pharmacy patient safety reporting program data dictionary...2017/12/11 · ncc merp harm categories...

Updated: 12/11/2017 Data Dictionary for Pharmacies 1

The data dictionary provides detailed descriptions of each element in the reporting form. If you have questions or need more information about a particular reporting form question, use the data dictionary to locate specific information about that question. If questions remain after you have consulted the data dictionary, please contact the Commission at 971-266-8079 or [email protected].

How to Use This Document

Each item on the reporting form will appear in its own table including (but not limited to) the following information: question location on the form; question description; responses, where relevant; and a short guide for use, where relevant. The following table defines each row of any given data dictionary table. The tables appear in the same order as on the form. Please use the bookmarks and search features in this document to locate the information you are looking for.

If you need additional assistance or have questions about this document, please contact your patient safety consultant for additional information.

Example of Information Provided in this Data Dictionary

[Question text as it appears in the online form]

Question Location [Indicates on which tab the question can be found in the online form]

Description [Describes the data the question is intended to gather]

Prompt [Provides additional information needed to answer the question as it appears on the online form]

Responses [Lists the possible responses options for multiple choice questions in the order in which they appear on the form]

Go-To Logic [Explains what triggers the appearance of this question, where relevant] [Explains which additional questions will appear based on your answer to this question, where relevant]

Required [Indicates if the question is required; i.e., Yes/No]

Question Type [Indicates the format in which the question appears on the online form (e.g.,. date, text input, dropdown menu, checkbox, etc.)]

Maximum Length [Indicates the maximum length a response can be (i.e., number of characters allowed), if applicable]

Minimum Value [Indicates the lowest value a number field will accept, if applicable]

Maximum Value [indicates the highest value a number field will accept, if applicable]

Guide for Use [Provides instructions for how to answer this question; e.g., additional information to answer the question, when to answer it, inclusions, exclusions, etc.]

PHARMACY Patient Safety Reporting Program

Data Dictionary

mailto:[email protected]://oregonpatientsafety.org/reporting-programs/http://oregonpatientsafety.org/reporting-programs/


Content Quick Links

How to Use This Document 1

Example of Information Provided in this Data Dictionary 1

Content Quick Links 2

General Information Tab 3

Harm Category Tab 7

Event Tab 14

Medication or Other Substance Event Type Algorithm 14

Contributing Factors Tab 26

Review Tab 32

Summary Tab 34

Appendix I: List of Pharmacies and Pharmacy Affiliations 35

Pharmacy 35

Affiliation 35

Appendix II: Harm Categories and Algorithm 38

NCC MERP Harm Categories 38

Harm Category Algorithm 39

Appendix III: Medication or Other Substance Event Type Descriptions 40

Appendix IV: Contributing Factor Descriptions 42

Communication 42

Device, equipment, or supply 44

Computer system (Health Information Technology) 46

Human or environmental 47

Medication Event-Specific Factors 48

Organizational 49

Policy or procedure 52

Patient 53


General Information Tab

Date filled Question Location General Information Tab Description Date the pharmacy completed filling the medication Prompt Date the pharmacy processed the prescription. Go-To Logic n/a Required Yes Question Type Date

Format mm/dd/yyyy Guide for Use The date that the new prescription or refill was entered into the system, prepared, filled, and

checked.

Event date Question Location General Information Tab Description Date medication was within the control of the patient or the person acting for the patient Prompt Date medication was within patient control, or date event initiated if medication did not

reach patient Go-To Logic n/a Required Yes Question Type Date

Format mm/dd/yyyy Guide for Use Date the event generating the report occurred, not the date that harm occurred

Date discovered Question Location General Information Tab Description Date pharmacy was notified of the event Prompt Date pharmacy was notified of the event Go-To Logic n/a Required Yes Question Type Date

Format mm/dd/yyyy Guide for Use The date that the pharmacy first became aware of the event.

Who brought this event to the pharmacy’s attention? Question Location General Information Tab Description Determination of who notified the pharmacy of the event or unsafe condition Prompt Check all that apply Responses Patient

Care provider Family member Pharmacist Pharmacy intern Pharmacy staff Pharmacy technician Prescribing provider Unknown Other (please describe)

Go-To Logic n/a Required Yes Question Type Checkboxes


Guide for Use The question “Who else was aware of this event” on the Review Tab will capture information about individuals who knew about the event but did not bring it to the pharmacy’s attention (see page 32 in this document).

Select your pharmacy Question Location General Information Tab Description Determination of which facility is reporting Prompt n/a Responses Pharmacies displayed depend on user rights; a full list is available in Appendix I: List of

Pharmacies and Pharmacy Affiliations Go-To Logic n/a Required Yes Question Type Select Dropdown Guide for Use See Appendix I: List of Pharmacies and Pharmacy Affiliations

Patient’s gender Question Location General Information Tab Description Patient’s self-identified gender Prompt Please use the patient’s self-identified gender Responses Female

Male Unknown

Go-To Logic n/a Required Yes Question Type Select Dropdown Guide for Use Note: If you are reporting an event that impacted multiple patients, please complete a

separate form for each patient with their specific demographic data. Other sections of the form may be copied and pasted. If you have questions about this procedure, please contact a patient safety consultant.

Patient’s age Question Location General Information Tab Description Patient’s age at the time of the event being reported Prompt n/a Go-To Logic n/a Required Yes Question Type Number Maximum Length 3 Minimum Value 0 Maximum Value 128 Guide for Use Note: If you are reporting an event that impacted multiple patients, please complete a


Age unit Question Location General Information Tab Description Unit of time in which patient’s age is measured Prompt n/a Responses Years

Months Weeks


Days Default Years Go-To Logic n/a Required Yes Question Type Select Dropdown Guide for Use Select the appropriate unit for the patient’s age. Always choose “years” unless the patient is

less than one year of age.

Note: If you are reporting an event that impacted multiple patients, please complete a separate form for each patient with their specific demographic data. Other sections of the form may be copied and pasted. If you have questions about this procedure, please contact a patient safety consultant.

Patient’s race Question Location General Information Tab Description Patient’s self-identified race Prompt Check all that apply Responses American Indian or Alaskan Native

Asian Black or African American Native Hawaiian or Pacific Islander White Other Unknown

Go-To Logic n/a Required Yes Question Type Checkboxes Guide for Use Note: If you are reporting an event that impacted multiple patients, please complete a


Patient’s ethnicity Question Location General Information Tab Description Patient’s self-identified ethnicity Prompt Check one Responses Hispanic

Not Hispanic Unknown

Go-To Logic n/a Required Yes Question Type Radio Buttons Guide for Use Note: If you are reporting an event that impacted multiple patients, please complete a


Contact name Question Location General Information Tab Description Name of participant pharmacy’s Patient Safety Reporting Program contact person Prompt Who should we contact for clarification or feedback? Go-To Logic n/a Required Yes


Question Type Text Input Maximum Length 128 Guide for Use No further information provided

Contact email address Question Location General Information Tab Description Email address of participant pharmacy’s Patient Safety Reporting Program contact person Prompt n/a Go-To Logic n/a Required No Question Type Text Input

Format: must be a valid email address Maximum Length 100 Guide for Use No further information provided

Contact phone Question Location General Information Tab Description Phone number of participant pharmacy’s Patient Safety Reporting Program contact person Prompt n/a Go-To Logic n/a Required Yes Question Type Text Input

Format: (xxx) xxx-xxxx Maximum Length 15 Guide for Use No further information provided

Contact extension Question Location General Information Tab Description Phone extension of participant pharmacy’s Patient Safety Reporting Program contact person Prompt n/a Go-To Logic n/a Required No Question Type Text Input Maximum Length 10 Guide for Use No further information provided


Harm Category Tab

Did an actual adverse event occur? Question Location Harm Category Tab Description Determination of whether or not an adverse event occurred Prompt Adverse event: an event resulting in unintended harm or creating the potential for harm that

is related to any aspect of a patient’s care (by an act of commission or omission) rather than to the underlying disease or condition of the patient. Adverse events may or may not be preventable.

