Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol.

INTRODUCTION: Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose-response nature of any identified association, to inform future hypertension management. METHODS AND ANALYSIS: The study will use data from 2 of Australia's largest cohort studies; the Australian Longitudinal Study on Women's Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004-2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used. ETHICS AND DISSEMINATION: Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings. TRIAL REGISTRATION NUMBER: NCT05972785.

Pharmacists and Pharmacy Technicians' Perceptions of Scopes of Practice Employing Agency Theory in the Management of Minor Ailments in Central Indonesian Community Pharmacies: A Qualitative Study.

Community pharmacy staff assist in the management of minor ailments. Agency Theory underpins relationships between health professionals and patients. This study explores pharmacists' and pharmacy technicians' perceived scopes of practice of minor ailment services in community pharmacies. Twelve one-on-one semi-structured interviews used an open-ended interview guide for each cohort of community pharmacists and pharmacy technicians, between June and July 2021. Purposive sampling selected a diversity of pharmacists and pharmacy technicians. Interviews were transcribed verbatim, thematically analysed assisted by NVivo version 20. Agency Theory aided the interpretation. Three main themes emerged: (1) inconsistencies in practice, (2) the lack of understanding of the scopes of practice of pharmacists and pharmacy technicians, and (3) provision of prescription-only medicines for some minor ailments or to fulfil patient requests. Several sub-themes included pharmacy staff involvement, education and training, provision of prescription-only medicines, and weak regulatory enforcement. Agency Theory indicated pharmacy patients (principals) delegated authority to pharmacists and pharmacy technicians (agents), which was confused by partial pharmacist absence. The lack of defined scopes of practice for pharmacists and pharmacy technicians disrupted established professional relationships. The scopes of practice and roles of the pharmacist and pharmacy technicians should be clearly defined, assisted by practice guidelines.

The Clinical Suitability of an Artificial Intelligence-Enabled Pain Assessment Tool for Use in Infants: Feasibility and Usability Evaluation Study.

BACKGROUND: Infants are unable to self-report their pain, which, therefore, often goes underrecognized and undertreated. Adequate assessment of pain, including procedural pain, which has short- and long-term consequences, is critical for its management. The introduction of mobile health-based (mHealth) pain assessment tools could address current challenges and is an area requiring further research. OBJECTIVE: The purpose of this study is to evaluate the accuracy and feasibility aspects of PainChek Infant and, therefore, assess its applicability in the intended setting. METHODS: By observing infants just before, during, and after immunization, we evaluated the accuracy and precision at different cutoff scores of PainChek Infant, which is a point-of-care mHealth-based solution that uses artificial intelligence to detect pain and intensity based solely on facial expression. We used receiver operator characteristic analysis to assess interpretability and establish a cutoff score. Clinician comprehensibility was evaluated using a standardized questionnaire. Other feasibility aspects were evaluated based on comparison with currently available observational pain assessment tools for use in infants with procedural pain. RESULTS: Both PainChek Infant Standard and Adaptive modes demonstrated high accuracy (area under the curve 0.964 and 0.966, respectively). At a cutoff score of ≥2, accuracy and precision were 0.908 and 0.912 for Standard and 0.912 and 0.897 for Adaptive modes, respectively. Currently available data allowed evaluation of 16 of the 17 feasibility aspects, with only the cost of the outcome measurement instrument unable to be evaluated since it is yet to be determined. PainChek Infant performed well across feasibility aspects, including interpretability (cutoff score defined), ease of administration, completion time (3 seconds), and clinician comprehensibility. CONCLUSIONS: This work provides information on the feasibility of using PainChek Infant in clinical practice for procedural pain assessment and monitoring, and demonstrates the accuracy and precision of the tool at the defined cutoff score.

Assessing procedural pain in infants: a feasibility study evaluating a point-of-care mobile solution based on automated facial analysis.

