From Brain to Bedside: Incorporating fundamental pharmacology-related topics into practical patient care

Terry Altringer, Pharm.D. Clinical Pharmacy Coordinator – Trinity Health Residency Program Director – Trinity Health Adjunct Preceptor – NDSU College of Pharmacy Disclosure Statement

• The presenter has no actual or potential conflicts of interest in relation to this presentation Objectives

1. Review the general principles of safe and accurate drug administration 2. Describe how basic pharmacologic and pharmacokinetics parameters impact bedside care 3. Discuss common patient specific variables that affect the actions of drugs 4. Discuss how to safely monitor patients after drug administration 5. Review the importance of patient-directed medication education Secondary Objectives

• To provide an overview of medication safety • To encourage you to continue to learn and practice ways to improve the safety of medication use The Unthinkable Day

https://www.youtube.com/watch?v=XEbf9bl iOus Story: Admission of a patient…

3 month old male admitted with respiratory distress most likely due to bronchiolitis.

Staff Nurse: “I received report at 7 p.m. and was reviewing the orders and saw that he had some medications due.” Both Reglan and Digoxin were due at 2000. I went to the medication room and prepared the medications. “I saw that he had some medications due…”

“I checked the online • Looked meds up on the formulary and confirmed the online formulary. Reglan and Digoxin were ordered in the correct dose • Checked the dose. and route. I checked the labels on the syringe and double • Checked the med. checked the dose against the • Took labeled syringes to order on the medication patients room. administration record. I took the medication to the bedside.” “Preparing to administer the medication…” Next steps... • Open the patient’s MAR to do the 5 R’s • What questions do you have? • What are the clinical indications for these two meds in this infant? • Prepare to barcode scan patient ID band and medications. “I told mom I was giving Digoxin and Reglan..”

Mom said, “At home I give the Reglan, the other medication must be a new one.”

I told her it was ordered by the doctor for the baby’s heart.

Mom said, “Is there something wrong with his heart?” Mom said “Is there something wrong with his heart?”

• I said “Let me double check his • The charge nurse called chart.” the senior resident who • I looked at the chart. The said the child had no patient was here for cardiac issues and should respiratory distress. I did not not have an order for see anything about a heart Digoxin. problem. • Turns out the order was • I called the resident who electronically placed in reported, “I do not know of the wrong chart. any heart problems in this patient.” • “What if mom had • I called my charge nurse. not been there?” 21st Century Nursing The Basic Medication Management Process

Planning

Selection & Evaluation Procurement

Nursing’s Role Monitoring Storage

Last Line of Defense for Patient (26-32% of medication errors)

Ordering & Administration Transcribing

Preparing & Dispensing The “Real” Medication Management Process Why understanding medication safety matters • 82% of Americans take at least 1 medication, 29% take >5 • In 1999; 44,000–98,000 deaths occurred each year due to medical mistakes. (IOM Report) • Every year medication errors injure at least 1.5 million Americans and cause 7,000 deaths. • Adverse drug events (ADEs) cause more than 1 million ED visits and 280,000 hospitalizations annually • ADEs comprise the largest single category of adverse events experienced by hospitalized patients, accounting for about 19 percent of all injuries – Increased morbidity, mortality, prolonged hospitalization, and higher cost

Medication Error (ME): Adverse Drug Event (ADE): Any mistakes occurring in the medication An injury resulting from medication use process, regardless of whether an use, including physical harm, mental injury occurred or whether the potential for harm, or loss of function. injury was present.

