Introduction
Chronic pain management is one of the most serious challenges that are faced by public health in the United States. With the growing use of opioids for the purpose of pain relief, the problem is complicated by the opioid use disorder epidemic. According to the recent proceedings of a workshop, the results of which were published by the National Academies Press, 47,000 persons deceased because of opioid overdose (Alper, Olchefske, & Graig, 2019). The poor understanding of the addictive features of opioids along with overprescription can be noted as the key reasons for this epidemic. Therefore, there is an urgent need to examine the current risks and regulations that exist in the given field, thus contributing to addressing the identified public health issues. Although opioids are regarded as an effective means of pain management, which is regulated by the CDC, HHS, and other national agencies, prescription drug overdose epidemic tends to grow in the US, being the leading cause of preventable and accidental deaths.
Examining the Risks and Regulations in the US
Contemporary Strategies for Chronic Pain Management
Chronic pain is a widespread problem that arises in the practice of many specialties who work with pain syndrome. According to the International Association for the Study of Pain (IASP), chronic pain lasts for more than three months. The prevalence of chronic pain, according to various authors, ranges from 7 to 55%, and it is assessed that about 100 million people currently live with chronic pain in the US (Conner et al., 2018). In a number of patients with severe acute pain or chronic pain (lasting more than six months), the use of non-opioid analgesics does not allow to achieve a sufficient pain-relieving effect, which leads to inadequate analgesia. The most widespread types of chronic pain are post-trauma, post-surgical, headache, arthritis, cancer, lower back, psychogenic, and neurogenic conditions.
In the early 2000s, pain management became one of the key complaints expressed by patients, when pain was recognized as the “fifth vital sign” along with temperature, blood pressure, respiratory rate, and heart rate. Every patient during every medical visit answered a question about pain, including during hospitalization cases (Tompkins, Hobelmann, & Compton, 2017). The quality of treatment was evaluated by the extent of pain. The state subsidies to hospitals were based on the quality of treatment, and high pain scores directly reduced these subsidies. The economic situation forced hospitals and practitioners to suppress pain by any means. Opinions about the possibility of using opioids for the treatment of pain have altered in the last three decades (Conner et al., 2018). If earlier the possibility of chronic use of opioids was considered only for pain caused by cancer, opioids have also been utilized in the management of non-cancer pain.
The subjective assessment of pain and constant attention to it led to an opioid epidemic and an extremely liberal prescription of opioids and opioid use disorder (OUD). By 2012, 53.7 percent morphine, 99 percent hydrocodone, 85 percent oxycodone, and about 30 percent fentanyl in the world were produced and sold in the US (Ostling et al., 2018). The Bureau of Statistics reported that in 2012, 255,207,954 prescriptions were issued for drug dispensing (81.3 for every 100 people in the country) (Jones et al., 2018). By 2017, the efforts of many public organizations, professional associations, and the government reduced the issuance of such prescriptions to 191,218,272, or 58.7 for every 100 people (Jones et al., 2018). Although this is still not the optimal number since prescription drug overdose mortality remains extremely high.
Recently, a number of randomized clinical trials were conducted to assess the effectiveness of narcotic analgesics in the treatment of chronic pain. The World Health Organization (WHO) included opioids in a three-step scheme for the selection of analgesic therapy. It is to be used when physiotherapy, massages, and therapy with other analgesic drugs (paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and tricyclic antidepressants) cannot provide sufficient control over a patient’s pain and quality of life. One of the reasons for the refusal to take opioids is concerns about the development of drug dependence during their use (Ostling et al., 2018). For practitioners, it can be difficult to identify whether a patient is at a high risk of developing an addiction or not since no clear definitions are identified. The risk assessment guidelines are based on a universal precaution approach that should be individualized to the needs of a particular patient.
To prevent addiction development, risk assessment tools should be used by practitioners in the course of addressing pain. Namely, not only the current condition of a patient but also his or her family history and substance abuse history should be examined. The clinical screening tools can include the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R), the Opioid Risk Tool (ORT), and other questionnaires to identify behavioral risk factors. In addition, the abuse deterrent strategies are developed and implemented in pain medicine. The Federal Agency for Food and Drug Administration (FDA) declares that abuse deterrent opioids are a relatively new strategy that aims to address the very causes of the problem, such as dissolving to inject and crushing to snort. The evaluation and monitoring of deterrent strategies is also under development, which implies various laboratory studies and practical research. Abuse-deterrent opioid formulations and policies are viewed as the additional efforts to combat the opioid prescription overdose epidemic.