Responses Yes No

Go-To Logic If “yes,” opens the question “Did the event reach the patient?” If “no,” assigns harm category A (circumstances that have the capacity to cause harm) and section is complete.

Required Yes Question Type Radio buttons Guide for Use See Appendix II: Harm Categories and Algorithm

Did the event reach the patient? Question Location Harm Category Tab Description Determination of whether or not the event reached the patient Prompt Includes medications that make it into the patient’s possession (an error of omission does

reach the patient) Responses Yes

No Go-To Logic Only appears if the question “Did an actual adverse event occur” was answered “yes.”

If “yes,” opens the question “Did the event contribute to or result in patient death?” If “no,” assigns harm category B (event occurred that did not reach the patient) and opens the question “What prevented the event from reaching the patient?”

Required If this question appears on your form, it is required Question Type Radio buttons Guide for Use See Appendix II: Harm Categories and Algorithm

Did the event contribute to or result in patient death? Question Location Harm Category Tab Description Determination of whether or not the event resulted in or contributed to the patient’s death Prompt n/a Responses Yes

No Go-To Logic Only appears if the question “Did the event reach the patient?” is answered “yes.”

If “yes,” assigns harm category I (event may have contributed or resulted in patient’s death) and section is complete. If “no,” opens the question “Was the patient harmed?”


Was the patient harmed? Question Location Harm Category Tab Description Determination of whether or not the patient was harmed Prompt Harm: any physical injury or damage to the health of a person requiring additional medical


care, including both temporary and permanent injury Responses Yes

No Go-To Logic Only appears if the question “Did the event contribute to or result in patient death?” is

answered “no.” If “yes,” opens the question “Was an intervention necessary to sustain life required?” If “no,” opens the question “Was an intervention to preclude harm/extra monitoring required?”


Was an intervention to preclude harm/extra monitoring required? Question Location Harm Category Tab Description Determination of whether or not extra monitoring or an intervention to preclude harm was

required Prompt Monitoring: to observe or record physiological or psychological signs Responses Yes

No Go-To Logic Only appears if the question “Was the patient harmed?” is answered “no.”

If “yes,” assigns harm category D (event reached patient and required monitoring to confirm that it resulted in no harm and/or required intervention to preclude harm) and opens the question “Which intervention to preclude harm was required?” If “no,” assigns harm category C (event reached patient but did not cause patient harm) and section is complete.


Was an intervention necessary to sustain life required? Question Location Harm Category Tab Description Determination of whether or not an intervention necessary to sustain life was required Prompt Intervention necessary to sustain life: includes cardiovascular and/or respiratory support

(e.g., CPR, defibrillation, intubation) Responses Yes

No Go-To Logic Only appears if the question “Was the patient harmed?” is answered “yes.”

If “yes,” opens the question “Was the harm permanent?” If “no,” opens the question “Was the harm temporary?”


Was the harm permanent? Question Location Harm Category Tab Description Determination of whether or not patient harm was permanent Prompt Permanent harm: harm lasting more than 6 months or where the end harm is not known Responses Yes

No Go-To Logic Only appears if the question “Was an intervention necessary to sustain life required?” is

answered “yes.” If “yes,” assigns harm category G (event may have contributed to or resulted in permanent


patient harm) and section is complete. If “no,” assigns harm category H (event required intervention necessary to sustain life) and section is complete.


Was the harm temporary? Question Location Harm Category Tab Description Determination of whether or not patient harm was temporary Prompt n/a Responses Yes

No Go-To Logic Only appears if the question “Was an intervention necessary to sustain life required?” is

answered “no.” If “yes,” opens the question “Did the event require any of the following significant interventions?” If “no,” assigns harm category G (event may have contributed to or resulted in permanent patient harm) and section is complete.

Required If this question appears on your form, it is required Question Type Radio buttons Guide for Use No further information provided

Did the event require any of the following significant interventions? Question Location Harm Category Tab Description Determination of the intervention(s) performed as a result of the adverse event Prompt Check all that apply. A “significant intervention” is an intervention intended to address side

effects that have the potential to be life-threatening if not addressed. Responses No significant intervention

Treatment in an emergency department Hospital admission Respiratory or cardiovascular support (e.g., ventilation, tracheotomy) Administration of an antidote Other significant intervention (please describe)

Go-To Logic Only appears if the question “Was the harm temporary?” is answered “yes.” If “No significant intervention” is selected, no other response can also be selected, the form assigns harm category E (event may have contributed to or resulted in temporary harm but did not require significant intervention) and section is complete. If any response(s) other than “No significant intervention” is selected, assigns harm category F (event may have contributed to or resulted in temporary harm and required a significant intervention) and section is complete. If “other significant intervention,” a text box for description will open.

Required If this question appears on your form, it is required Question Type Checkboxes


Guide for Use A “significant intervention” is an intervention intended to address side effects that have the potential to be life-threatening if not addressed.

Treatment in an emergency department INCLUDES:

• Treatment by a physician or other medical provider in an emergency department EXCLUDES:

• Evaluation only by a physician or other medical provider, without treatment

Hospital admission INCLUDES:

• Admission to a hospital as a result of the adverse event

Respiratory and cardiovascular support (e.g., ventilation, tracheotomy) INCLUDES:

• Respiratory and/or cardiovascular support that was required as a direct result of the adverse event

Administration of antidote INCLUDES:

• Administration of a rescue drug or antidote (e.g., narcan, epinephrine)

The Harm Category for this event is: Question Location Harm Category Tab Description Harm category assigned by answering questions adapted from the NCC-MERP Harm Category

Algorithm Prompt n/a – harm category automatically assigned by reporting system Responses Category A

Circumstances that have the capacity to cause an adverse event

Category B An event occurred that did not reach the patient (an “error of omission” does reach the patient)

Category C An event occurred that reached the patient but did not cause patient harm

Category D An event occurred that reached the patient and required monitoring to confirm that it resulted in no harm to the patient and/or required intervention to preclude harm

Category E An event occurred that may have contributed to or resulted in temporary harm to the patient but did not require a significant intervention

Category F An event occurred that may have contributed to or resulted in temporary harm to the patient and required a significant intervention

Category G An event occurred that may have contributed to or resulted in permanent patient harm

Category H An event occurred that required intervention necessary to sustain life

Category I An event occurred that may have contributed to or resulted in patient’s death

Go-To Logic n/a – harm category automatically assigned by reporting system Required n/a – harm category automatically assigned by reporting system Question Type n/a – harm category automatically assigned by reporting system Guide for Use If you chose more than one event type, please select the highest applicable level of harm. See


Appendix II: Harm Categories and Algorithm.

What prevented the event from reaching the patient? Question Location Harm Category Tab Description Determination of what process prevented the near miss from reaching the patient Prompt n/a Responses Fail-safe/safeguard worked effectively

Action by pharmacist or staff who made the error prevented the event form reaching the patient

Action by pharmacist or staff (other than person making the error) prevented the event from reaching the patient

Action by patient or patient’s family member prevented the event from reaching the patient Unknown Other (please describe)

Go-To Logic Only appears if harm category is B If “other,” a text box for description will open.

Required No Question Type Select Dropdown Guide for Use The answer selections are intended to be mutually exclusive; however, if it appears to you

that “Fail-safe/safeguard worked effectively” and one of the other selections both apply, select “Fail-safe/safeguard worked effectively.”

Which intervention to preclude harm was required? Question Location Harm Category Tab Description Specification of intervention(s) performed to preclude harm as a result of the adverse event Prompt Check all that apply Responses Monitoring, including observation, physiological examination, laboratory testing, phlebotomy,

and/or imaging studies Medication therapy (excluding administration of rescue drug or antidote) Referral for evaluation Unknown Other intervention (please describe)

Go-To Logic Only appears if harm category is D If “other intervention,” a text box for description will open

Required If this question appears on your form, it is required Question Type Checkboxes Guide for Use Monitoring

INCLUDES:

• Observation for symptoms by the patient or family member/caregiver

Medication therapy INCLUDES:

• Change in medication, strength, dose, and/or route EXCLUDES:

• Administration of a rescue drug or antidote. If a rescue drug or antidote was required, the patient suffered harm.