BACKGROUND: The management of procedural pain in infants is suboptimal, in part, compounded by the scarcity of a simple, accurate, and reliable method of assessing such pain. In this study, we aimed to evaluate the psychometric properties of the PainChek Infant, a point-of-care mobile application that uses automated facial evaluation and analysis in the assessment of procedural pain in infants. METHODS: Video recordings of 40 infants were randomly chosen from a purposely assembled digital library of 410 children undergoing immunisation as part of their standard care in Prishtina, Kosovo, between April 4, 2017, and July 11, 2018. For each infant recording, four 10 s video segments were extracted, corresponding to baseline, vaccine preparation, during vaccination, and recovery. Four trained assessors did pain assessments on the video segments of 30 infants, using PainChek Infant standard, PainChek Infant adaptive, the Neonatal Facial Coding System-Revised (NFCS-R) single, the NFCS-R multiple, and the Observer administered Visual Analogue Scale (ObsVAS), on two separate occasions. PainChek Infant's performance was compared to NFCS-R and ObsVAS using correlation in changes in pain scores, intra-rater and inter-rater reliability, and internal consistency. FINDINGS: 4303 pain assessments were completed in two separate testing sessions, on Aug 31, and Oct 19, 2020. The study involved videos of 40 infants aged 2·2-6·9 months (median age 3·4 months [IQR 2·3-4·5]). All pain assessment tools showed significant changes in the recorded pain scores across the four video segments (p≤0·0006). All tools were found to be responsive to procedure-induced pain, with the degree of change in pain scores not influenced by pre-vaccination pain levels. PainChek Infant pain scores showed good correlation with NFCS-R and ObsVAS scores (r=0·82-0·88; p<0·0001). PainChek Infant also showed good to excellent inter-rater reliability (ICC=0·81-0·97, p<0·001) and high levels of internal consistency (α=0·82-0·97). INTERPRETATION: PainChek Infant's use of automated facial expression analysis could offer a valid and reliable means of assessing and monitoring procedural pain in infants. Its clinical utility in clinical practice requires further research. FUNDING: PainChek.

Exploring instruments used to evaluate potentially inappropriate medication use in hospitalised elderly patients in Kosovo.

OBJECTIVES: A number of instruments are used to identify potentially inappropriate medications (PIMs) in the elderly. In this study we identify PIMs in elderly patients and aim to compare three different instruments used to assess PIMs. METHODS: In this prospective cohort study, we compared medications of elderly patients against three commonly used instruments: Beers' list, PRISCUS and STOPP/START, at the point of hospital admission and discharge in the nephrology clinic of Kosovo's largest hospital. Readmission risk was evaluated using the LACE Index and correlations with the number of PIMs and PIMs criteria were analysed. RESULTS: Of 184 patients admitted to the nephrology clinic, 84 met study inclusion criteria. Patients had a median of three drugs at admission and four at discharge. Hospital readmission risk was high with median LACE Index being 11 (63% of patients). A higher number of PIMs was associated at the point of discharge compared with admission for all three tools (Beers' list: 29% vs 38 %, P=0.04; STOPP/STRART: 20% vs 23%, P<0.001; PRISCUS list: 12% vs 21%, P<0.001). The number of drugs at admission predicted the number of PIMs at discharge only when using Beers' criteria (P=0.006). At discharge, each increase in medication was associated with an increase in PIMs based on Beers' [0.134; (P=0.007)] and STOPP/START criteria [0.130; (P=0.005)]. Nitrofurantoin was the main PIM identified with Beers' and PRISCUS list in comparison to proton- pump-inhibitors being the most prevalent agents identified with STOPP/START criteria. CONCLUSIONS: There are differences when using Beers' criteria, STOPP/START criteria and PRISCUS list during identification of PIMs in elderly patients with high readmission risk. These differences should be considered when identifying PIMs in hospital settings.

Assessment of lower urinary tract symptoms among calcium channel blocker-users and its impact on quality of life.

