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Standard Implementation Protocol for Medication Reconciliation

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					                                               VOLUME 1

                          The Standard Operating Protocol




Action on Patient Safety (High 5s) – Medication Reconciliation, Volume 1   Version 1.0; 09/3/10 Page 1 of 21
                                            Attribution Statement

The High 5s Project is a patient safety collaboration among a group of countries and the WHO
Collaborating Centre for Patient Safety in support of the World Health Organization (WHO), World
Alliance for Patient Safety.

The Project, which is coordinated by the WHO Collaborating Centre for Patient Safety (designated
as The Joint Commission and Joint Commission International), has received generous funding from
the U.S. Agency for Healthcare Research and Quality, WHO, and the Commonwealth Fund.

The Mission of the High 5s Project is to facilitate implementation and evaluation of standardized
patient safety solutions within a global learning community to achieve measurable, significant, and
sustained reductions in highly important patient safety problems. The countries currently
participating in the High5s Project are Australia, Canada, France, Germany, the Netherlands, Saudi
Arabia, Singapore, the United Kingdom and the United States of America. In this collaboration,
Canada has led development of the medication reconciliation standard operating protocol, the
United Kingdom has led development of the concentrated injectables protocol, and the United
States of America has led development of the correct site surgery protocol. All of the participating
countries have provided technical expertise in the development of the implementation, performance
measurement, event analysis, and evaluation frameworks that are integral to the standard operating
protocols.




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                             Standard Operating Protocol
                   Assuring Medication Accuracy at Transitions in Care

    The following Standard Operating Protocol (SOP) has been developed solely for use within the context of the
    Action on Patient Safety (“High-5s”) initiative, an internationally coordinated, limited participation
    activity for testing the feasibility of implementing standardized patient safety protocols and determining the
    impact of the implementation on certain specified patient safety outcomes. Because the efficacy of this and other
    High-5 SOPs have not yet been demonstrated, their implementation outside of the High-5s testing
    environment is not recommended at this time. Results of this initiative, when completed, will be published and
    the refined SOPs, as appropriate, with be made available for general implementation.


                                               About This Volume

Volume 1 – The Standard Operating Protocol is the primary reference document for hospitals and LTAs
participating in the High 5s project. It outlines the standard steps of medication reconciliation. Volume 2, 3, and 4
include a “SOP at a glance” section meant to highlight key steps of the SOP as a quick reference.


                                          About The Other Volumes

Volume 2 – Evaluation and Required Components will assist participating hospitals and Lead Technical Agencies
(LTAs) in evaluating the implementation and impact of the High 5s Medication Reconciliation Standard Operating
Protocol (SOP). This volume provides a detailed explanation of each evaluation component (what to measure, when,
how) and shows how it contributes to reducing the risk of adverse drug events as well as to the success of the High 5s
Project.

Volume 3 – The Information Management System (IMS) describes the tools and procedures for data collection in an
efficient and effective manner using the High 5s information management system.

Volume 4 – The Getting Started Kit provides practical guidance and examples that will support hospitals in
performing medication reconciliation, implementing the SOP and evaluating its impact.




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                                                                  Table of Contents

Description of the patient safety problem to be addressed ......................................................................5
Basic principles and rationale ........................................................................................................................5
A Word about Standardization .....................................................................................................................6
Phased implementation of medication reconciliation and scope of High 5s .........................................7
The Context for Medication Reconciliation ...............................................................................................7
Detailed specifications for the steps in the medication reconciliation process .....................................9
            Best Possible Medication History (BPMH) ...................................................................................9
            Medication reconciliation at admission ..........................................................................................9
            Medication reconciliation at internal hospital transfer.............................................................. 11
            Medication reconciliation at discharge ........................................................................................ 11
Patient and family involvement ................................................................................................................. 12
Permissible adaptations in the medication reconciliation process ........................................................ 12
Implementation strategy for medication reconciliation ......................................................................... 12
            Oversight of the implementation: ................................................................................................ 13
            Project work plan ........................................................................................................................... 13
            Risk assessment of the proposed medication reconciliation process ..................................... 14
            Pilot test of the medication reconciliation process ................................................................... 14
            Spread methodology ...................................................................................................................... 15
            Communication plan ..................................................................................................................... 15
            Evaluation strategy ......................................................................................................................... 15
            Maintenance and improvement strategy ..................................................................................... 16
Appendix A ................................................................................................................................................... 17
References ..................................................................................................................................................... 19




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Description of the patient safety problem to be addressed
It is well known that adverse drug events (ADE’s) are a leading cause of injury and death within
health care systems.1,2,3 Up to 67% of patients’ prescription medication histories have one or more
errors.4 Often there is no defined process for medication reconciliation and/or a lack of knowledge
and understanding of the inherent complexity of this process. If a process does exist, there is often
no process owner or no person responsible for ensuring the process is successful. As a result, there
may be no source of accurate and complete up-to-date medication information for the patient. The
impetus for this standard operating protocol is the prevention of ADEs by improving the
medication reconciliation process.


