This document discusses reducing harm from high-risk medications. It begins by defining high-risk medications as those most likely to cause significant harm, even when used correctly. Many high-risk medications like heparin, insulin, morphine and propofol are intravenous. The document then analyzes errors in administering and dispensing high-risk medications at a hospital in India. Over 100 patients and medication samples were observed, finding around 45% error rate. Interventions like additional training and labeling were implemented. A follow-up study found the error rate reduced to 1.2%. The document promotes strict storage, dispensing and monitoring policies for high-risk medications.

1. Reduction
of harm from high
risk medications

2. Apollo Medicine 2012 June
Volume 9, Number 2; pp. 160e165 Article on Quality
Reduction of harm from high risk medications
Gaurav Loriaa
ABSTRACT
High risk medications: High risk medications are medicines that are most likely to cause significant harm to the
patient, even when used as intended. The Institute for Safe Medication Practices (ISMP) reports that the incident
rates of this group of medicines may not necessarily be higher than the other medicines but when incidents occur the
impact on the patients would be serious (significant).
In seeking to improve patient safety, the primary focus should be on preventing errors with the greatest potential for
harm. Many of the highest risk medications e e.g., heparin, insulin, morphine, and propofol e are delivered by IV
infusion. 61% of the most serious and life threatening potential adverse drug events (ADEs) are IV drug related.
IV administration often results in the most serious outcomes of medication errors.
Copyright © 2012, Indraprastha Medical Corporation Ltd. All rights reserved.
Keywords: High risk medication, ISMP, High alert medications
INTRODUCTION
ISMP defines High Alert Medications as, “drugs that bear
a heightened risk of causing significant patient harm when
they are used wrongly. Although mistakes may or may not
be more common with these drugs, the consequences of an
error are clearly more devastating to patients.”
HIGH RISK MEDICATIONS: (ACCEPTED
WORLDWIDE)
1) Concentrated electrolytes: >0.9% sodium chloride,
magnesium sulphate, and potassium chloride
2) Anticoagulants: heparin
3) Human insulin: human actrapid, human insulatard
and other insulins (all short, long and intermediate
acting)
4) Narcotics: morphine, fentanyl, pethidine
5) Chemotherapeutic agents
6) Look alike and sound alike drugs (LASA)
The risks caused due to the high risk medications are
given in the table below
Coordinator Quality e Apollo Group, Consultant Quality e Apollo Clinics, 108 Nehal Chambers, Apollo Hospitals, Jubilee Hills, Hyderabad, India.
a The project was done at the time when we had only concentrated electrolytes as our high alert medications. This project was done and after the
results we added other drugs (high risk) in our list as well.
Received: 30.4.2012; Accepted: 1.5.2012; Available online: 8.5.2012
Copyright 2012, Indraprastha Medical Corporation Ltd. All rights reserved.
doi:10.1016/j.apme.2012.05.001

3. Reduction of harm from high risk medications Article on Quality 161
OBJECTIVES OF THE STUDY
d To know the current status of the care in the delivery of
high risk medications to the patients
d To intervene if any care in the delivery of the high risk
medications is still required
METHODOLOGY OF STUDY
d A random study was conducted in the hospital in all
ICUs, 1st and 2nd floors.
d The study had been carried out for 6 weeks.
d Over 100 patients were studied with regard to the care in
administration of high risk medications.
d Over 100 samples were studied with regard to the
dispensing of the high risk medications to the patients
from the pharmacy and storage in the pharmacy.
INCLUSIONS OF THE STUDY
d All the patients in the ICUs, 1st and 2nd floors were
included in the study.
d The case files of all the patients were referred for the
required information.
d These patientswere observed for the proper administration of
the high risk medications in the respective departments.
d The dispensing of the high risk medicines was observed
during morning and the evening time.
EXCLUSIONS OF THE STUDY
d LASA drugs were excluded.
d Dispensing during the night time was excluded.
d Chemo drugs were excluded for the three quarters of the
study.
INTERPRETATIONS
The errors observed in the administration and transcrip-tions
were
d Drugs indented but not administered
d Drugs not written in the high alert chart by the physicians
d No double signatures in the drug chart after adminis-tering
the narcotics
d Hypoglycaemia not monitored and documented.
d Magnesium levels were not monitored after the adminis-tration
of the electrolyte magnesium sulphate
d Blood pressure, when improper after the administration
of fentanyl not corrected
d Indications for the drugs not written in the drug chart
especially in case of chemo drugs
d Correct date is not written in the drug chart
d Wrong drugs are written in the high alert chart
d Stop orders not written in the high alert chart
DETAILED DESCRIPTION OF THE INTERPRE-TATIONS
OF THE STUDY
d Among 110 patients observed for the administration of
the high risk medications, 50 errors were found to occur
i.e., at the rate of 45.5% (Fig. 1)
Medicine group Risks to the patient
Anticoagulants Narrow therapeutic index,
potential for clot or bleed,
interactions with other
medications even herbal
medicines, over the counter
drugs and food
Opiates Sedation, respiratory depression,
confusion, lethargy, nausea,
vomiting, constipation
Insulin Loss of blood sugar control in
post-operative patients, achieving
blood sugar control without
causing hypoglycaemia
Concentrated
electrolytes
Increase in the level of the
electrolytes leading to lethal effects
LASA Risk of administration of the
incorrect medications and the
consequent adverse effects
Graph Analyzed results- errors in high risk medication
administration.

