Knowledge of relevant regulatory considerations related to quality data collection Adequate knowledge of the use of MedDRA for coding purposes, as applicable. This is particularly important for concepts such as coding of definitive versus provisional diagnoses (with or without symptoms) and not inferring diagnoses A thorough understanding of and compliance with an organisation’s agreed-upon “data process to clarify information The “Data Quality, Coding and MedDRA” presentation in the ‘General/Basics’ section of the “Training Materials” page of the MedDRA website () is another useful resource. This customisable slide set is intended for use at investigator meetings and for training personnel involved with data collection (such as clinical research associates and clinical coordinators). It provides an overview of the importance and benefits of good quality data as it relates to MedDRA. Quality assurance checks A thoughtful and thorough quality assurance (QA) process supports the goal of maximising data quality. QA checks during the data management process ensure compliance with established organisational procedures and metrics. Examples of inaccurate MedDRA coding which QA checks could identify include: Reported Inaccurately Selected LLT QA Review Outcome Allergic to CAT scan Allergic to cats This inaccurate LLT was selected by an autoencoder which matched the words “Allergic to CAT scan” from the reported term Feels pressure in eye Intraocular pressure This inaccurate LLT refers to the name of the test for intraocular pressure; the appropriate term to reflect the symptom being described in the report would be LLT Sensation of pressure in eye These checks can identify coding errors with MedDRA before the database is locked and erroneous data become part of a data analysis.
Seek clarification whether the report is a device issue or a device use error, since this is a very important distinction. Attempt to code the verbatim information and avoid inferences. Examples for Coding Medication Errors This sub-section provides examples for coding medication errors in various categories. The tables are organised in the following way: The first column describes a scenario The second column indicates whether this scenario is considered a medication error in the context of the MTS:PTC or not, or if this is unknown from the provided information The third column provides the selected LLT(s) and, if helpful, the relevant PT(s) or HLT(s) The fourth column provides additional comments and explanations regarding the term selection The LLTs may fall into more than one category and the concepts presented may overlap across tables. Accidental exposures to products Scenario Medication error? LLT Comment A died after accidental exposure to a transdermal patch which had fallen off another person and got stuck to the child Yes Accidental exposure to product by child Medicinal adhesion issue In this example, the poor adhesion is a contributing quality issue. Death would be captured as an outcome. Person tried to commit suicide by overdosing on prescription opioids and heroin No Multiple drug overdose intentional Attempted suicide This is not a medication error as the person intended to overdose Person took street heroin to get high but died of a heroin overdose No Overdose Opioid abuse It is not known that the overdose was intentional; do not code as accidental overdose because the scenario is in the context of drug abuse, not a medication error. Death would be captured as an outcome.
Parent accidentally injected himself in the while using an auto-injector to administer the drug to the child Yes Accidental exposure while administering drug The parent was not the intended patient and was accidentally exposed to the drug. The selected LLT captures the reported information with specificity, e.g., that the accidental exposure occurred administering the drug. Patient with visual impairment experienced choking after accidentally swallowing a desiccant tube that was the same colour and similar size as the tablets in the bottle Yes Accidental ingestion of product desiccant Product appearance confusion Choking Accidental exposure is captured as well as the contributing factor of look-alike product confusion. LLT Visual impairment be captured in medical history. 2-year-old child took some antibiotics that were accidentally left on the kitchen counter Yes Accidental drug intake by child Adolescent died of overdose taking 200 doses of a nasal inhalant in under 15 minutes, in an attempt to get high No Drug abuse Overdose Overdose in the context of abuse is not a medication error nor Intentional misuse (which implies therapeutic use according to the table in MTS:PTC, Section 3.16). Death would be captured as an outcome. Adult ingested 2 tablets of 100 mg strength Unknown This is not an informative report and further information should be sought. There is nothing to code in the provided text. Adult intentionally ingested 2 tablets of 100 mg strength No Intentional misuse by dose change This is an example of intentional misuse and
