Int J Clin Pharm DOI 10.1007/s11096-013-9900-y
REVIEW ARTICLE
A comprehensive review of the impact of clinical pharmacy services on patient outcomes in mental health Tom E. Richardson • Claire L. O’Reilly Timothy F. Chen
•
Received: 1 September 2013 / Accepted: 25 November 2013 Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2013
Abstract Background The importance of pharmacists in mental healthcare is starting to be recognised around the world. However few studies have focused on the evidence supporting pharmacist involvement in the inpatient mental healthcare setting. Aim Evaluate types of outcomes achieved and level of evidence supporting clinical pharmacy services in inpatient mental health settings. Methods Medline, PyscINFO and International Pharmaceutical Abstracts databases were searched from January 1990 to March 31 2013. Studies were included if in an inpatient setting, published in English, and reported an intervention provided by a pharmacist or involving a pharmacist with a pivotal role in an intervention team. Data were extracted according to sample population and size, study design and outline, country, role of the pharmacist in the study, and the main results of the study. The level of evidence for each study was assessed using Australia’s National Health and Medical Research Council’s hierarchy of clinical evidence and results were categorised as having economic, clinical and/or humanistic outcomes. Results Eighteen articles met the inclusion criteria. A range of pharmaceutical services provided by pharmacists in inpatient mental healthcare were identified. These services highlight the role of pharmacists as reviewers of medication charts, laboratory results and medication prescribing and as educators of patients and other health care professionals. Six studies included a control or comparison group and had pre and post intervention measures. These comprised of three randomised control trials, one historical control study and two case series post and pre-post tests, corresponding to
evidence levels of II, III-3 and IV respectively. Seven studies reported clinical outcomes, two economical and one humanistic outcomes. One study reported both clinical and economical outcomes. Seven studies focused on impact evaluation measures. Conclusions Pharmacists provide a variety of services and play a significant role in inpatient mental healthcare. However, the level of evidence supporting these services is limited and the type of outcomes achieved is narrow. Keywords Clinical pharmacy Mental health Pharmaceutical services Pharmacists Psychiatry
Impact of findings on practice •
•
•
Pharmacists are well equipped to provide a variety of clinical pharmacy services in the inpatient mental health setting. Implementing clinical pharmacy services in inpatient mental health has significant potential for improving economic, clinical and humanistic outcomes for patients and the mental healthcare system. The direct impact of clinical pharmacy services may be established through the conduct of studies with more robust study designs such as randomised control trials or comparative effectiveness trials.
Introduction T. E. Richardson (&) C. L. O’Reilly T. F. Chen Faculty of Pharmacy, The University of Sydney, Sydney, NSW 2006, Australia e-mail: [email protected]
The global prevalence and burden of mental illness is becoming more apparent. Approximately 18.1–36.1 % of the global population suffers from lifelong mental illness
123
Int J Clin Pharm
[1], with substance abuse and mental illness accounting for 22.9 % of all years lived with disability [2]. In the United States approximately 11.1 % of the non-institutionalised population uses a psychotropic medication (e.g. antidepressants, antipsychotics, anxiolytics) and it is predicted that the total indirect and direct costs of mental illness result in an annual economic burden of $317 billion [3, 4]. Pharmacists are therefore well positioned to enhance mental health services and reduce the significant cost burden from inappropriate psychotropic drug use. The role of the pharmacist in healthcare has been evolving from primarily dispensing and stock management to clinical pharmacy services involving patient and peer education, adverse drug reaction and drug interaction monitoring, screening of major diseases and medication review [5–8]. These clinical pharmacy services have become highly specialised, encompassing a variety of areas including geriatrics [9], emergency medicine [10] and ambulatory care [11], and have been shown to improve patient quality of life [12]. With the complexity of issues surrounding mental health patients and mental healthcare, pharmacists are uniquely positioned to provide significant support and expertise to enhance the level and quality of mental healthcare in areas such as medication adherence [13]. The importance of pharmacists in mental healthcare has been recognised by the pharmacy profession around the world. Since 1996 the Board of Pharmaceutical Specialties in the United States has implemented a certification process for pharmacists who have completed a psychiatric residency or at least 4 years of practice to formally recognise their abilities in mental healthcare [14]. A similar credentialing process is conducted by the College of Mental Health Pharmacy (CMHP) in the UK [15]. In addition, the CMHP as well as the Australian Pharmacy Council, the Pharmaceutical Society of Australia, and the Society of Hospital Pharmacists Australia have each developed competency statements, frameworks or standards of practice for the expected contribution and role of pharmacists in all areas of mental healthcare [16–19]. These documents highlight key areas and activities where clinical pharmacy services can be employed in both inpatient and outpatient settings. The role of pharmacists in outpatient mental health has been demonstrated [20, 21], however few studies have focused on the role of pharmacists in inpatient mental health and the level of evidence to support their role.
Aim The aim of this review was to evaluate the level of evidence supporting the role of pharmacists in inpatient
123
mental healthcare. In order to do this, the pharmaceutical services provided by mental health pharmacists, the type of outcome achieved from these services and the level of evidence supporting these services were reviewed.
Methods Search strategy Publications from January 1 1990 through to March 30 2013 were sought from the databases Medline, PyscINFO and International Pharmaceutical Abstracts. A broad search was conducted by exploding the medical subject headings (MeSH) pharmacist, pharmaceutical services, clinical pharmacy, pharmacy services and combining them with mental health, psychiatry, mental disorders, psychotropic drugs, antipsychotic agents and antidepressants. The type of intervention was also searched, using the terms education, consultation, professional role, cooperative behavior and prescribing. In addition reference lists and citing articles of relevant articles were manually searched. Selection criteria Studies included needed to demonstrate a process or program conducted by pharmacists in a hospital setting, which directly involved mental health patients or mental healthcare providers. In studies where multidisciplinary models were used pharmacists needed to play an integral role in the intervention delivery. Only studies in English were included. Studies were excluded if they were: conducted in primary care (e.g. community pharmacy practice) or in outpatient settings; published as an abstract only; literature reviews; case reports or editorials (Fig. 1). Data analysis Studies were assigned a level of evidence according to Australia’s National Health and Medical Research Council’s hierarchy of clinical evidence (Table 1) [22]. This hierarchy was modeled on evidence evaluation frameworks from the National Institute for Health and Clinical Excellence (NICE) [23], the National Health Service Centre for Reviews and Dissemination [24] and the Centre for Evidence Based Medicine [25]. The NHMRC hierarchy assigns a level of evidence to the outcome of a study based on the study’s design and its appropriateness to assess the effect of an intervention with minimal possibility for bias. Assigning a level of evidence moves to verify the results of an intervention, and therefore studies receiving a level of evidence of I represent the
Int J Clin Pharm Fig. 1 Search taxonomy, inclusion criteria and results
Table 1 National Health and Medical Research Council’s hierarchy of clinical evidence [22] Level of evidence
Study design
I
A systematic review of randomized controlled trials
II
A randomized controlled trial
III-1
A pseudorandomized controlled trial
III-2
A comparative study with concurrent controls Non-randomized experimental trial Cohort study Case–control study Interrupted time series with a control group
III-3
A comparative study without concurrent controls
outcome evaluation focuses on the longer term effects of the study. Outcomes were further categorised according to the ECHO model of outcome assessment [26]. Depending on the achieved outcome from the pharmacist intervention, studies were categorised as clinical, humanistic or economic. Studies where changes or improvements to the patient’s care were seen were classified as having a clinical outcome. Studies which resulted in changes in quality of life or functional status of the patient were classified as having humanistic outcomes. Studies where the pharmacist interventions resulted in economic changes to the patient directly or the healthcare system, were classified as having an economic outcome.
