Drug-induced Adverse Events

Drugs that Suppress Lactation, Part 2.

Fri, 2018-09-07 06:22
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Drugs that Suppress Lactation, Part 2.

Breastfeed Med. 2017 05;12:199-201

Authors: Anderson PO

PMID: 28338339 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

The Pregnancy-Breastfeeding Interface.

Fri, 2018-09-07 06:22
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The Pregnancy-Breastfeeding Interface.

Breastfeed Med. 2017 Jan/Feb;12:2-4

Authors: Anderson PO

PMID: 27935739 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

[Current characteristics of tuberculosis and human immunodeficiency virus co-infection in a cohort of hospitalized patients in Medellín, Colombia].

Thu, 2018-09-06 08:57
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[Current characteristics of tuberculosis and human immunodeficiency virus co-infection in a cohort of hospitalized patients in Medellín, Colombia].

Biomedica. 2018 Aug 01;38(0):59-67

Authors: Ruiz L, Maya MA, Rueda ZV, López L, Vélez LA

Abstract
INTRODUCTION: Tuberculosis (TB) is an important cause of morbidity and mortality in HIV patients. It is unknown if the advent of molecular diagnostic methods and a greater availability of antiretroviral therapy (ART) in our country have changed some characteristics of the TB/HIV co-infection.
OBJECTIVE: To describe the epidemiology, clinical features, diagnosis, resistance patterns, tuberculosis drug effects and mortality in co-infected patients.
MATERIALS AND METHODS: Retrospective study based on the review of medical records of hospitalized co-infected adults in a university hospital in Medellín, Colombia.
RESULTS: A total of 178 patients was included in the study. TB and HIV diagnosis was simultaneous in 49.4%. In the moment of TB diagnosis, the median CD4 count was 61 cells/μL (27-145). Pulmonary tuberculosis (PTB) occurred in 28% of patients, extrapulmonary (EPTB) in 23%, and mixed TB in 48.9%. The main EPTB affectations were lymphatic (55.4%), gastrointestinal (35.9%), and of the central nervous system (18.7%). Ziehl-Neelsen stain was positive in 137 patients (77%), mycobacterium culture in 121 (68%), and TB-PCR, in 85 of those patients in whom the test was done. Rifampicin resistance was detected in six cases (4.9%). Transaminases (ALT) increased in half of the patients during TB treatment, but only 10% met liver-toxicity criteria. In-hospital mortality was 11.3%. The single risk factor associated with mortality was CD4 count <50/μL (RR=3.9; 95% CI: 1.36-11.37; p=0.01).
CONCLUSIONS: When it occurs as an opportunistic infection, TB usually leads to the diagnosis of advanced HIV disease. If used appropriately, TB diagnosis in these patients can be done by conventional methods. It is always necessary to monitor liver function during TB treatment and to rule out drug resistance.

PMID: 30184364 [PubMed - in process]

Categories: Literature Watch

[The safety of decitabine as bridging pretreatment regimen before hematopoietic stem cell transplantation in pediatric hematological malignancies].

Thu, 2018-09-06 08:57
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[The safety of decitabine as bridging pretreatment regimen before hematopoietic stem cell transplantation in pediatric hematological malignancies].

Zhonghua Nei Ke Za Zhi. 2018 Sep 01;57(9):679-682

Authors: Fan LY, Hu SY, Xiao PF, Lu J, Li J, Yao YH, Ling J, Kong LJ, Liu H, Bian XN

Abstract
The safety of decitabine as bridging treatment before allogeneic hematopoietic stem cell transplantation (allo-HSCT) in children with refractory hematological malignancies was evaluated. All 11 cases succeeded in hematopoietic reconstitution. The main adverse reaction was hematological toxicity. Neither did infections occur, nor drug-induced liver damage and renal impairment during decitabine administration. Most cases showed grade Ⅰ-Ⅱgastrointestinal adverse events. One case was diagnosed as severe acute graft versus host disease and died of intracranial hemorrhage on day 61 after allo-HSCT. The other 10 patients survived. Decitabine bridge is a safe regimen before allo-HSCT in children with refractory hematological malignancies.