Referral for evaluation INCLUDES:

• Evaluation by a physician or other medical provider to determine if effects of the adverse event require treatment. If treatment is required, the patient suffered harm.

Unknown INCLUDES:


• The specific intervention used to preclude harm is unknown to the reporter EXCLUDES:

• The specific intervention used to preclude harm is known to the reporter, but the ultimate outcome (e.g., if patient actually saw provider) is unknown. Select a specific intervention from the available responses.

From the patient’s perspective, how did the event impact him or her? Question Location Harm Category Tab Description Specification of the effect of the adverse event on the patient’s health or life situation from

his or her perspective Prompt Check all that apply Responses Patient noted no impact

Patient felt inconvenienced Patient reported no or only partial symptom relief Patient expressed minor side effects as a result of the adverse event Patient expressed significant side effects as a result of the adverse event The impact on the patient is unknown Other (please describe)

Go-To Logic Only appears if harm category is C, D, E, F, G or H If “other intervention,” a text box for description will open.

Required No Question Type Checkboxes Guide for Use No further information provided

What was the patient’s response to the event? Question Location Harm Category Tab Description Describes the patient’s response to the adverse event Prompt Check all that apply Responses Satisfied with resolution

Concerned or anxious Upset or angry Threatened legal action or Board of Pharmacy report Unknown Other (please describe)


Required Yes Question Type Checkboxes Guide for Use This question applies to the patient’s reaction at the time of PSRP report submission,

regardless of their initial reaction.

What was the pharmacy’s response to the event? Question Location Harm Category Tab Description Describes the pharmacy’s response to the adverse event Prompt Check all that apply Responses Apologized, empathized

Changed label Corrected at refill Counseled patient after adverse event Referred incident to corporate offices for action or follow up Referred to provider or referred for evaluation Refunded payment, provided store credit or gift card


Replaced medication Other (please describe)


Required Yes Question Type Checkboxes Guide for Use This question is intended to capture how the pharmacy corrected the problem for the specific

patient. This question does not capture how the pharmacy has corrected the system-level problem to prevent future recurrence for all patients. Participants are required to provide at least one cause (why it occurred) and an associated system-level action plan on the Summary Tab. Action plans outline the steps an organization will take to prevent future adverse events and are a critical component of the root cause analysis.


Event Tab

Medication or Other Substance Event Type Algorithm

To streamline the process of determining the appropriate medication or other substance event type, the

Commission, in consultation with practicing pharmacists, has created an algorithm comprised of a series

of questions. In this document, references to “algorithm” mean the full series of questions that are used

to determine the appropriate event type.

For ease of use, the questions in this data dictionary appear alphabetically. Some questions may appear

more than once in the online form if the participant indicates that more than one medication or

substance is involved in the event. Due to the algorithm’s complexity, we are currently developing a

comprehensive, easy-to-understand flowchart to help users visualize the series of questions in the order

in which they would appear. The flowchart is coming soon!

To apply a single event type to each adverse event report, the algorithm organizes event types in a

hierarchy in the Commission’s. This hierarchy helps to reduce the time needed to complete a report by

limiting the number of questions. Table 1 provides an overview of the event type hierarchy used by the

algorithm.

Table 1: Medication event algorithm event type hierarchy

Medication or other substance event type

Top Incorrect patient Incorrect medication or substance Medication omitted

Incorrect strength or concentration Incorrect dose

Incorrect dosage form Incorrect route Incorrect or incomplete labeling

Incorrect directions Incorrect quantity, amount or size

Brand substitution Generic substitution

Medication or substance contraindicated (includes documented allergies and sensitivities) Allergic reaction due to unknown allergy Adverse reaction not due to allergy or known contraindication

Drug interaction Patient counseling omitted Medication taken incorrectly Expired medication or substance Bottom Other Medication Event


At what stage in the process did the event originate, regardless of the stage at which it was discovered? Question Location Event Tab – Additional Questions Section Description The stage in the process at which the event originated Prompt n/a Responses Purchasing

Storing or stocking Prescribing or ordering (receipt of prescription) Entry Filling Dispensing Distribution or delivery Administering Consulting or counseling Unknown Other (please describe)

Go-To Logic If “other,” a text box for description will open. Required Yes Question Type Select Dropdown Guide for Use Purchasing: purchasing for stock or for a particular patient

Storing or stocking: maintaining the substance under special environmental conditions and in accordance with appropriate security and regulatory requirements

Prescribing or ordering (receipt of prescription): the issuance of an order by an authorized professional for the delivery or administration of a substance to a patient. This may be done in writing, verbally or through an electronic order entry system.

Entry: entering the prescription (hard copy, fax, phone, electronic) into the pharmacy dispensing system (includes collecting/verifying patient information)

Filling: picking/selecting substances from stock, NDC verification, pouring, counting, compounding/reconstituting, labeling, replenishing automated counting devices, and measuring and apportioning doses, such as the filling of cartridges and unit-dose syringes

Dispensing: checking/verifying final prescription, drug utilization review (DUR), and assuring accurate labeling of the prepared substance

Distribution or delivery: packaging and providing the prescription and all printed information to the patient or patient’s agent

Administering: delivering the substance to the patient either by injection, inhalation, or other means

Consulting or counseling: providing information to the patient regarding the correct way to take the medication

Monitoring: determining the presence or absence of any unintended adverse effects prior to the patient leaving the premises

Brand Name Question Location Event Tab – Additional Questions Section Description Identification of the brand name of the product involved in the event Prompt Optional Go-To Logic Please refer to flow chart (coming soon!) Required No Question Type Text Input Guide for Use No further information provided


Briefly describe the way the patient was supposed to use the medication and the actual directions given to the patient. Question Location Event Tab – Additional Questions Section Description Intended directions as and actual directions as prepared for the patient Prompt The intended directions are how patient was supposed to use the medication. The actual

directions are what the patient actually received. Go-To Logic Please refer to flow chart (coming soon!) Required No Question Type Text Input Guide for Use No further information provided

Did the patient have an actual or potential contraindication, allergic reaction, adverse reaction, or drug interaction? Question Location Event Tab – Additional Questions Section Description Determination if a contraindication, allergic reaction, adverse reactions, or drug interaction

occurred Prompt n/a Responses Yes

No Unknown

Go-To Logic Please refer to flow chart (coming soon!) Required If an event type has not been determined by the algorithm, this question is required

If an event type has been determined by the algorithm, this question is not required Question Type Radio Buttons Guide for Use No further information provided

Did the patient take the medication(s) or other substance(s) correctly? Question Location Event Tab – Additional Questions Section Description Determination if patient used the medication as prescribed and dispensed Prompt n/a Responses Yes

No Unknown

Go-To Logic Please refer to flow chart (coming soon!) Required If this question appears on your form, it is required Question Type Radio Buttons Guide for Use No further information provided

Generic name Question Location Event Tab – Additional Questions Section Description Identification of the generic name of the product involved in the event Prompt n/a Go-To Logic Please refer to flow chart (coming soon!) Required Yes Question Type Text Input Guide for Use No further information provided

How preventable was the incident? Question Location Event Tab Description Determination of how preventable the specific incident being reported was Prompt n/a


Responses Almost certainly could have been prevented Likely could have been prevented Likely could not have been prevented Almost certainly could not have been prevented Unknown

Go-To Logic Only appears if the Harm Category is C, D, E, F, G, H or I Required No Question Type Dropdown select Guide for Use No further information provided

Please provide the intended and actual dosage form Question Location Event Tab – Additional Questions Section Description Intended medication dosage form and actual medication dosage form prepared for the

patient Prompt The intended dosage form is what the patient should have gotten. The actual dosage form is

what the patient received. Responses Aerosol

Capsule Chewable Cream, gel, or lotion Ear drops Enteric-coated Extended- or sustained-release Eye drops Immediate-release Inhaler Long-acting Nasal spray Nebulizer Ointment Paste Pill or tablet Powder Skin patch Solution or suspension Suppository Vaginal ring Vaporizer Other (please describe)

