Development of prescribing safety indicators related to mental health disorders and medications: Modified e-Delphi study.

AIM: To develop a set of prescribing safety indicators related to mental health disorders and medications, and to estimate the risk of harm associated with each indicator. METHOD: A modified two-stage electronic Delphi. The first stage consisted of two rounds in which 31 experts rated their agreement with a set of 101 potential mental health related prescribing safety indicators using a five-point scale and given the opportunity to suggest other indicators. Indicators that achieved 80% agreement were accepted. The second stage comprised a single round in which 29 members estimated the risk of harm for each accepted indicator by assessing the occurrence likelihood and outcome severity using two five-point scales. Indicators were considered high or extreme risk when at least 80% of participants rated each indicator as high or extreme. RESULTS: Seventy-five indicators were accepted in the first stage. Following the second stage, 42 (56%) were considered to be high or extreme risk for patient care. The 42 indicators comprised different types of hazardous prescribing, including drug-disease interactions (n = 12), drug-drug interactions (n = 9), inadequate monitoring (n = 5), inappropriate duration (n = 4), inappropriate dose (n = 4), omissions (n = 4), potentially inappropriate medications (n = 3) and polypharmacy (n = 1). These indicators also covered different mental health related medication classes, including antipsychotics (n = 14), mood stabilisers (n = 8), antidepressants (n = 6), sedative, hypnotics and anxiolytics (n = 6), anticholinergic (n = 6) and nonspecific psychotropics (n = 2). CONCLUSION: This study has developed the first suite of prescribing safety indicators related to mental health disorders and medications, which could inform the development of future safety improvement initiatives and interventional studies.

A qualitative exploration of pharmacovigilance policy implementation in Jordan, Oman, and Kuwait using Matland's ambiguity-conflict model.

BACKGROUND: As Arab countries seek to implement the 'Guideline on Good Pharmacovigilance Practice (GVP) for Arab countries', understanding policy implementation mechanisms and the factors impacting it can inform best implementation practice. This study aimed to explore the mechanisms of and factors influencing pharmacovigilance policy implementation in Arab countries with more established pharmacovigilance systems (Jordan, Oman), to inform policy implementation in a country with a nascent pharmacovigilance system (Kuwait). RESULTS: Matland's ambiguity-conflict model served to frame data analysis from 56 face-to-face interviews, which showed that policy ambiguity and conflict were low in Jordan and Oman, suggesting an "administrative implementation" pathway. In Kuwait, policy ambiguity was high while sentiments about policy conflict were varied, suggesting a mixture between "experimental implementation" and "symbolic implementation". Factors reducing policy ambiguity in Jordan and Oman included: decision-makers' guidance to implementors, stakeholder involvement in the policy's development and implementation, training of policy implementors throughout the implementation process, clearly outlined policy goals and means, and presence of a strategic implementation plan with appropriate timelines as well as a monitoring mechanism. In contrast, policy ambiguity in Kuwait stemmed from the absence or lack of attention to these factors. Factors reducing policy conflict included: the policy's compliance with internationally recognised standards and the policy's fit with local capabilities (all three countries), decision-makers' cooperation with and support of the national centre as well as stakeholders' agreement on policy goals and means (Jordan and Oman) and adopting a stepwise approach to implementation (Jordan). CONCLUSIONS: Using Matland's model, both the mechanism of and factors impacting successful pharmacovigilance policy implementation were identified. This informed recommendations for best implementation practice in Arab as well as other countries with nascent pharmacovigilance systems, including increased managerial engagement and support, greater stakeholder involvement in policy development and implementation, and undertaking more detailed implementation planning.

Examining trends in type 2 diabetes incidence, prevalence and mortality in the UK between 2004 and 2014.

