Thanks to Anne C. Byrne, RN, Medical Monitor at Northwest Georgia Regional Hospital. This presentation was developed from one she designed for that

Thanks to Anne C. Byrne, RN, Medical Monitor at Northwest Georgia Regional Hospital. This presentation was developed from one she designed for that hospital. 1

Note that an actual variance occurs when an individual DOES NOT receive what has been ordered. When a medication is not signed for and it is discovered more than 24 hours later, it becomes an ACTUAL variance (i.e., omission) as it cannot be verified that the medication was given. If the sign- off is corrected prior to the 24-hour period or there is documentation to support that it was administered in another part of the record, it does not become an actual variance. So check all MARs and individual/patient med drawers after each med pass to be sure nothing has been missed. Potential variances are learning opportunities and verify that the multiple check points have worked and a variance has been stopped before it reached the individual. What happened? How did it happen and how can it be prevented in the future? This is what we hope to learn from the variance reports. When you picked up the most recent physician order, did you check that there were no orders above that had not been signed off? Review each order set you deal with from the point of the last red-line. This will help stop variances at the earliest opportunity. When transcribing, it often helps to read the order out loud to yourself and restate the order out loud as you transcribe it to the MAR. This involves more of your senses in the process and increases your awareness. It improves the focus on the task at hand to help prevent errors. 4

The examples of events on this slide are neither an actual nor potential medication variance because they do not lead to (or risk leading to) an actual medication variance. You still initiate a Medication Variance Report, but your hospital will track these events separately from medication variance episodes. 5

For example, an individual is prescribed a medication for 3 times a day. The nurse did not immediately see the order. Therefore, it did not get transcribed; and the individual did not receive this medication for 2 full days. Although the individual missed 6 doses of the medication, only one medication variance episode occurred. So, you would complete only one Medication Variance Report. 6

Note to Facilitator/Trainer: When going through the next few slides of variance examples, refer to a blank Medication Variance Report for a more complete list of possible types of variances. Follow along in Section 2, letter D. of the form as you are going through these examples. Prescribing: Physicians are human and they make errors. You are part of a team, and the physician is a team member. Be supportive and ask for clarification if an order does not look correct. Look up the usual dosage and usage information. The physicians will appreciate your support if you question them with respect and have the knowledge of the medication to substantiate your question. Transcribing: When transcribing it is NEVER OK to alter what the physician has ordered. It is not OK to transcribe an order that has not been signed by the physician. Do not fax or transcribe an unsigned order. If unsigned it may not be complete. You cannot assume otherwise. Return the chart to the physician or call him/her to obtain the signature. 7

Dispensing: For example, med ordered for twice a day is only provided/dispensed once a day (i.e., wrong frequency). Administration: For example, an IM only med is given PO or a PO med is given IM (i.e., wrong route). A medication is given when there is no valid order or a medication is not given when ordered (i.e., omission). 8

Documentation: It cannot be assumed that a med was given if the MAR is not signed after 24 hours. Sign the MAR as soon as you administer a medication. Do not allow distractions to interrupt this process. Make medication administration your priority when you are assigned to meds. If someone interrupts you, just say- I am documenting medications, and I will be with you as soon as I am finished. Drug Security: In addition to the security of narcotics and the medication rooms, drug security could relate to: meds left at the bedside an employee s personal medication left in a purse or drawer in an unsecured area accessible to individuals drugs d or medications brought in by family or friends Be alert! 9

Ordering/Procurement: The unit does not order and have available, when needed, medication that is usually administered from stock; or the order is transcribed and signed off by the nurse but never faxed to the pharmacy. If an order is not sent, the medication would not be available. 10

Note to Facilitator/Trainer: Refer to a blank Medication Variance Report as you cover the next few slides on reporting. 11

You would also complete Section 1 of the Medication Variance Report if someone else (non-nurse) reports the variance to you. Example: HST reports to you that he saw a pill fall out of an individual s mouth 10 minutes after medication was administered. The more information you can provide at the time the variance is discovered, the more able we are to identify the system or process issues that led to the variance. Example of a description of chain of events: The individual s medication drawer had enough medication for 3 times a day dosing. The MAR I was looking at said it was to be given daily at Hour of Sleep. What was the individual supposed to get? I then looked at the label on the bag containing the medication and it read 3 times a day. I reviewed the order to verify the MAR. The order was indeed for 3 times a day. The MAR was incorrect. This was incorrectly transcribed 2 days ago. This individual has missed 2 doses for 2 days. We had a new PRN nurse on the unit the day this was transcribed. We were short staffed and there were a bunch of new orders written. Breakdown points=transcribing (wrong frequency) and Administration (wrong frequency). The Critical Breakdown point is Transcribing because it then led to the Administration variance. This is an actual variance as it reached the individual who missed 4 doses of prescribed medication. i Contributing factors: (important to help determine factors that influenced the event) Human Factors: Staffing Issues In the Nursing section: New Employee and Hourly Use critical thinking to identify variance: Does the number of dispensed doses match the doses expected by frequency on the MAR? If not, ask WHY? Does the pharmacy label on the packaging match the MAR? Again, if not ask WHY? Check the physician order. That is the starting point in the process. 12

