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Table 2 Characteristics of studies (Part 2)

From: Adverse drug reactions in primary care: a scoping review

Study authorTypes of adverse eventsClasses of drugs associated with drug reactionsIncidence/prevalencecausesConsequences
Gandhi et al [26]Drug related and allergic reactions.
These included:
central nervous system (33%), gastrointestinal events (22%) and cardiovascular events (18%)
Selective serotonin- reupake inhibitors (18, 10%)
Beta-blockers (16, 9%)
Angiotensin-converting-enzyme inhibtors (15, 8%)
Nonsteroidal anti-inflammatory agents (15,8%)
Calcium-channel blocers (12, 7%)
Penicillins (7, 4%)
Oral corticosteroids (7, 4%)
Nonnarcotic analgesic agents (6, 3%)
The rate of adverse events reported in this staged was 27 per 100 patientsAn inappropriate choice of drugs, drug interaction drug allergy in individual patients. When physicians failed to respond to medication-related symptoms when patients failed to inform physicians about medication-related symptoms.Fatal and life threatening 0%
Serious 13%
Significant 87%
Preventable
Gurwitz et al [27]Drug related events:
Neuropsychiatric - 199 (24%)
Haemorrhagic - 159 (20%)
Gastrointestinal - 140 (17%)
Renal/electrolytes - 80 (10%)
Metabolic/endocrine - 64 (8%)
Dermatological - 36 (4%)
Cardiovascular 36 (4%)
- Warfarin - 121 (15%)
Atypical antipsychotic agents - 92 (11%) Loop diuretics - 69 (8%) Opioids - 51 (6%)
Antiplatelets - 46 (6%)
ACE inhibitors - 45 (6%)
Antidepressants - 43 (5%)
Laxatives - 43 (5%)
Benzodiazepines - 39 (5%)
There were 815 adverse drug events, of which
42% were judged preventable. The overall rate of adverse drug events were 9.8 per 100 resident- months.
Dispensing errors
Monitoring errors
Prescribing errors (wrong drug choice, wrong dose)
Death (< 1%)
Life threatening (4%)
Serious (23%)
Less serious (72%)
Hakkarainen et al [28]Drug related
- gastrointestinal disorders (21.6%)
- General disorders and administration site conditions (12.3%)
- Cardiac disorders (8.9%)
- Nervous system disorders (8.8%)
- Vascular disorders (8.8%)
- Psychiaric disorders (7.8%)
- Investigations (5.8%)
Respiratory, thoracic and mediastinal disorders (4.7%)
- Drugs for the nervous system (psychoanaleptics 17.8%, psycholeptics 15.6%, analgesics 14.1%)
- Drugs for the cardiovascular system to 37.8% (β-adrenoceptor blocking agents 15.6%, diuretics 14.1%, agents acting on the renin-angiotensin system 11.9%).
- Drugs for blood 9.6% (antithrombotic agents 8.1%)
- Drugs for the musculoskeletal system 8.2% (antiinflammatory and anti-rheumatic products 7.4%)
The 3 month prevalence of serious ADEs in the general population was 1.2% (95% CI 0.9, 1.6%).
- In 4970 included individuals the prevalence of ADEs was 12.0% (95% confidence interval (CI) 11.1, 12.9%).
-Advanced age
-Other causes not specified
• Hospital admission (14%)
Jacobs & Ross [29]Drug related, allergic and idiosyncratic
- Seizures
- Peripheral neuropathy
- Hearing loss and vestibular
disturbances
- Psychoses and confusion
- Gastrointestinal symptoms
(nausea, vomiting and
diarrhoea)
- Jaundice
- Arthralgia
- Skin rashes
Highly active antiretroviral therapy and Anti-tuberculosis
Drugs
-terizidone,
-ethionamide
-Rifampicin
-Ethionamide
-Stavudine
Adverse events were recorded for 80.6% of patients- HIV positive patients were more likely to experience ADR than HIV negative patients• Unspecified
Kaushal et al [30]Drug related, allergic- Penicillin or derivative
-Steroids, inhaled
- Antifungal, topical
- Antihistamine
- Histamine H2 receptor antagonist - Bronchodilators, inhaled
- Cephalosporins
- Macrolides
- Steroids, oral
- Ophthalmic preparations
- Stimulants
- Ibuprofen
There was a total of 57 preventable ADEs (rate 3%; 95% CI, 3–4%) and
226 non- preventable ADEs (rate 13%; 95% CI,11–15%) in the medical care of 1788 patients.