Go-To Logic Please refer to flow chart (coming soon!) Required No Question Type Select dropdown Guide for Use No further information provided

Please provide the intended and actual dose Question Location Event Tab – Additional Questions Section Description Intended medication dose and actual medication dose prepared for the patient Prompt The intended dose is what the patient should have gotten. The actual dose is what the

patient received. Go-To Logic Please refer to flow chart (coming soon!) Required No Question Type Text Input


Guide for Use No further information provided

Please provide the intended and actual quantity, amount or size Question Location Event Tab – Additional Questions Section Description Intended medication quantity, amount or size and actual medication quantity, amount or size

prepared for the patient Prompt The intended quantity, amount or size is what the patient should have gotten. The actual

quantity, amount or size is what the patient received. Go-To Logic Please refer to flow chart (coming soon!) Required No Question Type Text Input Guide for Use No further information provided

Please provide the intended and actual route Question Location Event Tab – Additional Questions Section Description Intended medication route and actual medication route prepared for the patient Prompt The intended route is what the patient should have gotten. The actual route is what the

patient received. Responses Cutaneous, topical application, including intradermal, ointment, spray, patch

Subcutaneous Ophthalmic Oral, including sublingual or buccal Otic Nasal Inhalation Intramuscular Rectal Vaginal Unknown Other (please describe below)

Go-To Logic Please refer to flow chart (coming soon!) Required No Question Type Select dropdown Guide for Use No further information provided

Please provide the intended and actual strength or concentration Question Location Event Tab – Additional Questions Section Description Intended medication strength or concentration and actual medication strength or

concentration prepared for the patient Prompt The intended strength or concentration is what the patient should have gotten. The actual

strength or concentration is what the patient received. Go-To Logic Please refer to flow chart (coming soon!) Required No Question Type Text Input Guide for Use No further information provided

This event is: Question Location Event Tab – Additional Questions Section Description Determination of the type of medication or other substance event

Medication or other substance event type assigned by answering questions in the Additional Questions section of the Event Tab.

Prompt n/a – medication or other substance event type automatically assigned by reporting system


Responses Adverse reaction not due to allergy or known contraindication Allergic reaction due to unknown allergy Brand substitution Drug interaction Expired medication or substance Generic substitution Incorrect directions Incorrect dosage form Incorrect dose Incorrect medication or substance Incorrect patient Incorrect quantity, amount or size Incorrect route Incorrect strength Incorrect or incomplete labeling Medication or substance contraindicated (includes documented allergies and sensitivities) Medication taken incorrectly Medicaion omitted Other (please describe)

Go-To Logic If “other,” a text box for description will open. Required n/a – medication or other substance event type automatically assigned by reporting system Question Type n/a – medication or other substance event type automatically assigned by reporting system Guide for Use See Appendix III: Medication or Other Substance Event Type Descriptions for definitions and

common inclusions and exclusions

Type of other substance Question Location Event Tab – Additional Questions Section Description Determination of the type of medication or substance involved in the event Prompt n/a Responses Biological products (including vaccines)

Nutritional products Contrast media Radiopharmaceuticals Other (please describe)

Go-To Logic Only appears if “What type of medication or substance was involved?” is answered “Other substance.” If “other,” a text box for description will open.

Required No Question Type Select Dropdown Guide for Use Biological product (including vaccines): any virus, therapeutic serum, toxin, antitoxin, or

analogous product applicable to the prevention, treatment or cure of disease or injury

Contrast media: a type of drug used to enhance the contrast of structures or fluids within the body during medical imaging

Nutritional products: includes dietary supplements; vitamins or minerals; enteral nutritional products, including infant formula; parenteral nutritional products

Radiopharmaceutical: a radioactive chemical or pharmaceutical preparation that is labeled with a radionuclide in tracer or therapeutic concentration that is used as a diagnostic or therapeutic agent

Type of prescription Question Location Event Tab – Additional Questions Section


Description Identification of the type of prescription involved in the event Prompt n/a Responses New prescription

Refill prescription Transfer prescription Reassigned prescription number

Go-To Logic Please refer to flow chart (coming soon!) Required Yes Question Type Select Dropdown Guide for Use New prescription: any medication that receives a new prescription number in the pharmacy

system, irrespective of whether the patient is continuing on the medication

Refill prescription: any medication that has a pre-existing prescription number in the pharmacy system

Transfer prescription: prescriptions that were filled or entered into one pharmacy system and are transferred to another

Reassigned prescription number: Any prescription that requires a new prescription number, even if it is a medication, strength, and dose that patient is continuing.

Was counseling provided during this patient encounter? Question Location Event Tab – Additional Questions Section Description Determination of whether the pharmacist discussed the medication with the patient Prompt n/a Responses Yes

No Patient refused counseling Unknown

Go-To Logic Please refer to flow chart (coming soon!) Required If an event type has not been determined by the algorithm, this question is required

If an event type has been determined by the algorithm, this question is not required Question Type Radio Buttons Guide for Use No further information provided

Was the medication or other substance expired? Question Location Event Tab – Additional Questions Section Description Determination of whether the medication had passed the manufacturer expiration date Prompt n/a Responses Yes

No Unknown

Go-To Logic Please refer to flow chart (coming soon!) Required If this question appears on your form, it is required Question Type Radio Buttons Guide for Use No further information provided

Was the provided counseling correct? Question Location Event Tab – Additional Questions Section Description Determination of whether all of the information regarding the medication and its use were

accurate Prompt n/a Responses Yes

No (please describe)


Unknown Go-To Logic Please refer to flow chart (coming soon!) Required No Question Type Radio Buttons Guide for Use No further information provided

Was this medication or substance dispensed to this patient? Question Location Event Tab – Additional Questions Section Description Determination if the prescribed medication or substance was given to this patient Prompt n/a Responses Yes

No Go-To Logic Please refer to flow chart (coming soon!) Required Yes Question Type Radio Buttons Guide for Use No further information provided

Was this medication or substance intended for another patient? Question Location Event Tab – Additional Questions Section Description Determination if medication was prescribed for a different patient Prompt n/a Responses Yes

No Go-To Logic Please refer to flow chart (coming soon!) Required If this question appears on your form, it is required Question Type Radio Buttons Guide for Use No further information provided

Was this medication or substance prescribed for this patient? Question Location Event Tab – Additional Questions Section Description Determination of the medication or substance prescribed for this patient Prompt n/a Responses Yes

No Go-To Logic Please refer to flow chart (coming soon!) Required If this question appears on your form, it is required Question Type Radio Buttons Guide for Use No further information provided

Was this medication or substance used by this patient? Question Location Event Tab – Additional Questions Section Description Determination if the medication or substance was used by this patient Prompt n/a Responses Yes

No Unknown

Go-To Logic Please refer to flow chart (coming soon!) Required No Question Type Radio Buttons Guide for Use No further information provided


Were any of the following incorrect? Question Location Event Tab – Additional Questions Section Description Identification of what was incorrect about the prescribed and dispensed (or potentially

dispensed) medication involved in event Prompt Check all that apply Responses All were correct

Strength or concentration Dose Dosage form Route Quantity (includes amount and size) Label Brand or generic substitution

Go-To Logic Please refer to flow chart (coming soon!) Required Yes Question Type Radio Buttons Guide for Use Strength or concentration: the amount of drug in the dosage form or a unit of the dosage

form INCLUDES

• 250 mg/5 mL suspension instead of a 250 mg/1 mL suspension

• 50 mg tablet dispensed instead of a 25 mg tablet

Dose: the amount of drug taken within any one time period

INCLUDES:

• Two tablets taken instead of one tablet as prescribed

• One tablet taken once a day instead of twice a day

Dosage form: the physical form of a dose of medication

INCLUDES:

• Extended- or sustained-release medication instead of immediate-release

• For a complete list of dosage forms, please see the Guide for Use for “Please provide the intended and actual dosage form” on page 17 of this document

Route: the method by which a drug enters the patient

INCLUDES:

• For a complete list of routes, please see the Guide for Use for “Please provide the intended and actual route” on page 18 of this document

Label: the printed information placed on the medication container by the pharmacy and provided to the patient, which contains required information (e.g., medication, dose, prescriber), appropriate way to take the medication, etc.

