1. Medication Safety: The Role of Poison centers G. Randall Bond, MD Medical Director Cincinnati Drug and Poison Information Center Cincinnati Children’s Hospital Medical Center Professor Clinical Pediatrics and Emergency Medicine University of Cincinnati School of Medicine

2. To Err is Human Institute of Medicine estimated that 44,000 to 98,000 people die annually due to medical errors and that medication-related errors represent one of the most common types of errors in hospitalized patients. To Err is Human. Institute of Medicine 1999

3. Medication Safety Are medications safe for use? Rare but serious ADE Are medications used safely? “Medication errors”

4. Medication Safety Past = “error” Individual focused Practitioner focused Knowledge focused Blame focused Wrong Drug Wrong Dose Wrong Patient Wrong Route

5. Problem: individual error Solution: Know more Be more careful

6. But …improvement science suggests: In a human process, carefulness can only reduce error rate to 1%-10%. So with a 4 step process, each with 5% error risk… 0.95 x 0.95 x 0.95 x 0.95= 0.81 Likelihood of error is 19% 1 in 5 patients? A simple multi-step process

7. Medication Safety Future = “safety system failure” System/process focused Shared responsibility Multi-party empowered Prevention focused Drug choice--condition and patient factors Drug ordering and communication Drug preparation Drug delivery to caregiver Communication about how Drug delivery into patient

8. Role for Poison centers?

9. Poison centers as agent to reduce pediatric medication related injuries Classic poison center function. How are we doing?

10. AAPCC data (age < 6 years): 1990 2.2 ped. pharm. exp. per 1000 pop. served 7.9 ped. pharm. deaths per 100 M pop. served 2006 1.8 ped. pharm. exp. per 1000 pop. served 7.0 ped. pharm. deaths per 100 M pop. served From www.aapcc.org

11. Impact seems minimal decrease in both, but is it impact of poison centers’ prevention effort or … Impact of altered reporting patterns? Shift from iron to opioid deaths in children! “indirect reports” included? Aggressive discovery of deaths by PC Already max. benefit of previous PC impact? Already max. benefit of previous societal prevention acts? Changes in the medications available? Safety packaging and dispensing? Limited OTC quantities? Impact of non-drugs? Role of improved ICU care?

12. Poison centers as agents to understand the process

13. Understanding the process: PCs as source of detailed root cause analysis Some reports. Few at NACCT or EAPCCT

14. Understanding the process: using pooled PC medication misuse & injury data All US NPDC data queried: Age < 5 years 2000-2004 Therapeutic error or misuse Outcome—severe injury or death Look for agents and cause

15. Tzimenatos et al. # 238 severe injuries or death 162 exposure occurred in the home* 70 exposure occurred in health care facilities* 107 (45%) < 1 year of age 171 due to excessive dosing # Submitted, unpublished *Error may have occurred elsewhere

16. Specific issues Anticonvulsants 25 low margin, levels rose Fosphenytoin 6 all 10 fold errors Cough and cold meds 18 parental excess Acetaminophen 27 parent confusion, misdose, combo Local anesthetics 11 excess dosing by physicians Metoclopramide 18 small volume non-standard suspension Methylergonovine 7 all as neonate got mothers med Clonidine 7 … two 1000 fold errors

17. What makes a medication higher risk for patient injury? Basic toxicity (low therapeutic/toxic margin) Variable dosing (pediatrics) Med is unfamiliar to prescriber, dispenser or user (e.g., antidotes) Toxicity only in special circumstances (renal failure, neonate, interaction, genetics) Subject to imprecise communication (phone, handwritten)

18. What makes a medication higher risk for patient injury? Dose/Volume confusion risk (variable concentration, small pt. size) Use in high stress environment (e.g., code) User misperception of risk (“intentional” dosing errors—physician, nurse, parent, self) High risk for mistake—name (look alike sound alike), size or color (tablet or container) Use in multi-med and multi patient environment (L & D) Administration (oral or aerosol dose by syringe/pump in IV environment)

19. Poison center inquiry for ADE reports? ADE or interaction could be the reason for symptoms initiating the call… Every call is an opportunity to learn--Sentinel events, even near miss event (double dose, wrong med taken). Why? How? Planned investigation– e.g., OTC meds

20. Poison center inquiry for ADE reports? Database inquiry--exposures calls not suicide, therapeutic error, misuse, … by medication for symptom complaint pattern PC data is pooled, spontaneous, need-driven, public inquiry,—not dependent on a single physician making the connection.

21. Unusual ADEs e.g., suicidal thoughts SSRI, montelukast have been linked Drug specific OD rate ( / 1000 calls) / sales with some adjustment for indication and severity * Caution OD report may not reflect baseline meds and may be biased toward antidepressants

22. Poison centers as supplemental educator/risk assessor US call for a national agenda to reduce medication error includes… “Paradigm shift in the patient provider relationship…patients to take a more active role in their own healthcare…communicate more…improve quality and accessibility of information about medications provided to consumers …internet…” Preventing Medication Errors. IOM report 2006

23. Poison centers as supplemental educator/risk assessor Cincinnati Drug and Poison Info Center served 5 million population in 2007 45,000 “exposure” calls including hospital 6,000 medication inquiries from physicians 10,000 medication inquiries from public 170,000 “pill ID calls” of which 97,000 involved abusable drugs

24. USA—65 PCs, 300 million pop. Potentially 1,000,000 medication inquiries at current DPIC levels More if developed as a resource and funded!

25. Poison centers as harm reduction agent? Cincinnati Drug and Poison Info Center served 5 million population in 2007 45,000 “exposure” calls including hospital 6,000 medication inquiries from physicians 10,000 medication inquiries from public 170,000 “pill ID calls” of which 97,000 involved abusable drugs

26. Poison centers as harm reduction agent? The new Erowid or Dance-Safe in the age or prescription drug abuse—info as a harm reduction tool? We tried it—97,000 times last year Unclear that it reduced harm (they likely take it anyway). No follow up. No data. No one to support it (Funding?)

27. What can European poison centers do that US poison centers can’t? Different legal system means more willingness to share adverse events for help Greater access to physician reports Generally more complete reports Link to public health authority allows access to hospital charts and more “invasive” data gathering Integrated public health systems allow better assessment of medication use/impact/interaction/genetics

28. Toxbase, etc. and internet issues Online resources are cheap, but limit case related data collection. How many times do physicians use databases to see if symptoms are known side effects? Brief question or problem description as the “price” for access?

29. Poison center as a contributor to medication error Wrong answer Solution: data availability & use Poor communication Solution: inclusion standards & summary Miscommunication Solution: Conflict resolution for clarity Look alike sound alike Solution: spell or read back & describe Mis-entry of conversation Solution read back, fax?

30. Poison Centers are here to help