Evaluation of Harms
In 2017, the US government officially recognized the opioid epidemic to be a public health issue, assigning it an emergency status. Deaths from prescription drug overdose compose the key risk factor that is well-known by pain management practitioners. According to Jones et al. (2018), “64,000 people died from drug overdoses in 2016; over 42,000 of those were opioid deaths. This represents a 20% increase from the total of 52,000 drug overdose fatalities in 2015” (p. 13). The most significant contribution to the identified situation was made by fentanyl that was the cause of more than 20,000 deaths, while prescription drugs accounted for 15,000 (Jones et al., 2018). The highest rates of prescription drug overdose are noted among people who were aged between 25 and 54 years, which points to the reducing life expectancy in this category.
Among the key risks, there is accidental or intentional misuse, as well as sharing drug injections with other people. Considering that opioids are strong medications, overdose signs should be clearly understood by the patients who take them to avoid further complications. For example, slowed breathing, extremely pale skin, heartbeat reduction, vomiting, dizziness, the inability to awaken, and other similar symptoms signalize the need to urgently help a person (Ostling et al., 2018). While prescription drug overdose is dangerous to all patients, there are certain groups of patients that are most vulnerable. In the elderly, opioid use is associated with an increase in side effects such as sedation, nausea, vomiting, constipation, urinary retention, and falling. As a result, older people taking opioids are at greater risk for injury and related death. However, opioids do not cause any specific organ toxicity, unlike many other drugs, such as aspirin and paracetamol. They are not associated with kidney toxicity and upper gastrointestinal bleeding.
In pregnant women, miscarriage and abstinence syndrome during opioid use present threats to both the mother and her child. From 2000 to 2009, the rate of fetal death and neonatal abstinence syndrome increased by 300 percent, and the evidence shows that the reported level of non-medical opioid use is only one percent (Ostling et al., 2018). The universal screening is recommended for pregnant women who used opioids earlier, which should be conducted during the first visit and also once in a trimester. Alcohol and other types of substance abuse are considered to be the aspects that escalate the likelihood of opioid overdose and intentional misuse. The presence of such chronic diseases as obesity, diabetes, and hypertension in pregnant females and older adult patients also raise their vulnerability.
Addiction development, which is the key potential harm of using opioids in chronic pain management, provides psychological and neurological effects. Alper et al. (2019) found that patients using morphine during treatment did not show the signs of addiction. Moreover, after treatment aimed at reducing the severity of pain, the dose of opiates can be gradually reduced until it is completely canceled. However, if the opioid intake was interrupted abruptly, physical ailments may occur from rapid drug withdrawal. The main symptoms comprise diarrhea and anxious agitation as the body is used to the constant use of opioids, and it takes time to adapt to their absence. The risk of drug addiction is not affected by the period of action of the drugs. It is equally possible with the use of both short-acting opioids and dosage forms with prolonged maintenance of the therapeutic concentration of opioids in the blood (Alper et al., 2019). The pharmacological form of the drugs did not affect the risk of drug addiction. Cases of drug abuse have been described both among patients who received injections and those who took tablet forms.
The evidence shows that when opioids are used in the long run, they can create unpredictability in the body and lead to potentially fatal breathing slower. It is considered from a medical point of view, approaching toxicity goes unnoticed, because the analgesic effect ends long before the half-life of the drug. According to the Centers for Disease Control and Prevention (CDC), methadone was included in 31 percent of opioid-related deaths in the US between 1999 and 2010 and 40 percent as the only drug, which is much greater than other opioids. It was revealed that the use of long-term opioids can stop OUD and minor side effects that have been common. It should be stated, however, that often, patients start using heroine as the alternative to the prescribed opioids since their doctors can no longer offer it.
In many respects, the problem is complicated by the situation with health insurance in the US. According to the National Academy of Medicine (NAM), approximately 100 million adult Americans suffer from chronic pain. The majority of them understands the risks of taking opioids and, thus, would prefer using some alternative methods of treatment: procedures, herbal remedies, physical exercises, and so on. However, a significant part of the US population can hardly afford such methods, because they are either not able to get medical insurance, or they cannot get such help under the existing plans. Consequently, people are forced to use inexpensive opioid medications to alleviate their pain by using the available methods.