AIMS: Contemporary data describing type 2 diabetes prevalence, incidence and mortality are limited. We aimed to (1) estimate annual incidence and prevalence rates of type 2 diabetes in the UK between 2004 and 2014, (2) examine relationships between observed rates with age, gender, socio-economic status and geographic region, and (3) assess how temporal changes in incidence and all-cause mortality rates influence changes in prevalence. METHODS: Type 2 diabetes patients aged ≥16 years between January 2004 and December 2014 were identified using the Clinical Practice Research Datalink (CPRD). Up to 5 individuals without diabetes were matched to diabetes patients based on age, gender and the general practice. Annual incidence, prevalence and mortality rates were calculated per 10 000 person-years at risk (95% CI). Survival models compared mortality rates in patients with and without type 2 diabetes. RESULTS: Prevalence rates of type 2 diabetes increased from 3.21% (3.19; 3.22) in 2004 to 5.26% (5.24; 5.29) in 2014. Incidence rates remained stable, overall, throughout the study period. Higher incidence and prevalence rates were related to male gender and deprivation. Individuals with type 2 diabetes were associated with higher risk of mortality (Hazard ratio 1.26 [1.20; 1.32]). Mortality rates declined in patients with and without diabetes throughout the study period. The incidence and prevalence of type 2 diabetes in patients aged 16 to 34 years increased over time. CONCLUSIONS: The rising prevalence of type 2 diabetes in the UK over the last decade is probably explained by patients living longer rather than by increasing incidence of type 2 diabetes.

Longitudinal analyses of gut mucosal microbiotas in ulcerative colitis in relation to patient age and disease severity and duration.

Bacteria belonging to the normal colonic microbiota are associated with the etiology of ulcerative colitis (UC). Although several mucosal species have been implicated in the disease process, the organisms and mechanisms involved are unknown. The aim of this investigation was to characterize mucosal biofilm communities over time and to determine the relationship of these bacteria to patient age and disease severity and duration. Multiple rectal biopsy specimens were taken from 33 patients with active UC over a period of 1 year. Real-time PCR was used to quantify mucosal bacteria in UC patients compared to 18 noninflammatory bowel disease controls, and the relationship between indicators of disease severity and bacterial colonization was evaluated by linear regression analysis. Significant differences were detected in bacterial populations on the UC mucosa and in the control group, which varied over the study period. High clinical activity indices (CAI) and sigmoidoscopy scores (SS) were associated with enterobacteria, desulfovibrios, type E Clostridium perfringens, and Enterococcus faecalis, whereas the reverse was true for Clostridium butyricum, Ruminococcus albus, and Eubacterium rectale. Lactobacillus and bifidobacterium numbers were linked with low CAI. Only E. rectale and Clostridium clostridioforme had a high age dependence. These findings demonstrated that longitudinal variations in mucosal bacterial populations occur in UC and that bacterial community structure is related to disease severity.

Comorbidity clusters and in-hospital outcomes in patients admitted with acute myocardial infarction in the USA: A national population-based study.

BACKGROUND: The prevalence of multimorbidity in patients with acute myocardial infarction (AMI) is increasing. It is unclear whether comorbidities cluster into distinct phenogroups and whether are associated with clinical trajectories. METHODS: Survey-weighted analysis of the United States Nationwide Inpatient Sample (NIS) for patients admitted with a primary diagnosis of AMI in 2018. In-hospital outcomes included mortality, stroke, bleeding, and coronary revascularisation. Latent class analysis of 21 chronic conditions was used to identify comorbidity classes. Multivariable logistic and linear regressions were fitted for associations between comorbidity classes and outcomes. RESULTS: Among 416,655 AMI admissions included in the analysis, mean (±SD) age was 67 (±13) years, 38% were females, and 76% White ethnicity. Overall, hypertension, coronary heart disease (CHD), dyslipidaemia, and diabetes were common comorbidities, but each of the identified five classes (C) included ≥1 predominant comorbidities defining distinct phenogroups: cancer/coagulopathy/liver disease class (C1); least burdened (C2); CHD/dyslipidaemia (largest/referent group, (C3)); pulmonary/valvular/peripheral vascular disease (C4); diabetes/kidney disease/heart failure class (C5). Odds ratio (95% confidence interval [CI]) for mortality ranged between 2.11 (1.89-2.37) in C2 to 5.57 (4.99-6.21) in C1. For major bleeding, OR for C1 was 4.48 (3.78; 5.31); for acute stroke, ORs ranged between 0.75 (0.60; 0.94) in C2 to 2.76 (2.27; 3.35) in C1; for coronary revascularization, ORs ranged between 0.34 (0.32; 0.36) in C1 to 1.41 (1.30; 1.53) in C4. CONCLUSIONS: We identified distinct comorbidity phenogroups that predicted in-hospital outcomes in patients admitted with AMI. Some conditions overlapped across classes, driven by the high comorbidity burden. Our findings demonstrate the predictive value and potential clinical utility of identifying patients with AMI with specific comorbidity clustering.

