MINISTRY OF HEALTH

QUALITY MANAGEMENT AND PATIENT SAFETY DIRECTORATE

HAIL, SAUDI ARABIA

HIGH ALERT MEDICATION MANAGEMENT PLAN

Our path to improved Patient Safety

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 TABLE OF CONTENTS

Introduction____________________________________3

Important Terminology and Definition______________4

Purpose, Goals, Objectives________________________5

Component of High Alert Medication Program_______6

Key Success Factors______________________________7

Sustaining Overtime______________________________7,8

Roles and Responsibilities__________________________8

Risk Factors _____________________________________9,10

Key Concept in Safeguarding the High Alert Mediations__ 12-14

Review and Annual Evaluation______________________15

Approval ________________________________________15

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 INTRODUCTION

High-alert medications (HAM) carry a higher risk of harm than other medications and errors
in the administration of HAM can have catastrophic clinical outcomes. The purpose of this
program is to ensure safe medication practices and to eliminate medication errors that cause
harm to our patients.

Hospital leadership, physicians, nurses, pharmacists, quality leaders, must worked together to
1).standardize high-alert medication-handling practices; 2) enhance education programs
related to medication practices, embedding these into annual core competencies of all staff
who handle high-alert medications; 3) develop monitoring functions at both the regional and
local levels to ensure sustainability and ongoing systems improvements.

These errors most frequently occur in the prescribing and administering stages. Medication
errors are a significant and often preventable health care problem. Although many medication
errors may not cause grave harm to patients, some medications are known to carry a higher
risk of harm than other medications and errors in the administration of these medications can
have catastrophic clinical outcomes. These medications are identified as high-alert
medications (HAM) and require special considerations. One of the National Quality Forum's
30 Safe Practices for Better Healthcare3 is to identify all high-alert drugs, and establish
policies and processes to minimize the risks associated with the use of these drugs.

Adopting a culture of safety and remaining mindful about safety are two areas that the
hospital can improve upon. Hospitals should not be afraid to report risks, errors and near
misses related to high-alert medications so that they, as well as others, can learn from their
mistakes and willingly make changes to improve patient safety. Mindfulness, rather than
complacency, about patient safety should be at the forefront of every hospital staff members
thoughts and action. bearing in mind that deviations from the quality standard of the
medication system may cause damage to the patient

"Medication errors have caused serious problems in health

care organizations. It makes sense to be aware of risk reduction information
and react to it before something serious
takes place.

Important Terminologies and definitions

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 1. High alert medications are those medications that bear a heightened risk of causing
a significant harm or other adverse outcomes when they are used in error. The
consequences of an error are clearly more devastating to patients.

2. Independent Double Check A procedure in which two authorized, qualified

practitioners will separately check each component of the work process. For example,
one person calculating a medication dose for a specific patient and a second
individual independently performing the same calculation (not just verifying the
calculation) and matching the results. A pharmacist will be consulted in the event that
agreement cannot be reached.
Ten rights
IV pump settings
Volume standardization
Label accuracy
IV tubing connections
Site of line insertion
An independent double check is required for break-relief only if there is an expected bag
change, change in drug dose, rate of infusion or pump settings
3. A Culture of Safety

Awareness, understanding, and ownership of medication safety at all

levels of the organization

Mindset of constant vigilance and situational awareness to prevent

medication errors

Emphasis on identification of system faults and latent errors

A just culture where individuals are treated fairly when errors occur

4. Time out must involve the entire care procedure team, use active communication, to
be documented and must at least includes:
a. Verification of Correct patient identity (use two patient identifiers).
b. Correct side and site (verify appropriateness of drug and if giving
medication IV, verify patency of IV line). All medications administered
by the intrathecal route, time out must be conducted immediately before
starting administration/ procedure, in the location where the procedure
will be done.

Purpose
1. Standardizing medication handling practices.
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 2. Enhancing education programs related to medication practices, embedding these into
annual core competencies of all staff who handle medications.
3. Developing monitoring functions to ensure sustainability and on-going systems
improvements.
4. To provide the health care workers involved in the medication management with
current information regarding the standardization of high alert medication handling
practices and the safe administration of medications.

Goals of High Alert Medication Program

1. Eliminate harm

2. Promote standardization

3. Monitor performance

4. Generate ongoing system improvements

5. Ensure sustainability

Objectives:
1. To develop and implement the high-alert medication program

2. Standardization of labeling system, storage, ordering, preparation and administration.

3. To enhanced the strategies to reduce medication administration errors with IV heparin

and improve patient outcomes

4. To emphasize the independent double check and time out when giving High Alert
Medications .This includes change of shift, change of primary assignment, transfer of
patients between units or levels of care.