PMID: 30180454 [PubMed - in process]

Categories: Literature Watch

Causes of low peak bone mass in women.

Thu, 2018-09-06 08:57
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Causes of low peak bone mass in women.

Maturitas. 2018 May;111:61-68

Authors: Chew CK, Clarke BL

Abstract
Peak bone mass is the maximum bone mass that accrues during growth and development. Consolidation of peak bone mass normally occurs during early adulthood. Low peak bone mass results from failure to achieve peak bone mass genetic potential, primarily due to bone loss caused by a variety of conditions or processes occurring at younger ages than usual. Recognized causes of low peak bone mass include genetic causes, endocrine disorders, nutritional disorders, chronic diseases of childhood or adolescence, medications, and idiopathic factors.

PMID: 29673833 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

[Safety of SGLT2 inhibitors. A review of the adverse drug reactions registered in a national database].

Thu, 2018-09-06 08:57
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[Safety of SGLT2 inhibitors. A review of the adverse drug reactions registered in a national database].

Semergen. 2018 Jan - Feb;44(1):23-29

Authors: Esteban-Jiménez O, Navarro-Pemán C, Urieta-González L

Abstract
OBJECTIVE: To analyse the adverse drug reactions (ADRs) caused by Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) notified in Spain since they have been on the market.
MATERIAL AND METHODS: An analysis was made of all the notifications registered in the Spanish Pharmacovigilance System of drugs for human use, arising from the use of SGLT2i.
RESULTS: A total of 311 notifications were recorded, of which 169 (54.34%) were related to dapagliflozin, 81 (26.05%) to empagliflozin, and 61 (19.61%) to canagliflozin. There was a ratio of 52.1% women to 47.9% men. The mean age was 62.07±12.17years. There were 167 (53.7%) notifications were classified as non-serious and 144 (46.3%) as serious. A total of 534 ADRs were notified, with the most common being urinary tract infections in 37 (6.9%) cases, diabetic ketoacidosis in 30 (5.6%), balanoposthitis in 24 (4.5%), ketoacidosis in 16 (3%), vulvovaginal candidiasis in 16 (3%), dizzy spells in 11 (2.1%), and 10 (1.9%) with dysuria, Candida balanitis, and vulvovaginal pruritus. As regards the outcomes of the 534 ADRs, 55.6% recovered with no sequelae, with 14% still recovering, 4.9% not recovered, fatal in 1.1%, and unknown in 24.3%.
CONCLUSIONS: The majority of the ADRs notified are infections of the urogenital tract, ketoacidosis, and kidney damage. Although the majority of the former were not serious, the ketoacidosis and kidney damage were, leading to hospital admission and being life threatening in some patients. For these reasons, it is recommended that they are, prescribed with caution, the warnings published by the health authorities consulted, as well as notify any ADR that is suspected in this therapeutic group, in order to improve and provide us with further knowledge.

PMID: 29183654 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Choosing Medication Alternatives During Breastfeeding, Avoiding Alternative Facts.

Thu, 2018-09-06 08:57
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Choosing Medication Alternatives During Breastfeeding, Avoiding Alternative Facts.

Breastfeed Med. 2017 Jul/Aug;12(6):328-330

Authors: Anderson PO

PMID: 28650212 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

The Pharmacoeconomic Aspects of Antibiotic Stewardship Programs.

Wed, 2018-09-05 08:22
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The Pharmacoeconomic Aspects of Antibiotic Stewardship Programs.

Med Clin North Am. 2018 Sep;102(5):937-946

Authors: Cunha CB

Abstract
Optimal antimicrobial therapy must take into account the key factors in antibiotic selection, that is, spectrum, tissue penetration, resistance potential, safety profile, and relative cost-effectiveness. The least expensive drug is usually accompanied by other concerns, such as high resistance potential, poor side effect profile, pharmacokinetic properties that limit penetration into target tissue (site of infection), and/or suboptimal activity against the presumed/known pathogen. It is false economy to preferentially select the least expensive antibiotics solely because of its acquisition cost. Therapeutic failure and hidden costs may make an apparently less expensive antibiotic most costly in the end.