Basic principles and rationale



 Medication reconciliation is the formal process in which health care professionals partner
         with patients to ensure accurate and complete medication information
                                transfer at interfaces of care.



The safe use of medications in the diagnosis and treatment of patients requires knowledge and
consideration of all the medications that the patient is currently taking or receiving in order to avoid
omissions, duplications, dosing errors, and potential adverse interactions with new drugs being
prescribed. Medication reconciliation is a formal process in which health care professionals partner
with patients to ensure accurate and complete medication information transfer at interfaces of care.

Medication reconciliation at admission involves using a systematic process to obtain a best possible
medication history (BPMH), which reflects an accurate and complete list of all medications taken
prior to admission. The BPMH is used to create admission orders or is compared to admission
medication orders in order to identify and resolve discrepancies. It is designed to prevent potential
medication errors and adverse drug events.


As used in this SOP, the term “Medications” includes ALL prescribed (based on the advice of
prescriber) and non-prescribed medications (not based on prescriber’s advice) which include:
     prescribed (medications the patient is instructed to take by the prescriber)
     non-prescribed (the prescriber did not advise the patient to take the medication)
     prescription
     non-prescription (e.g., over-the counter (OTC) or herbal medication)
     recreational and
     ‘prn’ (i.e., “as needed”) medications required by patient




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The development, maintenance and communication of a complete and accurate medication list (the
BPMH) throughout the continuum of care—whenever and wherever medications are used— is
essential for reducing adverse drug events. The key to the success of medication reconciliation at all
interfaces is to first have a process working effectively at admission to the health care facility.
Appropriate admission medication reconciliation is the foundation to support and facilitate efficient
and appropriate reconciliation at internal transfers and discharge.


                                               Guiding Principle:

                            An up-to-date and accurate patient medication list is
                             essential to ensure safe prescribing in any setting.




A Word about Standardization
The basic assumption being tested in the High 5s initiative is that process standardization will
improve patient safety. We know that in a general sense, the tendency for a process to fail is
diminished in relation to the consistency with which it is carried out; that is, the degree to which it is
standardized. Despite this, efforts in recent years to standardize health care processes through the
introduction of practice parameters, protocols, clinical pathways, and so forth have been met with
limited enthusiasm among practitioners and are only slowly affecting the actual delivery of care.
Achieving process consistency while retaining the ability to recognize and accommodate variation in
the input (for example, the patient’s severity of illness, co-morbidities, other treatments, and
preferences) is one of the major challenges to standardization in health care. Process variation to
meet individual patient needs is an essential principle of modern medicine; variation to meet
individual health care organization or practitioner preferences need not be.

The thesis being tested in the High 5s initiative is that standardization will be advantageous—will get
better overall results more safely—even if we concede that each practitioner working independently
could get better results than the others by using a personally favored, but different, process than the
others. Assuming each is a good practice, it matters less which process is selected as the basis for
standardization; standardization matters most. Standardization trumps “best practice” when it
comes to safety.

And the High 5s initiative is taking standardization a couple of steps further than the usual efforts to
minimize variation—it not only seeks to standardize certain processes among individuals within a
health care organization but to standardize them in multiple organizations in multiple countries
around the world. Is it possible to standardize on this scale? If it is, will it measurably improve the
safety of care? These are the questions we hope to answer. You can help.




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Phased implementation of medication reconciliation and Scope of High 5s:

Considering the complexity and resource requirements for implementing a comprehensive program
of medication reconciliation for all patients across the full continuum of care, a phased
implementation is recommended. This “High 5” Standard Operating Protocol addresses all aspects
of medication reconciliation but will focus its initial (Phase 1) implementation as follows:

        Limited to patients age 65 or older admitted through the emergency department to
         inpatient services.

Inpatient units (acute care wards) excludes patients admitted to short stay observation units (SOU).
SOUs are designated areas that accommodate patients who require a brief period of observation or
therapy but do not require admission to an inpatient ward.
Note that although formal measurement activity in Phase I of this High5 initiative will focus
on the admission process, participating hospitals are strongly encouraged to begin implementing
procedures for medication reconciliation for all patients and at all points of transfer and discharge,
as described in Volume 4 – Getting Started Kit.
Hospitals may individually choose to broaden the scope of patients receiving formal medication
reconciliation and/or points of care at which medication reconciliation is performed, however data
for these additional patients/sites will not be collected and/or analyzed as part of the High 5s
project at this time.
Subsequent phases of implementation will expand the scope to include all patients at all
entry points in all inpatient and outpatient settings. Also, medication reconciliation data collection
for patients being transferred and for various discharge scenarios will be added in later phases.


