Pharmacy Foundations Part 2 PDF

PHARMACY FOUNDATIONS PART 2 CHAPTER CONTENT Background Medication Errors System- Based Causes 988 988 988 989 Response 989 . . . . Reporting • •Organizations that Specialize in Error Prevention 989 990 Evaluation and Quality Improvement ... 990 The joint Commission (TjC) .. National Patient Safe...

PHARMACY FOUNDATIONS PART 2 CHAPTER CONTENT Background Medication Errors System- Based Causes 988 988 988 989 Response 989 . . . . Reporting • •Organizations that Specialize in Error Prevention 989 990 Evaluation and Quality Improvement ... 990 The joint Commission (TjC) .. National Patient Safety Coals 990 Select National Patient Safety Coals 990 Methods Reduce Medication Errors 991 to Common Avoid "Do Not Use" Abbreviations 991 Tall Man Lettering 991 Do Not Use Abbreviations .... . 991 991 High Alert Drugs Medication Therapy Management 992 Medication Reconciliation . 992 Indications and Proper Instructions 993 on Prescriptions 993 Use of The Metric System Do Not Identify Medications Based on 993 Packaging Alone Avoid Multiple - Dose Vials 993 Safe Practices For Emergency Medications / Crash Carts 994 Dedicate Pharmacists To High Risk Areas 994 994 Monitor for Drug-Food Interactions Education 994 Five Rights of Medication Administration 994 Use of Technology and Automated Systems 995 Computerized Prescriber Order Entry and Clinical Decision Support 995 Barcoding... 995 Automated Dispensing Cabinets . 995 Patient Controlled Analgesia Devices 9% Infection Control in Hospitals 9% Common Types of Hospital- Acquired 9% ( Nosocomial) Infections Universal Precautions to Prevent Transmission 997 Catheter -Related Bloodstream Infections 997 Hand Hygiene... 997 Safe Injection Practices 998 Sharps Disposal 998 ' * ** * • « • — CHAPTER 76 MEDICATION SAFETY & QUALITY IMPROVEMENT BACKGROUND A study from the Institute of Medicine (IOM ) , To Err is Human (1999 ) , increased awareness of the prevalence of medical errors. This study found that up to 98,000 Americans die each year in U.S. hospitals due to preventable medical errors, 7,000 from medication errors alone. These numbers understated the problem because they did not include preventable deaths due to medical treatments outside of hospitals. Since the release of the IOM study, there has been a greater focus on the quality of healthcare provided in the U.S. The Joint Commission (T]C) and the Institute for Safe Medication Practices (ISMP) are two organizations actively involved in improving medication safety. MEDICATION ERRORS The formal definition of a medication error developed by the National Coordinating Council for Medication Error Reporting and Prevention ( NCC MERP) is "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer.” This can include errors made in prescribing, order communication , product labeling and packaging, compounding, dispensing, administration, education and monitoring. Do not confuse medication errors with adverse drug reactions ( ADRs). ADRs are generally not avoidable, although they may be more likely to occur if the drug is given to a patient at high - risk for certain complications. Refer to the Drug Allergies & Adverse Reactions chapter for a discussion of ADRs. A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or risk thereof. When a sentinel event occurs, it is important to find out what went wrong and implement measures to prevent it from happening again. CONTENT LEGEND t ; * Study Tip Cal 18 SYSTEM- BASED CAUSES Experts in medication safety agree that the most common cause of medication errors is a problem with the design of the medical system itself , not usually an individual making an error. Instead of blaming the ist ” or the "lazy technician” ( or the prescriber ) , RxPrep Course Book | RxPrep 02019, RxPrep 02020 healthcare professionals should find ways to improve the system. Errors will always occur, but the goal is to design systems to prevent medication errors from reaching the patient. Some "at risk" behaviors that can compromise patient safety are included below. ERRORS OF OMISSION AND COMMISSION Error of Omission Something was left out that is needed for safety Example: failing to warn a patient about an important side effect with a new medication AT- RISK BEHAVIORS THAT CAN COMPROMISE PATIENT SAFETY Error of Commission Drug and Patient- Related Failure to check/reconcile home medications and doses Example: prescribing bupropion to a patient with a history of seizures Something was done incorrectly Dispensing medications without complete knowledge of the medication Not questioning unusual doses