Monitoring, Reporting, and Communicating

Monitoring, Reporting, and CommunicatingADR-Monitoring and Reporting ProgramsA comprehensive ADR-monitoring and reporting program should be an integral part of an organizations overall drug use system.

One form concurrent(during drug therapy) surveillance system is based on reports of suspected ADRs by pharmacists, physicians, nurses, or patients.

Another form of concurrent surveillance monitors for alerting orders.Alerting Orders

Are prescriptions which alert pharmacists that an ADR may have occurred and that an investigation needs to be conducted.Three types of Alerting Orders:Tracer drugs Abrupt discontinuation or decreases in dosage of a drugStat orders for laboratory assessment of therapeutic drug levels

Tracer Drugs

Tracer drugs are commonly used to treat ADRs (e.g., orders for immediate doses of antihistamines, epinephrine and corticosteroids.

When tracer drugs are used, an ADR may have occurred

Abrupt discontinuation or decreases in dosage of a drug

The assumption being that the discontinuation occurred because of a negative reaction to the medicationStat orders for laboratory assessment of therapeutic drug levels

Alerts the pharmacist that some concern exists in the mind of the prescriber that too much or too little drug is in the patients systemOne type of prospective (before drug therapy) surveillance system focuses on monitoring high-risk drugs or patients with a high risk of ADRsHigh-risk drugs:Adrenergic agonist (IV) (e.g., epinephrine)Adrenergic antagonist (IV) (e.g., propanolol, metoprolol)Anesthetics (e.g., Ketamine)Antithrombotics (e.g., Warfarin, low molecular weight Heparin)Cardioplegic SolutionsHypertonic DextroseDialysis Solutions

9High-risk drugs:Epidural and intrathecal medicationsHypoglycemic Agents (P.O)Inotropic Agents (e.g., digoxin, milrinone)InsulinMethotrexate for non-oncologic useSedatives (e.g., Midazolam) Narcotics/ OpiatesNeuromascular blocking agents(e.g., succinylcholine)

10High-risk drugs:NitroprussideOxytocinPotassium Chloride and Sodium Chloride for injectionPromethazine (IV)Radiocontrast agentsTotal parental nutrition

11Populations at greater risk for ADRs are those with the most trouble adjusting to the negative consequences. Those include the following:12Pediatric patients are at greater risk because drug responses are less predictable than with adults due to pharmacokinetic variations.

This problem is aggravated because of the lack of clinical trials conducted in pediatric populations.13Elderly are at greater risk due to issues of polypharmacy, multiple prescribers, adherence problems, changes in renal function and metabolism and greater sensitivity to medications 14Oncology patients commonly suffer ADRs because they are exposed to highly toxic therapeutic regimens and often are immunocompromised. 15What to do when ADRs occur?Prescribers, nurses and pharmacists should be notified ~ Notification should be made to the pharmacy surveillance program for recording and analysis.~Attempts should be made to determine the cause/s of each suspected ADR using the patients16medical and medication history, the circumstances of adverse event, and what might be found in any literature review.

~Ideally, a systematic method for assigning the probability of the reported or suspected ADR (e.g., confirmed or definite, likely, possible and unlikely) should be used to categorize each ADR.17In case SERIOUS or UNEXPECTED ADRs occurIt should be reported to the FOOD and Drug Administration(FDA) or the drugs manufacturer (or both).18Medication Reconciliation

Medication ReconciliationIs the process of resolving discrepancies with what the patient has been taking in the past with what the patient should be taking at the moment.Medication reconciliation is an opportunity for pharmacist to use their knowledge and skills to enhance patient safety by identifying and resolving drug-related problems as patients transition through out the health care systemReconciliation attempts to correct problems such as:Omissions in therapyMedication DuplicationErrors in dosingPotential drug interactions

Medication Reconciliation ProcessVerification~ The most up-to-date list of medications currently being taken by the patient within the hospital or other institution is developed by using one or more sources of information brought to the institutionSources of Informationpharmacy profilemedical recordspatient or caregiver interview patient medication

2. Clarification~ The medication and dosages are checked for appropriateness.

3. Reconciliation~ Clinical decisions are then made based upon a comparison of newly prescribed medications against what was prescribed previously 4. Transmission~Therapy changes are communicated to those people who need to know about the changes including providers on both end of transition (e.g., hospital pharmacist and community pharmacist, surgeon, internist. This includes providing the patient or caregiver with a copy of final medication list.