Original Article Journal of Addictions Nursing & Volume 25 & Number 3, 114Y121 & Copyright B 2014 International Nurses Society on Addictions
Managing Prescription Drug Diversion Risks Caring for Individuals at Home Juliann Pancari, RN-BC, BSN, MEd, CHPCA, CAADC, CCS, ICCDPD m Carolyn Baird, DNP, MBA, RN-BC, CARN-AP, ICCDPD
Abstract As the Society for the Study of Addiction concluded in their 2010 study of prescription drug diversion and sourcing, friends and family members are identified as a significant source for drugs being abused. The 2010 National Conference of State Legislatures reported that a national drug survey found more than half of the nonmedical users of prescription pain relievers acquire them at no cost from a friend or relative (Hanson, 2010). The Harvard Medical Letter (2011) reported that 70% of prescription drug abusers identify their source as a family member or friend. Specific to this article, the family member or friend may be associated with the individual receiving home care or hospice services in their home. As the life span across the United States increases, the graying of America presents healthcare providers with many societal and managed care challenges. In addition to managing patient symptoms and related treatment, home care and hospice care providers need to expand their plan of care to include the risks of drug diversion. Keywords: addiction, aging, diversion, end-of-life care, home care, hospice, opiate, prescription drug abuse, prescription medications, substance abuse
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he graying of America presents healthcare providers with many societal and managed care challenges. Goals for healthcare excellence include achieving outcomes that demonstrate appropriate utilization of resources and fiscal allocations and exceed the expectations of the patient and his family, as well as the provider and financial intermediaries. hospice and home care services are a critical part of this plan, providing a care option that supports an individual’s desire to age and die with dignity in their home where they are most comfortable and have their most valued social support.
Juliann Pancari, RN-BC, BSN, MEd, CHPCA, CAADC, CCS, ICCDPD, Gentiva Hospice, Pittsburgh, Pennsylvania, and Nursing Faculty, Pittsburgh Technical Institute, Oakdale, Pennsylvania. Carolyn Baird, DNP, MBA, RN-BC, CARN-AP, ICCDPD, Counseling and Trauma Services, Canonsburg, Pennsylvania. The authors report no conflict of interest. The authors alone are responsible for the writing and content of this article. Correspondence related to content to: Juliann Pancari, 134 Greenwood Dr., Bridgeville, PA 15017. E-mail: [email protected] DOI: 10.1097/JAN.0000000000000036 114
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The issues considered in formulating the care plan for the individual identified are complex and interrelated. The choice to pursue palliative rather than curative measures entails intensive and emotional interactions with all involved in the individual’s life. development of the action plan/plan of care must comprehensively meet the needs of this individual within all best practice medical and regulatory guidelines. Ideally, the concerted efforts and commitment on the part of family and health professional caregivers to maintain the individual at home results in a successful reduction in hospital and emergency room services. The home care and hospice provider is responsible for managing the patient’s symptoms and treatment, including medications and related therapies, as well as goals and interventions tailored to the individualized plan of care. Outcome measurement and the establishment of best practices include a thorough clinical review of both effective management and under management of pain. One common clinical finding in both areas is the increase in prescribing opioids for analgesia. What is significant for the individual being medically managed and treated for comorbidities, particularly in cases of progressive disease with the prognosis of death within 6 months or less, is that the environment of care may be especially appealing to a caregiver with addiction to prescription drugs. As the Society for the Study of Addiction concluded in their 2010 study of prescription drug diversion and sourcing, friends and family members are identified as a significant source for drugs being abused (Fischer, Bibby, & Bouchard, 2010). Furthermore, the 2010 National Conference of State Legislatures reported that according to a national drug survey more than half of the nonmedical users of prescription pain relievers get them from a friend or relative for free (Hanson, 2010). The Harvard Medical Letter (2011) reported that 70% of prescription drug abusers identify their source as a family member or friend. That family member or friend may be a casual friend, extended family member, or a member of the immediate family of the individual receiving home care or hospice services in their home (see Figure 1). Assessing the effectiveness of a medication for symptom management can be achieved by various parameters and reliable measures. It is essential that this assessment includes steps to minimize the risk of drug diversion as part of every patient’s plan of care. Addiction and substance abuse have no boundaries and are not isolated to the behavioral health community. The treatment and assessment of dual disorders and co-occurring disorders cannot be adequately addressed without also considering July/September 2014
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Statistics from the Harvard Mental Health Letter (2011) reveal that over half of individuals who use prescription drugs nonmedically were able to get them from a friend or relative for free. Of these, 11.4% paid that relative or friend for them, and an additional 9% stole them from their friend or relative. In the case of more than three quarters of them, one doctor was responsible for prescribing them. This availability has led to a 96.6% increase in drug-related deaths over the last 5 years. Dr. Len Paulozzi, of the Centers for Disease Control and Prevention, has said, ‘‘The prescription drug abuse problem is a crisis that is steadily worsening’’ (Hanson, 2010, p. 22). In response to this growing concern, the White House Office of National Drug Control Policy developed a national approach, Epidemic: Responding to America’s Prescription Drug Abuse Crisis. This four part plan includes the following: 1. 2. 3. 4.
FIGURE 1. Where are prescription drugs obtained (National Institute on Drug Abuse, 2014)?
the presence of a medical diagnosis. For individuals in behavioral health, self-medicating, with both prescription and illicit drugs to include alcohol, will always compromise recovery and inhibit achieving wellness/treatment goals. Whether the goal is to drown out the voices, numb the feelings from trauma, promote sleep, lose weight, or achieve a desired mood, healthcare providers must be cognizant of these factors and widen their scope of managing the plan of care to include the risk that prescription drugs may be diverted from the intended patient.
DRUG DIVERSION The matter of drug diversion is a global one, not isolated to hospitals and nursing facilities, nor is it solely related to professionals and paraprofessionals providing services in the environment of care. The National Survey on Drug Use and Health is a trending survey of national drug use statistics. It is conducted annually by the Substance Abuse and Mental Health Services Administration (SAMHSA) on a randomly chosen segment of the population reflecting individuals aged 12 and older who reside in the United States. Statistics from the 2010 survey showed that 22.6 million Americans used illicit substances in the month prior to the survey. This included the nonmedical use of prescription psychotherapeutics (SAMHSA, 2011). These numbers have not changed from 2002 to 2010, but recently there has been a sharp rise in the abuse of prescription drugs. Although marijuana has the highest percentage of use and abuse, prescription drugs have risen to second place (Schneider Institute for Health Policy, 2001). Journal of Addictions Nursing
mandatory education for prescribers, prescription monitoring programs, proper disposal of unused medications, and law enforcement involvement (Executive Office of the President of the United States, 2011a).
