Medication Administration F-332 and F-333 : Med Pass and Medication Errors
Robert J. Regan, R. Ph.Pharmacy InspectorHealth Investigation Division Bureau of Health Professions Surveyor, Complaint Investigation Unit Bureau of Health Systems Michigan Department of Community Health 1993-2008
“….Before I speak, I want to say something” -Justice Sandra Day O’Connor, giving a speech in 2001 at the New York University Law School.
Sandra Day O’Connor, David Souter Breyer, Thomas, Ginsberg, Alito Kennedy, Stevens, Roberts, Scalia, Souter
Overview Descriptions of applicable federal regulations and guidance. Significant vs. non-significant errors. Medication pass procedures. Medication error detection methodology. Some curious medication related issues.
F-332 and F-333: Medication Errors §483.25(m ) The facility must ensure that-- F-332 §483.25(m)(1) It is free of medication error rates of 5 percent or greater; and F-333 §483.25(m)(2) Residents are free of any significant medication errors. -CMS State Operations Manual, Appendix PP
CMS: Medication Error Defined Medication Error -- The observed preparation or administration of drugs or biologicals which is not in accordance with: • 1. Physician’s orders; • 2. Manufacturer’s specifications (not recommendations) regarding the preparation and administration of the drug or biological; • 3. Accepted professional standards and principles which apply to professionals providing services. Accepted professional standards and principles include the various practice regulations in each State, and current commonly accepted health standards established by national organizations, boards, and councils. -CMS State Operations Manual, Appendix PP
CMS: Significant Med Error Defined • “Significant medication error” means one which causes the resident discomfort or jeopardizes his or her health and safety. • Discomfort may be a subjective or relative term used in different ways depending on the individual situation. -CMS State Operations Manual, Appendix PP
CMS: Determining Significance “Determining Significance” -- Professional judgment. Three general guidelines: • “Resident Condition”-- For example, a diuretic erroneously administered to a dehydrated resident may have serious consequences, but not with a normal fluid balance. If the resident’s condition requires rigid control, a single missed or wrong dose can be highly significant. • “Drug Category”-- If the drug has a Narrow Therapeutic Index (NTI) , requiring titration to a specific blood level, a single error could alter that level and precipitate symptoms or toxicity. Examples of NTI drugs: Dilantin, Tegretol, Coumadin, Lanoxin, theophylline and lithium . • “Frequency of Error”-- If an error occurred with any frequency, such as omitting a drug several times, as verified by reconciling the number of tablets delivered with the number administered, classifying that error as significant would be more in order. This conclusion should be considered in concert with the resident’s condition and the drug category. -CMS State Operations Manual, Appendix PP
Significant vs. Clinically Significant Bain 1Christine A. Dollaghan 21 Idaho State University, Pocatello2 University of Pittsburgh Bain 1Christine A. Dollaghan 21 Idaho State University, Pocatello2 University of Pittsburgh Bain 1Christine A. Dollaghan 21 Idaho State University, Pocatello2 University of Pittsburgh (-C. A. Dollaghan,University of Pittsburgh) • “Significant ” means an error which causes the resident discomfort or jeopardizes his or her health and safety. (-CMS guidance , F-333, pp381) • “Clinically Significant” (an error that) results in a change in function or comfort that (a) can be shown to result from treatment rather than from natural or other uncontrolled factors, (b) can be shown tobe real rather than random, and (c) can be shown to be importantrather than trivial.
