Table 2 Characteristics of studies (Part 2)

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 patients

An 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.

unspecified

No 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 conditions

There 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 E

unspecified

Unspecified

Lin et al [34]

Drug related

Elderly 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 related

Insulin therapy and oral therapy

There 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 related

Biological 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

Unspecified

356 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 reactions

Hospitalisations (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.

-Comorbidities

Slower 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 Iatrogenic

Emergency visits hospital admission

Woods et al [43]

Drug related

unspecified

There 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 education

Hospitalisations

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