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Despott R, Sultana J, Camilleri L, Vella Szij J, Serracino Inglott A. Risk management of medication errors: a novel conceptual framework. Expert Opin Pharmacother 2023; 24:523-534. [PMID: 36794331 DOI: 10.1080/14656566.2023.2178899] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/17/2023]
Abstract
BACKGROUND Medication error is a common cause of patient harm. The study aims to propose a way to manage the risk of medication errors in a novel way, by identifying practice areas where mitigating patient harm should be prioritized using a risk management approach. METHODS Suspected Adverse Drug Reactions (sADRs) in Eudravigilance database over three years were reviewed to identify preventable medication errors. These were classified using a new method based upon the root cause underlying pharmacotherapeutic failure. The correlation between severity of harm and type of medication error, and other clinical parameters was investigated. RESULTS Overall, 2294 medication errors were identified from Eudravigilance, of which 1300 (57%) were due to pharmacotherapeutic failure. Most cases of preventable medication error involved prescribing (41%) and administration (39%). The variables which significantly predicted severity of medication errors were pharmacological group, patient age, number of drugs prescribed, and route of administration. The drug classes most strongly associated with harm included cardiac drugs, opioids, hypoglycaemics, antipsychotics, sedatives, and antithrombotic agents. CONCLUSION The findings of this study highlight the feasibility of using a novel conceptual framework to identify areas of practice at risk of pharmacotherapeutic failure where Interventions by healthcare professionals in these areas are most likely to improve medication safety.
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Affiliation(s)
| | - Janet Sultana
- Pharmacy Department, Mater Dei Hospital, Msida, Malta.,Exeter College of Medicine and Health, University of Exeter, Exeter UK
| | - Liberato Camilleri
- Department of Statistics and Operations Research, University of Malta, Msida, Malta
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2
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Lonsdale DO, Baker EH, Kipper K, Barker C, Philips B, Rhodes A, Sharland M, Standing JF. Scaling beta-lactam antimicrobial pharmacokinetics from early life to old age. Br J Clin Pharmacol 2018; 85:316-346. [PMID: 30176176 DOI: 10.1111/bcp.13756] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/02/2018] [Revised: 08/02/2018] [Accepted: 08/22/2018] [Indexed: 12/13/2022] Open
Abstract
AIMS Beta-lactam dose optimization in critical care is a current priority. We aimed to review the pharmacokinetics (PK) of three commonly used beta-lactams (amoxicillin ± clavulanate, piperacillin-tazobactam and meropenem) to compare PK parameters reported in critically and noncritically ill neonates, children and adults, and to investigate whether allometric and maturation scaling principles could be applied to describe changes in PK parameters through life. METHODS A systematic review of PK studies of the three drugs was undertaken using MEDLINE and EMBASE. PK parameters and summary statistics were extracted and scaled using allometric principles to 70 kg individual for comparison. Pooled data were used to model clearance maturation and decline using a sigmoidal (Hill) function. RESULTS A total of 130 papers were identified. Age ranged from 29 weeks to 82 years and weight from 0.9-200 kg. PK parameters from critically ill populations were reported with wider confidence intervals than those in healthy volunteers, indicating greater PK variability in critical illness. The standard allometric size and sigmoidal maturation model adequately described increasing clearance in neonates, and a sigmoidal model was also used to describe decline in older age. Adult weight-adjusted clearance was achieved at approximately 2 years postmenstrual age. Changes in volume of distribution were well described by the standard allometric model, although amoxicillin data suggested a relatively higher volume of distribution in neonates. CONCLUSIONS Critical illness is associated with greater PK variability than in healthy volunteers. The maturation models presented will be useful for optimizing beta-lactam dosing, although a prospective, age-inclusive study is warranted for external validation.
