PHAR 5 – Chapter 6: Medication Safety Safety Medication misadventures iatrogenic hazards or incidents associated with indicated drug therapy resulting in patient harm that can be attributable to error, immunologic response, or idiosyncratic response
Adverse drug events ADRs that result in an injury – injury – large large or small – small – preventable or unpreventable – unpreventable – due due to the use or lack of intended use of a drug expected, well known reactions to medications that are severe enough to require extensive medication management
Drug-related problems events associated with drug therapies hamper optimal patient health medication errors, ADRs, ADEs, and side effects
Drug-related morbidity failure of a drug to achieve its intended health outcome due to unresolved DRPs
Medication errors negative outcomes not all DRPs are medication errors may or may not cause adverse consequences because some mistakes have no clinical effects
Sentinel events unexpected incidents resulting in death or the potential for serious physical or psychological injury they signal the need for immediate investigation and response
Classification based on their impact on patients No Error A Capacity to cause error Error, No harm B Did not reach patient C Reached patient: No harm D Reached Patient and monitored to cause no harm to patient Error, Harm E Temporary harm: required Intervention F Temporary Harm: required hospitalization G Permanent Patient Harm H Required intervention to sustain Life Error, DEATH I Resulted in patient’s patient’s death
Latent injuries propensity or predisposition for harm during the process of care that actually does not result in patient injury
Classification based on where they exist within the medication use system Prescribing
Wrong drug
Transcribing and interpretation Dispensing
Illegible
Administration and monitoring
Correct drug, wrong patient Misinterpretation
Wrong dose, form or route Omission
Error in preparation or calculation Incorrect handling or storage, missed dose
Error in drug utilization review Failure to review a prescribed regimen for appropriaten ess
Potential injuries mistakes in prescribing, dispensing, or medication administration that have the potential to cause an injury but did not, either by luck or because they were intercepted Errors of commission occur when the patient receives either a correct drug or an incorrect drug
Preventing medication errors keep up with the medication literature for drug error information and take action for prevention verify the accuracy of new prescription, data, monitor for errors and near misses, make corrections as needed, and report errors to external reporting programs patient identifies should be verified using bar codes patient should be educated about ways to prevent medication errors patient should be engaged in managing their own medication regimens electronic prescribing should be used trivial warnings to prescribed and pharmacists should be avoided in medication decision-support systems prescription filling technology needs to be assessed and improved monitor patients for high risk side effects review patient medication records especially when transitioning between types of care
Wrong patient or drug Wrong drug, dose, route, administratio n, time, infusion rate
Adverse drug reactions DRPs that are unexpected, unintended, undesired, or excessive responses may or may not be the result of medical error allergic reactions: immunologic hypersensitivities to » drugs » idiosyncratic reactions: abnormal responses drugs that are peculiar to individuals) » side effects: expected, well-known reactions that require little or no change in patient management drug withdrawal symptoms, drug-abuse syndromes, accidental poisonings, and drug overdose complcations
Principles of quality improvement the status quo is unacceptable safety can be enhanced by improving the core processes of the medication use system safety errors must be patient-centered quality must be assured solutions to safety problems should address, not individuals
PDSA Cycle of Safety Improvement Plan – Plan – plan plan your small change Do – Do – implement implement this small change Study – Study – what what impact did this small change have? Act – Act – make make another small change
ADR monitoring and reporting reporting programs Alerting orders - alert pharmacists that an ADR may have occurred and that an investigation needs to be conducted 1. “tracer” drugs – commonly – commonly used to treat ADRs (antihistamines, epinephrine, and corticosteroids) 2. abrupt discontinuation or decrease decrease in dosage of a drug 3. stat orders for laboratory assessments of therapeutic drug levels
At risk of ADRs 1. pediatric patients – patients – less less predictable pharmacokinetics 2. elderly patients – patients – poly poly pharmacy, multiple prescribers, adherence problems, change in renal function and metabolism, greater sensitivity to medications 3. oncology patients – patients – exposed exposed to highly toxic therapeutic regimens and immunocompromised Actions taken after ADRs ADRs 1. prescribers, nurses, pharmacists should be notified 2. determine the cause/s using the patient’s medical and medication history 3. determine the circumstances after the adverse events and what might be found in any literature review 4. assign the probability of the reported or suspected ADR and categorize 5. serious or unexpected ADR should be reported to FDA or manufacturer (or both) Types of ADRs Type A
Augmented, Predictable
Type B
Bizarre, Unpredictable
Type C
End-of-use
Type D
Delayed
Occurs consequent but in excess of drug primary pharmacological effect. Occurs different (idiosyncratic) to known drug pharmacologic effect. Usually due to patient’s genetic defect or immunological response. Of qualitative nature Occurs by sudden stoppage of chronic drug use due to e xisting adaptive changes. Occurs after long period of time even after drug stoppage
Medication reconciliation process of resolving discrepancies with what a patient has been taking in the past with what the patient should be taking at the moment correct problems such as omissions in therapy, medication duplications, errors in dosing, and potential drug interactions conducted each time a patient transitions across departments or locations
Chapter Chapter 7: medication di stribution systems The role of the pharmacist has always been to ensure that patients receive the appropriate medication in an acceptable dosage forms that facilitates safe a dministration and improved outcomes
Medication Distribution Methods
1.
