Background
Material and methods
Definitions of the key concepts used in this study
Drug-related problem (DRP) | An event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes [20]. Drug-related problems can be caused by medication errors, but there might be no error involved. A medication error does not necessarily lead to a drug-related problem; there can be no problem or a potential problem |
Adverse Drug Event (ADE) | |
Potential Adverse Drug Event | Definition 1: Those adverse drug events that did not cause an injury to a patient, but which had the potential to harm [24] Definition 2: A potential adverse drug event is a medication error with the potential to cause an injury, but which does not actually cause any injury, either because of specific circumstances, chance, or because the error is intercepted and corrected [23] |
Medication Error (ME) | Definition 1: A medication error is a failure in the treatment process that leads to, or has the potential to lead to, harm to the patient [12] Definition 2: It is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer [4]. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use Definition 3: A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient [25] |
Adverse Drug Reactions (ADR) |
Aim of the study
Study design and setting
Material
Research method
Aggregated System Category | Aggregated System Subcategory | Aggregated System Sub-subcategory |
---|---|---|
1. Drug selection (n = 22) | 1.1 Inappropriate drug due to contraindication, ineffectiveness, regimen (regular rather than “when required”) or safer alternative available (n = 7) | 1.1.1 Precaution with the use of this drug (n = 1) 1.1.2. Drug (absolutely) contraindicated (n = 5) 1.1.3. An unnecessary drug is taken because of the use of another drug 1.1.4. Drug is not the most safe/effective treatment for the patient’s medical condition according to guidelines (n = 1) 1.1.5. Drug is not effective for the indication being treated 1.1.6. Medical condition is refractory to drug |
1.2 No indication for drug (n = 4) | 1.2.1. No (documented) indication apparent (n = 4) 1.2.2. No indication due to duplication 1.2.3. Indication does not warrant drug treatment | |
1.3 Inappropriate combination of drugs, or drugs and food, or drugs and alcohol (n = 4) | 1.3.1. A drug interaction may cause/causes an undesirable reaction by increasing the therapeutic effect of one or both drugs (n = 3) 1.3.2. A drug interaction may cause/causes an undesirable reaction by decreasing the therapeutic effect of one or both drugs (n = 1) 1.3.3. A drug interaction may cause/causes a hypersensitivity reaction | |
1.4 Indication not treated/missing therapy | (no sub-subcategory) | |
1.5 More cost-effective drug available | (no sub-subcategory) | |
1.6 Synergistic/preventive drug required and not given (n = 7) | 1.6.1. Preventive drug therapy is required to reduce the risk of developing a new condition (n = 2) 1.6.2. A medical condition requires additional pharmacotherapy to attain synergistic or additive effects (n = 5) | |
2. Drug form (n = 1) | 2.1 Inappropriate or suboptimal drug form (n = 1) | (no sub-subcategory) |
3. Dose selection (n = 13) | 3.1 Drug dose too low (n = 1) | (no sub-subcategory) |
3.2 Drug dose too high (n = 8) | (no sub-subcategory) | |
3.3 Dosage regimen not frequent enough | (no sub-subcategory) | |
3.4 Dosage regimen too frequent | (no sub-subcategory) | |
3.5 Deterioration/improvement of disease state requiring dosage adjustment (n = 3) | 3.5.1. Deterioration of disease state requiring dosage adjustment (n = 3) 3.5.2. Improvement of disease state requiring dosage adjustment | |
3.6 Dosage instructions unclear, incomplete, or not understood by patient/carer (n = 1) | (no sub-subcategory) | |
4. Treatment duration (n = 11) | 4.1 Duration of treatment too short (n = 7) | (no sub-subcategory) |
4.2 Duration of treatment too long (n = 4) | (no sub-subcategory) | |
5. Drug use process (n = 18) | 5.1 Inappropriate timing of administration and/or dosing intervals by patient/carer/nurse (n = 5) | (no sub-subcategory) |
