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First Published: December 2, 2004

High-Alert Medications:Questions, Answers, and

Safety Tips

1

Acknowledgements________________________________________________________________________ 2

Purpose & Objectives _____________________________________________________________________ 3

Introduction _____________________________________________________________________________ 4

Chemotherapeutic Agents __________________________________________________________________ 7

Safety Tips_____________________________________________________________________________ 7

Electrolytes ______________________________________________________________________________ 8

Safety Tips_____________________________________________________________________________ 8

Heparin ________________________________________________________________________________ 11

Safety Tips____________________________________________________________________________ 11

Warfarin (Coumadin) ____________________________________________________________________ 12

Safety Tips____________________________________________________________________________ 13

Insulin _________________________________________________________________________________ 14

Safety Tips____________________________________________________________________________ 14

Opioids ________________________________________________________________________________ 15

PCA Pump Errors _____________________________________________________________________ 16

Safety Tips____________________________________________________________________________ 18

Routes for Opioid Administration ________________________________________________________ 19

Neuromuscular Blocking Agents ___________________________________________________________ 20

Safety Tips____________________________________________________________________________ 21

Conclusion______________________________________________________________________________ 22

Appendix _______________________________________________________________________________ 23

References ______________________________________________________________________________ 24

Post Test Viewing Instructions _____________________________________________________________ 25

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ACKNOWLEDGEMENTS

RN.com acknowledges the valuable contributions of… …Bette Case, author of High-Alert Medications: Questions, Answers, and Safety Tips. Since 1993, Bette has practiced as an independent consultant to a broad spectrum of healthcare organizations including American Mobile Healthcare, Inc., professional schools, professional organizations, hospitals, disease management companies, managed care organizations, a public health department and providers of continuing nursing education. She works with her clients to assist them in achieving their goals by using educational, competency management and quality improvement strategies. She is also a partner in Clinical Care Solutions, Inc., which focuses its business on improving medication safety. She presents continuing education offerings at a variety of national and regional conferences. She has published on the topics of critical thinking, test construction, competency testing, precepting and career development. She has also written numerous continuing education self-study courses and prepared competence tests for a variety of nursing specialties. She serves on the editorial board of the Journal of Continuing Education in Nursing and on a regional advisory board for Advance Magazines. Prior to establishing her consulting practice, she held leadership positions in the school of nursing and the nursing department at Michael Reese Hospital and Medical Center in Chicago, IL. She has taught nursing students of all levels and college of education students. As a practicing nurse she enjoyed the roles of staff LPN, medical surgical staff nurse, school health nurse and camp nurse. She is an active member of the Nursing Staff Development Organization (NNSDO) and was among the first group of nurses to receive certification in Nursing Staff Development and Continuing Education from the American Nurses Association Credentialing Center (ANCC). She earned her BSN at Syracuse University and her MSN and Ph.D. in educational psychology at Loyola University of Chicago.

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PURPOSE & OBJECTIVES

The purpose of High-Alert Medications: Questions, Answers, and Safety Tips is to introduce the learner to several high alert medications that are considered to have the highest risk to patients. After successful completion of this course, the participant will be able to:

1. Explain why certain drugs and drug classifications are classified as high-alert medications. 2. Give examples of nurses’, pharmacists’ and others’ perceptions of high-alert medications as reported in

a 2003 Institute for Safe Medicine Practices study.

3. Identify important safety precautions when administering chemotherapy agents.

4. Identify important safety precautions when administering electrolytes.

5. Identify important safety precautions when administering heparin.

6. Identify important safety precautions when administering warfarin. 7. Identify important safety precautions when administering insulin.

8. Identify important safety precautions when administering neuromuscular blocking (paralytic) agents.

9. Identify important safety precautions when administering opioids.

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INTRODUCTION

Why are certain medications identified as high-alert medications? High-alert medications have the highest risk for causing injury when misused (JCAHO, 1999). These medications have narrow therapeutic indexes – that is, there is a small difference between a therapeutic dose and a harmful dose. Data collected and analyzed by the Joint Commission for Accreditation of Healthcare Facilities (JCAHO), the Institute for Safe Medical Practices (ISMP), and the United States Pharmacopoeia (USP) have identified the medications most often involved in medication errors that result in injury or death.

High-Alert Medications

Medication or Classification Reason Designated as High-Alert Medication: Improper dose, administration, or monitoring can lead to…

Chemotherapy Agents Serious and fatal results due to the highly toxic nature of these drugs.

Electrolytes Renal dysfunction or failure, cardiac arrest, coma, respiratory arrest, seizures, rhabdomyolosis*, and death.

Heparin Fatal bleeding (from a dose too high) or thrombotic events (from a dose too low).

Insulin Cardiac changes, electrolyte disturbances, seizures, coma and death.

Neuromuscular Blocking (Paralytic) Agents

Respiratory paralysis, muscle paralysis and death.

Opioids Respiratory depression, coma and death. Warfarin Fatal bleeding (from a dose too high) or thrombotic events (from a

dose too low).

*Rhabdomyolosis is an acute, sometimes fatal disease characterized by destruction of muscle tissue.

High-Alert Medications: True or False? Based upon ISMP Survey on High-Alert Medications (2003b)

1. Most nurses and pharmacists indicated that their hospitals considered IV potassium chloride (KCl) and

parenteral chemotherapeutic agents to be high-alert medications and had special precautions in place.

True False

2. Nurses and pharmacists surveyed agreed that IV adrenergic agonists and IV adrenergic antagonists should be considered high-alert medications.

True False

3. Ninety percent of nurses, pharmacists and others responding to the survey identified warfarin (Coumadin) as a high-alert medication.

True False

4. Eighty percent or more of the nurses, pharmacists and others responding to the survey identified only five medications/classifications as high-alert medications.

True False

5. The number of high-alert medications identified by 80% or more of the nurses responding was larger than the number of high-alert medications identified by 80% or more of the pharmacists.

True False

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ANSWERS High-Alert Medications: True or False?