NOTE: Neither Actual nor Potential - This variance does not involve the individual and does not have the potential to lead to an actual variance (e.g., narcotic sign-out error, narcotic count not documented or failure to have informed consent signed). Episodes that are neither actual nor potential are not considered a medication variance and will be tracked separately by the hospital. Skip to section 2F of the Medication Variance Report. 13

Outcome-Was there an injury? If so, how serious? What is a breakdown point? A single point in the medication process that is directly involved in a medication variance episode. Often, there are multiple breakdown points per medication variance episode. So often, there are multiple breakdown points associated with one Medication Variance Report. Example: The prescriber ss writing is unclear on a once-a-day med order. The pharmacy reads the order as 4 times a day. The nurse reads the order the same way and transcribes it as 4 times a day. The individual then receives the medication 4 times a day. In this example, there were four breakdown points: prescribing, dispensing, transcribing and administering. Contributing Factors What factors led to the medication variance? Corrective Actions - What actions are needed and what actions were taken to correct the problem and prevent future variances? 14

The Medication Surveillance Committee includes nurses, physician representative(s) and pharmacy representative(s). The role of this committee is to look for opportunities to reduce the incidence of medication variances.the committee will review all MVRs for completeness and may send the MVR back to the originator to provide additional information. Critical Breakdown Point - What was the critical breakdown point of the variance (i.e., at what step in the medication process did the variance begin)? Using the example on the previous slide, what was the critical i breakdown point of that variance? The unclear/illegible handwriting of the physician started the variance (prescribing). It then became an actual variance when the individual received more medication than the physician intended. The prescribing critical breakdown point (handwriting) was followed by breakdown points of transcribing, dispensing, and ultimately administration. Asking the physician to clarify at either the pharmacy or nursing checkpoint would have stopped the variance before it reached the individual. Speak up-do not be afraid to ask for clarification. No one wants a mistake to happen but mistakes do happen. We all have to stay alert and support each other to ensure safety for our individuals. Intensive Analysis - An intensive root cause analysis is done for medication variances in which harm occurs to the individual. An intensive analysis may also be done to assess trends and clusters in actual and potential medication variances. 15

Where do the most variances occur; at what point in the process? What is the most common critical breakdown point? What can be done to make that part of the process safer? Small changes can have big impacts. Look at your own process. What can you do to make your process more accurate and reduce the number of variances? If you find something that works, let your Nurse Manager know. It may be something to share across the facility. 16

The nurse does not make notifications to the individual or family. This is the role of the physician. 17

Fault tolerant means there are multiple points where an error can be caught and corrected before reaching the individual. The nurse is at the point of transcription and administration. Administration is the last and most critical checkpoint. THINK! THINK! THINK! If the medication provided does not match the MAR, which one is correct? Double check the physician order. There may have been a transcription variance, or there may have been a dispensing variance at the pharmacy stocking point. For example, a medication transcribed to the MAR as 4 times a day is only provided by the pharmacy as a once-a-day dose. Do not assume you have missing doses for the other 3 doses. Do not borrow from another patient drawer. Check the order to see if it was transcribed correctly. If you have difficulty reading what the physician has written, ask him/her to clarify. When patient safety is involved, it is never OK to assume. If you are unsure of anything or an order seems unusual - CLARIFY! Always double check your work when transcribing an order to the MAR. Transcription is the breakpoint where many variances (errors) occur. This leads to administration variances and places the individual at risk. You are responsible for your actions. Never rush when transcribing orders. If you are tired, you are more prone to errors-if you are fatigued, ask someone else to check your work for errors. When you are administering medications, focus on that as your number one priority. Do not multi-task when performing medication-related tasks. If an interruption is unavoidable, stop the medication-related task and attend to the other task. When you return, start what you were doing from the beginning and review what you have already done to be sure you do not miss a step. 18

THE NON-PUNITIVE REPORTING ENVIRONMENT A. Medication variance episodes are captured with MVRs in an effort to establish trends and patterns, to learn from the analysis of those trends and patterns, and to prevent reoccurrence, thus improving individual safety. B. There must be a non-punitive, supporting environment for all staff to report medication variance episodes. The environment must encourage, and not in any way discourage the reporting of medication variance episodes. C. The Clinical Director or Designee of the Clinical Director is responsible for establishing and maintaining a non-punitive environment, and for educating staff regarding non-punitive reporting. D. Any actions taken to punish staff, instill fear, or otherwise discourage the reporting of medication variance episodes are to be reported to the Clinical Director or to the Designee of the Clinical Director. E. The non-punitive reporting environment does not apply where there is intent to cause individual harm. 19