• Adverse Drug Reaction (ADR), or non- Preventable ADE: Any ADE that occur due to Potential ADE pharmacological (aka, Near Miss or properties of the Close Call): drug. Medication errors that Preventable ADE (pADE): pose a significant risk ADEs resulting from a but do not cause harm medication error that can be to a patient. avoided. Causes of Fatal Medication Errors

• Among fatal medication errors, the Institute of Medicine (IOM) identities 3 main categories: – Human factors Communication mistakes – Account for 90% of all errors – Name confusion (LASA) • More specifically – Performance deficits (29.8%) – e.g., IV instead of IM – Knowledge deficits (14.2%) – drug-drug interaction – Miscalculation of dose (13%) – decimal placement Which patients are most at risk of medication error? • Patients on multiple medications (polypharmacy) • Patients with another condition, (e.g. heart failure, renal impairment, pregnancy) • Patients who cannot communicate well • Patients who have more than one doctor • Patients who do not take an active role in their own medication use • Vulnerable populations (Newborn, children, geriatrics, impaired) In what situations are staff most likely to contribute to a medication error? • Inexperience • Rushing • Doing two things at once – “multitasking” • Interruptions • Fatigue, boredom, being on “automatic pilot” leading to failure to check and double-check • Lack of checking and double checking habits • Poor teamwork and/or communication between colleagues • Reluctance to use memory aids - ?Pride Types of Medication Errors • Wrong patient • Wrong drug • Wrong route • Wrong time • Wrong dose • Omitted dose • Wrong dosage form • Wrong diluent • Wrong strength/concentration • Wrong infusion rate Ways to prevent medication errors 1. Know the patient 2. Know the drug(s) 3. Communication (SBAR) – [60% of sentinel events] 4. Drug packaging & labeling . Double-check high alert medications 5. Storage, stock, standardization, and distribution 6. Drug device acquisition, use, and monitoring 7. Environmental factors 8. Staff education 9. Patient education 10. Quality processes and risk management Application of Pharmacology in Nursing Practice • Your responsibilities with regard to medications extend far beyond the Rights of Drug Administration. • Your medication knowledge has a wide range of practical applications in patient care and patient education. • You are part of the healthcare team that contributes to maximum patient benefit and minimum harm. • Application should be directed at individualized treatment. General Principles of accurate drug administration Five Rights 1. Right patient 2. Right drug 3. Right dose 4. Right route 5. Right time 5 Rights of Medication Administration

Right Patient:

• Open the correct patient’s Chart/MAR. • Look at the ID Band. • Barcode scan. • Do I have the correct patient? 5 Rights of Medication Administration Right Medication:

• Is this the right medication for the right patient? • Meds are located: – Patient specific bin or carts in the medication room – Locked medication alcoves in patient’s room – Automated Dispensing Cabinets (Pyxis, Omnicell) • Know the clinical indication for this patient to be receiving this medication. Why does this specific patient need this specific medication? 5 Rights of Medication Administration

Right Dose:

• The ordered dose needs to match the dose on the medication label. • Is the dose correct for the weight of the child, if applicable? • Is the dose correct for the clinical indications and route? 5 Rights of Medication Administration Right Route:

• Know the correct route of administration: – Oral – Enteral • NG [nasogastric tube], GT [gastrostomy], JT [jejunostomy] – Parenteral • IV [intravenous], IM [intramuscular], SQ [subcutaneous] – Rectal – Intradermal – Transdermal – Transmucosal 5 Rights of Medication Administration

Right Time:

• Is the medication due at this time? Check to see when it was last given. • Ensure the order has not changed which will impact the time it is due. Key Reminder

• The physician order and the corresponding eMAR/MAR entry are the sole source of truth. • Do not rely on other forms of secondary information such as: – Handheld barcode administration device – Notes from a colleague. • Always check the medical record! Develop checking habits

• Remember, computerized systems still require checking! • If you always check it will become a habit! • Some useful maxims … – Unlabeled medications should never be administered. – Never administer a medication unless you are 100% sure you know what it is.