Historical control study Two or more single arm study Interrupted time series without a parallel control group IV
Case series with either post-test or pre-test/post-test outcomes
highest quality of evidence to support the intervention. In order to receive a classification of a certain level of evidence according to the NHMRC hierarchy, the intervention studies must compare the intervention to a control. Study findings were categorised as either impact or outcome evaluation measures. Impact evaluation is concerned with the immediate effects of the study, whilst
Results Eighteen articles satisfied the search criteria and were included in the review (Table 2). Ten of these studies were conducted in the US [27–36] and ten published in the last decade [27, 29, 31, 32, 35, 37–41]. Eleven of these studies involved a sample consisting of patients with a variety of psychiatric conditions present on the ward [27–29, 31, 33– 35, 40, 42–44]. Studies also specifically utilised paediatric and adolescent psychiatric patients [41], patients with depressive or persistent mood affective disorder [37] or schizophrenia [38]. Patients currently taking narrow therapeutic agents (e.g. clozapine, warfarin or lithium) [32], on
123
Sample size (n)
278 (control = 87, intervention 1 = 93, Intervention 2 = 98)
962 patients, 386 nurses, 169 doctors
97 (control = 46, Intervention = 51)
551
105
References
Al-Saffar et al. [37]
123
Thompson et al. [39]
Shaw et al. [43]
McKee and Cleary [32]
Suehs et al. [35]
Case series post test
Historical control study
Randomised control trial
Randomised control trial
Randomised control trial
Study design
Table 2 Summary of studies included in review
IV
III-3
II
II
II
Level of evidence
US
US
Scotland
England
Kuwait
Country
Psychiatric patients
Lithium, clozapine or warfarin patients
Psychiatric patients
Patients on antipsychotic medication
Depressive or persistent mood affective disorder
Study population
Pharmaceutical consultation service after referral from physician
Reduce adverse drug reactions through intensive pathological monitoring
Patient education and development of discharge summaries for use by community pharmacist
Multifaceted intervention for doctors and nurses to reduce antipsychotic polypharmacy
Comparison between control, educational leaflets (I1), and educational leaflets plus counselling sessions (12) on adherence to antidepressants
Study outline
Pharmacist conducted reviews and provided recommendations
Pharmacist evaluated laboratory results
Pharmacist developed discharge summary and conducted follow up visits
Impact; outcomeclinical
Impact; outcomeclinical
66.9 % of recommendations implemented. In patients where [%80 of recommendations were implemented a reduction in CGI-S of 0.44 points was seen (p = 0.036)
Impact; outcomehumanistic
Impact
Impact; outcomeclinical
Evaluation measure
ADRs: decreased from 6 % to 3 % for lithium, 2–1 % for clozapine and increased from 0 to 0.5 % for warfarin
Drug knowledge improved and maintained at 12 weeks post discharge for both groups (p = 0.05). Fewer medication problems and increased compliance at 12 weeks for intervention group (but no statistical support). No significant difference in readmissions
Reduction in antipsychotic polypharmacy: OR 0.43 (0.21–0.90)
Improved adherence at 5 months as measured by pill counting and self reporting: I1: OR 3.0 (1.7–5.3), I2: OR 5.5 (3.2–9.6)
Pharmacist run counselling sessions
Pharmacist conduction academic detailing and facilitated a chart reminder system
Results
Role of pharmacist in study
Int J Clin Pharm
Prospective evaluation
Prospective evaluation
69 (204 interventions)
320 interventionsa
153 (282 interventions)
109 (229 interventions)
3,204 drug use evaluationsa
1,426
Alderman [42]
Campbell et al. [27]
Dolder et al. [29]
Dorevitch and Perl [44]
Goad and Ezell [30]
Hazra et al. [38]
–
–
Retrospective evaluation
Retrospective evaluation
–
–
–
–
IV
Level of evidence
Prospective evaluation
Prospective evaluation
Case series pre-post test
93 (historical control = 48, intervention = 45)
Canales et al. [28]
Study design
Sample size (n)
References
Table 2 continued
Canada
US
Israel
US
US
Australia
US
Country
Schizophrenia
Patients taking antipsychotics or antiparkinonian agents
Psychiatric patients
Psychiatric patients
Psychiatric patients
Psychiatric patients
Psychiatric patients
Study population
Prescriber prompting and education about the use of antipsychotic polypharmacy
Drug use evaluations were conducted to monitor prescribing of antipsychotics and antiparkinsonian drugs
Pharmaceutical consultation service after referral from physician
Audit of pharmaceutical services
Cost avoidance as a result of pharmacy student clinical interventions
Audit of pharmaceutical services
Intensive pharmaceutical services (obtaining drug histories, baseline assessments, drug monitoring, drug education)
Study outline
Pharmacist prompted prescribers and provided education
Pharmacist conducted the drug use evaluation
Pharmacist conducted reviews and provided recommendations
Pharmacist conducted clinical interventions
Pharmacy student run interventions
Pharmacist conducted clinical interventions
Pharmacist conducted intensive pharmaceutical services
Role of pharmacist in study
Decrease in polypharmacy from 18.3 to 6.6 % (p \ .001)
84 % of inpatient prescribing adhered to the drug use conditions evaluated, compared to 64 % for the ambulatory care clinic
88.2 % of recommendations implemented, with 67.9 % patients experienced a satisfactory response (patient improvement) as determined by the research team
67.0 % of pharmacist interventions accepted
97.0 % of proposed interventions accepted. $6,000–$24,000 cost avoided
91.7 % of proposed interventions accepted
Significant overall outcome improvement as measured by BPRS (93 % had 20 % decrease: p = 0.024, 62 % had 30 % decrease: p = 0.002, 22 % had 40 % decrease: p \ 0.001). 65 % had 50 % symptom improvement for depression: p = 0.003. Reduction in ADRs: p = 0.002–0.042
Results
Impact
Impact
Impact; outcomeclinical
Impact
Impact; outcomeeconomic
Impact
Impact; outcomeclinical
Evaluation measure
Int J Clin Pharm
123
123 Retrospective evaluation
2,200 interventionsa
29 (135 interventions)
30 (125 recommendations)
83
242 (1,466 prescriptions)
Marino et al. [31]
Morton et al. [33]
Stanislav et al. [34]
Stoner et al. [36]
Ved and Coupe [40]
–
–
Prospective clinical audit
–
–
–
Level of evidence
Prospective evaluation
Retrospective evaluation
Retrospective evaluation
Study design
Sample size (n)
References
Table 2 continued
England
US
US
US
US
Country
Psychiatric patients
Schizophrenia or Bipolar disorder patients
Psychiatric patients
Psychiatric patients
Psychiatric patients
Study population
Three cycles of audit to improve prescription quality
Evaluations of antipsychotic or antidyskinetic induced movement disorders were conducted and recommendations formulated
Pharmacokinetic or pharmacotherapeutic consultation service after referral from physician
Pharmaceutical consultation service after referral from physician
Compare interventions conducted by hospital pharmacists, pharmacy faculty staff and pharmacy students
Study outline
Pharmacist conducted ward reviews in between audits
Pharmacist conducted movement disorder evaluations and gave recommendations
Pharmacist conducted reviews and provided recommendations
Pharmacist conducted clinical interventions
Pharmacist and pharmacy students conducted clinical interventions
Role of pharmacist in study
After third cycle 99.5 % of all prescriptions considered legible
130 recommendations were proposed, of which 82.0 % were implemented by the physician. 93 % of patients experienced complete or partial resolution of extrapyramidal symptoms after recommendations were implemented.
60.0 % of interventions implemented. In patients where [50 % of recommendations were implemented positive outcomes occurred in 76 % of patients compared to 14 % where \50 % recommendations implemented
79.0 % of proposed interventions implemented
98.8 % of proposed interventions accepted. $125,500 cost avoided over the 1.5 year period
Results
Impact
Impact; outcomeclinical
Impact; outcomeClinical
Impact
Impact; outcomeeconomic
Evaluation measure
Int J Clin Pharm
Impact; outcomeeconomic and clinical 98.0 % of interventions implemented, with 86 % of interventions viewed as having a positive effect on patient care by an independent panel. Implementation of this pharmacy service resulted in 14 % decrease in drug cost per patient day
an antipsychotic medication [39] or antidyskinetic agent [36] also formed the sample in some studies. Services provided The majority of studies (13 of 18) [27, 29–36, 40–42, 44] focused on the clinical role of pharmacists in ensuring the quality use of medicines, including the review of medication charts, laboratory monitoring and the prescribing of medications. Five of these studies reported on pharmacist (or pharmacy student) initiated medication management review services [27, 29, 31, 41, 42] such as the identification of drug related problems, whilst four studies reported on referrals from physicians to pharmacists to address specific clinical issues such as non-response to therapy and polypharmacy [33–35, 44]. Three studies focused on prescription quality. One of these involved an audit of prescription quality [40] and two studies used drug use evaluation methods to assess the concordance of prescribing of antipsychotic and antiparkinsonian medications to current guidelines [30] and the prevalence of extrapyramidal adverse effects [36]. One study evaluated the pharmacist’s role in reviewing specific laboratory results to minimise the likelihood of adverse effects and toxicity [32]. Four of the 18 studies evaluated the contributions made by clinical pharmacists in providing educational services. Two of these involved direct patient counselling and the provision of information resources [37] or discharge summaries [43]. The other two studies used academic detailing methods to reduce the prevalence of antipsychotic polypharmacy [38, 39]. Only one of the 18 studies reported on the clinical role of pharmacists as experts in medication management in conjunction with the provision of educational services [28]. In this study pharmacists conducted medication histories, performed baseline and weekly assessments, monitored for adverse drug reactions, provided recommendations, participated in multidisciplinary team meetings, ran education classes for other healthcare professionals and counselled patients about their medication before discharge.
Patient number unknown
Level of evidence
a
ADRs adverse drug reactions, CGI-S Clinical Global Impression-Severity score, BPRS Brief Psychiatric Rating Scale
– Prospective evaluation and retrospective cost analysis 6 (48 interventions) Virani and Crown [41]
Canada
Child and adolescent psychiatric patients
Pharmaceutical clinical interventions, their impact on patient care and the cost savings generated
Pharmacist conducted clinical interventions
Evaluation measure Level of evidence Study design Sample size (n) References
Table 2 continued
Country
Study population
Study outline
Role of pharmacist in study
Results
Int J Clin Pharm
Of the 18 studies reviewed, one-third employed a study design which compared patients receiving the intervention to a control group of patients who did not receive the intervention. Half of these studies used a randomised control trial study design, signifying a level of evidence of II [37, 39, 43]. The other three studies included the use of a historical control study [32], a case series post test [35], and a case series pre-post test [28], which signify a level of evidence for these studies to be III-3 and IV respectively.
