Safety and Quality in Pharmacotherapy
Objectives
• Discuss the QSEN initiative related to safe administration of medications.
• Describe the “five-plus-five” rights of medication administration.
• Analyze safety risks for medication administration.
• Discuss safe disposal of medications.
• Discuss high-alert drugs and strategies for safe administration.
• Describe application of safe practices when ordering medications on the Internet.
• Discuss safety bases of pregnancy categories.
• Apply the nursing process to safe administration of medications.
Key Terms
absorption, p. 130
distribution, p. 130
informed consent, p. 124
medication reconciliation, p. 126
pharmacogenetics, p. 130
right assessment, p. 123
right patient, p. 121
right documentation, p. 123
right dose, p. 122
right drug, p. 121
right evaluation, p. 124
right route, p. 123
right time, p. 122
right to education, p. 123
right to refuse, p. 124
stock drug method, p. 122
tolerance, p. 123
toxicity, p. 130
unit dose method, p. 122
http://evolve.elsevier.com/KeeHayes/pharmacology/
Nearly 4 billion prescriptions were written in the United States in 2010, according to the IMS Institute for Healthcare Informatics. Prescription medicines, over-the-counter (OTC) drugs, or dietary supplements are used by 80% of adults. The Institute for Safe Medication Practices reports that 33% of adults take at least five medications daily.
Medication errors are the most frequent malpractice claims against hospitals and nurses, costing about $5000 per error. More than $3 million is awarded (on average) by the courts for serious errors. The cost of the patient and family suffering is not calculable.
The focus of this chapter is the Quality and Safety Education for Nurses (QSEN) initiative as it relates to safe medication administration and prevention of medication-related errors. The six QSEN competencies focus on patient/family–centered care, collaboration and teamwork, evidence-based practice, quality improvement, safety, and informatics. (Refer to Chapter 11 and the QSEN website, www.qsen.org.)
“Five-Plus-Five” Rights of Medication Administration
The rights of medication administration are the foundation for medication safety. The nurse following the original five rights of medication administration will give (1) the right patient the (2) right drug (3) in the right dose via (4) the right route at the (5) right time. Experience shows that five additional rights are essential to professional nursing practice: (1) right assessment, (2) right documentation, (3) patient's right to education, (4) right evaluation, and (5) patient's right to refuse.
The right patient determination is essential. The Joint Commission (TJC) requires two forms of identification before administration of the medication. Some patients are unable to respond or answer to any name, so the nurse must verify patient identification each time he or she administers a medication.
Nursing implications include the following:
• Verify the patient by checking the patient's identification bracelet. Some facilities put the patient's photo on the health record.
• Distinguish between two patients with the same first or last name; have warnings highlighted in a bright color on identification (ID) tools such as a med card, bracelet, or Kardex.
• Some institutions have ID bracelets coded for allergy status. Be aware of whether such a policy exists at your institution.
• When patients do not wear ID bracelets (e.g., in schools, occupational health departments, outpatient departments, or health care provider offices), the nurse must accurately identify the individual by other means when administering a medication.
The nurse must be sure that the right drug is administered. Medication orders may be prescribed by any licensed health care provider (HCP) having authority from the state to prescribe drugs. These include a physician (MD), dentist (DDS), podiatrist (DPM), advanced practice registered nurse (APRN), or physician assistant (PA). In some health care settings, medical students write drug orders; these orders must be countersigned by an attending or staff physician or other prescribing health care provider before they are considered official. The law requires that handwritten prescriptions be written on a tamperproof prescription pad and filled by a pharmacist at a drugstore or hospital pharmacy. Depending on agency policy, drug orders may be written on order sheets and signed by the duly authorized person. A telephone order (TO) or verbal order (VO) for medication must be “read back” to the HCP as an accuracy check and cosigned by the prescribing health care provider within 24 hours. The nurse must comply with the institution's policy regarding a TO, which sometimes requires that two licensed nurses listen to and sign the order.
As part of the electronic health record (EHR), prescriptions may also be entered directly into the patient's record, electronically signed by the HCP, sent directly to the pharmacy, and recorded as part of the patient record. A strong safety feature of the EHR is the ability to identify untoward drug interactions with the patient's current drugs and the newly prescribed/ordered medications. The EHR has decreased medication errors by eliminating some opportunities for errors such as transcription errors.
The use of computerized order systems has added speed and a safety feature to the order process. Orders can be written from virtually any location and sent electronically. The computer will not process the order unless all necessary information is included. Because the order is computerized, illegible orders or signatures are prevented.
