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welcome to quality assurance for community pharmacies part 2 the system's approach to investigating drug incidents before we begin we would like to acknowledge the assistance of ismp canada for their contributions in developing this presentation which includes material from the 2006 canadian root cause analysis framework the objectives of this presentation are to understand the importance of conducting a thorough analysis of drug incidents drug errors and adverse drug events how systems design and human factors contribute to the potential for air and solution development the process for conducting a thorough incident analysis the importance of using incidents as learning opportunities to prevent future recurrence and how the standards of practice tie in with quality assurance and incident analysis we will use a case example to illustrate the principles and process for incident analysis please keep this in mind as we move through the presentation our case example involves a patient with a prescription for novolin ge 3070 pen fill twice daily via insulin pen the patient obtained an insulin refill and the next morning inserted the new cartridge into the pen a short time later the patient was found sweating profusely his pupils were dilated he had a decreased level of consciousness and his blood glucose was low at 2.5 millimoles per liter more details on this case will follow but for now let us turn our attention to understanding incident analysis incident analysis is a tool used to perform a comprehensive system-based review of critical incidents we would like to emphasize that incident analysis is a system-based review this is important because incident analysis directs attention away from the actions of the individuals and toward the system-based causes of events incident analysis presumes that faulty systems not personal failures are the root causes of events why does incident analysis make this presumption well because accidents result from the sequence of events and tend to fall in recurrent patterns regardless of the personnel involved as such incident analysis seeks to identify root and contributory factors in risk reduction strategies and to develop action plans that lead to system modifications thus preventing future occurrences an important part of incident analysis is the development of ways to measure the effectiveness of action plans to ensure that changes implemented have been successful while the definition of incident analysis sounds like a mouthful it really is quite simple incident analysis has three goals and those are to determine what happened why did it happen and what can be done to reduce the likelihood of a recurrence [Music] how do the three goals of incident analysis assist in ensuring compliance with the standards for the operation of licensed pharmacies well goals one and two or determining what happened and why it happened helped the pharmacy team with reporting investigating documenting and evaluating drug incidents that occur in the pharmacy as per solp 6.3 a further the third goal asking what can be done to reduce the likelihood of recurrence facilitates the review and feedback process that is vital to preventing drug incidents as required by solp 6.3 b note that it is also important for the licensee to implement a process for responding to complaints or concerns as per solp 6.3 c as discussed in part one of the presentation pharmacists and pharmacy technicians are encouraged to use the relate respond toolkit to help them in establishing positive relationships with patients so that they will be less likely to have to respond to complaints later the relate respond toolkit can be ordered from hqca or contact your acp pharmacy practice consultant there is a need to analyze drug errors in order to mitigate future risk a pharmacy team may use incident analysis as the basis for establishing the system policies and procedures that are necessary to minimize the risk of a drug incident or adverse drug event the use of a binder dedicated to drug incident reporting is strongly encouraged it is helpful for the pharmacy team to keep a copy of the quality assurance section of solp standard 6 at the start of the drug incident reporting binder standard 6 in essence functions as a procedure that pharmacy staff can follow when drug incidents arise when drug errors occur the entire pharmacy team not just the pharmacy manager needs to be on board as per solp 6.1 b involving the entire team promotes openness and thoughtfulness the more staff that are actively involved in providing solutions to drug errors the more likely they will be to buy into changes that need to be implemented in spite of everyone's best efforts errors happen in all health care settings when we look at the kinds of incidents that occur repeatedly it is clear that there is something more going on than just the people who were involved for example in september 2006 three babies died in a u.s hospital after heparin ten thousand units were inadvertently administered instead of heparin ten units per milliliter a one thousand fold overdose a little more than a year later the error was replicated in another hospital in a different part of the country fortunately in this case the baby survived the core problem was identified as the look-alike appearance of the two strengths of heparin the incorrect strength had inadvertently been stalked in the neonatal icu by pharmacy staff the manufacturer subsequently changed the appearance of the heparin vial dennis quaid's twins were involved in the second series of heparin incidents he was shocked to learn that medical errors were a common problem in health care and has since become a patient safety advocate he was the keynote speaker at the american society of hospital pharmacists annual clinical mid-year conference in 2009. ultimately the purpose of a critical incident investigation is to prevent a similar event which improves patient safety solp 6.6 supports this through review of drug error reports to determine if any changes are necessary to prevent future drug errors and to assess if the changes implemented by the pharmacy team were successful in improving patient safety incident analysis relies heavily