Medication Safety~ Best Practices Guide by BhFk7Br8


									 An approach to medication safety
  based on principles developed in
 high-risk industries and consistent
   with recent national reports on
  safety in health care released in
  the United Kingdom and United
          States of America.

A Systems Approach to the
Reduction of Medication Errors
Medication errors are often dealt with in a non-systematic, punitive, and ineffective
manner, with little analysis and knowledge of the factors influencing error generation.

Typically, the individual is blamed for their carelessness. By focusing on the individual,
the complete set of contributing factors cannot be known. Instead, vain attempts will be
made to change human behavior - one of the most change-resistant aspects of any
system. A punitive, person-centered approach therefore, severely hampers effective
improvements in safety.

By contrast, as in other high-risk industries, a systems-centered approach to error
reduction is routine. Through effective, non-punitive incident reporting, which includes
reports of near-misses and system problems, the systems-approach allows the
complete set of contributing factors underlying an event to be understood and

Feedback to participants and targeted improvement in the workplace is important to
demonstrate that incident data are being used appropriately. Medication errors are a
serious problem, which warrants a well-reasoned approach to its improvement.

Error Reduction Initiative

Medication error reduction is a clinical improvement initiative based on fundamental
principles of quality improvement that include rapid cycle methodology, collaborative
learning among participants, and sharing promising practices and lessons learned.

The focus of the initiative is on reducing the errors associated with high risk medication
and medication administration issues. Examples include reducing adverse drugs events
that occur with chemotherapy, insulin, heparin and warfarin, patient-controlled analgesia
and other infusions pumps, concentrated electrolytes, as well as automated dispensing
cabinets. These are high volume and/or high risk situations. The medications involved
can cause a great deal of harm to patients when mistakes occur. A miscalculation on a
chemotherapy dose can be lethal.

Rapid Cycle Methodology

Rapid cycle methodology has been utilized in health care and is based on action
research principles. It emphasizes the need to identify, in short cycles, a plan of action,
a testing of that action with a few patients and then building on the success of that to the
next step of the process.

One example is patients unable to get their heparin monitored in a timely fashion. The
team would look at the steps in the process of a patient being on heparin and getting
blood tests at appropriate intervals, then improve each step itself, checking to see if
implementing a change in the process works or not with a few patients and then moving
on to the next step in the process.

The kinds of interventions employed are checklists, reminders, standard operating
procedures, standard protocols, and best practices. Simple interventions exercised are
postings on the walls, clinical reminders, and laminated checklists and reminders. The
approach varies, and it’s introducing the tools and techniques then applying those to
health care to make the system safer.

Rapid cycle techniques are implemented to reduce the number of steps, reduce the
number of hand-offs, and use tools in order to calculate dosing. Physician order entry
systems are a very good way of eliminating a lot of medication errors. Change the
processes done today, within the existing system, to make improvements.

Point-of-Care Medication Error Reduction

1. Think workflow.

Implementing a safety check for medication adds another step; therefore, if the system
employed does have added benefits, that is, reduces effort and work in another area, it
will become a hindrance, not a help. Look to streamline the system in workflow.

2. Analyze product design.

Healthcare professionals have expressed dissatisfaction big, bulky, user unfriendly
electronic devices. Clinicians desire small, wireless, handheld devices; keypads that are
easy to use, with one hand; and displays that are easy to read in ambient lighting. The
best systems are built to last.

3. Scrutinize software capabilities.

Clinicians are not "techies”; therefore, devices must be easy to use and intuitive-based
to the daily routine. Software must easily prompt clinicians through the safety check

4. Assure one-to-one.

For the integrity of the process, the system deployed must allow for continuity and ease
of use, as well as increased compliance and reporting capabilities.

5. Assess integration

System must seamlessly integrate eMAR with pharmacy and hospital-wide systems.
Avoid one vendor for an end-to-end solution. Select the best solution for the system
from a vendor that can assure integration.

6. Allow for communication.

Communication is a key component. Systems that encourage interaction between
clinicians in the form of real-time alerts, order changes and additions, order verification
features, and ensuring accurate and up-to-date patient care, will gain greater visibility
into the other's process.

Quality Assurance Plan

1. Trustworthy.

Those who receive and act on error reports must earn trust. The program must prove it
is sensitive to clinician’s concerns. Feelings of trust are fostered by leaders who
demonstrate a clear passion for safety, acknowledge the high-risk nature of health care
and human fallibility. Manage errors to assess system performance, not staff

2. Confidential

Those who receive reports must keep the identities, the names of the clinicians involved
in the errors, and the location of the event confidential.