The components of a drug order are as follows:
• Date and time the order is written
• Drug name (generic preferred)
• Frequency and duration of administration (e.g., × 7 days, × 3 doses)
• Any special instructions for withholding or adjusting dosage based on nursing assessment, drug effectiveness, or laboratory results
• Physician or other health care provider's signature or name if TO or VO
Although the nurse's responsibility is to administer drugs as ordered, the drug order is incomplete and the drug should not be administered if any one of the components is missing. Clarification of a questionable order must be done in a timely manner. The health care provider is usually contacted, and the conversation content is documented. Nurses must know all of the components of a drug order and question any orders that are incomplete or unclear, give a dosage outside of the recommended range, or are contraindicated by patient allergy or laboratory test results. Nurses are legally liable if they give a prescribed drug and the dosage is incorrect or the drug is contraindicated for the patient's health status. Once the drug has been administered, the nurse becomes liable for the predicted effects of that drug.
The following is an example of a drug order and its interpretation:
1/1/14, 1010 Lasix 40 mg, PO, daily [signature]. (Give 40 mg of Lasix by mouth daily.)
To avoid drug error, the drug label should be read three times: (1) at the time of contact with the drug bottle/container or the prepackaged drug unit, (2) before measuring the drug, and (3) after measuring the drug. First dose, one-time, and “as needed” (PRN) medication orders should be checked against the original orders. Nursing interventions related to a drug order include the following:
• The nurse should be well versed in the patient's health history and previously performed assessments.
• Check that the medication order is complete and legible. If the order is not complete or legible, notify the nurse manager and health care provider.
• Know the patient's allergies.
• Know the reason the patient is to receive the medication.
• Check the drug label three times before administration of the medication.
• Know the date the medication was ordered and any ending date (e.g., for controlled substances and antibiotics and for limited or a specific number of doses). Some agencies have “automatic stop orders” that are generally facility specific. Examples of such orders include controlled drugs that need to be renewed every 48 hours, antibiotics to be renewed every 7 to 14 days, and cancellations of all medications when the patient goes to surgery.
The right dose refers to verification by the nurse that the dose administered is the amount ordered and that it is safe for the patient for whom it is prescribed. The right dose is based on the patient's physical status, including renal and hepatic function. Renal and hepatic function are important considerations because many drugs are cleared through the kidneys and metabolized by the liver. Patient weight is another important consideration in multiple contexts, such as pediatrics and many medical, surgical, and critical care situations. In most cases, the right dose for a specific patient is within the recommended range for the particular drug. Nurses must calculate each drug dose accurately (see Chapter 14).
Before calculating a drug dose, the nurse should have a general idea of the answer based on knowledge of the basic formula or ratios and proportions. Recheck the calculation of drug doses if a fraction of a dose or an extremely large dose is calculated. Consult a peer or a pharmacist whenever doubt exists.
The stock drug method and unit dose method are the two most frequently used methods to dispense drugs (Table 12-1). In the traditional stock drug method, the drugs are dispensed to all patients from the same containers. In the unit dose method, drugs are individually wrapped and labeled for single doses for each patient. The unit dose method, which is popular in many institutions and community settings, has reduced dosage errors because no calculations are required.
TABLE 12-1
| STOCK DRUG METHOD | UNIT DOSE METHOD |
| Description | |
| Drugs are stored on unit and dispensed to all patients from the same container | Drugs are packaged in doses for 24 h by the pharmacy |
| Advantages | |
| Always available Cost-efficiency of large quantities |
Saves time for nurse; no dose calculation required Billed for specific doses More accountability Less chance for contamination and error |
| Disadvantages | |
| Drug errors are more prevalent with multiple “pourers” More risk of abuse by health care workers Less accountability for amount used; unable to track usage Increased opportunity for contamination (multiple pourers challenge aseptic/sterile status) |
Potential delay in receiving drug Not immediately replaceable if contaminated More expensive |
Automated dispensing cabinets assist the nurse in correctly and quickly administering medications. This technology improves patient care by promoting accurate and quick access to medications, locked storage for all medications, and electronic tracking for controlled substances. Pharmacists can review orders using a link to the pharmacy information system and current clinical patient data, interface with other databases (e.g., the laboratory), and bar-code doses. Automation of medication administration saves time, decreases costs associated with the administration of medications, and allows the ability to automatically collect documentation information. An activity report menu is a useful feature. Flexible dose modes are available, including single-dose, multi-dose, and multiple medications.
Nursing interventions related to the right dose include the following:
• Calculate the drug dose correctly. When in doubt, recalculate the drug dose and check with another nurse. In many settings, the first nurse to administer the particular drug to the patient must calculate the dose according to the stated formulary doses and sign in the nurse's signature space once the safety parameter has been established. In some settings, two registered nurses (RNs) are required to check dosage for specific medications such as insulin and heparin.
• Check the American Hospital Formulary, the drug package insert, or other drug references for the recommended range of specific drug doses.