on systems theory and human factors engineering principles in terms of understanding how errors happen and how best to make changes to prevent recurrence the systems approach recognizes that individual practitioners work in an imperfect system and in order to make the system safer it is necessary to look beyond the actions of an individual our culture is shifting in an important way from blaming the involved providers to what david marx has called a just culture that's where practitioners are accountable for their actions within the system not for the way the system was set up sometimes practitioners are set up for heirs by factors that are beyond their control or error prevention that requires unrealistic levels of personal vigilance in a just culture practitioners are expected to practice in a way that minimizes the opportunity for heirs in their own practice and also to proactively identify opportunities for air and bring them forward to the team for discussion and resolution it is important to separate human resources processes such as discipline from a quality of care review discipline is reserved for cases in which practitioners acted with malicious intent or where there is clear negligence if staff involved in the incident believe that information provided to the incident analysis team will be used in a disciplinary forum they are unlikely to be forthcoming with details of the incident or to document the incident this cannot be emphasized enough if the staff do not document their account of the incident for fear of being disciplined the risk of the incident being repeated is increased as it remains uninvestigated and unresolved therefore the threat of discipline rather than improving patient safety outcomes has the opposite effect as david mark suggests disciplining employees in response to honest mistakes does little to improve overall system safety this illustration depicts the sharp end blunt end concept the sharp end is where the care is provided to the patient and while there are many things that may need to be corrected here many contributing factors to heirs have their roots much further back in decisions that impact how care is provided and they're beyond the control of individual practitioners for example some pharmacies are staffed based on the number of prescriptions filled daily however depending on the practice setting and the volume patterns a standard staffing algorithm may not meet the needs of the practice setting the figure shown here illustrates james reason swiss cheese model simply put the holes in the swiss cheese represent weaknesses within our systems and they vary in size and position when these individual weaknesses align an error can occur resulting in patient harm the holes or weaknesses within our practice can be caused by active failures in other words unsafe acts directly linked to the air such as slips lapses mistakes and violations slips can be thought of as actions not carried out as intended or planned for example a freudian slip when saying something lapses are missed actions and emissions in other words when somebody has failed to do something due to lapses of memory and or attention because they've forgotten something for example a pharmacist is tired mistakes are a specific type of air brought on by a faulty planner intention in other words somebody did something believing it to be correct when it was in fact wrong for example a pharmacist making a recommendation for an antibiotic based on an outdated clinical practice guideline when a more recent clinical practice guideline suggests using a different antibiotic violations sometimes appear to be human errors but they differ from slips lapses and mistakes because they are deliberate or illegal for example deliberately failing to follow proper procedures active failures occur at the point of contact between an individual and some aspect of a larger system they are generally readily apparent and almost always involves someone at the front line active failures are sometimes referred to as errors at the sharp end as shown in the previous illustration in other words errors at the sharp end are noticed first because they are committed by the person closest to the patient latent failures are failures of organization or design that may have laying dormant for a long time but have finally contributed to the occurrence of an error in other words accidents waiting to happen latent failures are therefore at the blunt end a common latent failure in pharmacy practice is the lack of regularly reviewed dispensing procedures if for example the licensee has not introduced a procedure for the systematic checking of expiry dates and removal of expired medicines from stock this is one latent failure or a hole in the cheese to compound the risk if the licensee has not introduced a dispensing procedure with a provision for date checking of all medicines at the point of dispensing another latent failure is permitted if on top of this you add an active failure such as pharmacist fatigue an out-of-date medicine may be dispensed resulting in an ineffective treatment and or serious patient harm to sum up each slice of cheese represents an intended barrier to an error the more defenses you put up the better also the fewer holes and the smaller the holes the more likely you are to catch or stop errors before undertaking an incident analysis the team needs to ensure that this is the appropriate tool to use if there is any suggestion that the actions of a practitioner were intentional or in other words to cause harm the incident should be managed using a different pathway there may still be system-based learning but the quality improvement and administrative processes need to be conducted separately team composition is critical to a successful incident analysis it is important to include those who understand how the day-to-day work is done as well as management staff in addition the team should include as many different perspectives as possible a community pharmacy team should include the licensee staff pharmacists pharmacy technicians and pharmacy employees in addition it is helpful to include people who are somewhat unfamiliar with the dispensary processes such as the front shop manager and or customer