A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators.

BACKGROUND: In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing countries' PV systems' performance. METHODS: EMBASE, MEDLINE, CINAHL Plus and Web of Science were searched for peer-reviewed studies published in English between 2012 and 2021. Reference lists of included studies were screened. Included studies were quality assessed using Hawker et al.'s nine-item checklist; data were extracted using the WHO PV indicators checklist. Scores were assigned to each group of indicators and used to compare countries' PV performance. RESULTS: Twenty-one unique studies from 51 countries were included. Of a total possible quality score of 36, most studies were rated medium (n = 7 studies) or high (n = 14 studies). Studies obtained an average score of 17.2 out of a possible 63 of the WHO PV indicators. PV system performance in all 51 countries was low (14.86/63; range: 0-26). Higher average scores were obtained in the 'Core' (9.27/27) compared to 'Complementary' (5.59/36) indicators. Overall performance for 'Process' and 'Outcome' indicators was lower than that of 'Structural'. CONCLUSION: This first systematic review of studies evaluating PV performance in developing countries provides an in-depth understanding of factors affecting PV system performance.

Development of the adult complexity tool for pharmaceutical care (ACTPC) in hospital: A modified Delphi study.

BACKGROUND: Hospital pharmacists play an essential role in patient care; however, a lack of resources means pharmacists are unable to review all patients daily. Consequently, there is a demand for reliable screening tools to allocate care to patients with urgent and/or complex pharmaceutical needs. Several tools have been developed, but no broad consensus exists on the design of a screening tool to be used in the adult hospital setting. OBJECTIVE: To obtain expert consensus on the design of a pharmaceutical care complexity screening tool for use on admission to hospital. METHODS: Two Delphi studies were conducted: the first sought to gain consensus from experts including pharmacists, academics and physicians on the components of a pharmaceutical complexity tool, the second to achieve consensus from UK chief pharmacists and clinical service pharmacy managers on the clinical appropriateness and practicality of the tool. Tool components and Delphi statements were identified and refined from our previous systematic review, UK survey and interview study of prioritisation tools. A valid definition for consensus was used. RESULTS: Over 300 components were extracted from the interview data and systematic review and then refined for inclusion in the first Delphi study. Thirty-three experts completed Delphi One and consensus was reached on 92 components. Components were grouped into demographic, clinical and medication components and condensed to 33 items, which were included in the first draft of the Adult Complexity Tool for Pharmaceutical Care (ACTPC). The tool stratified patients into highly, moderately or least complex. Forty expert panellists completed Delphi Two and consensus was reached on review frequency and experience of pharmacy practitioner at each level. These decisions were incorporated into the final version of the ACTPC. CONCLUSIONS: The ACTPC is the first systematically designed and internationally agreed tool for use on medical admission to hospital. It has potential to enable the delivery of targeted patient-centred pharmaceutical care.

Patient prioritisation for hospital pharmacy services: current approaches in the UK.

OBJECTIVES: To survey and explore current approaches to deployment of pharmaceutical care prioritisation tools in acute hospitals in the UK. METHODS: A national online survey was circulated electronically to chief pharmacists of hospitals to determine if they use a prioritisation tool or process. Where such mechanisms exist, respondents were invited to participate in a semistructured telephone interview to explore the development, evaluation and application of their tool and share relevant documentation. Interviews were transcribed and thematically analysed. RESULTS: Seventy hospitals (70/130) used a tool or process to prioritise clinical pharmacy services. Thirty-six interviews were conducted, and two were excluded. The majority of tools had been developed in-house. Few hospitals had undertaken formal evaluations of their prioritisation tool. Pharmacy prioritisation tools ranged in complexity and often included a combination of pharmacy service prioritisation, such as medicines reconciliation, and a section to assign an individual patient prioritisation level. Determining the priority of a patient based on the identification of set indicators instilled confidence in pharmacists by ensuring they were not missing high-risk patients. Electronic prioritisation tools were especially useful at retrieving real-time data to prioritise workload, improving workflow and ensuring continuity in patient care. Drawbacks of using prioritisation tools included lack of tool sensitivity across certain specialties and time spent using the tool if not all information was accessible. CONCLUSIONS: Prioritisation tools were seen to be useful for prioritising workload and ensuring the right patients are seen at the right time. As few hospitals had formally evaluated their tools, it is important to rigorously and systematically develop an evidence-based prioritisation tool that is both useable and acceptable. Further research to evaluate such tools would be needed to ensure it improves patient health outcomes and efficiency in pharmacy services.