123
Int J Clin Pharm
The remaining 12 studies reviewed did not compare the intervention of interest to a control group. Instead five studies employed a prospective evaluation study design, where clinical pharmacist interventions were undertaken and documented over a varied period of 1–12 months and their acceptance rate was reported [27, 29, 40, 42, 44]. The acceptance rate of clinical pharmacist interventions was also retrospectively evaluated in three studies [31, 33, 34]. One study prospectively evaluated the effect of pharmacists in reducing extrapyramidal symptoms resulting from antipsychotic or antidyskinetic drug use [36]. Two studies utilised retrospective study designs to examine drug use evaluations conducted by clinical pharmacists [30], and clinical pharmacist education and prompting of prescribers about antipsychotic polypharmacy use [38]. Virani and Crown [41] were the only group to employ a study design incorporating a prospective analysis to document clinical pharmacist interventions and a retrospective cost analysis to determine the financial benefit of these interventions. These 12 studies therefore present clinical pharmacist activities in an exploratory format and cannot be assigned a level of evidence. Types of outcomes achieved Outcomes as a result of clinical pharmacists were measured in eleven of the 18 studies reviewed, with clinical outcomes being reported in 7 studies [28, 32, 34–37, 44], economic outcomes in 2 studies [27, 31] and one study reporting humanistic outcomes [43]. Furthermore, one study reported both clinical and economical outcomes being achieved as a result of a clinical pharmacist service [41]. The remaining 7 studies [29, 30, 33, 38–40, 42] focused on the direct impact of the clinical pharmacist service, such as the implementation rate of recommendations, rather than measuring economic, clinical or humanistic outcomes. Therefore these studies are interesting to note, but cannot be evaluated according to type of outcome.
Discussion This review suggests that clinical pharmacists play a wide role in the provision of inpatient mental healthcare. The fundamental role of clinical pharmacists as reviewers of medication charts, laboratory results and medication prescribing is well supported, with 13 out of the 18 articles reviewed focusing on pharmacists reviewing medication charts [27, 29, 31, 33–35, 41, 42, 44], laboratory results [32], past and present medications [30, 36] and the quality of prescriptions [40]. The role of clinical pharmacists as drug experts was explored through the implementation of
123
clinical pharmacist lead educational sessions for doctors and nurses, as well as medication counselling sessions for patients [37–39, 43]. This role as drug experts was further acknowledged by physicians in several studies where the clinical pharmacist services were initiated by referral and therefore actively sought after [33–35, 44]. A study in the United States by Canales et al. [28]. demonstrated the direct clinical benefit of clinical pharmacists acting as reviewers and educators on patient outcomes. In this study the clinical pharmacist undertook intensive clinical pharmacy services, which involved attending staff briefings, performing baseline assessments and weekly reviews, providing pharmacotherapy recommendations, obtaining medication histories, reviewing drug administration records daily, monitoring for adverse drug reactions, conducting weekly education classes and counselling patients before discharge. This intensive clinical pharmacy service resulted in overall clinical outcome improvement with significant improvement in Brief Psychiatric Rating Scale and Clinical Global Improvement scores. This intensive service was also shown to reduce depressive symptoms, as measured by the Hamilton depression scale, by 50 % in 65 % of the intervention group (p = 0.003), and significantly reduce the occurrence of adverse drug reactions as measured by the Barnes (p = 0.042), Simpson (p = 0.002) and the Abnormal Involuntary Movement (p = 0.024) scales. In Australia pharmacists in a hospital setting are expected to perform similar tasks in mental healthcare [17–19], however only one study reviewed demonstrated their occurrence in an Australian hospital [42]. Yet this study did not look at educational activities or patient counselling and it did not aim to measure the benefit of pharmacy services on clinical outcomes. In order to assess pharmacy services in inpatient mental health, a variety of study designs were employed each providing varying levels of clinical evidence according to the NHMRC hierarchy of clinical evidence. Only six reviewed studies were designed to portray the benefits of clinical pharmacy services compared to no clinical pharmacy services and were assigned levels of evidence. Three of these studies were randomised control trials and therefore represent a high level of evidence of II to support the role of pharmacists in mental health. However it is important to recognise that often studies with lower levels of evidence can provide support for an intervention as effectively as randomised control trials [45]. Thompson et al. [39] employed a randomised control trial to demonstrate the effect of pharmacists in reducing antipsychotic polypharmacy through prescriber education and prompting, yet Canales et al. [28] utilised a pre-post test study design to demonstrate the correlation between implementing intensive pharmaceutical services and improved patient
Int J Clin Pharm
outcomes. Canales et al. [28] therefore represents a moderate level of evidence of IV. However it is difficult to conclude that Thompson et al. [39] supports the role of pharmacists in mental health to a greater extent than Canales et al. [28] simply because they employed a randomised control trial, which has a higher level of evidence. The remaining 12 studies reviewed depict the role of clinical pharmacists in inpatient mental health in an exploratory and descriptive nature. The goal of the NHMRC hierarchy of clinical evidence is to highlight and emphasise studies designed to minimise bias when proving a correlation between an intervention and an outcome [22]. These 12 studies did not implement a control or comparison group for the intervention, demonstrating that the majority of literature pertaining to the role of clinical pharmacists in inpatient mental health, does not aim to portray a correlation between clinical pharmacy services and outcomes. Bias in these studies is relatively unregulated and therefore they cannot be assigned a level of evidence. However they still provide insight into the role of pharmacists in inpatient mental health. In comparison to other broader reviews, the levels of evidence to support the role of pharmacists in other areas has been more substantial. Kaboli et al. [46] demonstrated a relatively high level of evidence supporting the role of clinical pharmacists in any inpatient setting with 36 studies comparing clinical pharmacy services to a control, 21 of these being randomised controlled trials. Finley et al. [21] also demonstrated high levels of evidence for pharmacists in all settings of mental health with 16 studies comparing pharmacy services to a control. With only 6 studies comparing clinical pharmacy services to a control in our review, it is evident that better designed studies are necessary to provide a solid evidence base for the role of clinical pharmacists in inpatient mental health. Outcome evaluation identified 11 studies that measured both the impact and outcomes resulting from clinical pharmacy services in inpatient mental health. Of these 7 focused on clinical outcomes where clinical changes and patient improvements were reported. These studies largely focused on improved symptom severity and reduced adverse drug reactions as a result of clinical pharmacy services. Two studies highlighted the economic benefit of clinical pharmacy services, with significant cost avoidance from $6000 up to $125,500 after the implementation of clinical pharmacist medication chart reviews and interventions. Virani and Crown [41] measured both economic and clinical outcomes, with clinical pharmacist interventions having a positive effect on patient outcomes and significantly reducing drug cost per patient day by 14 %. However, this study has significant limitations, with patient outcomes not being assessed using validated scales of symptom severity, rather independent assessors’ opinions.
In comparison, Shaw et al. [43] was the only study which measured a humanistic outcome as a result of clinical pharmacist services in inpatient mental health. In this study they demonstrated improved patient drug knowledge, increased compliance and fewer medication problems as the result of clinical pharmacists providing patient discharge summaries to community pharmacists. Many clinical pharmacy services are discussed in the reviewed studies; however more studies are required to determine the effect of these services on clinical, economic and humanistic outcomes. In comparison seven studies focused only on the immediate impact of the clinical pharmacy service of interest and did not measure outcomes. In three of these studies clinical pharmacist interventions were undertaken where patient chart reviews were conducted and recommendations formulated to address pharmaceutical or medical issues uncovered [29, 33, 42]. The main findings of these studies were the rate at which clinical pharmacist recommendations were adopted and implemented by treating physicians. The aim of these seven studies was service implementation and therefore the authors did not ascertain whether these recommendations resulted in clinically significant improvements in economic, clinical or humanistic outcomes. Utilising the NHMRC evidence hierarchy inherently has limitations in itself as it solely allocates a level of evidence according to study design, not the quality of the study, in which subject selection, group allocation and follow up is monitored for bias. With only one study being conducted in a multi-centre setting [39], the generalisability of results and outcomes from reviewed studies is limited. This review was also limited to the inpatient setting, therefore narrowing its scope. The broad definitions of each type of outcome in the ECHO model of outcome assessment allows for categorisation of outcomes achieved by clinical pharmacist services in inpatient mental health. From this review it is apparent that current evidence supports the clinical benefit of pharmaceutical services in inpatient mental health and future research into economic and humanistic benefits may be beneficial. However due to the broad definitions of each type of outcome, categorising studies as economic, clinical or humanistic is subject to author opinion. Furthermore, this review highlights the difficulty in performing high level analysis and comparison on different pharmaceutical services implemented in mental health, as the data available in studies is limited by inherent heterogeneity. As no standardised parameters are used to measure the impact or outcome resulting from pharmaceutical service implementation in mental healthcare it is difficult to compare which pharmaceutical service has greatest effect on outcomes.
123
Int J Clin Pharm
Conclusion Pharmacists can play a significant role in mental healthcare through the provision of a variety of pharmaceutical services. The majority of studies in the literature focus on the role of pharmacists as reviewers of medication charts, laboratory results and medication prescribing, as well as providers of pharmacotherapeutic education to patients and other healthcare professionals. However, the level of evidence supporting these roles is limited and the type of outcomes achieved is narrow. Funding
None.
Conflicts of interest
None.