Drug administration
Lack of patient education about adverse events
Delay in notifying about adverse events
None of the preventable ADEs were life threatening,8(14%) were
serious
Kowski et al [31]Drug related
sleepiness,
difficulty concentrating, tiredness,
memory problem.
Antiepileptics (levetiracetam, lamotrigine, valproic acid, controlled- release carbamazepine)Of the Lack of the 438 patients included, 91 (21%) of them had a Liverpool Adverse event profile of more than 45 indicating a high burden of adverse events.-Females
-Drug resistance
-lack of seizures remission
-partial epilepsy
Dose reduction
Change to another anti-epileptic
Lahon et al [32]Drug related;
- neurological
- gastrointestinal
- hepatic
- dermatological
- haematological
- endocrinological
Antipsychotics, antidepressants and mood stabilisers
-serotonin norepinephrine
reuptake inhibitors (SNRI),
-duloxetine,
-Selective serotonin reuptake
There was 119 of adverse drug reactions recorded in 64 cases of the 222 patients included.unspecifiedNo life threatening adverse event was reported
Li & Tian [33]Drug related, allergic and idiosyncratic (Type A and B) drug reactions
- Gastrointestinal
- Central nervous system related
- Respiratory
Oral antibiotics used to treat skin conditionsThere were 18 type A ADR that are gastrointestinal-related (12), elevated liver enzymes (2), central nervous system related (2), phototoxicity (1), and amenorrhea (1). There were 10 type B ADR consisting of urticaria (8), exanthema (1), and respiratory related (1). There were 4 ADR in NCCMERP category D and 24 ADR in the category EunspecifiedUnspecified
Lin et al [34]Drug relatedElderly patients receiving inappropriate medications (PIM);
- Amiodarone
- Chlorzoxazone
- Bisacodyl
- Nifedipine
- Amitriptyline
The incidence of adverse outcome in patients receiving potentially inappropriate medications was 25.1% compared to 17.5% in patients not receiving PIMs (P < 0.001).Elderly patients prescribed a large number if medications
Advanced age
Emergency visits (14.6%).
Hospitalization (10.1%),
Death (0.4%)
Milligan et al [35]Drug relatedInsulin therapy and oral therapyThere were 684 reports related to insulin and 84 incidents related to oral glucose-lowering agents.-Advanced age
- administration/supply (69%)
- wrong/unclear dose
- wrong Strength (25%),
- omission of medicine (17%)
-Wrong frequency (12%)
-Prescribing error (19%)
no harm one death was reported
Montserrat-Capella et al [36]Drug related, allergic - hallucinations, −gastrointestinal bleeding, −constipation/diarrhoea,
-convulsions, electrolyte imbalance,
-falls
- metabolic alkalosis,
-nausea/vomiting and
-sexual dysfunction
Only specified in specific case studies where examples of adverse events are identified. (e.g. patient diagnosed with Parkinson treated with pramipexole and carbidopa had side effects such as nausea, vomiting and cramps)The prevalence of adverse events was 5.2% (95%CI 4.2–6.1%)-Insufficient knowledge of the disease by physician (14.7%),
-Short consultation time not being long enough (8.6%)
-Incomplete physical examination of the patient (6.9%),
-Inappropriate follow-up interval (5.2%). -Patient complexity (11.9%)
Hospital admission
Moderate disability to patients (12%).