Intensive insulin protocol implementation and outcomes in the medical and surgical wards at a Veterans Affairs Medical Center.

BACKGROUND: Hyperglycemia is an important marker for clinical outcomes and mortality in hospitalized patients. New national standards have been established emphasizing the importance of improving inpatient glycemic control in individuals with diabetes or new-onset hyperglycemia. Implementation of these new standards is complex and requires a multidisciplinary team approach. A basal-bolus insulin regimen approach has been shown to improve inpatient glycemic control. Few studies have been published regarding basal-bolus insulin protocol outcomes in the non-intensive care unit (ICU) setting. OBJECTIVE: To evaluate the efficacy of a basal-bolus insulin protocol on inpatient glycemic control in a non-ICU setting, as measured by mean blood glucose and number of hypoglycemic episodes per patient admission. METHODS: A retrospective, observational, single-center study was conducted to compare blood glucose control pre- (October 2006-March 2007) and postprotocol (November 2007-January 2008) implementation. Inclusion criteria consisted of patient admission to a medical or surgical ward for at least 72 hours, with a diagnosis of diabetes, or presentation with 2 blood glucose readings greater than 180 mg/dL. Patients admitted to the ICU or those not admitted to a medical or surgical ward were excluded. RESULTS: Following protocol implementation, the mean +/- SD blood glucose level increased from 174 +/- 88 mg/dL to 188 +/- 95 mg/dL (p < 0.001) and the hypoglycemic incidents significantly decreased, from 1.11 to 0.51 events per patient admission (p < 0.0025). CONCLUSIONS: In this pilot study, implementation of a basal-bolus insulin protocol significantly reduced hypoglycemic events; however, mean blood glucose values increased. These results suggest that a basal-bolus insulin protocol can reduce hypoglycemia; however, factors such as protocol compliance, barriers in overcoming the use of the traditional sliding scale insulin regimens, staff education, and change of work-flow habits can influence the overall efficacy and impact of a basal-bolus insulin protocol on inpatient glycemic control.

Evaluation of a clinical scoring scale to direct early appropriate therapy in heparin-induced thrombocytopenia.

BACKGROUND: Heparin-induced thrombocytopenia (HIT) is a serious adverse effect associated with heparin therapy. Current laboratory confirmation for immune mediated HIT often results in false positives and unnecessary treatment, exposing individuals to possible complications. As a result, clinical evaluation has been recommended in conjunction with laboratory testing. We hypothesize that utilization of a clinical scoring scale, the 4T's, will result in the initial appropriate therapy for suspected HIT. METHODS: This is a retrospective chart review of 108 patients who underwent ELISA testing for HIT at a university hospital. The 4T's scale was applied, stratifying individuals into low, intermediate, and high-risk categories. Each risk score was compared to the ELISA results to determine if the 4T's can predict the diagnosis of HIT and result in appropriate management. ELISA optical density scores as well as incidence of adverse events were also compared among risk categories. STUDY RESULTS: Individuals with low risk correlate with a negative ELISA compared to intermediate and high-risk individuals (p = 0.01 and p<0.01) and also were significantly more likely to predict institution of appropriate therapy (p<0.01). Median optical density scores were 0.184 (0.046-2.116), 0.226 (0.067-1.887), and 0.476 (0.096-1.309) for low, intermediate, and high 4T scores. Major adverse events include thrombosis and bleeding. CONCLUSIONS: Individuals with low risk were more likely to receive initial, appropriate therapy and were also significantly more likely to have a negative ELISA test result. Individuals with low risk determined by the 4T score therefore may have therapy and serologic testing for HIT withheld.

National survey of pharmacy services in free medical clinics.