OBJECTIVE: To investigate the prevalence and severity of lower urinary tract symptoms among calcium channel blocker users, and the impact on patients' quality of life. METHODS: The cross-sectional study was conducted at one hospital and 2 community pharmacies in Lahore, Pakistan, from November 2017 to July 2018, and comprised patients using calcium channel blockers. Data was collected using standardised scales to assess lower urinary tract symptoms and quality of life. Data was analysed using SPSS 22. RESULTS: Of the 410 subjects, 315 (76.8%) were males. The overall median age was 50.84 years, IQR 19 with 126 (30.7%) aged 41-50 years. Of the total, 108 (26.3%) patients were on calcium channel blockers alone, while the rest were taking it in combination with other drugs. Prevalence of lower urinary tract symptoms was 307 (74.9%); mild 103 (25.1%), moderate 201 (49.1%) and severe 106 (25.9%). The symptoms were significantly associated with reduced quality of life (p<0.05). CONCLUSION: Majority calcium channel blockers users had clinically significant lower urinary tract symptoms which significantly reduced patients' quality of life.

Simulated medication errors: A means of evaluating healthcare professionals' knowledge and understanding of medication safety.

OBJECTIVE: To determine multi-disciplinary perceptions of the clinical significance of medication errors (MEs), the responsible health professional(s), the contributing factors and potential preventive strategies. METHODS: The five simulated ME cases represented errors from five wards at a children's hospital in Australia. Pre-determined answers for each case were developed through consensus among the researchers. The root cause analysis (RCA) was undertaken via a questionnaire disseminated to physicians, nurses and pharmacists at the study hospital to seek their opinions on the ME cases. Agreement model between the participants and pre-determined responses regarding the contributing factors was conducted using general estimating equation (GEE) analysis. RESULTS: Of the 111 RCA questionnaires distributed, 25 were returned. The majority (93%) of respondents rated the significance of the MEs as either 'moderate' or 'life-threatening'. Furthermore, they correctly identified two contributing factors relevant to all cases: dismissal of policies/procedures or guidelines (90%) and human resources issues (87%). GEE analysis revealed varied agreement patterns across the contributing factors. Suggested prevention strategies focused on policy and procedures, staffing and supervision, and communication. CONCLUSION: Simulated case studies had potential use to seek front-line healthcare professionals' understanding of the clinical significance and contributing factors to MEs, along with preventive measures.

Dr Google Is Here to Stay but Health Care Professionals Are Still Valued: An Analysis of Health Care Consumers' Internet Navigation Support Preferences.

BACKGROUND: The Internet offers great opportunities for consumers to be informed about their health. However, concerns have been raised regarding its impact on the traditional health consumer-health professional relationship. Our recent survey of 400 Australian adults identified that over half of consumers required some form of navigational support in locating appropriate Web-based health information. We propose that support provided by health professionals would be preferred by consumers; this preference is regardless of whether consumers have a need for navigational support. Secondary analysis of the survey dataset is presented here to quantify consumer-reported support preferences and barriers when navigating Web-based health information. OBJECTIVE: We aimed to quantitatively identify consumers' support preferences for locating Web-based health information and their barriers when navigating Web-based health information. We also aimed to compare such preferences and barriers between consumers identified as needing and not needing support when locating Web-based health information. METHODS: Chi-square (χ2) tests identified whether each listed support preference differed between subgroups of consumers classified as needing (n=205, 51.3%) or not needing (n=195, 48.8%) navigational support; degree of association, via phi coefficient (φ) tests, were also considered to ascertain the likely practical significance of any differences. This was repeated for each listed barrier. Free-text responses regarding additional support preferences were descriptively analyzed and compared with the quantitative findings to provide a richer understanding of desired support for health information searches. RESULTS: Of the 400 respondents, the most preferred mode of navigational support was involvement of health professionals; this was reported by participants identified as needing and not needing navigational support. While there was a significant difference between groups, the degree of association was small (χ21 [N=400]=13.2; P<.001; φ=.18). Qualitative data from the free-text responses supported consumers' desire for health professional involvement. The two most commonly reported barriers when navigating desired Web-based health information were (1) volume of available information and (2) inconsistency of information between sources; these were reported by participants with and without a need for navigational support. While participants identified with a need for navigational support were more likely to report volume (χ21 [N=387]= 4.40; P=.04; φ=.11) and inconsistency of information (χ21 [N=387]= 16.10, P<.001, φ=.20) as barriers, the degrees of association were small to moderate. CONCLUSIONS: Despite concerns in the literature that the popularity of the Internet could compromise the health consumer-health professional relationship, our findings suggest the contrary. Our findings showed that health professionals were found to be the most commonly preferred mode of navigational support, even among consumers classified as not needing navigational support. Further research into how health professionals could assist consumers with Web-based health information seeking could strengthen the health consumer-health professional relationship amidst the growing use of "Dr Google."