Education about the seriousness of drug diversion is not limited to professional resources. Public awareness is occurring through resources such as local newspapers. One local newspaper reported that the problem with prescription drugs is that they can be found in medicine cabinets. Citing the Centers for Disease Control and Prevention’s January 2012 report, more than 27,000 unintentional drug overdoses occurred in 2007 (Centers for Disease Control, 2012). The rates of opioid analgesic abuse and overdose deaths are highest among men, persons between the ages of 20 and 64 years, non-Hispanic Whites, and poor and rural populations (Charleston Daily Mail, 2012; Coben et al., 2010). Diversion by Caregivers in All Healthcare Settings The prevalence of substance use and addiction among nurses is comparable to the general public; abuse associated with drugs categorized as illicit is lower. Nurses are at increased risk for abuse of prescription medications (Darbro et al., 2011). Other medical professionals such as physicians and pharmacists are also more likely to use prescription drugs for reasons other than what they are prescribed for and in greater amounts than prescribed or to use them without a prescription. However, the high visibility of nurses, their greater representation in the workforce, and the vulnerability of women to substance abuse and addiction have drawn more attention. Areas of specialization identified as more at risk are emergency medicine, critical care, and anesthesia. Stress and other risk factors unique to the healthcare environment have been identified. Awareness of these risk factors has increased the focus on problems of drug diversion in healthcare settings, has increased peer assistance efforts, and has changed the way hospitals and clinics manage patient medications and controlled substances using Pyxis systems www.journalofaddictionsnursing.com
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and fingerprint access. Healthcare providers who are diverting medications may leave facilities with strong monitoring programs for settings with less restrictive access. These settings have been identified as nursing homes, home health, hospice, and community. Diversion by Medication When discussing prescription drug abuse, it is important to remember that psychotherapeutic drugs other than opioids may be abused. Statistics exist for opioid and opioid-like pain relievers, tranquilizers, stimulants, and sedatives available by prescription but not for psychoactive drugs such as Seroquel, bupropion, and buprenorphine. According to the 2010 National Survey on Drug Use and Health, first time nonmedical use was reported by 2.4 million individuals aged 12 and older or 6,600 new users each day. Broken down the numbers for new users was 2.0 million for pain relievers, 1.2 million for tranquilizers, 624,000 for stimulants, and 252,000 for sedatives (SAMHSA, 2011). The average age of individuals’ first time nonmedical use is 22.3 years. Pain relievers account for the earliest average first time use at 21 years. Others are stimulants at 21.2 years, sedatives at 23.5 years, and tranquilizers at 24.6 years. The nonmedical use of OxyContin has been identified as one of the leading causes of the current epidemic of prescription drug abuse and accounts for 598,000 new users each year with an average age of 22.8. The Police Chief in one community referenced the Drug Enforcement Agency (DEA) in reporting that opioids such as OxyContin and Vicodin, central nervous system depressants such as Xanax and Valium, and stimulants such as Concerta and Adderall are the most commonly abused prescription drugs (Lehr, 2012). REGULATORY COMPLIANCE AND MONITORING Availability of prescription drugs has been recognized as an area that needs more control and uniformity of regulatory over-
TABLE 1
sight. Manipulation of the system is well defined in the article on sourcing to include ‘‘prescription shopping’’ or ‘‘double doctoring.’’ The end-users of these medications may falsify illness to obtain a prescription from the physician, consult with more than one source to get more than one prescription for the same or similar drug, and even cross state lines to obtain prescriptions. ‘‘Script doctors’’ are those prescribers who are most likely to prescribe the requested drug (Fisher et al., 2010). One alarming example of ‘‘doctor shopping’’ occurred in 2008 when a woman in Georgia successfully identified 58 prescribers for Oxycodone. As a result, she obtained 3,655 pills in 1 year, an amount that would be considered to be a 1,679-day supply (AARP, Inc., 2012). The Government Accountability Office reported that in 2011 approximately 170,000 nationwide Medicare beneficiaries visited five or more physicians to obtain the drug and supply that fulfilled their needs (AARP, Inc., 2012). Clinical protocols and evidence-based practice provide guidelines for medication appropriateness to include dosage and frequency. As a result, monitoring of physician prescribing practices has intensified. Response to inquiries related to what the Centers for Medicare and Medicaid Services is doing to address prescription drug abuse included several measures to increase education and improve technology, focusing efforts on decreasing fraud and abuse, by initiating processes that allow information sharing between entities to include Centers for Medicare and Medicaid Services, the DEA, and prescribers and by providing training for healthcare professionals to be able to readily identify aberrant prescribing practices and prescription drug abuse (AARP, Inc., 2012). Stimmel (1997) identified several federal and state monitoring systems that have been in place to support efforts to readily detect inappropriate sale and use of mood-altering substances (see Table 1). The Society for the Study of Addiction credits prescription monitoring programs (PMPs) as key in diversion control efforts (Fischer et al., 2010). PMPs are surveillance systems that
Types of Prescription Drug Monitoring Programs
Initials
Name
Purpose
ARCOS
Automation of Reports and Consolidated Orders System
The Drug Enforcement Agency maintains this measure and requires all manufacturers and distributors to report transfers of controlled substances.
PADS
Prescription Abuse Data System
Established by the American Medical Association, the primary focus is to identify state-specific drug prescribing problem areas and the plan to address the identified problem.
MADAS
Medicaid Abusable Drug Audit System
Supports the ability to monitor all prescriptions for controlled substances that are paid for by Medicaid funding.
MCPPs
Multiple Copy Prescription Programs
Requires triplicate or duplicate copies of prescriptions for identified mood altering drugs, directing one copy to be maintained by the prescribing pharmacy, one to be submitted to the state, and a third one given to the prescribing physician for their records. The goal of this system is to deter forgeries, excessive prescribing, and attempts to alter the original prescription.
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document and record prescription or dispensing details about both the provider and the individual patient (Hanson, 2010). Most PMPs are electronic. This real-time data include both provider and patient prescription medication use and dispensing. Irregularities such as requests for and actual repeat dispensing as well as excessive prescription amounts are easier to identify and potential for abuse can be addressed. If warranted, this information may be utilized for further legal or regulatory investigation for fraudulent prescribing practices (Hanson, 2010; Maxwell, 2011). Statewide efforts have also increased to be able to share the information collected in the PMPs to reduce the opportunity for prescription drug seekers to obtain the drug by crossing state lines (Federation of State Medical Boards, 2013). Vicky R. McPheron from the National Conference of State Legislatures reported that most states are using prescription drug monitoring programs to help regulatory and law enforcement agencies and public health officials collect and analyze controlled substance prescription data. Statewide databases contain information from pharmacists and other prescribers on drugs dispensed in the state. Most states keep track of drugs with the most potential for abuse, such as painkillers, tranquilizers, stimulants, and some steroids, referred to as Schedules II, III, and IV drugs. As of late 2009, 40 states had laws establishing the monitoring programs and 33 states had programs in operation (Hanson, 2010). Funds for supporting the development and interoperability of these programs are made available through the National All Schedules Prescription Electronic Reporting Act (Executive Office of the President of the United States, 2011b; see Figure 2).
PMPs may be effective on the front end of managing prescription drugs; however, management of these medications once they are dispensed remains in the hands of the patient within the environment of care. Facility administration and diversion processes include internal pharmacy procedures and daily administration logs. Professional program development has been in place to support the investigation of individuals committing diversion violations. What remains more challenging is medication managed in the home, either by the individual for whom it is intended or by caregivers. In some instances, visitors or other family members coming into the home become involved in diversion of these medications. The Uniform Controlled Substances Act, initially written in 1970 and revised in 1990, recognizes the importance of the medical use of controlled substances. The Act distinguishes patients from addicts, emphasizes the importance of patient confidentiality, permits the use of chronic narcotic analgesic therapy for intolerable pain, and establishes a program to detect drug diversion (Stimmel, 1997, p. 334). Unfortunately, current medical practice and control efforts cannot monitor whether prescription drugs dispensed to consumers in the community are consumed as prescribed (Hanson, 2010). A recent report from the Executive Office of the President of the United States (2011a) recommends that regulations be established to include mandated measures, much like those already in place for firearms and hazardous materials management. This would involve securing prescriptions customarily diverted by ‘‘lock and key’’ measures. Even though this approach would be voluntary, educating caregivers about this option would be beneficial.
FIGURE 2. States with prescription drug monitoring programs (Executive Office of the President of the United States, 2011c). Journal of Addictions Nursing
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In some states, ‘‘take back’’ programs have been established so that individuals may have a safe and secure resource to dispose of unused, unneeded, or expired prescription drugs. The U.S. Department of Justice Drug Enforcement Administration Office of Diversion Control (2014) has orchestrated national takeback initiatives. This effort has had tremendous success in ridding homes and neighborhoods of expired and unwanted medications. At the DEA’s third National Prescription Drug Take-Back Day on October 29, 2011, more than 377,086 pounds of medications were turned in for safe and proper disposal at the 5,327 take-back sites across 50 states and U.S. territories. There have actually been four take-back days with April 2012 being the most recent. In the former three events alone, the partnership between the DEA, state, local and tribal law enforcement agencies, and community groups resulted in removing more than 995,185 pounds (498.5 tons) of these medications. More than 3,945 state, local, tribal, and community groups participate in raising awareness of this public health issue. The Office of Diversion Control facilitates disposal by offering to locate a collection site for interested groups, by coordinating with law enforcement agencies to host a collection site, and by providing access to the Take-Back Day Partnership Toolbox, which supplies useful downloads for parties interested in this initiative. The general public may also inquire about safe drug disposal by calling 1-800-882-9539. It is mandated that healthcare providers establish a process to dispose of unused medications in an environmentally responsible manner. Any measures taken to reduce risk of diversion and abuse by controlling access by potential abusers will in turn positively impact the environment. Although providers are encouraged to review Federal, state, and local laws regarding drug disposal, the Executive Office of the President of the United States (2011b) advises against the former practice of flushing expired or unwanted medications down the toilet. The Food and Drug Administration has identified some exceptions, and some pharmacies will label bottles when it is environmentally safe to flush the drug contained therein. In the absence of a take-back program, they recommend sealing expired or unwanted medications in bags along with used kitty litter, coffee grounds, or other material that makes retrieval of the medications wholly undesirable. Furthermore, in an effort to protect identity and preserve the privacy of personal health information, all identifying information should be scratched out on the prescription label. Individual home care and hospice providers are encouraged to have policies in place for managing these medications and their disposal in the home. Some of these measures, to include administration logs and lock boxes, will be discussed later in this article. Healthcare providers in the home may have processes in place to pick up emergency boxes and assist the home caregiver to properly dispose of the unused medications. Most hospice and home care providers have policies prohibiting nurses from transporting medications to and from the environment of care. Such directive helps to secure the physical safety and professional reputation of the clinician. Transporting a controlled substance can make one a target of drug abusers, and assuming responsibility for medication that is 118