Based upon ISMP Survey on High-Alert Medications (2003 a, 2003b)

1. Most respondents indicated that their hospitals considered IV potassium chloride and parenteral chemotherapeutic agents to be high-alert medications and had special precautions in place.

TRUE: 364 persons were surveyed, including nurses (60), pharmacists (232, and others (72). 90% responded that their facilities identified IV KCl and parenteral chemotherapeutic agents as high-alert medications with special precautions in place. These were the only medications of the 33 classifications and specific medications that more than 80% indicated that their facilities identified as high-alert. Eighty percent responded that IV heparin was considered a high-alert drug by their facilities. The 30 other drugs and classifications on the list were all considered high-alert medications by less than 80% of the respondents’ facilities. 2. Nurses and pharmacists surveyed agreed that IV adrenergic agonists and IV adrenergic antagonists

should be considered high-alert medications. FALSE:

Percentages of Nurses and Pharmacists Identifying the Drugs as High-Alert Drugs

Medication or Classification % Nurses (n = 60)

% Pharmacists (n = 232)

IV Adrenergic Agonists 92% 63% IV Adrenergic Antagonists 81% 43%

3. Ninety percent of nurses, pharmacists, and others responding to the survey identified warfarin (Coumadin) as a high-alert medication.

FALSE: Seventy-three percent of the total 364 respondents classified warfarin as a high-alert medication. Fifty-three percent responded that their facilities treat warfarin as a high-alert medication. Among the nurses (n=60), 59% considered warfarin a high-alert medication. Among the pharmacists (n=232), 75% considered warfarin a high-alert medication. In addition to its narrow therapeutic index and need for close monitoring, warfarin interacts with numerous other drugs, herbal products, and other substances (such as vitamins E and K, and alcohol). 4. Eighty percent or more of the nurses, pharmacists, and others responding to the survey identified only

eight medications or classifications as high-alert medications. TRUE: Respondents identified a total of 8 high-alert medications.

Percentage of Respondents Identifying the Drug as High-Alert

Medication or Classification % of TOTAL (n=364): Nurses (n = 60), Pharmacists (n = 232,) and others (n=72)

Parenteral chemotherapeutic agents 98% Neuromuscular blocking agents 94%

IV potassium chloride (KCl) 96% Hypertonic sodium chloride injection 91%

IV insulin 90% IV potassium phosphate 90%

IV heparin 87% IV thrombolytics/fibrinolytics 82%

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5. The number of high-alert medications identified by 80% or more of the nurses responding was larger

than the number of high-alert medications identified by 80% or more of the pharmacists. TRUE: Eighty percent or more of the nurses considered a total of 14 medications to be high-alert medications; Eighty percent or more of the pharmacists considered a total of 8 medications to be high-alert medications.

Medications or Classifications considered high-alert by 80% or more of the NURSES

Medications or Classifications considered high-alert by 80% or more of the PHARMACISTS

Medication/Classification (e.g.,)

% of nurses

Medication/Classification (e.g.,)

% of pharmacists

Parenteral chemotherapeutic agents 96% Parenteral chemotherapeutic agents 100%IV adrenergic agonists (epinephrine) 92% IV potassium chloride 98%Neuromuscular blocking agents 91% Neuromuscular blocking agents 95%IV insulin 91% Hypertonic sodium chloride injection 94%IV potassium chloride 91% IV insulin 90%Inhaled and IV general anesthetic agents 88% IV potassium phosphate 90%IV potassium phosphate 88% IV heparin 89%IV thrombolytics/fibrinolytics 87% IV thrombolytics/fibrinolytics 82%IV conscious sedation agents (midazolam) (Versed)

86%

Cardioplegic solutions 86%Oral conscious sedation agents – children (chloral hydrate)

84%

IV narcotics/opiates 83%IV adrenergic antagonists (propranolol [Inderal])

81%

IV heparin 81%

The only medication on the list for the pharmacists, but not the nurses, was hypertonic sodium chloride injection which 73% of the nurses considered to be a high-alert medication

The seven medications on the list for the nurses but not the pharmacists are:

Medication/Classification % of pharmacists who considered the medication high-alert

Inhaled and IV general anesthetic agents 75%

IV conscious sedation agents (midazolam) 73% IV narcotics/opiates 70% Oral conscious sedation agents – children (chloral hydrate) 66% IV adrenergic agonists (epinephrine) 63%

Cardioplegic solutions 58%

IV adrenergic antagonists (propranolol [Inderal]) 43%

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CHEMOTHERAPEUTIC AGENTS What is it about chemotherapy that makes it prone to confusion and mix-ups?

Complex regimens Use of brand names, nicknames, abbreviations, and acronyms Dosing by EITHER body weight OR body surface area (BSA) Doses in EITHER mg/m2 OR mg/kg Possible confusion between the TOTAL dose over the course of treatment and the INDIVIDUAL

DOSE for a single treatment.

Why is special training required for RNs who administer parenteral chemotherapy? The drugs can be hazardous to the RN who administers them unless proper precautions are

observed. Safe handling and disposal of the drugs require special procedures. Extravasation is a potential complication that requires specific monitoring. Treatment regimes are complex and require calculations to check and recheck dosages. Fatalities

have resulted from inaccurate calculations and from inaccurate doses and dosing intervals. Special checks and rechecks of the infusion pump are required at specified times. Wrong route has led to fatalities, specifically with vincristine administered intrathecally when the

intended route was intravenous. Knowledge and experience are needed in order to identify orders that are unusual, confusing, or

potentially dangerous.

Safety Tips Follow facility policy and procedure strictly. Assure that orders conform to institutional policy, especially

related to abbreviations, use of generic name, and dosage requirements.

Carefully review facility approved reference material regarding precautions related to administering the drug and monitoring the patient who is receiving it.

Verify the order: dose, route, and schedule. Deviation from commonly used medication administration schedules is common, including lapses of days between doses.

Double check the dose and the schedule for administration. Follow facility policy regarding verbal orders. Do not crush oral chemotherapeutic medication. Crushing

requires the use of a biological safety cabinet and should be performed in the pharmacy.

