Independent Study Module
Pamela S. Dickerson, PhD, RN-BC
PRN Continuing Education
October-December, 2011

Objectives:

• Identify current issues related to patients' safe use of medications.
• Describe actions that can be taken by nurses to help patients safely manage their medications.

Introduction

A substantial role of the nurse is to protect patient safety. Evidence today indicates that patient safety is being compromised in several ways related to use of medications, resulting in poorer than expected regulation of chronic conditions, unexpected outcomes from taking medications, and sometimes even death when medications are used inappropriately. This study will examine current efforts underway to help patients manage their medications, including the significant role of the nurse in patient teaching and disease management.

The Importance of the Issue

The Agency for Healthcare Research and Quality (AHRQ) has been engaged in publishing a series of reports focusing on “closing the quality gap”. Most recently, the focus of this initiative has been on analysis of strategies to assist patients in adherence to medical plans of care related to self-administration of medications (AHRQ, 2011). The way patients follow (or don’t) the recommended plan of care has significant implications for the provider in assessing the outcomes of the plan. Providing quality care has several key components: a well-educated, knowledgeable, and caring provider; a plan of care based on best available evidence according to standards; clear communication between the provider and the patient to discuss implementation strategies for the plan; and active engagement of the patient in adhering to the plan. All of these components impact the ultimate outcome – did the care enable patient and provider to reach their collaborative goal?

The goals established by patient and provider may address one or more of the following:

1. Increase quality of life – this may include comfort or ability to function
2. Decrease risk of a disease condition getting worse
3. Decrease risk of complications from a disease condition
4. Decrease risk of death from the disease or its complications

The AHRQ report identifies that “poor adherence clearly poses a threat to the health of the US population”, creating a gap between potential and actual quality of care. This is particularly a point of concern for patients with chronic illnesses, as medication treatment plans are significant in control of the condition over time and prevention of morbidity and mortality.

The Institute of Medicine (2006) published a report entitled Preventing Medication Errors as part of its Quality Chasm series. This report suggests that in any given week, four out of five adults in the US takes at least one medication (prescription, over-the-counter, or dietary supplement), and about 1/3 of adults take five or more different medications. By volume alone, there is risk that some of these medications will have undesirable effects. For those who ingest multiple medications (polypharmacy), the risk is even higher due to interactions between drugs. Unfortunately, often one prescriber doesn’t know what another has ordered, or prescribers are not aware of over-the-counter medications patients are taking. Sometimes, too, patients will tell the prescriber about “medications” (pills) they purchase over-the-counter, but fail to recognize that such things as eye drops, ear drops, nasal sprays, topical creams, and herbal products are also “medications”.

Drug overdose rates have risen dramatically in the US in the past 40 years, and resulted in over 27,000 unintentional drug deaths in 2007 (CDC, 2010). A major cause of death is inappropriate use of opioid analgesics, far exceeding deaths from illegal substances such as cocaine and heroin. Partly because of an initiative begun several years ago to ensure adequate pain control for patients, there has been a significant increase in the number of opioid medications prescribed. Ohio is among the states with high death rates from these substances. For both men and women, death rates from overdoses are highest in the 45-54 year-old age group. Nonmedical use of prescription and over-the-counter drugs is now a major cause of visits to emergency rooms (over one million visits in 2008). “Non-medical” use may include taking more or less than the prescribed amount, taking a drug for a purpose other than that for which it was prescribed, taking a drug prescribed for someone else, or substance abuse. Statistics do not reflect drug use as part of a suicide attempt.

Data published by the Ohio Department of Health (2010) indicates that the majority of people who take pain relievers get them free from a family member or friend. An Ohio Youth Risk Behavior Survey conducted in 2007 indicated that 26.5% of high school students reported that they had used a prescription drug without a personal prescription at least once in their lives.

The Ohio Department of Health, the Healthy Ohio program, and the Ohio Injury Prevention Partnership have produced a document entitled “Epidemic of Prescription Drug Overdose in Ohio” (http://www.healthyohioprogram.org/ASSETS/8D54F439CB7B4144B5B18573C7C586DA/drugfs.pdf). According to this resource:

• Unintentional drug poisoning became the leading cause of injury death in Ohio in 2007
• Ohio’s death rate from unintentional drug poisoning increased 300% in 10 years (between 1999 and 2008)
• Between 2006 and 2008, an average of four Ohioans died every day due to drug overdoses
• The drug category most responsible for the increase in injury death is opioids
• There is a “strong relationship” between increase in sales of prescription opioids and fatal unintentional drug poisonings
• Use of multiple drugs of all types increases the risk
• The age group most at risk is 45-54, with more males than females affected
• Sixteen percent of people who died from unintentional drug poisonings in 2008 had been “doctor shopping” – getting prescriptions filled from at least five different prescribers in a year
• Twenty-five percent of the people who died from unintentional opiate poisonings in 2008 did not have a record of having received a valid prescription for the opiate within two years prior to death, indicating that these drugs had been obtained by diversion (getting them from a source other than an authorized prescriber and pharmacist)

As a result of these findings, the Ohio Drug Abuse Task Force was formed. The task force submitted a report to the governor in October of 2010 (http://www.odh.ohio.gov/ASSETS/895B95C591534F7A82A815A69A00011E/OPDATF%20final%20report.pdf). Reasons for the “epidemic” of drug abuse and related injuries are attributed to self-prescribing habits of many people, direct-to-consumer advertising by pharmaceutical companies, the availability of various types of medications through the internet, the proliferation of “pill mills”, and the growing use of opioids for pain management. Recommendations in the report include involvement of law enforcement, regulatory agencies, treatment providers, and public health entities to decrease the problem. These recommendations led to legislation passed by the Ohio General Assembly in May of 2011, which will be described later in this study.

Reasons for Non-adherence

Research reported by AHRQ indicates that there is a 20-50% non-adherence rate with medications for chronic conditions. More specifically, 20-30% of people don’t fill their prescriptions, and up to 50% fill the prescription but don’t take the medication as prescribed. This lack of adherence to the prescribed plan for use of medications tends to be worse with patients who have “silent” conditions like hypertension or hypercholesterolemia. When there is no clear evidence of a disease presence, there seems to be less motivation for the patient to take the medication. Similarly, people who are prescribed antibiotics often take the medication only until symptoms disappear, rather than taking the full does of the medication as prescribed. Unfortunately, people then often "stockpile" the remainder of the medication, leading to the potential for self-medication later. The saved portion of the antibiotic may be past its expiration date, may be the wrong antibiotic for the new infection, and certainly will not be the "full dose" of drug to treat the new condition. Poor adherence to medication prescriptions results in a higher rate of complications, more need for hospitalization, and higher risk of death.

AHRQ identifies both system and individual factors that impact appropriate use of medications.

System factors affecting lack of adherence to a medication plan include:

• Lack of ability to purchase the medication (either initially or for refills)
• Inadequate instructions for taking the medication
• Insufficient labeling on the medication container
• Inadequate information given to the patient about the benefits and risks of the medication
• Lack of access to a healthcare provider for monitoring of the condition and effectiveness of the plan of care

Individual factors which may cause a patient not to take a medication as prescribed include:

• Inability to understand the need for the medication or how to take it
• Lack of motivation to take the medication
• Lack of insurance coverage for the medication or associated provider visits
• Substance abuse, depression, or other psychosocial issues impacting adherence
• Personal schedules or issues impacting the ability to take the medication as prescribed

Non-adherence takes many forms. Taking more or less of a medication than prescribed, taking the medication on a different schedule than prescribed, omitting doses of the drug, or taking it in a way that is not recommended (with food, on an empty stomach, at bedtime, etc.) are examples.

Examples of lack of clarity in instructions include such things as:

Take with meals - does this mean before, during or after the meal? What if the patient eats only twice a day - does that mean take two pills a day? What if the patient has three meals and two snacks per day - does that mean to take three pills or five?

Take at bedtime - does it really matter whether the patient goes to bed at 8 pm or midnight? What about the person who works night shifts - when should he/she take the medication? Why is bedtime preferred - if the provider doesn't explain that, the patient won't see the value and is less likely to adhere to the plan.

The purpose of the literature review and analysis conducted by AHRQ was to “maximize the quality of care for adults with chronic disease by seeking to identify individual – and system-level interventions that have been shown to improve medication adherence”.

Vulnerable Populations

Although medication adherence is key to quality care for any patient, there are some groups of patients that are particularly at risk. Those from minority groups, those with low health literacy, and the elderly are among the most vulnerable. Health literacy is defined by the Centers for Disease Control and Prevention (CDC) as the ability to take in, understand, and act on health information. Clearly a person who does not understand the importance of the medication, cannot read or understand the instructions on the medication label, or does not have the physical or mental capability to follow the instructions is at risk for non-adherence to the medication plan.