Floor stock system consisted of individual storage area on each nursing unit where medications were kept prior to nurse preparing them to administer to patients medications were largely unsecured pharmacist’s role - place bulk containers of medications in the unit storage area -> Drug room - there were multiple doses in each bottle to supply all patients receiving the drug on the nursing unit nurse’s role - prepare the patient-specific medications for both oral and IV use - would read the physician order, go into the drug room to select the drug and prepare it, and then administer it to the patient - would request new medication (for new orders) to be stocked in the nursing unit other characteristics - pharmacist would never see the physician order - pharmacist would stock the medications - it required minimal pharmacy resources - it was assumed to be safe - patients were charged for the drugs administered to them or were billed a daily fee (per diem) for the drugs Patient prescription system Involved the pharmacist to a greater extent by requiring a review of the patient order Physician writes>nurse transcribes>pharmacist prepares Pharmacist prepares a 2 to 5 day supply of medications for the patient Patients are charged for the medications dispensed Pharmacist’s role - Review the patient order - Place only limited judgement on whether it was correct or appropriate to the patient Nurse’s role - Store the medication in the nursing unit - Prepare the individual dose for the patient - Contact pharmacist to send refills
2.
3.
Unit dose system
Pharmacy-coordinated method dispensing and controlling medications in health care institutions Medications contain in unit dose packages, dispensed in ready-to-administer form and not more than 24-hour supply being delivered Pharmacists dispenses patient-specific medications to be administered, not prepared, b y the nurse Advantages - Reduction in medication errors - Decrease in total cost of medicationrelated activities - More efficient use of pharmacy and nursing personnel - Improved drug control and drug use monitoring - More accurate patient billing for medications - Greater control by pharmacists over work patterns and scheduling - Reduction of inventories maintained on nursing units Other characteristics - Placed pharmacists front and center in the medication use cycle - Required pharmacists to review every medication order prior to dispensing - Duplicate carbon copies were provided to pharmacists to prevent transcription errors - Required the pharmacy to have and maintain a patient medication profile - Carts are filled by technicians and checked by pharmacists Process: 1. Medication orders written and sent to pharmacy 2. Pharmacist receives and reviews order 3. Order is entered into the drug profile 4. Order is filled by tech and checked by pharmacist 5. Medication is set to floor by courier, by pneumatic tube, or with nurse 6. New order is recorded into the MAR (medication administration record) 7. On the unit, nurse checks the medication against the patient’s MAR 8. Nurse administers the medication to the patient 9. Nurse records when and how the drug was administered on the patient’s MAR
Medication delivery from pharmacy to patient care unit Medication category Delivery/storage method Stable scheduled medications A 24-hour supply is kept in a patient- specific bin on the medication cart in the unit Unstable scheduled Automatic delivery of medications medications to the unit 1 hr before administration time Scheduled IV/TPN solutions Automatic delivery of medications to the unit before administration time PRN medications A limited supply is kept in a patient-specific bin on the medication cart Controlled medications A limited patient- specific supply is secured in an automated dispensing cabinet or in a medication cart STAT (immediately) Delivered by the pharmacy in medications response to a request form the unit Emergency medications Emergency drug kits are located on units and replaced by the pharmacy in response to a request from the unit Investigational medications Per investigational drug protocol Models of UDS a. Centralized Emanates from the pharmacy (centralized location) All processes occurs in the main pharmacy – pharmacy – order processing, drug packaging, cart fill, and medication dispensing Advantage: All resources can be localized into one area Drug inventory can be minimized Disadvantage: Pharmacist is not able to directly interact with the physician and nurse Clinical service is limited b. Decentralized There are pharmacy satellites located throughout the institution Order is routed to a designated satellite, processed by the pharmacist and dispenses the first dose of medication directly to the nursing station Pharmacists are closely located to patient care areas There is still a need for a centralized pharmacy Advantages: Faster order filling Increased physician and nursing satisfaction Better professional relationships between pharmacy and the departments Separation of clinical services Fewer dispensing errors Decreased need for floor stock medications