References 1. Kessler RC, Aguilar-Gaxiola S, Alonso J, Chatterji S, Lee S, Ormel J, et al. The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psychiatr Soc. 2009;18(1):23–33. 2. Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, et al. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 [cited 29 Oct 2013]. http://www. sciencedirect.com/science/article/pii/S0140673613616116. 3. Paulose-Ram R, Safran MA, Jonas BS, Gu Q, Orwig D. Trends in psychotropic medication use among U.S. adults. Pharmacoepidemiol Drug Saf. 2007;16(5):560–70. 4. Insel TR. Assessing the economic costs of serious mental illness. Am J Psychiatry. 2008;165(6):663–5. 5. Pande S, Hiller JE, Nkansah N, Bero L. The effect of pharmacistprovided non-dispensing services on patient outcomes, health service utilisation and costs in low- and middle-income countries. Cochrane Database Syst Rev. 2013;(2). 6. Tan EC, Stewart K, Elliott RA, George J. Pharmacist consultations in general practice clinics: the pharmacists in practice study (PIPS). Res Soc Adm Pharm. 2013 [cited 29 Oct 2013]. http:// www.sciencedirect.com/science/article/pii/s1551741113001551. Accessed on Oct 29 2013. 7. Castelino RL, Bajorek BV, Chen TF. Retrospective evaluation of home medicines review by pharmacists in older Australian patients using the medication appropriateness index. Ann Pharmacother. 2010;44(12):1922–9. 8. Ayorinde AA, Porteous T, Sharma P. Screening for major diseases in community pharmacies: a systematic review. Int J Pharm Pract. Epub 20 May 2013. 9. Tett S, Higgins G, Armour C. Impact of pharmacist interventions on medication management by the elderly: a review of the literature. Ann Pharmacother. 1993;27(1):80–6. 10. Kane S, Weber R, Dasta J. The impact of critical care pharmacists on enhancing patient outcomes. Intensive Care Med. 2003;29(5):691–8. 11. Singhal P, Raisch D, Gupchup G. The impact of pharmaceutical services in community and ambulatory care settings: evidence and recommendations for future research. Ann Pharmacother. 1999;33(12):1336–55. 12. Pickard AS, Hung S-Y. An update on evidence of clinical pharmacy services’ impact on health-related quality of life. Ann Pharmacother. 2006;40(9):1623–34.
123
13. Rubio-Valera M, Serrano-Blanco A, Magdalena-Belio J, Fernandez A, Garcia-Campayo J, Pujol MM, et al. Effectiveness of pharmacist care in the improvement of adherence to antidepressants: a systematic review and meta-analysis. Ann Pharmacother. 2011;45(1):39–48. 14. Stoner SC, Ott CA, Dipaula BA. Psychiatric pharmacy residency training. Am J Pharm Educ. 2010;74(9):163. 15. College of Mental Health Pharmacy. Credentialing—full CMHP membership (MCMHP). 2013; http://www.cmhp.org.uk/ credentialing. Accessed on Nov 1 2013. 16. College of Mental Health Pharmacy. Membership portfolio—competencies. 2013; http://www.cmhp.org.uk/membership/membershipportfolio-competencies. Accessed 6 Aug 2013. 17. Australian Pharmacy Council. Statement of mental health care capabilities for pharmacists 2009. Canberra; 2010. http://pharmacy council.org.au/PDF/Pharmacists%20Capability%20Statement%20% 20June%20%2709%20%28v5%29.pdf. Accessed on 6 Aug 2013. 18. Pharmaceutical Society of Australia. Mental health care project: a framework for pharmacists. Canberra; 2013. http://www.psa.org. au/download/policies/mental-health-framework.pdf. Accessed on 6 Aug 2013. 19. SHPA Committee of Specialty Practice in Mental Health Pharmacy. Standards of practice for mental health pharmacy. J Pharm Pract Res. 2012;42(2):142–5. 20. Jenkins MH, Bond CA. The impact of clinical pharmacists on psychiatric patients. Pharmacotherapy. 1996;16(4):708–14. 21. Finley PR, Crismon ML, Rush AJ. Evaluating the impact of pharmacists in mental health: a systematic review. Pharmacotherapy. 2003;23(12):1634–44. 22. NHMRC. NHMRC additional levels of evidence and grades for recommendations for developers of guidelines. Stage 2 consultation. Early 2008–end June 2009. Canberra: National Health and Medical Research Council; 2009; http://www.nhmrc.gov.au/_files_nhmrc/ file/guidelines/stage_2_consultation_levels_and_grades.pdf. Accessed 20 May 2013. 23. National Institute for Health and Clinical Excellence. The guidelines manual. London: National Institute for Health and Clinical Excellence; 2007. 24. Khan K, Ter Riet G, Glanville J, Sowden A, Kleijnen J. Undertaking systematic reviews of research on effectiveness. CRD’s guidance for those carrying out or commissioning reviews. York: University of York; 2001. 25. Phillips B, Ball C, Sackett D, Badenoch D, Straus S, Haynes B, et al. Oxford centre for evidence-based medicine levels of evidence. Oxford: Centre for Evidence-Based Medicine; 2001. 26. Gunter MJ. The role of the ECHO model in outcomes research and clinical practice improvement. Am J Manag Care. 1999; 5(4 Suppl):S217–24. 27. Campbell AR, Nelson LA, Elliott E, Hieber R, Sommi RW. Analysis of cost avoidance from pharmacy students’ clinical interventions at a psychiatric hospital. Am J Pharm Educ. 2011;75(1). Article 8. 28. Canales PL, Dorson PG, Crismon ML. Outcomes assessment of clinical pharmacy services in a psychiatric inpatient setting. Am J Health Syst Pharm. 2001;58(14):1309–16. 29. Dolder C, Szymanski B, Wooton T, McKinsey J. Pharmacist interventions in an inpatient geriatric psychiatry unit. Am J Health Syst Pharm. 2008;65(19):1795–6. 30. Goad JD, Ezell JR. Drug-use evaluation programs for psychotropic medications. Am J Hosp Pharm. 1990;47(1):132–6. 31. Marino J, Caballero J, Llosent M, Hinkes R. Differences in pharmacy interventions at a psychiatric hospital: comparison of staff pharmacists, pharmacy faculty, and student pharmacists. Hosp Pharm. 2010;45(4):314–9. 32. McKee J, Cleary S. High-risk, high-alert medication management practices in a regional state psychiatric facility. Hosp Pharm. 2007;42(4):323–30.
Int J Clin Pharm 33. Morton WA, Mendenhall AR, Windsor PG, Lydiard B. Clinical psychopharmacy consultations: acceptance of recommendations on an adult inpatient psychiatric unit. Hosp Pharm. 1995;30(9): 786–90. 34. Stanislav SW, Barker K, Crismon ML, Childs A. Effect of a clinical psychopharmacy consultation service on patient outcomes. Am J Hosp Pharm. 1994;51(6):778–81. 35. Suehs BT, Mican LM, Campbell AH. Retrospective evaluation of an inpatient psychiatric pharmacist consultation service. J Am Pharm Assoc. 2011;51(5):599–604. 36. Stoner SC, Worrel JA, Jones MT, Farrar CA, Ramlatchman LV. Pharmacist-designed and -implemented pharmaceutical care plan for antipsychotic-induced movement disorders. Pharmacotherapy. 2000;20(5):583–8. 37. Al-Saffar N, Deshmukh AA, Carter P, Adib SM. Effect of information leaflets and counselling on antidepressant adherence: open randomised controlled trial in a psychiatric hospital in Kuwait. Int J Pharm Pract. 2005;13(2):123–31. 38. Hazra M, Uchida H, Sproule B, Remington G, Suzuki T, Mamo DC. Impact of feedback from pharmacists in reducing antipsychotic polypharmacy in schizophrenia. Psychiatry Clin Neurosci. 2011;65(7):676–8. 39. Thompson A, Sullivan SA, Barley M, Strange SO, Moore L, Rogers P, et al. The DEBIT trial: an intervention to reduce
40.
41.
42.
43.
44. 45.
46.
antipsychotic polypharmacy prescribing in adult psychiatry wards—a cluster randomized controlled trial. Psychol Med. 2008;38(05):705–15. Ved P, Coupe T. Improving prescription quality in an in-patient mental health unit: three cycles of clinical audit. Psychiatr Bull. 2007;31(8):293–4. Virani A, Crown N. The impact of a clinical pharmacist on patient and economic outcomes in a child and adolescent mental health unit. Can J Hosp Pharm. 2003;56(3):158–62. Alderman CP. A prospective analysis of clinical pharmacy interventions on an acute psychiatric inpatient unit. J Clin Pharm Ther. 1997;22(1):27–31. Shaw H, Mackie CA, Sharkie I. Evaluation of effect of pharmacy discharge planning on medication problems experienced by discharged acute admission mental health patients. Int J Pharm Pract. 2000;8(2):144–53. Dorevitch A, Perl E. The impact of clinical pharmacy intervention in a psychiatric inpatient hospital. J Clin Pharm Ther. 1996;21:45–8. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342(25):1887–92. Kaboli PJ, Hoth AB, McClimon BJ, Schnipper JL. Clinical pharmacists and inpatient medical care: a systematic review. Arch Intern Med. 2006;166(9):955–64.