REPORTING Not checking/ verifying allergies Medication errors, preventable adverse drug reactions, hazardous conditions and "close calls" or "near misses" should be reported. Medication errors are reported to the appropriate bodies so that changes can be made to the system to prevent similar errors in the future. Without reporting, these events may go unrecognized and will likely happen again because others will not learn from the incident. Communication Not addressing questions/concerns Rushed communication Technology Overriding computer alerts without proper consideration Not using available technology Work Environment Trying to do multiple things vs.focusing on a single complex task Inadequate supervision and orientation/ training RESPONSE Institutions should have a plan in place for responding to medication errors. The plan should address the following: Internal notification: who should be notified within the institution and within what time frame? External reporting: who should be notified outside of the institution? Disclosure: what information should be shared with the patient /family? Who will be present when this occurs? Investigation: what is the process for immediate and long term internal investigation of an error? - Improvement: what process will ensure that immediate and long- term preventative actions are taken? EXAMPLE OF AN ADR (NOT A MEDICATION ERROR ) A 55 - year- old female has a history of herpes zoster. She has no other known medical conditions. The patient reports considerable "shingles pain” that "runs from my back through my left breast." She received a prescription for pregabalin. The patient returned to the clinic with complaints of ankle swelling, which required drug discontinuation. This problem would not be attributable to a medication error made by the prescriber of pregabalin or by the pharmacist who dispensed it. Rather, this is a side effect that can occur with the use of this drug. In a pharmacy, the staff member who discovers the error should immediately report it using the established reporting structure to the appropriate office (e.g., corporate office, the owner of an independent pharmacy, designated hospital office). Many state boards of pharmacy require quality assurance programs to promote pharmacy processes to prevent medication errors. Error investigations need to take place quickly (often as soon as within 48 hours of the incident ) so that the sequence of events remains clear to those involved. Many states mandate the ethical requirement that errors be reported to the patient and the prescriber as soon as possible. Many medication error reporting systems within hospitals are electronic; however, some hospitals still maintain a paper reporting system. The hospital's Pharmacy and Therapeutics ( P&T) committee and Medication Safety Committee (or similar entity ) should be informed of the error. ORGANIZATIONS THAT SPECIALIZE IN ERROR PREVENTION Organizations that specialize in error prevention can analyze the system - based causes of errors and make recommendations. The ISMP National Medication Errors Reporting Program ( MERP ) is a confidential national voluntary reporting program that provides expert analysis of the system causes of medication errors and provides recommendations for prevention. Medication errors and close calls can be reported on the ISMP website ( www.ismp.org). Professionals and consumers should be encouraged to report medication errors using this site even if the error was reported internally. When there are _ 76 I MEDICATION SAFETY & QUALITY IMPROVEMENT many reports of a particular error, the manufacturer may be required to take measures to increase safety (e.g., REMS program , name change, packaging change) . met. These will be included in the institution's protocol. The Study Tip Gal and text describe some of the most important 2019 hospital NPSGs related to medication safety. Every pharmacist should make it a practice to read medication error reports and use the information to improve their own NPSG 03.05.01: Reduce the likelihood of harm associated anticoagulant therapy practice setting. EVALUATION AND QUALITY IMPROVEMENT A root cause analysis ( RCA ) is a retrospective investigation of an event that has already occurred which includes reviewing the sequence of events that led to the error. The information obtained in the analysis is used to design changes that will hopefully prevent future errors. The RCA can be of great value in capturing both the big picture perspective and the details of the error. Targeting corrective measures at the