Task 5e Procedures • The medication pass must be conducted on every Initial and Standard survey; and on Partial Extended, Abbreviated Standard and Revisit, as necessary; • • Review for the provision of licensed pharmacist consultation on the initial survey and on any other survey type, if the survey team has identified concerns, • o That the facility does not have a licensed pharmacist; and/or • o That the licensed pharmacist may not have performed his/her functions related to the provision of pharmaceutical services; • • Review pharmaceutical procedures if concerns have been identified regarding the availability of medications; accurate and timely medication acquisition; receiving, dispensing, administering, labeling, and storage of medications; reconciliation of controlled medications ; and the use of qualified, authorized personnel to handle and dispense medications. -CMS State Operations Manual, Appendix P
“You can observe a lot just by watching.“ -Yogi Berra
Task 5e Med Pass Procedures: Observing the medication pass: • Be as neutral and unobtrusive as possible; • Observe different routes and/or forms of medications such as intravenous (IV), intramuscular (IM), or subcutaneous (SQ) injections; transdermal patches; inhaler medications; eye drops; and medications provided through enteral tubes; • Initially observe the administration of at least 20-25 medications, observing as many staff administering medications as possible to facilitate a review of the facility’s entire medication distribution system; • Record, from the medication label, the name and dose/concentration of each medication. Also record the route and the expiration date, if expired; • Record the quantity administered. In the absence of a number, it is assumed to be one; Multiple tablets or capsules of the same medication “count as one observation.” -CMS State Operations Manual, Appendix P
Med Pass Procedures (cont.): • Observe whether staff confirmed the resident’s identity prior to giving medications. • Record the techniques and procedures that staff used to handle and administer medications, such as proper hand hygiene, checking pulses, flushing gastric tubes, crushing medications, route and location of administration (e.g., sub-Q or IM injection, eye, ear, inhalation, or skin patch), shaking and/or rotating, giving medications with or between food or meals, whether medications are under the direct control/observation of the authorized staff; and • Observe whether staff immediately documented the administration and/or refusal of the medication after the administration or the attempt. Note any concerns. -CMS State Operations Manual, Appendix P
Med Pass Procedures (cont.): On Form CMS-677 (The Medication Pass Worksheet), the column marked “Record” is for the purpose of recording the prescriber’s actual order if different than what was observed as administered. -CMS State Operations Manual, Appendix P
Med Pass Procedures (cont.): • Compare observations with prescriber’s orders (Reconciliation).A medication error is the preparation or administration of medications or biologicals that is not in accordance with any of the following: • • The prescriber’s order (whether given incorrectly or omitting an ordered dosage); • • Manufacturer’s specifications (not recommendations) regarding the preparation and administration of the medication or biological; • • Accepted professional standards and principles that apply to professionals providing services; • If one or more errors are found, observe the administration of another 20-25 medications. • Calculate the facility’s medication error rate: Error Rate = (SE + NSE) / Opportunities x 100 Opportunities = Doses given plus the doses ordered but not given. -CMS State Operations Manual, Appendix P
Med Pass Procedures (cont.): • Example. You observed 46 medications administered during the med pass. There were two errors (observed), and then during reconciliation, you find a drug order not transcribed to the MAR and therefore the medication was omitted (3 errors). Error Rate = (SE + NSE) / Opportunities x 100 Opportunities = Doses given plus the doses ordered but not given. SE = Significant Errors NSE = Non-significant Errors
Med Pass Procedures (cont.): • Example. You observed 46 medications administered during the med pass. There were two errors (observed), and then during reconciliation, you find a drug order not transcribed to the MAR and therefore the medication was omitted (3 errors). Error Rate = (SE + NSE) / Opportunities x 100 Opportunities = Doses given plus the doses ordered but not given. Error Rate = (3) / 47 x 100 3/47 = .0638 Rate = 6.4 %
Med Pass Procedures (cont.): • For error rates of 5% or greater (without rounding up), cite F-332. *Previous example was correctly rounded up since it didn’t increase the rate to 5%. • For any significant errors, then also cite at F-333. -CMS State Operations Manual, Appendix P
F333: Non-Med Pass Errors NOTE: If a significant medication error has been identified during the course of a Resident Review, including a complaint investigation, it is not necessary to have observed a medication pass in order to cite a deficiency (at F333). -CMS, SOM, Appendix p, instructions for task 5e.
Med Error Detection Methodology The facility determines who will be passing the medications, not the surveyor. This is especially true for annual surveys.