OBJECTIVES: To characterize the current model of pharmacy services in free clinics, identify the extent to which free clinics serve as training sites for student pharmacists and residents, elucidate pharmacy service gaps in free clinics, and compare results to a 2001 survey. DESIGN: Descriptive, non-experimental, cross-sectional study. SETTING: Free medical clinics in the United States in early 2008. PARTICIPANTS: Clinics registered at www.freeclinicfoundation.org. INTERVENTION: A 26-point questionnaire addressed clinic and pharmacy demographics, pharmacy services, medication storage and distribution processes, and systems management. Survey invitations were sent via postal mail, with responses submitted via hardcopy or online (Survey Monkey). Nonresponders received a second mailing 4 weeks later. MAIN OUTCOME MEASURES: Characteristics determined by survey responses. RESULTS: 42% of clinics responded (216 of 518). The median annual clinic budget was $145,000, with 1% to 20% spent on medications. Of responding clinics, 30% had a licensed pharmacy that was staffed on average by 3.4 pharmacist volunteers and 0.1 pharmacist employees. Of the 83.5% (177 of 212) that dispensed drugs, clinics filled 67 prescriptions per day with cardiovascular, gastrointestinal, and anti-infective agents as top classes. Pharmacy personnel provided mainly traditional (e.g., distributive) services (61.1%), and 19.3% of clinics trained student pharmacists. Since 2001, the number of clinics (355 vs. 518) and prescriptions dispensed (29 vs. 67 per day) increased but the percentage with a licensed pharmacy (33% vs. 30%) and mean number of pharmacist volunteers/employees (3.8/0.1 vs. 3.4/0.1) remained constant. CONCLUSION: The model of free clinic pharmacy services is a modified community practice. Pharmacy personnel have the opportunity to expand their role and pharmacy practice in free clinics.

Risk management of teratogenic medicines: A systematic review.

AIM: To systematically identify studies of implementing risk management measures when prescribing teratogenic medicines for women of childbearing age and studies reporting risk perceptions of teratogenic medications. METHODS: MEDLINE, CINAHL, Scopus, EMBASE, and International Pharmaceutical Abstracts were searched. Studies were included in the risk management section if they reported any of the following risk management measures: teratogenic counseling, contraceptive counseling, pregnancy testing before starting treatment, pregnancy testing during treatment, use of contraception before starting treatment, and use of contraception during treatment. Studies were included in the perceptions section if they reported perceived teratogenic risk as numerical value. RESULTS: Fifty-five studies were included in the risk management section and seven studies were included in the perceptions sections. Prevalence of risk management measures varied as follows: teratogenic counseling (9.5%-99.3%), contraceptive counseling (6.1%-98%), pregnancy testing before starting treatment (0%-95.1%), pregnancy testing during treatment (12.7%-100%), contraception use before starting treatment (15.7%-94%), and contraception use during treatment (1.7%-100%). A proper estimation of the teratogenic risk was reported for thalidomide (by general practitioners and obstetric/gynecologists), for etretinate (by pregnant women), and for misoprostol (by pregnant and nonpregnant women). An under-estimation was reported for warfarin and retinoids (by general practitioners and obstetric/gynecologists). And over-estimation was reported for thalidomide, valproate, lithium, isotretinoin, phenytoin, warfarin and etretinate by different populations. CONCLUSION: Considerable variation in the implementation of risk management measures when prescribing teratogenic medicines to women of childbearing age is reported in the literature. A common tendency to over-estimate the risk of teratogenic medications was evident.

Qualitative risk assessment of follicle stimulating hormone injectable products.

BACKGROUND: Gonadotropin injections for fertility treatment regimens are usually self-injected, typically over 8-12 days during the assisted reproductive technology cycle. Parenteral gonadotropins are available in different formulations and administered through various systems. A user experience study and risk assessment were performed to evaluate different product types for risks to the patient when preparing and administering injections. METHODS: Nine women of child-bearing age each prepared and administered injections of six products representing single- and multidose vials of menotropin for reconstitution (Merional® and Menopur®), follicle stimulating hormone (FSH) reusable pen injectors with (Puregon®), and without cartridges (Gonal-f®), and single-use FSH pre-filled pens (Bemfola®). Risk assessments based on user feedback were made with reference to EU regulations for implementing practices for safe use of injectable products. RESULTS: Products requiring reconstitution with diluent in glass ampoules were associated with medium risk for sharps injury and a lower level of user confidence. Pen injectors were considered easy-to-use, with a low risk of sharps injury. Single-use pens were associated with the lowest risk of dosing errors. CONCLUSIONS: The study identifies differences in the risks for both sharps injuries and dosing errors between FSH delivery options that practitioners should consider when making a treatment choice.

Eleven-year multimorbidity burden among 637 255 people with and without type 2 diabetes: a population-based study using primary care and linked hospitalisation data.