The Context for Medication Reconciliation

Effective and efficient implementation of a process for medication reconciliation will require
integration of its steps into existing processes for medication management and patient flow, rather
than simply adding new tasks. It is therefore important to identify the other aspects of patient care
with which medication reconciliation must interface, including the following:
        Patient admission/intake
        Initial patient assessment
        Medication ordering, preparation and dispensing
        Documentation of care
        Internal patient transfer procedures
        Communication of information among providers
        Discharge planning
        Patient education and discharge instruction

Recognizing that medication reconciliation is largely a matter of information management, the
specifics of implementation will depend to a considerable degree on the health care organization’s
existing systems and processes for collecting, using, and communicating information, for example,


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hand-written paper medical records versus electronic medical records. The information management
activities in support of medication reconciliation should be integrated as much as possible into these
existing systems and processes by adapting the tools currently used (forms, data collection tools,
etc.) and aligning work flow to optimize efficiency of the integrated process.

Finally, the culture of the organization with respect to interdisciplinary collaboration and teamwork
will significantly influence the efficiency and effectiveness of the medication reconciliation process.
This process is best conducted in an environment of shared accountability and it is in this context
that the operational protocol is based.




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Detailed specifications for the steps in the medication reconciliation process:
Best Possible Medication History (BPMH)
A Best Possible Medication History (BPMH) is a medication history obtained by a clinician
which includes a thorough history of all regular medication use (prescribed and non-prescribed),
using a number of different sources of information.

Types of medication to be noted on the BPMH include ALL prescribed (based on the advice of
prescriber) and non-prescribed medications (not based on prescriber’s advice) which include:
     prescribed (medications the patient is instructed to take by the prescriber)
     non-prescribed (the prescriber did not advise the patient to take the medication)
     prescription
     non-prescription (e.g., over-the counter (OTC) or herbal medication)
     recreational and
     ‘prn’ (i.e., “as needed”) medications required by patient

The BPMH involves a systematic process for obtaining a medication history, verifying medication
information with more than one source as appropriate:
    1. Patient and/or family medication interview where possible.
    2. Other sources of information include:
        contacting community pharmacists, physicians, and/or home care providers
        inspection of medication vials/patient medication lists
        government medication database
        previous patient health records

If a patient or family is unable to participate in a medication interview, other sources may be utilized
to obtain medication histories and/or to clarify conflicting information. Other sources should never
be a substitute for a thorough patient and/or family medication interview, if they are possible.

The BPMH is a record of medication information that includes: medication name, dose, frequency
and route of administration of medications a patient is taking. It is a ‘snapshot’ of the patient’s actual
medication use, even though it may be different from what was prescribed. Using tools such as a
guide to gather the BPMH may be helpful for accuracy and efficiency. (Figure 6 – Best Possible
Medication History Interview Guide)

The BPMH is different and more comprehensive than a routine primary medication history (which
is often a quick patient medication history). (Please see Volume 4 – Getting Started Kit for
examples)

Medication reconciliation at admission
Admission medication reconciliation processes generally fit into two models: the proactive process
or the retroactive process, or a combination of the two. The proactive model occurs when the BPMH
is created prior to writing admission medication orders. In the retroactive model, admission orders are
written before the BPMH is created. In both models, reconciliation takes place between the BPMH
and the admission orders, discrepancies are identified and resolved.


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   Proactive medication reconciliation Model at admission
    1. Create the BPMH
    2 Using the BPMH, admission medication orders (AMOs) are written by the prescriber.
    3. Verify that the prescriber has assessed every medication on the BPMH, identifying and resolving any
        discrepancies with the prescriber, if any.



Proactive medication reconciliation model at admission




In the proactive model, the BPMH is created and documented upon patient arrival/decision to admit
the patient and is used by the prescriber to write the admission medication orders (AMO). Some
teams have created paper based or electronic formats to document the BPMH that leads to
medication orders by providing room for the prescriber to indicate whether the medications should
be continued, discontinued or modified.

This process depends on the BPMH being created before admission orders (AMOs) are written. In
some situations such as: inadequate staffing to perform a BPMH, medical status of the patient,
complex patients with extensive medication histories, or incomplete information available to
complete a BPMH prior to the AMO; a process should be in place to reconcile the AMOs to the
BPMH within 24 hours as in the retroactive process.

In the retroactive model, the BPMH is compared against the admission medication orders.
Discrepancies are identified and resolved with the prescriber, if appropriate. Discrepancies between
the admission medication orders and the BPMH can be divided into 3 main categories: intentional,
undocumented intentional or unintentional.



   Retroactive medication reconciliation model
    1. Primary medication history is taken
    2. Admission medication orders are written by prescriber
    3. Create the BPMH
    4. Compare the BPMH against the patient’s admission medication orders, identify and
          communicate any discrepancies to the prescriber within 24 hours of the decision to admit the patient.




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*A Primary Medication History (PMH) is the initial medication history taken by an available clinician
at the time of admission.
Retroactive Medication Reconciliation Model at admission


                                                                                 Communicating any
                                                                                 discrepancies to the
                                                                                 prescriber must be
                                                                                 done within 24 hours
                                                                                 of the decision to
                                                                                 admit the patient.
Appendix A provides, in tabular form, additional detail on how it will be done, who will do it, when
it should be done, what tools are needed, and the inputs and outputs of the step. For a sample of
forms that may be useful in the implementation and documentation of medication reconciliation
please refer to Volume 4 - Getting Started Kit.