The right time is the time the prescribed dose is ordered to be administered. Daily drug dosages are given at specified times during a day, such as twice a day (b.i.d.), three times a day (t.i.d.), four times a day (q.i.d.), or every 6 hours (q6h), so that the plasma level of the drug is maintained at a therapeutic level. Every drug cannot be given exactly when ordered; therefore, health care agencies have policies that specify a range of times within which drugs can be administered before or after the appointed time. When a drug has a long half-life (
), it is usually given once a day, although many depot preparations have a 
of days. Drugs with a short 
are given several times a day at specified intervals. Some drugs are given before meals, and others are given with meals or other food depending on the effect of the gastrointestinal (GI) environment on absorption of the drug.
Use of military time reduces administration errors and decreases documentation. Many nursing settings use military time, which is a 24-hour clock. See Figure 12-1 for military time in comparison with standard time. Nursing interventions related to the right time include the following:
• Administer drugs at the specified times (refer to agency policy).
• Administer drugs that are affected by food (e.g., tetracycline) 1 hour before or 2 hours after meals.
• Administer drugs that can irritate the stomach (gastric mucosa)—for example, potassium and aspirin—with food. Some medications are absorbed better after eating.
• Adjust the medication schedule to fit the patient's lifestyle, activities, tolerances, or preferences, as appropriate and if possible.
• Check whether or not the patient is scheduled for any diagnostic procedures such as endoscopy or fasting blood tests that contraindicate the administration of medications. Determine per policy if the medication should be given before or after the test is completed.
• Check the expiration date. Discard the medication or return it to the pharmacy (depending on policy) if the date has passed.
• Administer antibiotics at even intervals (e.g., q8h rather than t.i.d.) throughout a 24-hour period so therapeutic blood levels are maintained.
The right route is necessary for adequate or appropriate absorption. The right route is ordered by the health care provider and indicates the mechanism by which the medication enters the body. The more common routes of absorption include oral (by mouth): liquid, elixir, suspension, pill, tablet, or capsule; sublingual (under the tongue for venous absorption); buccal (between the gum and cheek); via feeding tube; topical (applied to the skin); inhalation (aerosol sprays); instillation (in nose, eye, or ear); suppository (rectal or vaginal); and five parenteral routes: intradermal, subcutaneous (subQ), intramuscular (IM), intravenous (IV), or intraosseous (IO).
Nursing interventions related to the right route include the following:
• Assess the patient's ability to swallow before administering oral medications; make sure that the patient is not NPO.
• Do not crush or mix medications in other substances without consulting a pharmacist or a reliable drug reference. Do not mix medications with sweet substances to trick children into taking them. Do not mix medications in an infant's formula feeding.
• If the medication is or must be mixed with another substance, explain this to the patient. For example, many children's medicines have flavor added (e.g., bubble gum– or banana-flavored antibiotics) to make them palatable.
• Use aseptic technique when administering drugs. Sterile technique is required with the parenteral routes.
• Administer drugs at the appropriate sites for the route.
• Stay with the patient until oral drugs have been swallowed.
The right assessment requires collection of appropriate data before administration of the drug. Examples of assessment data include apical heart rate before the administration of digitalis preparations or serum blood sugar levels before the administration of insulin.
The right documentation requires the nurse to immediately record the appropriate information about the drug administered. This includes (1) the name of the drug, (2) the dose, (3) the route (injection site if applicable), (4) the time and date, and (5) the nurse's initials or signature. Documentation of the patient's response to the medication is required with a variety of medications: (1) opioids (How effective was pain relief?); (2) non-opioid analgesics (How effective was pain relief?); (3) sedatives (How effective was relaxation?); and (4) antiemetics (Was nausea/vomiting decreased or eliminated?). Unexpected reactions to the medication (Was there any GI irritation or signs of skin sensitivity?) should also be documented. Patient responses are not necessarily verbal; they could be physiologic (e.g., Did blood pressure go down in response to an antihypertensive? Did LDL cholesterol go down in response to a statin?). Delay in charting could result in forgetting to chart the medication, and another nurse could administer the drug, assuming that the drug was not administered because it was not charted. Do not sign off medications before administration because the medication may not be administered to the patient for some reason. Graphic formats or computerized systems (Figure 12-2) assist in accurate and timely recording of drugs administered.
The right to education requires that patients receive accurate and thorough information about the medication and how it relates to their particular condition. Patient teaching also includes therapeutic purpose, expected result of the drug, possible side effects of the drug, any dietary restrictions or requirements, skill of administration, and laboratory test result monitoring. This right is a principle of informed consent, which is the individual having the knowledge necessary to make a decision. An informed patient and family is critical to preventing medication errors.
The right evaluation refers to an appraisal of a drug's therapeutic and adverse effects. Evaluation in this context asks, “Did the medication do for the patient what it was supposed to do?” It is essential for the nurse's practice to evaluate the therapeutic effect of the medication as well as any side effects and adverse reactions. This evaluation is an important aspect of patient safety.
