MCG Health. Disclosures. Objectives. Implementing An Adverse Drug Reaction Monitoring Program in the Hospital Setting

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1 MCG Health Implementing An Adverse Drug Reaction Monitoring Program in the Hospital Setting Dianne B. May, Pharm.D., BCPS Associate Professor University of Georgia College of Pharmacy 478-bed Medical Center Ambulatory Care Center with more than 80 outpatient practice sites Specialized Care Center housing a 13-county regional trauma center 154-bed Children s Medical Center Medical College of Georgia the health sciences university of the state of Georgia, composed of the schools of Allied Health, Dentistry, Graduate Studies, Medicine and Nursing Objectives Disclosures After attending the lecture and discussion, the attendee should be able to: Describe the importance of reporting adverse drug reactions within a hospital setting. Describe the possible methods of reporting adverse drug reactions within a hospital setting. Dianne May has nothing to disclose concerning possible financial or personal relationships with commercial entities (or their competitors) mentioned in this presentation. Cite specific examples of pharmacy quality improvement projects based on reported adverse drug reactions. 1

2 Putting Things into Perspective... Interesting statistics from the medical literature A medicine ward: 23% patients had an adverse drug reaction (ADR), 30% of the elderly had ADR Over 15% of people receiving medications say they have experienced an ADR 3-5% of hospital admissions are caused by ADRs In US hospitals, ADRs were responsible for 4.6% of deaths Establishing an Adverse Drug Reaction (ADR) Program 1. Develop definitions and classifications for ADRs 2. Assign responsibility for ADR program and obtain approval from key groups 3. Develop policies and procedures for screening/handling/evaluating ADRs reported including reviewing for trends ASHP Guidelines on Adverse Drug Reaction Monitoring and Reporting. Am J Health-Syst Pharm. 1995;52: Establishing an Adverse Drug Reaction (ADR) Program 4. Promote awareness of adverse drug reactions and importance of reporting Newsletters, s Conferences / Inservices 5. Establish mechanisms for reporting ADRs Form (paper or computerized) Hot line Conferences / Inservices ASHP Guidelines on Adverse Drug Reaction Monitoring and Reporting. Am J Health-Syst Pharm. 1995;52: Step 1: Define and Classify ADRs Define what the institution categorizes as an ADR Many definitions and varying terminology have been described in the literature: Adverse event Adverse drug event Adverse drug reaction Medication error Side effect 2

3 Term Definition Example Adverse Event Adverse Drug Event Making Sense of the Terminology Harm in patient administered medication but not necessarily caused by the medication Harm caused by the use of a medication; may include adverse drug reaction or medication error Traumatic death while taking simvastatin Hematoma from eptifibitide overdose Making Sense of the Terminology Term Definition Example Medication Error Inappropriate use of a medication that may or may not result in harm; may be preventable Error that occurs with prescribing, transcribing, dispensing, administering, adherence or monitoring of a drug Failure to renew prednisone order on transfer from ICU to medical ward ADVERSE DRUG REACTION Harm caused by the use of a medication at normal doses; unexpected Congestive heart failure from metoprolol; anaphylaxis to penicillin Side Effect Usually predictable or dosedependent effect of a medication that is not the principal effect for which the drug was chosen Diphenhydramine causing drowsiness when being used for itching Making Sense of the Terminology MCG Health ADR Definition Medication errors more common than adverse drug events but do not always result in harm ~ 25% of adverse drug events are due to medication errors Any noxious or unintended reaction to a drug that has been administered in standard doses by the proper route for the purposes of prophylaxis, diagnosis, or treatment. World Health Organization Nebecker, et al. Ann Intern Med. 2004;140:

4 Classifying ADRs Why is it Important? Classifications Based on Causality/Probability Helps describe and quantify data Helps organize for presentation Identifies causative drugs to determine trends Identifies drugs that tend to cause most severe reactions so can prioritize activities Causality and probability of ADR Dechallenge / Rechallenge Temporal relationship between medication use and adverse drug effect Time frame Previously reported in literature Tool for assessing Naranjo algorithm Naranjo Algorithm for ADR Causality Assessment Yes No Don t Know 1. Previous reports? Did ADR appear after suspect drug administered? Did ADR improve when drug was discontinued? Did ADR reappear when drug was readministered? Are there alternative causes for reaction? Did reaction appear when a placebo was given? Were serum (or other fluid) concentrations toxic? Was severity of reaction dose-dependant? Did patient have similar reaction to the same or similar drug in any previous exposure? Was ADR confirmed by any objective evidence? Score Naranjo Algorithm Interpretation of the Total Score Score Classification > 9 Highly Probable 5-8 Probable 1-4 Possible 0 or less Doubtful Naranjo CA, Busto U, Sellers EM, et al. Clin Pharmacol Ther 1981;30(2): Naranjo CA, Busto U, Sellers EM, et al. Clin Pharmacol Ther 1981;30(2):

5 Classifications Based on Severity Minor No antidote, therapy or prolonged hospitalization required Moderate Change in drug therapy or specific treatment needed; Increased hospitalization Severe Potentially life-threatening causing permanent damage, or requiring ICU Lethal Directly or indirectly contributes to death of patient Lasagna and Karch classification system MCG Health ADR Classification E. The individual experienced temporary harm and required treatment or intervention. F. The individual experienced temporary harm and required initial or prolonged hospitalization. G. The individual experienced permanent harm. H. The individual experienced harm and required intervention necessary to sustain life (e.g. transfer to ICU). I. The individual died. UHC (University Hospital Consortium) Classifying ADRs Why is it Important? Helps describe and quantify data Helps organize for presentation Identifies causative drugs to determine trends Identifies drugs that tend to cause most severe reactions so can prioritize activities Let s look at some specific examples Classifying ADRs Why is it Important? Helps describe and quantify data 8% (3/37) of ADRs resulted in hospital admission Drug Class Harm Score Total Anti-Infectives E = 8, F = 1 35% (13/37) Contrast Dye E = 2 5% (2/37) Anticoagulants % (4/37) Antihypertensives F = 2, H = 1 11% (4/37) Chemotherapy E = 1, F = 1 11% (4/37) Anxiolytics/ Analgesics E = 1 8% (3/37) 5

6 Classifying ADRs Why is it Important? Helps organize for presentation Classifying ADRs Why is it Important? Identifies causative drugs to determine trends IV Potassium cardiovascular toxicities IV Potassium Guidelines developed IV Phenytoin skin necrosis Distribution from Pharmacy instead of from floor stock system Benzocaine Topical Spray methemoglobinemia Product selection changed Classifying ADRs Why is it Important? Identifies drugs that tend to cause most severe reactions so can prioritize activities Anticoagulation Warfarin every inpatient educated Development of Anticoagulation Clinic Anti-Infectives Pharmacist-run vancomycin and aminoglycoside pharmacokinetic service Antimicrobial Stewardship Program Step 2: Assign Responsibility and Approval for ADR Program Assign who in the pharmacy is responsible for coordinating ADR activities Identify key individuals in other departments Determine reporting and approval structure Pharmacy and Therapeutics Committee Quality Improvement Committee 6

