Medication
VARIANCE
Reporting, managing and tracking
medication errors, omissions and
treatment errors
Revised July 2006
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How to Complete the Medication
Variance Report
Why must this form be completed?
When a situation occurs that is considered to be urgent, emergency measures must be undertaken without
delay, with notifications to follow.
A Medication variance report form must be completed in accordance with the Provider Manual or developmental
center policy or procedure to promote continuous quality improvement and best practice for all individuals.
Reporting, managing and tracking medication errors, omissions or treatment errors are necessary to identify
causes of the variance. Managing errors, omissions or treatment errors provide prompt and thorough healthcare
after an occurrence and evaluation of the severity of the event. Taking corrective action to prevent further
occurrences promotes continuous quality improvement.
Distribution of completed forms is determined by the Provider Manual or per developmental center policy or
procedure. Only one medication variance per medication variance form. This means each drug will require its
own form.
How do I complete the form?
The Medication Variance Report form is to be completed by the assigned agency personnel.
All information must be legible. Print or type the information. The form is to be completed using black ink if
printed.
This information is used for tracking and trending and must be completed in its entirety.
Unless indicated, you may choose more than one option for each section.
Section 1:
Name_____________________
Age______________________
SS / case#_________________
The printed or typed name of the individual.
The current age of the individual.
Social security number / case number of the individual.
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Section 2:
Time and Location of Event (circle)
Day of the week:____________
Date/time of event___________
____:____(circle AM/PM)_____
Location__________________
Agency___________________
Physician Notified___________
Date/Time_________________
Circle the appropriate abbreviation for the day of the occurrence.
Print or type the month/day/year (00/00/00) of the occurrence.
Print or type the time of the occurrence and circle if AM or PM.
Indicate location where occurrence happened (home, residence,
community location such as park, mall, school, etc.).
Indicate the name of the agency completing the form.
Indicate “yes” or “no”.
Print or type the month/day/year (00/00/00) / time the physician notified.
Who was involved?
Section 3:
Practitioner / Staff Involved
Classification
Indicate by putting a check “√” or an “x” next to the classification of the
person involved in the variance. If “other” is chosen, please print or type
the choice.
Nurse_____________________
This would be the RN or the LPN involved in administering medication.
Pharmacist_________________
This would be the pharmacist receiving and/or filling the order.
Physician__________________
This would be the practitioner who initiated the original order. It may
include the MD, Nurse Practitioner, Physicians Assistant, the dentist, or
other licensed specialist.
Direct Support Staff__________
This is staff hired to care for the individual.
Respiratory Therapist________
This is the licensed respiratory therapist involved.
Other_____________________
Please print or type the title of the person involved.
Status
Indicate by putting a check “√” or an “x” next to the status of the
person involved in the variance.
If “other” is chosen, please print or type the choice.
Regular___________________
This would be any person (staff or licensed) that is assigned to assist
the individual on a routine or regular basis.
Agency/Contract____________
This would include staff who are hired or contracted from an agency
other than the provider agency (e.g. home health, hospice, etc.).
Float_____________________
This would be staff that normally work for the facility or agency, but do
not routinely assist this individual.
Other____________________
Print or type the title of the person involved. This may include family
members, volunteers, or other natural supports.
*Not Certified_______________
Person involved is not currently certified to administer medications
within the DMRS system. A choice in this area requires investigator
notification and submission of a Reportable Incident Form along with
the Variance Report.
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What is the duration of the variance?
The duration of days is the length of time the event lasted. Please indicate the length of time on the line
provided.
When an entire “day” of 24 hours is not required, please indicate the number of “hours” of the event instead.
When the event is immediately discovered the time period may be indicated by a “0” (zero) in the space.
For example: when a medication was ordered on the morning of the 6th of the month, was available for the
person, and the medication was not obtained until the afternoon of the 9th, that would be a duration of 2½ days.
If a medication was ordered as “STAT” and the medication was available to give within 2 hours, but was not
administered for 4 hours, then the duration would be 2 hours.
What medication and dosage was involved?
This section involves two different processes, yet may involve the same or a different medication. The
descriptions of the choices are the same. Only one drug variance must be included per form. When a person has
an event involving several drugs, this will require the completion of several forms as each medication has
different properties.
Please mark this section carefully as it will include both the drug ordered and the drug given.
Section 4:
Medication and Doses Involved
Drug ordered and route______
Print or type the name of the drug ordered on the “line” just above the
route. Each drug will require a separate entry.
Route____________________
Indicate by putting a check “√” or an “x” next to the route to be used for
the administration of the drug. Each drug will require a separate entry.
If “other” is chosen, please print or type the choice.
Drug given and route________
Print or type the name of the drug given on the “line” just above the
route. Each drug will require a separate entry.
Route____________________
Indicate by putting a check “√” or an “x” next to the route to be used for
the administration of the drug. Each drug will require a separate entry.
If “other” is chosen, please print or type the choice.
IV push___________________
Intravenous route ordered to be administered over a short period of
time.
IV drip____________________
Intravenous route ordered to be administered over a designated time
period.
