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© 2010 Pharmacists Mutual Ins. Co.
Medication Errors: What Are The Risks and What Can I Do About Them?
Medication Errors: What Are The Risks and What Can I Do About Them?
by Don R. McGuire Jr., R. Ph., J.D.General Counsel
Pharmacists Mutual Insurance Company
May 14, 2010
Maine Pharmacy Association
© 2010 Pharmacists Mutual Ins. Co.
Intentional Torts
Assault Battery False Imprisonment Defamation Invasion of Privacy Malicious
Prosecution
© 2010 Pharmacists Mutual Ins. Co.
Negligence
Elements –Duty–Breach of Duty
–Damages–Proximate Cause
© 2010 Pharmacists Mutual Ins. Co.
Duty
The requirement to behave in a certain manner for the benefit another
Does not mean warning about everything
The actor must take reasonable steps to prevent foreseeable harm
Professionals have different duties than “ordinary” people
© 2010 Pharmacists Mutual Ins. Co.
Breach of Duty
Standard of Care – how you know when the duty is performed
Reasonable Person Standard – what would a reasonable person do in the same or similar circumstances?
Legal Standard – law requires certain behavior
Others – professions, codes of ethics, etc.
© 2010 Pharmacists Mutual Ins. Co.
Breach of Duty
Failure to perform the Duty (nonfeasance)
Duty performed inadequately or incorrectly (malfeasance)
Breach when Rx filled incorrectly easy to spot
© 2010 Pharmacists Mutual Ins. Co.
Proximate Cause
The breach of the duty must be the direct cause of the injury
Superceding or Interceding Cause
Can be lack of drug or addition of drug or both
© 2010 Pharmacists Mutual Ins. Co.
Damages (Harm)
Patient must have been harmed in order to be compensated
Many states require underlying physical injury to make claim for emotional injury
Harm if not taken?
© 2010 Pharmacists Mutual Ins. Co.
Defenses to Negligence
Contributory Negligence
Comparative Fault
Assumption of the Risk
© 2010 Pharmacists Mutual Ins. Co.
Contributory Negligence
Common law concept Plaintiff cannot be even 1% at
fault and still recover Defense merely needs to show
some fault by plaintiff to win
© 2010 Pharmacists Mutual Ins. Co.
Comparative Fault
Replaces Contributory Negligence Plaintiff has their percentage of
fault subtracted from the damages award
2 versions – Pure - plaintiff recovers damages, less their % of fault–Modified – If plaintiff responsible
for 50% or more, then no recovery
© 2010 Pharmacists Mutual Ins. Co.
Remedies
Compensatory Damages
Punitive Damages and Exemplary Damages
Injunction
© 2010 Pharmacists Mutual Ins. Co.
What Can I Do?Protect yourself & your patient!
Risk Management Techniques
1. Avoid the risk.2. Control the environment.3. Retention of the financial risk.
4. Transfer of the financial risk.
© 2010 Pharmacists Mutual Ins. Co.
1. Identify the Risk2. Select the Technique3. Implement the Technique
4. Monitor and make necessary changes
Controlling the environment--
The Risk Management Process
© 2010 Pharmacists Mutual Ins. Co.
Pharmacists Mutual Claims Study 2010
1989 through 2009
Notes: *Non-bodily Injury = release of conf. information, false arrest, libel, slander
49.8%
27.5%
9.0%1.7% 7.9% 1.6%
2.5%
© 2010 Pharmacists Mutual Ins. Co.
Pharmacists Mutual Claims Study 2010
1989 through 2009*Others
Compounding
Illegal
Generic
C.R. Cap
0.0% 0.2% 0.4% 0.6% 0.8% 1.0% 1.2% 1.4%
1.4%
0.3%
0.6%
0.2%
© 2010 Pharmacists Mutual Ins. Co.
Pharmacists Mutual Claims Study 2010
Drugs Delivered in Mechanical Claims 1996-2009
Coumad
in®
Levoth
yroxin
e
Anti Diab
etics
amox
icillin
/Aug
men
tin®
Topro
l®/m
etop
rolo
l
amitr
ipty
line/E
lavil®
lisin
opril
predniso
ne
insu
lin
aten
olol
Lipito
r®
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
7.0%
8.0%
7.5%6.1%
4.6%
3.5% 3.5% 3.3% 3.3% 3.2% 3.2% 3.0% 2.9%
© 2010 Pharmacists Mutual Ins. Co.
Triple Check . . .. . . Plus Two
Check three timesPlus 1 --Check NDC numbers
Plus 2 --"Show & Tell"–Never deliver a
prescription "in a bag"
© 2010 Pharmacists Mutual Ins. Co.
Risk Management & Patient Care
“What did your doctor tell you this was for?”
“What are your allergies?”
“What other medication are you taking?”
“What possible side-effects did the doctor go over with you?”
© 2010 Pharmacists Mutual Ins. Co.
Pharmacist Only Questions
Why does my medication look different this time?
Why are the directions different from those my doctor told me?
Are you sure you spelled my doctor’s name correctly?
If I’m allergic to aspirin can I take this?
© 2010 Pharmacists Mutual Ins. Co.
The Problem with Telephoned Rx Dr.. meant Lidex . . . . . . the pharmacist heard
and filled the prescription with . . .
Rxpatient: John -------------
Efudex 1 tubeSig: Apply ut dic
© 2010 Pharmacists Mutual Ins. Co.
The Telephone Rx
“Echo & Verify”
© 2010 Pharmacists Mutual Ins. Co.
Telephone RxPatient: Betty Smith
Penicillin VK 250 mg# 30Sig: i tid
Dr. Smithby Nancy,
RN
Telephone RxPatient: Betty Smith
Penicillin VK 250 mg# 30Sig: i tid
Dr. Smithby Nancy,
RN
Telephone Prescriptions
V10/22/04drm
© 2010 Pharmacists Mutual Ins. Co.
2 Dosage Unit Rule
Technicians cannot know usual dose of every drug
Typical prescriptions do not need more than 2 units to deliver the dose
Sigs with 3 or more units should be flagged for R.Ph. review
© 2010 Pharmacists Mutual Ins. Co.
"Mark It"
Identify those prescription items causing "problems"
Place colored tape on that part of the shelf
To cause "a second thought"
© 2010 Pharmacists Mutual Ins. Co.
If You Didn’t Document It, It Wasn’t Done.
but …Where?When?What?
© 2010 Pharmacists Mutual Ins. Co.
What NOT to do ...Excerpt from letter from
patient's attorney to pharmacy . . .
"As you are already aware Mrs..... _________ attempted to contact you regarding this error and was told, 'If you aren't dead, don't worry about it."
The patient immediately hired a lawyer.