Adverse Drug Events in Patients with Dementia and Neuropsychiatric/Behavioral, and Psychological Symptoms, a One-Year Prospective Study
Abstract
:1. Introduction
2. Methods
2.1. Design and Study Setting
2.2. Definitions
- The Barthel index, a scale that measures disability or dependence on activities of daily living. Its values range between 0 and 100, with the lowest score indicating a high dependency [28].
- The global deterioration scale (GDS) determines cognitive function. It has 7 different stages: Stages 1–3 are the pre-dementia stages, and stages 4–7 are the dementia stages [29].
- The Tinetti balance assessment: Scoring of the Tinetti assessment tool is done on a three-point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures: An overall gait assessment score, an overall balance assessment score, and a combined gait and balance score. The maximum score for the gait component is 12 points. The maximum score for the balance component is 16 points. The maximum total score is 28 points. In general, residents who score below 19 are at a high risk of falls. Residents who score in the range of 19–24 points have a risk of falls [33].
- The Downton fall risk index: The Downton fall risk index includes well-documented risk factors for falls and therefore offers satisfactory content validity and also seems to be very easy to administer. The Downton fall risk index includes 11 risk items which are scored at one point each. Scores are summed to give a total index score with a range of 0–11. A score of 3 or more is taken to indicate a high risk of falls [34].
- The anticholinergic burden was determined using the drug burden index (DBI) [35,36]: Anticholinergic burden is defined as the cumulative effect of taking one or more drugs that are capable of producing adverse anticholinergic effects. High scores have been associated with an increased risk of suffering adverse events (including falls, delirium and cognitive disorders). The DBI scale measurement of the anticholinergic effect is based on the calculation of a mathematical formula that takes into account the prescribed dose and the minimum effective dose of the drug.
2.3. Ethics
2.4. Data Collection
- (i)
- Demographic: Age, gender, and length of stay.
- (ii)
- Pharmacological: Number and type of drugs, dosage, frequency, route of administration, and starting prescription date (if possible). Qualitative classification of drugs under the anatomical therapeutic chemical code (ATC) classification system.
- (iii)
- Clinical: Diagnosis (ICD-10 International Classification of Diseases, 10th Revision), dementia type, geriatric syndromes (falls, Tinetti, and Downton), dysphagia, pain, ulcers, constipation, dyspnea, hearing loss, visual impairment, malnutrition, insomnia, depressive-anxiety syndrome, incontinence, and cognitive assessment (according to the GDS-FAST scale, functional assessment (according to the Barthel Index)).
2.5. Statistical Analysis
3. Results
3.1. General Characteristics
3.2. Adverse Drug Events
3.3. Adverse Drug Events-Falls
4. Discussion
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Variable | Results |
---|---|
Number of patients | 65 |
Age | 84.85 years (SD = 6.68; rank = 68–96) |
Gender | Women = 39 (60%); men = 26 (40%) |
Place of origin | Home = 36 (55.4%); acute hospital = 27 (41.5%); intermediate care = 2 (3.1%) |
Length of stay (days) | 58. 5 (median) |
Geriatric syndromes | Previous falls = 47 (72.30%) previous fractures 12 (18.46%) |
Constipation = 44 (67.7%) | |
Depression/anxiety = 21 (32.3%) | |
Dysphagia = 21 (32.3%) | |
Dyspnea = 3 (4.6%) | |
Hearing loss = 10 (15.4%) | |
Incontinence = 44 (67.7%) | |
Insomnia = 22 (33.8%) | |
Malnutrition = 6 (9.2%) | |
Pain = 15 (23.1%) | |
Ulcers = 16 (24.6%) | |
Visual impairment = 21 (32.3%) | |
Type of dementia | Alzheimer’s disease = 20 (30.8%) |
Vascular = 5 (7.7%) | |
Mixed = 3 (4.6%) | |
Diagnosis not completed = 28 (43.1%) | |
Lewy body = 5 (7.7%) | |
Others = 4 (6.2%) | |
Functional abilities (Barthel Index) | Some dependence or independence (BI 80–100) = 6 (9.2%) |
Slight dependence (BI 60–75) = 16 (24.6%) | |
Moderate dependence (BI 40–55) = 18 (27.7%) | |