PMID: 30126582 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Legal Liability of Generic vs Brand Drug Manufacturers for Inadequate Product Labels.

Wed, 2018-09-05 08:22
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Legal Liability of Generic vs Brand Drug Manufacturers for Inadequate Product Labels.

JAMA. 2018 Aug 14;320(6):547-548

Authors: Boumil MM, Curfman G

PMID: 30039167 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Exercise caution in prescribing medications for lower urinary tract symptoms in the elderly

Wed, 2018-09-05 08:22
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Exercise caution in prescribing medications for lower urinary tract symptoms in the elderly

Ceylon Med J. 2017 12 26;62(4):253--54

Authors: Fernando DM, Goonawardena SA

PMID: 29394866 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Prevalence and nature of statin drug-drug interactions in a university hospital by electronic health record mining.

Wed, 2018-09-05 08:22
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Prevalence and nature of statin drug-drug interactions in a university hospital by electronic health record mining.

Eur J Clin Pharmacol. 2018 Apr;74(4):525-534

Authors: Morival C, Westerlynck R, Bouzillé G, Cuggia M, Le Corre P

Abstract
AIM: Our aim was to describe prevalence, nature, and level of severity of potential statin drug-drug interactions in a university hospital.
METHODS: In a cross-sectional study, statin drug-drug interactions were screened from medical record of 10,506 in-patients treated stored in the clinical data warehouse "eHOP." We screened drug-drug interactions using Theriaque and Micromedex drug databases.
RESULTS: A total of 22.5% of patients were exposed to at least one statin drug-drug interaction. Given their lipophilicity and CYP3A4 metabolic pathway, atorvastatin and simvastatin presented a higher prevalence of drug-drug interactions while fluvastatin presented the lowest prevalence. Up to 1% of the patients was exposed to a contraindicated drug-drug interaction, the most frequent drug-drug interaction involving influx-transporter (i.e., OATP1B1) interactions between simvastatin or rosuvastatin with cyclosporin. The second most frequent contraindicated drug-drug interaction involved CYP3A4 interaction between atorvastatin or simvastatin with either posaconazole or erythromycin. Furthermore, our analysis showed some discrepancies between Theriaque and Micromedex in the prevalence and the nature of drug-drug interactions.
CONCLUSIONS: Different drug-drug interaction profiles were observed between statins with a higher prevalence of CYP3A4-based interactions for lipophilic statins. Analyzing the three most frequent DDIs, the more significant DDIs (level 1: contraindication) were reported for transporter-based DDI involving OATP1B1 influx transporter. These points are of concern to improve prescriptions of statins.

PMID: 29255993 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Adverse drug reaction reporting: how can drug consumption information add to analyses using spontaneous reports?

Wed, 2018-09-05 08:22
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Adverse drug reaction reporting: how can drug consumption information add to analyses using spontaneous reports?

Eur J Clin Pharmacol. 2018 Apr;74(4):497-504

Authors: Svendsen K, Halvorsen KH, Vorren S, Samdal H, Garcia B

Abstract
PURPOSE: Spontaneous reporting of adverse drug reactions (ADRs) is a cornerstone in pharmacovigilance. However, information about the underlying consumption of drugs is rarely used when analysing spontaneous reports. The purpose of this study was to combine ADR reports with drug consumption data to demonstrate the additional information this gives in various scenarios, comparing different drugs, gender-stratified sub-populations and changes in reporting over time.
METHODS: We combined all Norwegian ADR reports in 2004-2013 from the EudraVigilance database (n = 14.028) with dispensing data from the Norwegian Prescription Database (more than 800 million dispensed prescriptions during 2004-2013). This was done in order to calculate drug-specific consumption-adjusted adverse drug reaction reporting rates (CADRRs) by dividing the number of reports for each drug with the number of users of the drug during the same time period.
RESULTS: Among the ten drugs with the highest number of ADR reports and the ten drugs with the highest CADRR, only four drugs were in both categories. This indicates that drugs with a high number of reports often also have a high number of users and that CADRR captures drugs with potentially relevant safety issues but a smaller number of users. Comparing reported ADRs in females and males using methylphenidate, we found that the two groups report different ADRs. Finally, we showed that changes in ADR reporting for simvastatin and atorvastatin during 2004-2013 were due to changes in consumption and that atorvastatin had a higher CADRR but fewer reports than simvastatin.
CONCLUSIONS: CADRR provides additional information compared with number of reports alone in studies using spontaneous reports. It is important for researchers to adjust for consumption whenever possible in pharmacovigilance studies.