The patient has the right to refuse the medication. Patients can and do refuse to take a medication. It is the nurse's responsibility to determine, when possible, the reason for the refusal and, if the reasoning is not sound, to take reasonable measures to facilitate the patient's taking the medication. Explain to the patient the risk of refusing to take the medication, and reinforce the reason for the medication. When a medication is refused, the refusal must be documented immediately, and follow-up is always required. The nurse manager, primary nurse, or health care provider should be informed when the omission may pose a specific threat to the patient, and when a change is expected in the laboratory test values, such as with insulin and warfarin (Coumadin).
Consider all medication errors serious or potentially serious. A medication error may involve one or more of the following: administration of the wrong medication or IV fluid; the incorrect dose or rate; administration to the wrong patient, by the incorrect route, or at the incorrect schedule interval; administration of a known allergenic drug or IV fluid; omission of a dose; or discontinuation of medication or IV fluid that was not discontinued.
Nurses' Rights When Administering Medications
In addition to the rights of medication administration, there are six rights for nurses who administer medications. These rights provide an additional layer of safety by ensuring that the nurse has what is needed to provide safe medication administration.
The nurses' six rights are (1) the right to a complete and clear order; (2) the right to have the correct drug, route (form), and dose dispensed; (3) the right to have access to information; (4) the right to have policies to guide safe medication administration; (5) the right to administer medications safely and to identify problems in the system; and (6) the right to stop, think, and be vigilant when administering medications. Discussion of these rights can assist in increasing the safety of medication administration.
The right to a complete and clear order requires that the drug, dose, route, and frequency be ordered by the health care provider. Prescription orders entered directly into a computer ensure that the prescription is legible. However, the nurse must question the health care provider if the order is not complete or is unclear.
The nurse has the right to have the correct drug, route (form), and drug dispensed. Dispensing medications correctly is the role of the pharmacist. Automated medication administration systems may be programmed to allow nurses access to many kinds of medications, rather than the safer unit dose access.
The right to have access to information includes the right to expect current and readily accessible drug information (e.g., hospital formulary, nursing drug reference). This right is a must. Nurses are only to administer drugs with which they are knowledgeable.
Nurses have the right to have policies to guide safe medication administration. Health care administration's role is to provide the structure on which nurses administer drugs safely. In each facility, policies guide nursing practice. Not following policy or administering medication without policies is not acceptable and places nurses at risk for losing their nursing license.
The right to administer medications safely and to identify problems in the system encompasses nurses' right and responsibility to speak up when they are first aware of situations that impinge negatively on safe administration of medications. Nurses should be an advocate for safety in the health care setting.
Nurses have the right to stop, think, and be vigilant when administering medications. When unsure, nurses have the right and responsibility to stop and think, consult with other health professionals, and check their institution's policies. Safety is the basis for these actions.
Culture of Safety
The Institute of Medicine (IOM) classic report of 1999, To Err Is Human: Building a Safer Health Care System, spurred work on identifying health care system changes to decrease errors. A medication error may be defined as “any preventable event that may cause or lead to inappropriate medication use or harm to a patient.”
Possible causes of medication errors include dramatic increase in the number of drugs available; violation of the rights of nursing medication administration; lack of drug knowledge; memory lapses; transcription, dispensing, or delivery problems; inadequate monitoring; distractions; overworked staff; lack of standardization; equipment failures; inadequate patient history; and poor interdepartmental communication.
In response to the escalating number of medication errors causing human deaths and costing billions of dollars, in 2002 the FDA proposed a rule titled Bar Code Label Requirements for Human Drug Products and Blood, which has increased the prominence of this coding. At a minimum, the bar code contains the drug's national drug code that “uniquely identifies the drug, its strength, and its dosage form.” A revision to this rule eliminates blood and blood products because they have had bar codes since 1985. Most staff embrace bar coding once they are proficient with its use. They note, however, that bar coding is a tool but not a substitute for critical thinking.
Computerized prescriber order entry systems interact with laboratory, pharmacy, and patient data. This integrated system of patient data is the basis for the success of bar coding. With bar coding, the patient's medication administration record (MAR), a part of the database that is encoded in the patient's wristband, is accessible to the nurse using a handheld device. After scanning the patient's wristband, the nurse sees the individual's MAR on the device. To administer a medication, nurses first scan the drug's bar code, then the number of the patient's medical record, and finally the nurse's own ID badge code. The patient's MAR is then updated accordingly. (Figure 12-3 shows a nurse scanning a patient's wristband.) The nurse receives verification on the handheld device of the five rights, warnings, and clinical alerts (e.g., drug is discontinued, drug is not ordered for patient).