for his back pain instead of the recommended 1 tablet is not a medication error Miscellaneous medication errors/issues Scenario Medication error? LLT Comment Pharmacist reported that the product label was confusing and that it could result in a patient receiving the wrong dosage form Yes Circumstance or information capable of leading to medication error Product label confusion Wrong dosage form This is an example of a potential medication error since the report does not state that the wrong product was actually dispensed or administered. The LLT Circumstance or information capable of leading to medication error captures that the error is a potential one. The most specific code for the reported type of potential medication error should be selected and the contributing factor, label confusion. Patient drew her insulin out of the pen with a syringe because she was confused by the numbers on the outside of the dosage window, and did not want to mistakenly take too much insulin using the pen Yes Wrong device used Product design confusion The patient uses a device to prevent an error, due to her initial confusion with the pen markings. The confusion and the consequent use of the wrong device are both within a scenario of a medication error, so there is no need to add Intentional device misuse. Patient experienced hypoglycaemia after he used his insulin pen cartridge as a vial. He reported that he did so because he had leftover insulin syringes and did not want to waste them. No Intentional device misuse Hypoglycaemia This is an example of Intentional misuse: there is a therapeutic purpose but there is no mention of a medication error
Wrong dose administered Patient split their tablet (labelling doesn’t advise against splitting the tablet) No The report does not mention an error, instead it confirms that this is not a medication error because the label does not advise not to split. There is nothing to code in the provided text. Prescriber advised patient to split the tablet, unaware that the labelling states to swallow whole. Patient split the tablets. Yes Drug prescribing error Tablet split by mistake This is a prescribing error that resulted in the patient splitting the tablet. This is not a case of off label use, as the prescriber was unaware that the tablet should not be split. Patient should be on Drug A but instead got Drug B; it is unclear where the error occurred Yes Wrong drug This is a “Wrong drug” medication error; the stage where the error occurred is not stated (e.g., at prescribing, dispensing, selection, or administration) A generic was incorrectly substituted for the brand name product although the physician specifically prescribed the brand name product with no substitution Yes Product substitution (HLT Medication errors, product use errors and issues NEC) Patient had thrown medicated opioid patches in the open bin instead of disposing as recommended in the label. Their child experienced an overdose after playing with the patches. Yes Incorrect disposal of medication Accidental exposure to product by child Accidental overdose
Product administration errors/issues Dose omission As per the MedDRA Concept Description, dose omission is ‘the failure to administer an ordered dose to a patient before the next scheduled dose, if any. This excludes patients who refuse to take a medication, a clinical decision (e.g., contraindication), or other reasons not to administer (e.g., patient sent for test). For the purposes of retrieval and analysis, in general, a dose omission should be considered to be a suspected medication error. There may be scenarios where doses are missed which are not considered medication errors and therefore a term such as LLT Therapy interrupted should be used to help to distinguish these. LLT Therapy interrupted / PT Therapy cessation is included in HLT Therapeutic procedures NEC and is not a medication error concept. Scenario Medication error? LLT Comment Health provider was unable to mix the contents of the two syringes because the plunger was and this resulted in leakage where the two syringes were connected. The defective plunger resulted in the dose not being given. Yes Drug dose omission Syringe This is an example of a product quality issue leading to a medication error Patient was not the dose of the drug, as the nurse accidentally administered the diluent to a patient instead of using the diluent to reconstitute the vial containing the active ingredient Yes Drug dose omission Inappropriate reconstitution technique (PT Product preparation error) Drug administration error In this scenario, a preparation leads to a medication error Missed dose Unknown Missed dose (PT Drug dose omission) Patient couldn’t take medication for a week because the pharmacy was out of the medication No Temporary interruption of therapy Product availability issue This event is neither intentional nor a medication error. Use LLT Temporary interruption of therapy and capture that external factors