Follow required special procedures for handling and disposing of drugs.

Assure that supportive medications are ordered if indicated. Assess electrolyte and fluid status on an ongoing basis. Monitor for signs of hypersensitivity or anaphylaxis. Assure that the patient is well informed about the drug, its effects, and the dosing regime. This is

essential upon discharge. Provide written instructions that include information about when and how to contact the healthcare provider. Ask the patient to repeat back the information in his own words to assure understanding. Within the inpatient setting, a well-informed patient can serve as an additional protection against error.

Oncology Nursing Society recommends, and most

facilities’ policies require that only registered nurses who

have completed special training administer parenteral

chemotherapy agents. Therefore, the safety tips are limited to precautions when

administering oral and topical chemotherapy agents to

patients who have cancer, or alternative conditions for

which these agents are prescribed (such as

methotrexate for psoriasis or rheumatoid arthritis).

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ELECTROLYTES

The following electrolytes are considered high-risk medications: Calcium Magnesium Phosphorus Potassium Chloride Sodium Chloride 3% (hypertonic saline)

There’s been a lot of publicity about potassium toxicity. In fact it even figures into the plot of some murder mysteries. What symptoms can I watch for in addition to lab values? Weakness Flaccid paralysis of extremities ECG changes Paresthesias

Confusion Shock Hypotension

Safety Tips For all electrolytes: o Make a habit of checking serum electrolyte values regularly for any

patient who is receiving electrolyte replacement or experiencing loss of electrolytes (e.g., due to vomiting, n.g. drainage, diarrhea).

o Pay careful attention to route – especially to distinguish between IV, IV piggyback, and IV push.

o Pay careful attention to dosage. Clarify any confusion re: milligrams (mg) and millequivalent (mEq).

o Verify both the electrolyte dosage and diluent (amount and electrolyte composition).

o Infuse solutions containing electrolytes using an IV infusion pump. Adhere to maximum hourly dosage limits. Double check programming of the pump.

o Know and monitor for the symptoms of hyper- and hypo- states of electrolytes. Remember that imbalance of one electrolyte may affect another. Serious and fatal imbalances can develop quickly.

o Because electrolytes are administered as salts (i.e., a combination of two electrolytes), there is a potential for imbalance of two electrolytes. Assure that the order names a salt and not only an electrolyte (e.g., “sodium phosphate” rather than “phosphate” – which might be interpreted to mean either sodium phosphate or potassium phosphate.)

o If the latest serum electrolyte results differ greatly from previous results in an unexplained way, it may be prudent to repeat the test before acting on possibly errant findings.

Specific Calcium Tips o Clarify any order that fails to specify the calcium salt. o Administer only orally or IV. Tissue sloughing and necrosis can result from IM or subcutaneous

administration. o If the patient who is receiving oral calcium has diarrhea, monitor carefully as malabsorption may result. o Assess serum phosphorus level. If elevated, calcium phosphate may form and precipitate into the

vasculature causing organ injury. o Assess serum albumin level. o For the patient who is receiving a calcium channel blocker along with a preparation of calcium, assess

blood pressure frequently. Calcium will antagonize the effect of the calcium channel blocker.

According to some sources, IV KCL

results in 12 deaths annually in the U.S.

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o IV administration:

IV push at a rate of 0.7 mEq/min – 1.8 mEq/min (except in cardiac arrest). Cardiac arrhythmias, sinus bradycardia, and cardiac arrest may result from too rapid administration – especially if the patient is also receiving digoxin (Lanoxin).

Monitor for hypotension, dizziness, syncope, flushing, nausea, or vomiting. Assess IV site frequently. Local irritation and necrosis can occur. Administer via a small

needle into a large vein. Do not infuse a calcium salt in the same IV line as phosphate containing solutions (e.g. TPN).

Specific Magnesium Tips o Infuse IV at 1 gram or less per hour. For preeclampsia, 2 grams per hour can be administered by

specially trained personnel. o Monitor renal function. o Administer oral doses with a full glass of water. Oral magnesium can causes diarrhea. o Administer intramuscular doses into a large muscle mass, preferably gluteal. o Oral magnesium salts interact with oral quinolone antibiotics and with tetracyclines, causing decreased

absorption of these antibiotics. Allow one to three hours between doses of oral magnesium and doses of these drugs (e.g., ciprofloxacin, doxycycline).

o Replacement of magnesium may take three to seven days.

Specific Phosphorus Tips o Oral powder packs must be completely dissolved in six to eight ounces of water or skim milk. o Oral doses should be divided into three or four doses per day to avoid cathartic effect. o Different forms and products contain different amounts of potassium and sodium although they may

contain the same amount of phosphorus. Products are not necessarily interchangeable, check the electrolyte content of any product presented as a substitution for what is ordered (e.g., K Phos Neutral contains less potassium and more sodium than Neutra Phos).

o Administer cautiously if calcium level is elevated. Calcium phosphate may precipitate into the vasculature and result in organ injury.

o Monitor level of sodium or potassium if combined with the phosphate the patient is receiving.

Risky Calcium

Interactions between calcium and phosphorus can produce calcium phosphate which precipitates and injures organs.

Calcium content of different calcium salts varies greatly. Calcium chloride is three times as potent as calcium gluconate (Lacy, p. 209).

Low albumin levels cause calcium levels to appear falsely low. Direct measurement of ionized calcium, or estimate of total serum calcium using a formula is recommended (Lacy, p. 209).

Calcium should not be administered intramuscularly, subcutaneously or intravenously into small veins. Severe necrosis and sloughing may result from improper administration.

Orders sometimes fail to specify the dose in mEq, instead stating amps or vials.

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o Monitor serum phosphate levels. Symptoms of hypophosphatemia do not appear until the level is <1 mg/dL.

o For IV administration: Use only when the patient cannot tolerate oral doses. Sodium phosphate is preferable to potassium phosphate in order to avoid hyperkalemia. Dose should be ordered in mMol. Maximum rate 32mMol per 24 hours. Administer in 250 – 500 mL of normal saline or D5W. Administer over six to twelve hours. Rapid infusion can cause toxicity. Monitor plasma concentrations every six hours.

