Medication Errors

To Err is Human

but

We can build a Safer Health Care

System

Definitions:• Medication Error:

Any preventable drug event that may cause or lead to inappropriate or

irrational medication use, which leads to patient harm.

• Adverse Drug Event (ADE):Any injury or major discomfort resulting from use of a drug.

• Adverse Drug Reaction (ADR):Any response to a drug that is undesirable and unintended and that

occurs at doses normally used in human for prophylaxis, diagnosis or

therapy of a disease.

• Therapeutic Failure:A suboptimal response to drug therapy.

The Magnitude

of

Medication Errors

• 44,000 to 98,000 people die every year in

U.S. due to Medication Errors that could

have been prevented.

Institute of Medicine in U.S.A.

reported:

USFDA reported:

• One death every day is due to Medication

Error.

• 1.3 million people are injured every year

due to it.

• It costs over 1 billion U.S. dollars to the

society due to it.

• Drug related mortality and morbidity costs

140 billion US$

Where it takes place:

A) Hospitals: The biggest center of ADE due to

Medication Errors.

• 30% of hospital admissions are due to ADE, arising out ofME.

• 1 to 3% of these ADE are serious.

• 30 to 40% of these ADEs could have been prevented.

ME: Medication Error ADE: Adverse Drug Event

B) Community Pharmacy:• Another center of ADE/ME

• 18% ADEs happen due to ME at retail pharmacy

• Out of these 18% ADEs 5 to 10% are admitted tohospitals

• ADEs at retail pharmacy, also happen due to poorpatient education, which results in non-compliance.

Medication Errors happen

due to:

• Misreading the Rx (24%)

• SALA drugs (16%)

• Selecting previous drugs/dose

from previous Rx (11%)

• Confusion of Packing (7%)

At Community Pharmacy Level

Situation in India:

• 20,000 manufacturing units of drugs.

• 300 units in organized sector.

• Producing Rs. 20,000 crores worth of drugs.

• 85% of the drugs sold in domestic market.

• Which means, 16,000 drug formulations exist

in India.

• This huge number arrive at Retail / Hospital

Pharmacy level.

Prevention of Medication Errors:

Prevention of Medication Errors, leads to

Safe use of Drugs

An editorial in Lancet considered MEs worse than a crime.

• Communications of Drug orders

* Prescription Errors

* Dispensing Errors

• Patient Education- patient taking wrongly

• Patient Information- wrong information given by pharmacists

• Drug Information- use of internet to know about drugs

• Environmental Factors- medicine loosing potency

Categories of the most Prevalent

Medication Errors:

Prescription Errors:

• Handwriting: Poorly written, incomplete or

illegible prescriptions

• Drug with similar names: SALA Drugs.

• Zeros and Decimal Points.

• Metric and Apothecary systems.

• AbbreviationsPharmacist dispensed daonil, antidiabetic drug, in place of

prescribed diovol, an antacid, because the prescription was

poorly written. As the patient was not diabetic, he died of

hypoglycaemia.

Sound alike drug names in India

(SALA DRUGS)

Brand name Generic name use

Aldactone spironolactone diuretic

Aldarone amiodarone antiarrythmic

Epitril clonazepam anticonvulsant

Enapril enalepril ACE inhibitor

Abbreviation Intended Misinterpretation

• > and < Greater than Often used the

Less than Opposite

• g Microgram Mistaken as mg

• cc cubic centimeter Misread as ‘u’

• IU International Unit Mistaken as IV

• qd, QD Every day Confused

QOD every other day for each other

2..

Unapproved Abbreviations Leading to

Medication Errors:

Continued….

Abbreviation Intended Misinterpretation

• Zero after 1 mg Misread as 10 mg

decimal(1.0)

• Zero not Half mg (0.5) Misread as 5 mg

written before

decimal (.5mg)

Written Medication Orders: Decimals

Avoid whenever possible1

Use 500 mg for 0.5 g

Use 125 mcg for 0.125 mg

Never leave a decimal point “naked” 1, 2, 3

Haldol .5 mg Haldol 0.5 mg

Never use a terminal zero

-Colchicine 1 mg not 1.0 mg

Space between name and dose1,3

Inderal40 mg Inderal 40 mg

1. Cohen MR. Medication Errors. Causes, Prevention, and Risk Management; 8.1-8.23.

2. Jones EH. Clev Clin J Med 1997; 64: 355-9.

3. Cohen MR. Am Pharm 1992; NS32; 32-3.

Ideal Prescription Should have

• Patients Name & Address.

• Patient specific Data (Age, Gender).

• Generic and Brand Name of the drug (ideally both)

• Drug strength expressed in metric units

• Dosage form (Tab, caps, ligament, susp, inj. etc.)

• Complete direction of use, including route of

administration.

• Purpose of medication (indication)

• Duration of therapy

If any details are missing,

illegible, incomplete or not

understood,

DO NOT HESITATE- CALL THE

DOCTOR

Dispensing Errors:

Pharmacists are ultimately responsible for

accurate dispensing of medications.

The failure in this part of the chain of medication

use process, results in dispensing error.

• Workload, Fatigue and stressOverworked pharmacists, due to:

Increase in Rx

Shortage of pharmacists.