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issued to another individual carries with it the risk of being accused of acting outside of the scope of nursing practice by engaging in unlawful dispensing. Just as home healthcare services have a responsibility to provide for disposal of sharps in approved containers, the individual plan of care must also effectively address medications and related supply management. the Commission on behalf of the Executive Office of the President of the United States (2011b) emphasized the need for all stakeholders to support and promote an evidence-based public education campaign to target appropriate use, secure storage, and provide for environmentally responsible disposal of prescription drugs, especially controlled substances. This requires the cooperation of the full spectrum of individuals and organizations involved in patient care, as well as community, professional, and law enforcement agencies. CARING FOR INDIVIDUALS WHERE THEY ARE Eligibility and diagnosis-specific protocols determine length of stay and coverage limits for hospitalization, and managed care governs allocation of healthcare dollars when individuals reside in facilities. Add these factors to the personal preferences of individuals and their families, and it is no wonder that many patients prefer to remain in a private home to receive the care they need for as long as is practicable. When the environment of care is other than a 24/7 facility, the challenges and partnerships with community and healthcare professionals, the patient, family, and caregivers becomes primary. Many caregivers are family members who reside full time in the home. In other instances, family and friend caregivers develop a schedule that rotates who is in the home at various times and days of the week. home care and hospice service providers assist the patient and his family to adequately provide the care that is needed. Communication between healthcare professionals and caregivers is vital. many home caregivers do not have healthcare backgrounds; therefore, it is the home care or hospice case manager who must assess the educational needs of the caregiver and address any deficiencies. This includes reviewing the plan of care and related interventions, discussing the assessment of the patient’s condition and related symptoms, and having resources in place for both the caregiver and healthcare professional to cooperatively provide the best care possible. Many caregivers in the home receive instruction in wound care and dressing changes as well as the importance of medication schedules and symptom assessment. They are given the responsibility to administer medications as prescribed and report when relief has or has not been achieved. Whereas the Harvard Mental Health Letter (2011) reported that consensus exists that prescribing opioids for chronic pain caused by cancer or experienced at the end of life is appropriate and humane, many family caregivers remain concerned that these medications impair the patient’s ability to communicate or cause the patient to become unresponsive, which can present challenges in basic care and is often uncomfortable for family July/September 2014
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to witness. The report from the Executive Office of the President of the United States (2011b) cites education as key to achieving adequate pain relief while avoiding incapacitation. In addition to caregivers in the home, visitors may have the opportunity to access medications and supplies in the environment of care. One community went so far as to recommend that prescription medications should not be kept in a medicine cabinet, the nightstand at the bedside, or in the kitchen. This increases easy access by others (Lehr, 2012). Diversion of medications is theft. In many instances, the patient and caregivers are unaware that medication may draw the attention of others and be available to anyone who comes into their place of residence (Burke, 2011). One cannot overlook the access to used needles and the importance of a secure storage and needle disposal system. With regards to medication management, resources and evidence-based clinical knowledge related to evaluating results with the medication prescribed must be reviewed at every visit as early identification of care issues, including undermedication, poor response to medication, and discrepancies between medication counts and administration records, can be discovered in a timely fashion. The fact remains that it may be interpreted as abuse when inadequate pain control has been identified in an individual who is being given subtherapeutic doses of a prescribed medication (World Federation of Right to Die Societies, 2000) and may indicate that diversion is occurring in the home environment of care. Healthcare providers may also develop a written ‘‘at home’’ agreement with the patient and identified caregivers as an additional means of documenting measures taken and monitoring concerns related to care and safety issues, including drug discrepancies. Should an investigation be warranted and a subsequent report made to authorities, consistent and thorough documentation will serve as evidence that the healthcare provider took all precautions to minimize threats to patient care or safety and that these matters were communicated to patient and caregivers whenever possible. It is the responsibility of the healthcare professional to confirm that the plan of care is being followed and to immediately address any suspicion that the medication is not being administered as prescribed. The plan of care should ensure that prescribed care, including medication schedules, is meeting the patient’s needs. It should also ensure that care is being provided in a safe environment. Anything less requires revision and further investigation. MEDICATION AND SYMPTOM MANAGEMENT IN THE HOME SETTING Because many caregivers have limited medical knowledge, caregiver education is essential. Forms used by home care and hospice staff may make total sense to another healthcare provider but are not so clear to a lay person. It is important that any notes or logs that case managers will be asking caregivers to complete are fully understood by the caregiver. At every visit, the home care or hospice staff member should review this information and provide feedback to the caregiver. Thorough documentation not Journal of Addictions Nursing
only supports excellence in quality of services delivered but results in more favorable outcomes. Communication between the home care or hospice case manager is verbal at every visit. In addition, the healthcare professional may utilize other methods to assess safety in the environment of care. The healthcare professional should provide the caregiver with the tools that support care. Many of these resources substantiate appropriateness of care delivery and provide an opportunity to determine whether under medicating or diversion of prescribed medications is occurring. The healthcare provider is familiar with the medication administration record but the home caregiver may also benefit from a log listing dates and times in which medication was administered. Such a log serves as a reminder of the administration schedule and is a resource useful to the healthcare provider when assessing a medication’s effectiveness. Documenting pain often requires some variability. Numerical measures such as the 1Y10 scales or a visual scale such as Wong Baker FACES (www.wongbakerfaces.org) provide tracking opportunities especially when associated with a time of the day. Adjustments in administration schedules will support relief and provide comfort. In addition, caregivers should be educated about other indicators of pain including grimaces, moans, and agitation. When either verbal or nonverbal symptoms of discomfort are noted by the healthcare provider, one of the first questions asked of the caregiver should be the last time medication given and the time it was administered. This also presents an opportunity to identify when the caregiver is uncomfortable administering the prescribed medications or if the caregiver needs further education about this aspect of the plan of care. Relative to suspected diversion, when reported or documented administration is more or less than what is identified in the plan of care, additional clinical assessment is warranted. Whenever possible, obtaining laboratory levels will help to determine therapeutic levels and assist the case manager and prescriber to make necessary modifications in dosage or schedule. Should the level reveal subtherapeutic levels, further investigation is needed. If the healthcare management team determines that the dosage and related schedule defined in the plan of care should be adequate to achieve the desired outcome and a review of medication on hand reveals missing supply that medication documented as administered also supports favorable patient response, the process to investigate possible diversion begins. In addition to clinical signs that the medication is not managing the patient’s pain, a report by the caregiver that medication has been lost, accidentally thrown away, or other reasons why medication cannot be accounted for would prompt discussion about diversion in the home. Given measures to monitor requests to fill prescriptions earlier than prescribing practices, reasons would need to be provided in order for prescribers or pharmacies to fill the prescription. This would trigger the ‘‘watch’’ for patterns of frequent requests. Identifying a secure place to store prescription medications and limit access is advised. The use of a lock box is a simple approach. Access by key would curtail unauthorized access. Both the caregiver and the home care or hospice case managers could establish a count log to be kept in this lock box. Discrepancies www.journalofaddictionsnursing.com
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between the count and the administration log could provide the first indicator of mismanagement of the medication as prescribed to include the possibility of theft or diversion. This check and balance system would also support disposal of expired or other medications that may no longer be part of the current plan of care. WHEN PRESCRIPTION DRUG DIVERSION IS SUSPECTED IN THE HOME Individuals with chronic illnesses, the elderly, and those requiring palliative or hospice care are particularly vulnerable in the home care setting. Statistics gathered by the American Psychological Association (2012) estimate that around 2.1 million older individuals experience treatment that may meet the criteria for abuse or neglect. It may be physical abuse ranging from shoving or slapping and escalating to restraining and severe beatings. Emotional or psychological abuse can entail name-calling, the ‘‘silent treatment,’’ manipulation, threats, and intimidation. Sometimes the abuse may be benign neglect such as inadvertent exposure to heat, cold, infection, hunger, or untreated illness or more deliberate attempts to cause harm by withholding food, medical treatment, a safe caring environment, or therapeutic doses of medication (www.gentiva.com). Most abuse and neglect occur in the home (American Psychological Association, 2012). Caregivers may be family, friends, or employees whose responsibilities include providing for the physical, social, and emotional well-being of the person. Failure to meet those needs, whether arising from casual disregard or deliberate action, may be considered abuse or neglect. For those individuals whose condition renders them especially dependent and vulnerable, caregivers have increased responsibility to advocate for safety and quality of life. assessing symptoms to determine if symptoms are illness or medication related and working proactively with caregivers serve to support and enhance patient well-being. Pain symptomatology is one of the areas where there is the most potential for difficulty. Caregivers frequently lack sufficient knowledge about pain and its management and have a great deal of difficulty sufficiently medicating pain. Cultural factors and fear of causing the individual under their care to become addicted are also at issue. The American Nurses Association has identified the issue of effective pain management as a patient right. The American Nurses Association position statement, Pain Management and Control of Distressing Symptoms in Dying Patients, states that nurses have a social responsibility and an ethical obligation to provide effective pain management (www.nursing world.org). This obligation would seem to include monitoring the effectiveness of pain medication provided by caregivers under their shared care and determining if neglect takes place during their absence. In those cases in which the patient appears to be receiving therapeutic doses of pain medication but is not experiencing relief, one may suspect that the medication has been tampered with so that some of it may have been diverted to the use of others. When a patient is receiving medication according to the instructions for administration but there is insufficient medication for the course of administration, diversion must 120