The role of the pharmacist in the management of type 2 diabetes: current insights and future directions.

Type 2 diabetes is a chronic disease occurring in ever increasing numbers worldwide. It contributes significantly to the cost of health globally; however, its management remains in the most part less than optimal. Patients must be empowered to self-manage their disease, and they do this in partnership with health care professionals. Whilst the traditional role of the pharmacist has been centered around the supply of medicines and patient counseling, there is an evergrowing body of evidence that pharmacists, through a range of extended services, may contribute positively to the clinical and humanistic outcomes of those with diabetes. Further, these services can be delivered cost-effectively. This paper provides a review of the current evidence supporting the role of pharmacists in diabetes care, whilst providing a commentary of the future roles of pharmacists in this area.

Avoiding Treatment Interruptions: What Role Do Australian Community Pharmacists Play?

OBJECTIVE: To explore the reported practice of Australian community pharmacists when dealing with medication supply requests in absence of a valid prescription. METHODS: Self-administered questionnaire was posted to 1490 randomly selected community pharmacies across all Australian states and territories. This sample was estimated to be a 20% of all Australian community pharmacies. RESULTS: Three hundred eighty five pharmacists participated in the study (response rate achieved was 27.9% (there were 111 undelivered questionnaires). Respondents indicated that they were more likely to provide medications to regular customers without a valid prescription compared to non-regular customers (p<0.0001). However, supply was also influenced by the type of prescription and the medication requested. In the case of type of prescription (Standard, Authority or Private) this relates to the complexity/probability of obtaining a valid prescription from the prescriber at a later date (i.e. supply with an anticipated prescription). Decisions to supply and/or not supply related to medication type were more complex. For some cases, including medication with potential for abuse, the practice and/or the method of supply varied significantly according to age and gender of the pharmacist, and pharmacy location (p<0.05). CONCLUSIONS: Although being a regular customer does not guarantee a supply, results of this study reinforce the importance for patients having a regular pharmacy, where pharmacists were more likely to continue medication supply in cases of patients presenting without a valid prescription. We would suggest, more flexible legislation should be implemented to allow pharmacists to continue supplying of medication when obtaining a prescription is not practical.

Consumer Use of "Dr Google": A Survey on Health Information-Seeking Behaviors and Navigational Needs.

