POLICY IH.MOM.

005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

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POLICY ON HIGH RISK MEDICATION

Version 03

Name of responsible (ratifying) committee

PHARMACY AND THERAPEUTIC COMMITTEE

Document Manager (job title) Manager – Department Of Quality

Date issued 30th SEPTEMBER 2020

Review date 31st AUGUST 2023 ( or as required)

Electronic location NABH Policies

( Department Desktop and Server)
Physical Location Manager – Department Of Quality

Version Tracking
Version Date Ratified Brief Summary of Changes Author

MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

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4.7. POLICY- HIGH RISK MEDICINES

1.0 Purpose
To define a list of High Risk Drugs being used in the hospital and to ensure proper and safe storage,
safe usage and dispensing protocols, safe administration protocols and proper monitoring after
administration

2.0 Abbreviations and Definitions

Medication errors are one of the most common causes of avoidable harm to patients in health care
organizations. Majority of medication errors result in death or serious injury to the patient. All efforts,
including a focus on high risk drugs, which cause sentinel events, are worthy goals.

High risk medications are medication involved in a high percentage of medication errors or sentinel
events and medications that carry risk for abuse, error and other adverse outcomes. These are
medications that have the highest risk of causing injury when misused.
Examples include:
- medications with a low therapeutic window
- controlled substances
- psychotherapeutic medications
- look alike and sound alike medications
- concentrated electrolytes

3.0 Responsibility
Physicians, Medical Officers and Nursing

4.0 Scope
- Hospital wide

5.0 Policy
Indus Hospital has a policy which lists out High Risk Drugs, and defines procedures for safe storage ,
verification before dispensing and administration according to 6R’sand also monitoring of patients
after the High Risk Medication is administered to a patient

MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

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6.0 Procedure
6.1 Medication Errors can happen because of any of the following PROCESSES
• Prescribing
• Ordering
• Dispensing
• Preparation
• Administration
• Labeling
• Packaging
• Nomenclature Communication
• Use and Monitoring of Treatment
Or in simple words
COMMON RISK FACTORS
• Poorly written medication orders
• Incorrect dilution procedures
• Confusion between IM, IV, intrathecal, epidural preparations
• Confusion between strengths of the same medications
• Ambiguous labeling on concentration and total volume of medications
• Wrong infusion rate
• Look alike or sound alike product and similar packaging

MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

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6.2 STRATEGIES T0 AVOID ERRORS INVOLVING HIGH RISK MEDICATION

A list of HIGH RISK DRUGS being used in Indus Fatehgarh Sahib hospital is defined .
The list includes medications with low therapeutic window, Look Alike Sound Alike medication,
Controlled Substances, Psychotropic substances , Concentrated electrolytes etc . Annexure A
The top six high-alert medications are
1. Insulin;
2. Opiates;
3. Injectables: potassium chloride (or phosphate) concentrates;
4. Intravenous anticoagulants (heparin); and
5. Sodium chloride solutions above 0.9 percent,
6. Sedatives and hypnotics

1. STORAGE • Stored in individual labelled containers under single lock and

(IN PHARMACY key in all areas
AND PATIENT • List of High Risk Drugs is finalized by PTC and displayed where the
AREAS) drugs are stored.
• Checking of High Risk Drugs takes place in every shift at the Nursing
Stations and the same is documented in STOCK REGISTERS
• LASA policy is followed where applicable
• Names of Look Alike are highlighted in pink and Sound Alike in green
2 PRESCRIPTION • Do not use abbreviations while prescribing High Risk Medications
(BY • Specify the dose, route, and rate of infusion for High Alert
CONSULTANTS) Medications prescribed (eg: IV Dopamine 5mcg/kg/min over 1
minutes)
• Prescribe oral liquid medications with the dose specified in milligrams
• Do not use trailing zero when prescribing (eg: 5.0mg can be
mistaken as 50mg)
3 INDENTING • Avoid ordering High Alert Medications verbally. In cases of emergency,
(BY NURSING) phone orders have to be repeated and verified
4 DISPENSING • Two persons at the pharmacy must check the medicine to be
(BY dispensed.

MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

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PHARMACY)Ref: • One must read the indent out aloud and the second must read the
IH.MOM.010 – name of the medicine that is being picked from the storage area.
Safe Dispensing • Secondly all risk medications are sent to the patient areas in pouches
of medication marked in a “BLACK DOT”
And Labelling
Requirements
5 ADMINISTRATION • The following particulars should be independently counter checked
(BY NURSING against the prescription or medication chart at the bedside by two
STAFF) appropriate persons before administration prior to dispensing these
high risk medications according to the 6Rs
- Right Patient name and UHID
- Right Drug
- Right Route
- Right Dose /strength
- Right Time
- Right Documentation
- Expiry date must be checked too
• Return all unused medication to pharmacy when no longer required
6 MONITORING • Patients are monitored after they have been given High Risk Drugs for
(BY NURSING any adverse reaction
AND MEDICAL • Closely monitor vital signs, laboratory data, patient’s response before
OFFICERS) and after administration of medication. The Nursing Staff is trained on
“GUIDELINES FOR MONITORING POST ADMINISTRATION
EFFECTS FOR HIGH RISK DRUGS” given in the MEDICATION
ADMINISTRATION RECORD – IH.NURS.004
• The results of monitoring are documented in the POST MEDICATION
ADMINISTRATION MONITORING CHART, given in the
MEDICATION ADMINISTRATION RECORD – IH.NURS.004
• Antidotes and resuscitation equipment in wards
• Any adverse reaction is attended to immediately and documented

MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

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6.3.TRAINING
1. All personal shall be trained prior to handling of High Alert Medication and documentation kept.
2. Staff must be trained to prevent potential errors and enable them to response promptly when
mistakes do occur
6.4 INFORMATION -SPECIFICATIONS OF DILUTION (FOR NURSING AND MEDICAL OFFICERS)
1. References or dilution guide should be made available in the wards

MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

Page 7 of 13
Revision No: 00 Version No: 03

6.4.1. SHORT ACTING INSULIN

Strength/unit 100 units/ml (1000 units/vial)
Diluents for infusion NS
Method of administration - Slow IV bolus: administer undiluted solution over 3-5 minutes
- Continuous IV infusion: dilute 50 units insulin in 50 ml NS ( 1
units/ml)

Remarks - Monitor sign and symptoms of hypoglycemia

- If hypoglycemia occurs, stop infusion. For conscious patient,
give sweetened drink. For unconscious patient, administer
D50% or glucagon. Check blood glucose after 15 minutes
- MAY CAUSE NEUROHYPOGLYCEMIA AND CAN BE FATAL
- Overlap with IV infusion for 1 hour with SC insulin (when
converting IV infusion to SC insulin)

6.4.2 POTASSIUM CHLORIDE

Strength/unit 10% W/V, 10Ml
Diluents for infusion NS
Max recommended concentration (peripheral line): 80mmol/L or 6g/L
Max recommended concentration (central line): 150mmol/L or 11g/L
Method of correcting - Normal, slow and safe correction of hypokalemia in open wards
hypokalemia 1g KCl should be diluted in 500ml NS and transfused over 2-3
hours in a peripheral line. (infusion rate not exceeding
20mmol/hr)
- Rapid correction of hypokalemia 1g KCl should be diluted in the
desired concentration of NS in an infusion pump through
central line at rate of 1 hour or less under continuous ECG
monitoring (in an ICU setting)
Remarks - Caution in pt with cardiac disease
- Do not administer undiluted or iv push 1g KCL = 13.4mEq KCl
6.4.3DIGOXIN 0.5mg/2ml
Strength/unit 0.5mg/2ml

MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

Page 8 of 13
Revision No: 00 Version No: 03

Diluents for infusion NS

D5%
Method of administration - Dilution: dilute 0.5mg (1 ampoule) in 50ml for IV infusion
- Slow infusion is preferred over bolus administration (at least 5
minutes or longer)
- IV infusion should be given over 10-20 minutes

Remarks - Arrhytmias may be precipitated by digoxin toxicity. So,

monitoring of HR is necessary before, during, and after digoxin
administration
- IM route is not recommended -> due to painful and a/w muscle
necrosis
- Rapid injection is not recommended as it may cause systemic
and coronary arteriolar constriction
- Digitalized patient with hypoalcemia should be given IV calcium
slowly and in a small amount to avoid serious arrhythmias
6.4.4 HEPARIN 25000IU/5Ml
Strength/unit 25,000iu/ml
Diluents for infusion NS

Method of correcting - Dilution: 1 vial diluted with 50ml

hypokalemia - CONVERSION FROM IU/HOUR TO ML/HOUR
o ->By dividing with 500IU
o ->eg: from 700IU/hour -> 1.4ml/hour

Remarks - MODERATELY HIGH DOSE CAN CAUSE EXCESSIVE INTERNAL

BLEEDING THAT MAY LEAD TO PARALYZING OR LETHAL
STROKES

6.5Certain guidelines for use of high risk medications are as under

MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

Page 9 of 13
Revision No: 00 Version No: 03

6.5.1 Insulin:
- Do not store insulin and heparin near each other.
- Spell out and write the word "units" instead of "U."
- Checking of infusion pump rates and concentration settings by nursing
6.5.2 Opiates:
- Limit the opiates availability in floor stock.

6.5.3 Injectable Potassium Chloride or Phosphate Concentrate:

- Concentrated potassium chloride/phosphate (15%) shall not be made available outside
pharmacy except area only under exceptional circumstances where it would labeled for a
particular patient and kept under lock and key.
- Commercially available premixed IV solutions shall be made available in all patient care units.
- Incase more concentrated Potassium Chloride is required than the premixed IV form, then
concentrated Potassium Chloride will be dispensed from pharmacy against indent for that
patient.
6.5.4Intravenous Anticoagulants (Heparin)
- Separate heparin and insulin.

6.5.5 Sodium Chloride Solutions above 0.9 percent

- Limit access of sodium chloride solutions (above 0.9 percent)

6.5.6 All other high risk medications (Sedatives and Hypnotics) to be administered by doctor or
trained nurse.
- These drugs to be stored under lock and key with label of high risk medications and log to be
maintained.
- Antidote of these drugs to be kept with the units.

6.6 LIST OF HIGH RISK DRUGS

The list is prepared taking into consideration statutory requirements e. g. NDPS Act, FDA- Schedule of
Drugs. This list is maintained according to our organization and is reviewed periodically
MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

Page 10 of 13
Revision No: 00 Version No: 03

NOTE: HIGH RISK DRUGS ARE STORED IN A SINGLE LOCK & NARCOTIC DRUGS IN DOUBLE LOCK AND
KEY

HIGH RISK MEDICATIONS

S.N Categories of
o Medications Specific Medication
Narcotics and Opioids NOT APPLICABLE

Tramadol , Butorphanol ,Tapentadol, Codeine, Pentazocin

Neuro Muscular blocking
2 agents Atracurium, Succinyl Choline , Vecuronium, Rocuronium
Intravenous Anaesthetic
3 Drugs Propofol, Thiopentone Sodium
4 Antipsychotic Haloperidol
Sedatives and Hypnotics Alprazolam , Chlordiazepoxide, Clonazepam,
5 Clobazam ,Diazepam ,Lorazepam, Midazolam,
Phenobarbitone ,Promethazine ,Zolpidem
6 Intravenous Anticoagulants Heparin 25000 Units
Injectable Concentrated Conc. Potassium Chloride , Conc. Sodium Chloride (3%),
7 Electrolyte Calcium Gluconate,
Calcium Chloride, Cardioplagia , Magnesium Sulphate 25%
8 Insulins All Forms of Insulin
9 Chemotherapeutic Drugs All Chemotherapeutic Drugs
10 Radiocontrast Agents Meglumine Diatrizoate ,Iohexol
HIGH RISK MEDICATION
Medications which have higher potential for Medication Error or high risk of abuse or heightened risk
of causing significant patient harm, are called High Risk Medications.
MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