Interventions

The AHRQ report contends that “support of adherence to treatment of chronic illness…requires active engagement of patients in their treatment over time”. A number of studies have been done related to adherence to medication regimens, but because they have had different approaches to types of conditions, types of patients, and adherence strategies, it is difficult to determine specific effective intervention strategies.

The Agency for Healthcare Research and Quality published a consumer guide to taking medicines safely (Clancy, 2008). Specific suggestions include:

• Take a list or a bag with all your medicines when you go to the doctor's office, pharmacy, or hospital. Make sure you include all prescription and over-the-counter medicines as well as vitamins and supplements. If your doctor prescribes a new medicine, ask if it is safe to take it with your other medicines.
• Ask questions about your medicines. Choose a pharmacist and doctor you feel comfortable with. Ask them to use plain language when they answer your questions. If you think you'll need help, have a friend or relative come with you to ask questions and remind you of the answers.
• Make sure your medicine is what your doctor ordered. Because many drugs have names that sound or look alike, your doctor and pharmacist should take steps to prevent mix-ups. But it's always wise to double-check. Ask your pharmacist if you think the medicine you received is different than what your doctor told you or wrote on the order. If you are getting a refill, make sure the medicine looks the same as the kind you got before.
• Ask how to use the medicine correctly. Read the directions on the label, and ask your pharmacist or doctor to explain anything you don't understand. Find out if there are medicines, foods, or activities (like driving or using alcohol or tobacco) you should avoid when taking the medicine. Ask if you need to have a test to check if the medicine is working or is causing a side effect.
• Ask about possible side effects. "Side effects" are reactions, like getting an upset stomach after taking an antibiotic, that aren't part of the intended effect of the medicine. Side effects can occur with many medicines. Ask your doctor or pharmacist if your medicine can cause side effects, what types of side effects you should watch for, and whether they are likely to be serious. Some side effects, like dizziness, may go away after you have been taking a medicine for a while. Call your doctor if you have a side effect that is serious or does not get better. Your doctor may need to change your medicine or adjust the dose.

The United States Food and Drug Administration (FDA) has developed the Safe Use Initiative to address the issue of proper and safe medication use. As noted on the FDA web site, http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/default.htm,

The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the healthcare community. The goal of the Safe Use Initiative is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use.

This source estimates that up to three billion prescriptions are written each year in the US. Errors in prescribing, dispensing, and/or administration (either self-administered or other-administered) have the potential to significantly impact consumer health and well-being. In its 2007 report, the Institute of Medicine (IOM) indicated that 1.5 million or more adverse drug event occur each year in our healthcare system, with resultant costs exceeding $4 billion per year.Therefore, interventions to prevent avoidable drug events save money and save patients’ lives and health.

The Centers for Disease Control and Prevention (CDC) has begun a Medication Safety Program as part of its Division of Healthcare Quality Promotion. In part, this is due to the fact that there are over 27,000 unintentional drug poisonings in the US each year. CDC defines drug poisoning as follows: “A poisoning occurs when a person’s exposure to a natural or manmade substance has an undesirable effect. A drug poisoning occurs when that substance is an illegal, prescription, or over-the-counter drug.”

Based on these concerns, the CDC offers a number of recommendations to various stakeholders.

For providers:

• Prescribe non-opioid medications for pain, unless there are clear indications to use opioids. In that case, use the lowest dose possible.
• Consult with a pain specialist if pain control is difficult to achieve.
• Avoid prescribing long-acting or controlled-release opioids for acute pain.
• Use available state monitoring resources related to drug monitoring

For insurance companies and pharmacy benefits managers:

• Identify patients receiving high doses of opioids from two or more prescribing sources or other inappropriate uses, and notify the prescriber(s)
• When use of multiple prescribers cannot be justified, prescriptions should be limited to one prescriber and one pharmacy

For states:

• Use existing monitoring programs to report to providers if patients under 65 are receiving opioids for more than 6 weeks by two or more prescribers or if there are other signs of inappropriate use.
• If no state monitoring program exists, work to create one.