Specific Potassium Chloride (KCl) Tips o Monitor renal function. o Always dilute KCl, never give KCl IV push. o Oral products differ in their action. For example, K-Dur tablets are long acting, but K-Lor powder is

immediately absorbed for rapid effect. o Administer at a rate of no more than 10 mEq per hour peripherally; administer at a rate of no more than

20 mEq per hour via central line. * o Administer IV riders of 40 mEq/100mL via central line as the concentration can cause vein irritation. * o Administer oral preparations with a full glass of water to avoid gastric irritation. Do not crush tablets.

Instruct the patient to swallow tablets whole, without chewing. o Follow guidelines for recommended maximum concentrations of KCl

60 mEq/L – maintenance fluids 20 mEq/100 mL or 40 mEq/250 mL – peripheral line 40 mEq/100mL – central line

o Assess cardiac status. Monitoring may be indicated. o Assess electrolyte levels for both potassium and magnesium:

Serum potassium levels every four hours. Desired level 3.5 mEq/L – 5 mEq/L. Serum magnesium. Desired level 1.6 mg/dL – 2.5 mg/dL. Adequate magnesium levels are

necessary to correct hypokalemia. o Assess IV site for infiltration and phlebitis. KCl irritates the vein.

* Always follow your facility policy regarding any medication administration.

Specific Sodium Chloride (NaCl) 3% (hypertonic saline) Tips o Use should be restricted to initial treatment of acute, serious, and symptomatic hyponatremia. o Administer only via a central line and with an infusion pump. o Maximum rate of infusion = 1 mEq/kg/hour. o Toxicity is directly related to both the rate and magnitude of change in serum sodium levels. Symptoms

are primarily neurologic. o Osmotic demyelinization syndrome is a rare but dangerous adverse effect.

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HEPARIN

What types of errors are most common with heparin? Calculation and dosing errors, due calculating the dose based upon the patient’s weight in kilograms. Vials of insulin and heparin have been stored in close proximity and mistaken for one another. Infusion pump programming errors, e.g. setting a bolus rate and neglecting to reset the pump for a

continuous infusion rate. Heparin lock flush solution is sometimes mistakenly used for heparin therapy. Abbreviations: o The use of the abbreviation “U” for units has been mistaken for a zero, leading to a ten-fold overdose. o The use of the abbreviation “cc” (cubic centimeter) has led to overdoses when mistaken for zeros. The

Institute for Safe Medication Practices (ISMP), the Joint Commission for Accreditation of Healthcare Organizations (JCAHO), the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) advise writing out the word units and using mL rather than cc.

What creates risks with low molecular weight heparin preparations such as enoxaparin (Lovenox)? Low molecular weight (LMW) heparins peak in 3 – 5 hours, remain effective for 12 hours, and have a half-life elimination 2 – 3 times longer than heparin. Serious adverse effects have occurred when heparin was administered to patients who still had active enoxaparin in their systems. LMW heparin units are not interchangeable with units of heparin; not all LMW heparin units are interchangeable. The effects of LMW are not evident in aPTT since LMW heparin acts differently than heparin. LMW strongly inhibits clotting factor Xa and has only a small effect on aPTT. LMW heparin is to be administered only via deep subcutaneous injection.

Safety Tips

Base the dose on a recent and accurate body weight. Assure that the patient is not receiving medications that affect blood clotting or the action of heparin (e.g.,

LMW heparin). Assure that aPTT blood draws occur at the appropriate times (4 – 6 hours after initial dose or dose change). When withdrawing blood from a heparinized central line, withdraw and discard at least 10 mL of blood

before obtaining a sample for clotting studies (for adults). Before adjusting doses on a sliding scale, assure accuracy of the latest aPTT. If the result deviates greatly

from previous results without explanation, an error may exist due to timing of the draw or other issues. Assure that orders are complete and conform to facility policy. Always use an infusion pump for IV administration; use independent double checks to assure accuracy of

both dosage calculation and pump programming. When a bolus is ordered, administer from a vial and not by adjusting the rate of the infusion. Monitor platelets to check for heparin-induced thrombocytopenia. Monitor for obvious bleeding and for subtle signs of bleeding, including shortness of breath, headache,

decrease in blood pressure, weakness, and dizziness. Assure that protamine sulfate, the antidote for heparin, is available.

Report to the physician:

o Signs of bleeding: Gross hematuria Hematoma formation or extension Excessive bleeding or oozing at incision or IV site Hemoglobin decrease of > 2 grams per deciliter (g/dL) or total hemoglobin of < 8 g/dL.

o Platelets less than 100,000mm3 or a decrease of 50,000/mm3

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WARFARIN (COUMADIN)

Why is the patient’s medication profile of critical significance for the patient who is receiving warfarin? More than 150 drugs and numerous other substances, including many over-the-counter drugs and food substances are known to interact with warfarin. Most common reported interactions involve: Acetaminophen – enhanced anticoagulant effects Aspirin – increased bleeding tendency Sulfamethoxazole/trimethoprim (Bactrim, Septra) – enhanced anticoagulation effects Cimetadine (Tagamet, Pepcid)- enhanced anticoagulation effects Ciprofloxacin/levofloxacin (Cipro)- enhanced anticoagulation effects Fluconazole (Diflucan) - enhanced anticoagulation effects Erythromycin/clarithromycin (Biaxin) - enhanced anticoagulation effects Metronidazole (Flagyl)- enhanced anticoagulation effects Nonsteroidal anti-inflammatory drugs (NSAIDs) (Celebrex, Naprosyn) - enhanced anticoagulation effects;

also increases risk of gastrointestinal irritation Levothyroxine (Synthroid) – potentiates effect of warfarin

Other drugs interactions that decrease anticoagulation effects include: Aluminum Hydroxide (AlternaGEL) (by causing decreased absorption) Barbiturates (Amytal, Seconal, Luminal, Nembutal, Tuinal) Estrogens (Premarin, etc.) Carbamazepine (Tegretol) Phenytoin (Dilantin) – may increase or decrease effect

Other drugs interactions that increase anticoagulation effects include: Allopurinol (Zyloprim) Influenza vaccine Isoniazid (INH) Phenytoin (Dilantin) – may increase or decrease effect Propranolol (Inderal) Ranitidine (Zantac) SSRIs (Selective Seratonin Reuptake Inhibitors) (Prozac, Zoloft, Paxil)

In addition, foods and other substances affect warfarin metabolism: Vitamins. Vitamin K is the antidote for warfarin. Vitamin E increases the effect of warfarin. The patient

who takes warfarin should maintain a consistent intake of vitamin K and E. Ethanol. Acute alcohol ingestion decreases metabolism of warfarin, increasing the effect of the drug.