123
REVIEW ARTICLE
A comprehensive review of the impact of clinical pharmacy services on patient outcomes in mental health Tom E. Richardson • Claire L. O’Reilly Timothy F. Chen
•
Received: 1 September 2013 / Accepted: 25 November 2013 Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2013
Abstract Background The importance of pharmacists in mental healthcare is starting to be recognised around the world. However few studies have focused on the evidence supporting pharmacist involvement in the inpatient mental healthcare setting. Aim Evaluate types of outcomes achieved and level of evidence supporting clinical pharmacy services in inpatient mental health settings. Methods Medline, PyscINFO and International Pharmaceutical Abstracts databases were searched from January 1990 to March 31 2013. Studies were included if in an inpatient setting, published in English, and reported an intervention provided by a pharmacist or involving a pharmacist with a pivotal role in an intervention team. Data were extracted according to sample population and size, study design and outline, country, role of the pharmacist in the study, and the main results of the study. The level of evidence for each study was assessed using Australia’s National Health and Medical Research Council’s hierarchy of clinical evidence and results were categorised as having economic, clinical and/or humanistic outcomes. Results Eighteen articles met the inclusion criteria. A range of pharmaceutical services provided by pharmacists in inpatient mental healthcare were identified. These services highlight the role of pharmacists as reviewers of medication charts, laboratory results and medication prescribing and as educators of patients and other health care professionals. Six studies included a control or comparison group and had pre and post intervention measures. These comprised of three randomised control trials, one historical control study and two case series post and pre-post tests, corresponding to
evidence levels of II, III-3 and IV respectively. Seven studies reported clinical outcomes, two economical and one humanistic outcomes. One study reported both clinical and economical outcomes. Seven studies focused on impact evaluation measures. Conclusions Pharmacists provide a variety of services and play a significant role in inpatient mental healthcare. However, the level of evidence supporting these services is limited and the type of outcomes achieved is narrow. Keywords Clinical pharmacy Mental health Pharmaceutical services Pharmacists Psychiatry
Impact of findings on practice •
•
•
Pharmacists are well equipped to provide a variety of clinical pharmacy services in the inpatient mental health setting. Implementing clinical pharmacy services in inpatient mental health has significant potential for improving economic, clinical and humanistic outcomes for patients and the mental healthcare system. The direct impact of clinical pharmacy services may be established through the conduct of studies with more robust study designs such as randomised control trials or comparative effectiveness trials.
Introduction T. E. Richardson (&) C. L. O’Reilly T. F. Chen Faculty of Pharmacy, The University of Sydney, Sydney, NSW 2006, Australia e-mail: [email protected]
The global prevalence and burden of mental illness is becoming more apparent. Approximately 18.1–36.1 % of the global population suffers from lifelong mental illness
123
Int J Clin Pharm
[1], with substance abuse and mental illness accounting for 22.9 % of all years lived with disability [2]. In the United States approximately 11.1 % of the non-institutionalised population uses a psychotropic medication (e.g. antidepressants, antipsychotics, anxiolytics) and it is predicted that the total indirect and direct costs of mental illness result in an annual economic burden of $317 billion [3, 4]. Pharmacists are therefore well positioned to enhance mental health services and reduce the significant cost burden from inappropriate psychotropic drug use. The role of the pharmacist in healthcare has been evolving from primarily dispensing and stock management to clinical pharmacy services involving patient and peer education, adverse drug reaction and drug interaction monitoring, screening of major diseases and medication review [5–8]. These clinical pharmacy services have become highly specialised, encompassing a variety of areas including geriatrics [9], emergency medicine [10] and ambulatory care [11], and have been shown to improve patient quality of life [12]. With the complexity of issues surrounding mental health patients and mental healthcare, pharmacists are uniquely positioned to provide significant support and expertise to enhance the level and quality of mental healthcare in areas such as medication adherence [13]. The importance of pharmacists in mental healthcare has been recognised by the pharmacy profession around the world. Since 1996 the Board of Pharmaceutical Specialties in the United States has implemented a certification process for pharmacists who have completed a psychiatric residency or at least 4 years of practice to formally recognise their abilities in mental healthcare [14]. A similar credentialing process is conducted by the College of Mental Health Pharmacy (CMHP) in the UK [15]. In addition, the CMHP as well as the Australian Pharmacy Council, the Pharmaceutical Society of Australia, and the Society of Hospital Pharmacists Australia have each developed competency statements, frameworks or standards of practice for the expected contribution and role of pharmacists in all areas of mental healthcare [16–19]. These documents highlight key areas and activities where clinical pharmacy services can be employed in both inpatient and outpatient settings. The role of pharmacists in outpatient mental health has been demonstrated [20, 21], however few studies have focused on the role of pharmacists in inpatient mental health and the level of evidence to support their role.
Aim The aim of this review was to evaluate the level of evidence supporting the role of pharmacists in inpatient
123
mental healthcare. In order to do this, the pharmaceutical services provided by mental health pharmacists, the type of outcome achieved from these services and the level of evidence supporting these services were reviewed.
Methods Search strategy Publications from January 1 1990 through to March 30 2013 were sought from the databases Medline, PyscINFO and International Pharmaceutical Abstracts. A broad search was conducted by exploding the medical subject headings (MeSH) pharmacist, pharmaceutical services, clinical pharmacy, pharmacy services and combining them with mental health, psychiatry, mental disorders, psychotropic drugs, antipsychotic agents and antidepressants. The type of intervention was also searched, using the terms education, consultation, professional role, cooperative behavior and prescribing. In addition reference lists and citing articles of relevant articles were manually searched. Selection criteria Studies included needed to demonstrate a process or program conducted by pharmacists in a hospital setting, which directly involved mental health patients or mental healthcare providers. In studies where multidisciplinary models were used pharmacists needed to play an integral role in the intervention delivery. Only studies in English were included. Studies were excluded if they were: conducted in primary care (e.g. community pharmacy practice) or in outpatient settings; published as an abstract only; literature reviews; case reports or editorials (Fig. 1). Data analysis Studies were assigned a level of evidence according to Australia’s National Health and Medical Research Council’s hierarchy of clinical evidence (Table 1) [22]. This hierarchy was modeled on evidence evaluation frameworks from the National Institute for Health and Clinical Excellence (NICE) [23], the National Health Service Centre for Reviews and Dissemination [24] and the Centre for Evidence Based Medicine [25]. The NHMRC hierarchy assigns a level of evidence to the outcome of a study based on the study’s design and its appropriateness to assess the effect of an intervention with minimal possibility for bias. Assigning a level of evidence moves to verify the results of an intervention, and therefore studies receiving a level of evidence of I represent the
Int J Clin Pharm Fig. 1 Search taxonomy, inclusion criteria and results
Table 1 National Health and Medical Research Council’s hierarchy of clinical evidence [22] Level of evidence
Study design
I
A systematic review of randomized controlled trials
II
A randomized controlled trial
III-1
A pseudorandomized controlled trial
III-2
A comparative study with concurrent controls Non-randomized experimental trial Cohort study Case–control study Interrupted time series with a control group
III-3
A comparative study without concurrent controls
outcome evaluation focuses on the longer term effects of the study. Outcomes were further categorised according to the ECHO model of outcome assessment [26]. Depending on the achieved outcome from the pharmacist intervention, studies were categorised as clinical, humanistic or economic. Studies where changes or improvements to the patient’s care were seen were classified as having a clinical outcome. Studies which resulted in changes in quality of life or functional status of the patient were classified as having humanistic outcomes. Studies where the pharmacist interventions resulted in economic changes to the patient directly or the healthcare system, were classified as having an economic outcome.