'The difference between truth and fiction…fiction has to make sense.' -Wilhelm Wexler in The International (2009)
Four examples from the SOMthat the “editorial committee” could revise: SOM Page PP 383-384 (F-332 & F-333 Guidance): Wrong Time Example: Drug Order Administered Significance Digoxin 0.25mg at 8 a.m. At 9:30 am NS Wrong Dosage Form Example: Drug Order Administered Significance Mellaril tab 10mg Liquid Concentrate NS* *If correct dose was given. Wrong Dose Example: Drug Order Administered Significance Digoxin 0.125mg everyday 0.25mg S Omissions Examples (Drug ordered but not administered at least once): Drug Order Significance Motrin 400mg TID NS Comments: SOM Page 388: Count a wrong time error if administered 60 minutes earlier or later than scheduled time, BUT ONLY IF THAT WRONG TIME ERROR CAN CAUSE THE RESIDENT DISCOMFORT OR JEOPARDIZE THE RESIDENT’S HEALTH AND SAFETY. Counting a drug with a long half-life (e.g., digoxin) as a wrong time error when it is 15 minutes late is improper because this drug has a long half-life (beyond 24 hours) and 15 minutes has no significant impact on the resident. If the patient received 10mg of Mellaril, is that an error? This would have to occur multiple days for significance. An omission that causes discomfort may fit the description of significant. -CMS State Operations Manual, Appendix PP
Med Error Detection Methodology Examples of Medication Errors Omissions Examples : Drug Order Significance Haldol 1mg BID NS Motrin 400mg TID NS Quinidine 200mg TID S Tearisol Drops 2 both eyes TID NS Metamucil one packet BID NS Multivitamin one daily NS Mylanta Susp. one oz., TID A C NS Nitrol Oint. one inch S Drugs administered without a physician’s order: Drug Order Significance Feosol NS Coumadin 4mg S Zyloprim 100mg NS Tylenol 5 gr NS Motrin 400mg NS Wrong Dose Examples: Drug Order Significance Timoptic 0.25% 1 gtt OS TID (3 gtts) NS Amphojel 30ml QID (15ml ) NS Dilantin 125 SUSP 12ml (2ml ) S Wrong Route of Administration Examples: Drug Order Significance Cortisporin Otic 4 to 5 QID (Left Eye) S Wrong Dosage Form Examples: Drug Order Significance Colace Liquid 100mg BID (Capsule) NS Dilantin Kapseals 100mg 3 HS Prompt) S Wrong Drug Examples: Drug Order Significance Tums (Oscal ) NS Vibramycin (Vancomycin ) S Wrong Time Examples: Drug Order Significance Percocet 2 Tabs 20 min. before painful treatment 2 Tabs given 3 after treatment S -CMS State Operations Manual, Appendix PP
Med Error Detection Methodology Failure to Follow Manufacturers Specifications or Accepted Professional Standards …The following situations in drug administration may be considered medication errors: • Failure to “Shake Well”: The failure to “shake” a drug product that is labeled “shake well.” This may lead to an under dose or over dose. • Insulin Suspensions: Roll or mix gently…without creating air bubbles. • Crushing Medications that should not be Crushed: Crushing tablets or capsules that the manufacturer states “do not crush.” Exceptions to the “Do Not Crush” rule: • The prescriber orders, with risk-benefit analysis.. • The facility provides literature demonstrating that it’s not a problem. • Inadequate Fluids with Medications: when the manufacturer specifies that adequate fluids be taken with the medication. For example: • Bulk laxatives (e.g., Metamucil, Fiberall, Serutan, Konsyl, Citrucel); • NSAIDs -Adequate fluid is not defined by the manufacturer but is usually 4-8oz. The surveyor should count fluids consumed during meals or snacks (e.g., within~ 30 minutes). • Potassium supplements (solid or liquid dosage forms) should be administered with or after meals with a full glass (e.g., approximately 4 - 8 ounces of water or fruit juice). This will minimize gastrointestinal irritation. & cathartic effect. -CMS State Operations Manual, Appendix PP
Med Error Detection Methodology • Administration without food or antacids when the manufacturer specifies that food or antacids be taken with or before the medication is considered a medication error. • Elderly, debilitated are at greater risk of gastritis and GI bleeds with : Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). • Commonly used NSAIDs are: Motrin, Advil , Indocin, Naprosyn. • Medications Administered via Enteral Feeding Tubes: • Check the placement . NOTE: If the placement is not checked, evaluate under F281 standards of quality. • Flush the enteral feeding tube with at least 30 ml of preferably warm water before and after medications are administered. Failure to flush, before and after, would be counted as one medication error and would be included in the med error rate. • The administration of enteral nutrition formula and administration of Dilantin should be separated to minimize interaction. -CMS State Operations Manual, Appendix PP