Chronic daily alcohol use increases the metabolism of warfarin, decreasing the effect of the drug. Herbs and Nutraceuticals. Decreased response to warfarin – St. John’s wort, Coenzyme Q10, alfalfa (large

vitamin K content). Increased response to warfarin – cat’s claw, dong quai, evening primrose, feverfew, red clover, horse chestnut, garlic, green tea, ginseng, and ginkgo.

There are many potential and somewhat unpredictable interactions with warfarin. Encourage patients to notify their prescribers of changes in diet or medications. Doses are adjusted regularly based on laboratory studies. Warfarin doses are adjusted based on prothrombin time (PT) and International Normalized Ratio (INR) values. INR is a standardized PT value generated from the PT ratio and the International Sensitivity Index (ISI). Hemoglobin is also monitored to detect bleeding that is not otherwise evident. Normal PT is 10.9 – 12.9 seconds. Therapeutic PT is 1.5 – 2 times the control; therapeutic INR is 2 – 3 depending upon indication. An increase in INR may be observed 36 – 72 hours after administration of warfarin.

Partial thromboplastin time (aPTT) which is used to

monitor heparin therapy is increased by warfarin. This is

a test interaction, however aPTT is not used to monitor

warfarin therapy.

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Safety Tips Be alert for the affects of the patient’s disease condition, treatment or changes in medications or diet during

hospitalization. The elderly and patients who have congestive heart failure or liver disease experience more pronounced effects of warfarin. Warfarin has a narrow therapeutic index. Events during hospitalization can greatly alter a patient’s response to warfarin.

Assess carefully for evidence of bleeding – especially when the patient’s condition may produce bleeding (such as peptic ulcer disease, cancer, and other conditions that produce a heightened risk for internal bleeding).

Assure that warfarin is discontinued in advance of invasive procedures. Call this need to the attention of the physician when the patient is receiving warfarin. Depending upon the patient’s situation, discontinuation of warfarin may be recommended from 3 – 5 days in advance of an invasive procedure.

Maintain consistency. o Because so many substances affect the action of warfarin, any change in medication profile or food

intake (including NPO) may affect the patient’s response. INR should be measured at the time a change is initiated and a few days later, since interaction effects may not develop immediately. The onset of anticoagulation effects occurs 36 – 72 hours after administration and full therapeutic effect is evident in 5 – 7 days.

o Administer warfarin at the same time each day. o Do not administer warfarin with food. o Administer warfarin at a separate time from other drugs. Other drugs may decrease absorption of

warfarin. o Administer warfarin 1 – 2 hours before or 6 hours after cholestyramine or sucralfate, because these

drugs bind warfarin. o Avoid intramuscular injections. o Advise the patient to maintain consistency in dietary intake of vitamin K and in the time of day he takes

warfarin. Verify strength of tablets – tablets of different strength may look alike Inform the patient of the INR result and warfarin dose before administering warfarin. Assure that the warfarin antidote, vitamin K (phytonadione) is available. Educate the patient regarding the need to: o Consult his provider for any indications of bleeding, severe diarrhea (which alters vitamin K absorption)

and in advance of any dental or surgical procedures. Warfarin is usually discontinued 3 days prior to surgery. Depending upon the patient’s risk and INR, discontinuing 4 – 5 days in advance of an intrusive procedure may be recommended. Advise the patient of subtle signs of bleeding such as:

Dark tarry stools Dizziness Weakness Shortness of breath

Decreased urine output Headache Mental status changes.

o Adhere to prescribed doses. And, if a dose is missed, simply resume the next dose, rather than “making it up.”

o Adhere to schedule for PT, INR testing. o Maintain consistent diet and time of taking warfarin. o Maintain a safe environment to decrease the risk for falls and other injuries. o Wear a MedicAlert ID bracelet or necklace (www.medicalert.org).

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INSULIN Why are IV infusions of insulin more potentially dangerous than IV infusions of other drugs? The action of regular insulin administered IV, (the only insulin administered intravenously), has an onset of 15 minutes and peaks in 15 – 30 minutes. Programming errors can have serious or lethal effects in a short period of time. What makes insulin therapy so complicated? Individuals differ in their response to insulin. An individual may require more than one type of insulin. Many factors affect response to insulin, including activity, food intake, concurrent medications, illness,

weight, type of diabetes and other factors. Numerous insulin preparations are available. Know the onset, peak, duration, route, and time of

administration (in relation to meals and bedtime) for the preparations in use in your facility: Rapid-acting insulins (Regular administered IV, lispro [Humalog], aspart [Novolog]) Short-acting insulins (regular administered subcutaneously and via subcutaneous pump) Intermediate-acting insulins (lente, isophane insulin suspension, insulin zinc suspension) Long-acting insulins (ultralente, insulin glargine, extended insulin zinc suspension) Insulin combinations (isophane insulin suspension and regular insulin 70/30 and 50/50; lispro

protamine suspension and lispro 75/25, and aspart protamine suspension and aspart 70/30).

