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- Medication Errors

- Opioid Unintentional Overdose Epidemic

- Pharmacy Safety

- PMP

- Forgeries

MEDICATION ERROR REPORTING

• Critical in preventing future medication errors

• 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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QUESTIONED Rx’S ARE ALWAYS WRONG UNTIL

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:

The name of the medication

How to take it

What it’s for

If the medication looks different, talk to the pharmacist

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm096403.htm

PATIENT COUNSELING Estimate: half of medication-related deaths

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/lessonid/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=91

“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.

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When an error occurs •Be compassionate

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/showarticle.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/

Improving Medication Safety in Community Pharmacy: Assessing Risk and Opportunities for Change

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ISMP Community Pharmacy Medication Safety Tools and Resources •Root Cause Analysis (RCA) Workbook for

Community/Ambulatory Pharmacy

• ISMP Medication Safety Self

Assessment for Community/Ambulatory Pharmacy

Resources: http://www.nccmerp.org/

OPIOID Unintentional

Overdose Epidemic, United States

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=mm6450a3_w#fig1 accessed 1/11/2016

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Source: https://www.cdc.gov/drugoverdose/data/index.html accessed 1/3/2017

http://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates

http://www.cdc.gov/drugoverdose/epidemic/providers.html

http://www.drugabuse.gov/publications/research-reports/relationship-between-prescription-drug-abuse-heroin-use/subset-users-may-naturally-progress-rx-opioids-to-heroin

1999 - 2014

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.

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http://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates http://www.cdc.gov/vitalsigns/PrescriptionPainkillerOverdoses/index.html

http://www.cdc.gov/vitalsigns/prescriptionpainkilleroverdoses/infographic.html

http://www.cdc.gov/drugoverdose/epidemic/riskfactors.html

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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

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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

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Unintentional Injury Deaths by Year and Cause of Injury Death, NM, 1999-2014

https://ibis.health.state.nm.us/indicator/complete_profile/InjuryUnintenDeath.html

Top Rx Drugs in Overdose Death, NM 2015

0 20 40 60 80 100

oxycodonealprazolam

morphinediazepam

hydrocodonemethadone

fentanylzolpidemtramadol

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

<=20 >20-40 >40-60 >60-80 >80-120 >120-200 >200

Ris

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<=

20

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

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10.00

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70.00

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90.00

100.00

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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

Slide Credit: James Davis, MA, Drug Epidemiologist, NM DOH

0

5

10

15

20

25

30

35

40

none 1-9 10-29 30-89 90+

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No

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Days of Overlap in 6 mo (different prescribers)

Relative Risk of Rx opioid OD Death by days of overlap

Opioid

Slide Credit: James Davis, MA, Drug Epidemiologist, NM DOH

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0.00

5.00

10.00

15.00

20.00

25.00

30.00

35.00

40.00

45.00

None <10 d 10-29d 30-89d 90+d

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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

Slide Credit: James Davis, MA, Drug Epidemiologist, NM DOH

Drug Overdose Death by Age, Gender, and Drug

Type, NM, 2010-2014

0

2

4

6

8

10

12

14

16

18

20

0-4

5-1

4

15-

24

25-

34

35-

44

45-

54

55-

64

65-

74

75-

84

85+

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Prescription Opioid Heroin Both

0-4

5-1

4

15-

24

25-

34

35-

44

45-

54

55-

64

65-

74

75-

84

85+

Source: UNM OMI/UNM GPS Slide credit: James Davis, DOH

Women Men

410 400

80

890

0

100

200

300

400

500

600

700

800

900

1,000

1 2 3 4

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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

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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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http://www.cdc.gov/vitalsigns/heroin/infographic.html#use

OPIOID OVERDOSE AND

ABUSE EPIDEMIC RESPONSE

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

Prescription Drug Abuse: Strategies to Stop the Epidemic

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

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Rx drug misuse, abuse and overdose related laws in NM

• Requiring a Physical Examination before Prescribing

• Setting Prescription Drug Limits

• Prohibiting “Doctor Shopping”/Fraud**

• Requiring Patient Identification before Dispensing

• PMP utilization

• Medical provider education

**general language

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.html#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.

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http://findtreatment.samhsa.gov/

Pharmacy Safety

RxPATROL.COM

PMP

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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

• Long term use of opioids

• High doses of opioids

• Overlapping prescriptions of opioids from

different prescribers

• Multiple Provider Episodes ( MPE: Doctor and

pharmacy shopping)

• The combination of opioids and sedative-

hypnotics

• The combination of opioids, benzodiazepines

and carisoprodol

FORGERIES •ARE THE FOLLOWING

PRESCRIPTIONS • STOLEN Rx FORMS?

• PHOTOCOPIED PRESCRIPTIONS?

• COMPUTER SCANNED

PRESCRIPTIONS?

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