Additionally, TJC has taken steps to prevent drug errors. As part of their National Patient Safety Goals, TJC announced in 2004 that all accredited organizations may no longer use selected abbreviations, acronyms, and symbols because they can be misinterpreted or misread. See Table 12-2 for this “Do Not Use” list, and see Table 12-3 for a list of acceptable abbreviations. Visit TJC's website at www.jointcommission.org and the Institute for Safe Medication Practices at www.ismp.org for current detailed safety information.
TABLE 12-2
| In 2005, The Joint Commission issued a new list of abbreviations that should not be used, but instead should be written out to avoid misinterpretation. Below is the list of “Do Not Use” abbreviations followed by a list of abbreviations that could possibly be included in future “Do Not Use” lists. | |
| Abbreviation | Preferred |
| q.d., Q.D. | Write “daily” or “every day.” |
| q.o.d., Q.O.D. | Write “every other day.” |
| U | Write “unit.” |
| IU | Write “International Unit.” |
| MS, MSO4 | Write “morphine sulfate.” |
| MgSO4 | Write “magnesium sulfate.” |
| .5 mg | Use zero before a decimal point when the dose is less than a whole (write 0.X mg). |
| 1.0 mg | Do not use a decimal point or zero after a whole number (write X mg). |
| The following abbreviations could possibly be included in future TJC “Do Not Use” lists. | |
| Abbreviation | Preferred |
| c.c. | Use “mL” (milliliter). |
| Mg | Use “mcg” (microgram). |
| > | Write “greater than.” |
| < | Write “less than.” |
| Drug name abbreviations | Write out the full name of the drug. |
| Apothecary units | Use metric units instead. |
| @ | Write “at.” |
Please visit www.jointcommission.org and www.ismp.org for more detailed safety information.
TABLE 12-3
| TJC lists acceptable abbreviations in three categories: drug measurements and drug forms, routes of medication administration, and times of administration. Selected abbreviations are listed here. These are frequently used in drug therapy and must be known by the nurse. | |
| Drug Measurements and Drug Forms | |
| Abbreviation | Meaning |
| Cap | Capsule |
| Dr | Dram |
| Elix | Elixir |
| g, gm, G, GM | Gram |
| Gr | Grain |
| Gtt | Drops |
| Kg | Kilogram |
| l, L | Liter |
| m2 | Square meter |
| mcg, µg | Microgram |
| mEq | Milliequivalent |
| Mg | Milligram |
| mL, ml | Milliliter |
| m, min | Minim |
| Oz | Ounce |
| Pt | Pint |
| Qt | Quart |
| SR | Sustained release |
ss.,  |
One half |
| Supp | Suppository |
| Susp | Suspension |
| T.O. | Telephone order |
| T, tbsp. | Tablespoon |
| t, tsp | Teaspoon |
| V.O. | Verbal order |
| Routes of Medication Administration | |
| Abbreviation | Meaning |
| A.D., ad | Right ear |
| A.S., as | Left ear |
| A.U., au | Both ears |
| ID | Intradermal |
| IM | Intramuscular |
| IV | Intravenous |
| IVPB | Intravenous piggyback |
| KVO | Keep vein open |
| L | Left |
| NGT | Nasogastric tube |
| O.D., od | Right eye |
| O.S., os | Left eye |
| O.U., ou | Both eyes |
| PO, po, os | By mouth |
| ® | Right |
| SC, subc, sc, SQ, subQ | Subcutaneous |
| SL, sl, subl | Sublingual |
| TKO | To keep open |
| Vag | Vaginal |
| Times of Administration | |
| Abbreviation | Meaning |
| AC, ac | Before meals |
| ad lib | As desired |
| B.i.d., b.i.d. | Twice a day |
 |
With |
| Hs | Hour of sleep |
| NPO | Nothing by mouth |
| PC, pc | After meals |
| PRN, p.r.n. | Whenever necessary, as needed |
| Q | Every |
| Qam | Every morning |
| Qh | Every hour |
| q2h | Every 2 hours |
| q4h | Every 4 hours |
| q6h | Every 6 hours |
| q8h | Every 8 hours |
 |
Without |
| SOS | Once if necessary: if there is a need |
| Stat | Immediately |
| T.i.d., t.i.d. | Three times a day |
Please visit www.jointcommission.org and www.ismp.org for more detailed safety information.
Another safety feature is the black box, or boxed, warning, the FDA's strongest labeling requirement, which warns health care providers of risks associated with certain drugs.
Joint Commission 2013 National Patient Safety Goals
TJC 2013 National Patient Safety Goals focus on problems in health care safety and how to solve them. National Patient Safety Goals program links for ambulatory health care, behavioral health care, critical access hospital, home care, hospitals, laboratory services, long-term care, long-term care (Medicare/Medicaid), and office-based surgery are found at www.jointcommission.org/standards_information/npsgs.aspx. As an example, the first three National Patient Safety Goals for hospitals have relevance for medication safety. They are as follows: Goal 1. Identify patients correctly; Goal 2. Improve staff communication; and Goal 3. Use medicines safely. The full text of the goals is available on TJC's website.