Quantity: the number, amount or size of the medication dispensed to the patient

Were any other medications or substances involved in this event? Question Location Event Tab – Additional Questions Section Description Adds the initial set of questions for an additional medication related to the adverse event

being reported Prompt Please include other medications (including those which can be given without a prescription)

that contributed to the adverse event. Responses Add medication Go-To Logic Please refer to flow chart (coming soon!) Required n/a Question Type Action button



What kind of actual or potential contraindication, allergic reaction, adverse reaction, or drug interaction occurred? Question Location Event Tab – Additional Questions Section Description Type of contraindication, allergic reaction, adverse reactions, or drug interaction that

occurred or could have occurred Prompt n/a Responses Contraindication - Documented allergy, sensitivity or intolerance

Contraindication - Drug-drug Contraindication - Drug-food Contraindication - Drug-disease Contraindication - Other (please describe) Undocumented allergy, sensitivity or intolerance Other adverse reaction Unanticipated drug interaction

Go-To Logic Please refer to flow chart (coming soon!) Required If “Did the patient have an actual or potential contraindication, allergic reaction, adverse

reaction, or drug interaction?” is answered “yes,” this question is required Question Type Select dropdown Guide for Use See Appendix III: Medication or Other Substance Event Type Descriptions for definitions of

contraindication, drug interaction, unanticipated allergic reaction and adverse reaction.

What medication or substance was dispensed instead? Question Location Event Tab – Additional Questions Section Description Identification of the unprescribed medication or substance dispensed to the patient in place

of the prescribed medication or substance Prompt Please include medications that were intended for the patient but can be given without a

prescription (e.g., flu vaccine OTC) Responses None (No medication was dispensed to the patient)

[Null] Go-To Logic Please refer to flow chart (coming soon!) Required No Field Type Checkboxes Guide for Use Check “none” only if the patient did not receive the prescribed medication and no

substitution was given

What medication or substance was prescribed for the patient? Question Location Event Tab – Additional Questions Section Description Identification of the medication or substance that was prescribed for the patient Prompt Please include medications that were intended for the patient but can be given without a

prescription (e.g. flu vaccine, OTC) Responses Patient did not have a prescription

[Null] Go-To Logic n/a Required No Field Type Checkboxes Guide for Use Check “Patient did not have a prescription” only if the patient received a medication without

a prescription rather than in substitution for a prescribed medication.


What type of medication or substance was involved? Question Location Event Tab – Additional Questions Section Description Determination of the type of medication or substance involved in the event Prompt Check all that apply Responses Prescription medication

Over-the-counter (including herbal supplements) Compounded preparation (non-sterile) Compounded preparation (sterile) Other substance (including vaccines) Unknown

Go-To Logic If “Other substance,” opens the question “Type of other substance” Required No Question Type Checkboxes Guide for Use Medication: a chemical formulation designed to treat a health problem

Prescription medication: medication not available to the public without a physician’s or other medical provider’s authorization; usually requires processing by the pharmacist in order to be dispensed to the patient

Over-the-counter (including herbal supplements): medication available to the public without a physician’s or other medical provider’s authorization

Compounded preparation: medication formulated to address specific patient needs that are not found or available from pharmaceutical manufacturers; requires the intercession of an authorized compounder and is not available off the shelf

Other substance (including vaccines): includes biological products (e.g., vaccines), nutritional products (e.g., dietary supplements; vitamins or minerals; enteral nutritional products, including infant formula; parenteral nutritional products), contrast media, radiopharmaceuticals

What type of substitution? Question Location Event Tab – Additional Questions Section Description Determination if a generic or brand substitution occurred Prompt Select one Responses Generic substitution

Brand substitution Go-To Logic Please refer to flow chart (coming soon!) Required If this question appears on your form, it is required Question Type Radio Buttons Guide for Use Generic substitution: When a brand name medication is prescribed and a generic medication

is dispensed, or when one manufacturer’s generic medication is prescribed and the same generic medication produced by a different manufacturer is dispensed

Brand substitution: a brand of a medication other than the brand prescribed was dispensed

What was incorrect on the label? Question Location Event Tab – Additional Questions Section Description Elements of the label that were incorrect Prompt Check all that apply Responses Incorrect patient name

Incorrect directions Other (please describe)

Go-To Logic Please refer to flow chart (coming soon!) Required If this question appears on your form, it is required Question Type Checkboxes



Would this medication have been dispensed? See “Was this medication or substance dispensed to this patient?” on page 21. This is how the question is

worded for an unsafe condition, near miss, or if harm is undetermined.


Contributing Factors Tab

Communication Question Location Contributing factors tab Description Determination if any contributing factor(s) related to communication are known Prompt Were communication factors involved in this event? Responses Yes

No Go-To Logic If “yes,” opens the question “Communication factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided

Communication factors Question Location Contributing factors Description Determination of which contributing factor(s) related to communication are known Prompt Check all that apply Responses Healthcare team member factors

Among pharmacy staff Between manager or pharmacist and staff Hard to read fax or handwriting Unclear prescription With prescribing provider or other outside organizations Other (please describe)

Patients/families factors Culture Language Between staff and patient Misinterpreted directions Other (please describe)

Go-To Logic Only appears if “Communication” was answered “yes.” If “other,” a text box for description will open.

Required If “Communication” is answered “yes,” then one of these options must be selected; otherwise, it is not required.

Question Type Checkboxes Guide for Use See Appendix IV: Contributing Factor Descriptions for definitions and common inclusions and

exclusions

Device or supply Question Location Contributing factors Description Determination if any contributing factor(s) related to devices or supplies are know Prompt Were device or supply factors involved in this event? Responses Yes

No Go-To Logic If “yes,” opens the question “Device or supply factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided


Device or supply factors Question Location Contributing factors Description Determination of which contributing factor(s) related to devices or supplies are known Prompt Check all that apply Responses Availability

Design Function (e.g., defective, non-working) Maintenance Shortage Use or selection by pharmacist or staff Other (please describe)

Go-To Logic Only appears if “Device or supply” was answered “yes.” If “other,” a text box for description will open.

Required If “Device or supply” is answered “yes,” then one of these options must be selected; otherwise, it is not required.

Question Type Checkboxes Guide for Use Function includes devices or supplies that are defective, non-working, or do not meet code

See Appendix IV: Contributing Factor Descriptions for definitions and common inclusions and exclusions

Computer system (Health Information Technology) Question Location Contributing factors Description Determination if any contributing factor(s) related to health information technology are

known Prompt Were health information technology factors involved in this event? Responses Yes

No Go-To Logic If “yes,” opens the question “Health information technology factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided

Computer system (Health Information Technology) factors Question Location Contributing factors Description Determination of which contributing factor(s) related to health information technology are

known Prompt Check all that apply Responses Bar-coding

Electronic prescribing Integrated health record (including EHR/EMR) IVR (Integrated voice response) Patient profile incomplete or inaccurate Robot or autofill system Software Telepharmacy Other (please describe)

Go-To Logic Only appears if “Health information technology” was answered “yes.” If “other,” a text box for description will open.

Required If “Health information technology” is answered “yes,” then one of these options must be selected; otherwise, it is not required.


exclusions


Human or environmental Question Location Contributing factors Description Determination if any contributing factor(s) related to human or environmental factors are

known Prompt Were human or environmental factors involved in this event? Responses Yes

No Go-To Logic If “yes,” opens the question “Human or environmental factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided

Human or environmental factors Question Location Contributing factors Description Determination of which contributing factor(s) related to human or environmental factors are

known Prompt Check all that apply Responses Alarm fatigue

Clutter Interruptions or distractions Lighting Noise Provider or staff fatigue Provider or staff health issues Provider or staff stress Work area design and specifications Other (please describe)

Go-To Logic Only appears if “Human or environmental” was answered “yes.” If “other,” a text box for description will open.