BACKGROUND: The Internet provides a platform to access health information and support self-management by consumers with chronic health conditions. Despite recognized barriers to accessing Web-based health information, there is a lack of research quantitatively exploring whether consumers report difficulty finding desired health information on the Internet and whether these consumers would like assistance (ie, navigational needs). Understanding navigational needs can provide a basis for interventions guiding consumers to quality Web-based health resources. OBJECTIVE: We aimed to (1) estimate the proportion of consumers with navigational needs among seekers of Web-based health information with chronic health conditions, (2) describe Web-based health information-seeking behaviors, level of patient activation, and level of eHealth literacy among consumers with navigational needs, and (3) explore variables predicting navigational needs. METHODS: A questionnaire was developed based on findings from a qualitative study on Web-based health information-seeking behaviors and navigational needs. This questionnaire also incorporated the eHealth Literacy Scale (eHEALS; a measure of self-perceived eHealth literacy) and PAM-13 (a measure of patient activation). The target population was consumers of Web-based health information with chronic health conditions. We surveyed a sample of 400 Australian adults, with recruitment coordinated by Qualtrics. This sample size was required to estimate the proportion of consumers identified with navigational needs with a precision of 4.9% either side of the true population value, with 95% confidence. A subsample was invited to retake the survey after 2 weeks to assess the test-retest reliability of the eHEALS and PAM-13. RESULTS: Of 514 individuals who met our eligibility criteria, 400 (77.8%) completed the questionnaire and 43 participants completed the retest. Approximately half (51.3%; 95% CI 46.4-56.2) of the population was identified with navigational needs. Participants with navigational needs appeared to look for more types of health information on the Internet and from a greater variety of information sources compared to participants without navigational needs. However, participants with navigational needs were significantly less likely to have high levels of eHealth literacy (adjusted odds ratio=0.83, 95% CI 0.78-0.89, P<.001). Age was also a significant predictor (P=.02). CONCLUSIONS: Approximately half of the population of consumers of Web-based health information with chronic health conditions would benefit from support in finding health information on the Internet. Despite the popularity of the Internet as a source of health information, further work is recommended to maximize its potential as a tool to assist self-management in consumers with chronic health conditions.

Continued Dispensing: what medications do patients believe should be available?

Background. Continued Dispensing (CD) is a new medication supply method for certain medications in Australia. It aims to prevent treatment interruption as a result of patients' inability to obtain a new valid prescription. The only currently eligible patients for this service are statin and/or oral contraceptives users who have been using these medications for 6 months or more, have not utilized the CD method during the last 12 months, and cannot obtain an immediate appointment with the prescriber in order to get a new prescription. This study aimed to investigate patients' attitudes towards potential extension and expansion of this medication supply method. Methods. A randomly selected 301 users of these medications from all Australian States were recruited using Computer Assisted Telephone Interview (CATI). Result. The response rate was 79%. The majority of the participants (73.3%) did not agree with current restriction on CD utilization frequency. They also supported, to varying degrees, inclusion of all the proposed medications (support ranged from 44.2-78.4%). In this regard, participants who suffered from a specific disease did not differ significantly from those without the disease except in case of patients with depression (p = 0.001). Conclusions. Participants of this study strongly supported both CD extension and expansion. A future critical review of the current version of CD is highly recommended in order to enhance CD capability to achieve its goals.

Dr Google and the consumer: a qualitative study exploring the navigational needs and online health information-seeking behaviors of consumers with chronic health conditions.