Serious harm to patients (21.4%)
Rosales et al. (abstract) [37]Drug relatedBiological agent Biological agents
- (Etanercept (21.3)
- Infliximab (22.4%)
- Adalimumab (27.3%)
- Rituximab (19.2%)
- Other BA [Golimumab,
Certolizumab, Abatacept and Tozilizumab])
There were 286 courses of biological agents therapy in 146 patients.-Infection (50%)
-Advanced age
-Concomitatnt use of corticosteroids
-Presence of co-morbidities
Functional loss Infection
Death 2.7%
Discontinuation of medication (71% in the first year of treatment)
Schildmeijer et al [38]Drug related, allergic, idiosyncratic
- Healthcare-associated
infections
- Falls
- Pressure ulcers
- Skin, vessel or tissue harm
- Pain
- Psychological harm
- Other
- Neurological harm
Unspecified356 cases of AEs were identified in home care records. (37.7%; 95% CI 33.0 to 42.8)-Medical conditions (cardiac arrest, DVT, falls, nutritional, pain, oral health, self-inflicted harm)
- Laboratory modules
- Medication modules
- Continuity and transition modules
Temporary harm that required addition or extended healthcare (69.1%)
Shehab et al [39]Drug related, allergic
Allergic
1. diarrhoea, dizziness,
- Penicillins
- Cephalosporins
- Fluoroquinolones
- Sulfonamides and
trimethoprim
- Macrolides and ketolides
- Lincosamides
(clindamycin)
- Metronidazole
- Nitrofurans (nitrofurantoin)
- Vacomycin and linezolid
- Unspecified and other
antibiotics
- Two antibiotics from
different drug classes
From 6614 cases, systemic antibiotic accounted for 19.3% of the total ED visits for drug-related adverse events.
A total of 78.7% of drug-related adverse effects were attributed to allergic reaction and 6.1% led to hospitalization
Allergic reactionsHospitalisations (6.1%)
ED visits (19.3%)
Theitler et al. (Abstract) [40]Drug related fatigue (55.3%), dizziness (18.4%), tremor (15.8%),Different treatment of AED
- phenytoin,
-gabapentin,
-levetiracetam
-lamotrigine
Adverse drug reactions were reported by 34.9 to 49.1% during various visits.-ComorbiditiesSlower titration dose of Levetiracetam
Tomlin et al [41]Drug related, allergic
- Nausea, vomiting
- Headaches
- Sweating
- Sedation/drowsiness
- Tremors/shaking
- Diarrhoea
- Insomnia
- Anxiety/increased anxiety
- Dizziness
- Light-headedness
- Skin Rash
- Anaphylaxis
- Selective serotonin reuptake inhibitors (SSRIs)
-Antibacterials
-Analgesics
-antihypertensive
-lipid modifying agents
-skin preparations
37,397 reported cases of allergies, adverse events and other warnings, a total of 7.4% of all patients.
Adverse event were reported to be related to antibacterial (47.9%), NSAIDs (10.5%), analgesics(7.8%), antihypertensive medicines, lipid-modifying agents and skin preparations
Inconsistent consultation notes, drug safety signals and other medical warnings.Treatment changes
Tsang et al [42]Drug related, allergic idiosyncratic- Amoxycillin
-Systemic antibiotics
- BCG Vaccine
- Penicillins
- Anti-rheumatics
- Atenolol
- Simvastatin
- Salicylates
The rate of adverse drug reactions was 1.26 reactions per 1000 consultations.Patients over 65 years Computerized medical records IatrogenicEmergency visits hospital admission
Woods et al [43]Drug relatedunspecifiedThere were 827 medication related adverse events (31.7%) of all adverse events.
Preventable medications related adverse events were found to be 13.1% ranging from 3.1 to 23.1%.
medication factors (sound-alike, look alike medications) patient-related lack of educationHospitalisations
Serious permanent injuries
Death
Wucherer et al [44]Drug related-Cholinesterase inhibitors
-Anticholinergic drugs
-Antidementia drugs
6% of the study participants reported adverse drug event related to a prescribed medication
Of the 446 participants, 414 had at least one Drug related problem (92.8%).
Adverse events were observed in 27 participants with Drug related problem (6.1%).
-Administration and compliance problems
-Drug interactions
-Inappropriate drug choice
-Total number of drugs taken
-Formal diagnosis of a mental or behavioural disorder
• unspecified