PMID: 29255992 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Categorization and association analysis of risk factors for adverse drug events.

Wed, 2018-09-05 08:22
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Categorization and association analysis of risk factors for adverse drug events.

Eur J Clin Pharmacol. 2018 Apr;74(4):389-404

Authors: Zhou L, Rupa AP

Abstract
PURPOSE: Adverse drug events (ADE) are among the leading causes of morbidity and hospitalization. This review analyzes risk factors for ADE, particularly their categorizations and association patterns, the prevalence, severity, and preventability of ADE, and method characteristics of reviewed studies.
METHODS: Literature search was conducted via PubMed, Science Direct, CINAHL, and MEDLINE. A review was conducted of research articles that reported original data about specific risk factors for ADE since 2000. Data analyses were performed using Excel and R.
RESULTS: We summarized 211 risk factors for ADE, and grouped them into five main categories: patient-, disease-, medication-, health service-, and genetics-related. Among them, medication- and disease-related risk factors were most frequently studied. We further classified risk factors within each main category into subtypes. Among them, polypharmacy, age, gender, central nervous system agents, comorbidity, service utilization, inappropriate use/change use of drugs, cardiovascular agents, and anti-infectives were most studied subtypes. An association analysis of risk factors uncovered many interesting patterns. The median prevalence, preventability, and severity rate of reported ADE was 19.5% (0.29%~86.2%), 36.2% (2.63%~91%), and 16% (0.01%~47.4%), respectively.
CONCLUSIONS: This review introduced new categories and subtypes of risk factors for ADE. The broad and in-depth coverage of risk factors and their association patterns elucidate the complexity of risk factor analysis. Managing risk factors for ADE is crucial for improving patient safety, particularly for the elderly, comorbid, and polypharmacy patients. Some under-explored risk factors such as genetics, mental health and wellness, education, lifestyle, and physical environment invite future research.

PMID: 29222712 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

A comparison of two tools to screen potentially inappropriate medication in internal medicine patients.

Wed, 2018-09-05 08:22
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A comparison of two tools to screen potentially inappropriate medication in internal medicine patients.

J Clin Pharm Ther. 2018 Apr;43(2):232-239

Authors: Blanc AL, Spasojevic S, Leszek A, Théodoloz M, Bonnabry P, Fumeaux T, Schaad N

Abstract
WHAT IS KNOWN: Potentially inappropriate medication (PIM) is an important issue for inpatient management; it has been associated with safety problems, such as increases in adverse drugs events, and with longer hospital stays and higher healthcare costs.
OBJECTIVE: To compare two PIM-screening tools-STOPP/START and PIM-Check-applied to internal medicine patients. A second objective was to compare the use of PIMs in readmitted and non-readmitted patients.
METHOD: A retrospective observational study, in the general internal medicine ward of a Swiss non-university hospital. We analysed a random sample of 50 patients, hospitalized in 2013, whose readmission within 30 days of discharge had been potentially preventable, and compared them to a sample of 50 sex- and age-matched patients who were not readmitted. PIMs were screened using the STOPP/START tool, developed for geriatric patients, and the PIM-Check tool, developed for internal medicine patients. The time needed to perform each patient's analysis was measured. A clinical pharmacist counted and evaluated each PIM detected, based on its clinical relevance to the individual patient's case. The rates of screened and validated PIMs involving readmitted and non-readmitted patients were compared.
RESULTS: Across the whole population, PIM-Check and STOPP/START detected 1348 and 537 PIMs, respectively, representing 13.5 and 5.4 PIMs/patient. Screening time was substantially shorter with PIM-Check than with STOPP/START (4 vs 10 minutes, respectively). The clinical pharmacist judged that 45% and 42% of the PIMs detected using PIM-Check and STOPP/START, respectively, were clinically relevant to individual patients' cases. No significant differences in the rates of detected and clinically relevant PIM were found between readmitted and non-readmitted patients.
WHAT IS NEW AND CONCLUSION: Internal medicine patients are frequently prescribed PIMs. PIM-Check's PIM detection rate was three times higher than STOPP/START's, and its screening time was shorter thanks to its electronic interface. Nearly half of the PIMs detected were judged to be non-clinically relevant, however, potentially overalerting the prescriber. These tools can, nevertheless, be considered useful in daily practice. Furthermore, the relevance of any PIM detected by these tools should always be carefully evaluated within the clinical context surrounding the individual patient.