7 Step 3: Develop Policies for Screening/Evaluating ADRs Concurrent monitoring Identify high-risk patients and / or medications (prospective monitoring) Retrospective chart reviews Screen for indicator or trigger drugs/labs indicative of ADRs Review orders to discontinue or hold drugs or changes in dose Metformin (Glucophage ) Provide Concurrent ADR Monitoring Adverse Drug Reaction Monitoring Program Pharmacist/Nurse Communication An oral hypoglycemic agent indicated for the management of type 2 diabetes mellitus as monotherapy when hyperglycemia cannot be managed on diet alone. May be used concomitantly with a sulfonylurea or insulin to improve glycemic control. All medications have the potential for adverse drug reactions. As part of the patient assessment process, please observe your patient for the development of any of the following symptoms or any other unusual or unexpected reactions while he/she is receiving metformin (Glucophage ). Lactic acidosis Abdominal bloating Diarrhea Vomiting Headache Flatulence Anorexia Dizziness Low serum B12 levels Unpleasant/metallic taste NOTE: Metformin is contraindicated in patients with decreased renal function (Scr > 1.4 mg/dl). Temporarily hold prior to and for at least 48 hours subsequent to receiving iodinated contrast media. Reinstitute only after renal function has been re-evaluated and is normal. If any of these adverse reactions are observed, please notify your unit-based pharmacist or the Drug Information Center staff, ext Thank you for your participation in this patient assessment process. PLEASE ATTACH THIS FORM TO THE PATIENT'S MEDICATION ADMINISTRATION RECORD (MAR) FOR THE DURATION OF THERAPY WITH THIS MEDICATION. Identify High-Risk Patients (Prospective ADR Monitoring) Identify High-Risk Medication Classes (Prospective Monitoring) Elderly and pediatric patients Altered pharmacokinetic parameters Less published medical evidence on safe use and dosing guidelines Patients with impaired kidney or liver function Potential for drug accumulation if note dosed properly Polypharmacy (>5 drugs) patients (e.g., elderly, HIV, transplant) Anti-infectives Anti-tumor agents Anticoagulants Cardiovascular agents Anticonvulsive agents Diabetes therapy Antihypertensives Analgesics Anti-asthmatics Sedative-hypnotics Antidepressants Antipsychotics Peptic ulcer therapy Most Frequent Least Frequent 7

8 Screen for Indicator or Trigger Drugs/Labs Indicative of ADRs Example: Use of Trigger Drugs to Identify ADRs Drug Triggers Diphenhydramine Phytonadione Antidiarrheals Sodium Polystyrene Sulfonate Corticosteroids Epinephrine Naloxone Flumazenil Lab Triggers Digoxin Level Gentamicin Level Leukopenia Thrombocytopenia SCr Potassium Level Any drug level Use of Naloxone as Trigger for ADRs Shawn Gahagan, Pharm.D. Student, Tom Flynt, Pharm.D. Inclusion: All patients who received naloxone from April September 2010 Exclusion: Use of reversal for procedural sedation or post-anesthesia care unit or overdose that occurred outside hospital Example: Use of Trigger Drugs to Identify ADRs Naloxone given in 4.6% (17/363) of adult patients An opioid-induced ADR was documented in 94.1% (16/17) of patients Of the patients who received naloxone, 94.1% (16/17) received an appropriate dose of opioid analgesic Reversal of adverse drug reaction documented in 82.4% of patient s charts None were reported in hospital database Example: Use of Trigger Drugs to Identify ADRs Adverse Drug Reactions with Opioid Analgesics n=9 (52.9) n=1 (6) n=4 (23.5) n=3 (17.6) Oversedation Oversedation and Respiratory Depression Respiratory Depression Unknown 8

9 Example: Use of Trigger Drugs to Identify ADRs Opioid Analgesics Suspect for Documented ADR n=4 (23.5) n=4 (23.5) n=1 (6) Hydromorphone IV Hydromorphone PCA Morphine IV Step 4: Promote Awareness and Importance of Reporting s Newsletters Conferences / Inservices Morphine PCA n=4 (23.5) n=4 (23.5) MS Contin Oral Tablet Use of Newsletters to Promote Awareness of ADRs Use of Newsletters to Promote Awareness of ADRs 9

10 Use of Newsletters to Promote Awareness of ADRs Why Is ADR Reporting Important? Identifying patients at high-risk for ADRs Developing programs (educational or systematic) to prevent ADRs Provides forum for discussing managing ADRs and minimizing the effects Clearly defining a new drug s ADR profile as quickly as possible Recognizing a Classic ADR Recognizing a Classic ADR ~ 7 years Hypoprothrombinemia with moxalactam ~ 3-4 years Drug introduced Clindamycin causing pseudomembranous colitis Drug introduced Year Year 10