OBJECTIVES: To compare the patterns of 18 physical and mental health comorbidities between people with recently diagnosed type 2 diabetes (T2D) and people without diabetes and how these change by age, gender and deprivation over time between 2004 and 2014. Also, to develop a metric to identify most prevalent comorbidities in people with T2D. DESIGN: Population-based cohort study. SETTING: Primary and secondary care, England, UK. PARTICIPANTS: 108 588 people with T2D and 528 667 comparators registered in 391 English general practices. Each patient with T2D aged ≥16 years between January 2004 and December 2014 registered in Clinical Practice Research Datalink GOLD practices was matched to up to five comparators without diabetes on age, gender and general practice. PRIMARY AND SECONDARY OUTCOME MEASURES: Prevalence of 18 physical and mental health comorbidities in people with T2D and comparators categorised by age, gender and deprivation. Odds for association between T2D diagnosis and comorbidities versus comparators. A metric for comorbidities with prevalence of ≥5% and/or odds ≥2 in patients with T2D. RESULTS: Overall, 77% of patients with T2D had ≥1 comorbidity and all comorbidities were more prevalent in patients with T2D than in comparators. Across both groups, prevalence rates were higher in older people, women and those most socially deprived. Conditional logistic regression models fitted to estimate (OR, 95% CI) for association between T2D diagnosis and comorbidities showed that T2D diagnosis was significantly associated with higher odds for all conditions including myocardial infarction (OR 2.13, 95% CI 1.85 to 2.46); heart failure (OR 2.12, 1.84 to 2.43); depression (OR 1.75, 1.62 to 1.89), but non-significant for cancer (OR 1.12, 0.98 to 1.28). In addition to cardiovascular disease, the metric identified osteoarthritis, hypothyroidism, anxiety, schizophrenia and respiratory conditions as highly prevalent comorbidities in people with T2D. CONCLUSIONS: T2D diagnosis is associated with higher likelihood of experiencing other physical and mental illnesses. People with T2D are twice as likely to have cardiovascular disease as the general population. The findings highlight highly prevalent and under-reported comorbidities in people with T2D. These findings can inform future research and clinical guidelines and can have important implications on healthcare resource allocation and highlight the need for more holistic clinical care for people with recently diagnosed T2D.

Medication adherence and its effect on relapse among patients discharged from a Veterans Affairs posttraumatic stress disorder treatment program.

BACKGROUND: Clinical outcomes in patients with posttraumatic stress disorder (PTSD) can be affected by several factors, including medication adherence. PTSD is associated with an increased likelihood of missed appointments, medication underuse or abuse, and treatment nonadherence. OBJECTIVE: To evaluate medication adherence and its effect on relapse following discharge of veterans from a PTSD residential rehabilitation program (PRRP). METHODS: A retrospective evaluation of drug adherence and relapse in the 12 months following discharge of patients from a PRRP was performed. All veterans who were discharged from January 1, 2005, to December 31, 2006, and were receiving antidepressant therapy were included. Adherence to antidepressant therapy was assessed by electronic prescription claims and defined as a medication possession ratio of at least 0.8 in the year following discharge. Relapse was defined as a hospitalization for psychiatric symptomatology. Predictive factors of adherence were also explored. RESULTS: Twenty-eight of the 82 (34%) veterans included in our study were adherent to medication during the 12 months following discharge. Seventeen (20.7%) veterans were rehospitalized for psychiatric symptoms, but nonadherence was not significantly associated with relapse (p = 0.91). The total number of drugs that a veteran received was related to adherence; patients who had a higher median number of medications were more adherent (p = 0.014). Age, comorbid substance abuse, combat service, and service connection were not associated with drug adherence. CONCLUSIONS: The majority of patients who were discharged from a residential PTSD treatment program were nonadherent to antidepressant drug therapy. One in 5 veterans with PTSD was rehospitalized within 1 year; however, medication adherence did not affect this outcome.

Impact of nicotine replacement therapy on postoperative mortality following coronary artery bypass graft surgery.