Required If “Human or environmental” is answered “yes,” then one of these options must be selected; otherwise, it is not required.

Question Type Checkboxes Guide for Use Includes both individual and environmental factors, which influence behavior at work in a

way that can affect health and safety. See Appendix IV: Contributing Factor Descriptions for definitions and common inclusions and exclusions

Medication event Question Location Contributing factors Description Determination if any contributing factor(s) related to medications are known Prompt Were factors specific to a medication event involved? Responses Yes

No Go-To Logic If “yes,” opens the question “Medication event factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided

Medication event factors Question Location Contributing factors Description Determination of which contributing factor(s) related to medications are known Prompt Check all that apply


Responses Look-alike/sound-alike drugs Two or more prescriptions filled at the same time Medication therapy management (MTM) patient Multitasking Event carried through one or more refills Other (please describe)

Go-To Logic Only appears if “Organizational” was answered “yes.” If “multitasking,” opens the question “Please indicate which tasks.” If “event carried through one or more refills,” opens the question “Through how many refills was this event carried?” If “other,” opens a text box for description.

Required If “Medication event” is answered “yes,” then one of these options must be selected; otherwise, it is not required.


exclusions

Please indicate which tasks Question Location Contributing factors Description Determination of which tasks were performed while multitasking Prompt Check all that apply Responses Counseling or answering patient questions

Filling more than two prescriptions for the patient at the same time Filling prescriptions for more than one patient at the same time Responding to requests from pharmacy technicians or other staff Talking with prescribing provider Other (please describe)

Go-To Logic Only appears if “Medication event factors” was answered “multitasking.” If “other,” a text box for description will open.

Required If “Medication event factors” is answered “multitasking,” then one of these options must be selected; otherwise, it is not required.

Question Type Checkboxes Guide for Use No further guidance provided

Through how many refills was this event carried? Question Location Contributing factors Description Documentation of the number of times the medication was refilled for the patient before the

error was discovered Prompt Please indicate the specific number of refills through which the event was carried Go-To Logic Only appears “Were any of the following involved?” was answered “Event carried through

one or more refills.” Required If this question appears on your form, it is required Question Type Number Maximum Length 2 Minimum Value 0 Maximum Value 99 Guide for Use No further information provided

Organizational Question Location Contributing factors Description Determination if any contributing factor(s) related to the organization are known Prompt Were organizational factors involved in this event?


Responses Yes No

Go-To Logic If “yes,” opens the question “Organizational factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided

Organizational factors Question Location Contributing factors Description Determination of which contributing factor(s) related to the organization are known Prompt Check all that apply Responses Assignment or work allocation

Culture of safety Internal reporting Job orientation or training Management or leadership skills Patient wait or prescription backlog Production pressures Staff competencies Staffing levels Supervision Systems to identify risk Temporary staffing Other (please describe)

Go-To Logic Only appears if “Organizational” was answered “yes.” If “other,” a text box for description will open.

Required If “Organizational” is answered “yes,” then one of these options must be selected; otherwise, it is not required.


exclusions

Policy or procedure Question Location Contributing factors Description Determination if any contributing factor(s) related to policies or procedures are known Prompt Were policy or procedure factors involved in this event? Responses Yes

No Go-To Logic If “yes,” opens the question “Policy or procedure factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided

Policy or procedure factors Question Location Contributing factors Description Determination of which contributing factor(s) related to policies or procedures are known Prompt Check all that apply Responses Clarity of policy or procedure

Policy or procedure absent Pharmacist, technician or staff unfamiliar with policy or procedure Policy or procedure too cumbersome Policy or procedure unrealistic


Work-around more efficient Other (please describe)

Go-To Logic Only appears if “Policy or procedure” was answered “yes.” If “other,” a text box for description will open.

Required If “Policy or procedure” is answered “yes,” then one of these options must be selected; otherwise, it is not required.


exclusions

Patient Question Location Contributing factors Description Determination if any contributing factor(s) related to patient are known Prompt Were patient factors involved in this event? Responses Yes

No Go-To Logic If “yes,” opens the question “Patient factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided

Patient factors Question Location Contributing factors Description Determination of which contributing factor(s) related to patient are known Prompt Check all that apply Responses Behavioral status

Family dynamics or relationships Fragile health status Mental status Physical limitations Sensory impairment (vision, hearing, balance, etc.) Other (please describe)

Go-To Logic Only appears if “Patient” was answered “yes.” If “other,” a text box for description will open.

Required If “Patient” is answered “yes,” then one of these options must be selected; otherwise, it is not required.


exclusions


Review Tab

Date review and analysis completed Question Location Review tab Description Date the investigation, review, and analysis of the event was completed. Prompt n/a Go-To Logic n/a Required Yes Question Type Date

Format: mm/dd/yyyy Guide for Use No further information provided

Person hours spent in review Question Location Review tab Description Number of person hours spent in the investigation, review and analysis process Prompt Please approximate the combined total number of hours that all individuals involved

contributed to the review and analysis of this event Go-To Logic n/a Required Yes Question Type Number Guide for Use No further information provided

Who was notified of this event? Question Location Review tab Description Determination of which pharmacy or corporate executives were notified of the event. Prompt Check all that apply Responses PIC/Pharmacy manager

Prescribing provider Owner Corporate office None of these were notified

Go-To Logic n/a Required Yes Question Type Radio buttons Guide for Use No further information provided

Who else was aware of this event? Question Location Review tab Description Determination of who else was aware of this event, other than the individual(s) who

discovered the event and the individual(s) notified of the event. Prompt Check all that apply Responses Patient

Care giver, family member or patient representative Prescribing provider Other healthcare provider

Go-To Logic n/a Required Yes Question Type Radio buttons Guide for Use Select prescribing provider only if provider was not contacted by the pharmacy regarding the

event or if prescribing provider was the one who discovered the event.


Who was given written notification? Question Location Review tab Description Determination of who was given written notification of the event Prompt Check all that apply Responses Patient

Patient representative None given

Go-To Logic Serious harm events only. If “none given,” opens the question “Please specify why no written notification was given.”

Required Yes Question Type Checkboxes Guide for Use No further information provided

Please specify why no written notification was given Question Location Review tab Description Determination of why no one was given written notification of the event Prompt Check all that apply Responses Written notification pending

No organizational policy Not required by pharmacy organizational policy Not required by Commission definitions Oral disclosure Unable (please describe) Other (please describe)

Go-To Logic Only appears if “Who was given written notification?” is answered “none given.” If “other” or “unable,” a text box for description will open.

Required No Question Type Checkboxes Guide for Use No further information provided


Summary Tab

Complete account Question Location Summary Tab Description Complete, narrative account of event Prompt Briefly describe the situation that led to the event in a way that someone unfamiliar with the

event could easily recreate the event in another pharmacy. Include descriptions of the contributing factors that influenced the event. As appropriate, include individual level factors.

Go-To Logic n/a Required Yes Question Type Text area (memo field) Guide for Use No further information provided.

Causes and Action Plans Instructions: For the following questions, identify at least one system level cause that shows a clear link to the event. For each cause, identify an action plan your organization will take to prevent occurence of similar events.

Cause Question Location Summary Tab Description Cause or finding from event review and analysis Prompt n/a Go-To Logic n/a Required Yes Question Type Text area (memo field) Guide for Use No further information provided

Is this a root cause? Question Location Summary Tab Description Determination of whether or not cause or finding was a root cause Prompt n/a Responses Yes

No Go-To Logic n/a Required Yes Question Type Radio buttons Guide for Use A “root cause” is a condition or circumstance that prompted an action that led to the event,

near miss occurrence, or harm. Root causes are one or more steps removed from the action (or inaction) that directly precipitated the event or near miss. Correction of a root cause within the system can prevent (or significantly reduce the likelihood of) the recurrence of the event or near miss.