service staff some incident analysis teams are also starting to include patients or patient representatives on the team depending on the incident the team may also wish to include a physician or other health care provider enough cannot be said about the value of a multi-disciplinary analysis in understanding how an event happened and what changes need to be made to prevent recurrence involving all pharmacy team members and potentially the patient and other health care professionals uncovers new information not previously known by individuals in addition staff who participate in an incident analysis will be the change agents and will support the implementation of recommended actions there is greater acceptance of recommendations when all members of the team are involved incident analysis team selection is aligned with the acp standards of practice for pharmacists and pharmacy technicians which set out who needs to participate in quality assurance processes in the pharmacy both pharmacists and pharmacy technicians are required to participate in quality assurance we would like to emphasize that where a quality assurance program does not exist standard 1.10 specifies that a pharmacist must implement one that meets the minimum standards contained in sol p6 this is important to note as quality assurance is not the sole responsibility of the pharmacy manager rather all pharmacists working in a particular pharmacy are responsible for implementation of a quality assurance program an important aspect of the team approach to drug errors is to ensure that the quality assurance process occurs seamlessly even in the absence of the individual involved in the drug error in the interest of patient safety solp 6.4 b indicates that if the regulated member involved in the drug air is not on duty at the time of discovery the individual who discovers the drug error must initiate the quality assurance process recall the three questions that incident analysis seeks to address the diagram shows how and where they fit into the incident analysis process in order to identify what happened we first need to gather information to determine why it happened we must analyze the information gathered and identify contributing factors in root causes finally we need to develop an action plan in order to reduce the likelihood of recurrence the components of incident analysis are closely aligned with the acp standards for the operation of licensed pharmacies for instance solp 6.4 a requires that any suspected drug errors are investigated and documented within 24 hours of discovery this relates to information gathering and analysis of information and it helps provide answers to the questions of what happened and why did it happen solp 6.4 d requires the drug error documentation include a description of contributing factors and those actions taken to prevent recurrence identification of contributing factors helps to shed light on why the error happened while actions taken to prevent recurrence are part of developing an action plan to reduce the likelihood of recurrence of the drug error solp 6.5 f relates to the development of an action plan to reduce the likelihood of recurrence of the drug error via implementation of changes in practices procedures or staffing note that solp 6.6 through 6.8 are also important standards that relate to the drug air risk reduction action plan and these will be discussed in greater detail later in this presentation returning to the components of incident analysis we will now break down each of the parts into a sub-component which will be discussed and explained the first part of the analysis process is the information gathering step in this step the team takes their initial understanding of the incident and expands it to develop what is called a final understanding in gathering information we need to ask ourselves what sort of things we need to review examples include the prescription and transaction record drug labeling and packaging and the physical environment of the pharmacy additionally it is important to review ismp canada drug error reports to gain insight into how others may have handled similar drug incidents we also need to determine who we should talk to in order to get more information for example those directly and indirectly involved and others familiar with the usual work processes information is often presented in a flowchart format alternatively the team may use the incident report as the initial understanding using our case example involving the insulin-dependent diabetes patient we can develop our initial understanding of the incident patient obtains refill for several boxes of novolin 3070 patient injects insulin patient develops symptoms consistent with severe low blood sugar and reduced level of consciousness patients blood glucose is 2.5 millimoles per liter and is given sugar and food the insulin supply is checked and one box of novo rapid is found when the team has completed interviews and reviewed all the documentation a final understanding or timeline can then be created the figure shown is an illustration of a timeline using our case example by the time we've reached our final understanding we have answered the question of what happened in our diabetes patient when the insulin supply received by the patient was checked four boxes of novolin 30 70 intermediate plus short-acting insulin and one box of novel rapid rapid-acting insulin were found the patient injected the rapid-acting insulin resulting in hypoglycemia now that we know what happened we can proceed to ask why did it happen as you will see the answer to this question is not often straightforward as reasons for incidents are multifactorial and determining why an event occurred it is necessary to consider the system process design workflow and individual accountability for example workarounds to better understand why an error happen we need to understand the interrelationship between the design of our work environment and how we as health professionals interact with that environment human factors engineering is a branch of engineering science that focuses on how we as humans interact with the world around us hf engineers try to design products and processes to fit with our human characteristics so that