BACKGROUND: Nicotine replacement therapy (NRT) has recently been associated with increased mortality in patients in medical intensive care units (ICUs). Although NRT is frequently used in cardiothoracic surgery patients, no safety data exist for use in this population. OBJECTIVES: To ascertain the impact of NRT on in-hospital mortality following coronary artery bypass graft (CABG) surgery. METHODS: This was a retrospective matched cohort pilot study in a 22-bed cardiothoracic surgery ICU. Patients prescribed transdermal NRT after CABG were randomly selected and matched to current smokers not prescribed NRT according to Acute Physiology and Chronic Health Evaluation II scores (N = 134). Data on comorbid conditions and pack-year history were also obtained. To compare these patients with nonsmoking patients, a larger unmatched population was also evaluated. The total number of patients prescribed NRT, current smokers not prescribed NRT, and nonsmokers who were evaluated in our study was 2057. RESULTS: Sixty-seven NRT patients were well matched with 67 current smokers in terms of baseline demographics and procedures. Mortality was nonsignificantly higher in the NRT group versus the non-NRT smoker group (4.5% vs 0.0%; p = 0.080). In an evaluation of a larger population controlled for differences in baseline characteristics, an increase in mortality due to NRT was found (OR 6.06; 95% CI 1.65 to 22.21). In an a priori subgroup of the overall population, mortality was significantly higher in patients receiving NRT after off-pump CABG versus smokers not receiving NRT (OR 6.49; 95% CI 1.29 to 32.56). CONCLUSIONS: The use of NRT in a postoperative CABG surgery population resulted in a significant increase in mortality when adjusted for baseline characteristics. Patients receiving NRT after off-pump cardiac surgery may be particularly susceptible. Additional evaluation in large patient cohorts with prospective controls is warranted.

Effects of hyperglycemia on the development of new-onset diabetes after liver transplantation.

CONTEXT: New-onset diabetes after transplantation (NODAT) has been associated with cardiovascular and thrombotic complications, acute rejection, and infection in transplant recipients. NODAT in kidney transplantation is well described; however, data are lacking in liver transplant recipients. OBJECTIVE: To evaluate the incidence of new-onset diabetes within 6 months postoperatively in adult liver transplant recipients. DESIGN, PARTICIPANTS, SETTING, AND INTERVENTIONS: Patients who underwent a liver transplantation at our institution between January 2004 and December 2005 were retrospectively evaluated. NODAT was defined according to the diagnostic criteria of the American Diabetes Association/World Health Organization, persistent hyperglycemia (serum glucose > or = 200 mg/dL occurring 2 weeks after initial steroid induction and persisting for more than 2 weeks), or the need for hypoglycemic agents upon discharge. MAIN OUTCOMES: Incidence of NODAT within 6 months after transplantation in patients with poor glycemic control within the first 2 weeks after transplantation, acute rejection episodes, infections, hospital readmissions, and cardiovascular and thrombotic events. RESULTS: Forty-five patients were evaluated. Within the first 6 months after transplantation, NODAT developed in 11 (24%). Acute rejection, infection, hospital readmissions, cardiovascular events, and thrombotic events did not differ between the groups. CONCLUSION: Elevated fasting levels of blood glucose during the first 2 weeks after liver transplantation may be associated with an increased incidence of NODAT and may have predictive value. More studies are needed to determine the effects of recognition and treatment of hyperglycemia in recent transplant recipients.

A qualitative exploration of Bahrain and Kuwait herbal medicine registration systems: policy implementation and readiness to change.

BACKGROUND: The Kuwaiti drug regulatory authority (DRA) lack a structured classification system for the assessment of imported herbal medicines (HMs), which leads to ambiguity in the registration process. This study aimed to examine the policy development and implementation process in an established HM registration system (Bahrain) and harness lessons to inform recommendations for a suitable HM classification system and explore implementation readiness in Kuwait. METHODS: A sequential study design was chosen, with data collected in Bahrain (case 1), recommendations formed and readiness for implementation explored subsequently in Kuwait (case 2). With ethics and DRA approval in place, data sources were documentary review of regulatory policies, direct observations of HMs registration processes, and semi-structured interviews with twenty three key officials involved in the HMs registration processes. Data from all three sources were analysed thematically and findings triangulated. RESULTS: The classification policy in Bahrain was found to be based on evidence and extensive stakeholder engagement, resulting in a clear and organised HM registration process. The availability of HMs classification policies in other DRAs, officials' dedication and teamwork, and support by higher authority, were identified as the main facilitators in policy development and successful implementation. Barriers were the diversity of HM classifications worldwide, a lack of staff and resultant workload, and lack of training. Proposed recommendations for Kuwait were to adopt a clear definition of what constituted HMs, and to introduce a Traditional Herbal Registration based on this definition and the product's characteristics. Interviews in Kuwait showed that almost all participants were in favour of the proposed recommendations and were in support of timely implementation. Interviewees anticipated that consistency in the HM registration process would be the main benefit, increasing reviewer's confidence in making regulatory decisions. Interviewees also identified potential challenges which may impede successful implementation, including staff shortages, resistance to change by internal and external stakeholders, and the impact of cultural and traditional ways of working. CONCLUSIONS: Insights into the HM policy development and implementation process in Bahrain, and exploration of Kuwait's readiness to implement resultant recommendations informed an effective implementation process for a well-designed HMs policy for Kuwait and other Arab countries.