Safety Tips Double check to assure the correct insulin, especially when the patient is receiving more than one type;

names and variations of names can be mistaken for one another. Store insulin and heparin vials separately. Observe recommended abbreviations: units and mL. Know the symptoms of hypoglycemia and hyperglycemia. Know both early and late signs and symptoms. React promptly to blood glucose measurements. Be alert for any circumstances that will cause insulin requirements to vary (NPO, infection, change in

activity, steroid medications, TPN, or other circumstances that affect metabolism). Use only insulin syringes. Perform independent double checks on the vial and dose of insulin. IV administration o Use the insulin line only for insulin. o Always use an infusion pump. o Perform independent double checks of the rate and pump

programming. o Discontinuing the infusion:

Check blood glucose levels one hour prior to discontinuing Administer the first dose of subcutaneous insulin as ordered Continue the infusion for 30 – 60 minutes after the subcutaneous injection to prevent rebound

hyperglycemia. After discontinuing the infusion, check blood glucose levels before meals and at bedtime.

Teach the patient the signs and symptoms of hypoglycemia and hyperglycemia. Instruct the patient to report symptoms. Before administering insulin, always tell the patient: o The most recent blood glucose result. o That the medication is insulin. o The type of insulin. o The dose.

Routes of Administration for Insulin

IV – only regular Subcutaneous pump – lispro (Humalog), aspart (Novolog), regular Subcutaneous – all types

15

OPIOIDS

What assessments, in addition to counting respiratory rate and assessing pain level on a 10-point scale, are important with the patient who is receiving opioids?

Numerical Pain Scale

0 1 2 3 4 5 6 7 8 9 10

Zero Pain Worst Pain Imaginable or experienced

Heart rate and blood pressure Sedation level o S – Sleeping: Normal sleep, respiratory rate more than 8 per minute o 0 – None: Alert, awake o 1 – Mild: Responds to normal voice o 2 – Moderate: Responds to loud voice/shaking o 3 – Severe: Somnolent, difficult to arouse

Location, cause of pain Evidence of allergic reaction Nausea and vomiting Bowel and bladder function Total daily acetaminophen intake (not to exceed 4000 mg per day) – (see Safety Tips) Use of PRN drugs – is a change of drug or dosage indicated? Frequent monitoring – even at appropriate doses respiratory rate, heart rate, and blood pressure may be

suppressed. Careful monitoring during the first 24 hours and at night – hypoxia occurs most frequently during these

times. Assessments with bupivacaine o Blood pressure every hour for the first four hours and every four hours thereafter o Check for orthostatic hypotension prior to ambulation o Check strength and sensation in the lower extremities every two hours while awake for the first 24

hours. 0 – Normal strength and sensation 1 – Weak, but able to bend knees and ankles, normal sensation 2 – Unable to bend knees, normal sensation 3 – Unable to move legs, decreased sensation

Modified from McCaffery, M. & Pasero, C. (1999). Pain: Clinical Manual, (2nd ed.). p. 63. St. Louis: Mosby.

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PCA Pump Errors What can we learn from a fatal error involving a patient-controlled analgesia (PCA) pump?

The Fatal Error (ISMP, 2004a) The MD ordered “fentanyl PCA per protocol” Protocol o 50 mcg/mL concentration o 10 mcg demand dose o 6 minute lockout interval o Clinician boluses of 20 mcg every 5 minutes X 3, repeat every 4

hours as needed The nurse scrolled through a wide range of numbers to select the concentration. Accidentally, she

programmed 1 mcg/mL instead of the actual concentration of 50 mcg/mL. Then the nurse programmed the demand dose of 0.10mcg instead of the ordered demand dose of 10 mcg.

Two nurses were present when the nurse began programming the pump, but the other nurse left to take a telephone call. When the second nurse returned, the nurse read the settings, but the programming errors were missed.

Because of the programming errors, the patient was receiving only half the intended dose. (Programmed for 1 mcg/mL, although the actual concentration was 50 mcg/mL AND programmed for 0.10 mcg demand dose instead of 10 mcg. Therefore, the patient received 0.1 mL of the 50 mcg/mL concentration with each demand dose, or 5 mcg.)

The patient continued to complain of severe pain. The nurse on the next shift administered a 20 mcg bolus. She programmed the bolus dose correctly, but because the pump was programmed for a 1 mcg/mL concentration, the patient received 20 mL of the 50 mcg/mL concentration – a dose of 1,000 mcg. The patient was found unresponsive 15 minutes later, was transferred to ICU and died three days later.

In another serious error at the same hospital, the nurse programmed the correct settings, but failed to press “Enter” within a short period of time. The pump

therefore defaulted to a prior setting. The patient received an overdose resulting unresponsiveness and poor respiratory effort. These symptoms were thought to be

caused by post-operative hemorrhage and the patient was returned to the OR. When hemorrhage was ruled out, a seizure was suspected to have caused the symptoms. The patient recovered in ICU. It was only during investigation of the fatal event

that the cause of the second situation was recognized.

Avoid trailing “zeros” (0 after a decimal point).

The new JCAHO National Patient Safety Goals

prohibit trailing zeros in medication orders or

transcription.

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Lessons Learned (ISMP, 2004a):

Limit choices of drugs per PCA. Restrict fentanyl use to anesthesia or pain management team members only.

Improve access to information. Provide a quick reference sheet for nurses, including programming tips and maximum dose warnings for all medications administered per PCA.

Improve label readability. Match sequence of information on PCA medication labels with the sequence of information to be programmed and the sequence required in protocols, orders and other documentation. Highlight the concentration.

Program default settings. Fully employ the safety features of the pump, including programming default values for each concentration, locking out inappropriate ranges for concentrations not in use. Set zero as a default to force entries if only one default setting is allowed. Determine whether the pump can be set for maximum dose or maximum volume per drug. Assure that biomedical checks are performed on PCA pumps. Alert staff members to situations that will trigger default settings.

Introduce new pumps slowly. When a new pump is introduced, limit use to a small, controlled setting to identify any problems and assure that safety features are operational.

Suspect a problem. If the patient is not responding, re-verify all possible sources of error or pump malfunctions before administering a clinician bolus dose.