The Institute of Medicine (2006), as a result of its work on medication safety, has published a fact sheet for patients entitled “What You Can Do To Prevent Medication Errors” (http://iom.edu/~/media/Files/Report%20Files/2006/Preventing-Medication-Errors-Quality-Chasm-Series/medicationerrorsfactsheet.pdf ). Tips included in this document include:

At home:

• Keep a current list of all medications, including herbals and other related products
• Take the list with you to health care provider visits
• Seek reliable web sites and other credible sources of information about your medications

At the pharmacy:

• Double check that the drug you receive is what was ordered
• Talk with the pharmacist to review your medications and ask questions as needed, including information about how to take the medication, what side effects might occur, and how to address any problems that might arise
• Ask for written information about the medication

In the provider’s office or clinic:

• Ask for written information about the name of the drug, dosage, and instructions
• Be sure you understand how to take the drug properly, ask questions as needed
• Ask about side effects and what to do if they occur

In the hospital:

• Be sure you know what drugs you are being given
• Don’t accept any medications without an explanation of why you are receiving them
• If you are going to have surgery, ask about how you should change your pattern of taking medications, if needed
• Prior to discharge, clarify the medications you are to take at home

In Ohio, the Ohio Patient Safety Institute has published a brochure template that can be adapted for use by prescribers. The brochure, entitled “Medication Safety Begins With You”, can be found at http://www.ohiopatientsafety.org/meds/Brochures/MedBro8.5%20x%2011.pdf. It includes links to a number of credible web sites with medication safety information, as well as incorporating many of the tips recommended above. One notable feature encourages patients to “be your own best health care champion” by self-advocacy, asking questions, and sharing information with prescribers and pharmacists. A variety of additional resources for patients and providers can be found at http://www.ohiopatientsafety.org/meds/

The Ohio Department of Health has a program entitled “Prescription for Prevention”, which includes a plan for safe drug disposal days. This plan has been implemented to help Ohio residents clear their homes and medicine cabinets of medications that are no longer needed. People may have unneeded medications at home for several reasons, including but not limited to:

• they are prescribed the same drug they already have but in a different dosage – they fill the new prescription but don’t get rid of the old one
• they are prescribed a different drug for the same condition because the first drug wasn’t effective – they fill the new prescription but do not discard the old one
• they don’t take a medication (such as an antibiotic) as prescribed, so have some “left over” – they may decide to keep the medication for future use, not realizing that the medication may lose or gain potency over time or may not be appropriate for another type of problem
• they “forget” that they have a medication because it’s not in a place where medications are usually kept
• they “borrowed” a medication from a friend, family member, or another person
• they obtained a drug through illicit means

Regardless of the cause, drug disposal days, which have now been held in many communities across Ohio, allow and encourage citizens to clean their medicine cabinets and safely discard medications, no questions asked. This offers a safe alternative for those who are embarrassed or uncomfortable talking to their healthcare providers about “extra” medications they may have at home. These programs have proved to be very well received in the communities where they have been implemented.

Legislation was passed in Ohio in May of 2011 to address the issue of prescription drug abuse. Among other things, this legislation enhances the Ohio Automated Rx Review System (OARRS), limits prescribers’ ability to furnish certain drugs to patients, and improves regulation of pain management clinics. Additionally, this legislation supports a state-wide system to assist people with safe ways to discard unneeded medications.

Safe Disposal of Medications

Other than participation in drug disposal days, many people wonder about the safest way to discard medications they no longer need. The FDA has published a guide for medication disposal, available at http://www.fda.gov/forconsumers/consumerupdates/ucm101653.htm

This guide recommends:

1. Check the label on the medication packaging to see if there are specific disposal instructions. If so, follow those directions. Many opiates come with specific instructions to flush, so that the substance cannot be used by another person. The risk to the environment is less than the risk to other humans who might retrieve and use the drug.
2. Take the drugs out of their original container and mix them with coffee grounds, kitty litter, or another type of “undesirable substance” that would preclude their retrieval, put the material in a sealable bag or container, then throw it in the trash
3. Throw the medication container in the trash separately, but first scratch out all personally identifying information
4. Read and follow specific disposal instructions for aerosols and inhalers

One Example of a Plan to Help Patients Manage Medications

The FDA (2011) has been engaged in a public education campaign to inform people about the potential toxic effects of acetaminophen. This has become an important issue, since there have been a significant number of persons suffering liver damage or death as a result of taking more than the recommended dosage of this medication. In fact, acetaminophen overdose is the most common reason for the need for liver transplants as a result of liver damage. One of the problems is that many people presume that over-the-counter medications are “safe”. An additional problem with this particular drug is that is an ingredient in many other medications. Thereforea person taking acetaminophen as a self-selected over-the-counter medication for pain may not realize that he is contributing to liver damage because he is also taking prescribed medications containing the same drug. Because the prescriber is not aware of the self-selected medication, there is no way to monitor exactly how much acetaminophen the patient is ingesting. Part of this initiative is directed toward education of the public. Another significant part is informing prescribers and pharmacists to advise patients appropriately about use of over-the-counter acetaminophen in relation to prescribed medications containing the same ingredient. A third component of this initiative relates to pharmaceutical manufacturers clearly labeling both prescription and non-prescription drugs so consumers will know the ingredients of each.