Patient prioritization for pharmaceutical care in hospital: A systematic review of assessment tools.

BACKGROUND: Clinical pharmacy services improve patient safety, outcomes, and care quality; however, UK clinical pharmacy services face limited resources, insufficient capacity, and patients who present with increasingly complex medication regimes and morbidities. These indicate a need for the prioritization of pharmacy services. Several prioritization tools have been developed; however, there has been no comprehensive review of such tools to date. OBJECTIVE: A systematic review was conducted to provide a structured overview and description of existing assessment tools with a focus on study quality, themes, tool validity, risk factors, and high-risk drug classes. METHODS: Systematic searches for English-language publications (from 1990 to September 2017) were conducted in Embase, Medline, Scopus, International Pharmaceutical Abstracts, and Web of Science. Papers in the inpatient setting and in which the tool users were pharmacists or pharmacy technicians were included. Data on each study (e.g. aim and design) and the structure of tools (e.g. risk factors) from each included study were extracted by 2 independent reviewers. A descriptive analysis was conducted to summarize these tools along with a thematic analysis of study findings. The quality of each paper was assessed using the Hawker method. RESULTS: Nineteen studies involving 17 risk assessment tools were included. Most tools were developed in Europe (76.5%) and published in the last 5 years (82%). Most tools (88%) were designed to identify patients at greatest risk of adverse drug reactions, adverse drug events, or medication errors and to guide appropriate pharmaceutical care. Ten out of 17 tools (59%) were validated. None showed a measurable impact on prescription errors or adverse drug events. Keys themes identified from the studies were the positive impact of risk assessment tools on both patient care and provision of pharmacy services as well as the limitations of risk assessment tools. CONCLUSIONS: Current assessment tools are heterogeneous in their content, targeting diverse patient groups and clinical settings making generalization difficult. However, an underlying theme of all studies was that tools appear to achieve their aim in directing pharmaceutical care to where it is needed most which might provide reassurance and incentive for greater adoption and development of tools across clinical pharmacy services. However, further research is required to measure objectively the impact of tools on patient outcomes and on workforce efficiency so that comparisons can be made between tools.

Identifying potential prescribing safety indicators related to mental health disorders and medications: A systematic review.

BACKGROUND: Prescribing errors and medication related harm may be common in patients with mental illness. However, there has been limited research focusing on the development and application of prescribing safety indicators (PSIs) for this population. OBJECTIVE: Identify potential PSIs related to mental health (MH) medications and conditions. METHODS: Seven electronic databases were searched (from 1990 to February 2019), including the bibliographies of included studies and of relevant review articles. Studies that developed, validated or updated a set of explicit medication-specific indicators or criteria that measured prescribing safety or quality were included, irrespective of whether they contained MH indicators or not. Studies were screened to extract all MH related indicators before two MH clinical pharmacists screened them to select potential PSIs based on established criteria. All indicators were categorised into prescribing problems and medication categories. RESULTS: 79 unique studies were included, 70 of which contained at least one MH related indicator. No studies were identified that focused on development of PSIs for patients with mental illness. A total of 1386 MH indicators were identified (average 20 (SD = 25.1) per study); 245 of these were considered potential PSIs. Among PSIs the most common prescribing problem was 'Potentially inappropriate prescribing considering diagnoses or conditions' (n = 91, 37.1%) and the lowest was 'omission' (n = 5, 2.0%). 'Antidepressant' was the most common PSI medication category (n = 85, 34.7%). CONCLUSION: This is the first systematic review to identify a comprehensive list of MH related potential PSIs. This list should undergo further validation and could be used as a foundation for the development of new suites of PSIs applicable to patients with mental illness.