In many cases, when a person has already developed an addiction and comes to the doctor for a new prescription, the latter refuses to prescribe another course, understanding that this patient asks for drugs, not for pain. After that, a person begins to look for other ways to get opioids, often switching to heroin or, even worse, fentanyl. The latter appeared on the black market relatively recently as a synthetic substance that has about 100 times more powerful effect than morphine (Ciccarone, 2017). It was fentanyl, according to the National Institute on Drug Abuse (NIDA), which caused the rapid increase in deaths from overdoses. According to the study by the NIDA, if in 2011 about two thousand people died from an overdose of synthetic opioids in the USA, then by the middle of 2015, with the spread of fentanyl, the number of such deaths increased to 14 thousand people annually (Ciccarone, 2017). This illustrates the ineffectiveness of the existing guidelines for drug prescription, which leads to enormous costs for healthcare and adverse patient outcomes.
It is noteworthy that today, the government and public health organizations fail to help people in coping with OUD. As noted in a 2016 report by the CDC, only ten percent of Americans suffering from various drug use problems receive special assistance (Conner et al., 2018). The document explains that one of the reasons for this is the lack of medicines. In some states, people do not have access to such assistance because of its high cost, and where people are able to receive it, they have to queue for weeks and months (Boté, 2019). The danger of this situation is that pain management presents significant threats to patients’ health, and OUD can rapidly develop from inappropriate dosage, withdrawal, and overall approach to using opioids.
Review of FDA / CDC / HHS Guidelines and the US Policy
The government agencies such as the FDA, CDC, and the US Department of Health and Human Services (HHS) published new guidelines for managing chronic pain and prescribing drugs. Major professional pain organizations, such as the American Society of Anesthesiologists (ASA) and the American Society of Regional Anesthesia and Pain Medicine (ASRA) have also released practical recommendations for the treatment of chronic pain. The American Academy of Pain Management published numerous clinical recommendations since 2015 (Gross & Gordon, 2019). The whole collection of recommendations is collected by the organization of the Multiple Chronic Conditions Initiative. Practitioners and patients can familiarize themselves with the clinical guidelines for the treatment of cancer pain and a variety of clinical plans for varying degrees of prescription for treating pain in chronic disease conditions.
The FDA launched the national initiative for combating the prescription drug overdose, which is based on deploying a set of policies. According to Gross and Gordon (2019), the reduction of the opioid-associated harm is the paramount goal that includes balancing the needs of patients to minimize suffering and the existing operation of the healthcare practices. The FDA took the responsibility for following the strategies of affecting the contemporary prescribing practices and limiting the lawful supply of opioids. Accordingly, it is expected to reduce both demand and supply for such drugs, which should decrease the related mortality. These strategies are closely associated with the competence of practitioners to assess patient needs and the need to strengthen preapproval procedures (Gross & Gordon, 2019). Therefore, it is important to pay attention to the education of practitioners, who play the key role in overprescription of opioid drugs for pain relief. The shift towards drug approval decisions from the previously employed product-specific approach requires coordinated efforts of local and state governments.
Another initiative that was taken by the FDA is the prescription drug monitoring programs (PDMPs) that are valuable tools to make informed prescribing decisions. While the effectiveness of the PDMPs is confirmed in the course of various studies, some limitations should be noted. In particular, the fact that different states have varying requirements for opioid drug prescription restricts the usefulness of these programs. For example, if pharmacies are required to submit the substance dispensing information within one day, the failure to do so would result in the inability to see the prescription in the report. Accordingly, further development of the PDMP system is necessary to make it comprehensive yet easy to implement.
The CDC and HHS created the guidelines for practitioners, which are called to increase public awareness (“Opioid overdose: Guideline review”, 2018). These guidelines focus on a patient-centered approach that should be integrated into the clinical practices. The three key areas include the proper determination of when to start the opioid therapy, its dosage and discontinuation, as well as evaluating the potential harms of such an intervention for a certain patient. The establishment of treatment goals should be accompanied by the discussion of benefits and risks so that the patient can also participate in selecting the most relevant method of pain alleviation. A clinician is expected to also identify the available non-pharmacological therapy alternatives. The dosage considerations should be based on paying attention to the causes of pain, previous substance abuse cases, and concomitant diseases (“Opioid overdose: Guideline review”, 2018). Depending on the expected duration of pain management, long-acting or immediate-release opioids are to be selected. The follow-up and discontinuation strategies are to be viewed as an integral part of the treatment process.