work flows in a way that feels natural hfe is a fundamental concept to understanding how errors occur and what types of actions will be most effective in reducing recurrence this cartoon demonstrates how we encounter many things in life that are not well designed of course these things show up in our workplaces as well if we take a step back and look at the pharmacy work environment we can typically find examples of things that could probably use some improvement for instance a computer software program may not be designed in a very intuitive manner the dispensary workflow may not be efficient and medications often have look-alike or sound-alike names and similar packaging so why does design matter while some design problems are inconvenient while others may be unsafe let's use dispensary workflow to illustrate an example of a design problem that is inconvenient and potentially even unsafe it is quite commonplace for the majority of patient interaction in the form of pharmacist counseling to occur at the pickup counter meanwhile pharmacy technicians or employees frequently accept prescriptions directly from patients without reviewing the order for appropriateness as only a pharmacist can do pharmacists can relate to the numerous occasions where some crucial piece of information a drug allergy for instance is only discovered once the patient comes to pick up the medication resulting in the pharmacist having to call the doctor to change the medication thus making the patient wait an extra 30 minutes or longer if counseling in other words information gathering happened at the prescription intake counter this information would have been known to the pharmacist at the beginning of the dispensing process thus saving both the patient and the pharmacist's valuable time now imagine if the pharmacist did not remember to confirm allergy history of the pickup counter this could lead to an error that would result in patient harm a change in workflow designed so that pharmacist counsel at the intake counter is not only lean in other words it creates a time savings and efficiency it also improves patient safety a well-designed work environment matters all the more because of a simple reality pharmacies are busy pharmacists often juggle a huge workload they are forced to become multi-taskers they are frequently interrupted by phone calls and patients asking for help with otcs and they are often confronted with technology that just doesn't seem to want to cooperate because our systems and processes have not been designed from an engineering perspective they don't follow a logical sequence in addition our systems often reward efficiency without considering the potential safety implications individual practitioners may take shortcuts or work arounds believing that these efficiencies are improvements or in order to balance a heavy workload without realizing that there are safety implications the bottom line for human factors is that it is about making things more intuitive kim vincent an award-winning canadian engineering professor has written a very readable book about human factors if you find this concept interesting it is a great background resource and is available from login canada we are now going to move into the analysis portion of the incident analysis process we use diagramming to support the analysis diagramming helps to document the process and in addition it acts as a prompting tool moving the team deeper and helping to aid understanding the type of diagram we are going to use is called a tree diagram if you turn it sideways it looks like the roots of a tree basically we start with the harmful outcome we are trying to prevent and work backwards to the underlying or root causes contributing factors identify along the way may be actions something that someone did or conditions circumstances that exist over time a pharmacy example of an action might be a pharmacist checking a prescription while on the phone while a condition would be the distracting environment present in most community pharmacies there are four steps involved in creating the analysis diagrams the first step is to identify the problem or issue to be prevented identification of the problem may require some discussion on the part of the team in order to clearly articulate the issue this is the harm that you are trying to prevent if the patient recovered it will not be the actual outcome for instance in our example of the insulin-dependent diabetes patient the problem statement is acute hypoglycemia step one of the tree diagram is illustrated showing the incident and in this case the patient receiving rapid acting insulin instead of intermediate acting insulin resulting in an outcome of the patient experiencing a hypoglycemic reaction working backwards from the harm or potential harm in the precipitating incident the team asks a series of why and caused by questions to try to understand what the underlying causes were contributing factors may be actions which were momentary and fleeting for example checking a prescription while on the phone or conditions that exist over time such as a distracting environment in developing causal chains the pharmacy team should encourage brainstorming and discussion of all ideas in order to get a complete picture of why the error occurred in step two the team would examine the products and devices involved in the incident in this example we can observe that the outer packaging for novolin 3070 and novo rapid and the cartridges themselves are remarkably similar in appearance in the case example our preliminary causal chain might look something like this step 3 is about fully completing the diagram to understand how the event unfolded this is sometimes called the five levels of why by the time you've asked why did this action or condition cause that for the fifth time you have generally reached the point at which there's no more information available meaning you can't go any further note that in completing the diagram it is generally a good idea to work through one chain at a time once the diagram is complete review it with the group now that the diagram is complete step 4 is about identifying the root causes root causes are shown in yellow for example one of the root causes identified