Med Error Detection Methodology • Medications Instilled into the Eye: without achieving the following critical objectives: • Eye Contact: The eye drop, but not the dropper, must make full contact with the conjunctival sac and then be washed over the eye when the resident closes the eyelid; and • Sufficient Contact Time: Wait 3-5 min. between drops for optimal absorption. (Systemic effects of eye medications can be reduced by pressing the tear duct for one minute after eye drop administration or by gentle eye closing for approximately 3 min. after the administration.) • Metered Dose Inhalers (MDI): An error if administration doesn’t include the following: • o Shake the container well; • o Position in front of or in the resident’s mouth. Alternatively, a spacer may be used; For cognitively impaired residents, many clinicians believe that the closed mouth technique is easier for the resident and more likely to be successful. However, the open mouth technique often results in better and deeper penetration of the medication into the lungs, when this method can be used; and • o If more than one puff is required, (whether the same medication or a different medication) wait approximately a minute between puffs. • NOTE: Some residents with dementia may require oral dosage forms or nebulizers. -CMS State Operations Manual, Appendix PP
Med Error Detection Methodology • Timing Errors – • Ordered AC and given PC, (or PC/AC) always count as a medication error. • >60 minutes earlier or later than scheduled time of administration, BUT ONLY IF THAT WRONG TIME ERROR CAN CAUSE THE RESIDENT DISCOMFORT OR JEOPARDIZE THE RESIDENT’S HEALTH AND SAFETY. Counting a drug with a long half-life (e.g., digoxin) as a wrong time error when it is 15 minutes late is improper because this drug has a long half-life (beyond 24 hours) and 15 minutes has no significant impact on the resident. The same is true for many other wrong time errors (except AC AND PC errors). • Clarification: The “scheduled” time is flexible on most “Nx/day” orders. If the physician orders a specific time, or med is ordered “q N hours” then not administering the med within 60 minutes of “ordered’ time is counted as an error. • Some med pass assignments are obviously too time consuming for pool or new staff. If several patients are late it is evaluated at F-429 (Pharmacy Procedures). -CMS State Operations Manual, Appendix PP
Med Error Examples. • 1. Resident #A was prescribed Celebrex 100 MG at bedtime (scheduled for 9:00 P.M.). During the med pass observation, the medication was administered at 9:50 A.M. • 2. Resident #B was prescribed Tramadol 50mg one tablet every 6 hours around the clock. According to the MAR the medication was administered at 6:00 A.M. The next dose, scheduled for 12:00 P.M. was given at 10:10 A.M. -CMS State Operations Manual, Appendix PP
Medication Administration Issues • Nitroglycerin Patches-In 1993, nearly every nursing home in Michigan seemed to use these, and virtually all of them were being used continuously. Now, more patients use sustained release Isosorbide Mononitrate (Imdur) tablets---but do not crush.
Medication Administration Issues • Duragesic Patches • Diversion problems. Fentanyl is a highly addictive controlled substance that remains accessible and portable after administration. Even after 3 days, there is reportedly 60% of the drug remaining. • The “gel” type posed addition problems. • Staff should log the patch location and appearance every shift. Tablets might be easier. Variable absorption.
Medication Administration Issues • Insulin administration • Lantus is expensive but can be given once a day in the evening. • Here’s an insulin problem situation. An MAR says: Humulin R Insulin 100 IU/ml 7(am) ----------------------(next page)---------------------- - 8u two times a day 5(pm)
Medication Administration Issues • More on Inhalers • Shake Well • Important: instruct patient to “exhale.” • Wait a minute between puffs. • Clean the mouthpiece and store clean. • Give the bronchodilator first (Albuterol, or Ipatropium before steroids.)
Medication Administration Issues • Dosage calculations (Phenytoin, FeSO4 solution) • Avoid requiring dosage calculations by caregivers at the time of administration. • MAR’s should list # or volume if possible, rather than dose with a concentration or strength.
Medication Administration Issues • Patient identification Obviously, accuracy of med pass begins with the ability to know who the patients are. Procedures must be in place to ensure that patients are systematically identified. Methods include: • Ask the resident their name. • Check the wrist band for name/bar code. • Photo of resident in MAR. • Photo of resident posted at room or bed. • Ask staff who frequently work on the unit.
Resources: www.ismp.org • Do Not Crush List • Error-Prone Abbreviations List • Guidelines for Preventing Med Errors • Confused Drug Name List • High Alert Medications • FDA Safety Alerts • Black Box Warnings.
Resources: • www.fda.gov/CDER/drug/MedErrors • FDA’s Medication Error Information Website • www.ascp.com • American Society of Consultant Pharmacists • www.michigan.gov/healthlicense • 517-373-9196 • Health Regulatory Division, Bureau of Health Professions • www.ahrq.gov • Agency for Healthcare Quality and Research • www.patient safetyauthority.org • Pennsylvania Patient Safety Authority • www.macoalition.org • Massachusetts Coalition for the Prevention of Medical Errors