP/START version 1 and also the suggested additional criteria. The STOPP/START version 1 criteria were reviewed in terms June 2014, date last accessed]).
of the current evidence base to support them. Some of theversion 1 criteria were found to lack a ﬁrm evidence base, e.
For these reasons, we contend that STOPP/START cri- g. statin therapy for primary prevention of cardiovascular teria have practical clinical value. Although these ﬁndings are disease in diabetes mellitus. The authors proposed some recent, it has become clear that an updated version of new criteria, as did the expert panel members. We then STOPP/START criteria is required due to a changing evi- searched PubMed, Embase and Cochrane Library data- dence base underpinning the ﬁrst version of STOPP/ bases for recent published evidence to underpin each START, the licensing of important new drugs since 2008 version 1 criterion and the proposed new criteria. The key and the recognition of a more extensive list of PIMs than search words relating to each proposed criterion were had been included in version 1. In addition, a number of entered in the three databases and relevant articles identi- STOPP/START criteria were no longer considered com- ﬁed in the categories: systematic reviews, randomised con- pletely accurate or relevant, e.g. the use of calcium channel trolled trials (RCTs) and reviews. In addition, we examined blockers (of any kind) in patients with chronic constipation other sources, such as recently published textbooks, the (STOPP criterion) and the use of aspirin for primary preven- British National Formulary and NICE ( tion of cardiovascular disease in patients with diabetes (START criterion). It was also clear that a small number (12 , 1 March 2014, date last accessed) in total) of criteria in STOPP/START version 1 were lacking treatment guidelines for sources of references. Where we in clinical importance or prevalence and were therefore of did not ﬁnd systematic reviews to support a particular cri- less relevance compared with other criteria in the list. In add- terion, we searched for reviews or RCTs that indicated ition, there were some important criteria that were absent clearly that the criterion was evidence based and therefore from STOPP/START version 1. Finally, we considered that appropriate to include in STOPP/START version 2. Three STOPP/START criteria would be enhanced by seeking the members of the research team (the principal author and input of a wider ranging panel of experts from across Europe two postgraduate students under the principal author's than the panel of Irish and UK experts involved in the valid- supervision) read the selected articles to ensure their suit- ation of version 1; this was to reﬂect Europe-wide prescribing ability as support evidence. From the initial list of proposed practices in the general population of older people.
criteria, we removed criteria that did not have a clear evi- The aim of this study was to prepare and validate a new dence base. The remaining proposed criteria were organised version of STOPP/START criteria so as to reﬂect more according to physiological systems for further consensus as- complete and up-to-date sets of PIMs and PPOs that may sessment by the expert panel.
have serious negative effects on the health and well-being of We then made available all of the relevant reference older people in most clinical settings.
articles that constituted the support reference bank for theSTOPP/START version 2 draft criteria to the members of the expert panel; we provided the latter in an online referencepaper repository, using DropBox® software. The Delphi We proposed new criteria to be added to the 2008 list of panel members were offered the abstracts and full publica- STOPP/START criteria on the basis of an expanded evi- tion versions of all of the selected articles relating to each dence base since 2008. We evaluated these proposed new proposed criterion. Each of the selected articles provided an criteria in terms of their clinical importance, accuracy and evi- evidence base to support each proposed criterion, and it was dence base. If the proposed new criteria met these require- left to the discretion/need of each Delphi panel member to ments, we included them in the ﬁrst draft of the STOPP/ assess the evidence presented from the selected articles pro- START version 2 criteria for further validation.
vided by the literature search. We did not ask the Delphi We recruited a panel of 19 experts from 13 countries in panel members to read all articles in a systematic manner and Europe, who had recognised expertise in Geriatric to provide a standardised rating of each article offered as evi- Medicine and pharmacotherapy in older people. We asked dence to support individual criteria. Rather, the articles were each expert to comment on the 2008 STOPP/START cri- provided as a reference repository to be accessed whenever teria, in particular their opinions on their current validity the expert panel members needed to check the supporting STOPP/START criteria for IP in older people reference papers relating to particular proposed STOPP/ START criteria.
For the ﬁrst expert panel consultation, there was a list of 138 As with STOPP/START version 1, topics were chosen proposed STOPP/START criteria for evaluation. These for inclusion according to their considered importance included the original 87 STOPP/START version 1 criteria within each physiological system, provided they had a sound plus 37 possible additional criteria proposed by the Irish evidence base, following literature search.