Medication Reconciliation
Medication reconciliation is an important component of the culture of safety. Medication discrepancies are not new in the literature. There are three transition points where many discrepancies occur: hospital admission, intrahospital transfer, and discharge. Medication reconciliation was created to provide medication continuity during care transitions, thereby promoting patient safety.
Medication reconciliation is the process of comparing a patient's medication orders to all of the medications that the patient has been taking. The purpose is to avoid errors (e.g., omissions, duplications, dosing errors, drug interactions). Reconciliation must be conducted at every transition of care when the patient is taking any medications. Transitions include changes in care setting, service, health care provider, or level of care.
The medication reconciliation 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. Make clinical decisions based on the comparison.
5. Communicate the new list to appropriate caregivers and to the patient.
Tips for Medication Reconciliation
• Conduct a thorough medication interview with patient and/or caregivers to obtain and verify current medication status and regimens.
• Teach patient/caregiver the key role of managing medication information at all transitions.
• Advise patient to give a list to his or her primary care provider; update own list when change in dose, deletion/addition of medication, including OTCs; and carry medication information at all times in case of an emergency.
• Enlist support of primary care physicians (all health care providers) and community pharmacists to encourage patients to carry and update their medication list at every encounter.
• The Agency for Healthcare Research and Quality (AHQR) has created a patient handout that can help patients play an active role in their own safety. Nurses can distribute the handout, found at www.ahrq.gov/consumer/20tips.pdf, during patient teaching.
Since 2005, TJC has required hospitals to perform medication reconciliation for all patients. The revised NSPG 03.06.01 requires facilities to “maintain and communicate accurate patient medication information.” In addition, the Centers for Medicare and Medicaid Services Process of Care (Core) Measures require incorporating a reconciled medication list in the discharge instructions of all heart failure patients. In December 2011, the AHQR published Medications at Transitions and Clinical Handoffs (MATCH) Toolkit for Medication Reconciliation; it can be found at www.ahrq.gov/qual/match/match1.htm.
Disposal of Medications
The FDA collaborated with the White House Office of National Drug Control Policy (ONDCP) and in 2009 issued guidelines for appropriate disposal of prescription drugs. General guidelines include the following: Follow specific information on the drug label or drug insert. Unless specifically instructed, do not flush medications down the toilet, where they will pollute the environment and may be a danger to humans and animals. (Exceptions to this rule are listed in Box 12-1.) It is recommended that you remove the drug from its original container and dispose of it in a sealed bag with an undesirable substance such as used cat litter or used coffee grounds. This method is intended to make medications less attractive to people and animals. As needed, patients may take advantage of local community “drug take-back” programs that provide an opportunity for consumers to dispose of unwanted, unneeded, and/or expired medications in a safe manner. Some pharmacies will also take unused medications; this varies by state.
Before disposing of medication containers, all identifying information should be removed or obscured. Nurses and patients can consult a pharmacist with questions related to medication disposal.
Sharps Safety
The Occupational Safety and Health Administration (OSHA) Needlestick Safety and Prevention Act of 2000 resulted from the American Nurses Association's (ANA) campaign, Safe Needles Save Lives. The Needlestick Safety and Prevention Act requires that employers do the following:
• Identify, evaluate, and implement safer medical devices.
• Maintain a sharps injury log.
• Involve health care workers in deciding which devices are used.
• Implement engineering controls for sharps disposal containers, self-sheathing needles, and safer medical devices like sharps with engineered injury protection and needleless systems. These engineering controls must be used to eliminate or lessen employee exposure to blood borne pathogens.
• Train employees in the proper usage of the engineering and work practice controls to help keep them safe.
Employers must ensure that no preventable sharps injuries occur. The Consensus Statement and Call to Action (2012), a collaboration of the ANA, the International Healthcare Worker Safety Center at the University of Virginia, and many health care colleagues, focuses on five areas: (1) improving sharps safety in surgical settings; (2) understanding and reducing exposure risks in nonhospital settings (e.g., offices, clinics, and home settings); (3) involving front-line workers in the selection of safety devices; (4) addressing gaps in available safety devices and encouraging innovative designs and technology; and (5) enhancing worker education and training.
Safety Risks for Medication Administration
It is estimated that for every 100 medication administrations, there are 5 medication errors. Several reports indicate that the majority of medication errors occur when administering the drug (41%), followed by documenting (21%), dispensing (17%), prescribing (11%), monitoring (1%), and other (9%).