in our case is look-alike packaging in identifying root causes the bottom line is that we always want to ask ourselves if this factor were eliminated or corrected would there be a real chance to prevent a similar event from happening it is important to review the diagram to make sure that this is true for each of the identified root causes once the root causes have been identified we can move to the third goal of incident analysis which is to determine what can be done to reduce the likelihood of recurrence in redesigning the system to decrease the risk of errors we must not only determine strategies to make things safer but also make use of those strategies that will be most impactful or effective in reducing or eliminating recurrence of errors first let's talk about safety strategies there are essentially three strategies to remove or eliminate the hazard to provide safeguards or a control measure and to accept the hazard which is not an option the minimum safety strategy would be a control measure once we know which safety strategies are available to us the next step is to determine which ones will make the most impact in terms of effect the hierarchy of effectiveness is derived from the engineering literature many people are surprised to find education and information at the bottom of the hierarchy because these have historically tended to be the primary actions taken when things went wrong for example explaining why the problems have continued to recur those options for change that will be the most effective are known as high leverage options forcing functions are a type of high leverage change option they are design features that make it impossible to perform a specific erroneous act an example of a forcing function in the community pharmacy setting is the use of a barcode scanning system that does not allow for final verification of a product without a positive match between the selected product and the profiled medication another high leverage option is known as a constraint function a constraint function is a withholding step where a system process makes it improbable to perform a specific erroneous act unlike a forcing function a constraint may still be bypassed by humans an example of a constraint function is the removal of potassium chloride concentrate from patient care areas in hospitals automation and computerization are also high leverage options to improve safety examples include computerized prescriber order entry and automated dispensing computerized prescriber order entry or cpoe is any system in which clinicians directly enter medication orders and increasingly tests and procedures into a computer system which then transmits the order directly to the pharmacy these systems have become increasingly common in the inpatient setting as a strategy to reduce medication errors a cpoe system at a minimum ensures standardized legible and complete orders and thus has the potential to greatly reduce errors at the ordering and transcribing stages systems can be programmed to prohibit ordering medications until vital patient information such as allergies and weight are entered into the system an example of automated dispensing is the use of automated dispensing cabinets or adc's some adc drawers are designed not to open until you correctly enter specific patient information and the pharmacy has reviewed the patient's medication to make sure it is appropriate an example of the usefulness of computerization in patient identification is the potential for a hospital-based barcode-enabled point-of-care system each patient receives a bar-coded identification bracelet the barcode on the bracelet links the patient with their electronic health record each unit dose of medication for both prescription and non-prescription drugs is labeled with a bar code at the time the medication is dispensed for a patient pharmacy staff use a scanner to read the medication's code the computerized database matches this code with the information on the patient's health record to confirm that the correct medication is being dispensed before the medication is administered to the patient the nurse or other health care provider uses a bedside or portable scanner or reader to scan both the barcode on the patient's identification bracelet and the barcode on the label of the unit dose package of the medication to be administered the computer compares information on the patient's health record with information linked to the medication's bar code if there is a match a confirmation is issued and the medication dosage and time of administration are entered automatically into the patient's electronic health record if the information does not match for example an error in patient identification medication dose dosage form or administration time the nurse is alerted by an error message and a possible adverse event is avoided this process allows such near-misses to be captured for analysis so that the institution can address causes in a systematic way medium leverage options include reminders such as differentiation strategies an example is the use of tall man lettering for look-alike and sound-alike medication names labeling particularly that of generic drug manufacturers is notorious for appearing very similar to decrease the likelihood of selection error that often results when medications with similar labels are placed side by side on shelving consider strategies to enhance differentiation for example purchasing different strengths of medications from different manufacturers or purchasing different strengths in different size bottles for example prednisone five milligrams in one thousand or five thousand quantities and prednisone fifty milligrams in quantities of one hundred auxiliary warning labels may also be beneficial for higher strengths of medications available in multiple strengths for example note dose labels on warfarin 10 milligrams to optimize the value of the safeguard focus on look-alike products where selection error is likely to result in harm such as with high alert medications let's move on to the final components of the analysis and the real reason for undertaking it identification of root causes and development of action plans to prevent recurrence once the root causes have been