identified root cause is the best way to prevent similar problems from occurring in the future. A single intervention is not likely to prevent all future errors. Thus, RCA is often considered to be a repetitive process, and is frequently viewed as an important continuous quality improvement (CQl ) tool. An analysis can also be done prospectively to identify pathways that could lead to errors and to identify ways to reduce the error risk . Failure mode and effects analysis ( FMEA ) is a proactive method used to reduce the frequency and consequences of errors. FMEA is used to analyze the design of the system in order to evaluate the potential for failures, and to determine what potential effects could occur when the medication delivery system changes in any substantial way or if a potentially dangerous new drug will be added to the formulary. , There are many important elements to this goal including the requirements to use standardized dosing protocols and programmable pumps for heparin and to provide education to patients and families. Protocols should include starting dose ranges, alternate dosing strategies to address drug-drug interactions, communication with the dietary department to address drug-food interactions, requirements for a baseline INR , frequency of INR monitoring and monitoring for bleeding and HIT. NPSG 03.06.01: Maintain and communicate accurate patient medication information. This includes medication reconciliation, providing written information to the patient and conducting discharge counseling. The medication name, dose, frequency, route and indication ( at the minimum ) should be confirmed . Refer to the section on Medication Reconciliation later in this chapter. NPSG 07.03.01; 07.04.01; 07.05.01; 07.06.01: Implement evidence- based practices to reduce healthcare associated infections. These include recommendations to prevent healthcare associated infections with multidrug- resistant organisms SELECT NATIONAL PATIENT SAFETY GOALS J Appropriate identifiers: name, medical THE JOINT COMMISSION ( TJC) The Joint Commission on Accreditation of Healthcare organizations (TJC ) is an independent, not -for- profit organization that accredits and certifies more than 17, 000 healthcare organizations and programs in the U.S., including hospitals, healthcare networks, long- term care facilities, home care organizations, office - based surgery centers and independent laboratories. TJC focuses on the highest quality and safety of care and sets standards that institutions must meet to be accredited . An accredited organization must undergo an on-site survey at least every three years and surveys can be unannounced. NATIONAL PATIENT SAFETY GOALS o National patient safety goals ( NPSGs) are set annually by TJC for different types of healthcare settings (e.g., ambulatory care, behavioral health, hospital ) . Each goal includes defined measures called " Elements of Performance" that must be v? NPSG 01.01.01: Use at least two patient identifiers when providing care, treatment and services. record number, date of birth ® Inappropriate non- patient specific identifiers: zip code, physician name, room number **** NPSG 02.03.01: Report critical results of tests and diagnostic procedures on a timely basis. Includes lab and blood culture results: protocols must include acceptable length of time for reporting. NPSG 03.04.01: Label all medications, medication containers and other solutions on and off the sterile field in perioperative and other procedural settings. Numerous errors have been associated with removing medications from their original containers and placing them into unlabeled containers. NPSG 03.05.01: Reduce the likelihood of harm associated with anticoagulant therapy (see text). NPSG 03.06.01: Maintain and communicate accurate patient medication information (see text). NPSG 07.01.01: Comply with the Centers for Disease Control (CDC) hand hygiene guidelines . RxPrep Course Book | RxPrep © 2019, RxPrep © 2020 ( e.g., MRSA, C. difficile, VRE , multidrug- resistant gram negative bacteria ). The elements of performance address care of central lines, bloodstream infections, post -surgical infections and catheter -associated urinary tract infections. up should be labeled with tall man letters ( the letters that are different are tall man ). Here are two examples: COMMON METHODS TO REDUCE MEDICATION ERRORS Using tall man letters, which mix upper and lower case letters, draws attention to the dissimilarities in the drug names. The letters that are upper cases are the ones that are different between the two look -alike, sound -alike drugs. Safety -conscious organizations (e.g., ISMP, FDA, TJC ) have promoted the use of tall man letters as one means of reducing confusion between similar drug names. The FDA's and ISMP's approved tall man lettering information is available at: http:// www.ismp.org / tools / tallmanletters.pdf. AVOID “DO NOT USE” ABBREVIATIONS Abbreviations are unsafe and contribute to many medical errors. TJC standards include recommendations against the use of unsafe abbreviations. The minimum list of "Do Not Use" abbreviations per TJC is shown in the table. ISMP also publishes a list of error - prone abbreviations, symbols, and dosage designations which includes those on TJC's list and many others. All institutions accredited by TJC are required to have a list of abbreviations that may not be used in the facility. This list must include all of the abbreviations from the TJC “ Do Not Use" list, and any additional abbreviations selected by the institution (e.g., those that have resulted in significant errors at the site in the past ). The unapproved abbreviation list should be readily accessible in the institution (e.g., wall charts, pocket cards) . It is best to try to avoid abbreviations entirely. Electronic prescribing can virtually eliminate errors associated with poor handwriting. Despite this, handwritten prescriptions and progress notes are still used in many settings. See Study Tip Gal. DO NOT USE . U u (unit) POTENTIAL PROBLEM USE INSTEAD Mistaken for “0" Write "unit" (zero), the number “4" (four) or “cc" IU (International Unit) . . Q.O.D. QOD. q.o.d., Q.D., QD q.d. qd (daily) , Mistaken for IV (intravenous) or the number 10 (ten) Write "International Unit" Mistaken for each other Write "daily " Write “every other Period after the Q mistaken for “I" and the "O " mistaken for "I" day " Decimal point is missed resulting in a 10- fold dosing error Write X mg MS Can mean morphine sulfate or magnesium sulfate Write "morphine sulfate” MS04 and MgSC> 4 Confused with one another Write “magnesium sulfate” qod (every other day) CeleXA , CeleBREX predniSONE, prednisoLONE Drug dictionaries within computer systems and automated dispensing cabinets (ADC) often have alerts that prompt the provider to confirm that the correct medication is being ordered or withdrawn. For example a warning may appear on the screen of the ADC which will state: “This is DILAUDID . Did you want hydroMORPHONE ? ” to avoid confusion with morphine. DO NOT USE ABBREVIATIONS 0 How often should the potassium be given? Is that 8 or 80 units of Lantus? Coumadin 1or 10 mg? Once daily or four times per day? HIGH- ALERT DRUGS TALL MAN LETTERING Drugs with a heightened risk of causing significant patient harm if used in error, should be designated as high-alert. See the box on the following page for some examples from multiple The settings. patient -care at: “ high -alert" available list is ISMP http:// www.ismp.org /Tools/ highAlertMedicationLists.asp. ISMP's list represents the most common agents that are high risk, but an institution's list may include additional drugs based on experience in that setting. Look-alike, sound -alike medications are a common cause of medication errors. Poor handwriting and similar product labeling aggravate the problem. Drugs that are easily mixed High -alert medications can be used safely by developing protocols or order sets for use, using premixed products whenever possible, limiting concentrations available in Trailing zero (X.O mg) Lack of leading zero ( X mg) Write O.X mg 76 | MEDICATION SAFETY & QUALITY IMPROVEMENT HIGH ALERT MEDICATIONS Acute Care, Community/Ambulatory and/or Long-Term Care Settings Anesthetics, IV or inhaled (e.g., propofol) Antiarrhythmics, IV (e.g., amiodarone) Anticoagulants /Antithrombotics (e.g., heparin, warfarin) . Chemotherapeutics (e.g , methotrexate) Epidural/intrathecal drugs Hypertonic saline (greater than 0.9%) Immunosuppressants (e.g., cyclosporine) Inotropics (e.g. digoxin) . Insulins (e.g., insulin aspart, insulin U- 500) Magnesium sulfate injection Opioids Oral hypoglycemics (e.g., sulfonylureas) Parenteral nutrition Potassium chloride and phosphates for injection Sterile water for injection the institution and stocking high-alert products only in the pharmacy. See an example of safe use precautions for insulin and potassium chloride on the next page. Protocols for high risk drugs increase appropriate prescribing and reduce the chance of errors from inappropriate prescribing. Examples of Safe- Use Precautions DRUG PRECAUTIONS Insulin If U - 500 is stocked, specify conditions