Legal Responsibilities

• Nurse is legally responsible for safe and accurate administration of medications

• Nurse is expected to have sufficient drug knowledge to recognize and question erroneous orders Encourage patients to be actively involved in their care! • When prescribing a new (or any) medication provide patients with the following information: – Name and purpose of medication – Common side-effects

– Teach-back is a good way to validate patient understanding. – Allow time for questions. General Principles of Drug Therapy • Expected benefits should outweigh potential adverse effects • Drug therapy should be individualized • Drug effects on quality of life should be considered in designing a drug therapy regiment So let’s tackle some technical aspects Pharmacodynamics (PD) Pharmacokinetics (PK) What drug does to the body What body does to the drug Pharmacokinetics

https://www.youtube.com/watch?v=IOf- z0D1mHk Finer PK Points Worth Noting

Advantages Disadvantages Oral Practical, convenient, safe, High variability, potential administration** economic inactivation (stomach, liver) IV administration Rapid onset, more precise Higher cost, difficulty, control of drug amount, inconvenience, less reversible, suitability for irritant drugs potential for fluid overload, infection, embolism IM administration Suitable for insoluble drugs Inconvenient and discomfort and depot preparations SQ administration Suitable for insoluble drugs Inconvenient and discomfort and depot preparations, smaller volume

** Enteric Coated: Designed to release their content in the small intestine – not in the stomach. ** Sustained Release: Oral formulations designed to release their contents slowly, thereby permitting a longer interval between doses. These formulations should generally not be crushed, chewed or opened. Check with pharmacy. A quick word about half-life (t ½) • Defined as the time required for the amount of drug in the body to decline by 50%. • Drugs that have a short half-life must be administered more frequently than drugs with longer half-lives (most of the time). • When drugs are administered repeatedly, their levels will gradually rise and reach a “steady state” plateau. • The time to reach “steady state” is equivalent to about 4-5 half-lives. • When a drug is discontinued, most (~94%) will be eliminated over 4-5 half-lives. • Both the time it will take for a drug to be effective, and the time it will take for it to leave the body completely, depend on a drug's half-life. Half-life examples • Drugs with short half-lives will wear off quickly. – If the half-life is short and you want to keep the concentrations in your system steady, you have to take the drug every half-life. • The problem with drugs with really long half-lives is that they build up in the body and can get to really high concentrations, even if you are only taking them once per day. – For example, Prozac can still be in your system 6 weeks after you take the last dose.

Ativan (lorazepam) Short half-life (2-3 hours) May require more frequent dosing Coumadin (warfarin) Long half-life Good (prevents clotting) Bad (bleeding) Morphine Short half-life (2-3 hours) Dosing every 4 hours may not be enough Amiodarone Long half-life (100 days) May take a long time to achieve the full effect Side effects Pharmacokinetics (PK) Age-related variation • General principles: – Premature infants are not the same as adolescents – Children are not little adults – Infants and geriatric patients are more sensitive to drugs than adults and are therefore more prone to adverse reactions Pediatric Patients: Stages & Definitions • “Pediatrics” broadly encompasses all patients younger than age 16 years of age. • Many organs and functions are immature at birth.

Premature infants • Less than 36 weeks’ gestational age

Full-term infants • 36 to 40 weeks’ gestational age

Neonates • First 4 postnatal weeks

Infants • Weeks 5 to 52 postnatal

Children • 1 to 12 years old

Adolescents • 12 to 16 years old Age-related PK variation- Pediatrics BODY EFFECTS POSSIBLE DRUG RESPONSE Absorption More acidic (lower pH) Altered absorption of some Oral drugs Delayed gastric emptying Drug absorption prolonged and irregular Intramuscular (slow, erratic, delayed) More rapid absorption Transdermal (thin, increased blood flow) Increased toxicity potential Distribution Limited protein binding (albumin) More free drug (? Effect)

Volume of distribution (total body water) Requires higher dose as -Premature (85% of total body weight) volume increases. -Term (75% of total body weight) Reduced drug excretion -Adult (55% of total body weight) (longer half-life) Metabolism Immature liver with term newborns and Increased drug sensitivity children. Matures rapidly after about 1 month Drug effects normalize Generally complete at 1 year Excretion Immature kidneys at birth that increase Requires longer dosing with age, generally adult-like at 1 year intervals initially Drug Therapy in Pediatric Patients: Pharmacokinetics in Neonates and Infants