Historical control study Two or more single arm study Interrupted time series without a parallel control group IV
Case series with either post-test or pre-test/post-test outcomes
highest quality of evidence to support the intervention. In order to receive a classification of a certain level of evidence according to the NHMRC hierarchy, the intervention studies must compare the intervention to a control. Study findings were categorised as either impact or outcome evaluation measures. Impact evaluation is concerned with the immediate effects of the study, whilst
Results Eighteen articles satisfied the search criteria and were included in the review (Table 2). Ten of these studies were conducted in the US [27–36] and ten published in the last decade [27, 29, 31, 32, 35, 37–41]. Eleven of these studies involved a sample consisting of patients with a variety of psychiatric conditions present on the ward [27–29, 31, 33– 35, 40, 42–44]. Studies also specifically utilised paediatric and adolescent psychiatric patients [41], patients with depressive or persistent mood affective disorder [37] or schizophrenia [38]. Patients currently taking narrow therapeutic agents (e.g. clozapine, warfarin or lithium) [32], on
123
Sample size (n)
278 (control = 87, intervention 1 = 93, Intervention 2 = 98)
962 patients, 386 nurses, 169 doctors
97 (control = 46, Intervention = 51)
551
105
References
Al-Saffar et al. [37]
123
Thompson et al. [39]
Shaw et al. [43]
McKee and Cleary [32]
Suehs et al. [35]
Case series post test
Historical control study
Randomised control trial
Randomised control trial
Randomised control trial
Study design
Table 2 Summary of studies included in review
IV
III-3
II
II
II
Level of evidence
US
US
Scotland
England
Kuwait
Country
Psychiatric patients
Lithium, clozapine or warfarin patients
Psychiatric patients
Patients on antipsychotic medication
Depressive or persistent mood affective disorder
Study population
Pharmaceutical consultation service after referral from physician
Reduce adverse drug reactions through intensive pathological monitoring
Patient education and development of discharge summaries for use by community pharmacist
Multifaceted intervention for doctors and nurses to reduce antipsychotic polypharmacy
Comparison between control, educational leaflets (I1), and educational leaflets plus counselling sessions (12) on adherence to antidepressants
Study outline
Pharmacist conducted reviews and provided recommendations
Pharmacist evaluated laboratory results
Pharmacist developed discharge summary and conducted follow up visits
Impact; outcomeclinical
Impact; outcomeclinical
66.9 % of recommendations implemented. In patients where [%80 of recommendations were implemented a reduction in CGI-S of 0.44 points was seen (p = 0.036)
Impact; outcomehumanistic
Impact
Impact; outcomeclinical
Evaluation measure
ADRs: decreased from 6 % to 3 % for lithium, 2–1 % for clozapine and increased from 0 to 0.5 % for warfarin
Drug knowledge improved and maintained at 12 weeks post discharge for both groups (p = 0.05). Fewer medication problems and increased compliance at 12 weeks for intervention group (but no statistical support). No significant difference in readmissions
Reduction in antipsychotic polypharmacy: OR 0.43 (0.21–0.90)
Improved adherence at 5 months as measured by pill counting and self reporting: I1: OR 3.0 (1.7–5.3), I2: OR 5.5 (3.2–9.6)
Pharmacist run counselling sessions
Pharmacist conduction academic detailing and facilitated a chart reminder system
Results
Role of pharmacist in study
Int J Clin Pharm
Prospective evaluation
Prospective evaluation
69 (204 interventions)
320 interventionsa
153 (282 interventions)
109 (229 interventions)
3,204 drug use evaluationsa
1,426
Alderman [42]
Campbell et al. [27]
Dolder et al. [29]
Dorevitch and Perl [44]
Goad and Ezell [30]
Hazra et al. [38]
–
–
Retrospective evaluation
Retrospective evaluation
–
–
–
–
IV
Level of evidence
Prospective evaluation
Prospective evaluation
Case series pre-post test
93 (historical control = 48, intervention = 45)
Canales et al. [28]
Study design
Sample size (n)
References
Table 2 continued
Canada
US
Israel
US
US
Australia
US
Country
Schizophrenia
Patients taking antipsychotics or antiparkinonian agents
Psychiatric patients
Psychiatric patients
Psychiatric patients
Psychiatric patients
Psychiatric patients
Study population
Prescriber prompting and education about the use of antipsychotic polypharmacy
Drug use evaluations were conducted to monitor prescribing of antipsychotics and antiparkinsonian drugs
Pharmaceutical consultation service after referral from physician
Audit of pharmaceutical services
Cost avoidance as a result of pharmacy student clinical interventions
Audit of pharmaceutical services
Intensive pharmaceutical services (obtaining drug histories, baseline assessments, drug monitoring, drug education)
Study outline
Pharmacist prompted prescribers and provided education
Pharmacist conducted the drug use evaluation
Pharmacist conducted reviews and provided recommendations
Pharmacist conducted clinical interventions
Pharmacy student run interventions
Pharmacist conducted clinical interventions
Pharmacist conducted intensive pharmaceutical services
Role of pharmacist in study
Decrease in polypharmacy from 18.3 to 6.6 % (p \ .001)
84 % of inpatient prescribing adhered to the drug use conditions evaluated, compared to 64 % for the ambulatory care clinic
88.2 % of recommendations implemented, with 67.9 % patients experienced a satisfactory response (patient improvement) as determined by the research team
67.0 % of pharmacist interventions accepted
97.0 % of proposed interventions accepted. $6,000–$24,000 cost avoided
91.7 % of proposed interventions accepted
Significant overall outcome improvement as measured by BPRS (93 % had 20 % decrease: p = 0.024, 62 % had 30 % decrease: p = 0.002, 22 % had 40 % decrease: p \ 0.001). 65 % had 50 % symptom improvement for depression: p = 0.003. Reduction in ADRs: p = 0.002–0.042
Results
Impact
Impact
Impact; outcomeclinical
Impact
Impact; outcomeeconomic
Impact
Impact; outcomeclinical
Evaluation measure
Int J Clin Pharm
123
123 Retrospective evaluation
2,200 interventionsa
29 (135 interventions)
30 (125 recommendations)
83
242 (1,466 prescriptions)
Marino et al. [31]
Morton et al. [33]
Stanislav et al. [34]
Stoner et al. [36]
Ved and Coupe [40]
–
–
Prospective clinical audit
–
–
–
Level of evidence
Prospective evaluation
Retrospective evaluation
Retrospective evaluation
Study design
Sample size (n)
References
Table 2 continued
England
US
US
US
US
Country
Psychiatric patients
Schizophrenia or Bipolar disorder patients
Psychiatric patients
Psychiatric patients
Psychiatric patients
Study population
Three cycles of audit to improve prescription quality
Evaluations of antipsychotic or antidyskinetic induced movement disorders were conducted and recommendations formulated
Pharmacokinetic or pharmacotherapeutic consultation service after referral from physician
Pharmaceutical consultation service after referral from physician
Compare interventions conducted by hospital pharmacists, pharmacy faculty staff and pharmacy students
Study outline
Pharmacist conducted ward reviews in between audits
Pharmacist conducted movement disorder evaluations and gave recommendations
Pharmacist conducted reviews and provided recommendations
Pharmacist conducted clinical interventions
Pharmacist and pharmacy students conducted clinical interventions
Role of pharmacist in study
After third cycle 99.5 % of all prescriptions considered legible
130 recommendations were proposed, of which 82.0 % were implemented by the physician. 93 % of patients experienced complete or partial resolution of extrapyramidal symptoms after recommendations were implemented.
60.0 % of interventions implemented. In patients where [50 % of recommendations were implemented positive outcomes occurred in 76 % of patients compared to 14 % where \50 % recommendations implemented
79.0 % of proposed interventions implemented
98.8 % of proposed interventions accepted. $125,500 cost avoided over the 1.5 year period
Results
Impact
Impact; outcomeclinical
Impact; outcomeClinical
Impact
Impact; outcomeeconomic
Evaluation measure
Int J Clin Pharm
Impact; outcomeeconomic and clinical 98.0 % of interventions implemented, with 86 % of interventions viewed as having a positive effect on patient care by an independent panel. Implementation of this pharmacy service resulted in 14 % decrease in drug cost per patient day
an antipsychotic medication [39] or antidyskinetic agent [36] also formed the sample in some studies. Services provided The majority of studies (13 of 18) [27, 29–36, 40–42, 44] focused on the clinical role of pharmacists in ensuring the quality use of medicines, including the review of medication charts, laboratory monitoring and the prescribing of medications. Five of these studies reported on pharmacist (or pharmacy student) initiated medication management review services [27, 29, 31, 41, 42] such as the identification of drug related problems, whilst four studies reported on referrals from physicians to pharmacists to address specific clinical issues such as non-response to therapy and polypharmacy [33–35, 44]. Three studies focused on prescription quality. One of these involved an audit of prescription quality [40] and two studies used drug use evaluation methods to assess the concordance of prescribing of antipsychotic and antiparkinsonian medications to current guidelines [30] and the prevalence of extrapyramidal adverse effects [36]. One study evaluated the pharmacist’s role in reviewing specific laboratory results to minimise the likelihood of adverse effects and toxicity [32]. Four of the 18 studies evaluated the contributions made by clinical pharmacists in providing educational services. Two of these involved direct patient counselling and the provision of information resources [37] or discharge summaries [43]. The other two studies used academic detailing methods to reduce the prevalence of antipsychotic polypharmacy [38, 39]. Only one of the 18 studies reported on the clinical role of pharmacists as experts in medication management in conjunction with the provision of educational services [28]. In this study pharmacists conducted medication histories, performed baseline and weekly assessments, monitored for adverse drug reactions, provided recommendations, participated in multidisciplinary team meetings, ran education classes for other healthcare professionals and counselled patients about their medication before discharge.
Patient number unknown
Level of evidence
a
ADRs adverse drug reactions, CGI-S Clinical Global Impression-Severity score, BPRS Brief Psychiatric Rating Scale
– Prospective evaluation and retrospective cost analysis 6 (48 interventions) Virani and Crown [41]
Canada
Child and adolescent psychiatric patients
Pharmaceutical clinical interventions, their impact on patient care and the cost savings generated
Pharmacist conducted clinical interventions
Evaluation measure Level of evidence Study design Sample size (n) References
Table 2 continued
Country
Study population
Study outline
Role of pharmacist in study
Results
Int J Clin Pharm
Of the 18 studies reviewed, one-third employed a study design which compared patients receiving the intervention to a control group of patients who did not receive the intervention. Half of these studies used a randomised control trial study design, signifying a level of evidence of II [37, 39, 43]. The other three studies included the use of a historical control study [32], a case series post test [35], and a case series pre-post test [28], which signify a level of evidence for these studies to be III-3 and IV respectively.