under which it is to be used, which product will be stocked (vials and U- 500 syringes vs. pens), and how doses will be supplied Standardize all insulin infusions to one concentration Develop protocols for insulin infusions, transition from infusion to SC and sliding scale orders; use standard orders for management of hypoglycemia Do not use "U" for units; always label with “units" or "units = mL", but never just "mL" Do not place insulin in automated dispensing cabinets; all insulin orders should be reviewed by a pharmacist visual alert to the person pulling the medication. The bin can be labeled with warnings and include materials ( placed inside the bin ) that should be dispensed with the drug (such as oral syringes or MedGuides ) . In the hospital setting, certain drugs are classified as “ high -alert" and these can be placed in bins labeled with dispensing requirements. MEDICATION THERAPY MANAGEMENT Errors may be discovered during a comprehensive medication review ( CMR ) , through the process of medication therapy management ( MTM ). A personal medication record ( PMR ) is prepared , and a medication - related action plan ( MAP) is developed , preferably by a pharmacist -led team. The next steps involve interventions, referrals, documentation and plans for follow - up. Patients targeted for MTM include those with multiple chronic conditions who are taking multiple drugs and are likely to incur annual costs for covered drugs that exceed a predetermined level. Computer databases are used to identify patients with certain high - risk conditions (such as heart failure or uncontrolled diabetes) who are generally using many medications (some systems tag patients taking many chronic medications daily) and assign a pharmacist ( preferably ) to review profiles for proper use. The pharmacist can form a partnership with the patient and prescriber to remedy any issues or lapses. Often, these reviews identify missed therapy such as lack of an ACE inhibitor or ARB in patients with diabetes and albuminuria , missing beta blocker therapy post -MI, missing bisphosphonate therapy with high-dose chronic steroids, and others, since these are easily searchable in databases. A popular MTM initiative is to improve nonadherence in heart failure patients due to the high - rate of ED visits due to decompensated heart failure. MTM is also used to identify cost -savings, by promoting switches to generics or more affordable brands, or by suggesting patient assistance programs or low income subsidies for eligible members. prior to dispensing Potassium Chloride Remove all KCI vials from floor stock; all KCI infusions prepared in the pharmacy Use premixed containers Use protocols for KCI delivery which include indications for IV administration, maximum rate of infusion, maximum allowable concentration, guidelines for when cardiac monitoring is required, stipulation that all KCI infusions must be given via a pump, prohibition of multiple simultaneous KCI solutions (e.g., no IV KCI while KCI is being infused in another IV) Allow for automatic substitution of oral KCI for IV KCI, when appropriate Label all fluids containing potassium with a "Potassium Added’ sticker Any drug that is high- risk for significant harm if dispensed incorrectly can be placed in a medication bin that provides a are often actively involved in documenting home MEDICATION RECONCILIATION Medication reconciliation involves comparing a patient’s medication orders to all of the medications that the patient has been taking ( home medications including OTC and dietary supplements). This reconciliation is done to avoid medication errors such as omissions, duplications, dosing errors or drug interactions. Medication reconciliation (" med rec ” ) was previously done on paper forms, but it is now usually performed within the electronic health record ( EHR ). Prescribers can view sideby-side lists of home medications and ordered medications and address any discrepancies. This process is most effective when complete and accurate information is entered into the patient’s medical record. For this reason, pharmacy nts . RxPrep Course Book | RxPrep © 2019 RxPrep © 2020 medication use and performing medication reconciliation. In many hospitals, admission orders for a patient cannot be entered into the electronic system until medication reconciliation is completed by a physician , pharmacist or nurse. Medication reconciliation should be done at every transition of care in which new medications are ordered or existing orders are rewritten. Transitions of care include changes in