Patient taking contraindicated drug Unknown Contraindicated drug administered The report states that the patient is taking a contraindicated drug; circumstances are not provided The drug was administered in the abdomen rather than the arm muscle as recommended Unknown Drug administered at inappropriate site Patient inquired about possible overdose symptoms because she accidentally took an extra dose Yes Extra dose administered The patient is only inquiring about overdose symptoms (not reporting an overdose). Although the LLT does not capture that it was accidental, it falls under HLT Product administration errors and issues. Patient reported taking an expired drug for his headache Unknown Expired drug used Patient experienced respiratory arrest after the nurse misprogrammed the infusion pump to deliver the drug over 5 minutes instead of the intended 50 minutes Yes Drug administration rate too fast Inappropriate device programming Respiratory arrest Patient received oral imaging agent instead of intended IV imaging agent. The oral imaging agent was administered intravenously through a peripheral line by mistake. Yes Wrong drug administered Enteral formulation administered by other route The patient used a cracked insulin cartridge which resulted in a partial dose administered Yes Incorrect dose administered by device Cartridge cracked
Product confusion errors/issues Scenario Medication error? LLT Comment Patient was dispensed Drug Y instead of Drug X due to confusion of product packaging. Drug X and Drug Y had similar looking packaging. Yes Product packaging confusion drug dispensed Patient purchased over the counter (OTC) Drug X 10 g instead of intended Drug X 5 g because of confusion Yes Product confusion Wrong drug strength selected Patient accidentally took the wrong drug for a week because the tablets looked identical to his daily vitamin tablets Yes Look pill appearance Wrong drug administered Mix-up of 5 mg/ml with 50 mg/ml product Yes Wrong strength It is unclear whether the patient was administered the drug. ‘Strength’ pertains to the product itself; ‘dose’ is the amount of drug the patient receives / should receive. Patient was dispensed ‘Drillo’ instead of as the pharmacist misheard the name of the drug as ‘Drillo” when the physician ordered it over the telephone Yes Drug name Wrong drug dispensed Patient experienced skin ulceration applying the wrong topical cream. Error attributed to the creams packaged in the same size tube with similar red font and black background. Yes Product packaging confusion Wrong drug administered Skin ulceration noted that the product is labelled to prepare an IV bag for slow infusion over Yes (potential error) Product packaging confusion Capture the potential error and the contributing factor
recommended storage information. Product stored at wrong temperature. Pharmacy label placed incorrectly Product storage Monitoring errors/issues Scenario Medication error? LLT Comment Patient was hospitalized with thromboembolism because his INR wasn’t monitored as recommended in the labelling Yes Drug monitoring procedure not performed Thromboembolism Patient experienced rhabdomyolysis after taking two drugs that are labelled for a drug-drug interaction Yes Labelled drug-drug interaction medication error Rhabdomyolysis Literature report hypothesised a possible drug interaction caused the patient to experience hypotension No Drug interaction Hypotension Patient experienced type I hypersensitivity after receiving amoxicillin during surgery. The patient’s record had a documented history of amoxicillin allergy. The error was attributed to the lack of interoperability between the anaesthesia software and the hospital’s e-health record. Yes Hypersensitivity type I Documented hypersensitivity to administered drug Device computer software issue
Patient on anticoagulant undergoing surgery but it was not stopped prior to surgery as recommended in the labelling and patient experienced postoperative bleeding Yes Medication monitoring error Failure to suspend medication Postoperative bleeding Provider prescribed two drugs with known drug interaction because he was unaware of the interaction potential Yes Labelled drug-drug interaction medication error Drug prescribing error Preparation errors/issues Scenario Medication error? LLT Comment Caregiver wasn’t aware to remove the inner cover from an insulin pen needle when preparing the pen Yes Product assembly error during preparation for use Selected term, LLT Product assembly error during preparation for use, is more specific to the reported information than LLT Device use error Product was reconstituted with the diluent Yes Wrong solution used in drug reconstitution Pharmacy compounded the wrong strength product Yes Product compounding error Wrong strength Patient received only one component of a product because the wasn’t aware that the two components needed to be mixed together before administration Yes Product preparation error Single component of a two-component product administered