123
Int J Clin Pharm
The remaining 12 studies reviewed did not compare the intervention of interest to a control group. Instead five studies employed a prospective evaluation study design, where clinical pharmacist interventions were undertaken and documented over a varied period of 1–12 months and their acceptance rate was reported [27, 29, 40, 42, 44]. The acceptance rate of clinical pharmacist interventions was also retrospectively evaluated in three studies [31, 33, 34]. One study prospectively evaluated the effect of pharmacists in reducing extrapyramidal symptoms resulting from antipsychotic or antidyskinetic drug use [36]. Two studies utilised retrospective study designs to examine drug use evaluations conducted by clinical pharmacists [30], and clinical pharmacist education and prompting of prescribers about antipsychotic polypharmacy use [38]. Virani and Crown [41] were the only group to employ a study design incorporating a prospective analysis to document clinical pharmacist interventions and a retrospective cost analysis to determine the financial benefit of these interventions. These 12 studies therefore present clinical pharmacist activities in an exploratory format and cannot be assigned a level of evidence. Types of outcomes achieved Outcomes as a result of clinical pharmacists were measured in eleven of the 18 studies reviewed, with clinical outcomes being reported in 7 studies [28, 32, 34–37, 44], economic outcomes in 2 studies [27, 31] and one study reporting humanistic outcomes [43]. Furthermore, one study reported both clinical and economical outcomes being achieved as a result of a clinical pharmacist service [41]. The remaining 7 studies [29, 30, 33, 38–40, 42] focused on the direct impact of the clinical pharmacist service, such as the implementation rate of recommendations, rather than measuring economic, clinical or humanistic outcomes. Therefore these studies are interesting to note, but cannot be evaluated according to type of outcome.
Discussion This review suggests that clinical pharmacists play a wide role in the provision of inpatient mental healthcare. The fundamental role of clinical pharmacists as reviewers of medication charts, laboratory results and medication prescribing is well supported, with 13 out of the 18 articles reviewed focusing on pharmacists reviewing medication charts [27, 29, 31, 33–35, 41, 42, 44], laboratory results [32], past and present medications [30, 36] and the quality of prescriptions [40]. The role of clinical pharmacists as drug experts was explored through the implementation of
123
clinical pharmacist lead educational sessions for doctors and nurses, as well as medication counselling sessions for patients [37–39, 43]. This role as drug experts was further acknowledged by physicians in several studies where the clinical pharmacist services were initiated by referral and therefore actively sought after [33–35, 44]. A study in the United States by Canales et al. [28]. demonstrated the direct clinical benefit of clinical pharmacists acting as reviewers and educators on patient outcomes. In this study the clinical pharmacist undertook intensive clinical pharmacy services, which involved attending staff briefings, performing baseline assessments and weekly reviews, providing pharmacotherapy recommendations, obtaining medication histories, reviewing drug administration records daily, monitoring for adverse drug reactions, conducting weekly education classes and counselling patients before discharge. This intensive clinical pharmacy service resulted in overall clinical outcome improvement with significant improvement in Brief Psychiatric Rating Scale and Clinical Global Improvement scores. This intensive service was also shown to reduce depressive symptoms, as measured by the Hamilton depression scale, by 50 % in 65 % of the intervention group (p = 0.003), and significantly reduce the occurrence of adverse drug reactions as measured by the Barnes (p = 0.042), Simpson (p = 0.002) and the Abnormal Involuntary Movement (p = 0.024) scales. In Australia pharmacists in a hospital setting are expected to perform similar tasks in mental healthcare [17–19], however only one study reviewed demonstrated their occurrence in an Australian hospital [42]. Yet this study did not look at educational activities or patient counselling and it did not aim to measure the benefit of pharmacy services on clinical outcomes. In order to assess pharmacy services in inpatient mental health, a variety of study designs were employed each providing varying levels of clinical evidence according to the NHMRC hierarchy of clinical evidence. Only six reviewed studies were designed to portray the benefits of clinical pharmacy services compared to no clinical pharmacy services and were assigned levels of evidence. Three of these studies were randomised control trials and therefore represent a high level of evidence of II to support the role of pharmacists in mental health. However it is important to recognise that often studies with lower levels of evidence can provide support for an intervention as effectively as randomised control trials [45]. Thompson et al. [39] employed a randomised control trial to demonstrate the effect of pharmacists in reducing antipsychotic polypharmacy through prescriber education and prompting, yet Canales et al. [28] utilised a pre-post test study design to demonstrate the correlation between implementing intensive pharmaceutical services and improved patient
Int J Clin Pharm
outcomes. Canales et al. [28] therefore represents a moderate level of evidence of IV. However it is difficult to conclude that Thompson et al. [39] supports the role of pharmacists in mental health to a greater extent than Canales et al. [28] simply because they employed a randomised control trial, which has a higher level of evidence. The remaining 12 studies reviewed depict the role of clinical pharmacists in inpatient mental health in an exploratory and descriptive nature. The goal of the NHMRC hierarchy of clinical evidence is to highlight and emphasise studies designed to minimise bias when proving a correlation between an intervention and an outcome [22]. These 12 studies did not implement a control or comparison group for the intervention, demonstrating that the majority of literature pertaining to the role of clinical pharmacists in inpatient mental health, does not aim to portray a correlation between clinical pharmacy services and outcomes. Bias in these studies is relatively unregulated and therefore they cannot be assigned a level of evidence. However they still provide insight into the role of pharmacists in inpatient mental health. In comparison to other broader reviews, the levels of evidence to support the role of pharmacists in other areas has been more substantial. Kaboli et al. [46] demonstrated a relatively high level of evidence supporting the role of clinical pharmacists in any inpatient setting with 36 studies comparing clinical pharmacy services to a control, 21 of these being randomised controlled trials. Finley et al. [21] also demonstrated high levels of evidence for pharmacists in all settings of mental health with 16 studies comparing pharmacy services to a control. With only 6 studies comparing clinical pharmacy services to a control in our review, it is evident that better designed studies are necessary to provide a solid evidence base for the role of clinical pharmacists in inpatient mental health. Outcome evaluation identified 11 studies that measured both the impact and outcomes resulting from clinical pharmacy services in inpatient mental health. Of these 7 focused on clinical outcomes where clinical changes and patient improvements were reported. These studies largely focused on improved symptom severity and reduced adverse drug reactions as a result of clinical pharmacy services. Two studies highlighted the economic benefit of clinical pharmacy services, with significant cost avoidance from $6000 up to $125,500 after the implementation of clinical pharmacist medication chart reviews and interventions. Virani and Crown [41] measured both economic and clinical outcomes, with clinical pharmacist interventions having a positive effect on patient outcomes and significantly reducing drug cost per patient day by 14 %. However, this study has significant limitations, with patient outcomes not being assessed using validated scales of symptom severity, rather independent assessors’ opinions.
In comparison, Shaw et al. [43] was the only study which measured a humanistic outcome as a result of clinical pharmacist services in inpatient mental health. In this study they demonstrated improved patient drug knowledge, increased compliance and fewer medication problems as the result of clinical pharmacists providing patient discharge summaries to community pharmacists. Many clinical pharmacy services are discussed in the reviewed studies; however more studies are required to determine the effect of these services on clinical, economic and humanistic outcomes. In comparison seven studies focused only on the immediate impact of the clinical pharmacy service of interest and did not measure outcomes. In three of these studies clinical pharmacist interventions were undertaken where patient chart reviews were conducted and recommendations formulated to address pharmaceutical or medical issues uncovered [29, 33, 42]. The main findings of these studies were the rate at which clinical pharmacist recommendations were adopted and implemented by treating physicians. The aim of these seven studies was service implementation and therefore the authors did not ascertain whether these recommendations resulted in clinically significant improvements in economic, clinical or humanistic outcomes. Utilising the NHMRC evidence hierarchy inherently has limitations in itself as it solely allocates a level of evidence according to study design, not the quality of the study, in which subject selection, group allocation and follow up is monitored for bias. With only one study being conducted in a multi-centre setting [39], the generalisability of results and outcomes from reviewed studies is limited. This review was also limited to the inpatient setting, therefore narrowing its scope. The broad definitions of each type of outcome in the ECHO model of outcome assessment allows for categorisation of outcomes achieved by clinical pharmacist services in inpatient mental health. From this review it is apparent that current evidence supports the clinical benefit of pharmaceutical services in inpatient mental health and future research into economic and humanistic benefits may be beneficial. However due to the broad definitions of each type of outcome, categorising studies as economic, clinical or humanistic is subject to author opinion. Furthermore, this review highlights the difficulty in performing high level analysis and comparison on different pharmaceutical services implemented in mental health, as the data available in studies is limited by inherent heterogeneity. As no standardised parameters are used to measure the impact or outcome resulting from pharmaceutical service implementation in mental healthcare it is difficult to compare which pharmaceutical service has greatest effect on outcomes.
123
Int J Clin Pharm
Conclusion Pharmacists can play a significant role in mental healthcare through the provision of a variety of pharmaceutical services. The majority of studies in the literature focus on the role of pharmacists as reviewers of medication charts, laboratory results and medication prescribing, as well as providers of pharmacotherapeutic education to patients and other healthcare professionals. However, the level of evidence supporting these roles is limited and the type of outcomes achieved is narrow. Funding
None.
Conflicts of interest
None.