Action Plan Question Location Summary Tab Description The action plan that addresses the cause or finding and is designed to prevent occurrence of

similar events Prompt n/a Go-To Logic n/a Required Yes Question Type Text area (memo field) Guide for Use No further information provided


Appendix I: List of Pharmacies and Pharmacy Affiliations

Pharmacy Affiliation Broadway Apothecary Independent

Casey Eye Institute Pharmacy at OHSU OHSU

Community Pharmacy Redmond Independent

Consonus Pharmacy Services Independent

Costco Pharmacy #0766 (Wilsonville) Costco

Samaritan Albany General Hospital - Elm Street Pharmacy Samaritan Health Services

Fred Meyer Pharmacy #005 (Albany) Fred Meyer

Fred Meyer Pharmacy #021 (Bend) Fred Meyer

Fred Meyer Pharmacy #030 (Brookings) Fred Meyer

Fred Meyer Pharmacy #035 (Beaverton) Fred Meyer

Fred Meyer Pharmacy #040 (Portland) Fred Meyer

Fred Meyer Pharmacy #050 (Coos Bay) Fred Meyer

Fred Meyer Pharmacy #060 (Cornelius) Fred Meyer

Fred Meyer Pharmacy #063 (Clackamas) Fred Meyer

Fred Meyer Pharmacy #070 (Corvallis) Fred Meyer


Fred Meyer Pharmacy #090 (Salem) Fred Meyer


Fred Meyer Pharmacy #126 (Grants Pass) Fred Meyer

Fred Meyer Pharmacy #127 (Gresham) Fred Meyer



Fred Meyer Pharmacy #143 (Hillsboro) Fred Meyer


Fred Meyer Pharmacy #153 (Happy Valley) Fred Meyer

Fred Meyer Pharmacy #165 (Klamath Falls) Fred Meyer

Fred Meyer Pharmacy #195 (Medford) Fred Meyer

Fred Meyer Pharmacy #196 (Medford) Fred Meyer

Fred Meyer Pharmacy #218 (Warrenton) Fred Meyer

Fred Meyer Pharmacy #220 (Newberg) Fred Meyer


Fred Meyer Pharmacy #227 (Newport) Fred Meyer

Fred Meyer Pharmacy #240 (Milwaukie) Fred Meyer

Fred Meyer Pharmacy #242 (Oregon City) Fred Meyer


Fred Meyer Pharmacy #281 (Roseburg) Fred Meyer


Fred Meyer Pharmacy #325 (Eugene) Fred Meyer

Fred Meyer Pharmacy #328 (Springfield) Fred Meyer




Fred Meyer Pharmacy #372 (The Dalles) Fred Meyer

Fred Meyer Pharmacy #375 (Tigard) Fred Meyer

Fred Meyer Pharmacy #377 (Tillamook) Fred Meyer

Fred Meyer Pharmacy #393 (Tualatin) Fred Meyer


Pharmacy Affiliation Fred Meyer Pharmacy #417 (Eugene) Fred Meyer

Fred Meyer Pharmacy #462 (Scappoose) Fred Meyer

Fred Meyer Pharmacy #464 (Florence) Fred Meyer

Fred Meyer Pharmacy #482 (Beaverton) Fred Meyer


Fred Meyer Pharmacy #650 (Redmond) Fred Meyer

Fred Meyer Pharmacy #651 (Canby) Fred Meyer

Fred Meyer Pharmacy #660 (Wood Village) Fred Meyer

Fred Meyer Pharmacy #661 (Hillsboro) Fred Meyer

Fred Meyer Pharmacy #663 (Sandy) Fred Meyer

Fred Meyer Pharmacy #694 (Happy Valley) Fred Meyer

Geary Street Clinic Pharmacy Samaritan Health Services

Gordon’s Pharmacy & Gifts Good Neighbor

Grants Pass Pharmacy Independent

Haggen Pharmacy #2087 (Bend) Haggen

Hirons Drug #1 (E 18th) Hiron's

Howard's Drugs HealthMart

Kaiser Permanente Mail Order Pharmacy Kaiser Permanente

Kaiser Permanente Beaverton Pharmacy Kaiser Permanente

Kaiser Permanente Central Interstate Pharmacy Kaiser Permanente

Kaiser Permanente East Interstate Pharmacy Kaiser Permanente

Kaiser Permanente Gateway Pharmacy Kaiser Permanente

Kaiser Permanente Hillsboro Baseline Pharmacy Kaiser Permanente

Kaiser Permanente Home Infusion Pharmacy Kaiser Permanente

Kaiser Permanente Interstate South Pharmacy Kaiser Permanente

Kaiser Permanente Interstate Specialty Pharmacy Kaiser Permanente

Kaiser Permanente Keizer Station Pharmacy Kaiser Permanente

Kaiser Permanente Community Care Pharmacy Kaiser Permanente

Kaiser Permanente Mt Scott Pharmacy Kaiser Permanente

Kaiser Permanente Mt Talbert Pharmacy Kaiser Permanente

Kaiser Permanente Murrayhill Pharmacy Kaiser Permanente

Kaiser Permanente North Lancaster Pharmacy Kaiser Permanente

Kaiser Permanente Rockwood Pharmacy Kaiser Permanente

Kaiser Permanente Skyline Pharmacy Kaiser Permanente

Kaiser Permanente Sunnybrook Pharmacy Kaiser Permanente

Kaiser Permanente Tualatin Pharmacy Kaiser Permanente

Kaiser Permanente West Salem Medical Pharmacy Kaiser Permanente

Kaiser Permanente Westside Medical Center Pharmacy Kaiser Permanente

Luke-Dorf Pharmacy Independent

Mac Prescription Shop (NE 3rd) HealthMart

Murray Drugs Murray

Murray's Condon Pharmacy Murray

OHSU CHH Infusion Pharmacy OHSU

OHSU CHH Retail Pharmacy OHSU

OHSU Doernbecher Children’s Outpatient Pharmacy OHSU

OHSU Gabriel Park Pharmacy OHSU

OHSU Knight Cancer Institute Beaverton Hematology Oncology Outpatient Pharmacy

OHSU


Pharmacy Affiliation OHSU Mail Order Pharmacy OHSU

OHSU Outpatient Pharmacy OHSU

OHSU Richmond Clinic Pharmacy OHSU

Olive Branch Pharmacy Independent

Outside In Pharmacy Independent

Paulsen's Pharmacy Good Neighbor

Payless Drug (Gruman Dr, Eugene) Payless

Payless Drug (MLK Blvd, Eugene) Payless

Payless Drug (Portland) Payless

Postal Pharmacy HealthMart

Providence Specialty Pharmacy Services - Infusion/SPP Providence Health & Services

Quisenberry Pharmacies Quisenberry

Rinehart Pharmacy Independent

Rogue Community Health Pharmacy Independent

Rogue River Pharmacy #1138 Hi-School

Samaritan Pharmacy Services Samaritan Health Services

Trinity Valley Pharmacy Independent

Tualatin Pharmacy Good Neighbor

Virginia Garcia Beaverton Pharmacy Virginia Garcia

Virginia Garcia Hillsboro Pharmacy Virginia Garcia

Virginia Garcia McMinnville Pharmacy Virginia Garcia

Virginia Garcia Memorial Health Center Pharmacy (Cornelius) Virginia Garcia

Virginia Garcia Newberg Pharmacy Virginia Garcia

Willamette Compounding Pharmacy Quisenberry


Appendix II: Harm Categories and Algorithm

NCC MERP Harm Categories

Category A Circumstances that have the capacity to cause an adverse event No adverse

event

Category B An event occurred that did not reach the patient (an “error of omission” does reach the patient)

Adverse event, no

harm

Category C An event occurred that reached the patient but did not cause patient harm

Harm is defined as “any physical injury or damage to the health of a person requiring additional medical care, including both temporary and permanent injury”