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Affiliation(s)
- Dagan O Lonsdale
- Institute for Infection and Immunity, St George's, University of London, London, UK.,St George's University Hospitals NHS Foundation Trust, London, UK
| | - Emma H Baker
- Institute for Infection and Immunity, St George's, University of London, London, UK.,St George's University Hospitals NHS Foundation Trust, London, UK
| | - Karin Kipper
- Institute for Infection and Immunity, St George's, University of London, London, UK.,Institute of Chemistry, University of Tartu, Tartu, Estonia.,Analytical Services International Ltd
| | - Charlotte Barker
- Institute for Infection and Immunity, St George's, University of London, London, UK
| | - Barbara Philips
- Institute for Infection and Immunity, St George's, University of London, London, UK.,St George's University Hospitals NHS Foundation Trust, London, UK
| | - Andrew Rhodes
- St George's University Hospitals NHS Foundation Trust, London, UK
| | - Mike Sharland
- Institute for Infection and Immunity, St George's, University of London, London, UK.,St George's University Hospitals NHS Foundation Trust, London, UK
| | - Joseph F Standing
- Institute for Infection and Immunity, St George's, University of London, London, UK.,St George's University Hospitals NHS Foundation Trust, London, UK.,UCL Great Ormond Street Institute of Child Health, London, UK.,Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
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3
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Inkeri NM, Karjalainen M, Haanpää M, Kautiainen H, Saltevo J, Mäntyselkä P, Tiihonen M. Anticholinergic drug use and its association with self-reported symptoms among older persons with and without diabetes. J Clin Pharm Ther 2018; 44:229-235. [DOI: 10.1111/jcpt.12772] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/14/2018] [Accepted: 09/14/2018] [Indexed: 02/06/2023]
Affiliation(s)
| | - Merja Karjalainen
- Institute of Public Health and Clinical Nutrition, General Practice; University of Eastern Finland; Kuopio Finland
- Inner Savo Health Center; Suonenjoki Finland
| | - Maija Haanpää
- Ilmarinen Mutual Pension Insurance Company; Vantaa Finland
- Department of Neurosurgery; Helsinki University Hospital; Helsinki Finland
| | - Hannu Kautiainen
- Unit of Primary Health Care; Helsinki University Central Hospital; Helsinki Finland
- Primary Health Care Unit; Kuopio University Hospital; Kuopio Finland
| | - Juha Saltevo
- Central Finland Central Hospital; Jyväskylä Finland
| | - Pekka Mäntyselkä
- Institute of Public Health and Clinical Nutrition, General Practice; University of Eastern Finland; Kuopio Finland
- Primary Health Care Unit; Kuopio University Hospital; Kuopio Finland
| | - Miia Tiihonen
- School of Pharmacy; University of Eastern Finland; Kuopio Finland
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Kim SW, Park NC, Lee SW, Yang DY, Park JK, Moon DG, Yang SK, Lee SW, Moon KH, Ahn TY, Kim SW, Park K, Min KS, Ryu JK, Son H, Jung J, Hyun JS. Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial. J Sex Med 2018; 14:1018-1027. [PMID: 28760246 DOI: 10.1016/j.jsxm.2017.06.006] [Citation(s) in RCA: 30] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2017] [Revised: 05/24/2017] [Accepted: 06/18/2017] [Indexed: 11/30/2022]
Abstract
BACKGROUND Phosphodiesterase type 5 inhibitors and α-adrenergic blocking agents (α-blockers) are widely used for the treatment of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). AIMS To assess the efficacy and safety of fixed-dose combinations (FDCs) of tamsulosin and tadalafil compared with tadalafil monotherapy in patients with comorbid BPH-associated LUTS and ED. METHODS A randomized, double-blinded, active-controlled trial was conducted of 510 men with BPH-associated LUTS and ED. Patients were treated with FDCs of tamsulosin 0.4 mg plus tadalafil 5 mg (FDC 0.4/5 mg), tamsulosin 0.2 mg plus tadalafil 5 mg (FDC 0.2/5 mg), or tadalafil 5 mg for a 12-week treatment period. For a subsequent 12-week extension period, the patients were administered FDC 0.4/5 mg. OUTCOMES The primary outcomes were changes from baseline in total International Prostate Symptom Score (IPSS) and International Index of Erectile Function erectile function domain (IIEF-EF) score at week 12 to prove superiority and non-inferiority of FDCs compared with tadalafil 5 mg. The safety assessments were adverse reactions, laboratory test results, and vital signs at week 24. RESULTS The mean changes in total IPSS and IIEF-EF scores were -9.46 and 9.17 for FDC 0.4/5 mg and -8.14 and 9.49 for tadalafil 5 mg, respectively, which indicated superiority in LUTS improvement (P = .0320) and non-inferiority in ED treatment with FDC 0.4/5 mg compared with tadalafil 5 mg. However, the results from FDC 0.2/5 mg failed to demonstrate superiority in LUTS improvement. No clinically significant adverse events regarding the investigational products were observed during the 24-week period. CLINICAL IMPLICATIONS The FDC 0.4/5 mg is the first combined formulation of an α-blocker and a phosphodiesterase type 5 inhibitor that offers benefits in patient compliance and as add-on therapy in patients with comorbid BPH-associated LUTS and ED. STRENGTHS AND LIMITATIONS The study clearly demonstrated the advantage of FDC 0.4/5 mg. The main advantage of FDC 0.4/5 mg was the enhanced efficacy on BPH-associated LUTS comorbidity with ED, the lower incidence of side effects, and the simplification and convenience of therapy, which led to better overall patient compliance. However, the lack of a tamsulosin monotherapy control group was a limitation of this study. CONCLUSION The FDC 0.4/5 mg therapy was safe, well tolerated, and efficacious, indicating that combination therapy could provide clinical benefits for patients with BPH-associated LUTS complaints and ameliorate the comorbidity of ED. Kim SW, Park NC, Lee SW, et al. Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial. J Sex Med 2017;14:1018-1027.