Patient Teaching

Additional recommendations include clear communication between patients and prescribers. According to CDC, patients should as such questions as:

• Why am I taking this medicine?
• What are the common problems to watch for?
• What should I do if they occur?
• When should I stop this medicine?
• Can I take this medicine with other medicines that I take?

Asking these questions will help patients understand their medications and hopefully develop plans for safe use of all medications, both prescription and over-the-counter.

At home, there are additional precautions that can be taken for safe medication use. Things to include in patient teaching are:

• Use medications only for their intended purposes
• Dispose of medications properly when you are finished taking them, or when you have a new prescription that makes the previous one invalid
• Do not share medications with other people, even immediate family members
• Keep medications in a safe place. This may sound like a “no-brainer”, but bears reinforcement in light of the facts noted earlier about the number of people who are injured or die because they take medications not prescribed for them.
• Keep medications away from children and pets.
• Read instructions carefully to be sure medications are stored appropriately in the home. For example, the moisture and humidity in a bathroom may preclude storage of some medications in the bathroom “medicine” cabinet. Other medications should be kept out of direct sunlight or in a cool place. Still others require refrigeration.
• Do not keep medications past their expiration dates. The safe use of the medication may be compromised once the expiration date is past.
• Use a consistent healthcare provider and pharmacy. If your medical condition(s) require you to see a number of providers, be sure everyone knows ALL medications you are taking, not just the ones prescribed by that provider. Use of a consistent pharmacy allows the pharmacist to monitor possible drug interactions and/or incompatibilities.
• Keep a personal record of all medications (prescription, over-the-counter, herbals, medicated lotions/creams, etc.) you are taking and using. If you are taking/using several medications, a computer spreadsheet may help you keep an accurate list. Note the name of the medication, the dosage, the date prescribed, the prescriber, and any other relevant information. Be sure to update the list as change occur.
• Be sure you can read the label on the medication. If the print is too small or part of the label is obscured, ask the pharmacist for assistance.
• Take medications only as prescribed. Do not take more or less of the medication than instructions indicate. If you are concerned about not being able to afford your medication, do not split pills or otherwise adjust dosages to make the medication last longer. Talk to your prescriber about other options that might be less expensive or to see if the pharmacy has a program to assist with medication costs.
• Remember that both federal and state statistics indicate a high rate of drug diversion. Many people are obtaining their medications from sources other than their prescribers. Be cautious about medications that might be accessible to unauthorized persons, including teens or visitors to your home.

Summary

Safe use of medications has become a significant problem in the United States. Unintentional injury and death result from unsafe use of medications, and statistics support this to be a major area of concern. In the home, ambulatory care areas, and hospitals, steps need to be taken to assist patients in the safe use of medications. Additionally, patients need to be encouraged to be assertive and proactive in making sure they understand and use their medications appropriately. This study has highlighted the problems associated with unsafe medication use and presented a number of options to assist people in safe use of their medications.

References and Resources

Agency for Healthcare Research and Quality (2011).Closing the Quality Gap Series: Comparative Effectiveness of Medication Adherence Interventions. Retrieved 8/22/11 from http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=764#3444

Centers for Disease Control and Prevention (2011).Medication Safety Basics. Retrieved 9/10/11 from: http://www.cdc.gov/medicationsafety/basics.html

Centers for Disease Control and Prevention (2010).Unintentional Drug Poisonings in the United States. Retrieved 9/10/11 from: http://www.cdc.gov/HomeandRecreationalSafety/pdf/poison-issue-brief.pdf

Clancy, C. (2008) Tips for taking medicine safely. Retrieved 9/10/11 from http://www.ahrq.gov/consumer/cc/cc010208.htm

Institute of Medicine (2006).Preventing Medication Errors.Washington DC; National Academies Press.

Ohio Department of Health (2010).Drug Disposal Day Guidelines. Retrieved 9/10/11 from http://www.ohiopatientsafety.org/meds/Brochures/Drug%20Disposal%20Day%20Guidelines_FINAL.pdf

US Food and Drug Administration (2011). Safe Use Initiative: Acetaminophen Toxicity. Retrieved 9/10/11 from http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/ucm230396.htm