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 COMPONENTS OF HIGH ALERT MEDICATION PROGRAM

1. Development of the High Alert Medication List. Using the current literature,
recent medication related events and the expertise of the each member of
Pharmacy and Therapeutic Committee/ Medication Safety Committee, the
group broke down into working groups where the list was developed. Each
group had content and experience experts and was charged to bring forth
the listing of drugs, methods of administration and patient specific
requirements that the large group would evaluate. Decision making was
by consensus and the High Alert Medication List and management
requirements were established. It reviewed and updated yearly.
2. Establish the Scope of the Program The Committee should established that the
High Alert Medication List would have the following requirements:
The High Alert List and management requirements would be
standardized at all facilities throughout the hospital.
Any change to the list would require approval by the Medication
Safety Committee
The High Alert Medication List would apply across the
continuum of care, including special practice
Senior leadership would ensure the appropriate resources were
available for design, implementation and equipment requirements
3: Policies and Procedures - A team of pharmacists, nurses and quality
practitioners, with the guidance of physician partners (multidisciplinary
approach) will develop the policies and procedures of the High Alert medication.
Over a period of one month these were sent to subgroups of staff for comment
and through a dynamic change process the policies and procedures were
finalized into a working document. These received final approval from the
Chairman of Medication Safety Committee and final approval from the Hospital
Executive Committee.
4. Communication - A communication plan will be developed to ensure that
the message of medication safety would be consistent and that all in would be
aware of the program. Support for the program at the facility level is needed and
specific communication steps were taken to enlist the support of leadership to
ensure success.
5. Education An education plan will be established to accomplish the goal of
training all pharmacy, nursing and medical staff. Standardized education tools
were developed for use across the region/hospital. All training will be done from
orientation process and on renewable basis.
6. Elimination of unapproved abbreviations
7. Standardization of drugs, concentrations and procedures and to include the
standardization of labeling system of high alert medications.
8. Monitoring - An Audit group of the Medication Safety Committee will be
established to design monitoring tools and procedures to ensure complete
implementation, staff competency and the consistent application of the
requirements of the program.. Observational Audit monitoring tools to be
developed. These audits were designed to measure whether or not all
medications on the high alert medication list were handled specifically to policy
requires sustained a new and improved process. It should review the following:
The types of high alert medications stocked in patient care areas.(i.e. ward
stock) are specific to the needs of the patient treated and that any high
alert medication not used regularly shall be removed.
The quantity of each high alert medication stocked in patient care areas is
limited to the amount necessary to provide timely care.
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 High alert medication storage and labeling are in compliance policy and
procedures of the hospital.
.

Key Success Factors

Making a change of this magnitude can be extremely difficult. Our culture is one
of innovation and focus on results, and not one where a specific process
approach is often mandated. Given the seriousness of our issue, however, we
recognized the importance of consistency in meeting our goals. Our approach to
successful implementation included the following key steps:
1. Leadership endorsement: Key physician and nursing leaders from both the
hospital and the medical group endorsed the program and created visible
support
2. Constant communication and education: To held routine meetings with
the hospital leaders accountable to implement the High Alert Medication policy
and procedure, to answer questions, clarify misunderstandings, and continue to
communicate the consistent message. For the first
few months of the program these meeting to be held weekly. There will be a
meeting with leadership groups, nursing leadership groups and staff nurse
leadership groups to convey the need for a consistent program approach. In
addition, all nursing staff and others who give medications completed a
competency assessment and brief test on the 10Rs of giving medication.
administration.
3. Feedback loop: We established a process to use to request changes to the policy.
We review changes at the Medication Safety Committee meetings, and make a
decision to modify the policy and procedure or leave it as is. We also chartered
subgroups to work on particular that we honored the specific needs of these
specialties while adhering to the High Alert Medication principles.
4. Local accountability: Each hospital has a subcommittee Medication Safety
Committee. This committees responsibility is to ensure High Alert Medication
program is in place and to review trends and local issues for course correction
and action.
5. A collaborative meeting call will be established on a monthly basis to
discuss changes in the program; barriers; successful practices; etc. This call
not only provides a means of exchanging information but also is important to
sustaining the program.
6. Standardized procedures, high alert medication list, order sets, labeling and protocols
7. Program sustaining activities such as monthly medication safety calls, staff education
and testing for competency, monthly observation audits and coaching
8. Notification and investigation of all High alert medication errors, data analysis and
reporting and as as part of pharmacy indicator.
9. Comprehensive approach CPOE, BCMA, Smart infusion pumps, Nurse Knowledge
exchange.( Computerized Physician Ordering Entry, Bar Coded Medication
Administration)
10. Involvement of multidisciplinary team from all levels of the organization
11. Regional coordination and oversight by the Regional Medication Safety Committee

