• Most Boards of Pharmacy require hospital & medical facilities (including pharmacies) to report med errors
• NMBOP requires adverse drug event reporting
16.19.25 ADVERSE DRUG EVENT
• Incident - a drug that is dispensed in error, that is administered and results in harm, injury or death
• Harm - temporary or permanent impairment requiring intervention
The Pharmacist in Charge shall:
A. Develop and implement written error prevention procedures as part of the Policy and Procedures Manual.
B. Report incidents, including relevant status updates, to the Board on
Board approved forms within fifteen (15) days of discovery.
• “Significant Adverse Drug Event Reporting Form”
The Board shall:
A. Maintain confidentiality of information relating to the reporter and the patient identifiers.
B. Compile and publish, in the newsletter and on the Board web site, report
information and prevention recommendations.
C. Assure reports are used in a constructive and non-punitive manner.
MEDICATION ERRORS
• BOP receives sworn Complaints Alleging Misfilled Prescriptions.
• Not generated from Adverse Drug Event Reports.
• Most of these would not have occurred if the pharmacist complied with BOP requirements for: • Prospective Drug Review • Counseling
Medication Error Reduction
Prospective drug review
(1) Prior to dispensing any prescription, a pharmacist shall review the patient profile for the purpose of identifying: (a) clinical abuse/misuse; (b) therapeutic duplication; (c) drug-disease contraindications; (d) drug-drug interactions; (e) incorrect drug dosage; (f) incorrect duration of drug treatment; (g) drug-allergy interactions; (h) appropriate medication indication.
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PROVEN CORRECT
Presume the prescription is wrong until the pharmacist has satisfied him or herself it is correct.
ONLY THE RPh CAN COUNSEL
All clerks and technicians are taught that if there is a question regarding a prescription, the RPh (or intern) must take the question.
MEDICATION ERROR REDUCTION: PATIENT COUNSELING
Patients need to know:
How to take it
What it’s for
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm096403.htm
could have been prevented by appropriate and timely counseling .*
Show the patient the drug while asking:
1) Tell me what you take this drug for?
2) Tell me how do you take the medication? -how often, and
-directions for taking the medication
http://www.uspharmacist.com/continuing_education/ceviewtest/le ssonid/105916
REMEMBER THE PATIENT
•Patients provide a major safety check Counseling – not a “veiled offer” Wrong patient errors: Not opening
the bag at the point of sale Risk of dispensing correctly filled
Rx to wrong patient at POS – about 6 per month per (community) pharmacy
https://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=9 1
“To Err is Human” Building a Safer Health System
• the majority of medical errors are caused by faulty systems, processes, and conditions that: • lead people to make mistakes • fail to prevent mistakes When an error occurs, blaming an
individual does little to make the system safer and prevent someone else from committing the same error.
ISMP persistent safety gaffe #4 respond with empathy and concern
•Evaluate and address medication use system issues
Root cause analysis https://www.ismp.org/newsletters/acutecare/showarticl e.aspx?id=91
Root cause analysis (RCA):
• Process for identifying the basic or causal factors that underlie variation in performance, including the occurrence or risk of occurrence of a sentinel event.
• Focus is on systems and processes, not individual performance
• Identifying root causes illuminates significant, underlying, fundamental conditions that increase the risk of adverse consequences.
• RCA facilitates system evaluation, analysis of need for corrective action, tracking and trending
Resources:
http://www.ismp.org/communityRx/aroc/
Community/Ambulatory Pharmacy
http://www.nytimes.com/interactive/2016/01/07/us/drug-overdose-deaths-in-the- us.html?_r=1 By HAEYOUN PARK and MATTHEW BLOCH JAN. 19, 2016
Age-adjusted rate of drug overdose deaths and drug overdose deaths involving opioids 2000-2014
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm?s_cid=m m6450a3_w#fig1 accessed 1/11/2016
http://www.cdc.gov/drugoverdose/data/overdose.html
From 1999 through 2013, adults aged 55-64 experienced the greatest increase in the opioid-analgesic poisoning death rate.