alike Pharmacy prepared incorrect concentration because of confusion related to the way the strengths for the two active ingredients were stated on the Yes Wrong concentration prepared Product confusion The technician didn’t follow the instructions to mix the contents of the vial for 5 minutes reconstitution Yes Product preparation LLT Product preparation error (HLT Product preparation errors and issues) is more specific than LLT Wrong technique in product usage process (HLT Medication errors, product use errors and issues NEC) Respiratory therapist put the canister in an inhaler the wrong way Yes Product assembly error during preparation for use Prescribing errors/issues Scenario Medication error? LLT Comment Drug prescribed in error for unauthorised use Yes Drug prescribing error This is a prescribing error. Off label use should not be coded in addition. Off label use is an intentional act not an error. Prescribed Drug X instead of Drug Y because the names sounded alike Yes Drug prescribing error Drug name It is important to be able to identify the confusion as a root cause Prescribed 4 mg/kg instead of 0.4 mg/kg. Prescriber realised immediately and called nurse but nurse had already administered the drug. Yes Drug dose prescribing error Wrong dose administered Even though the error was detected it was not intercepted in time
Patient was switched to different insulin product but dose adjustment was not written on the prescription. Patient administered the wrong dose and experienced hypoglycaemia. Yes Drug dose prescribing error Wrong dose administered Hypoglycaemia Patient was prescribed 2 times the appropriate dose due to computerised prescriber order entry (CPOE) error Yes Drug dose prescribing error CPOE error Patient with intractable seizures and taking multiple drugs was prescribed a contraindicated drug Unknown Contraindicated drug prescribed LLT Seizures should be captured as medical history Patient was prescribed 0.5 mg to be taken by splitting the 1 mg tablet Unknown No event to code based on the stated information. It is not known if this is a prescribing error, off label use, or neither. If this is the ONLY information, this is not a case and should not be recorded. Patient prescribed 1 tablet daily for insomnia for many years. The product directions state that the product should not be taken for more than 2 weeks. Unknown Inappropriate prescribing Patient hospitalised for withdrawal symptoms after his unspecified opioids were inappropiately downtitrated Unknown Opiate withdrawal symptoms Inappropriate drug titration Patient prescribed 0.25 mg (off-label starting dose) No Off label dosing Physician ordered the wrong rate of administration for the IV Yes Incorrect drug administration rate
drug, and the patient experienced hypotension Hypotension Drug prescribing error When patient became pregnant, neurologist switched her to an extended release product twice daily (off label) instead of recommended once daily administration No Off label use Drug use for unapproved dosing regimen Patient accidentally received duplicate therapy because the prescriber didn’t realise the 2 drugs had the same active ingredient Yes Duplicate drug prescription Duplicate therapy error Product selection errors/issues Scenario Medication error? LLT Comment The patient confirmed that due to the cataract, the patient did not see well and ended up buying the infant formulation Yes Product selection error This is not a product name confusion. Cataract would be captured as medical history. Pharmacist selected the wrong drug because of name confusion, but the error was caught and corrected before the drug was dispensed Yes Intercepted wrong drug selected Drug name confusion It is important to capture the of the error The hospital selected the wrong bag and the patient received a transfusion of the wrong blood type prior to and during surgery Yes product selected Transfusion with incompatible blood ordered the wrong drug from the wholesaler because the drugs were Yes Wrong drug selected Drug name look-alike
be exposed to inappropriate storage conditions by the wholesaler Recalled product manufacturing distribution and storage activities, prior to the product reaching the medication use system Pharmacy mistakenly stocked the wrong drug in the automated dispensing system. Reporter attributed the error to both drugs being packaged in similar sized vials with look-alike container labels. Yes Drug label look-alike Wrong drug stocked Product packaging confusion Product transcribing errors/communication issues Scenario Medication error? LLT Comment Healthcare provider called in a prescription for Drug A, but pharmacy wrote down the prescription as Drug B Yes Transcription medication error Pharmacy dispensed 800 mg strength instead of 600 mg due to data error Yes Product data entry error Wrong drug strength dispensed Physician ordered insulin pens, but a transcription error transpired with the pharmacy and the patient was dispensed insulin in a vial with syringes instead Yes Transcription medication error Wrong device dispensed Patient had an issue communicating and was given the possible diagnosis of autism No Communication disorder Autism Despite the terms “issue” and “communicating” in the example, this is not a medication error and should not be captured under LLT Product