BACKGROUND: The abundance of health information available online provides consumers with greater access to information pertinent to the management of health conditions. This is particularly important given an increasing drive for consumer-focused health care models globally, especially in the management of chronic health conditions, and in recognition of challenges faced by lay consumers with finding, understanding, and acting on health information sourced online. There is a paucity of literature exploring the navigational needs of consumers with regards to accessing online health information. Further, existing interventions appear to be didactic in nature, and it is unclear whether such interventions appeal to consumers' needs. OBJECTIVE: Our goal was to explore the navigational needs of consumers with chronic health conditions in finding online health information within the broader context of consumers' online health information-seeking behaviors. Potential barriers to online navigation were also identified. METHODS: Semistructured interviews were conducted with adult consumers who reported using the Internet for health information and had at least one chronic health condition. Participants were recruited from nine metropolitan community pharmacies within Western Australia, as well as through various media channels. Interviews were audio-recorded, transcribed verbatim, and then imported into QSR NVivo 10. Two established approaches to thematic analysis were adopted. First, a data-driven approach was used to minimize potential bias in analysis and improve construct and criterion validity. A theory-driven approach was subsequently used to confirm themes identified by the former approach and to ensure identified themes were relevant to the objectives. Two levels of analysis were conducted for both data-driven and theory-driven approaches: manifest-level analysis, whereby face-value themes were identified, and latent-level analysis, whereby underlying concepts were identified. RESULTS: We conducted 17 interviews, with data saturation achieved by the 14th interview. While we identified a broad range of online health information-seeking behaviors, most related to information discussed during consumer-health professional consultations such as looking for information about medication side effects. The barriers we identified included intrinsic barriers, such as limited eHealth literacy, and extrinsic barriers, such as the inconsistency of information between different online sources. The navigational needs of our participants were extrinsic in nature and included health professionals directing consumers to appropriate online resources and better filtering of online health information. Our participants' online health information-seeking behaviors, reported barriers, and navigational needs were underpinned by the themes of trust, patient activation, and relevance. CONCLUSIONS: This study suggests that existing interventions aimed to assist consumers with navigating online health information may not be what consumers want or perceive they need. eHealth literacy and patient activation appear to be prevalent concepts in the context of consumers' online health information-seeking behaviors. Furthermore, the role for health professionals in guiding consumers to quality online health information is highlighted.

The difference in pharmacists' interventions across the diverse settings in a children's hospital.

AIMS: This study aimed to document and compare the nature of clinical pharmacists' interventions made in different practice settings within a children's hospital. METHODS: The primary investigator observed and documented all clinical interventions performed by clinical pharmacists for between 35-37 days on each of the five study wards from the three practice settings, namely general medical, general surgical and hematology-oncology. The rates, types and significance of the pharmacists' interventions in the different settings were compared. RESULTS: A total of 982 interventions were documented, related to the 16,700 medication orders reviewed on the five wards in the three practice settings over the duration of the study. Taking medication histories and/or patient counselling were the most common pharmacists' interventions in the general settings; constituting more than half of all interventions. On the Hematology-Oncology Ward the pattern was different with drug therapy changes being the most common interventions (n = 73/195, 37.4% of all interventions). Active interventions (pharmacists' activities leading to a change in drug therapy) constituted less than a quarter of all interventions on the general medical and surgical wards compared to nearly half on the specialty Hematology-Oncology Ward. The majority (n = 37/42, 88.1%) of a random sample of the active interventions reviewed were rated as clinically significant. Dose adjustment was the most frequent active interventions in the general settings, whilst drug addition constituted the most common active interventions on the Hematology-Oncology Ward. The degree of acceptance of pharmacists' active interventions by prescribers was high (n = 223/244, 91.4%). CONCLUSIONS: The rate of pharmacists' active interventions differed across different practice settings, being most frequent in the specialty hematology-oncology setting. The nature and type of the interventions documented in the hematology-oncology were also different compared to those in the general medical and surgical settings.

Patient attitudes towards a new role for pharmacists: continued dispensing.