STOPP/START criteria group; we also received suggestions When the review of the ﬁrst draft of version 2 criteria was for a further 14 criteria from the international expert review complete, we sent the draft criteria to each member of the panel. Of the 138 proposed criteria, 127 criteria had support- expert panel for review and feedback. We used SurveyMonkey® ing published evidence sufﬁcient to warrant their inclusion in software to facilitate an online Delphi validation, an established Round 1 of the Delphi validation which yielded 124 criteria method of achieving consensus [Using the Delphi validation with median Likert scores of 1 or 2. One hundred and seven method, we presented each criterion to the expert panel of these 124 criteria had median Likert scores with 75th members in the form of a statement, e.g. Antipsychotics (i.e.
centile values of 1 or 2 and were retained as validated criteria.
other than quetiapine or clozapine) in older patients with The remaining 17 criteria (7 STOPP and 10 START criteria) Parkinsonism or Lewy Body Disease should be avoided due formed the basis for Delphi consensus Round 2 which to the risk of severe extra-pyramidal symptoms. Each expert achieved consensus on 7 criteria; a third consensus validation panel member then chose his/her level of agreement with round was not required. The full list of references which sup- each statement, ranging from ‘strongly agree' to ‘strongly ports the new STOPP criteria and START criteria is given in disagree'. Panellists were also given a ‘don't know' option and and the ﬁnal list of had the opportunity to comment on each suggested criterion new STOPP criteria and the new START criteria is given in using free text feedback before moving to the next proposed criterion for evaluation.
A Likert scale was used to measure the responses: Fifteen of the criteria from STOPP/START version 1 0 = don't know; 1 = strongly agree; 2 = agree; 3 = neutral; were not included in STOPP/START version 2 (Table ) on 4 = disagree; 5 = strongly disagree. The median and inter- the basis of a lack of sufﬁciently robust or consistent evi- quartile range values were calculated for each response in dence in the published literature Table details those each iteration of the Delphi process. Criteria with a median criteria rejected during the Delphi consensus validation of value of 1 or 2 and a 75th centile value of not >2 were STOPP/START version 2.
retained. Criteria with a higher median value were excluded.
Following the ﬁrst validation round, we removed any pro- posed criteria that did not meet the retention requirements.
Table 1. STOPP/START version 1 criteria removed from We then drew up the second draft of the new criteria and pro- the proposed version 2 because of weak or equivocal ceeded to a second round of Delphi validation, once again supporting evidence using an online method, and inviting free text feedback frompanel members on each criterion. As in the ﬁrst validation Aspirin with no history of coronary, cerebral or peripheral arterial occlusive round, we excluded those criteria that did not meet the reten- tion requirements detailed previously. We planned to continue Calcium channel blockers with chronic constipation this process of repeated Delphi validation rounds until agree- Non-cardioselective beta-blocker with chronic obstructive pulmonary disease ment to retain or reject was reached on all proposed criteria Use of aspirin and warfarin in combination without histamine H2 receptor before declaring that the validation process was complete.
antagonist (except cimetidine because of interaction with warfarin) or protonpump inhibitor The construction and validation process of STOPP/ Dipyridamole as monotherapy for cardiovascular secondary prevention START version 2 is summarised as follows: Aspirin to treat dizziness not clearly attributable to cerebrovascular diseasePhenothiazines in patients with epilepsy Phase 1: Call for review of STOPP/START version 1 cri- Diphenoxylate, loperamide or codeine phosphate for treatment of severe teria and proposal of a new evidence-based cri- teria/removal of obsolete criteria.
Selective alpha-blockers in males with frequent urinary incontinence, i.e. oneor more episodes of incontinence daily Phase 2: Draft 1 of STOPP/START version 2 criteria.
First-generation antihistamines in patients with falls Phase 3: Search of PubMed, Embase and Cochrane data- Long-term opioids in patients with falls bases for systematic reviews, reviews and other refer- Long-term opioids in those with dementia unless indicated for palliative care ences to support STOPP/START version 2 criteria.
or management of moderate/severe chronic pain syndrome Phase 4: Draft 2 of STOPP/START version 2 criteria, with Metformin with type 2 diabetes mellitus +/− metabolic syndrome (in the support literature.
absence of renal impairment, i.e. serum creatinine > 150 μmol/l, or estimated Phase 5: Delphi validation Round 1 (19 experts).
GFR < 50 ml/min/1.73 m2) Phase 6: Draft 3 of STOPP/START version 2 criteria.
Aspirin for primary prevention of cardiovascular disease in diabetes mellitus Phase 7: Delphi validation Round 2 (19 experts).
Statin therapy for primary prevention of cardiovascular disease in diabetes Phase 8: Draft 4 of STOPP/START version 2 criteria (ﬁnal GFR, glomerular filtration rate.
D. O'Mahony et al.
Table 2. Proposed criteria rejected by the expert panel for has opened up the real possibility of applying the criteria in inclusion in STOPP/START version 2 using Delphi routine clinical practice globally.