The process of assessing risks and minimizing harms can be based on the consideration of prescription drug monitoring program (PDMP) information, which is available in a given state. A patient should be aware of possible complications, including addiction and OUD, understanding that the corresponding treatment can also be provided. The practitioners can use urine drug testing and / or questionnaires to determine the presence of OUD (“CDC’s response to the opioid overdose epidemic,” 2018). The appropriate initial assessment and further compliance with the mentioned guidelines are likely to contribute to adequate treatment of chronic pain and the prevention of prescription drug overdose.
Another recommendation by the CDC refers to support for providers and health systems, of which training is the fundamental intervention that is regarded as an evidence-based solution. To promote a safer environment, the CDC declares the importance of improving the way the opioids are prescribed. This is expected to accomplish via provider education to be offered at hospitals as well as online, interactive learning. For example, the official website of the mentioned organization offers online training for implementing the guidelines, which includes case-based content, integrated resources, and knowledge checks (“CDC’s response to the opioid overdose epidemic,” 2018). One should also point out the fact that online seminars, workshops, and case studies are available on demand for practitioners, who strive to improve their knowledge in prescribing opioids for chronic pain.
One of the important factors preventing the development of drug addiction is the correct selection of patients who are eligible for such treatment. Several questionnaires have been developed to assess the risk of drug addiction: the original Screener and Opioid Assessment for Patients with Pain (SOAPP), the Screening Instrument for Substance Abuse Potential (SISAP), et cetera. Patients also need to periodically monitor and adjust medications as necessary, consulting with pain management specialists (Boté, 2019). For example, early initiation of antiretroviral therapy is recommended to prevent and treat some forms of associated neuropathic pain.
It is also necessary to give the patients clear instructions on the regimen of taking the drug. It implies that the patient should not go to another doctor, including the ambulance and emergency care, to prescribe painkillers without notifying the current practitioner. The patient should not change the dose and the regimen of taking drugs without a doctor’s permission, even if the pain relief is ineffective (Ostling et al., 2018). It is suggested that the patient should come to the doctor’s office with used packages and unspent drugs. There is also the practice of signing a patient and doctor agreement on compliance with the regimen of drugs. The recommendations provide options for non-drug therapy, including cognitive-behavioral therapy, yoga, physical and occupational therapy, hypnosis, and acupuncture.
The review of the guidelines and suggestions that are developed by the FDA, CDC, and HHS shows that significant efforts are taken to address the prescription drug overdose problem. The fact that this health issue is officially recognized means that further actions would be devoted to increasing awareness among patients and practitioners (“Opioid overdose: Guideline review”, 2018). The recommendations provided by these organizations are based on the previous studies as well as the current environment, which points to their reliability.
It is important to stress that the collaboration between the agencies is another critical issue that should be assigned a top priority. In case they would contradict each other’s recommendations, the very healthcare system of the US may turn out to be ineffective in addressing the epidemic. It is clear that the government understands the problem and seeks the ways to eliminate it. In 2016, the 21st Century Cures Act was launched to provide additional grants for substance abuse issues investigation (“Opioid overdose: Guideline review”, 2018). However, there is still much to be done to identify, verify, and implement evidence-based strategies into practice. Therefore, further research is needed to achieve the mentioned goal and ensure that chronic pain management would be revolutionized. In spite of some improvements, uncertain impact, remaining harm to patients, and the failure to ensure long-term implications are the main challenges.
Conclusion
To conclude, the treatment of patients with chronic pain is one of the key tasks of public health in the US. It should be emphasized that only a collective approach can give the desired results: the treatment would be successful, if it is made with general planning and coordinated efforts. The most important issues in combating the current opioid epidemic, namely, prescription overdose, are the improvement of the quality of life of the patient and prevention of an addiction. The most effective measures are those aimed at a preliminary assessment of the individual risk of developing an addiction, rational dose management, and ongoing monitoring of the administration of drugs to patients. The simultaneous use of other painkillers and effective treatment of a disease that causes pain should also be achieved via provider training and health systems’ support.
References
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