BACKGROUND: In Australia, "continued dispensing" (CD) is a new model for supply of prescription medications. Under specific circumstances, community pharmacists are allowed to dispense a further one month supply of prescription only medications without a valid prescription. It allows continuation and treatment adherence when patients run out of statin and/or oral contraceptive (OC) medications, when it is not practical or they fail to plan accordingly to get a new prescription. OBJECTIVE: The aim of this study was to explore patient attitudes towards a CD model, including any perceived concerns or associated risks with CD prior to its introduction. METHODS: An Australia-wide computer-assisted telephone interview survey of statin and OC users aged 18 years or older was conducted in July 2013 prior to implementation of the CD model. A telephone number list was generated via a random number generation function based on a broad breakdown of the Australian population as outlined in the June 2013 Australian Bureau of Statistics data. The sample target for the survey was 300, consisting of 150 statin users and 150 OC users. RESULTS: There were a total of 301 respondents, comprising 151 statin users and 150 OC users. Approximately 37% of all respondents had experienced running out of their medications in the past 12 months, of whom 35.4% had temporarily stopped treatment and 33.6% requested their medication from a pharmacist without a valid prescription. OC users were more likely to run out of their medications (P=0.021). The majority of respondents had a regular pharmacy (86%) and therefore would be eligible for CD in the future. The majority of those surveyed had no concerns about CD or perceived it as posing no risks. Concerns raised included consultation privacy and the pharmacist's lack of access to their medical records. CONCLUSION: Australian users of statin and OC medications showed a high level of support for CD. Given that a significant proportion of patients temporarily stopped treatment when they ran out of medications and had no valid prescription, implementation of CD may alleviate the negative consequences of therapy interruption in statin and OC users in the short term. Longer-term solutions and opportunities to expand CD require further exploration.

Nature and frequency of medication errors in a geriatric ward: an Indonesian experience.

PURPOSE: To determine the nature and frequency of medication errors during medication delivery processes in a public teaching hospital geriatric ward in Bali, Indonesia. METHODS: A 20-week prospective study on medication errors occurring during the medication delivery process was conducted in a geriatric ward in a public teaching hospital in Bali, Indonesia. Participants selected were inpatients aged more than 60 years. Patients were excluded if they had a malignancy, were undergoing surgery, or receiving chemotherapy treatment. The occurrence of medication errors in prescribing, transcribing, dispensing, and administration were detected by the investigator providing in-hospital clinical pharmacy services. RESULTS: Seven hundred and seventy drug orders and 7,662 drug doses were reviewed as part of the study. There were 1,563 medication errors detected among the 7,662 drug doses reviewed, representing an error rate of 20.4%. Administration errors were the most frequent medication errors identified (59%), followed by transcription errors (15%), dispensing errors (14%), and prescribing errors (7%). Errors in documentation were the most common form of administration errors. Of these errors, 2.4% were classified as potentially serious and 10.3% as potentially significant. CONCLUSION: Medication errors occurred in every stage of the medication delivery process, with administration errors being the most frequent. The majority of errors identified in the administration stage were related to documentation. Provision of in-hospital clinical pharmacy services could potentially play a significant role in detecting and preventing medication errors.

Proton pump inhibitor-associated hypomagnesemia: what do FDA data tell us?

BACKGROUND: Proton pump inhibitors (PPIs) are a class of medications indicated for the treatment of gastric acid-related diseases. Hypomagnesemia is a rare but serious adverse effect of PPIs. OBJECTIVE: To address the association between the use of different PPIs and hypomagnesemia by examining the frequency of occurrence of hypo magnesemia among the reported adverse drug reactions from the Food and Drug Administration (FDA) Adverse Event Reporting System database. METHODS: We conducted a cross-sectional study of PPI-associated adverse effect cases reported to the FDA between November 1, 1997, and April 1, 2012. Logistic regression was used to examine the association of sex, age, and different PPIs with hypomagnesemia. χ² analysis was conducted to investigate the association of PPI-associated hypomagnesemia with hypocalcemia and hypokalemia. RESULTS: Among 66,102 subjects identified as experiencing 1 or more adverse effects while taking a PPI, 1.0% (n = 693) were reported to have hypomagnesemia. The mean (SD) age of PPI users presenting with hypomagnesemia was 64.4 (12.9) years. Results from logistic regression indicated that, compared with esomeprazole, all other PPIs had a higher rate of hypomagnesemia, with pantoprazole having the highest rate (OR 4.3; 95% CI 3.3-5.7; p < 0.001). The risk of female subjects having hypo magnesemia (OR 0.83; 95% CI 0.71-0.97; p = 0.016) was significantly lower than that of males. Elderly subjects (age >65 years) were at increased risk of PPI-associated hypomagnesemia (OR 1.5; 95% CI 1.2-1.7; p < 0.001). χ² analysis showed strong association between hypomagnesemia and both hypocalcemia (p < 0.001) and hypokalemia (p < 0.001). CONCLUSIONS: All PPIs were associated with hypomagnesemia, with esomeprazole having the lowest risk and pantoprazole having the highest risk. The risk of PPI-associated hypomagnesemia was higher in males and the elderly population. Hypocalcemia and hypokalemia commonly coexisted with PPI-associated hypomagnesemia.