PMID: 28990244 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Drug-related problems identified during medication review before and after the introduction of a clinical decision support system.

Wed, 2018-09-05 08:22
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Drug-related problems identified during medication review before and after the introduction of a clinical decision support system.

J Clin Pharm Ther. 2018 Apr;43(2):224-231

Authors: Verdoorn S, Kwint HF, Hoogland P, Gussekloo J, Bouvy ML

Abstract
WHAT IS KNOWN AND OBJECTIVE: To facilitate the identification of drug-related problems (DRPs) during medication review, several tools have been developed. Explicit criteria, like Beers criteria or STOPP (Screening Tool of Older Peoples' Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) criteria, can easily be integrated into a clinical decision support system (CDSS). The aim of this study was to investigate the effect of adding a CDSS to medication review software on identifying and solving DRPs in daily pharmacy practice.
METHODS: Pre- to post-analysis of clinical medication reviews (CMRs) performed by 121 pharmacies in 2012 and 2013, before and after the introduction of CDSS into medication review software. Mean number of DRPs per patient, type of DRPs and their resolution rates were compared in the pharmacies pre- and post-CDSS using paired t tests.
RESULTS AND DISCUSSION: In total, 9151 DRPs were identified in 3100 patients pre-CDSS and 15 268 DRPs were identified in 4303 patients post-CDSS. The mean number of identified DRPs per patient (aggregated per pharmacy) was higher after the introduction of CDSS (3.2 vs 3.6 P < .01). The resolution rate was lower post-CDSS (50% vs 44%; P < .01), which overall resulted in 1.6 resolved DRPs per patient in both groups (P = .93). After the introduction of CDSS, 41% of DRPs were detected by the CDSS. The resolution rate of DRPs generated by CDSS was lower than of DRPs identified without the help of CDSS (29% vs 55%; P < .01). The two most prevalent DRP types were "Overtreatment" and "Suboptimal therapy" in both groups. The prevalence of "Overtreatment" was equal in both groups (mean DRPs per patient: 0.84 vs 0.77; P = .22), and "Suboptimal therapy" was more frequently identified post-CDSS (mean DRPs per patient: 0.54 vs 1.1; P < .01).
WHAT IS NEW AND CONCLUSION: The introduction of CDSS to medication review software generated additional DRPs with a lower resolution rate. Structural assessment including a patient interview elicited the most relevant DRPs. Further development of CDSS with more specific alerts is needed to be clinical relevant.

PMID: 28971492 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Predictivity of Nonclinical Male Reproductive Findings for Human Effects.

Wed, 2018-09-05 08:22
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Predictivity of Nonclinical Male Reproductive Findings for Human Effects.