4. 162 Apollo Medicine 2012 June; Vol. 9, No. 2 Loria
Incorrect prescription
written by doctor
Junior doctors reluctant to take verbal order Staff not following 7R check before
Improper procedure for medicine administration
d Among all the errors which were observed
B 20% of the errors happened to be the absence of
double signature during the administration of the
high risk medications mostly concentrated
electrolytes
B 10% of the errors e high risk medications not written
in high alert chart of the drug chart by the physician
d Among the errors observed the areas of errors
B Absence of double signatured70% of was observed
in CT post
B The other areas were the errors were observeddPICU,
regency III floor, II floor, cancer block
d The reasons for the errors found are
B Lack of proper training to the staff with regard to the
specific drugs
B Lack of time
B Ignorance of the staff with respect to continuous
implementation of the policy guidelines
B Lack of monitoring by the accountable authority
d The interventions ought to be carried out to minimise
the errors were
Computer system fails to operate
MEDICATION
ERROR
Wrong selection of drugs
Time for 7R check not
available
First and foremost is the proper training of the staff
in terms of the policy which includes the list of the
high risk medicines and all its required guidelines
Monitoring the staff for the follow up of the policy
Putting up display charts depicting the policy of
administration of the high risk medications so that
the staff will be reminded of the policy
Make the senior staff accountable for the regular
implementation of the policy
Set up a deadline (time period) for the review of the
performance of the staff after the intervention
Review the performance of the hospital staff after
the intervention for the knowledge of the improve-ment
in the policy implementation
Reward the department or the staff who succeed in
following the policy and responsible for the change in
the implementation of the policy
Motivate the staff with regard to the policy
implementation
Periodical review (monthly) of the follow up of the
policy by the medication safety committee
MAN MACHINE
METHOD ENVIRONMENT
Floor wise dispensing
counters not available
Wrong verbal order taken
by staff
Staff not complying with two identifier
while labeling and administering drugs
Pharmacy staff not trained in drug selection
and packaging
Ward pharmacist not trained to check
prescriptions
Staff not motivated to report errors
Complicated indenting system,
time consuming
No training for
prescription
writing
Nurse not trained to
take verbal orders
INVENTORY
Out of stock
Delay in bringing
INTERPRETATION medicines from stores
Wrong interpretation of medicine
Illegible
Manual work
Look alike/ sound alike drugs
administration
Procedure for drug selection and
packaging not in place
Unorganized drug in IP pharmacy
Verbal order taken
Inappropriate organization
of drugs in IP pharmacy
Unorganized Imprest stock in ward
Noising factors in IP pharmacy
Fig. 1 Fish bone analysis - medication errors.

5. Reduction of harm from high risk medications Article on Quality 163
Make antidotes or rescue drugs available at the point
of care for immediate administration and establishing
protocols that allow for nurses to administer antidotes
or reversal agents per protocol without having to
contact a physician.
DISPENSING AND STORAGE OF THE HIGH
RISK MEDICATIONS
d The high risk medications must be stored in the hospital
pharmacy with special care
Electrolytes
The concentrated electrolytes (sodium chloride, potas-sium
chloride, magnesium sulphate) must be stored only
in the pharmacy. They must not be in the patient care areas
The concentrated electrolytes must be diluted under the
laminar hood of the pharmacy only by the person
responsible for dilution
While dispensing they must be sent with the HIGH
RISK MEDICATION sticker
Narcotics
Narcotic drugs (morphine, fentanyl, pethidine) must be
stored under the double lock chamber in the pharmacy.
The two keys must be with two separate persons among
the pharmacy staff/ nurses (in patient care areas)
After the reception of the indent by the pharmacy, the
indent must undergo double check by the pharmacy staff
and the staff responsible must unlock and take out the
drug and fill the details in the narcotic drug receipt
The drug must be sent with HIGH RISK MEDICA-TION
sticker
All the narcotics issued by the pharmacy will be docu-mented
in the NARCOTICS BOOK by the concerned
pharmacist
Insulin
All the insulin injections must be stored in a separate
refrigerator in the pharmacy
The insulin drugs must be sent with the HIGH RISK
MEDICATION sticker along with the ice pack
Heparin
Heparin must be stored in the lock and key
Heparin must be sent with HIGH RISK MEDICA-TION
sticker
Chemotherapeutic drugs
These drugs are stored in the refrigerator in the phar-macy
(usually chemo unit pharmacy)
They are sent with HIGH RISK MEDICATION sticker
The pharmacist who dispenses the drug takes the signa-ture
of the user department staff who received the drug
as it is costly and must not be misused
ERRORS IN DISPENSING
The errors encountered in dispensing of the high risk medi-cations
were
d Drugs sent without HIGH RISK MEDICATION sticker
d The concentrated electrolytes after dilution were handed
over directly to the nurse and confusion observed in the
dispensing staff whether the medicine has been dispensed
d The staffs which assemble the indented medicines and
send them to the concerned staff for verification forgets
to attach the HIGH RISK MEDICATION sticker and
have to be alerted by the verification staff. The chance
of medicine been dispensed without the HIGH RISK
MEDICATION sticker increases the chance of errors.
INTERPRETATION OF THE ERRORS IN
DISPENSING HIGH RISK MEDICATION
d Out of the 100 observations of dispensing of high risk
medication, 10% of errors were observed
d The dispensing process was taking place quite according
to the policy guidelines
d Out of all the errors, 50% were the error of sending the
medication withoutHIGHRISKMEDICATIONsticker