Undoubtedly, some criteria have greater clinical import- ance than others, and there may be an argument in favour of Rejected new STOPP criteria hierarchical prioritisation within the overall set of STOPP/ Diuretic for treatment of hypertension with concurrent urinary incontinence START criteria. However, we considered that such hierarch- (may exacerbate incontinence)SSRIs with concurrent bleeding diathesis, prescription of anticoagulants or ical prioritisation might introduce unnecessary complexity to antiplatelet agents (increased risk of bleeding in general), active peptic ulcer using STOPP/START, particularly when the criteria refer to disease or concurrent NSAID prescription (risk of gastrointestinal bleeding) potential rather than absolute medication inappropriateness.
SSRIs in patients with previous history of major non-traumatic bleeding or in Inevitably, there will be comparisons between STOPP/ combination with drugs that may promote peptic ulceration, e.g. NSAIDs START version 2 and Beers criteria version 4 published in (increased risk of recurrent major bleeding)Aspirin, clopidogrel, dipyridamole, vitamin K antagonists, direct thrombin 2012 Although we have included a new section in inhibitors or factor Xa inhibitors with concurrent high bleeding risk, i.e.
STOPP criteria containing three implicit prescribing rules, HAS-BLED score ≥3; HAS-BLED (hypertension, abnormal renal/liver STOPP/START, like Beers criteria, are essentially explicit function, stroke, bleeding history, labile INRs, elderly (age > 65 years), drugs criteria for PIMs. However, some important essential differ- that promote bleeding/alcohol) ences between STOPP/START and Beers criteria remain, Antidepressants of any kind in patients with recurrent falls Rejected new START criteria principally the list of PPO's (START criteria) and the avoid- Memantine for moderate–severe Alzheimer's disease ance of mention of some Beers criteria drugs that are now Dopamine agonist (e.g. ropinirole or pramipexole) for Restless Legs absent from most European drug formularies, e.g. guana- Syndrome once iron deficiency has been excluded benz, reserpine, mesoridazine, estazolam, trimethobenza- Statin therapy in diabetes mellitus, unless the patient is at end of life or more mide and metaxalone.
appropriate for palliationPhosphodiesterase type-5 inhibitor with persistent erectile dysfunction In STOPP/START criteria, we decided not to indicate the comparative clinical relevance/severity of each criterion, SSRI, selective serotonin reuptake inhibitor; NSAID, non-steroidal anti- since we considered almost all of the potential instances inflammatory drug.
of IP in STOPP and START lists to be non-trivial, i.e. poten- While these criteria have a significant supportive evidence, the expert panel didnot judge them to be of such high importance as to be considered potentially tially serious.
inappropriate in every case where they are encountered.
There are several PIM criteria sets in the published litera- ture [However, only ﬁve published studies describe the ap- plication of PIM criteria as an intervention tool for improving medication appropriateness . Three of these ﬁve STOPP/START criteria are important for several reasons.
studies describe the use of Beers criteria or variations of Since the ﬁrst iteration of STOPP/START in 2008, there Beers criteria , one study deals with inappropriate have been 74 published articles describing the use of prescribing in the elderly tool (IPET) criteria ] and one STOPP/START criteria in the PubMed database study with STOPP/START criteria . In our opinion, only those sets of PIM criteria that have tangible clinical beneﬁt November 2013, date last accessed)], including 5 review arti- when applied as an intervention merit serious attention.
cles and 45 original research articles involving STOPP/ Three of these ﬁve intervention studies used either Beers cri- START criteria in various clinical scenarios. These publica- teria or an adaptation of Beers criteria or IPET criteria as tions originate from 24 countries. A recent Australian study both the intervention and the primary outcome measure comparing Beers criteria, STOPP/START criteria and pre- . Gill et al.  reported that 37.9% of PIMs identiﬁed scribing indicators in Elderly Australians criteria concluded by IPET were discontinued by the prescribing physician, i.e.
that the number and scope of drug-related problems identi- the intervention and the outcome measure were essentially ﬁed by pharmacists was best represented by STOPP/ the same. Although all ﬁve studies report beneﬁt, only the START criteria ].
study by Gallagher et al. described an intervention (STOPP/ The fact that STOPP/START criteria have been success- START criteria) that was distinct from the outcome measure fully applied for both research and practical clinical purposes (Medication Appropriateness Index).
in several countries in Europe, Asia, Australia, North All explicit IP criteria essentially aim to improve medica- America and South America indicates that the criteria prob- tion appropriateness and/or avoid potentially serious ADRs ably have true global relevance. The relevance of STOPP/ and ADEs. IP criteria are clinically relevant if they signiﬁ- START criteria is further supported by the tangible clinical cantly reduce the rate of ADRs or ADEs when applied pro- beneﬁts demonstrated in the studies completed by our spectively to an unselected population of older patients in a group, alluded to in the Introduction.
particular clinical setting. STOPP/START criteria meet this Version 2 of STOPP/START, with 114 criteria, repre- essential requirement for clinical relevance on the basis of a sents a 31% increase in the total number of criteria included highly signiﬁcant reduction in ADR incidence in older hospi- in version 1. This number of criteria may be considered un- talised patients whose medication has been adjusted accord- wieldy by some users, particularly those in busy clinical prac- ing to STOPP/START criteria compared with similar older tice. Development of STOPP/START software applications patients receiving standard pharmaceutical care .