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be suspected. Diversion of medication is abuse and neglect, as the patient is not having his need for pain relief met, even when all efforts to provide for this aspect of care are in place. The caregiverVnurse, family member, or employeeVwho identifies that medication is missing and may have been diverted is responsible for reporting the alleged diversion. Healthcare professionals responsible for this individual’s care should schedule a care conference with all involved to discuss the plan. This would include restricting the quantity of the medication and any other action that facilitates proper use and execution of the medication management aspect of the plan of care. As with any ethical matter, healthcare providers may consult with an internal ethics committee. Membership is interdisciplinary to include administrators, physicians, nurses, and legal consultants. In some instances, individuals may have specific training or certification in ethics or law. A clinical case review will provide an opportunity to revise the plan of care to include the patient and identified caregivers and implement initiatives to ensure proper management of all medications in the home. Every state has agencies that are responsible for receiving and investigating allegations of abuse and neglect. One may contact the Eldercare locator at 1-800-677-1116 (American Psychological Association, 2012). The Area Agency on Aging sponsors the Eldercare Locator. The only information required is an address and a ZIP code. Making the report protects everyone, and no action is taken until a full investigation is made. The result can be anything from advocacy for the patient to mandated treatment in the event someone has been diverting medication. A number of additional resources are available. Partnership with law enforcement is always an option. Whereas entering the home based on suspicion alone is unlikely, local authorities may be willing to conduct surveillance of the neighborhood, and activities may identify a reason for further action. Frequently, when individuals are aware that concerns have been discussed with the legal entities, this may be enough to curb medication diversion and individuals who may be helping themselves to the home patient’s medications. The National Center on Elder Abuse (202-898-2586) provides information on prevention, training, technical assistance, and research. Most states have an information and referral line for locating services. Local telephone directories will have a number for the Area Agency on Aging that can give you that information. The place to report Medicaid fraud or provider abuse is to the Medicaid Fraud Control Units located in the State Attorney General’s office of each state. And finally, many states have Adult Protective Services that work with the Area Agency on Aging, Division or Department of Aging, or Department of Social Services. CONCLUSION This article reviews the significance of the risks associated with prescription drug diversion in the private home environment of care and offers suggestions for measures to monitor and minimize this occurrence. As pain management and comfort are key outcomes of home care and hospice service standards and resources and collaborative partnerships have been established to achieve July/September 2014
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these goals, the threats and challenges have also been identified. The potential for diversion and abuse of prescription drugs remains high. Multiple sources concur that prescription drug abuse is a threat to public health and public safety, as well as to the quality of life of the individuals for whom these medications are intended to provide symptom relief. Case management is always a part of home care and hospice services. The individualized plan of care identifies the nurse as the primary healthcare professional responsible for ongoing patient assessment and communication with all entities involved in the patient’s care. The nurse rarely acts alone to revise any aspect of the plan of care and is the professional responsible for putting the resources in place to manage the patient’s care in the home. The individualized plan of care identifies the nurse’s responsibility to assess the effectiveness of the prescribed medications in managing symptoms. As a result, the nurse is likely to be the first to become aware that the patient may not be receiving medications as prescribed. The assessment of the environment of care involves all members of the care team. Social workers may become aware of risk factors involving safety and the ability for care to be delivered in the home in accordance with the individualized plan of care. Consultation with the attending physician, home care medical director, and hospice medical director should be timely and provide specific clinical indicators so that revision of the plan of care to achieve desired outcomes can be made, and documentation supporting investigation or reporting suspicion of diversion of prescribed medications in the home environment of care can proceed. Our commitment to healthcare excellence must take all necessary action to ensure appropriateness and effectiveness of the healthcare service provided. With the foundation of evidencebased treatments and medications supporting optimum outcomes of service delivery, efficient and effective management of any risk that threatens to minimize these efforts becomes a critical day-to-day factor requiring attention. As noted in the report from the Executive Office of the President of the United States, ‘‘No one agency, system, or profession is solely responsible for this undertaking.’’ Regardless of the agency, system, or profession, all would agree that individuals deserve to be treated with dignity and to receive the care needed to ensure quality of life along the entire life span. For end-of-life care and terminal disease state management, that includes taking all necessary measures to eliminate prescription drug diversion in the place the individual calls home. REFERENCES AARP, Inc. (2012, September). What an outrage: Drug abuse at Medicare’s expense. AARP Bulletin, 53(7), 6. American Psychological Association. (2012). Elder abuse and neglect: In search of solutions. Retrieved from http://www.apa.org/pi/aging/resources/guides/ elder-abuse.aspx Burke, J. (2011). Fighting diversion at home and in the workplace. Retrieved from http://pharmacytimes.com/publications/Issue/2011/March2011/ DrugDiversion-0311
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Charleston Daily Mail-West Virginia News. (2012, April 9). Prescription pills are the real drug problem. West Virginians must be careful to dispose of their unused drugs. Retrieved from http://dailymail.com/Opinion/ Editorials/201204090043?page=2&build=cache Centers for Disease Control. (2012, January 13). CDC grand rounds: Prescription drug overdosesVAU.S. epidemic. Retrieved from http://www.cdc.gov/ mmwr/preview/mmwrhtml/mm6101a3.htm Coben, J. H., Davis, S. M., Furbee, P. M., Sikora, R. D., Tillotson, R. D., & Bossaete, R. M. (2010). Hospitalizations for poisoning by prescription opioids, sedatives, and tranquilizers. American Journal of Preventive Medicine, 38(5), 517Y534. Darbro, N., Bainer, J. K., Dilling, T. A., Hoehn, K. A., Lindle, A., Malliarakis, K. D., & Kenward, K. (2011). Substance use disorder in nursing: A resource manual and guidelines for alternative and disciplinary monitoring programs. Chicago, IL: National Council of State Boards of Nursing (NCSBN). Executive Office of the President of the United States. (2011a). Epidemic: Responding to America’s prescription drug abuse crisis. Retrieved http://www .whitehouse.gov/sites/default/files/ondcp/issues-content/prescriptiondrugs/rx_abuse_plan.pdf Executive Office of the President of the United States. (2011b). The administration’s response to the prescription drug epidemic: Action items. Retrieved http://www.whitehouse.gov/sites/default/files/ondcp/issuescontent/action_items_response_to_the_prescription_drug_epidemic.pdf Executive Office of the President of the United States. (2011c). District of Columbia drug control update. Retrieved from http://www.whitehouse.gov/ sites/default/files/docs/state_profile_-district_of_columbia.pdf Federation of State Medical Boards. (2013). Prescription drug monitoring programs: State by state overview. Retrieved from http://www.fsmb.org/pdf/ GRPOL_pmp_overview_by_state.pdf Fischer, B., Bibby, M., & Bouchard, M. (2010). The global diversion of pharmaceutical drugs non-medical use and diversion of psychotropic prescription drugs in North America: A review of sourcing routes and control measures. Adingdon, England: Centre for Applied Research in Mental Health and Addictions, Society for the Study of Addiction. Hanson, K. (2010). A pill problem: Prescription drug abuse is the fastest growing form of substance abuse. Retrieved from www.ncsl.org Harvard Mental Health Letter. (2011). Painkillers fuel growth in drug addiction. Retrieved from http://www.health.harvard.edu Lehr, K. (2012, April 5). Make sure your home isn’t inviting to potential abusers. Retrieved from Amelia Community Page at http://local.cincinnati.com/ share/news/story.aspx?sid=191540 Maxwell, J. C. (2011). The prescription drug epidemic in the United States: A perfect storm. Drug and Alcohol Review. Austin, TX: Addiction Research Institute, School of Social Work, The University of Texas at Austin. National Institute on Drug Abuse. (2014). Popping pills: Prescription drug abuse in America. Retrieved from http://www.drugabuse.gov/relatedtopics/trends-statistics/infographics/popping-pills-prescription-drugabuse-in-america Schneider Institute for Health Policy. (2001). Substance abuse: The nations number one health problem. Princeton, NJ: The Robert Wood Johnson Foundation. Stimmel, B. (1997). Pain and its relief without addiction: Clinical issues in the use of opioids and other analgesics. New York, NY: The Hawthorne Medical Press, Inc. Substance Abuse and Mental Health Services Administration. (2011). Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings. NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Administration. Retrieved from http://oas.samhsa.gov/NSDUH/2k10NSDUH/ 2k10Results.pdf The World Federation of Right to Die Societies. (2000). Lawsuit alleges elder abuse for inadequate pain control. Retrieved from http://www.worldrtd.net U.S. Department of Justice Drug Enforcement Administration Office of Diversion Control. (2014). Got drugs? National prescription drug takeback day. Retrieved from www.deadiversion.usdoj.gov/drug_disposal/ takeback/index.html
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Managing Prescription Drug Diversion Risks Caring for Individuals at Home Juliann Pancari, RN-BC, BSN, MEd, CHPCA, CAADC, CCS, ICCDPD m Carolyn Baird, DNP, MBA, RN-BC, CARN-AP, ICCDPD
Abstract As the Society for the Study of Addiction concluded in their 2010 study of prescription drug diversion and sourcing, friends and family members are identified as a significant source for drugs being abused. The 2010 National Conference of State Legislatures reported that a national drug survey found more than half of the nonmedical users of prescription pain relievers acquire them at no cost from a friend or relative (Hanson, 2010). The Harvard Medical Letter (2011) reported that 70% of prescription drug abusers identify their source as a family member or friend. Specific to this article, the family member or friend may be associated with the individual receiving home care or hospice services in their home. As the life span across the United States increases, the graying of America presents healthcare providers with many societal and managed care challenges. In addition to managing patient symptoms and related treatment, home care and hospice care providers need to expand their plan of care to include the risks of drug diversion. Keywords: addiction, aging, diversion, end-of-life care, home care, hospice, opiate, prescription drug abuse, prescription medications, substance abuse
T
he graying of America presents healthcare providers with many societal and managed care challenges. Goals for healthcare excellence include achieving outcomes that demonstrate appropriate utilization of resources and fiscal allocations and exceed the expectations of the patient and his family, as well as the provider and financial intermediaries. hospice and home care services are a critical part of this plan, providing a care option that supports an individual’s desire to age and die with dignity in their home where they are most comfortable and have their most valued social support.