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Affiliation(s)
- Sae Woong Kim
- Department of Urology, The Catholic University College of Medicine, Seoul, Korea
| | - Nam Cheol Park
- Department of Urology, Pusan National University School of Medicine, Busan, Korea
| | - Seung Wook Lee
- Department of Urology, Hanyang University College of Medicine, Seoul, Korea
| | - Dae Yul Yang
- Department of Urology, Hallym University College of Medicine, Seoul, Korea
| | - Jong Kwan Park
- Department of Urology, Chonbuk National University Medical School, Jeonju, Korea
| | - Du Geon Moon
- Department of Urology, Korea University College of Medicine, Seoul, Korea
| | - Sang-Kuk Yang
- Department of Urology, Konkuk University School of Medicine, Seoul, Korea
| | - Sung Won Lee
- Department of Urology, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Ki Hak Moon
- Department of Urology, Yeungnam University College of Medicine, Daegu, Korea
| | - Tai Young Ahn
- Department of Urology, Ulsan University College of Medicine, Seoul, Korea
| | - Soo Woong Kim
- Department of Urology, Seoul National University College of Medicine, Seoul, Korea
| | - Kwangsung Park
- Department of Urology, Chonnam National University Medical School, Gwangju, Korea
| | - Kweon Sik Min
- Department of Urology, Inje University College of Medicine, Busan, Korea
| | - Ji-Kan Ryu
- Department of Urology, Inha University School of Medicine, Incheon, Korea
| | - Hankil Son
- Clinical Research Team, Hanmi Pharmaceutical Co, Ltd, Seoul, Korea
| | - Jina Jung
- Clinical Research Team, Hanmi Pharmaceutical Co, Ltd, Seoul, Korea
| | - Jae Seog Hyun
- Department of Urology, Gyeongsang National University College of Medicine and Hospital, Jinju, Korea.
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Yong J, Lin D, Tan XR. Primary prevention of cardiovascular disease in older adults in China. World J Clin Cases 2017; 5:349-359. [PMID: 29026833 PMCID: PMC5618113 DOI: 10.12998/wjcc.v5.i9.349] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/28/2017] [Revised: 05/22/2017] [Accepted: 06/12/2017] [Indexed: 02/05/2023] Open
Abstract
Over the past two decades, the percentage of Chinese who is 60 years or older has increased from 5.2% in 1995 to 10.5% in 2015. Approximately 16% of the population in China was 60 years old and above in 2015. Since 1990, cardiovascular disease (CVD) has been the leading cause of death in China. Cardiovascular medications of older adults are usually more complicated than younger age groups due to polypharmacy, the presence of comorbidities and more susceptible to treatment-related adverse outcomes. Therefore, effective primary prevention of CVD for older adults is important in sustaining the health of older adults and reducing the burden of the healthcare system. Proper management of CVD-related risk factors, such as hypertension, dyslipidemia, diabetes and obesity, can remarkably reduce risks of CVDs in older Chinese. These risk factors can be modified by managing blood pressure, glucose and lipids via lifestyle modifications or receiving medications. Smoking cessation, healthy diets, strict alcohol intake and moderate physical exercise are examples of recommended lifestyle changes for remarkably recovering health conditions of older adults who have hypertension, dyslipidemia, obesity, diabetes or complications. Treatment prescriptions of older adults, in general, are recommended to be individualized and to be initiated at a low dose. The future directions for better primary CVD prevention in older adults include establishing guidelines for primary prevention of CVD for different older adults and further research on better management strategies of CVD risks for elderly Chinese.