According to the World Health Organization, this is the definition for an Adverse Drug Reaction. (Adverse Drug Reaction Reporting and Intensive Review of Serious or Lethal Adverse Drug Reaction, DBHDD Policy # 03-524, Effective Date: September 1, 2013) The term noxious means: physically harmful or destructive to living beings. We will focus on those reactions that t are undesirable and unusual. Lt Let s use Benadryl as an example: Sleepiness from Benadryl is not the desired effect for an allergic reaction; but we are well aware of it, and it causes no harm. Unless it is excessive, it would not require reporting. An individual is given 25mg of Benadryl for a rash and is difficult to arouse for over 4 hours. This is unusual and excessive and would be reported. 21

This is why we do the AIMS assessment and blood work for certain medications. New onset of these symptoms is reportable. Acute events requiring Stat or Now doses of drugs such as Cogentin would trigger an Adverse Drug Reaction Report. 22

This is a very serious, life threatening, condition that requires immediate medical intervention. *DIC Disseminated Idiopathic Coagulopathy (inability to clot and stop bleeding) 23

Many people take these drugs, not just individuals in state hospitals. It is not just individuals who can have adverse drug reactions. Any of us can. So, we need to be alert at home as well as at the hospitals. 24

Onset usually occurs within a few hours of taking a new drug or increasing dosage of a current drug. The potential for problems is increased if you combine more than one medication with the potential to cause the syndrome. 25

Issues of adverse drug reaction are a large part of the first dose monitoring effort. Observing an individual s response to a new drug can provide opportunity for early intervention. 26

Baseline height, weight and waist measurement and regular follow-up measurements are important in recognizing the onset of this syndrome. 27

Has the individual been started on a new medication or had a dosage change? Has there been a PRN med given that is new? Be prepared to answer these when you speak to the MD. Individual patient s needs always come before the paperwork. Be sure the individual is stable; then complete Section 1 of the ADR form. 28

Note to Facilitator/Trainer: Refer to a blank Adverse Drug Reaction Report form when reviewing this slide. EXAMPLE OF THE PROCESS Section 1: completed by the discovering practitioner Document-Date and time first observed:12/3/10 @12:30 PM Describe the Suspected ADR: Mr. Jones has received a first dose of a new antibiotic approximately 1 hour ago. During first dose monitoring he is verbalizing that his tongue feels swollen. His face is flushed and appears puffy. He denies experiencing any other symptoms such as difficulty swallowing or breathing. Before medical/pharmacy/nursing interventions: As the medication nurse, I notify my charge nurse of my observations and obtain vital signs. The Charge nurse calls the physician. A nurse is assigned to stay with and observe this patient while the physician is contacted. Mr. Jones is asked to let the nurse know if he has any difficulty swallowing or breathing or any other symptoms while waiting for the physician/aprn to arrive. (Ensure a crash cart available in case the reaction progresses). Charge Nurse contacts the physician/aprn and provides the nursing assessment and the individuals medication information as well as the suspicion of a reaction to the new antibiotic. If the individual has other allergies provide this information also. Document your observation, actions and interventions in Section One. Have a copy of the individual s MAR available for the physician/aprn to attach to the ADR form. Document the drug you believe is implicated in the reaction Interventions by medical/pharmacy/nursing: Physician/APRN comes to assess the patient and orders a now dose of Benadryl. Benadryl is administered by the medication nurse and the patient remains under observation with appropriate reassessments until the reaction subsides. 30

Section 2: The physician/aprn will review the individual s MAR, document their findings and score the ADR on the Probability Rating Tool on attachment A. The physician/aprn determines if this drug needs to be included on the individual s allergies list. If so, an order is submitted to pharmacy indicating the drug (s) implicated in the reaction to and the type and severity of the reaction. A physician/aprn order ensures this becomes part of the patient record. The outcome of the reaction is indicated on the ADR form. Section 3: The report is sent to the Clinical Director s office along with a copy of the MAR. 31

The physician must complete his/her portion. Reports are subject to a next-level review, and findings are reviewed in various committees (Pharmacy and Therapeutics; Medical Executive Committee). Tracking and trending of the occurrences and outcomes is done and reports are analyzed for opportunities for improvement. The focus is on improving how we do things to reduce risk and improve care of individuals. When it comes to Adverse Drug Reaction Reporting, it is individuals, co-workers, friends, families and ourselves that benefit. Information obtained in hospitals is used in identifying issues with drugs. If problems are not reported, drug safety is compromised for everyone. 32

Note to Facilitator/Trainer: Section E was added to the Procedure section of the Adverse Drug Reaction Reporting and Intensive Review of Serious or Lethal Adverse Drug Reaction, DBHDD Policy # 03-524, Effective Date: September 1, 2013. Hospitals routinely monitor the reporting of adverse drug reactions in order to identify any needed improvements in the reporting processes, as well as any training that may be needed. 33