References 1. Kessler RC, Aguilar-Gaxiola S, Alonso J, Chatterji S, Lee S, Ormel J, et al. The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psychiatr Soc. 2009;18(1):23–33. 2. Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, et al. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 [cited 29 Oct 2013]. http://www. sciencedirect.com/science/article/pii/S0140673613616116. 3. Paulose-Ram R, Safran MA, Jonas BS, Gu Q, Orwig D. Trends in psychotropic medication use among U.S. adults. Pharmacoepidemiol Drug Saf. 2007;16(5):560–70. 4. Insel TR. Assessing the economic costs of serious mental illness. Am J Psychiatry. 2008;165(6):663–5. 5. Pande S, Hiller JE, Nkansah N, Bero L. The effect of pharmacistprovided non-dispensing services on patient outcomes, health service utilisation and costs in low- and middle-income countries. Cochrane Database Syst Rev. 2013;(2). 6. Tan EC, Stewart K, Elliott RA, George J. Pharmacist consultations in general practice clinics: the pharmacists in practice study (PIPS). Res Soc Adm Pharm. 2013 [cited 29 Oct 2013]. http:// www.sciencedirect.com/science/article/pii/s1551741113001551. Accessed on Oct 29 2013. 7. Castelino RL, Bajorek BV, Chen TF. Retrospective evaluation of home medicines review by pharmacists in older Australian patients using the medication appropriateness index. Ann Pharmacother. 2010;44(12):1922–9. 8. Ayorinde AA, Porteous T, Sharma P. Screening for major diseases in community pharmacies: a systematic review. Int J Pharm Pract. Epub 20 May 2013. 9. Tett S, Higgins G, Armour C. Impact of pharmacist interventions on medication management by the elderly: a review of the literature. Ann Pharmacother. 1993;27(1):80–6. 10. Kane S, Weber R, Dasta J. The impact of critical care pharmacists on enhancing patient outcomes. Intensive Care Med. 2003;29(5):691–8. 11. Singhal P, Raisch D, Gupchup G. The impact of pharmaceutical services in community and ambulatory care settings: evidence and recommendations for future research. Ann Pharmacother. 1999;33(12):1336–55. 12. Pickard AS, Hung S-Y. An update on evidence of clinical pharmacy services’ impact on health-related quality of life. Ann Pharmacother. 2006;40(9):1623–34.
123
13. Rubio-Valera M, Serrano-Blanco A, Magdalena-Belio J, Fernandez A, Garcia-Campayo J, Pujol MM, et al. Effectiveness of pharmacist care in the improvement of adherence to antidepressants: a systematic review and meta-analysis. Ann Pharmacother. 2011;45(1):39–48. 14. Stoner SC, Ott CA, Dipaula BA. Psychiatric pharmacy residency training. Am J Pharm Educ. 2010;74(9):163. 15. College of Mental Health Pharmacy. Credentialing—full CMHP membership (MCMHP). 2013; http://www.cmhp.org.uk/ credentialing. Accessed on Nov 1 2013. 16. College of Mental Health Pharmacy. Membership portfolio—competencies. 2013; http://www.cmhp.org.uk/membership/membershipportfolio-competencies. Accessed 6 Aug 2013. 17. Australian Pharmacy Council. Statement of mental health care capabilities for pharmacists 2009. Canberra; 2010. http://pharmacy council.org.au/PDF/Pharmacists%20Capability%20Statement%20% 20June%20%2709%20%28v5%29.pdf. Accessed on 6 Aug 2013. 18. Pharmaceutical Society of Australia. Mental health care project: a framework for pharmacists. Canberra; 2013. http://www.psa.org. au/download/policies/mental-health-framework.pdf. Accessed on 6 Aug 2013. 19. SHPA Committee of Specialty Practice in Mental Health Pharmacy. Standards of practice for mental health pharmacy. J Pharm Pract Res. 2012;42(2):142–5. 20. Jenkins MH, Bond CA. The impact of clinical pharmacists on psychiatric patients. Pharmacotherapy. 1996;16(4):708–14. 21. Finley PR, Crismon ML, Rush AJ. Evaluating the impact of pharmacists in mental health: a systematic review. Pharmacotherapy. 2003;23(12):1634–44. 22. NHMRC. NHMRC additional levels of evidence and grades for recommendations for developers of guidelines. Stage 2 consultation. Early 2008–end June 2009. Canberra: National Health and Medical Research Council; 2009; http://www.nhmrc.gov.au/_files_nhmrc/ file/guidelines/stage_2_consultation_levels_and_grades.pdf. Accessed 20 May 2013. 23. National Institute for Health and Clinical Excellence. The guidelines manual. London: National Institute for Health and Clinical Excellence; 2007. 24. Khan K, Ter Riet G, Glanville J, Sowden A, Kleijnen J. Undertaking systematic reviews of research on effectiveness. CRD’s guidance for those carrying out or commissioning reviews. York: University of York; 2001. 25. Phillips B, Ball C, Sackett D, Badenoch D, Straus S, Haynes B, et al. Oxford centre for evidence-based medicine levels of evidence. Oxford: Centre for Evidence-Based Medicine; 2001. 26. Gunter MJ. The role of the ECHO model in outcomes research and clinical practice improvement. Am J Manag Care. 1999; 5(4 Suppl):S217–24. 27. Campbell AR, Nelson LA, Elliott E, Hieber R, Sommi RW. Analysis of cost avoidance from pharmacy students’ clinical interventions at a psychiatric hospital. Am J Pharm Educ. 2011;75(1). Article 8. 28. Canales PL, Dorson PG, Crismon ML. Outcomes assessment of clinical pharmacy services in a psychiatric inpatient setting. Am J Health Syst Pharm. 2001;58(14):1309–16. 29. Dolder C, Szymanski B, Wooton T, McKinsey J. Pharmacist interventions in an inpatient geriatric psychiatry unit. Am J Health Syst Pharm. 2008;65(19):1795–6. 30. Goad JD, Ezell JR. Drug-use evaluation programs for psychotropic medications. Am J Hosp Pharm. 1990;47(1):132–6. 31. Marino J, Caballero J, Llosent M, Hinkes R. Differences in pharmacy interventions at a psychiatric hospital: comparison of staff pharmacists, pharmacy faculty, and student pharmacists. Hosp Pharm. 2010;45(4):314–9. 32. McKee J, Cleary S. High-risk, high-alert medication management practices in a regional state psychiatric facility. Hosp Pharm. 2007;42(4):323–30.
Int J Clin Pharm 33. Morton WA, Mendenhall AR, Windsor PG, Lydiard B. Clinical psychopharmacy consultations: acceptance of recommendations on an adult inpatient psychiatric unit. Hosp Pharm. 1995;30(9): 786–90. 34. Stanislav SW, Barker K, Crismon ML, Childs A. Effect of a clinical psychopharmacy consultation service on patient outcomes. Am J Hosp Pharm. 1994;51(6):778–81. 35. Suehs BT, Mican LM, Campbell AH. Retrospective evaluation of an inpatient psychiatric pharmacist consultation service. J Am Pharm Assoc. 2011;51(5):599–604. 36. Stoner SC, Worrel JA, Jones MT, Farrar CA, Ramlatchman LV. Pharmacist-designed and -implemented pharmaceutical care plan for antipsychotic-induced movement disorders. Pharmacotherapy. 2000;20(5):583–8. 37. Al-Saffar N, Deshmukh AA, Carter P, Adib SM. Effect of information leaflets and counselling on antidepressant adherence: open randomised controlled trial in a psychiatric hospital in Kuwait. Int J Pharm Pract. 2005;13(2):123–31. 38. Hazra M, Uchida H, Sproule B, Remington G, Suzuki T, Mamo DC. Impact of feedback from pharmacists in reducing antipsychotic polypharmacy in schizophrenia. Psychiatry Clin Neurosci. 2011;65(7):676–8. 39. Thompson A, Sullivan SA, Barley M, Strange SO, Moore L, Rogers P, et al. The DEBIT trial: an intervention to reduce
40.
41.
42.
43.
44. 45.
46.
antipsychotic polypharmacy prescribing in adult psychiatry wards—a cluster randomized controlled trial. Psychol Med. 2008;38(05):705–15. Ved P, Coupe T. Improving prescription quality in an in-patient mental health unit: three cycles of clinical audit. Psychiatr Bull. 2007;31(8):293–4. Virani A, Crown N. The impact of a clinical pharmacist on patient and economic outcomes in a child and adolescent mental health unit. Can J Hosp Pharm. 2003;56(3):158–62. Alderman CP. A prospective analysis of clinical pharmacy interventions on an acute psychiatric inpatient unit. J Clin Pharm Ther. 1997;22(1):27–31. Shaw H, Mackie CA, Sharkie I. Evaluation of effect of pharmacy discharge planning on medication problems experienced by discharged acute admission mental health patients. Int J Pharm Pract. 2000;8(2):144–53. Dorevitch A, Perl E. The impact of clinical pharmacy intervention in a psychiatric inpatient hospital. J Clin Pharm Ther. 1996;21:45–8. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342(25):1887–92. Kaboli PJ, Hoth AB, McClimon BJ, Schnipper JL. Clinical pharmacists and inpatient medical care: a systematic review. Arch Intern Med. 2006;166(9):955–64.
123