Sustaining over time

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We believe that in addition to ongoing monitoring, constant attention to the
voice of our staff, physicians, and patients is key to successfully sustaining the
High Alert Medication Program over time. Improvements to the program as a
result of this input include:
1. Updating of the policy and procedure to improve usability.
2. The introduction of Computerized Physician Order Entry, Bar Boded
Medication Administration (CPOE), BCMA ) has dramatically reduced
medication errors related to administration.
3. Production of a video starring our nurses demonstrating the proper
technique for performing and independent double check. Standardized
ongoing competencies.
4. Patients coming to our hospital to provide input on how we can improve
our medication delivery process.
5. Replacing of existing IV pumps with smart pumps that alert the nurse if
the dose is out of an acceptable range
6. Actionable measurement (process audits)
7. Continue work to support a Just Culture
8. Share experiences internally and externally
9. Ongoing review of the High Alert Medication Program and policy
10 Standardized ongoing competencies
11 Intensive analysis of events to identify trends

ROLES AND RESPONSIBILITIES

1. Leadership Group
Ensure the mandatory policy and standards are implemented at all health
facilities

2. Quality and Patient Safety

Ensure systems are in place to:
- Implement the mandatory high-risk medicine policy and standards. -
Monitor compliance with the high-risk medicine policy and standards
3. Medication Safety Committee
Ensure a list of high risk medicines is current and maintained.
Ensure medication safety is a key consideration in all formulary decisions and
that when a medicine which is considered to be high-risk is added to the
formulary, it is included in the list of high risk medications.
Development and endorsement of policies, protocols and guidelines relating
to high risk medicines.
Receive reports on high risk medicine incidents, policy compliance rates and
formulate corrective action, if indicated.

4. Clinical Staff Involved In Medication Management

Comply with policy and standards for high-risk medicines.
Follow the hospital protocol/guidelines described in the facilities high-risk
medicines list.
When prescribing and supplying high-risk medicines, give clear advice to
ensure their safe administration
Maintain knowledge base relevant to area of practice.

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 Be aware of all medications identified as high alert.
Comply with independent double checks, storage and administration
requirements related to high alert medications
Shall engage the patient and or family in the process of high alert medication
administration and shall provide appropriate medication information/teaching.

BARRIERS

1. Resource allocation

2. Competencies and training

3. Workflow changes

Name of High Common Risk Factor Suggested Strategies

Alert Medication
Insulin Lack of dose check systems
Insulin and heparin vials kept in
close proximity to each other on a
nursing unit, leading to mix-ups
Use of "U" as an abbreviation for
"units" in orders (which can be
confused with "O," resulting in a
10-fold overdose)
Incorrect rates being programmed
into an infusion pump
Opiates and Narcotics Parenteral narcotics stored in
nursing areas as floor stock
Confusion between
hydromorphone and morphine
Patient-controlled analgesia (PCA)
errors regarding concentration
and rate particularly for
postoperative patients
whose pain severity is changing,
for that is often the setting
where opioid overdose occurs."
Establish a double check
system.
Standardized the arrangement
of High alert medications
with pop up label
Communicate the List of
prohibited abbreviations.
Use the free flow IV pump as
possible.
Limit the opiates and
narcotics available in floor
stock.
Educate staff about
hydromorphone and
morphine mix-ups.
Implement protocols that
include double-checks of the
drug, pump setting and
dosage

Parenteral narcotics stored in

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 nursing areas as floor stock
Patient-controlled analgesia (PCA)
errors regarding concentration
and rate
Injectable Potassium Storing concentrated potassium
Chloride or Phosphate chloride/phosphate outside of the
Concentrate pharmacy
Mixing potassium
chloride/phosphate
extemporaneously
Requests for unusual
concentrations
Intravenous Unclear labeling regarding
Anticoagulants concentration and total volume
(Heparin)
Multi-dose containers
Confusion between heparin and
insulin due to similar measurement
units and proximity
Sodium Chloride Storing sodium chloride solutions
Solutions (above 0.9 percent) on nursing
units
Large number of
concentrations/formulations
available
No double check system in place
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Remove potassium
chloride/phosphate from
floor stock.
Move drug preparation off
units and use commercially
available premixed IV
solutions.
Standardize and limit drug
concentrations.
Standardize concentrations
and use premixed solutions.
Use only single-dose
containers.
Separate heparin and insulin
and remove heparin from the
top of medication carts.
Limit access of sodium
chloride solutions (above 0.9
percent) and remove from
nursing units.
Standardize and limit drug
concentrations.
Double check pump rate,
drug, concentration and line
attachments.
 HIGH ALERT MEDICATION LABEL
LABEL TYPE MEDICATION CLASS USE