Birth Defects Res. 2018 01 15;110(1):17-26

Authors: Scialli AR, Clark RV, Chapin RE

Abstract
BACKGROUND: Testing of pharmaceutical products for reproductive toxicity in male laboratory animals is required for registration.
METHODS: We evaluated whether the results of studies showing male reproductive toxicity in experimental animals was predictive of reproductive effects in men participating in clinical trials. We surveyed companies for information on pharmaceutical candidates that had shown male reproductive toxicity in nonclinical studies for which there was information on male reproductive effects in clinical trials.
RESULTS: Among 12 pharmaceutical candidates submitted by five companies, only one compound that had shown male reproductive toxicity in experimental animals also demonstrated reproductive toxicity in men.
CONCLUSION: In this sample of compounds, nonclinical studies appeared to over-predict reproductive toxicity in men. We identified possible reasons for the apparent lack of predictivity of the experimental animal studies. Birth Defects Research 110:17-26, 2018. © 2017 Wiley Periodicals, Inc.

PMID: 28925605 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Ginseng phytochemicals as therapeutics in oncology: Recent perspectives.

Tue, 2018-09-04 07:52
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Ginseng phytochemicals as therapeutics in oncology: Recent perspectives.

Biomed Pharmacother. 2018 Apr;100:52-63

Authors: Majeed F, Malik FZ, Ahmed Z, Afreen A, Afzal MN, Khalid N

Abstract
During the last few decades, cancer has mushroomed as a major health issue; and almost all drugs used for its therapy are very toxic with lethal side effects. Complementary and alternative medicines gain popularity among health professionals in recent era owing to its preventive mechanism against side effect chemotherapeutic drugs. Efforts are focused by scientists to isolate compounds from medicinal plant that have chemotherapeutic attributes; and ability to neutralize the side effects of chemotherapy. Ginseng is an oriental medicinal recipe from Araliceae family and Panax species. The chemotherapeutic effect of ginsenoside is resultant of its appetites, anti-proliferative, anti-angiogenic, anti-inflammatory and anti-oxidant properties. The anticancer effect of ginseng is proven in various types of cancer, including; breast, lung, liver, colon and skin cancer. It increases the mitochondrial accumulation of apoptosis protein and downregulate the expression of anti-apoptotic protein. It also aids in the reduction of alopecia, fatigue and nausea, the known side effects of chemotherapeutic drugs. The aim of the present review is to provide the brief review of the recent researches related to mechanism of action of ginseng in different types of cancer as complementary and alternative medicine on different body organs.

PMID: 29421582 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Healthcare professionals' agreement on clinical relevance of drug-related problems among elderly patients.

Tue, 2018-09-04 07:52
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Healthcare professionals' agreement on clinical relevance of drug-related problems among elderly patients.

Int J Clin Pharm. 2018 Feb;40(1):119-125

Authors: Bech CF, Frederiksen T, Villesen CT, Højsted J, Nielsen PR, Kjeldsen LJ, Nørgaard LS, Christrup LL

Abstract
Background Disagreement among healthcare professionals on the clinical relevance of drug-related problems can lead to suboptimal treatment and increased healthcare costs. Elderly patients with chronic non-cancer pain and comorbidity are at increased risk of drug related problems compared to other patient groups due to complex medication regimes and transition of care. Objective To investigate the agreement among healthcare professionals on their classification of clinical relevance of drug-related problems in elderly patients with chronic non-cancer pain and comorbidity. Setting Multidisciplinary Pain Centre, Rigshospitalet, Copenhagen, Denmark. Method A pharmacist performed medication review on elderly patients with chronic non-cancer pain and comorbidity, identified their drug-related problems and classified these problems in accordance with an existing categorization system. A five-member clinical panel rated the drug-related problems' clinical relevance in accordance with a five-level rating scale, and their agreement was compared using Fleiss' κ. Main outcome measure Healthcare professionals' agreement on clinical relevance of drug related problems, using Fleiss' κ. Results Thirty patients were included in the study. A total of 162 drug related problems were identified, out of which 54% were of lower clinical relevance (level 0-2) and 46% of higher clinical relevance (level 3-4). Only slight agreement (κ = 0.12) was found between the panellists' classifications of clinical relevance using a five-level rating scale. Conclusion The clinical pharmacist identified drug related problems of lower and higher clinical relevance. Poor overall agreement on the severity of the drug related problems was found among the panelists.