Medication reconciliation at internal hospital transfer
To be successful, medication reconciliation must occur across the continuum of care. At the time of
internal hospital transfer, the goal of medication reconciliation is to consider not only what the
patient was receiving on the transferring unit but also any medications he or she was taking prior to
admission (at home or at another facility) that may be appropriate to continue, restart, discontinue
or modify. The transfer orders should be compared to the BPMH and the existing transferring unit
medication administration record (MAR). Discrepancies should be identified, reconciled or
corrected and changes to the transfer orders made as appropriate.

Medication reconciliation at discharge

On discharge the goal is to reconcile the medications the patient was taking prior to admission and
those initiated in hospital, with the medications they should be taking post-discharge to ensure all
changes are intentional and discrepancies are resolved prior to discharge. The BPMH, previous 24
hour MAR and the discharge prescription are compared and an evaluation of discontinued
medications, adjusted medications, unchanged medications to be continued, medications held in
hospital, non-formulary/formulary adjustments, new medications planned to start upon discharge
and any additional comments or information as appropriate is completed. Discrepancies should be
identified and reconciled. This process results in the creation of a “Best Possible Medication
Discharge Plan” (BPMDP), which will include a complete list of the medications the patient is to be
taking following discharge, instructions for the safe and effective use of those medications, and
arrangements for appropriate follow-up care.

At the end of the episode of care, the BPMDP should be communicated to the patient,
community pharmacy, primary care physician, or alternative care facility or health care
team/service that will next be providing care to the patient.

On receiving a BPMDP, the various recipients should assure that their records are updated
to accurately reflect the patient’s current medications. Further explanation of these processes and the
conceptual framework are found in Volume 4 – The Getting Started Kit.


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Patient and family involvement

Effectively engaging the patient and family in medication reconciliation is a key strategy for targeting
and preventing prescribing and administration errors, and thereby reducing harm. This involvement
should be expected and encouraged by the health care team by engaging the patient and family in
the development of a complete and accurate list of the patient’s medications, keeping them
informed about the medications the patient is receiving, educating them about the risks and what to
look for, and providing the means and encouragement to report any concerns they might have.
Patients and their families should in turn take an active role in the process by keeping an up to date
and accurate list of the medications they are taking and take greater responsibility for monitoring
their medications and reporting any unexpected changes in their condition after starting a new
medication5.

Permissible adaptations in the medication reconciliation process

The cultural and physical environment - the context in which this process will be implemented, as
well as the unique features and resources of the individual health care organization and the details of
its existing processes that interface with medication reconciliation, will influence its implementation.
In this Standard Operating Protocol, we seek uniformity of the basic steps in the process, their
interdependencies, and the minimum documentation and measurement requirements, while allowing
flexibility in the assignment of tasks to specific professional disciplines and the format of the
documentation and measurement tools. Any organization-specific adaptations of this Protocol,
beyond the permissible flexibility described above, must be reviewed by the Lead Technical Agency
and approved by the High 5s Steering Group based on the organization’s rationale for the change
and demonstration that the adaptation is equivalent to the process as presented in the Protocol.
It is the intent of this Protocol that the medication reconciliation process be conducted as an
interdisciplinary activity with responsibilities shared among physicians, nurses, pharmacists, and
other clinicians involved in the patient’s care. To the extent possible, a pharmacist should be
involved in gathering or validating the patient’s list of current medications (BPMH) and the
comparison of that list with medication orders. When a pharmacist is not available, those tasks
should be undertaken by a trained health care professional (e.g. physician, nurse, therapist, or
technologist/technician), based on the individuals’ qualifications for the tasks.

Implementation strategy for medication reconciliation

Medication reconciliation is a complex process that involves many professional disciplines in
virtually all settings of care—whenever and wherever medications are used. While the basic principle
of information-based medication use and its value to patient safety are generally accepted, the
process itself is often seen as burdensome and may be resisted if not implemented in a systematic
manner with appropriate oversight, resources, and early engagement of the participants in the
process. Additional details regarding implementation are found in Volume 4 - Getting Started Kit.
(templates, forms and examples).