6. 164 Apollo Medicine 2012 June; Vol. 9, No. 2 Loria
d Most of the errors were bound to be occurring at the
level of the staff which is assembling the medications
and sending for the verification
REASONS FOR THE ERRORS DURING
DISPENSING
Pharmacy was overcrowded with staff during the peak
time of morning (11 ame2 pm)
Chaos between the staff assembling, verifying, packing
and dispensing the medicines (leads to confusion among
the staff)
Staff unable to handle all the indents which resulted in
delay in dispensing and piling up of the indents
Slow connectivity of the intranet in the hospital due to
which there was a delay in the reception of the indent
INTERVENTIONS FOR PROPER IMPLE-MENTATION
OF THE POLICY GUIDELINES IN
DISPENSING THE HIGH RISK MEDICATIONS
U Pharmacy staff to be educated about the list of the
high risk medications
U Display charts made available for the policy guidelines
at
d Assembling counters e staff can identify the high
risk drugs and take steps to prevent the error of mixing
them with other drugs while replacing and error of not
placing the high risk sticker
d Verifying countersestaff can easily identify the medi-cines
if they are without sticker, identify the correct
medicine (in case of LASA), easy to alert the dispensing
staff not to mix with other drugs
d Packing and dispensing counters e staff can easily
separate them and dispense them mostly if it is an
immediate requirement because of the sticker placed
U Assignment of a separate dispensing staff for the high
risk medication to avoid the chaos
U Staff to be motivated to follow the policy guidelines
constantly (by reward etc.)
U Review of the performance after the intervention
U Periodical review of the policy and the performance
standards
U Adequate staff to be maintained in the pharmacy to
avoid chaos in the department
U Keep the staff educated about the updated policy
U Keep the intranet always active to prevent the delay in
the dispensing of the medications
U All the high risk medications to be kept at the separate
corner of the pharmacy for easy differentiation (except
narcotics which are in double lock)
U Keep all the high risk medicines at the place where the
insulin refrigerator is placed rather than at the other
corner which is not easily accessible. No chaos will
be observed in this situation after the change
d The areas to be concentrated to greater extent were
SICU, PICU, CT post, chemo unit, floors (II and III).
d A periodical review is carried out in the hospital after
the intervention to have a broader and comprehensive
study of the implementation intensity of the policy
guidelines with respect to the high risk medications.
d A near to 100% compliance would suggest that the
policy guidelines are been followed in the hospital in
a sustained manner and safe high risk medication prac-tise
can be delivered to the patients of the hospital.
On the whole the compliance of the hospital needed to
be improved with respect to the current status.
MODIFIED POLICY FOR HIGH ALERT
MEDICATIONS
d The high alert (concentrated electrolytes) must be prescribed
in a separate high alert medications chart in the drug chart
d All concentrated electrolytes must be stored in the phar-macy
only. They must not be in the patient care areas.
d All the narcotic drugs must be stored in a double lock
system and two keys with two different nurses
d The narcotic drugs should be discarded in the presence
of two witnesses in the sink and the empty ampoule
should be sent to the pharmacy in a black cover for
further discarding from the hospital
d The high risk medications must be administered in the
presence of a witness
d After the administration of the high risk medications,
monitoring must be done to check for any adverse events
d All the high risk medications must be dispensed with
HIGH RISK MEDICATION sticker
Action taken
After understanding the lacunae in the system, high alert policy
wasmodified and separate stickers were designed to ensure that
all high alert medications are labelled with instructions. Even
few more drugs like insulin, LASA etc were added into the
list to ensure that we have covered all high risk drugs as well.
The same was implemented effectively from October
2011.

7. Reduction of harm from high risk medications Article on Quality 165
Post implementation
A similar study was conducted on the same number of
patients during February 2012eMarch 2012.
The number of errors related to high alert drugs reduced
to 1.2% with respect to focused trainings, labelling, posters,
charts, etc and none of the errors actually reached the
patient.

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