All HIGH ALERT To be affixed to high alert

MEDICATION medication storage containers
( i.e ward stock and pharmacy
stock).

Exceptions: Narcotic (opiods)

It is not necessary to label each

storage container within the
narcotic (opioid) storage area. A
single large icon affixed to the
door of the locked storage area
(ie, cart or cupboard ) is
sufficient.

Neuromuscular Blocking agent To be affixed to the storage

containers only ( i.e. ward
stock and pharmacy stock)
No need to label the product.

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 Epidural product To be affixed to the storage
containers and to each ready
to administer epidural
product (including patient
specific)

STRATEGIES TO REDUCE ERRORS INVOLVING IN HIGH ALERT

MEDICATIONS

KEY STRATEGIES DESCRIPTION

Procurement Limit the drug strength in the hospital

Avoid frequent changes of brand or color and notify the other

healthcare staff if there are changes.

Inform all relevant personnel regarding in the hospital about

the new High Alert Medication listed

Storage Minimize High Alert Medications from clinical areas, where

possible.

High Alert Medications should stored individually in

separate labeled plastic container.

Label the shelves or containers used for storig High Alert

Medications as High Alert Medications

Prescribing Avoid using abbreviations when prescribing High Alert

Medications.

Avoid ordering High Alert Medciations verbally accept in

case of emergency orders have to be repeated and verified.

Prescribe oral liquid medications with the dose specified in

milligrams

Avoid using training zero when prescribing ( e.g. 5.0 mg can

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 be mistaken as 50 mg)

Reduce the total dose of High Alert Medications in

continuous IV drip bags ( e.g 12,500 Units of Heparin in 250
ml vs 25,000 in 500 ml) to reduce risk.

Dispensing /Supply All High Alert on medications containers , product packages,

vials or ampoules issued to wards/units need to have caution
label HIGH ALERT MEDICATIONS: except for parenteral
nutrition preparations.

High Alert Medications to be dispensed to patients should

not have cautioning label.

Accuracy check performance must be applied for the High

Alert Medications before dispensing the medications.

Counseling Educate the patient and or the patient family member and the
required informations such as: the purpose of taken
medicine, how to take the medicine and the common side
effect of using the n medicines.

Administration Nurses must double checked all High Alert medications

before giving the dose to the patient. The following
particulars shall be independently double checked against the
prescriptions or medications at the bedside by two
appropriate persons before administration:

Patients name and patient file number

Medication name, strength and dose

Route and rate ( pump setting and line placement

when necessary)

Expiry date

Ensure trained personnel do administration of intrathecal,

cytotoxic drugs, epidural analgesics and parenteral nutrition

Return all unused or remaining specially formulated

preparations to the pharmacy when no longer required.

Monitoring Closely monitor vital signs, laboratory data, patients

response before and after administration of High Alert
Medications.

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 Keep antidotes and resuscitation equipments in wards unit.

Evaluation
Evaluation of compliance of the High Alert medication Program will be carried out by the
Medication Safety Committee for performing out regular audits and evaluating the success
for implementation. Feedback of evaluation results should be provided to staff. Evaluation is
fundamentally connected to successful change management. Setting measurable goals can be
a useful tool to enhance uptake and implementation and tracking performance against these
goals and meaningful manner can assist with motivation and compliance.

Review of the Plan

This can be done by meetings with Medication Safety Committee group in order to review progress in
the improvement of particular aspects of the services.
The prior fiscal year program activities are summarized and incorporated into following year . The
evaluation identifies progress toward performance improvement goals and barrier that prevent desired
outcomes. In an annual basis the Medication Safety Committee receives an annual progress
evaluation.

References:
1. General Administration of Pharmaceutical Care

Approval:

Name Title Signature Date

Prepared by Imelda T. Morada QM and Patient Safety Directorate

Coordinator

PH. Ali Abdulla Director of QM and Patient safety

Alghomaiez Directorate
Reviewed by

Approved by:

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