PMID: 29248987 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Patient-reported common symptoms as an assessment of interventions in medication reviews: a randomised, controlled trial.

Tue, 2018-09-04 07:52
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Patient-reported common symptoms as an assessment of interventions in medication reviews: a randomised, controlled trial.

Int J Clin Pharm. 2018 Feb;40(1):126-134

Authors: Schoenmakers TWA, Wensing M, De Smet PAGM, Teichert M

Abstract
Background A 'Patient-Reported Outcome Measure, Inquiry into Side Effects' (PROMISE) instrument was developed for patients to report common symptoms in clinical medication reviews. Objective To determine changes in patient-reported drug-associated symptoms collected by PROMISE before and after community pharmacist-led clinical medication reviews compared with usual care. Setting Community pharmacies in the Netherlands. Methods Patients were randomised into an intervention group (IG) and a control group (CG). PROMISE was used to collect symptoms experienced during the previous month, and any suspected drug-associated symptoms from both groups at baseline and at follow-up after 3 months. IG patients received a one-time clinical medication review, while CG patients received usual care. Main outcome measure Mean number of drug-associated symptoms at follow-up. Results Measurements were completed by 78 IG and 67 CG patients from 15 community pharmacies. Mean numbers of drug-associated symptoms per patient at follow-up were 4.0 in the IG and 5.0 in the CG, with an incident rate ratio between the groups of 0.90 (95% CI 0.62-1.33). Mean numbers of drug-associated symptoms per patient reported at follow-up and persisting since baseline were 2.1 in the IG and 2.6 in the CG, with an incident rate ratio of 0.85 (95% CI 0.43-1.42). The lowest percentages of persisting drug-associated symptoms detected in the IG were 'palpitations' and 'stomach pain, dyspepsia' while in the CG they were 'stomach pain, dyspepsia' and 'trembling, shivering'. Conclusion PROMISE provided meaningful information on drug-associated symptoms in clinical medication reviews, however the number of drug-associated symptoms was not reduced by performing clinical medication reviews compared with usual care.

PMID: 29209863 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Drug-related problems identified during geriatric medication review in the community pharmacy.

Tue, 2018-09-04 07:52
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Drug-related problems identified during geriatric medication review in the community pharmacy.

Int J Clin Pharm. 2018 Feb;40(1):109-118

Authors: Rhalimi M, Rauss A, Housieaux E

Abstract
Background In line with the changing role of community pharmacists, we describe here a standardised procedure for detecting DRPs in elderly patients for use in community pharmacies. Objectives The primary aim was to describe the number and type of DRPs identified by community pharmacists in elderly patients. Secondary aims were to determine the number and type of associated pharmacist interventions (PIs) that were transmitted to the prescribers, and to identify risk factors associated with the occurrence of a PI. Setting Community pharmacies. Methods In this prospective, multicentre study, pharmacists received patients aged 65 and over. During a 30-min interview with patients who agreed to participate, patient characteristics were recorded such as age, weight, height, frailty (using the Short Emergency Geriatric Assessment grid), estimated renal function and compliance with treatment assessed by the Girerd scale. Main outcome measure DRPs characteristics. Results A total of 892 patients agreed to participate in 55 pharmacies. Among them 334 DRPs were identified and were associated with 259 PIs. Eighty-nine PIs of 259 were sent to the prescribing physicians; 70 (78%) were implemented by the general practitioner. Factors associated with the occurrence of a DRP are compliance problems [odds ratio (OR) = 1.8, 95% confidence interval (CI) (1.26-2.58)], frailty [OR = 1.3, 95% CI (1.01-1.66)], number of prescribed drugs per day [OR = 1.46, 95% CI (1.02-2.07)] and GFR < 60 mL/min [OR = 1.49, 95% CI (1.01-2.2)]. Conclusion This is the first standardised pharmaceutical assessment dedicated to the elderly carried out by community pharmacists in France. If implemented, it could help to find drug-related problems, identify frail elderly patients and ultimately decrease their exposure to iatrogenic medication errors.

PMID: 29188412 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

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