identified it is important to have a way of explaining them to others causal statements are intended to do just that in writing causal statements confirm that the contributing factor is a root cause once again we do this by asking ourselves the bottom line question if this factor were eliminated or corrected would it have prevented the outcome or mitigated the harm if the answer is yes then we can formulate a causal statement around this factor causal statements were developed out of the work of david marks who developed a number of rules of causation his work has been simplified into an algorithm the abc format if the analysis has been done correctly the root causes or antecedent represented by the letter a forms the beginning of the statement the general format is a this set of circumstances b increased or decreased the likelihood that c this set of consequences would or would not occur an example of a causal statement for our insulin case is shown a unclear role definition b increased the likelihood that a student would work outside their skill set in this case selecting the incorrect form of insulin c leading to the dispensing and administration of the incorrect insulin and the resulting acute hypoglycemia a second example of a causal statement from the insulin case would be that a pharmaceutical branding through look-alike packaging b increase the likelihood of incorrect product selection and dispensing of the incorrect insulin c leading to administration by the patient and the resulting acute hypoglycemia now we move into the final stage action development the ultimate purpose of the analysis actions are these specific ways in which the problems identified will be addressed they are not simply recommendations or suggestions actions should be clear and concise provide a long-term solution be objective and there should be a way of assessing their effectiveness once implemented in other words they should be measurable an easy way to remember this when developing an action plan is to think smart set goals that are specific measurable attainable relevant and timely a sample action plan including measurement strategies for our example case is shown here the incident analysis team should provide a summary of all the actions they consider reasonable to correct the identified underlying problems relevant to the event to the owner manager and other senior leaders who may not have been involved in the analysis the senior leadership will then make decisions about prioritization and implementation of recommendations and actions and will determine the allocation of required resources for best success one or two individuals are assigned to implement the actions again it is important to set smart goals and establish a specific time frame for completion of the implementation as it is easy to move on to other projects once the incident analysis has been done using this action plan template facilitates implementation of a smart action plan the role of pharmacy management is critical if the management team has been involved in the analysis they will understand the rationale for the changes that are being proposed it is highly frustrating for a team to be charged with undertaking an analysis only to find out at the end of the process that their findings and action plans are not supported by the leadership in redesigning the system to reduce error recurrence keep the following points in mind permanent fixes are the way to go temporary fixes for example workarounds are not effective and may compound the problem eliminating the step or function that results in the error is a very strong action and it is preferred however it's not always possible to completely remove a step or function so most actions implemented will likely be controls on the system training and policy development while important and necessary are not very strong or long lasting choose higher leverage options where possible examples of actions that might be implemented in our example case include both higher leverage strategies and lower leverage strategies a higher leverage strategy might include implementation of barcode scanning for every item dispensed an example of a lower leverage strategy could include staff education about high alert medications and the need for additional safeguards with such medications having reviewed the utility of incident analysis in quality assurance it is time to put it into action acp has created a template to document drug incidents using the principles of incident analysis while it is acceptable for pharmacies to use their own versions of drug incident reports the acp template has been designed to facilitate pharmacists and pharmacy technicians in meeting the minimum requirements of drug incident documentation as per the standards for the operation of licensed pharmacies therefore pharmacies choosing to use their own reports must at a minimum include all elements of documentation included in the acp template documentation includes patient information incident description initial understanding severity type of incident contributing factors detailed identification of root causes notifications the outcome of the investigation in other words problems identified using causal statements and the actions taken using higher leverage options for change whenever possible and resolution of the problem have the actions taken resolve the problem or problems identified in reporting investigating and evaluating drug errors the standards for the operation of licensed pharmacies gives us directions on how to proceed solp 6.4 indicates that we must be prompt in our response to a drug error by ensuring investigation and documentation of drug errors within 24 hours of discovery ideally the individual documenting an account of the error would be the individual involved in the drug error as they have first-hand knowledge of the incident having said that if the individual involved in the error is not on duty at the time of the discovery it is important that the individual who discovers the error initiates documentation to avoid delays in the quality assurance process use of acp's template for drug incident reporting allows for documentation that can be easily audited and reviewed this documentation must be kept