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The Drugs which are Look alike or Sound alike ; have higher potential for Medication Error.
Narcotics are the group of drugs, whose general availability is restricted and regulated by various
legal norms, because of their potential for abuse or addiction.
Drugs which have heightened risk of causing significant patient harm are also called High Alert
Medications.
Policy aims to reduce medication error, drug abuse and preventable Adverse Drug Events from High
Risk Medications.
Warning Signage
The storage in pharmacy stores for high alert medications should be clearly labelled. In the
Pharmacy stores, the list of High Risk Medications should be hanged.
Appropriate Waste Disposal
For disposal of Radioactive Drugs the process should be followed as per the ‘Policy on Radioactive
Drugs’ and as per guidelines laid down in the Atomic Energy (Safe Disposal of Radioactive Wastes)
Rules.
For disposal of Narcotic Drugs, process should be followed as per ‘Policy on Narcotic Drugs’ to limit
potential Drug Abuse and preventable Adverse Drug Events.
The left out amount of Narcotic injections should be diluted in water (under running water in sink)
and disposed in the presence of a witness like another staff nurse / Shift Incharge which should be
appropriately documented. Inappropriately disposed narcotic injections may cause medication errors
leading to adverse outcome or may promote drug abuse.

6.6 LIST OF HIGH RISK DRUGS

The list is prepared taking into consideration statutory requirements e. g. NDPS Act, FDA- Schedule of
Drugs. This list is maintained according to our organization and is reviewed periodically

7.0 IMPLEMENTATION:
Physicians, Pharmacy, Medical Officers and Nursing

8.0POLICY CROSS LINKS

Nil

MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

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Revision No: 00 Version No: 03

9.0 ATTACHMENTS

Amphotericin, vancomycin, and aminoglycosides, but may also

A Anti-infectives
include others

Ap Psychotropics Clozapine, lithium and depot injections

Potassium and
Injectable electrolyte preparations, for example potassium chloride
P concentrated
and magnesium sulphate, but may also include other medicines
electrolytes

I Insulin All insulins

Narcotics and All opioids, sedatives may include benzodiazepines and other
N
sedatives sedating agents

C Chemotherapy agents Cytotoxic chemotherapy

Heparin and other Heparins and all anticoagulants, including the New Oral
H
anticoagulants Anticoagulants

Epidural and Bupivacaine +/- fentanyl, bupivacaine +/- adrenaline (epinephrine),

E
intrathecal agents ropivacaine +/- fentanyl and other epidural or intrathecal agents

Neuromuscular Atracurium, cisatracurium, mivacurium, pancuronium, rocuronium,

Ne
blocking agents suxamethonium, vecuronium

MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES
 POLICY IH.MOM.005 – HIGH RISK MEDICATION

NABH MOM-2 (e) and 3(c )

Reference:

Issue Date : 30th SEPTEMBER 2020 Review Date: 31st AUGUST 2023 (as
req)

Page 13 of 13
Revision No: 00 Version No: 03

NOTE: HIGH RISK DRUGS ARE STORED IN A SINGLE LOCK AND KEY

MS NEELU AHLUWALIA
DR. VANDANA SHARMA

PREPARED & ISSUED BY: QUALITY DEPARTMENT APPROVED BY: DIRECTOR – ADMINISTRATIVE SERVICES