11 Step 5: Establish Mechanisms for Reporting ADRs Form (paper or computerized database) FDA s MedWatch ( Home grown varieties Hot line Pharmacy Drug Information Center Conferences / Inservices Home Grown Variety.. Paper Form Components of an Adverse Drug Reaction Form Patient identifier Date of event Reaction description Severity classification Medication causing the reaction Action taken Was patient rechallenged Person reporting event Reporting Methods at MCG Health Formal ADR Conferences Call the Pharmacy or tell pharmacist on floor Patient Safety Net (web-based reporting system) MedWatch Form available at FDA.gov FAX or scan to Pharmacy Formal ADR Conferences Two ADR Conferences at MCG Health Department of Internal Medicine ADR conference twice monthly Children s Medical Center ADR conference once monthly Both well attended by physicians, residents, and students 11

12 Formal ADR Conferences ADR Conference Format Goals of ADR Conferences Increase ADR reporting Create opportunity to discuss observed ADRs Provide those in training (and ourselves) with better skills for noticing and reporting ADRs Provide educational materials on drug-induced diseases Create environment for interdisciplinary patient care discussions Share trends and findings from ADR reports Observed ADRs since the last conference General description Patient name, medical record number Outcome Forward information to Pharmacy for documentation Short presentation (20-30 minutes) Pharmacy Allergy/Immunology MCG ADR Conference Use of Flyers to Educate Drug-Induced Fever Trisha Nguyen, PharmD, Pharmacy Practice Resident Gin Fleming, PharmD, Pharmacy Practice Resident Marinda Thomas, PharmD Candidate Jessica Space, PharmD Candidate 12

13 Objectives After attending the ADR Conference, the attendee should be able to: Define the incidence of drug fevers List the most common causative agents Describe the mechanism of drugs causing fever Describe the clinical presentation and differential diagnosis Outline a management strategy for drug fever Other Educational Topics Presented Initiating warfarin therapy ADRs with azoles Safety issues with insulin Adverse reactions with neuroleptics Anticholinergic drug reactions Warfarin drug interactions Proton pump inhibitors as a risk factor for Clostridium difficile diarrhea Use of cough and cold medications in children Educational Topics From Allergy/Immunology Sulfa allergies Penicillin allergies Cephalosporin allergies HIV and drug hypersensitivities Local anesthetic allergy More Educational Topics Drug-induced methemoglobinemia Drug-induced thrombocytopenia Drug-induced delirium Drug-induced pancreatitis Drug-induced osteoporosis Drug-induced oral reactions Drug-induced angioedema 13

14 Improvement in ADR Reporting Trends Improvement in ADR Knowledge Base ADR Conference with Medicine Department began in July % Test Scores by Participant Type (Pre and Post) 76% 74% 80% Year Number of ADRs Reported Per Month per month per month 70% 60% 50% 40% 30% 48% 55% 64% 66% 65% 54% 52% 46% 53% 62% Pre Post Current ~ 8-10 per month 20% 10% 0% Do you report this? Conclusions. Levofloxacin altered serum glucose Vancomycin red man syndrome Linezolid thrombocytopenia Diphenhydramine drowsiness Warfarin bleeding (increased INR) Drug interaction between warfarin and amiodarone Penicillin - anaphylaxis Establishing an ADR Monitoring Program is a very important role for pharmacists Many methods can be used to educate and inform other health care providers about ADRs Developing an ADR Conference can improve knowledge base about ADRs for health care providers and increase reporting Bottom Line: ADR Monitoring and Reporting can improve the care we provide for our patients! 14

15 Where Can You Go To Get More Information On ADRs? Meyler s Side Effects of Drugs ISBN 10: ; Editor: JK Aronson Adverse Drug Reactions 2nd Edition (2007) ISBN: ; Editor: Anne Lee Drug-Induced Diseases: Prevention, Detection and Management ISBN: ; Editor: James Tisdale Implementing An Adverse Drug Reaction Monitoring Program in the Hospital Setting Dianne B. May, Pharm.D., BCPS Associate Professor University of Georgia College of Pharmacy 15