for 10 years from the date of the discovery of the error on the slides that follow you will notice that the acp template allows for documentation of factors that contribute to the error actions taken to prevent recurrence and identification of the nature of the error all requirements of solp 6.4 the illustration shows a sample of a completed drug incident patient safety report based on our case example this section of the form allows for reporting of patient demographics the incident date and discovery date identification of the individual who discovered the incident and the person reporting it a description of the drug ordered and an incident description based on facts known at the time of the incident additional details of the drug incident investigation including root cause analysis findings may be appended to page four of the report page two of the incident report form allows the reporter to document the severity of the incident the type of incident and the factors that contributed to the incident page three of the incident report form identifies those individuals notified of the drug incident including the patient the prescriber the licensee and other regulated health professionals or staff is required it also allows the reporter to document the problems identified using causal statements in the abc format the actions to be implemented by the pharmacy team are also identified here as a reminder the pharmacy team should favor higher leverage change options such as automation or computerization and forcing functions in our diabetes case changing the pharmacy software system setup to allow for scanning of multiple drug packages is an example of a higher leverage change option involving computerization finally it is important that the pharmacy team evaluate whether the change options implemented have resolved the issue to the satisfaction of the patient and patient safety in general always ask has the potential for recurrence being mitigated the last page of the drug incident report allows the pharmacy team to attach any details relating to the investigation of the drug incident including the final understanding timelines and incident analysis findings with causal chains as applicable once investigation reporting and documentation of the drug incident has been completed it is important to share the result of the drug error review with all dispensary staff as per solp 6.8 staff who participate in an incident analysis will be the change agents and will support the implementation of recommended actions it is also important to consider whether there is learning from an incident analysis that can be shared with others in the healthcare community licensees are encouraged to report drug incidents drug errors adverse drug events and so-called near-misses to ismp canada's medication incident and near-miss reporting program many incidents could perhaps have been prevented if learning had been shared outside the organization where the incident occurred pharmacists can play a proactive role in preventing drug incidents both in the pharmacy and through educating other providers and patients about the potential for heirs and medications which require additional precautions due to their narrow therapeutic index high alert drugs are not more likely to be associated with errors but harm is more likely to result if an error occurs the standards of practice provide direction on how pharmacists can work to create safe systems by a quarterly review of drug incidents quarterly review of drug incidents is necessary to ensure changes implemented were successful in advancing patient safety and whether further safety strategies must be implemented to prevent future drug errors the drug incident quarterly review report available from acp's website should be used to document this quarterly review licensees are encouraged to review ismp canada drug air reports as part of their quarterly review in order to gain insight into how to prevent similar errors from happening the licensees quarterly review may identify further changes that need to be implemented having said that the licensee must not wait until their quarterly review to implement these changes if the protection of the public requires immediate action the licensee can help to create a safe system in the licensed pharmacy through development of policies and procedures to minimize the risk of drug incidents the licensee can also ensure that all staff are trained and are required as part of their employment to comply with all systems policies and procedures relating to quality assurance furthermore the licensee can ensure that staff are monitored to ensure compliance with all systems policies and procedures and provide remedial training as required so that staff may become competent patient safety advocates as mentioned earlier use of acp's quarterly review drug incident report template facilitates the development and evolution of safe systems in the pharmacy a sample of acp's drug incident quarterly review report is shown here for each quarter the licensee must document drug incidents and required actions reviewed this may include review of ismp canada drug air reports which may be of value in assisting the licensee to implement any further actions that may be required any significant findings for example repeated incidents of similar errors are there any patterns and further actions implemented and whether those actions resolve the issue the drug incident quarterly review report form is available on acp's website it is important to keep in perspective that healthcare workers are some of the most dedicated professionals in the world incident analysis reminds us that our systems are imperfect and redesign helps to strengthen our processes to reduce reliance on individual vigilance as the primary strategy for air reduction please remember that reporting medication incidents provides an excellent opportunity for others to learn from your experience links for both practitioner and consumer reporting are provided here for your reference thank you for participating in this session on the system's approach to investigating drug incidents you will find incident analysis to be of great value in your pharmacy's quest for continuing improvement and success