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Oversight of the implementation
   a. Identification of the Oversight Group for the implementation project (governing body or
       senior leadership group)
    b. Assign a senior administrative leader to provide direct oversight of the implementation
       activities, assignment of staff, allocation of time for staff to do the work, and allocation of
       other resources. This individual should have direct accountability for outcomes related to
       medication reconciliation.
    c. Assign one or more representatives of the professional disciplines involved in medication
       management—at a minimum, physicians, nurses, and pharmacists—to guide the design,
       testing, and roll-out of the medication reconciliation process and to serve as role models and
       “champions” of the new process for their respective disciplines
    d. Assign a facilitator—a person with knowledge of the medication management process and
       quality improvement methods and with project management skills—to develop and manage
       the project work plan

Project work plan
(All professional disciplines identified above must be involved in each step of the project work plan)
        a. Develop a detailed task list for design, testing, training, implementation, and
            measurement of the medication reconciliation process (see Volume 4 - Getting Started
            Kit for a sample task list —details may vary from one facility to another)
         b. Identify milestones and their target dates to include at least the following:
                       i. Approval of the project work plan
                      ii. Approval of the pilot test design
                      iii. “Go-live” date for the pilot test
                      iv. Presentation of pilot test results to the oversight group
                      v. “Go-live” date for full implementation
                  Full implementation of medication reconciliation for all eligible patients admitted to
                  all inpatient units through the emergency department in the facility.
         c. Identify dependencies and time frames for each of the project tasks
         d. Identify deliverables and due dates for each of the project tasks
         e. Assign resources to each of the tasks




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Risk assessment of the proposed medication reconciliation process (failure mode and effects
analysis)

“Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for evaluating a
process to identify where and how it might fail and to assess the relative impact of different failures,
in order to identify the parts of the process that are most in need of change.”1
      a. Describe the process (for example, through the use of a flowchart).
      b. Identify for each of the steps in the process and for each linkage between steps, the ways
         that the process could break down or fail to perform its desired function..
      c. Identify the possible effects that a breakdown or failure of the process could have on
         patients and the seriousness of the possible effects
      d. Prioritize the potential process breakdowns or failures
      e. Determine why the high priority breakdowns or failures could occur
      f. Implement controls, warnings, or protections to minimize the risk of harm to patients

Pilot test of the medication reconciliation process (Recommended, but optional)
      a. Identify one or more pilot test sites—for Phase 1, this will include the emergency
         department and, typically, a general medical inpatient unit that is representative of the overall
         functioning of the hospital
      b. (Optional) Collect baseline data identifying discrepancies within current processes on the
         pilot test site(s). For sites that do not have an established medication reconciliation process,
         baseline data is the first month of data collection as described below using the independent
         observer.
      c. Engage representatives from the pilot test site(s) to participate in the test design and
         implementation
      d. Integrate the proposed medication reconciliation process into the work flow of the pilot test
         site with adaptation, as necessary, to the unique features of the pilot test site
      e. Train the staff who will be participating in the pilot test of the new process—consider that
         these individuals may become the trainers for the rest of the hospital staff when the new
         process is ready for full implementation.
      f. Implement the new process on the pilot test unit
      g. Measure consistency and timeliness of implementation of each of the steps in the process
         (see below for recommendations for specific measures)
      h. Measure impact on other related or interfacing activities
      i.   Measure impact on patients




1
    IHI website:
http://www.ihi.org/IHI/Topics/Improvement/ImprovementMethods/Tools/Failure+Modes+an
d+Effects+Analysis+%28FMEA%29+Tool+%28IHI+Tool%29.htm Accessed August 5,2010


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    j.   Analyze pilot test data and present to oversight group for decision on next steps, including
         possible redesign of the process
    k. Any significant redesign of the process should be fully documented, retested on the pilot test
       site(s), and should result in sustained improvement before considering expanded
       implementation

Spread methodology
    a. Determine the sequence and timing of implementation in other areas of the organization.
    b. When the process has been stabilized in the pilot test site(s) and measurement reflects
       sustained improvement, consider spread of methodology to other areas of the organization.
       Sequential implementation, rather than concurrent implementation (the phased-in approach
       described above), is recommended to provide for adequate pre-implementation training,
       oversight and coaching during the early phases of implementation, and monitoring of the
       new process.

Communication plan
    a. Announce the organization’s decision and commitment to implement medication
       reconciliation as a participant in the WHO's Action on Patient Safety (High 5s) initiative.
    b. Provide rationale for participation in the initiative:
                  i. Description of the problem to be addressed (medication errors at transitions)
                      Share stories of medication reconciliation failures and discrepancies found in the
                      baseline data collection phase.
                  ii. The proposed solution (medication reconciliation)
                 iii. The costs and benefits of participation
                 iv. Incentives to clinical staff to participate (improved safety for patients; efficiencies
                     and lower risk exposure for staff)
    c. Provide regular updates to all staff on the progress of the project work plan.
    d. Provide feedback to all staff on the measurement data collected and analysed throughout the
       pilot test and implementation phases of the project. This will enhance buy-in and will
       highlight the effects of the improvements they are making over time.
    e. Recognize the contributions and successes of all staff participating in the project

Evaluation strategy
    The information obtained through the evaluation strategy is the basis for providing feedback to
    participating hospitals and countries. SOP implementation and impact will be evaluated
    according to the components described in the High 5s Evaluation Plan (Volume 2 – Evaluation
    Plan and Required Components). The components are:
    a. SOP Implementation Evaluation – self-reported narratives of the implementation experience
       and periodic on-site interviews and observations by the LTAs in a sample of participating
       hospitals.