Examples of risks to safety include the following:
• Pill splitting. In an effort to counteract steeply rising drug costs, some patients are cutting their pills in half. In the Half Tablet Program, with physician approval, patient costs are cut in half. However, splits can be dangerous. A minor dose change from uneven splitting can have a major effect on the patient. Patient attributes such as diminished vision, cognitive problems, and hand coordination problems can all contribute to the risk.
• Buying drugs over the Internet. This may be easy, but the buyer must be sure it is safe. Some websites are not state licensed or affiliated with pharmacies. They may not protect personal information; may not label, store, or ship medications correctly; and may sell expired medications. The FDA reports that consumers do not always get what they order and may not have someone available to verify if the drug is correct. Some sites may also sell counterfeit drugs (see the following paragraph). Patients should look for websites that require a prescription from a health care provider, have a licensed pharmacist to answer questions and a contact person if problems arise, are located in the United States, and are licensed by the state board of pharmacy.
Counterfeit Drugs
Counterfeit drugs look like the desired drug but may have no active ingredient, the wrong active ingredient, or the wrong amount of active ingredient. Improper packaging or contamination can also be problems. Counterfeit drugs may look remarkably like the real thing! To report suspect counterfeit products, call the FDA Office of Counterfeit Issues at 1-800-551-3989 or email DrugSupplyChainIntegrity@fda.hhs.gov.
To reduce the risk of exposure to counterfeit drugs, patients should do the following:
1. Purchase drugs only from licensed pharmacies. Refer to the National Association of Boards of Pharmacy (NABP) at www.nabp.net for information. The NABP reviews Internet pharmacies; after review, the NABP grants the Verified Internet Pharmacy Practice Sites (VIPPS) Accreditation Program seal. Visit www.nabp.net/programs/accreditation/vipps/.
2. Check the color, texture, shape, and taste (if applicable) of the drug when refilling a prescription. Patients should check with the pharmacist if they notice any changes.
3. Follow legislation in process to promote safe handling of drugs after they leave the authorized wholesaler by introducing “pedigree” requirements at federal and state levels.
Dosage Forms: To Crush or Not to Crush
Some medications can be crushed; consult with the health care provider or pharmacist. Do not crush any medication that has the suffix ER, SR, XR, SA, CR, MR, or XL; these are extended-release or sustained-release drugs, and crushing will change the location and speed of absorption. For a current complete listing of drugs that should not be crushed, see www.ismp.org/Tools/Donotcrush.pdf.
High-Alert Medications
When high-alert drugs are involved in medication errors, the consequences to patients are more serious. Classes/categories of high-alert medications include IV adrenergic agents, IV adrenergic antagonists, IV antiarrhythmics; IV inotropic agents, IV moderate sedation agents, anesthetic agents, antithrombotic agents, cardioplegic solutions, chemotherapeutic agents, dextrose (hypertonic >20%), dialysis solutions, epidural or intrathecal agents, hypoglycemics, liposomal forms of drugs, moderate sedation agents, narcotics/opiates, neuromuscular blocking agents, IV radiocontrast agents, total parenteral nutrition solutions, sterile water for injection, inhalation and irrigation in containers of >100 mL, and sodium chloride for injection (hypertonic, >0.9% concentration). See www.ismp.org/Tools/highalertmedications.pdf for a complete list of classes/categories and specific medications. The ISMP recommends the following strategies to optimize safety when dealing with high-alert drugs: standardizing the ordering, storage, preparation, and administration of these products; improving access to information about these drugs; limiting access to high-alert medications; using auxiliary labels and automated alerts; and employing redundancies such as automated or independent double-checks when necessary.
Look-Alike and Sound-Alike Drug Names
Nurses should be aware that certain drug names sound alike and are spelled similarly. Examples of drugs involved in medication errors and recognized as confused drug names include amaryl with reminyl; avinza with evista; cisplatin with carboplatin; Depakote with Depakote ER; ephedrine with epinephrine; and humalog mix 75/25 with Humulin 70/30. The FDA, ISMP, and TJC advocate the use of “tall man” letters as a safety strategy to reduce confusion between similar-sounding drugs. For example, rispiridone (Risperdal) is written as rispiriDONE, and ropinirole (Requip) is written as ropiniROLE to call attention to differences in spelling. Tall man letters should be used for computer listing and storage labeling.
Other Factors in Prevention of Medication Errors
Creating a distraction- and interruption-free environment is critical to safe administration of medications. Effective strategies include creating a taped area on the floor surrounding the unit dose machine and hanging a sign stating, “Medication preparation/administration in progress. Please do not disturb”; hanging a card stating “Please do not interrupt during medication administration” on every computerized cart; designating a “quiet zone” for medication preparation; and wearing a vestlike garment that reads “Thank you for not interrupting” during medication preparation and administration.
Overall, the nurse's role is best achieved by the application of the nursing process. The nursing process related to medication safety follows.
Nursing Process
Patient-Centered Collaborative Care
Medication Safety
Assessment
Assess vital signs and other patient parameters as appropriate. Report abnormal findings.