Category D An event occurred that reached the patient and required monitoring to confirm that it resulted in no harm to the patient and/or required intervention to preclude harm

Monitoring is defined as “to observe or record physiological or psychological signs”

Category E An event occurred that may have contributed to or resulted in temporary harm to the patient but did not require a significant intervention

A significant intervention is defined as “an intervention intended to relieve symptoms that have the potential to be life-threatening if not addressed”

Adverse event, harm

Category F An event occurred that may have contributed to or resulted in temporary harm to the patient and required a significant intervention

A significant intervention is defined as “an intervention intended to relieve symptoms that have the potential to be life-threatening if not addressed”

Category G An event occurred that may have contributed to or resulted in permanent patient harm

Permanent harm is defined as “harm lasting more than 6 months, or where end harm is not known (‘watchful waiting’)”

Category H An event occurred that required intervention necessary to sustain life

An intervention necessary to sustain life is defined as including “cardiovascular and/or respiratory support (e.g., CPR, defibrillation, intubation)”

Category I An event occurred that may have contributed to or resulted in patient’s death Adverse

event, death


Harm Category Algorithm

Adverse Event An event resulting in unintended harm or creating the potential for harm that is related to any aspect of a patient’s care (by an act of commission or omission) rather than to the underlying disease or condition of the patient; adverse events may or may not be preventable

Harm Any physical injury or damage to the health of a person and/or pain resulting therefrom, including both temporary and permanent injury

Permanent Harm Harm lasting more than six months or where the end harm is not known

Monitoring To observe or record physiological or psychological signs

Intervention May include change in therapy or active medical/surgical treatment

Intervention Necessary to Sustain Life Includes cardiovascular and/or respiratory support (e.g., CPR, defibrillation, intubation)

Significant Intervention An intervention intended to relieve symptoms that have the potential to be life-threatening if not addressed

Did an actual adverse

event occur?

Circumstances that have the

capacity to cause an adverse event

Category A

Did the event reach the

patient?

(An error of omission

does reach the patient)

Did the event

contribute to or result

in patient death?

Category I

Yes

No

No

No

Yes

Yes

Category B

Was the patient

harmed?

Category C

Was extra monitoring

or an intervention to

preclude harm

required?

Was an intervention

necessary to sustain life

required?

Was the harm

permanent?

Category H

Was the harm

temporary?

Category G

Category E Category F

No

No

No

Yes

No

Yes

Yes

Yes

Yes

No

Category D

Did the event

require a significant

intervention?

No

Adapted from “NCC MERP Index for Categorizing Medication Errors

Algorithm.” 2001 National Coordinating council for Medication Error

Reporting and Prevention.

Yes


Appendix III: Medication or Other Substance Event Type Descriptions

Event type Definition

Adverse reaction not due to allergy or known contraindication

Patient death or serious injury associated with being given a medication or other substance (at normal dosage during normal use) for which an adverse reaction occurred that was not due to an allergy or known contraindication.

INCLUDES: anticholinergic reaction syndrome as a result of medication administration; severe hypotensive event as a result of medication administration; other reactions that cannot be classified as an allergic reaction

EXCLUDES: unanticipated allergic reactions (see “allergic reaction”); documented allergies or sensitivities (see “medication or other substance contraindicated”)

Allergic reaction due to unknown allergy

Patient death or serious injury associated with being given a medication or other substance for which an unanticipated allergic reaction occurred either in the facility or at home and reported to facility

INCLUDES: an inappropriate immune response, such as a rash or hives, as a result of medication administration; anaphylaxis as a result of medication administration

EXCLUDES: allergic reactions due to documented allergies (see “medication or substance contraindicated”)

Brand substitution Patient death or serious injury associated with a brand substitution

EXCLUDES: generic substitutions (see “Generic substitution”), contaminated medications (see “Other medication or substance event”)

Drug interaction Patient death or serious injury associated with an unanticipated drug interaction.

INCLUDES: ordered medications interacting with recreational drugs

EXCLUDES: drug interactions due to contraindications (see “medication or other substance contraindicated”)

Expired medication or substance

Patient death or serious injury associated with being given a medication or other substance whose expiration date has passed.

INCLUDES: giving medications or other substances whose expiration date has passed

Generic substitution Patient death or serious injury associated with a generic substitution

EXCLUDES: brand substitutions (see “Brand substitution”), contaminated medications (see “Other medication or other substance event”)

Incorrect directions Patient death or serious injury associated with patient receiving incorrect directions for taking or applying medications.

INCLUDES: directions that correspond to the written prescription if the directions are incorrect; medications taken according to incorrect directions (i.e. directions to cut extended release tablet, or swallow chewable tablet); directions that were accurate, but misunderstood or forgotten by patient (see “Medication taken incorrectly”)

Incorrect dosage form Patient death or serious injury associated with being given a medication or other substance in the incorrect dosage form.

INCLUDES: sustained release instead of immediate release; giving tablet instead of liquid form

Incorrect dose Patient death or serious injury associated with being given a medication or other substance in the incorrect dose (i.e., too much or too little).

INCLUDES: giving too much or too little of a medication or other substance at once; overdose; underdose; extra dose; an error in compounding, mixing, etc. may result in incorrect dose

Incorrect medication or Patient death or serious injury associated with being given a medication or other


substance substance that was not ordered for him or her, or was intended for another patient.

INCLUDES: medication or other substance that was not ordered for patient; an error in compounding, mixing, etc. may result in giving an incorrect medication or substance

EXCLUDES: medication not appropriate to the patient’s clinical situation (e.g., giving a patient with a drug resistant infection a drug in the family to which the infection is resistant) (see “medication or other substance contraindicated”); medications intended for another patient (see “Incorrect patient”)

Incorrect or incomplete labeling

Patient death or serious injury associated with being given a medication or other substance with incorrect or incomplete labeling.

INCLUDES:

EXCLUDES: incorrect patient name on label (see “Incorrect patient”); incorrect directions on label (see “Incorrect directions”)

Incorrect patient Patient death or serious injury associated with medication being given to the wrong patient

INCLUDES: prescription, over-the-counter, compounded preparations

Incorrect quantity, amount or size

Patient death or serious injury associated with being given a medication or other substance in the incorrect quantity, amount or size

INCLUDES: giving 100 instead of 10 oxycontin

Incorrect route Patient death or serious injury associated with being given a medication or other substance through the incorrect route of administration.

INCLUDES: giving a suppository instead of tablet

Incorrect strength or concentration

Patient death or serious injury associated with being given a medication or other substance in the incorrect strength or concentration.

INCLUDES: concentrations that are too high or too low; patient is given an “unmixed” antibiotic that was supposed to mixed with another substance; patches applied that

are the wrong concentration (e.g., Fentanyl patch 25gm instead of 50gm); an error in compounding, mixing, etc. may result in incorrect strength or concentration

Medication or substance contraindicated (includes documented allergies and sensitivities)

Patient death or serious injury associated with being given a medication or other substance they should not have been given for a known, documented reason.

INCLUDES: patient given a medication or other substance, or a prescription for a medication or other substance, they should not have been given for a documented reason regardless of result; drug-drug contraindication; drug-food contraindication; drug-disease contraindication; drug-clinical condition contraindication

Medication taken incorrectly

Patient death or serious injury associated with a medication or other substance being incorrectly taken by the patient

INCLUDES: incorrect patient/family action (e.g., self-administration error)

EXCLUDES: medications taken according to incorrect directions (see “incorrect directions”)

Patient counseling omitted

Patient death or serious injury associated with not providing counseling during a patient encounter

INCLUDES: failure to warn of serious side effects requiring immediate notification of a health care professional

Other Patient death or serious injury associated with a medication or other substance event not otherwise included in the above categories.

INCLUDES: incorrect hard copy of prescription sent home with patient; incorrect preparation; contaminated medications


Appendix IV: Contributing Factor Desc

pharmacy patient safety reporting program data dictionary...2017/12/11 · ncc merp harm categories...

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