Juliann Pancari, RN-BC, BSN, MEd, CHPCA, CAADC, CCS, ICCDPD, Gentiva Hospice, Pittsburgh, Pennsylvania, and Nursing Faculty, Pittsburgh Technical Institute, Oakdale, Pennsylvania. Carolyn Baird, DNP, MBA, RN-BC, CARN-AP, ICCDPD, Counseling and Trauma Services, Canonsburg, Pennsylvania. The authors report no conflict of interest. The authors alone are responsible for the writing and content of this article. Correspondence related to content to: Juliann Pancari, 134 Greenwood Dr., Bridgeville, PA 15017. E-mail: [email protected] DOI: 10.1097/JAN.0000000000000036 114
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The issues considered in formulating the care plan for the individual identified are complex and interrelated. The choice to pursue palliative rather than curative measures entails intensive and emotional interactions with all involved in the individual’s life. development of the action plan/plan of care must comprehensively meet the needs of this individual within all best practice medical and regulatory guidelines. Ideally, the concerted efforts and commitment on the part of family and health professional caregivers to maintain the individual at home results in a successful reduction in hospital and emergency room services. The home care and hospice provider is responsible for managing the patient’s symptoms and treatment, including medications and related therapies, as well as goals and interventions tailored to the individualized plan of care. Outcome measurement and the establishment of best practices include a thorough clinical review of both effective management and under management of pain. One common clinical finding in both areas is the increase in prescribing opioids for analgesia. What is significant for the individual being medically managed and treated for comorbidities, particularly in cases of progressive disease with the prognosis of death within 6 months or less, is that the environment of care may be especially appealing to a caregiver with addiction to prescription drugs. As the Society for the Study of Addiction concluded in their 2010 study of prescription drug diversion and sourcing, friends and family members are identified as a significant source for drugs being abused (Fischer, Bibby, & Bouchard, 2010). Furthermore, the 2010 National Conference of State Legislatures reported that according to a national drug survey more than half of the nonmedical users of prescription pain relievers get them from a friend or relative for free (Hanson, 2010). The Harvard Medical Letter (2011) reported that 70% of prescription drug abusers identify their source as a family member or friend. That family member or friend may be a casual friend, extended family member, or a member of the immediate family of the individual receiving home care or hospice services in their home (see Figure 1). Assessing the effectiveness of a medication for symptom management can be achieved by various parameters and reliable measures. It is essential that this assessment includes steps to minimize the risk of drug diversion as part of every patient’s plan of care. Addiction and substance abuse have no boundaries and are not isolated to the behavioral health community. The treatment and assessment of dual disorders and co-occurring disorders cannot be adequately addressed without also considering July/September 2014
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Statistics from the Harvard Mental Health Letter (2011) reveal that over half of individuals who use prescription drugs nonmedically were able to get them from a friend or relative for free. Of these, 11.4% paid that relative or friend for them, and an additional 9% stole them from their friend or relative. In the case of more than three quarters of them, one doctor was responsible for prescribing them. This availability has led to a 96.6% increase in drug-related deaths over the last 5 years. Dr. Len Paulozzi, of the Centers for Disease Control and Prevention, has said, ‘‘The prescription drug abuse problem is a crisis that is steadily worsening’’ (Hanson, 2010, p. 22). In response to this growing concern, the White House Office of National Drug Control Policy developed a national approach, Epidemic: Responding to America’s Prescription Drug Abuse Crisis. This four part plan includes the following: 1. 2. 3. 4.
FIGURE 1. Where are prescription drugs obtained (National Institute on Drug Abuse, 2014)?
the presence of a medical diagnosis. For individuals in behavioral health, self-medicating, with both prescription and illicit drugs to include alcohol, will always compromise recovery and inhibit achieving wellness/treatment goals. Whether the goal is to drown out the voices, numb the feelings from trauma, promote sleep, lose weight, or achieve a desired mood, healthcare providers must be cognizant of these factors and widen their scope of managing the plan of care to include the risk that prescription drugs may be diverted from the intended patient.
DRUG DIVERSION The matter of drug diversion is a global one, not isolated to hospitals and nursing facilities, nor is it solely related to professionals and paraprofessionals providing services in the environment of care. The National Survey on Drug Use and Health is a trending survey of national drug use statistics. It is conducted annually by the Substance Abuse and Mental Health Services Administration (SAMHSA) on a randomly chosen segment of the population reflecting individuals aged 12 and older who reside in the United States. Statistics from the 2010 survey showed that 22.6 million Americans used illicit substances in the month prior to the survey. This included the nonmedical use of prescription psychotherapeutics (SAMHSA, 2011). These numbers have not changed from 2002 to 2010, but recently there has been a sharp rise in the abuse of prescription drugs. Although marijuana has the highest percentage of use and abuse, prescription drugs have risen to second place (Schneider Institute for Health Policy, 2001). Journal of Addictions Nursing
mandatory education for prescribers, prescription monitoring programs, proper disposal of unused medications, and law enforcement involvement (Executive Office of the President of the United States, 2011a).