OPIOID UNINTENTIONAL OVERDOSE EPIDEMIC, NEW MEXICO
Source: New York Times: How the Epidemic of Drug Overdose Deaths Ripples Across America. January 19, 2016
Slide credit: James Davis, MA, Drug Epidemiologist, NM DOH
New Mexico Overdose Deaths, 2003-2014 Age-adjusted rate of drug overdose deaths, 2010 and 2015
Source: CDC MMWR Increases in Drug and Opioid-Involved Overdose Deaths — United States, 2010–2015 Weekly / December 30, 2016 / 65(50-51);1445–1452
https://www.cdc.gov/drugoverdose/data/overdose.html
Drug Overdose Death Rates, New Mexico and United States, 1990-2015
0
5
10
15
20
25
30
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 1920212223242526
D e
a th
s p
e r
10 0
,0 0
0 p
o p
u la
ti o
n
Series2
Series1
Series3
Rates are age adjusted to the US 2000 standard population Source: United States (CDC Wonder); New Mexico (NMDOH BVRHS/SAES, 1990-1998,2014 ; NM-IBIS, 1999-2013)
Slide Credit: James Davis, MA, Drug Epidemiologist, NM DOH
NM: 24.8
US: 16.3
https://ibis.health.state.nm.us/indicator/complete_profile/InjuryUnin tenDeath.html
0 20 40 60 80 100
oxycodone alprazolam
morphine diazepam
hydrocodone methadone
fentanyl zolpidem tramadol
Overdose death involvements Deaths may involve more than one drug Source: NM Office of the Medical Investigator Slide Credit: James Davis, MA, Drug Epidemiologist, NM DOH
0.00
2.00
4.00
6.00
8.00
10.00
12.00
14.00
16.00
18.00
R is
k r
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ti ve
t o
Average Daily Dose (total MME/total days in 6 months)
Relative Risk of Prescription OD Death by Opioid Dose level, NM 2007-2011
Slide Credit: James Davis, MA, Drug Epidemiologist, NM DOH
0.00
10.00
20.00
30.00
40.00
50.00
60.00
70.00
80.00
90.00
100.00
Average dose level (morphine equivalents, MME)
Relative Risk of Rx OD Death by Opioid Dose and Days Prescribed in 6 months
160+ days
90-159 days
30-89 days
<30 days
0
5
10
15
20
25
30
35
40
R is
k r
e la
ti ve
t o
N o
n e
Days of Overlap in 6 mo (different prescribers)
Relative Risk of Rx opioid OD Death by days of overlap
Opioid
https://ibis.health.state.nm.us/indicator/complete_profile/InjuryUnintenDeath.html
https://ibis.health.state.nm.us/indicator/complete_profile/InjuryUnintenDeath.html
https://ibis.health.state.nm.us/indicator/complete_profile/InjuryUnintenDeath.html
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0.00
5.00
10.00
15.00
20.00
25.00
30.00
35.00
40.00
45.00
R is
k r
e la
ti ve
t o
N o
n e
Opioid-Sedative/Hypnotic overlap days in 6 months
Relative risk of OD death with Opioid/sedative- hypnotic overlap, NM 2007-2011
Prescription Drug OD
Illicit Drug OD
Drug Overdose Death by Age, Gender, and Drug
Type, NM, 2010-2014
Women Men
410 400
Estimated Costs of Prescription Opioid Abuse, Dependence, and Misuse, New Mexico, 2007
Note: New Mexico costs were estimated by multiplying estimated 2007 U.S. costs by the portion of 2007 U.S. prescription opioid overdose deaths that occurred in New Mexico (i.e., 231/14,408 = 0.016). Costs for the United States were derived in Birnbaum et al (2011) “Societal Costs of Opioid Abuse, Dependence, and Misuse in the United States,” Pain Medicine , April 12(4):657-67.