Insurance Compliance

• Interruptions and distractions (Phone Calls, cell phones, traffic

in front of stores)

• SALA Drugs

• Seeing what we expect to see

• Miscommunications

• Poor design of work place and workflow pattern

• Dependence on assistants

Potential causes of Dispensing Errors:

How to prevent Dispensing

Errors

• Lock or separate those drugs which frequently

cause errors

• Develop good SOP for drug storage

• Reduce distractions

• Design safe dispensing place

• Use reminders for SALA drugs

• Keep original treatment, the label and medication

together.

Prevent dispensing errors.. cont'd

• Have a final check with a colleague

• Check label of the container or carry bags

• Enter in computer the name of patient, drugs in

treatment manufacturer, no. of dosages and form of

dosage.

• Provide patient counseling on vital aspects of

medication like how to take, how long to take, any

avoidance of food/drink with the drugs.

CAUSES OF DISPENSING

ERRORS

From:

Good Pharmacy Practice Manual

Author: Raj Vaidya, Hindu Pharmacy, Goa

Indian Pharmaceutical Association

Illegible Handwriting

Long prescriptions

Billing Error

Picking wrong medicines from

shelves

Interruption by telephone

Improper mood of staff

Errors during verbal

communication

Queries by staff

Packing error

Therefore……..

DISPENSING is an important activity

where pharmacists come in direct contact

with the patient.

ENSURE good dispensing procedures at

all times.

DISPENSE ACCURATELY

AVOID dispensing errors.

A 40 year old male patient with Bipolar I disorder on carbamazepine (CBZ) presented

with complaints of diplopia, insomnia and irritability.

The levels of CBZ were found to be 17.41ug/ml, well above the therapeutic range. On

close history taking, it was found that the patient was taking CBZ from two different

manufacturers; Tegrital from Novartis Pharma and Zen retard from Intas

Pharmaceuticals.

Tegrital was prescribed by the neurologist and Zen retard was given by his general

practitioner.

He was instructed to discontinue Zen Retard and his subsequent blood level of CBZ

done 2 weeks later was 8.41 ug/ml, well within the therapeutic range. He also

improved symptomatically

Folinic acid confused with folic acid –

folinic acid a synonym for leucovorin calcium, a useful

antidote to folic acid antagonists

Nitroderm TTS – the TTS is mistaken by geriatric

patients as Tuesday Thursday and Saturday instead of

a weekly dose.What does TTS mean? TTS stands for Transdermal Therapeutic System

Transdermal patches: High risk for error?

Errors have been reported wherein patients receive or apply

multiple patches at once.

One man did not survive after his wife applied six fentanyl patches

to his skin at one time. Another common problem is that the old

patch is not removed when the new patch is applied.

There was a report of a patient who applied his new patch

directly on top of the old one. This continued until he had four

patches stuck to one another instead of to his skin.

Prescription of Lamivudine instead of Lamotrigine

(History taking and Therapeutic Drug Monitoring identifying a medication error)

42 year-old male business executive who presented with poor seizure control to the

Neurology OPD of our Institute. The patient was diagnosed to have generalized tonic

clonic seizures 15 years back.

Since the past several months he had weight gain and hence sodium valproate was

discontinued and lamotrigine (mood stabilizer) started.

He came back to the institute with complains of increasing frequency of seizure episodes

since 1 month of starting Lamotrigine. The neurologist referred him to the Therapeutic

Drug Monitoring (TDM) OPD to assess the levels of carbamazepine and lamotrigine.

Found that he was taking tablet Lamidac (LAMIVUDINE) (manufactured by-Zydus!!) 100

mg twice a day instead of Lamidus DT (LAMOTRIGINE) (manufactured by-Zydus)

patient said that the chemist dispensing the medications said that Lamidus was out of

stock and in lieu of which he was substituting lamidac

A patient with accidental

methotrexate overdose - a case

of medication error, a

preventable adverse event.

57-year-old male patient diagnosed to have psoriasis vulgaris

prescribed tablet methotrexate

7.5mg (3 tablets of 2.5mg each)

stat on Wednesday every week

along with folic acid 5mg

Stat is derived from

the Latin word statim

meaning with "no

delay" or "at once

Both the patient

and the pharmacist

mistook it for

"start".

patient inadvertently started

taking 7.5 mg methotrexate

daily starting from Wednesday

for a total of 6 days

methotrexate

overdose

Recommended dosage schedules for methotrexate in

psoriasis : Single oral doses of 7.5 mg once a week

In Maharashtra…

In rural Govt. hospital, in 2004

Pregnant lady in labour ward prescribed Primiprost tablets containing

dinoprostone (naturally occurring prostaglandin [PGE]

PRIMIPROST tablets are indicated for induction and augmentation of

labour.

The Pharmacist in Retail Pharmacy across the hospital gave

MISOPROST instead of PRIMIPROST since that brand was not available

in his store. Lady died in labour with foetus inside

MISOPROST contains Misoprostol… highly contraindicated in full term

labour…

Summary:• Medication errors and mis-management of medication use, are the

major cause of harm to patients.

• Care and Services provided by pharmacist in retail drug store and in

the hospital, have been shown to be the most effective method for

reducing Medication Errors.

• Prevention of Medication Errors reduce Adverse Drug Events.

• By understanding how errors occur and how then can be prevented,

pharmacists working in all spheres of Pharmacy Practice, can

ensure Safe use of drugs.

Remember:

We must remember that

‘‘there are no biologically safe drugs;

there are only SAFE

physicians or pharmacists’’.