Education about the seriousness of drug diversion is not limited to professional resources. Public awareness is occurring through resources such as local newspapers. One local newspaper reported that the problem with prescription drugs is that they can be found in medicine cabinets. Citing the Centers for Disease Control and Prevention’s January 2012 report, more than 27,000 unintentional drug overdoses occurred in 2007 (Centers for Disease Control, 2012). The rates of opioid analgesic abuse and overdose deaths are highest among men, persons between the ages of 20 and 64 years, non-Hispanic Whites, and poor and rural populations (Charleston Daily Mail, 2012; Coben et al., 2010). Diversion by Caregivers in All Healthcare Settings The prevalence of substance use and addiction among nurses is comparable to the general public; abuse associated with drugs categorized as illicit is lower. Nurses are at increased risk for abuse of prescription medications (Darbro et al., 2011). Other medical professionals such as physicians and pharmacists are also more likely to use prescription drugs for reasons other than what they are prescribed for and in greater amounts than prescribed or to use them without a prescription. However, the high visibility of nurses, their greater representation in the workforce, and the vulnerability of women to substance abuse and addiction have drawn more attention. Areas of specialization identified as more at risk are emergency medicine, critical care, and anesthesia. Stress and other risk factors unique to the healthcare environment have been identified. Awareness of these risk factors has increased the focus on problems of drug diversion in healthcare settings, has increased peer assistance efforts, and has changed the way hospitals and clinics manage patient medications and controlled substances using Pyxis systems www.journalofaddictionsnursing.com
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and fingerprint access. Healthcare providers who are diverting medications may leave facilities with strong monitoring programs for settings with less restrictive access. These settings have been identified as nursing homes, home health, hospice, and community. Diversion by Medication When discussing prescription drug abuse, it is important to remember that psychotherapeutic drugs other than opioids may be abused. Statistics exist for opioid and opioid-like pain relievers, tranquilizers, stimulants, and sedatives available by prescription but not for psychoactive drugs such as Seroquel, bupropion, and buprenorphine. According to the 2010 National Survey on Drug Use and Health, first time nonmedical use was reported by 2.4 million individuals aged 12 and older or 6,600 new users each day. Broken down the numbers for new users was 2.0 million for pain relievers, 1.2 million for tranquilizers, 624,000 for stimulants, and 252,000 for sedatives (SAMHSA, 2011). The average age of individuals’ first time nonmedical use is 22.3 years. Pain relievers account for the earliest average first time use at 21 years. Others are stimulants at 21.2 years, sedatives at 23.5 years, and tranquilizers at 24.6 years. The nonmedical use of OxyContin has been identified as one of the leading causes of the current epidemic of prescription drug abuse and accounts for 598,000 new users each year with an average age of 22.8. The Police Chief in one community referenced the Drug Enforcement Agency (DEA) in reporting that opioids such as OxyContin and Vicodin, central nervous system depressants such as Xanax and Valium, and stimulants such as Concerta and Adderall are the most commonly abused prescription drugs (Lehr, 2012). REGULATORY COMPLIANCE AND MONITORING Availability of prescription drugs has been recognized as an area that needs more control and uniformity of regulatory over-
TABLE 1
sight. Manipulation of the system is well defined in the article on sourcing to include ‘‘prescription shopping’’ or ‘‘double doctoring.’’ The end-users of these medications may falsify illness to obtain a prescription from the physician, consult with more than one source to get more than one prescription for the same or similar drug, and even cross state lines to obtain prescriptions. ‘‘Script doctors’’ are those prescribers who are most likely to prescribe the requested drug (Fisher et al., 2010). One alarming example of ‘‘doctor shopping’’ occurred in 2008 when a woman in Georgia successfully identified 58 prescribers for Oxycodone. As a result, she obtained 3,655 pills in 1 year, an amount that would be considered to be a 1,679-day supply (AARP, Inc., 2012). The Government Accountability Office reported that in 2011 approximately 170,000 nationwide Medicare beneficiaries visited five or more physicians to obtain the drug and supply that fulfilled their needs (AARP, Inc., 2012). Clinical protocols and evidence-based practice provide guidelines for medication appropriateness to include dosage and frequency. As a result, monitoring of physician prescribing practices has intensified. Response to inquiries related to what the Centers for Medicare and Medicaid Services is doing to address prescription drug abuse included several measures to increase education and improve technology, focusing efforts on decreasing fraud and abuse, by initiating processes that allow information sharing between entities to include Centers for Medicare and Medicaid Services, the DEA, and prescribers and by providing training for healthcare professionals to be able to readily identify aberrant prescribing practices and prescription drug abuse (AARP, Inc., 2012). Stimmel (1997) identified several federal and state monitoring systems that have been in place to support efforts to readily detect inappropriate sale and use of mood-altering substances (see Table 1). The Society for the Study of Addiction credits prescription monitoring programs (PMPs) as key in diversion control efforts (Fischer et al., 2010). PMPs are surveillance systems that
Types of Prescription Drug Monitoring Programs
Initials
Name
Purpose
ARCOS
Automation of Reports and Consolidated Orders System
The Drug Enforcement Agency maintains this measure and requires all manufacturers and distributors to report transfers of controlled substances.
PADS
Prescription Abuse Data System
Established by the American Medical Association, the primary focus is to identify state-specific drug prescribing problem areas and the plan to address the identified problem.
MADAS
Medicaid Abusable Drug Audit System
Supports the ability to monitor all prescriptions for controlled substances that are paid for by Medicaid funding.
MCPPs
Multiple Copy Prescription Programs
Requires triplicate or duplicate copies of prescriptions for identified mood altering drugs, directing one copy to be maintained by the prescribing pharmacy, one to be submitted to the state, and a third one given to the prescribing physician for their records. The goal of this system is to deter forgeries, excessive prescribing, and attempts to alter the original prescription.
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document and record prescription or dispensing details about both the provider and the individual patient (Hanson, 2010). Most PMPs are electronic. This real-time data include both provider and patient prescription medication use and dispensing. Irregularities such as requests for and actual repeat dispensing as well as excessive prescription amounts are easier to identify and potential for abuse can be addressed. If warranted, this information may be utilized for further legal or regulatory investigation for fraudulent prescribing practices (Hanson, 2010; Maxwell, 2011). Statewide efforts have also increased to be able to share the information collected in the PMPs to reduce the opportunity for prescription drug seekers to obtain the drug by crossing state lines (Federation of State Medical Boards, 2013). Vicky R. McPheron from the National Conference of State Legislatures reported that most states are using prescription drug monitoring programs to help regulatory and law enforcement agencies and public health officials collect and analyze controlled substance prescription data. Statewide databases contain information from pharmacists and other prescribers on drugs dispensed in the state. Most states keep track of drugs with the most potential for abuse, such as painkillers, tranquilizers, stimulants, and some steroids, referred to as Schedules II, III, and IV drugs. As of late 2009, 40 states had laws establishing the monitoring programs and 33 states had programs in operation (Hanson, 2010). Funds for supporting the development and interoperability of these programs are made available through the National All Schedules Prescription Electronic Reporting Act (Executive Office of the President of the United States, 2011b; see Figure 2).
PMPs may be effective on the front end of managing prescription drugs; however, management of these medications once they are dispensed remains in the hands of the patient within the environment of care. Facility administration and diversion processes include internal pharmacy procedures and daily administration logs. Professional program development has been in place to support the investigation of individuals committing diversion violations. What remains more challenging is medication managed in the home, either by the individual for whom it is intended or by caregivers. In some instances, visitors or other family members coming into the home become involved in diversion of these medications. The Uniform Controlled Substances Act, initially written in 1970 and revised in 1990, recognizes the importance of the medical use of controlled substances. The Act distinguishes patients from addicts, emphasizes the importance of patient confidentiality, permits the use of chronic narcotic analgesic therapy for intolerable pain, and establishes a program to detect drug diversion (Stimmel, 1997, p. 334). Unfortunately, current medical practice and control efforts cannot monitor whether prescription drugs dispensed to consumers in the community are consumed as prescribed (Hanson, 2010). A recent report from the Executive Office of the President of the United States (2011a) recommends that regulations be established to include mandated measures, much like those already in place for firearms and hazardous materials management. This would involve securing prescriptions customarily diverted by ‘‘lock and key’’ measures. Even though this approach would be voluntary, educating caregivers about this option would be beneficial.
FIGURE 2. States with prescription drug monitoring programs (Executive Office of the President of the United States, 2011c). Journal of Addictions Nursing
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In some states, ‘‘take back’’ programs have been established so that individuals may have a safe and secure resource to dispose of unused, unneeded, or expired prescription drugs. The U.S. Department of Justice Drug Enforcement Administration Office of Diversion Control (2014) has orchestrated national takeback initiatives. This effort has had tremendous success in ridding homes and neighborhoods of expired and unwanted medications. At the DEA’s third National Prescription Drug Take-Back Day on October 29, 2011, more than 377,086 pounds of medications were turned in for safe and proper disposal at the 5,327 take-back sites across 50 states and U.S. territories. There have actually been four take-back days with April 2012 being the most recent. In the former three events alone, the partnership between the DEA, state, local and tribal law enforcement agencies, and community groups resulted in removing more than 995,185 pounds (498.5 tons) of these medications. More than 3,945 state, local, tribal, and community groups participate in raising awareness of this public health issue. The Office of Diversion Control facilitates disposal by offering to locate a collection site for interested groups, by coordinating with law enforcement agencies to host a collection site, and by providing access to the Take-Back Day Partnership Toolbox, which supplies useful downloads for parties interested in this initiative. The general public may also inquire about safe drug disposal by calling 1-800-882-9539. It is mandated that healthcare providers establish a process to dispose of unused medications in an environmentally responsible manner. Any measures taken to reduce risk of diversion and abuse by controlling access by potential abusers will in turn positively impact the environment. Although providers are encouraged to review Federal, state, and local laws regarding drug disposal, the Executive Office of the President of the United States (2011b) advises against the former practice of flushing expired or unwanted medications down the toilet. The Food and Drug Administration has identified some exceptions, and some pharmacies will label bottles when it is environmentally safe to flush the drug contained therein. In the absence of a take-back program, they recommend sealing expired or unwanted medications in bags along with used kitty litter, coffee grounds, or other material that makes retrieval of the medications wholly undesirable. Furthermore, in an effort to protect identity and preserve the privacy of personal health information, all identifying information should be scratched out on the prescription label. Individual home care and hospice providers are encouraged to have policies in place for managing these medications and their disposal in the home. Some of these measures, to include administration logs and lock boxes, will be discussed later in this article. Healthcare providers in the home may have processes in place to pick up emergency boxes and assist the home caregiver to properly dispose of the unused medications. Most hospice and home care providers have policies prohibiting nurses from transporting medications to and from the environment of care. Such directive helps to secure the physical safety and professional reputation of the clinician. Transporting a controlled substance can make one a target of drug abusers, and assuming responsibility for medication that is 118