IM_______________________
Route is ordered to be injected into the muscle.
SC______________________
Route is ordered to be introduced just beneath the skin (subcutaneous).
PO______________________
Route is ordered to be given orally (in the mouth).
Per Rectum_______________
Route is ordered to be placed into the rectum.
Per tube__________________
Route is ordered to be administered by way of an enteral tube.
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Per trach__________________
Route is ordered to be administered by way of a tracheotomy.
Topical___________________
Route is ordered to be placed on surface of the skin or mucous
membrane.
Vaginal___________________
Route is ordered to be placed into the vaginal area.
Other____________________
Print or type the route ordered by the practitioner.
What happened?
Section 5:
What happened? (check all that apply)
Incorrect:_________________
Indicate the incorrect procedure that caused the variance.
Indicate by putting a check “√” or an “x” for all that apply.
If “other” is chosen, please print or type the reason.
Person___________________
The individual is not the person who was ordered to receive the drug.
Drug_____________________
The wrong drug was given.
Dose_____________________
The amount of drug given was not the amount ordered.
Route____________________
The drug was given by an incorrect route (oral, nasal, rectal, etc.)
Formulation_______________
The drug was not the specified formula.
IV Rate___________________
The drug was not administered at the specified rate.
IV Solution________________
The specified fluid was not administered as ordered.
Time____________________
The drug was given outside the limits of the approved time.
Position__________________
The person was not placed in a safe position to receive the drug.
Texture__________________
The wrong consistency was used for the drugs administration.
Dose Omitted_____________
The drug was not given; the MAR did not indicate reason or was not
signed.
Given when criteria not met__
The drug was administered when criteria clearly prohibited its
administration.
Extra dose given___________
More than the ordered amount was given, or given after discontinued.
Given despite allergy_______
Drug was given in the presence of documented allergy to the drug.
Treatment Error___________
Physician’s orders were not followed as written for the treatment
ordered.
Other___________________
Print or type the reason for the variance.
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What is the form of the variance?
Medication variances are either “actual” or “potential”. (Refer to SECTION 8 of this form to assist in determining)
Actual_____________________
Variance falls into Category C-I (Section 8) according to the
severity of the event. The medication actually reached the
individual yet may or may not have caused harm.
Potential___________________
Variance falls into Category A-B (Section 8) according to the of
severity of the event. The medication never reached the
individual. Circumstances or events that have the capacity to
cause harm.
What caused the variance?
A medication variance is defined as any preventable event that may cause or lead to inappropriate medication
use or person harm while the medication is in the control of the health professional, person, or consumer. Such
events may be related to professional practice, health care products, procedures, and systems, including
prescribing; order communication; product labeling; packaging, and nomenclature; compounding; dispensing;
distribution; administration; education; monitoring; and use.
In this section it is necessary to categorize the variance. This section also involves a description of the event that
caused the variance. It is your opinion as to why you think this event occurred. Please print or type the response
in the space provided.
Section 6:
Description of variance: In your opinion why did this event occur?
Please be specific and refer to the example descriptions included for each term. First indicate by putting a check
“√” or an “x” next to the type of event. Then print or type a response in the space provided under the choice.
Prescribing_________________
Event may include an incomplete or unclear order, an excessive
quantity of medication prescribed for a person’s age or weight, wrong
drug, wrong dose, wrong route, wrong person, wrong position, wrong
texture, wrong frequency, interaction with existing drug therapy,
contraindications, known allergies, incorrect drug selection, illegible
orders, etc.
Transcribing________________
Event may include documentation errors, an order entered on the wrong
Person’s MAR, order content changed during schedule revision,
incorrect verbal order (only licensed person can take a verbal order),
incorrect charting, etc.
Procurement / Storage________
Event may include lack of standardized storage locations, lack of safe
drug storage and stocking practices, unsecured drug, lack of
standardization of stock drug concentrations (applies to facilities only),
expired drugs, provider failed to fill prescription, drug found on floor with
unknown origin, packaged with a meal, mixed together in a container,
unmarked container, provider failed to have adequate supply of
medication available, etc.
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Dispensing_________________
Event may include mislabeled drug, wrong drug stocked or withdrawn
from supply, inaccurate dose calculation, etc.
Administering_______________
Event may include drug label misread or not read, drug received by
wrong person, person identification not verified, person not available to
receive drug, drug not given, extra dose given, wrong dose, wrong time,
wrong drug preparation, wrong route, positioning incorrect for person to
receive drug, wrong consistency for person, refusal of medication,
administering the medication but failing to initial the block on the MAR,
administering the medication prescribed to treat behaviors without
consent, pre-pouring or administering medication someone else has
prepared, etc.
Monitoring__________________
Event may include inaccurate documentation of person’s weight,
necessary tests or procedures not ordered, test/procedure results
misinterpreted, test/procedure results not charted or charted incorrectly,
lapse in profile or new order review, failure to notify other
services/programs of new or changes in medications, etc.
Why did it happen?