3. Clear and Easy

The report must be a prompt, descriptive narrative of the event. Ask questions that are
specific to the type of event to encourage the most pertinent information, decisions, and
actions. Event-reporting mechanisms must be easily accessible.

4. Rewarding

Recognition for playing a positive role in safety must be acknowledged by organizational
leaders and management. The largest reward is to know that the report resulted in
effective system-level action.

5. Credible and Useful

Few things impede reporting more than perceived inaction and failure to use the
information. Management must provide rapid, useable feedback about how the reports
are being applied to improve systems.

6. Reinforced Imperative

Those who receive reports must establish a mechanism for mentoring clinicians
regarding the error-reporting process. The importance of reporting hazards and errors
must be stressed with clear expectations for reporting activities in all job descriptions
and performance evaluations.

Optimizing Patient Safety

1. Develop policies and procedures for providing complete incident reports submitted to
designated entities for each Quality Related Event (QRE) occurrence. A QRE is defined
as any departure from the appropriate dispensing of a prescribed medication that is not
corrected prior to the delivery of the medication.

The term “quality-related event” includes variations from the specifications of a
prescription, such as wrong drug, strength, directions, and wrong dosage form. The
term also includes packaging or warnings that fail to meet recognized standards, the
delivery of a medication to the wrong patient, and failure to detect and appropriately
manage a significant actual or potential problem with a patient’s drug therapy.

Recommended Actions:

      • Create a system for reporting medication errors, promote analysis of the
      occurrence of the QRE and prevent similar events from recurring.

      • Promote a non-punitive atmosphere for reporting of medication errors.

      • Voluntarily report QRE to organizational management.

2. Institute a system to review incident reports. Perform root cause analysis and include
information from such review in the quality improvement programs. Reviewers to
include pharmacists, pharmacy technicians, and appropriate management personnel.

Recommended Actions:

      • Evaluate the QRE's that have occurred on a regular basis, summarize, spot
      patterns, and identify the root cause of the QRE’s.

      • Implement improvements/interventions based on the information gathered as
      part of the root cause analysis and create a scalable report format.

      • Publicize changes to clinicians.

3. Develop and implement an effective work flow plan that is evaluated periodically to
maximize effective use of space, equipment, technology, and clinicians.

Recommended Actions:

      • Develop policies and procedures to ensure that the appropriate individuals are
      completing appropriate tasks, at the appropriate time.

      • Consider the use of automated devices and technology to aid clinicians.

      • Explore ways to optimize services.

      • Evaluate the workflow.

4. Develop and implement a comprehensive technician-training program that requires
pharmacy technician trainees to demonstrate competence functioning as pharmacy
technicians and qualify for registration as technicians.

Recommended Actions:

      • Include a checklist and file a copy with policies and procedures documentation.

      • Require technicians registered by the Board to meet and maintain certification

      • Provide Continuing Education (CE) opportunities for pharmacy technicians.

      • Require competency in the technician’s area of work, and review annually.

5. Develop policies and procedures that insure patient profiles are routinely updated for
drug allergies, (patient weight-based dosed drugs), adverse reactions, over-the-counter
medication usage, alternative medication/herbal remedy usage, and health related
changes such as pregnancy, new diagnosis or change in health status.

Recommended Actions:

      • Develop a policy that requires allergy information be updated.

      • Develop a policy of updating patient’s weight.

      • Ask patients about their use of OTC medications and herbal remedies, and
      document responses in the patient profile.

      • Update patient profiles as part of the regular dispensing process.

6. Utilize available age and weight adjusted dosing guidelines when appropriate.

Recommended Actions:

      • Verify pediatric dosing to ensure proper dose.

      • Develop specific pediatric and geriatric guidelines for age and weight adjusted

      • Acquire or utilize reference materials, textbooks and /or computer software that
      directly addresses pediatric and geriatric dosing.

      • When appropriate and necessary, verify that the doses are appropriate for the

7. Provide clinicians access to appropriate website reference materials.

Recommended Actions:

      • Provide Internet access to clinicians to research clinical information.

      • Establish a clinical department to serve as a resource.

      • Require reference materials, such as computer software programs relevant to
      the particular practice setting.

8. Develop written policies and procedures to assure outdated stock or stock with an
expiration date that does not allow sufficient time for dispensing by pharmacy is
segregated from other stock and either prepared to return to manufacturer or destroyed
and documented.

Recommended Actions:

      • Periodically inspect the expiration date on medication stock bottles.