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issued to another individual carries with it the risk of being accused of acting outside of the scope of nursing practice by engaging in unlawful dispensing. Just as home healthcare services have a responsibility to provide for disposal of sharps in approved containers, the individual plan of care must also effectively address medications and related supply management. the Commission on behalf of the Executive Office of the President of the United States (2011b) emphasized the need for all stakeholders to support and promote an evidence-based public education campaign to target appropriate use, secure storage, and provide for environmentally responsible disposal of prescription drugs, especially controlled substances. This requires the cooperation of the full spectrum of individuals and organizations involved in patient care, as well as community, professional, and law enforcement agencies. CARING FOR INDIVIDUALS WHERE THEY ARE Eligibility and diagnosis-specific protocols determine length of stay and coverage limits for hospitalization, and managed care governs allocation of healthcare dollars when individuals reside in facilities. Add these factors to the personal preferences of individuals and their families, and it is no wonder that many patients prefer to remain in a private home to receive the care they need for as long as is practicable. When the environment of care is other than a 24/7 facility, the challenges and partnerships with community and healthcare professionals, the patient, family, and caregivers becomes primary. Many caregivers are family members who reside full time in the home. In other instances, family and friend caregivers develop a schedule that rotates who is in the home at various times and days of the week. home care and hospice service providers assist the patient and his family to adequately provide the care that is needed. Communication between healthcare professionals and caregivers is vital. many home caregivers do not have healthcare backgrounds; therefore, it is the home care or hospice case manager who must assess the educational needs of the caregiver and address any deficiencies. This includes reviewing the plan of care and related interventions, discussing the assessment of the patient’s condition and related symptoms, and having resources in place for both the caregiver and healthcare professional to cooperatively provide the best care possible. Many caregivers in the home receive instruction in wound care and dressing changes as well as the importance of medication schedules and symptom assessment. They are given the responsibility to administer medications as prescribed and report when relief has or has not been achieved. Whereas the Harvard Mental Health Letter (2011) reported that consensus exists that prescribing opioids for chronic pain caused by cancer or experienced at the end of life is appropriate and humane, many family caregivers remain concerned that these medications impair the patient’s ability to communicate or cause the patient to become unresponsive, which can present challenges in basic care and is often uncomfortable for family July/September 2014
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to witness. The report from the Executive Office of the President of the United States (2011b) cites education as key to achieving adequate pain relief while avoiding incapacitation. In addition to caregivers in the home, visitors may have the opportunity to access medications and supplies in the environment of care. One community went so far as to recommend that prescription medications should not be kept in a medicine cabinet, the nightstand at the bedside, or in the kitchen. This increases easy access by others (Lehr, 2012). Diversion of medications is theft. In many instances, the patient and caregivers are unaware that medication may draw the attention of others and be available to anyone who comes into their place of residence (Burke, 2011). One cannot overlook the access to used needles and the importance of a secure storage and needle disposal system. With regards to medication management, resources and evidence-based clinical knowledge related to evaluating results with the medication prescribed must be reviewed at every visit as early identification of care issues, including undermedication, poor response to medication, and discrepancies between medication counts and administration records, can be discovered in a timely fashion. The fact remains that it may be interpreted as abuse when inadequate pain control has been identified in an individual who is being given subtherapeutic doses of a prescribed medication (World Federation of Right to Die Societies, 2000) and may indicate that diversion is occurring in the home environment of care. Healthcare providers may also develop a written ‘‘at home’’ agreement with the patient and identified caregivers as an additional means of documenting measures taken and monitoring concerns related to care and safety issues, including drug discrepancies. Should an investigation be warranted and a subsequent report made to authorities, consistent and thorough documentation will serve as evidence that the healthcare provider took all precautions to minimize threats to patient care or safety and that these matters were communicated to patient and caregivers whenever possible. It is the responsibility of the healthcare professional to confirm that the plan of care is being followed and to immediately address any suspicion that the medication is not being administered as prescribed. The plan of care should ensure that prescribed care, including medication schedules, is meeting the patient’s needs. It should also ensure that care is being provided in a safe environment. Anything less requires revision and further investigation. MEDICATION AND SYMPTOM MANAGEMENT IN THE HOME SETTING Because many caregivers have limited medical knowledge, caregiver education is essential. Forms used by home care and hospice staff may make total sense to another healthcare provider but are not so clear to a lay person. It is important that any notes or logs that case managers will be asking caregivers to complete are fully understood by the caregiver. At every visit, the home care or hospice staff member should review this information and provide feedback to the caregiver. Thorough documentation not Journal of Addictions Nursing
only supports excellence in quality of services delivered but results in more favorable outcomes. Communication between the home care or hospice case manager is verbal at every visit. In addition, the healthcare professional may utilize other methods to assess safety in the environment of care. The healthcare professional should provide the caregiver with the tools that support care. Many of these resources substantiate appropriateness of care delivery and provide an opportunity to determine whether under medicating or diversion of prescribed medications is occurring. The healthcare provider is familiar with the medication administration record but the home caregiver may also benefit from a log listing dates and times in which medication was administered. Such a log serves as a reminder of the administration schedule and is a resource useful to the healthcare provider when assessing a medication’s effectiveness. Documenting pain often requires some variability. Numerical measures such as the 1Y10 scales or a visual scale such as Wong Baker FACES (www.wongbakerfaces.org) provide tracking opportunities especially when associated with a time of the day. Adjustments in administration schedules will support relief and provide comfort. In addition, caregivers should be educated about other indicators of pain including grimaces, moans, and agitation. When either verbal or nonverbal symptoms of discomfort are noted by the healthcare provider, one of the first questions asked of the caregiver should be the last time medication given and the time it was administered. This also presents an opportunity to identify when the caregiver is uncomfortable administering the prescribed medications or if the caregiver needs further education about this aspect of the plan of care. Relative to suspected diversion, when reported or documented administration is more or less than what is identified in the plan of care, additional clinical assessment is warranted. Whenever possible, obtaining laboratory levels will help to determine therapeutic levels and assist the case manager and prescriber to make necessary modifications in dosage or schedule. Should the level reveal subtherapeutic levels, further investigation is needed. If the healthcare management team determines that the dosage and related schedule defined in the plan of care should be adequate to achieve the desired outcome and a review of medication on hand reveals missing supply that medication documented as administered also supports favorable patient response, the process to investigate possible diversion begins. In addition to clinical signs that the medication is not managing the patient’s pain, a report by the caregiver that medication has been lost, accidentally thrown away, or other reasons why medication cannot be accounted for would prompt discussion about diversion in the home. Given measures to monitor requests to fill prescriptions earlier than prescribing practices, reasons would need to be provided in order for prescribers or pharmacies to fill the prescription. This would trigger the ‘‘watch’’ for patterns of frequent requests. Identifying a secure place to store prescription medications and limit access is advised. The use of a lock box is a simple approach. Access by key would curtail unauthorized access. Both the caregiver and the home care or hospice case managers could establish a count log to be kept in this lock box. Discrepancies www.journalofaddictionsnursing.com
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between the count and the administration log could provide the first indicator of mismanagement of the medication as prescribed to include the possibility of theft or diversion. This check and balance system would also support disposal of expired or other medications that may no longer be part of the current plan of care. WHEN PRESCRIPTION DRUG DIVERSION IS SUSPECTED IN THE HOME Individuals with chronic illnesses, the elderly, and those requiring palliative or hospice care are particularly vulnerable in the home care setting. Statistics gathered by the American Psychological Association (2012) estimate that around 2.1 million older individuals experience treatment that may meet the criteria for abuse or neglect. It may be physical abuse ranging from shoving or slapping and escalating to restraining and severe beatings. Emotional or psychological abuse can entail name-calling, the ‘‘silent treatment,’’ manipulation, threats, and intimidation. Sometimes the abuse may be benign neglect such as inadvertent exposure to heat, cold, infection, hunger, or untreated illness or more deliberate attempts to cause harm by withholding food, medical treatment, a safe caring environment, or therapeutic doses of medication (www.gentiva.com). Most abuse and neglect occur in the home (American Psychological Association, 2012). Caregivers may be family, friends, or employees whose responsibilities include providing for the physical, social, and emotional well-being of the person. Failure to meet those needs, whether arising from casual disregard or deliberate action, may be considered abuse or neglect. For those individuals whose condition renders them especially dependent and vulnerable, caregivers have increased responsibility to advocate for safety and quality of life. assessing symptoms to determine if symptoms are illness or medication related and working proactively with caregivers serve to support and enhance patient well-being. Pain symptomatology is one of the areas where there is the most potential for difficulty. Caregivers frequently lack sufficient knowledge about pain and its management and have a great deal of difficulty sufficiently medicating pain. Cultural factors and fear of causing the individual under their care to become addicted are also at issue. The American Nurses Association has identified the issue of effective pain management as a patient right. The American Nurses Association position statement, Pain Management and Control of Distressing Symptoms in Dying Patients, states that nurses have a social responsibility and an ethical obligation to provide effective pain management (www.nursing world.org). This obligation would seem to include monitoring the effectiveness of pain medication provided by caregivers under their shared care and determining if neglect takes place during their absence. In those cases in which the patient appears to be receiving therapeutic doses of pain medication but is not experiencing relief, one may suspect that the medication has been tampered with so that some of it may have been diverted to the use of others. When a patient is receiving medication according to the instructions for administration but there is insufficient medication for the course of administration, diversion must 120
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be suspected. Diversion of medication is abuse and neglect, as the patient is not having his need for pain relief met, even when all efforts to provide for this aspect of care are in place. The caregiverVnurse, family member, or employeeVwho identifies that medication is missing and may have been diverted is responsible for reporting the alleged diversion. Healthcare professionals responsible for this individual’s care should schedule a care conference with all involved to discuss the plan. This would include restricting the quantity of the medication and any other action that facilitates proper use and execution of the medication management aspect of the plan of care. As with any ethical matter, healthcare providers may consult with an internal ethics committee. Membership is interdisciplinary to include administrators, physicians, nurses, and legal consultants. In some instances, individuals may have specific training or certification in ethics or law. A clinical case review will provide an opportunity to revise the plan of care to include the patient and identified caregivers and implement initiatives to ensure proper management of all medications in the home. Every state has agencies that are responsible for receiving and investigating allegations of abuse and neglect. One may contact the Eldercare locator at 1-800-677-1116 (American Psychological Association, 2012). The Area Agency on Aging sponsors the Eldercare Locator. The only information required is an address and a ZIP code. Making the report protects everyone, and no action is taken until a full investigation is made. The result can be anything from advocacy for the patient to mandated treatment in the event someone has been diverting medication. A number of additional resources are available. Partnership with law enforcement is always an option. Whereas entering the home based on suspicion alone is unlikely, local authorities may be willing to conduct surveillance of the neighborhood, and activities may identify a reason for further action. Frequently, when individuals are aware that concerns have been discussed with the legal entities, this may be enough to curb medication diversion and individuals who may be helping themselves to the home patient’s medications. The National Center on Elder Abuse (202-898-2586) provides information on prevention, training, technical assistance, and research. Most states have an information and referral line for locating services. Local telephone directories will have a number for the Area Agency on Aging that can give you that information. The place to report Medicaid fraud or provider abuse is to the Medicaid Fraud Control Units located in the State Attorney General’s office of each state. And finally, many states have Adult Protective Services that work with the Area Agency on Aging, Division or Department of Aging, or Department of Social Services. CONCLUSION This article reviews the significance of the risks associated with prescription drug diversion in the private home environment of care and offers suggestions for measures to monitor and minimize this occurrence. As pain management and comfort are key outcomes of home care and hospice service standards and resources and collaborative partnerships have been established to achieve July/September 2014
Copyright © 2014 International Nurses Society on Addictions. Unauthorized reproduction of this article is prohibited.