Variances occur despite all efforts. All medication errors, omissions or treatment errors must be reported,
managed, and tracked. The agency will review the event to attempt to identify the cause of the event.
To assist with tracking and trending it is necessary to check the critical breakdown point in case that a primary
event (e.g. prescribing) resulted in a number or secondary event (e.g. transcribing, dispensing and administering
the wrong dose). This will be helpful in focusing performance improvement on the critical event.
Section 7: Contributing Factors:
In your opinion, were there factors that made this variance difficult to prevent or detect?
Product____________________
May include unclear manufacturing labeling, “sound-alike” drug names,
“look-alike” packaging, omission or misuse of a prefix or suffix such as
“fos” phenytoin or diltiazem “CD”, incomplete labeling, illegible labeling,
etc.
Medication Use System________
May include side-by-side storage of look-alike drugs, lack of
standardization in practice, competing distractions, lack of capacity to
identify individual, lack of capacity to monitor controlled substances, etc.
Communication Dynamics______
May include lack of clear, accurate, and timely written and oral
communications related to drug regimen (a person has the right to
refuse medications and the agency has the responsibility to notify the
practitioner in a timely manner, reporting of suspected side effects,
etc.), lack of interactions that are free of fear of intimidation, punishment
and embarrassment, etc.
Other______________________
List and explain this situation. Please print legibly.
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What is the severity of the variance?
Medication variances are classified by the reporting entity according to severity utilizing the classifications
recommended by the National Coordinating Council for Medication Error Reporting and Prevention.
Each classification contains one or more categories. The form assigns both a classification and a category.
Harm is defined as temporary or permanent impairment of the physical, emotional, or psychological function or
structure of the body and/or pain resulting therefore, requiring intervention.
Section 8:
event.
Severity of the variance (check only one). Use your best judgment to rate the severity of the
Classification I
Category A___
Circumstances or events that have the capacity (potential) to cause a
medication-use variance. (e.g. medication count indicates the drug was
given, but the MAR was not signed as given; person refused
medication, no note was placed on MAR yet practitioner was notified,
etc.)
Classification II Category B___
Variance occurred, but was detected before it reached the individual.
(e.g. drug was placed in container for distribution and staff recognized
that it was incorrect and never gave the drug; person questioned the
drug and it was verified to be incorrect and corrected before person took
it, etc.)
Classification II Category C___
Variance occurred, reached the individual, but caused no harm or is
unlikely to cause harm. (e.g. person took drug, physician notified and
states “no harm”, etc.)
Classification II Category D___
Variance will require additional person monitoring, but is unlikely to
result in a change in vital signs or cause harm. (e.g. Monitoring of
baseline data will assist in determining this category.)
** A selection in this classification and category requires the completion of a Reportable Incident form. (In addition to this form)
Classification III Category E___
Variance requires intervention and caused or is likely to cause the
person temporary harm. (e.g. person took drug, physician notified and
requests to bring person to office or send to ER for evaluation, etc.) **
Classification III Category F___
Variance caused or is likely to cause temporary harm requiring
hospitalization. (e.g. person took drug, physician notified, evaluation
required and admitted to hospital and recovered completely from event,
etc.) **
Classification III Category G___
Variance caused or is likely to cause permanent harm to the person.
(e.g. person took drug, physician notified, evaluation done, admitted to
hospital, recovered from event but has lasting repercussions or effects,
etc.) **
Classification III Category H___
Variance resulted in a near death event (e.g. anaphylaxis, cardiac
arrest), required intervention necessary to sustain life. **
** A selection in this classification and category requires the completion of a Reportable Incident form. (In addition to this form)
Classification IV Category I___
Variance resulted in or contributed to the person’s death. **
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Your comments.
Section 9:
Your comments.
In your opinion, are there improvements or changes that can be made to help prevent a similar event from
occurring again? Be as brief as possible. Print or type your response.
Also include any interventions that you consider necessary for the improvements. Interventions may include, but
are not limited to such things as:

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review initial training with……….
intense monitoring of direct support staff…………..
correction made to MAR and will continue to monitor MAR for next 3 months……
medications obtained from pharmacy, staff to request medications by ……………
medication pass observation of ________for next 3 months by………
review agency procedure for…………
review of prescription prior to transcription onto MAR………
obtain copy of prescription from physicians office within one working day…….
Actions/Outcomes:
This section may be completed at the time of the review by the agency. These actions/outcomes are designed to
assist the agency in understanding the matter of the variance. Examples may include, but are limited to:
 monitored vital signs
 sent to ER
 recovered
 no changes in baseline
Signatures.
This form is to be signed by the person who completed the form and also signed by the supervisor or the
reviewer of the document. All signatures are to be legible and include the title of the person.
The date is to include the month, day and year.
ADDITIONAL NOTATIONS:
**A copy of the Variance form must be submitted with the Reportable Incident Form** indicates that a copy of the
completed variance form must be sent in at the same time that the reportable incident form is sent.
* A copy of the Variance form must be submitted to the Investigator with the Reportable Incident Form * indicates
that a copy of both the variance form and the reportable incident form must be sent to the investigator.
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