Source: 20130110 Costs for Mike (from Brad, 01-10-13).pptx – Note was modified from original
Sources: US: Weighted national estimates from HCUP Nationwide Inpatient Sample (NIS), 2000, Agency for Healthcare Research and Quality (AHRQ), based on data collected by individual States and provided to AHRQ by the States. Total number of weighted discharges in the U.S. based on HCUP NIS = 36,417,565. New Mexico: 2000-2013 Hospital Inpatient Discharge Data (HIDD). Slide credit: James Davis, MA, Drug Epidemiologist, NM DOH
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Series2 1.7 2.1 1.5 1.7 1.9 1.6 1.9 2.3 3.0 3.5 3.9 5.5 7.4 8.1
Series3 1.3 1.1 1.3 1.3 1.6 2 2.3 2.3 2.8 3.6 5 5.2 6.1
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
s
Rate of Neonatal Abstinence Syndrome per 1,000 live births, NM (2000-2013) & U.S. (2000-
2012)
Past 30-day Painkiller Use to Get High Grades 9-12, New Mexico, 2007-2013
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Prescription Drug Abuse Prevention Plan
• expands upon the Administration’s National Drug Control Strategy and includes action in four major areas to reduce prescription drug abuse: •Education •Tracking and monitoring •Proper medication disposal •Enforcement
http://www.whitehouse.gov/sites/default/files/ondcp/policy- and-research/rx_abuse_plan.pdf
October 2013
Key recommendations • Educate the public to understand the risks of Rx drug
use to avoid misuse in the first place; • Ensure responsible prescribing practices, including
increasing education of healthcare providers and prescribers to better understand how medications can be misused and to identify patients in need of treatment;
• Increase understanding about safe storage of medication and proper disposal of unused medications, such as through "take back" programs;
• Make sure patients do receive the pain and other medications they need, and that patients have access to safe and effective drugs
http://healthyamericans.org/reports/drugabuse2013/ Source: 2015 National Survey on Drug Use and Health
• Requiring a Physical Examination before Prescribing
• Setting Prescription Drug Limits
• Prohibiting “Doctor Shopping”/Fraud**
• PMP utilization
Harm Reduction • Rescue Drug Law:
In 2001, NM became the 1st state to amend its laws to make it easier to provide naloxone, and to administer (good faith, reasonable care) without fear of legal repercussions. (NMSA 24-23-1, 24-23-2; NMAC 7.32.7)
March 2016, SB 262 / HB 277 signed into law : significantly expanded naloxone access (possess, store, distribute, prescribe, administer). NMSA 24-23-1
Naloxone standing orders (issued NM DOH March 2016) Any person acting under a standing order issued by a licensed
prescriber may store or distribute an opioid antagonist
A licensed prescriber may directly or by SO prescribe, dispense, or distribute an opioid antagonist to (several categories)
Harm Reduction •Good Samaritan Law: In 2007, NM became the 1st state to amend its laws to encourage summoning aid in the event of an overdose. (NMSA 30-31- 27.1 )
Source: The Network for Public Health Law, last updated April 2015 http://www.cdc.gov/vitalsigns/heroin/infographic.ht ml#use
Household Pharmaceutical Disposal Program http://www.cabq.gov/police/programs/pharmaceuticals/ /
• Six area command substations, Monday through Friday from 8 a.m. to 5 p.m. Complete list is on the web page.
• Household medications
• Only pills, no chemo or medical waste - web page has instructions and details.
RxPATROL.COM
PMP
http://findtreatment.samhsa.gov/
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https://newmexico.pmpaware.net/login
Duties of a pharmacist • A RPh SHALL REQUEST AND REVIEW A PMP
REPORT IF: • PERSON EXHIBITS POTENTIAL
ABUSE/MISUSE OF OPIATES • OVER-UTILIZATION • EARLY REFILLS • MULTIPLE PRESCRIBERS • SEDATED/INTOXICATED • UNFAMILIAR PATIENT • PAYING CASH INSTEAD OF INSURANCE
Duties of a pharmacist
•OPIATE Rx FROM UNFAMILIAR PRACTITIONER •OUT OF STATE OR USUAL
GEOGRAPHIC AREA
Duties of a pharmacist
•A RPh SHALL REQUEST AND REVIEW A PMP REPORT IF: •providing opiates for a patient
that is receiving chronic pain management prescriptions.
High Risk Prescribing Patterns
• High doses of opioids
different prescribers
pharmacy shopping)
hypnotics
and carisoprodol