these goals, the threats and challenges have also been identified. The potential for diversion and abuse of prescription drugs remains high. Multiple sources concur that prescription drug abuse is a threat to public health and public safety, as well as to the quality of life of the individuals for whom these medications are intended to provide symptom relief. Case management is always a part of home care and hospice services. The individualized plan of care identifies the nurse as the primary healthcare professional responsible for ongoing patient assessment and communication with all entities involved in the patient’s care. The nurse rarely acts alone to revise any aspect of the plan of care and is the professional responsible for putting the resources in place to manage the patient’s care in the home. The individualized plan of care identifies the nurse’s responsibility to assess the effectiveness of the prescribed medications in managing symptoms. As a result, the nurse is likely to be the first to become aware that the patient may not be receiving medications as prescribed. The assessment of the environment of care involves all members of the care team. Social workers may become aware of risk factors involving safety and the ability for care to be delivered in the home in accordance with the individualized plan of care. Consultation with the attending physician, home care medical director, and hospice medical director should be timely and provide specific clinical indicators so that revision of the plan of care to achieve desired outcomes can be made, and documentation supporting investigation or reporting suspicion of diversion of prescribed medications in the home environment of care can proceed. Our commitment to healthcare excellence must take all necessary action to ensure appropriateness and effectiveness of the healthcare service provided. With the foundation of evidencebased treatments and medications supporting optimum outcomes of service delivery, efficient and effective management of any risk that threatens to minimize these efforts becomes a critical day-to-day factor requiring attention. As noted in the report from the Executive Office of the President of the United States, ‘‘No one agency, system, or profession is solely responsible for this undertaking.’’ Regardless of the agency, system, or profession, all would agree that individuals deserve to be treated with dignity and to receive the care needed to ensure quality of life along the entire life span. For end-of-life care and terminal disease state management, that includes taking all necessary measures to eliminate prescription drug diversion in the place the individual calls home. REFERENCES AARP, Inc. (2012, September). What an outrage: Drug abuse at Medicare’s expense. AARP Bulletin, 53(7), 6. American Psychological Association. (2012). Elder abuse and neglect: In search of solutions. Retrieved from http://www.apa.org/pi/aging/resources/guides/ elder-abuse.aspx Burke, J. (2011). Fighting diversion at home and in the workplace. Retrieved from http://pharmacytimes.com/publications/Issue/2011/March2011/ DrugDiversion-0311
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Charleston Daily Mail-West Virginia News. (2012, April 9). Prescription pills are the real drug problem. West Virginians must be careful to dispose of their unused drugs. Retrieved from http://dailymail.com/Opinion/ Editorials/201204090043?page=2&build=cache Centers for Disease Control. (2012, January 13). CDC grand rounds: Prescription drug overdosesVAU.S. epidemic. Retrieved from http://www.cdc.gov/ mmwr/preview/mmwrhtml/mm6101a3.htm Coben, J. H., Davis, S. M., Furbee, P. M., Sikora, R. D., Tillotson, R. D., & Bossaete, R. M. (2010). Hospitalizations for poisoning by prescription opioids, sedatives, and tranquilizers. American Journal of Preventive Medicine, 38(5), 517Y534. Darbro, N., Bainer, J. K., Dilling, T. A., Hoehn, K. A., Lindle, A., Malliarakis, K. D., & Kenward, K. (2011). Substance use disorder in nursing: A resource manual and guidelines for alternative and disciplinary monitoring programs. Chicago, IL: National Council of State Boards of Nursing (NCSBN). Executive Office of the President of the United States. (2011a). Epidemic: Responding to America’s prescription drug abuse crisis. Retrieved http://www .whitehouse.gov/sites/default/files/ondcp/issues-content/prescriptiondrugs/rx_abuse_plan.pdf Executive Office of the President of the United States. (2011b). The administration’s response to the prescription drug epidemic: Action items. Retrieved http://www.whitehouse.gov/sites/default/files/ondcp/issuescontent/action_items_response_to_the_prescription_drug_epidemic.pdf Executive Office of the President of the United States. (2011c). District of Columbia drug control update. Retrieved from http://www.whitehouse.gov/ sites/default/files/docs/state_profile_-district_of_columbia.pdf Federation of State Medical Boards. (2013). Prescription drug monitoring programs: State by state overview. Retrieved from http://www.fsmb.org/pdf/ GRPOL_pmp_overview_by_state.pdf Fischer, B., Bibby, M., & Bouchard, M. (2010). The global diversion of pharmaceutical drugs non-medical use and diversion of psychotropic prescription drugs in North America: A review of sourcing routes and control measures. Adingdon, England: Centre for Applied Research in Mental Health and Addictions, Society for the Study of Addiction. Hanson, K. (2010). A pill problem: Prescription drug abuse is the fastest growing form of substance abuse. Retrieved from www.ncsl.org Harvard Mental Health Letter. (2011). Painkillers fuel growth in drug addiction. Retrieved from http://www.health.harvard.edu Lehr, K. (2012, April 5). Make sure your home isn’t inviting to potential abusers. Retrieved from Amelia Community Page at http://local.cincinnati.com/ share/news/story.aspx?sid=191540 Maxwell, J. C. (2011). The prescription drug epidemic in the United States: A perfect storm. Drug and Alcohol Review. Austin, TX: Addiction Research Institute, School of Social Work, The University of Texas at Austin. National Institute on Drug Abuse. (2014). Popping pills: Prescription drug abuse in America. Retrieved from http://www.drugabuse.gov/relatedtopics/trends-statistics/infographics/popping-pills-prescription-drugabuse-in-america Schneider Institute for Health Policy. (2001). Substance abuse: The nations number one health problem. Princeton, NJ: The Robert Wood Johnson Foundation. Stimmel, B. (1997). Pain and its relief without addiction: Clinical issues in the use of opioids and other analgesics. New York, NY: The Hawthorne Medical Press, Inc. Substance Abuse and Mental Health Services Administration. (2011). Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings. NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Administration. Retrieved from http://oas.samhsa.gov/NSDUH/2k10NSDUH/ 2k10Results.pdf The World Federation of Right to Die Societies. (2000). Lawsuit alleges elder abuse for inadequate pain control. Retrieved from http://www.worldrtd.net U.S. Department of Justice Drug Enforcement Administration Office of Diversion Control. (2014). Got drugs? National prescription drug takeback day. Retrieved from www.deadiversion.usdoj.gov/drug_disposal/ takeback/index.html
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