setting, service, practitioner or level of care. Common examples are hospital admission, transfer into or out of an ICU and at hospital discharge. This process comprises five steps: 1. Develop a list of current medications 2. Develop a list of medications to be prescribed 3. Compare the medications on the two lists 4. Note discrepancies and make clinical decisions based on the comparison 5. Communicate the new list to appropriate caregivers and to the patient Discharge medication reconciliation is an opportunity for the prescriber to address any of the patient's home medications that were “on hold ” during the hospitalization and which medications used during the hospitalization should be continued when the patient goes home. Discrepancies are addressed and the patient is educated. Though most often discussed in the hospital context, medication reconciliation can be equally important in ambulatory care, as many patients receive prescriptions from more than one outpatient provider and may go to several pharmacies. EXAMPLE OF THE BENEFIT OF MEDICATION RECONCILIATION Ann is an 82- year-old female. Her only medication for the previous ten years has been atenolol 25 mg daily. Ann recently developed influenza She began to have trouble breathing and was taken to . the hospital. It was discovered that Ann had pneumonia and heart failure. She was prescribed lisinopril, carvedilol and furosemide. Ann was discharged to transitional care and received the new medications plus her home medication (atenolol). The consultant pharmacist conducted a medication review to reconcile the medications and, after discussion with the physician, the pharmacist wrote an order to discontinue the atenolol. INDICATIONS AND PROPER INSTRUCTIONS ON PRESCRIPTIONS An indication for use that is written on the prescription (such as lisinopril 10 mg once daily for hypertension) helps pharmacists ensure appropriate prescribing and drug selection. Using the term “as directed ” is not acceptable on prescriptions because the patient often has no idea what this means and the pharmacist cannot verify a proper dosing regimen. Occasionally, this term is used on the bottle along with a separate dosing calendar, such as with warfarin. It would be preferable to write “ use per instructions on the dosing calendar ” since the patient may not understand how to take the medication and may not be aware that a separate dosing calendar exists. USE OF THE METRIC SYSTEM Measurements should be recorded in the metric system only. Prescribers should use the metric system to express all weights, volumes and units. Computer systems generally have a drop-down menu for selecting the correct units (e.g., lb vs. kg) and easily converting between units. It is critical to record the correct units, since many calculations (CrCl or eGFR ) and dosing checks are performed automatically by the EHR system based on the height and/or weight recorded for the patient. With the increasing prevalence of overweight and obesity in the U.S., it is not uncommon to care for patients weighing 100 kg (or more); but serious errors can occur if this weight was intended to be 100 lb. DO NOT IDENTIFY MEDICATIONS BASED ON PACKAGING ALONE Look -alike packaging can contribute to errors. If unavoidable, separate look-alike drugs in the pharmacy and patient care units, or repackage. Never rely on the package to identify the right drug product. Pharmacies frequently have to purchase products from different manufacturers ( and these may look vastly different ) . EXAMPLE OF AN ERROR DUE TO MISIDENTIFICATION OF A CONCENTRATION BASED ON THE PACKAGING The intravenous catheters of three neonates in a NICU unit were flushed with the adult therapeutic dose of heparin (10,000 units / mL) rather than the heparin flush dose of 10 units/ mL. This accident did not result in fatalities although two of the babies required the reversal agent protamine. Three babies died from a similar incident the previous year at a different hospital. The overdose was administered because the nurse thought she was using a lower concentration of heparin. Due to the high-risk associated with heparin overdose, high concentration heparin vials should not be present in patient care areas. Instead, therapeutic doses should be sent by the pharmacy department. AVOID MULTIPLE- DOSE VIALS Multiple -dose vials pose risk for cross-contamination ( infection ) and over -dosing. If used , they should be (ideally) designated for a single patient and labeled appropriately. Discard the remainder when the patient is done with the medication , or is discharged.