The prevalence of co-administration of clopidogrel and proton pump inhibitors.

BACKGROUND: Recent studies have suggested that proton pump inhibitors (PPIs) may inhibit the antiplatelet activity of clopidogrel, increasing the risk of major cardiovascular events in patients taking clopidogrel and PPIs together. AIM: The primary aim of this study was to determine the prevalence of co-prescription of clopidogrel and PPIs amongst residents of aged-care facilities in New South Wales, Australia. METHODS: One-year prescription records of 791 aged-care residents were analysed for prevalence of co-prescribing of clopidogrel and PPIs, and aspirin with clopidogrel and PPIs. Prevalence of co-prescribing of clopidogrel, aspirin and PPI in diabetic patients and clopidogrel with various CYP2C19 inhibitors was also examined. RESULTS: Of the 791 residents studied, 60 were prescribed clopidogrel, 248 were on aspirin and 326 were prescribed a PPI. Among residents who were prescribed PPIs, 155 were prescribed omeprazole, 72 pantoprazole, 15 lansoprazole, 44 esomeprazole and 51 rabeprazole. Eleven of these residents had taken more than one PPI during the study period. Thirty-nine residents took a combination of clopidogrel and a PPI (any PPI) for a mean 203 days (SD 12). Thirteen residents were on the combination of aspirin and clopidogrel for a mean of 202 days (SD 111). Nine residents took the combination of clopidogrel, aspirin and a PPI (any PPI) for a mean of 173 days (SD 81). Only one patient on clopidogrel was receiving a CYP2C19 inhibitor in addition to a PPI. CONCLUSIONS: A significant number of residents in this cohort were taking a combination of clopidogrel and a PPI, mainly omeprazole. Residents who were on the combination of clopidogrel and a PPI, with or without aspirin, were on these combinations for a significantly long duration, which could increase their risk of adverse cardiovascular events.

Amiodarone-induced pulmonary toxicity.

AIMS: A number of factors have been hypothesized to increase the risk of amiodarone-induced pulmonary toxicity (AIPT). This study aimed to confirm these risk factors and determine whether a cohort of tertiary hospital patients diagnosed with AIPT demonstrated comparable characteristics. METHODS: Phase I of this study involved compilation of a database of adverse reactions to amiodarone reported to the Australian and US drug agencies, and identification of risk factors for AIPT using logistic regression analysis. In Phase II, AIPT cases were identified via a retrospective review of medical records of patients discharged from Fremantle Hospital and Health Service, Western Australia (FHHS) between 2000 and 2005 with diagnosed interstitial lung disease. Data were collected regarding these patients' risk factors for AIPT and compared with those previously identified in Phase I. RESULTS: A total of 237 cases of AIPT were identified from agency data. Patients aged > 60 years and those on amiodarone for 6-12 months (odds ratio 18.28, 95% confidence interval 6.42, 52.04) were determined to be at the highest risk of AIPT. Australian data also suggested increased risk in patients who had received cumulative doses of 101-150 g. The seven AIPT cases identified among the FHHS patients were all at high risk of AIPT based on their age and duration of amiodarone therapy. CONCLUSION: Contrary to previous findings, only patient age and the duration of amiodarone therapy were confirmed as significant risk factors for AIPT. Targeted monitoring of these patients may facilitate early identification and management of AIPT.