Employ independent double checks. Define a clear independent double check process. Employ smart pumps and bar code technology where available, but do not solely on technology.

Additional PCA Safety Recommendations (Husch, et al., 2004):

Educate the patient preoperatively. Emphasize the importance of ONLY the patient pressing the button (not relatives or other visitors). Change tubing when concentration or medication is changed. Always use PCA with maintenance IV fluid. Clear the pump history only for medication changes. Standardize concentrations throughout the facility. Color code different concentrations.

Additional Precautions for patient-controlled epidural analgesia (PCEA) pumps (Husch, et al., 2004):

Perform independent double checks by two RNs: check and verify PCEA pump settings at the time of initiation and change in dose, medication, concentration, or medication cartridge.

The pain medication ordered per PCEA should be the only medication administered via the PCEA line Question an order for PCEA for patients who are receiving low molecular weight heparin or fibrinolytic

therapy. PCEA is contraindicated for these patients. Observe bolus dose precautions o Remain at the bedside during and for 5 minutes after the bolus dose o Administer a maximum bolus volume less than or equal to the current hourly rate of infusion

Maintain a closed system after discontinuing the infusion. The epidural catheter may be left in place after the infusion is discontinued. A lock is placed at the distal end of the catheter. The line does not need to be flushed since the epidural space is free space and not prone to clotting.

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Safety Tips Refresh your knowledge about pain management, addiction, tolerance, and dependence. Many people have

experienced pain unnecessarily because of misunderstandings. Learn equianalgesic equivalents and question orders that provide inadequate pain control or toxic doses.

(See the Appendix for Equianalgesic Scale.) Pay careful attention to orders. Avoid dangerous assumptions. Sound-alike opioids, varying concentrations

and inappropriate routes of administration contribute to many opioid errors. Assess allergies. Allergies have played a role in many patient injuries from opioid administration. Assess medication profile for concurrent opiods. Institute bowel regime to prevent constipation. Particularly in the elderly patient, constipation can create

intense discomfort and serious problems. Prevent acetaminophen toxicity. Hepatotoxicity due to acetaminophen has proven fatal in patients who

received excessive doses of combination drugs. Total daily dose for adults with normal liver function should not exceed 4000 mg per day. Be alert for concurrent orders of more than one drug containing acetaminophen.

Trade Name Opioid Content Acetaminophen Content

Darvocet N-100 Propoxyphene 100 mg 650 mg Norco Hydrocodone 10 mg 325 mg Percocet-5/325 Codeine 5 mg 325 mg Tylenol None 325 mg Tylenol Extra Strength None 500 mg Tylenol #3 Codeine 30 mg 300 mg Tylenol #4 Codeine 60 mg 300 mg Vicodin Hydrocodone 5 mg 500 mg Vicodin Extra Strength Hydrocodone 7.5 mg 750 mg

Keep up-to-date with opioid information. For example, in June 2004, the FDA released additional label warnings associated with oxycodone with aspirin combination (Percodan, Percodan-Demi) tablets. Newly added contraindications include (Waknine, 2004):

Children or teenagers with viral infection with or without fever due to the risk of Reye's syndrome associated with use of aspirin in certain viral illnesses.

Patients with allergic reactions to nonsteroidal anti-inflammatory drugs. Patients with the syndrome of asthma, rhinitis, and nasal polyps because it can cause severe

urticaria, angioedema, and bronchospasm. Patients with known oxycodone sensitivity. Patients with significant respiratory depression in unmonitored settings or in the absence of

resuscitative equipment. Patients with acute or severe bronchial asthma or hypercapnia. Patients with suspected or known paralytic ileus.

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Routes for Opioid Administration Note: IM administration is not recommended due to highly variable absorption. Recommended routes: oral, transdermal, rectal, IV, subcutaneous, epidural, and intrathecal.

Route Special Precautions

Oral

Do not crush or split sustained-release preparations Be alert for similar trade names:

Oxycodone (OxyContin) and morphine (MS Contin) are long-acting drugs.

Oxycodone (Roxicodone) and morphine (Roxanol) are immediate-release preparations. Roxanol is a liquid.

Examine labels carefully: oral liquids are prepared in various concentrations.

Transdermal

Remove old patches prior to placing new ones. Affix to flat body surfaces such as back or chest. Document time and site on MAR. Monitor body temperature. Fever or excessive warmth

increases drug absorption and can lead to overdose.

IV See also PCA and PCEA recommendations

Contact pharmacy to clarify any potential incompatibilities with IV fluids.

Verify concentration on pharmacy label. Perform independent double checks of continuous infusion rate

calculations. Before adjusting hourly infusion rate, consider total usage

including boluses over at least the previous 12 hours. More bolus doses may be needed in the first few hours to achieve a steady state; adjustment based on only first few hours might lead to overdose.

Reserve continuous IV infusion for long-duration pain. For sporadic or episodic pain, use bolus doses rather than

increases in the rate of a continuous infusion.

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NEUROMUSCULAR BLOCKING AGENTS

What is the proper use of neuromuscular blocking agents in intubation? Neuromuscular blocking agents are used to paralyze skeletal muscles as an adjunct to general anesthesia and tracheal intubation. Because the agents provide no sedation or pain relief, the patient should receive appropriate sedation/analgesia and experience the effects prior to administration of a neuromuscular blocking agent. The neuromuscular blocking agent should be discontinued before the patient is extubated. The agent atracurium was administered instead of vancomycin in the incident reported in the news story below. Although the error was not caused by a sound look-alike name, the neuromuscular blocking agent, vecuronium might also potentially be mistaken for vancomycin. Neuromuscular blocking agents have also been confused with vaccines.

Administration Issues Neuromuscular Blocking Agents: Administer ONLY

By clinicians experienced with these drugs. Via intermittent rapid IV injection or continuous IV infusion. When the patient is properly ventilated. When the patient is sedated and experiencing analgesia.