Severe dependence (BI 20–35) = 12 (18.5%) | |
Total dependence (BI 0–15) = 13 (20%) | |
Cognitive function (Global deterioration scale (GDS)) | Incipient (GDS 3) = 16 (24.6%) |
Mild (4) = 18 (27.7%) | |
Moderate (5) = 16 (24.6%) | |
Severe (6) = 13 (20.0%) | |
Very severe (7) = 2 (3.1%) | |
Comorbidity | Certain infectious and parasitic diseases 3 (4.6%) |
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism 10 (15.4%) | |
Diseases of the circulatory system 54 (83.1%) | |
Diseases of the digestive system 15 (23.1%) | |
Diseases of the ear and mastoid process 5 (7.7%) | |
Diseases of the eye and adnexa 11 (16.9%) | |
Diseases of the genitourinary system 21 (32.3%) | |
Diseases of the musculoskeletal system and connective tissue 19 (29.2%) | |
Diseases of the nervous system 18 (27.7%) | |
Diseases of the respiratory system 8 (12.3%) | |
Diseases of the skin and subcutaneous tissue 1 (1.5%) | |
Endocrine, nutritional and metabolic diseases 39 (60%) | |
Injury, poisoning and certain other consequences of external causes 17 (26.2%) | |
Mental and behavioral disorders 10 (15.4%) | |
Neoplasms 11 (16.9%) | |
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified 9 (13.8%) |
Anatomical Main Group | Therapeutic Subgroup | Drug | n ADE | % |
---|---|---|---|---|
A—Alimentary tract and metabolism | 2 | 4 | ||
Drugs for acid related disorders | 1 | 2 | ||
Ranitidine | 1 | 2 | ||
Drugs used in diabetes | 1 | 2 | ||
Metformin | 1 | 2 | ||
C—Cardiovascular system | 8 | 16 | ||
Agents acting on the renin-angiotensin system | 1 | 2 | ||
Losartan | 1 | 2 | ||
Antihypertensives | 2 | 4 | ||
Doxazosin | 2 | 4 | ||
Calcium channel blockers | 2 | 4 | ||
Diltiazem | 1 | 2 | ||
Nifedipine | 1 | 2 | ||
Cardiac therapy | 2 | 4 | ||
Digoxin | 1 | 2 | ||
Nitroglycerin (patches) | 1 | 2 | ||
Diuretics | 1 | 2 | ||
Furosemide | 1 | 2 | ||
N—Nervous system | 40 | 80 | ||
Analgesics | 7 | 14 | ||
Fentanyl | 2 | 4 | ||
Morphine | 1 | 2 | ||
Pizotifen | 1 | 2 | ||
Tramadol | 3 | 6 | ||
Antiepileptics | 3 | 6 | ||
Valproic acid | 1 | 2 | ||
Clonazepam | 2 | 4 | ||
Psychoanaleptics | 7 | 14 | ||
Citalopram | 1 | 2 | ||
Donepezil | 3 | 6 | ||
Galantamine | 1 | 2 | ||
Mirtazapine | 1 | 2 | ||
Venlafaxine | 1 | 2 | ||
Psycholeptics | 23 | 46 | ||
Haloperidol | 2 | 4 | ||
Lormetazepam | 1 | 2 | ||
Lorazepam | 2 | 4 | ||
Midazolam | 1 | 2 | ||
Olanzapine | 1 | 2 | ||
Quetiapine | 10 | 20 | ||
Risperidone | 6 | 12 |
ADE | n | % |
---|---|---|
Drowsiness/somnolence | 13 | 27.7 |
Weakness and hypoactivity | 6 | 12.8 |
Hypotension | 5 | 10.6 |
Syncope | 4 | 8.5 |
Agitation | 3 | 6.4 |
Hallucinations | 3 | 6.4 |
Delirium | 3 | 6.4 |
Akathisia | 2 | 4.3 |
Hypoglycemia | 2 | 4.3 |
Constipation | 2 | 4.3 |
Nausea and vomiting | 1 | 2.1 |
Diarrhea | 1 | 2.1 |
Tremor | 1 | 2.1 |
Priapism | 1 | 2.1 |
Drug Class | Number of Patients under Prescription | % |
---|---|---|
Hypotensors not diuretics | 13 | 72.2 |
Antidepressants | 11 | 61.1 |
Antipsychotics | 10 | 55.6 |
Benzodiazepines | 9 | 50.0 |
Diuretics | 7 | 38.9 |
Antiparkinsonians | 3 | 16.7 |
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Hernández, M.H.; Mestres, C.; Modamio, P.; Junyent, J.; Costa-Tutusaus, L.; Lastra, C.F.; Mariño, E.L. Adverse Drug Events in Patients with Dementia and Neuropsychiatric/Behavioral, and Psychological Symptoms, a One-Year Prospective Study. Int. J. Environ. Res. Public Health 2019, 16, 934. https://doi.org/10.3390/ijerph16060934
Hernández MH, Mestres C, Modamio P, Junyent J, Costa-Tutusaus L, Lastra CF, Mariño EL. Adverse Drug Events in Patients with Dementia and Neuropsychiatric/Behavioral, and Psychological Symptoms, a One-Year Prospective Study. International Journal of Environmental Research and Public Health. 2019; 16(6):934. https://doi.org/10.3390/ijerph16060934
Chicago/Turabian StyleHernández, Marta H., Conxita Mestres, Pilar Modamio, Jaume Junyent, Lluís Costa-Tutusaus, Cecilia F. Lastra, and Eduardo L. Mariño. 2019. "Adverse Drug Events in Patients with Dementia and Neuropsychiatric/Behavioral, and Psychological Symptoms, a One-Year Prospective Study" International Journal of Environmental Research and Public Health 16, no. 6: 934. https://doi.org/10.3390/ijerph16060934