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    b. Performance Measures – quantitative measurement of processes and outcomes associated
       with the SOP. The data collected for the performance measures is subject to validation (see
       section on data quality in Volume 3 – The High 5s Information System)
    c. Event Analysis – identification and analysis of any adverse events directly associated
       with/related to the SOP or its implementation
    LTAs and participating hospitals will use the High 5s Information Management System, a secure
    interactive web-based platform designed specifically to support all implementation and
    evaluation activities associated with the High 5s project, to provide general demographic data
    about participating hospitals and specific data regarding the emergency and inpatient facilities to
    enable comparative evaluations across all participating hospitals implementing this SOP.

    a. Self-reported narratives of the implementation experiences
    b. Aggregate level performance measure data
    c. The LTA will develop and maintain a method of collecting event analysis data separate and
       apart from the High 5s Information Management System. These data will not be entered
       into the High 5s Information Management System by the participating hospital; the LTA will
       de-identify and aggregate the data and then enter the aggregated data into the High 5s
       Information Management System.

    Regular and ongoing feedback in the form of quantitative and qualitative reports will be
    provided on the information described above. The methods for data collection and feedback
    are described in detail in Volume 3 – The High 5s Information System.

Maintenance and Improvement strategy
   a. Once the medication reconciliation process is implemented in all settings that are included in
       the current phase of implementation, regular monitoring of key parameters should continue
       for at least one year.
    b. Opportunities to improve efficiency and effectiveness of the process should be identified,
       prioritized and, as appropriate, acted upon.
    c. Evidence of “drifting” from the intended procedures should be analyzed to identify the
       reasons and to determine an appropriate response—for example: additional training; process
       redesign; technical support.
    Volume 4 – Getting Started Kit provides additional information on implementing medication
    reconciliation and measuring its effectiveness.




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Appendix A: Tabular listing of steps in the medication reconciliation process on admission

Step of process                       Detail                         Who?              When?               Tools                Input                  Output
Obtain best          Gather sources of information              Patient/family;   Ideally, before     Standardized       Patient’s list/wallet   Complete and
possible             available as a starting point;             ED nurse (e.g.    admission orders    form developed     card; patient and/or    accurate history of
medication           interview patient using open ended         triage);          written—at least    by organization;   family interview;       patient’s
history (BPMH)       questions and a systematic process         admitting         within 24 hours     paper-based or     medications             preadmission
on admission         (e.g. BPMH interview guide); the           nurse;            of admission        electronic         brought by pt (e.g.     medications in a
                     BPMH forms the basis for                   pharmacist;                                              examination of          consistent place in
                     reconciliation across the                  pharmacy tech;    Note: It will be                       vials); primary care    the patient’s health
                     continuum of care. It involves             physician.        important to                           physician,              record
                     documentation of all medications                             identify criteria                      community
                     a patient is currently taking at                             for when the                           pharmacist,
                     home including drug name, dose,                              BPMH should be                         referring health care
                     frequency & route of                                         obtained more                          facility
                     administration. Types of                                     urgently and
                     medications include ALL:                                     within what time
                     prescribed and non-prescribed                                frame.
                     medications (i.e. prescriber did not
                     advise patient to take it),
                     prescription, non-prescription
                     (over the counter - OTCs), herbals
                     and medications taken on an as-
                     needed basis.




Action on Patient Safety (High 5s) – Medication Reconciliation, Volume 1                                                          Version 1.0; 9/3/10 Page 17 of 21
Appendix A: Tabular listing of steps in the medication reconciliation process on admission


Step of process         Detail                      Who?                       When?             Tools                 Input                Output
                        This may be accomplished
                         with the use of a form or                                At the time   Standardized form
   Use the BPMH to       electronic system where                               admission orders    developed by
create admission orders the prescriber will clearly                               are written.  organization; pre-
                          indicate whether each                                (within 24 hours     printed or
   (Proactive Model)    medication on the BPMH                                   of admission)      electronic
                          is to continue, hold or                                                                                               Complete &
                                                                                                                             BPMH
                           discontinue, modify.       Pharmacist,                                                                            accurate admission
                                                                                                                        Admission orders
                                                       nurse or                                                                                    orders
           OR                       OR                                                OR                 OR              (paper based or
                                                    pharmacy tech
                                                                               When admission                              electronic)
 Compare BPMH with                                         in
                                                     collaboration             orders are written
   admission orders,                                                                              Standardized form
                        Look for any discrepancies with Physician                or as soon as
 identify discrepancies                                                                              developed by
                         between the BPMH and                                       possible
  and revise admission                                                                            organization; pre-
                              admission orders                                    thereafter.
 orders as appropriate.                                                                               printed or
                                                                               (within 24 hours
  (Retroactive Model)                                                                                 electronic
                                                                                 of admission)
Measurement of MR 2,
      MR 3, MR 4:                                                                                  Patient Level:
                         Look for any outstanding
(for selected sample of                                        Independent     After medication     Independent       BPMH, other
                         discrepancies between the                                                                                       Complete and
30 eligible patients who                                         Observer       reconciliation     Worksheet to        sources of
                          BPMH, other sources of                                                                                      accurate medication
     have received                                             (pharmacist,       process is    identify medication information and
                             information & the                                                                                               orders
       medication                                              nurse, other)      complete.      discrepancies (see admission orders.
                              admission orders.
reconciliation within 24                                                                             Volume 2.)
  hours on admission)