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Affiliation(s)
- Jian Yong
- First Affiliated Hospital of Shantou University Medical College, Shantou 515041, Guangdong Province, China
| | - Dong Lin
- First Affiliated Hospital of Shantou University Medical College, Shantou 515041, Guangdong Province, China
| | - Xue-Rui Tan
- First Affiliated Hospital of Shantou University Medical College, Shantou 515041, Guangdong Province, China
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Raikou V, Varvaresou A, Panderi I, Papageorgiou E. The efficacy study of the combination of tripeptide-10-citrulline and acetyl hexapeptide-3. A prospective, randomized controlled study. J Cosmet Dermatol 2017; 16:271-278. [PMID: 28150423 DOI: 10.1111/jocd.12314] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 01/03/2017] [Indexed: 02/03/2023]
Abstract
BACKGROUND Bioactive peptides have beneficial effects on the skin. OBJECTIVE We investigated to evaluate the effect of acetyl hexapeptide-3 and tripeptide-10 citrulline and the possible synergism between these two peptides. METHODS Twenty-four healthy volunteers were randomized to receive combination of acetyl hexapeptide-3 with tripeptide-10 citrulline (Group G1), tripeptide-10 citrulline (Group, G2), acetyl hexapeptide-3 (Group G3), or neither peptide (Group G4) for 60 days. Skin properties evaluated included skin microtopography, parameters cR2 and cR3, and transepidermal water loss (TEWL) using a skin visioscan and a tewameter, respectively. RESULTS After 20 days, the measurements between G1 and G2 groups (cR2 P=.045, cR3 P=.044), G2 and G3 groups (cR2 P=.017, cR3 P=.017), G3 and G4 groups (CR2 P=.022), and G2 and G4 groups (cR3 P=.028) from baseline were significant. After 60 days, measurements between groups G1 and G3 (cR2 P=.016, cR3 P=.025), groups G2 and G3 (cR2 P=.044, cR3= P=.044), and groups G1 and G4 (cR2 P=.025) were significant. After 20 days, changes in TEWL between groups G1 and G3 (P=.03), groups G2 and G3 (P=.045), and groups G3 and G4 (P=.025) were significant. After 40 days, changes between groups G2 and G3 (P=.028) and groups G3 and G4 (P=.01) from baseline were significant. CONCLUSION Our results confirm the antiwrinkle activity of acetyl hexapeptide-3. A significant decrease in TEWL with acetyl hexapeptide-3 treatment is observed. We provided clinical evidence for the antiwrinkle efficacy of tripeptide-10 citrulline and possibly TEWL. The underlying mechanism by which these two peptides can act synergistically was not clear in this study.
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Affiliation(s)
- Vassiliki Raikou
- Laboratory of Cosmetic Science, Department of Aesthetics and Cosmetology, Technological Educational Institute of Athens, Athens, Greece
| | - Athanasia Varvaresou
- Laboratory of Cosmetic Science, Department of Aesthetics and Cosmetology, Technological Educational Institute of Athens, Athens, Greece
| | - Irene Panderi
- Division of Pharmaceutical Chemistry, School of Pharmacy, University of Athens, Athens, Greece
| | - Effie Papageorgiou
- Department of Medical Laboratories, Technological Educational Institute of Athens, Athens, Greece
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Klamer TT, Wauters M, Azermai M, Durán C, Christiaens T, Elseviers M, Vander Stichele R. A Novel Scale Linking Potency and Dosage to Estimate Anticholinergic Exposure in Older Adults: the Muscarinic Acetylcholinergic Receptor ANTagonist Exposure Scale. Basic Clin Pharmacol Toxicol 2017; 120:582-590. [DOI: 10.1111/bcpt.12699] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/22/2016] [Accepted: 11/01/2016] [Indexed: 12/13/2022]
Affiliation(s)
- Therese T. Klamer
- Division of Pharmacoepidemiology & Clinical Pharmacology; Utrecht Institute for Pharmaceutical Sciences; Utrecht University; Utrecht The Netherlands
- Heymans Institute of Pharmacology; Clinical Pharmacology Research Unit; Ghent University; Ghent Belgium
| | - Maarten Wauters
- Heymans Institute of Pharmacology; Clinical Pharmacology Research Unit; Ghent University; Ghent Belgium
| | - Majda Azermai
- Heymans Institute of Pharmacology; Clinical Pharmacology Research Unit; Ghent University; Ghent Belgium
| | - Carlos Durán
- Heymans Institute of Pharmacology; Clinical Pharmacology Research Unit; Ghent University; Ghent Belgium
- Ecuadorian Center for Clinical Research, Health Information and Assessment (CIEC); Yachay Public Company; Quito Ecuador
| | - Thierry Christiaens
- Heymans Institute of Pharmacology; Clinical Pharmacology Research Unit; Ghent University; Ghent Belgium
| | - Monique Elseviers
- Heymans Institute of Pharmacology; Clinical Pharmacology Research Unit; Ghent University; Ghent Belgium
- Centre For Research and Innovation in Care (CRIC); University of Antwerp; Wilrijk Belgium
| | - Robert Vander Stichele
- Heymans Institute of Pharmacology; Clinical Pharmacology Research Unit; Ghent University; Ghent Belgium
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Fontenot HB, Collins Fantasia H. Women's Health, Pharmacology, and Aging. J Obstet Gynecol Neonatal Nurs 2014; 43:224-5. [DOI: 10.1111/1552-6909.12283] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022] Open
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