      • Periodically inspect the expiration date on medication containers in the
      refrigerator or freezer.

      • Identify short dated items with a colored label, indicating expiration date.

      • Check expiration dates on all products prior to completing the filling and
      dispensing of medication.

9. Develop procedures to ensure drug recalls are acted upon in a timely manner.

Recommended Actions:

       • Adopt procedure that personnel receiving recall notice are required to
       immediately bring recall notification to the clinician’s attention.

10. Explore the reasons for out-of-stock items.

Recommended Actions:

       • Collect data and analyze trends related to out-of-stock items.

       • Utilize a computer program to determine inventory employing
       maximum/minimum strategies.

       • Consider auto replacement technology.

       • Refer to the FDA shortage list

11. Adopt a policy allowing for continuation of therapy for out of stock or unavailable

Recommended Actions:

       • Inform clinician that the medication is out of stock or unavailable.

       • If known, inform clinician when the medication would be available.

       • If the availability from the manufacturer will result in interruption of therapy, offer
       to call the physician to discuss a change in therapy.

12. Develop policies and procedures, which continually improve pharmacy practice by
incorporating strategies to optimize therapeutic outcomes.

Recommended Actions:

       • Consider disease state management programs and certification programs to
       enhance delivery of pharmaceutical care.

       • Initiate a program to monitor HbA1C levels of diabetic patients.

       • Counsel patients with diabetes regarding the proper use of glucose monitoring
       equipment, insulin, syringes, injection techniques, and insulin pens.

      • Implement a program to encourage high-risk patients to have cholesterol levels

      • Encourage patients with asthma to demonstrate proper use of Metered Dose
      Inhalers, spacers and peak-flow meters.

      • Institute and promote procedures to determine if patients utilizing chronic care
      medications are adhering to prescribed medical regimens.

      • Develop a plan for the acquisition of adherence software within an acceptable
      time frame.

      • Provide counseling and conduct activities to help increase immunization rates
      for patients at high risk for pneumonia and influenza.

13. Develop policies and procedures, which continually ensure the integrity of
Biologicals and Pharmaceuticals.

Recommended Actions:

      • Require maintaining a daily temperature log on file, and use of an automatically
      calibrating thermometer on all refrigeration units storing any biological or

14. Develop and implement written policies and procedures that enhance anti-
counterfeiting measures regarding the receipt, storage and security of controlled

Recommended Actions:

      • Visually examine all deliveries promptly on receipt to identify contents and
      determine if any contaminated, damaged, misbranded, expired or suspected
      counterfeit drugs are included in the shipment.

      • Quarantine any drugs or devices found to be unacceptable for further
      examination and determination.

      • Inspect medication during final verification to assure product accuracy and

      • Request wholesalers to certify that all medications delivered to the pharmacy,
      not accompanied by a pedigree, are purchased directly from the manufacturer.

      • Report suspected counterfeit medications to Med Watch (the FDA Safety
      Information and Adverse Event Reporting Program), the Board and appropriate
      law enforcement authorities within three business days.

      • Maintain records of counterfeit reports from manufacturers and other sources
      for a minimum of a three year period.

      • Consult NABP’s “National Specified List of Susceptible Drug Products”
      available for reference at

      • Educate clinicians the risks of counterfeit medications.

      • Encourage clinicians to promptly report, it suspect that a medication is

      • Remind clinicians to be aware of noticeable differences in medications or
      packaging and the occurrence of any adverse events.

      • Alert clinicians to the important role pharmacists play in identifying, reporting
      and responding to counterfeit drug events.

15. Develop and implement written policies and procedures regarding the identification
of medication when requested by a clinician or medical professional. Resources for
Non-Emergency Product Identification Requests

[If emergency: call poison control center at 1-800-222-1222]

Recommended Actions:

1. When a prescription is associated with the medication to be identified:

      a. Verify the prescription content with the original copy of the prescription
      dispensed making sure that the markings on the unidentified medication match
      the prescription medication dispensed and identified from the original

      b. If unidentified medication cannot be verified then refer to #2.

2. Identification of a medication with manufacturer’s code and/or NDC code or other
markings on the product:

       a. Utilize available resources and references to identify medication by
       manufacturers’ identification codes, NDC code, or drug name.

       b. If medication cannot be identified then refer to #3.

3. Identification of a medication that has no markings and/or is a formulation (liquid) that
is not positively identifiable:

       a. Call the poison control center and describe medication and indication for use if

       b. In non-emergency situations, obtain services for laboratory product analysis,
       example: or


To top