Action on Patient Safety (High 5s) – Medication Reconciliation, Volume 1                                                       Version 1.0; 9/3/10 Page 18 of 21
References:

   Safer Health care Now! Medication Reconciliation Getting Started Kit, http://www.saferhealth
    carenow.ca/Default.aspx?folderId=82&contentId=124
   ISMP Canada Safety Bulletin. June 9, 2006, Volume 6, Issue 3 Medication Reconciliation—In the
    Hospital and Beyond, http://www.ismp-canada.org/download/ISMPCSB2006-03MedRec.pdf
   The case for medication reconciliation. Nursing Management 2005; 36(9):22.
   Massachusetts Coalition for the Prevention of Medical Errors. www.macoalition.org/initiatives.shtml
   Safer Health care Now! http://www.saferhealth carenow.ca/Default.aspx?folderId=82&contentId=124
   Rogers G et al. Reconciling medications at admission: safer practice recommendations and
    implementation strategies. Jt Comm J Qual Saf 2006; 32(1):37-50.
   Gebhart F. Setting up a medication reconciliation system. Drug Topics 2005; 149(2) (Health-System
    Edition supplement):1-2.
   Ketchum K, Grass CA, Padwojski A. Medication reconciliation. AJN 2005; 105(11):78-85.
   Building a case for medication reconciliation. ISMP Medication Safety Alert 10 (8), April 21, 2005.
    http://www.ismp.org/Newsletters/acutecare/articles/20050421.asp
   Medication errors involving reconciliation failures. USP Patient Safety CAPSLink, October 2005.
    http://www.usp.org/hqi/practitionerPrograms/newsletters/capsLink/#archives
   Using medication reconciliation to prevent errors. Sentinel Event Alert, The Joint Commission. Issue
    35, January 23, 2006.
    http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_35.htm
   2006 National Patient Safety Goals. The Joint Commission.
    http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsg_cah.htm
   Tam VC, Knowles SR, Cornish PL, Fine N, Marchesano R, Etchells EE. Frequency, type and clinical
    importance of medication history errors at admission to hospital: a systematic review. CMAJ,
    2005;173:510-515.
   Canadian Council on Health Services Accreditation. CCHSA Patient/Client Safety Goals & Required
    Organizational Practices. Frequently Asked Questions [updated June 6, 2005]. Ottawa, ON.
    http://www.cchsa-ccass.ca/default.aspx?page=137
   Canadian Council on Health Services Accreditation. CCHSA Patient Safety Goals and Required
    Organizational Practices. http://www.cchsa
    ccass.ca/upload/files/pdf/Patient%20Safety/PS%20ROP%20version%202%201%20for%202007%20
    E.pdf
   Ong S, Olavo A Fernandes OA , Cesta A, Bajcar JM, Drug-Related Problems on Hospital Admission:
    Relationship to Medication Information Transfer, The Annals of Pharmacotherapy: Vol. 40, No. 3, pp.
    408-413
   Cesta A, et al. The EMITT Study: Development and Evaluation of a Medication Information Transfer
    Tool. Ann Pharmacother 2006;40:1074-81.
   Institute for Health care Improvement, Getting Started Kit: Prevent Adverse Drug Events
    (Medication Reconciliation ). http://www.ihi.org
   Whittington J., Cohen H. OSF Health care’s journey in patient safety. Qual Manag Health Care. 2004; 13
    (1):53-59.
   Nickerson A, MacKinnon NJ, Roberts N, Saulnier L, Drug-Therapy Problems, Inconsistencies and
    Omissions Identified During a Medication Reconciliation and Seamless Care Service, Health care
    Quarterly - Special Edition, Volume 8, October 2005, Pages 65-72.


Action on Patient Safety (High 5s) – Medication Reconciliation, Volume 1     Version 1.0; 9/3/10 Page 19 of 21
   Santell, JP. Reconciliation Failures Lead to Medication Errors. Joint Commission Journal on Quality and
    Patient Safety.2006;32(4):225-229.
   Forster AJ, et al, Institute of Medicine, Report Brief: Preventing Medication Errors – Quality Chasm
    Series. http://www.iom.edu/Object.File/Master/35/943/medication%20errors%20new.pdf
   Pronovost P, Hobson DB, Earsing , Lins ES, Rinke ML, Emery K, et al. A practical tool to reduce
    medication errors during patient transfer from an intensive care unit. Journal of Clinical Outcomes
    Management 2004;11:26-33.
   Bell CM, Rahimi-Darabad P, Orner AI. Discontinuity of chronic medications in patients discharged
    from the intensive care unit. J Gen Intern Med 2006;21:937-41.