STOPP/START criteria for IP in older people The present validation study shows the need to update Topinkova (Czech Republic), Prof. Tomasz Grodzicki and revise explicit IP criteria on a regular basis. The total (Poland), Prof. Adalsteinn Gudmundsson (Iceland), Prof.
number of STOPP/START criteria has increased by 31% Jean-Pierre Baeyens (Belgium), Prof. Mirko Petrovic (Belgium), from version 1 to version 2 between 2008 and 2013. Most of Prof. Anne Spinewine (Belgium), Prof. Pierre Olivier Lang the extra criteria do not pertain to new drugs with new indi- (Switzerland), Dr Thomas Fruehwald (Austria) and Dr Wolfgang cations arriving on the market during that 5-year time inter- von Renteln-Kruse (Germany).
val. Rather, they arise from new trial information, newsystematic reviews and expert panel suggestions for addi- Conflicts of interest tional criteria.
Although there are research data to indicate that the ﬁrst D.O.'M. and S.B. hold a patent, with others, called A iteration of STOPP/START as an intervention has clinical Prescription Decision Support System (based on STOPP & relevance in the acute hospital setting, it remains to be seen START prescribing guidelines), lodged with the European whether STOPP/START version 2 offers further ADR/ Patent Ofﬁce (Munich); patent No. 11757950.8–1952. They ADE prevention beneﬁts to older patients in various clinical also possess a shareholding in Clinical Support Information settings. A recently funded European Commission Seventh Systems®, a software company established for the purpose Framework Programme project, called SENATOR of developing and marketing STOPP & START criteria as a (19 June 2014, date last accessed)], set of software products.
will examine the efﬁcacy of a new pharmacotherapy opti-misation software intervention based largely on STOPP/START criteria. The primary outcome measure of the inter- national multi-centre RCT designed to test SENATOR soft- This research was supported by grant funding provided by ware's efﬁcacy will be ADR incidence in older peoplehospitalised with acute illness.
the Health Research Board of Ireland (HRB; grant numberHRA_HSR/2010/14).
Supplementary data • PIMs and PPOs are commonly encountered in older people. PIMs and PPOs are closely related to ADEs and ADRs, but they are preventable.
• STOPP/START criteria have been shown to be signiﬁcant- ly associated with ADEs in acutely ill older people, unlike Disclaimer (STOPP/START criteria Beers criteria.
• In single-centre RCTs, STOPP/START criteria used as an intervention signiﬁcantly improve medication appropriate- Whilst every effort has been made to ensure that the poten- ness and reduce the incidence of ADRs in older people in tially inappropriate prescribing criteria listed in STOPP/ hospital, compared with standard pharmaceutical care.
START version 2 are accurate and evidence-based, it is • Since the ﬁrst publication of STOPP/START criteria in emphasized that the ﬁnal decision to avoid or initiate any 2008, the therapeutics evidence base as it applies to older drug referred to in these criteria rests entirely with the pre- people has expanded signiﬁcantly, indicating the need for scriber. It is also to be noted that the evidence base under- updating and revision of STOPP/START criteria. The lying certain criteria in STOPP/START version 2 may present study describes this process, resulting in a 31% in- change after the time of publication of these criteria.
crease of the number of STOPP/START criteria compared Therefore, it is advisable that prescribing decisions should with the 2008 version, i.e. 114 criteria.
take account of current published evidence in support of oragainst the use of drugs or drug classes described inSTOPP/START version 2 criteria.
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the following persons: Prof. Stephen Jackson (UK), Dr Una 2. Atkin PA, Veitch PC, Veitch EM, Ogle SJ. The epidemiology Martin (UK), Prof. Sylvie Legrain (France), Dr Marie Laroche of serious adverse drug reactions among the elderly. Drugs (France), Dr Alfonso Cruz-Jentoft (Spain), Prof. Antonio Aging 1999; 14: 141–52.
Cherubini (Italy), Prof. Graziano Onder (Italy), Prof. Tischa 3. Onder G, van der Cammen TJ, Petrovic M, Somers A, van der Cammen (The Netherlands), Dr Paul Jansen Rajkumar C. Strategies to reduce the risk of iatrogenic illness (Netherlands), Dr Jens-Ulrik Rosholm (Denmark), Prof. Eva in complex older adults. Age Ageing 2013; 42: 284–91.
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