5.2 Drug underused/underadministered (n = 4) | 5.2.1. The patient chose to take the wrong dose, which was lower than prescribed 5.2.2. The patient chose to take a drug on a “when required” basis rather than on a regular basis 5.2.3. The patient misunderstood the directions 5.2.4. The patient felt better or worse 5.2.5. The patient had a fear of adverse effects 5.2.6. The patient did not believe the drug was effective/believed the drug was toxic 5.2.7. The patient occasionally forgot to take the drug 5.2.8. The drug was underadministered by the health care professional/carer (n = 4) | |
5.3 Drug overused/overadministered (n = 3) | 5.3.1. The patient chose to take the wrong dose, which was higher than prescribed 5.3.2. The patient misunderstood the directions 5.3.3. The patient forgot they had already taken the drug 5.3.4. The drug was overadministered by carer or health care professional (n = 3) | |
5.4 Drug not taken/administered at all | 5.4.1. The patient chose to discontinue a drug by choice or for an illogical or irrational reason 5.4.2. Patient forgot to take the drug | |
5.5 Wrong drug selected, taken, or administered | (no sub-subcategory) | |
5.6 Drug abused | (no sub-subcategory) | |
5.7 Patient, carer, or nurse unable to use/does not use drug/form as directed (n = 1) | 5.7.1. Patient uses drug incorrectly through difficulty or ignorance 5.7.2. Patient barriers are present (n = 1) | |
5.8 Adequate information not provided or not understood or misunderstood or not followed (n = 5) | 5.8.1. Adequate information about drug not provided (n = 3) 5.8.2. Incorrect information about drug provided 5.8.3. Adequate information about disease state management not provided or not understood or not followed (n = 2) 5.8.4. Incorrect information provided about disease state | |
5.9 Patient uses or stores drug inappropriately | 5.9.1. Inappropriate use/storage 5.9.2. Stockpiling | |
6. Logistics (n = 11) | 6.1 Prescribed drug not available (n = 1) | 6.1.1. The patient/carer had difficulties obtaining the drug 6.1.2. A drug has been discontinued, is not on formulary, or is out-of-stock (n = 1) 6.1.3. A drug order does not meet legislative requirements |
6.2 Drug order incorrect, incomplete, poorly legible/illegible or discrepant (also known as transferring error) (n = 2) | 6.2.1. A drug order is incorrect or incomplete 6.2.2. Drug order/transition of care discrepancy (n = 2) 6.2.3. The way in which information/directions were written caused the patient/carer to misuse the drug | |
6.3 Error in drug selection (n = 8) | 6.3.1. Doctor chooses the wrong drug 6.3.2. Pharmacist selects the wrong/expired drug from dispensary shelf 6.3.3. Nurse administers drug from the wrong patient’s drug chart 6.3.4. Patient takes someone else’s drug (n = 8) | |
7. Monitoring (n = 14) | 7.1 Monitoring too frequent | 7.1.1. Monitoring of disease state too frequent 7.1.2. Therapeutic drug monitoring too frequent 7.1.3. Monitoring for the effect/adverse effect of drug too frequent |
7.2 No or too infrequent monitoring (n = 14) | 7.2.1. Monitoring of disease state absent or too infrequent (n = 4) 7.2.2. Therapeutic drug monitoring absent or too infrequent (n = 5) 7.2.3. Monitoring for the effect/adverse effect of drug absent or too infrequent (n = 5) 7.2.4. Monitoring may have occurred but is unavailable or not documented | |
7.3 Inappropriate test ordered | (no sub-subcategory) | |
7.4 Patient unable to attend/pay for monitoring | (no sub-subcategory) | |
8. Unexpected or adverse drug reaction or no obvious cause of DRP (n = 2) | 8.1 An adverse drug reaction occurred (n = 2) | 8.1.1. A drug causes an undesirable reaction that is not dose related 8.1.2. A drug causes an undesirable reaction at normal therapeutic dose (n = 2) 8.1.3. Allergic drug reaction |
8.2 No obvious cause of treatment failure | (no sub-subcategory) | |
9. Other: A cause that cannot be classified into one of the 8 categories (n = 8) |
Results
Characteristic | N | % |
---|---|---|
Error settinga | 64 | 100 |
Assisted living facility | 16 | 25 |
University hospital (secondary and tertiary care) | 10 | 16 |
Primary care ward (inpatient care outside the hospital) | 10 | 16 |
Central hospital (secondary care) | 10 | 16 |
Primary care hospital | 9 | 14 |
Public health center (outpatient care) | 4 | 6 |
Home care | 3 | 5 |
Community pharmacy | 1 | 2 |
Private medical center (outpatient care) | 1 | 2 |
Severity of harm | 58 | 100 |
Death | 21 | 36 |
Severe harm | 9 | 16 |
Non-severe harm | 19 | 33 |
No harm | 3 | 5 |
Not able to assess | 6 | 10 |