Common Agents

Neuromuscular Blocking Agents Ultra-short Duration:

Succinylcholine (Anectine) Short Duration:

Mivacurium (Mivacron)

Federal regulators have cited a Hammond hospital for giving a fatal dose of medication to a fire captain who was recovering from open-heart surgery. The U.S. Centers for Medicare and

Medicaid Services will decide whether to penalize St. Margaret Mercy Healthcare Centers after Indiana state health officials conduct a second, more thorough investigation of hospital

operations, said Bob Daily, operations manager of the federal agency's regional office in Chicago.

Q: What is the greatest danger associated with neuromuscular blocking agents? A: When administered without respiratory support in place, respiratory arrest can occur.

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Intermediate Duration: Atracurium (Tracrium) Cisatracurium (Nimbex) Rocuronium (Zemuron) Vecuronium (Norcuron)

Long Duration Doxacurium (Nuromax) Gallamine Metocurine (Metubine) Pancuronium (Pavulon) Pipecuronium (Arduan) Tubocurarine

Safety Tips Store and label to prevent confusion with other drugs. Safety agencies have recommended that

agents be labeled “ Caution: Paralytic. “ Monitor: o Serum potassium level – hypokalemia may potentiate the drug; hyperkalemia and cardiac arrest

may occur when patients who have had a spinal cord injury or stroke receive succinylcholine. o Effects of the drug. A peripheral nerve stimulator may be used. o Heart rate, blood pressure, and mechanical ventilator status. Neuromuscular blocking agents

increase the frequency of bradycardia and hypotension associated with opioids. Severe hemodynamic instability may result in patients with cardiovascular disease or neurologic injury.

Adjust infusion rate according to patient response.

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CONCLUSION

Take extra care when administering high-alert drugs. These drugs have narrow therapeutic indexes and therefore little room for error without serious consequences. It is significant that many of the drugs identified in this course are commonly used drugs that have been in use for many years. Watchdog groups continue to identify the roles of other familiar drugs in fatal errors. For example, the death of a 16-year-old boy from epinephrine overdose resulted from confusion about dose concentrations (such as 1:1,000 or 1 mg/mL and 1:10,000 or 0.1 mg/mL), confusion about concentration when dealing with so many zeros, and the lack of labeling that warns clinicians to dilute the most concentrated preparations. ISMP has petitioned the USP requesting labeling changes and changes to prevent confusion of epinephrine with ephedrine (ISMP, 2004b). Refer to resources such as the ISMP Medication Safety Alert! to keep current with high-alert drugs and high-risk situations related to medication administration (www.ismp.org -consider subscribing to free e-mail updates). Resist the temptation to let familiarity breed complacency when administering high-alert drugs. Please Read: This publication is intended solely for the use of healthcare professionals taking this course, for credit, from RN.com It is designed to assist healthcare professionals, including nurses, in addressing many issues associated with healthcare. The guidance provided in this publication is general in nature, and is not designed to address any specific situation. This publication in no way absolves facilities of their responsibility for the appropriate orientation of healthcare professionals. Hospitals or other organizations using this publication as a part of their own orientation processes should review the contents of this publication to ensure accuracy and compliance before using this publication. Hospitals and facilities that use this publication agree to defend and indemnify, and shall hold RN.com, including its parent(s), subsidiaries, affiliates, officers/directors, and employees from liability resulting from the use of this publication. The contents of this publication may not be reproduced without written permission from RN.com.

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APPENDIX

(McCaffery & Pasero, 1999)

Drug Dose (mg) Parenteral Dose (mg) Oral Duration

(hour) Morphine 10 30 3-4

Hydromorphone (Dilaudid) 1.5 7.5 3-4

Oxycodone (Oxycontin) 20-30 3-4

Levorphanol (Levo-Dromoran) 2 4 6-8

Methadone 2-5 6-12

Codeine 200 3-4

Hydrocodone (Vicodin) 30-75 3-4

Meperidine (Demerol) 100 300 3-4

Fentanyl (Duragesic) 0.1-0.25 mg (100-250 mcg)

Microgram per hour dose of transdermal fentanyl approximates ½ of the

milligram per day dose of oral morphine up to 200

mg per day

72

Equianalgesic Dose Chart

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REFERENCES

Chicago Sun-Times. (March 15, 2002). Feds cite hospital for fatal error. Husch, M., Groszek, J.& Rooney, D. (2004). High-alert medications and safe practices: a study guide for nurses. Marblehead, MA: hcpro. Institute for Safe Medication Practices. (2003a). Results for ISMP survey on high-alert medications. Retrieved August 27, 2004 from http://www.ismp.org/S/SurveyHosp1.asp Institute for Safe Medication Practices. (2003b). Survey on high-alert medications: Differences between nursing and pharmacy perspectives. ISMP Medication Safety Alert! Huntingdon Valley, PA: Author. Also available at http://www.ismp.org/msaarticles/survey3print.htm Institute for Safe Medication Practices. (2004a). Misprogram a PCA pump? It's easy! ISMP Medication Safety Alert! 9(15), Huntingdon Valley, PA: Author. Also available at http://www.medscape.com/viewarticle/487852?src=mp Institute for Safe Medication Practices. (2004b). ISMP petitions USP on epinephrine issues. ISMP Medication Safety Alert! 9(16), Huntingdon Valley, PA: Author. Also available at http://www.medscape.com/viewarticle/487854?src=mp. Joint Commission on Accreditation of Healthcare Organizations. (1999). High-alert medications and patient safety. Sentinel Event Alert. Oakbrook, IL: Author. Also available at http://www.jcaho.org/about+us/news+letters/sentinel+event+alert/sea_11.htm McCaffery, M. & Pasero, C. (Eds.). (1999). Pain: Clinical Manual (2nd ed.). (pp 17-18, 63, 108-113). St. Louis: Mosby.

Waknine, Y. (2004). FDA safety labeling changes: CombiPatch, efudex, percodan, and axert. Medscape Medical News. Retrieved September 14, 2004 from http://www.medscape.com/viewarticle/488866?src=mp © Copyright 2004, AMN Healthcare, Inc.

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