Annotated References: Potential impact of medication reconciliation

        Hospital Admission- General Medicine. Cornish et al6 found that 54% of the patients (n= 151,
         prescribed at least four medications) who were admitted to a general medicine ward in a tertiary care
         teaching had at least one unintended discrepancy. In this study, 39% of discrepancies were judged
         to have the potential to cause moderate to severe discomfort or clinical deterioration. The most
         common discrepancy (46%) consisted of the omission of a regularly used medication.
        Hospital Admission- Emergency Department. In a community hospital, Vira and colleagues7
         assessed the potential impact of medication reconciliation in 60 randomly selected patients who were
         prospectively enrolled at the time of hospital admission. Overall, 60% of the patients had at least
         one unintended variance (discrepancy) between their admission orders and the medications they
         were taking at home and 18% had at least one clinically important variance. None of the variances
         had been detected by usual clinical practice before formal reconciliation was conducted.
        Involvement of pharmacy technicians. The utilisation of pharmacy technicians to initiate the
         reconciling process by obtaining medication histories for a scheduled surgical population reduced
         potential ADEs by 80% within three months of implementation.8
        Hospital Admission- Surgery. Kwan et al.9 conducted a randomized controlled trial with 464
         surgical patients at an acute care teaching hospital. Results demonstrated that multidisciplinary
         medication reconciliation (pharmacists, nurses and physicians partnering proactively with the
         patient) in a preadmission clinic resulted in a 50% reduction in the number of patients with
         discrepancies linked to home medications. Furthermore, the collaborative intervention also resulted
         in a greater than 50% reduction in the number of patients with discrepancies with the potential to
         cause possible or probable harm compared to standard of care (29.9% vs. 12.9%).
        Cost-effectiveness. Karnon and colleagues10 conducted a model-based cost-effectiveness analysis
         of interventions aimed at preventing medication errors at hospital admission with medication
         reconciliation. The aim of the study was to assess the incremental costs and effects (measured as
         quality adjusted life years) of a range of medication reconciliation interventions. Findings
         demonstrated that all five interventions, for which evidence of effectiveness was identified, were
         estimated to be extremely cost effective when compared to the baseline scenario. In this paper, the
         pharmacist-led reconciliation intervention had the highest expected net benefits and a probability of
         being cost-effective of over 60% by a quality-adjusted life year value of £ 10 000.
        Health care Professional Workload. There is evidence that a successful medication reconciliation
         process can reduce workload and rework associated with patient medication management. After
         implementation, nursing time at admission was reduced by over 20 minutes per patient. The amount
         of time pharmacists were involved in patient discharge was reduced by over 40 minutes.11

Action on Patient Safety (High 5s) – Medication Reconciliation, Volume 1         Version 1.0; 9/3/10 Page 20 of 21
End Notes
1
    Preventing medication errors. Institute of Medicine, 2006.
2
 Baker GR, Norton PG. The Canadian Adverse Events Study: the incidence of adverse events among
hospitalized patients in Canada. Can Med Assoc J. 2004; 170(11): 1678-1686.
3
 A safer place for patients: learning to improve patient safety. National Audit Office, 2005.
http://www.nao.org.uk/pn/05-06/0506456.htm
4
 Sullivan C et al. Medication reconciliation in the acute care setting: opportunity and challenge for
nursing. J Nurse Care Qual 2005; 20(2):95-98.
5
 Pronovost P et al. Medication reconciliation: a practical tool to reduce the risk of medication errors. J
Crit Care 2003; 18(4):201-205.
6
 Cornish PL, Knowles SR, Marchesano R, et al. Unintended medication discrepancies at the time of
hospital admission. Arch Intern Med 2005;165:424-9.
7
 Vira T, Colquhoun M, Etchells EE. Reconcilable differences: correcting medication errors at hospital
admission and discharge. Qual Saf Health care 2006;000:1–6.
8
 Michels RD, Meisel S. Program using pharmacy technicians to obtain medication histories. Am J Health-
Sys Pharm. 2003;60:1982-1986.
9
 Kwan Y, Fernandes OA, Nagge JJ, Wong GG, Huh J, Hurn DA , et al. Pharmacist medication
assessments in a surgical preadmission clinic. Arch Intern Med 2007;167:1034-1040.
10
  Karnon, Jonathan; Campbell, Fiona; Czoski-Murray, Carolyn Model-based cost-effectiveness analysis of
interventions aimed at preventing medication error at hospital admission (medicines reconciliation) Journal
of Evaluation in Clinical Practice, Volume 15, Number 2, April 2009 , pp. 299-306(8).
11
 Rozich JD, Howard RJ, Justeson JM, Macken PD, Lindsay ME, Resar RK. Standardization as a
mechanism to improve safety in health care: impact of sliding scale insulin protocol and reconciliation of
medications initiatives. Jt Comm J Qual Saf. 2004;30(1):5-14.




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