• Babies under the age of one year are “more sensitive” to drugs • Immaturity of organs puts neonates & infants at risk for: – more intense, more prolonged responses – increased risk of adverse effects due to kinetics – Age-related unique adverse effects • Example: kernicterus • At the age of 1 year, most pharmacokinetic parameters in children are similar to those of adults Age-related PK variation - Geriatrics

BODY EFFECTS POSSIBLE DRUG RESPONSE Absorption Less acidic (higher pH) Altered absorption of some drugs Decreased blood flow Slowed absorption Decreased motility and gastric emptying Delayed onset/effect Distribution Decreased body water and more fat tissue Variable with each drug Decreased serum protein More “free” drug May require lower dose Metabolism Aging liver produces less microsomal Decreased metabolism enzymes Reduced blood flow Prolonged half-life May require lower dose Excretion Reduced blood flow Drug accumulation Reduced glomerular filtration rate (GFR) May require less frequent administration, longer dosing intervals Drug-Drug Interactions

• Too many to even begin to discuss. • Look them up or consult with pharmacy Drug-Solution Compatibility Drug-Solution Compatibility

• Because drugs can interact in solution, never combine two or more drugs in the same container or IV line unless you are certain (with evidence) that a direct interaction will not occur. • Pharmacists routinely use Trissel’s or King’s Guide for compatibility info. Don’t be afraid to call! Drug-Food Interactions • Food may reduce the rate or extent of drug absorption (orally administered). • For some drugs, food may increase the extent of absorption (e.g., grapefruit juice). • Drugs may increase drug toxicity. • ‘On an empty stomach’ typically means to take the drug 1 hour before or 2 hours after a meal. Practical Aspects of Drug Safety – Some Parting Thoughts

• As previously mentioned, nursing responsibilities with regard to medication administration extend far beyond the Rights of Drug Administration. • Drug therapy application for the nurse should center around individualized treatment for each patient. • You are the patient’s last line of defense. • Never leave medications unattended. • Check and double check. • Listen to your instinct. Ask if in doubt. • Listen to the family. The 5 C’s of a Healthcare Culture of Safety?

. Competence . Communication . Collaboration and Coordination . Compassion Top 6 Priorities for Nurses + 1 (By a Nurse for a Nurse)

1. Detail oriented 2. Don’t take shortcuts – this does not mean identifying and resolving inefficiencies 3. Be a life-long learner 4. Stay sharp and professional 5. Be punctual – be on time 6. Be even tempered 7. Never Assume! You are a NURSE What you do is valuable & important

https://www.youtube.com/watch?v=4peIFul usSk Cited References

1. Slone Epidemiology Center at Boston University. Patterns of medication use in the United States, 2006. 2. U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. National Action Plan for Adverse Drug Event Prevention. Washington, DC: 2014. 3. Kohn L T, Corrigan J M, Donaldson MS (Institute of Medicine) To err is human: building a safer health system. Washington, DC: National Academy Press, 2000 4. Institute of Medicine (U.S.). Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C.: National Academy Press, 2001. 5. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324:377. 6. Classen DC, Pestotnik SL, Evans RS, et al. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA 1997; 277:301. 7. Phillips DP, Christenfeld N, Glynn LM. Increase in US medication-error deaths between 1983 and 1993. Lancet 1998; 351:643. 8. Fanikos J, Cina JL, Baroletti S, et al. Adverse drug events in hospitalized cardiac patients. Am J Cardiol 2007; 100:1465. 9. Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA 1997; 277:307. 10. Simonsen et al.: Differences in medication knowledge and risk of errors between graduating nursing students and working registered nurses: comparative study. BMC Health Services Research 2014 14:580. 11. Pirinen H et al.: Registered Nurses’ Experiences with the Medication Administration Process. Advances in Nursing, vol. 2015, pp.1-10. 12. Lehne RA. (2013). Pharmacology for Nursing Care. St. Louis, Missouri:W.B. Elsevier Saunders. Thank you for allowing me the pleasure of speaking with you!