Assess patient including patient history and ability to swallow (for PO medications).
Assess medication order for completeness and with recommended parameters. Know purpose and expected effect of medication and interactions with other medications, including OTC and herbal preparations.
Assess medication storage area (e.g., Does refrigerator storage meet requirements for medication storage?).
Planning
Nursing Interventions
Use relevant resources appropriately.
Avoid contamination of own skin or inhalation of substances to minimize exposure.
Administer only medications you prepared.
Determine patient's preferred language for communication, and mobilize resources to provide communication in this language.
Identify patient by appropriate means (scanned name band, verbal confirmation).
Remain with patient until medication has been taken.
Administer medications according to the five-plus-five rights: right patient, right drug, right dose, right time, right route; plus right assessment, right documentation, right evaluation, right to education, right to refuse.
Monitor subjective responses, physiologic alterations, and laboratory test results to identify therapeutic effects and adverse effects.
Discard needles and syringes in appropriate container; be alert to sharps safety.
Use aseptic/sterile technique appropriate for route of administration.
Thoroughly document administration of medication(s) in the designated format in a timely manner.
Document patient refusal to take medication, and notify health care provider.
Patient Teaching
Counsel patient and family on anticipated effects of medications.
Counsel patient on side effects and adverse reactions and what to report promptly to health care provider.
Advise patient what foods to eat and/or avoid.
Advise patient on taking medications before, with, or after meals, as appropriate, to promote optimal absorption.
Evaluation
Resources for Preventing Errors in Medication Administration
Several resources address medication errors and their prevention: (1) Pathways for Medication Safety was developed through the collaborative efforts of the American Hospital Association, the Health Research and Educational Trust, and the ISMP, with support from the Commonwealth Fund. Pathways for Medication Safety is a set of tools designed to assist hospitals through a system-based approach to reduce medication errors. (2) An FDA database of medication errors and “near misses” assists all health care personnel to identify, implement, and evaluate strategies to prevent medication errors. It is strongly suggested that health care workers report errors or near misses to the FDA. Reports are confidential. (3) The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) specializes in medication errors from an interdisciplinary perspective. (4) The nurse must consult drug references (e.g., United States Pharmacopeia, National Formulary, and American Hospital Formulary drug reference handbook); human resources (e.g., pharmacists); and technology resources (Micromedix, Palm Pilot Epocrates) when unsure about the expected therapeutic effect, contraindications, dosage, potential side effects, or adverse reactions and interactions of a medication. (5) FDA MedWatch: Subscribe at fda@service.govdelivery.com for notifications on drug recalls, counterfeit products, and safety alerts.
Pregnancy Categories
The FDA has developed a classification system related to the effects of drugs on the fetus. Table 12-4 lists the FDA's pregnancy categories and describes each category's effect on the fetus. Note: Prescription drug labeling revisions for health care providers are expected from the FDA. The purpose of the changes is to optimize informed decision making for pregnant patients and for patients of childbearing age who may wish to become pregnant. Both the pregnancy and lactation subsections will have three principal components: risk summary, clinical considerations, and a data section. The current pregnancy categories will be eliminated when the revisions have been completed.
TABLE 12-4
| PREGNANCY CATEGORY | DESCRIPTION |
| A | No risk to fetus. Studies have not shown evidence of fetal harm. |
| B | No risk in animal studies, and well-controlled studies in pregnant women are not available. It is assumed there is little to no risk in pregnant women. |
| C | Animal studies indicate a risk to the fetus. Controlled studies on pregnant women are not available. Risk versus benefit of the drug must be determined. |
| D | A risk to the human fetus has been proved. Risk versus benefit of the drug must be determined. It could be used in life-threatening conditions. |
| X | A risk to the human fetus has been proved. Risk outweighs the benefit, and drug should be avoided during pregnancy. |
Factors That Modify Drug Response
Effects on the patient from drugs are complex owing to alterations in physiology. Nurses must complete thorough assessments of patients to accurately evaluate drug effects. Examples of factors that modify drug responses specifically related to safety include absorption, distribution, metabolism, excretion, toxicity, pharmacogenetics, pre-existing disease state, and drug-drug interaction. See discussions of factors that modify drug response in Chapters 1, 3, 4, 6, 7, and 8.
Guidelines for Medication Administration
General guidelines for medication administration are listed in Boxes 12-2 and 12-3. Nurses should follow these guidelines to enhance safety when administering medications. Application of the nursing process to medication administration is presented in Chapter 13.
Key Websites
National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP): www.nccmerp.org
Proper disposal of prescription drugs: http://www.whitehouse.gov/sites/default/files/ondcp/issues-content/prescription-drugs/rx_abuse_plan.pdf
U.S. Food and Drug Administration (FDA): www.fda.gov