Analgesic Medication Shortages: Inform Our Patients via a Shared Decision-Making Process

The anesthesiology community is faced with a shortage of many perioperative medications. Drug shortages can adversely affect patterns of patient care and patient safety, with reports of increased medication errors, prolonged recovery of care, postoperative nausea and vomiting, and patient complaints.1–3 Based on media and opinion reports, shortages of analgesic medications, (ie, morphine, fentanyl, hydromorphone, ketamine, and the local anesthetic bupivacaine) have potential to generate public awareness and anxiety due to impact on the patient’s pain and recovery experience.4,5 Medication shortages are common around the world.1,2,6–8 Multiple factors contribute to the global shortages of generic drugs including industry consolidation with few suppliers, low profit margins, poor manufacturing processes, lack of available raw or bulk materials, recalls of affected or related products, changes in product formulations, natural disasters, increased global demands, regulatory issues, and lack of timely early notification of drug shortages.1,2,6–8 Many patients wish to be informed of medication shortages that may impact their medical care. Hsia et al9 found the majority of 256 patients surveyed wanted to be informed of a drug shortage that might affect their care, even in a “minor” capacity according to the patient perspective, such as the differences in side effects between aspirin and acetaminophen. Using the scenario of a hypothetical shortage of neostigmine, three-fourths of survey respondents wanted to be informed of “slight differences” in side effects, with 39% of respondents preferring to delay surgery in this case until the shortage resolved.9 Over 80% of survey respondents said that they would prefer to delay surgery if the substituted drug’s side effects were major.9 However, anesthesiologists often fail to disclose drug shortages to their patients.10 The inadequate performance of informed consent may be due to suboptimal timing of the informed consent discussion, time constraints, need for complex explanations to patients/families, and poor disclosure of risks.11–14 Patient engagement through shared decision-making—a strategy to empower the patient to actively make an evidenced-based choice in his/her treatment—may offer an improvement over traditional informed consent.15 Shared decision-making differs from informed consent in that it is a 2-way sharing of information between the physician and patient which actively elicits patient’s understanding, preferences, and values to make a choice between different options.15,16 In this essay, the ethical and legal responsibilities of informed consent will be contrasted to a shared decision-making process in the context of engaging patients in discussion of decisions regarding their postoperative pain management in the era of drug shortages. PATIENT PERSPECTIVE ON TREATMENT OF POSTOPERATIVE PAIN Adequate treatment of postoperative pain is a major worry for patients. A 2014 survey of 300 patients in the United States found that pain after surgery was their most frequent concern, reported by 80% of respondents.17 In contrast, fewer respondents were concerned with whether they would have full recovery after surgery (50%) or whether surgery would improve their condition (62%).17 Patients also often have preferences regarding specific opioid treatment due to analgesic medication side effects or allergies. Patient satisfaction and recovery experience are highly dependent on adequate treatment of postoperative pain. Patient satisfaction survey scores increased after creation of a group of pain service interventions to improve postoperative pain treatment.18 Severe postoperative pain reduced patient’s health-related quality of life in the immediate postoperative period.19 Inadequate treatment of postoperative pain may also have longer-term adverse outcomes. In a prospective study of 95 women scheduled for breast cancer surgery, clinically meaningful acute postoperative pain independently predicted more intense chronic pain measured 3 months after surgery.20 Whether analgesic medication shortages actually compromise pain management during and after surgery has not been scientifically studied. However, national reporting systems1 and surveys2,3 reported that substitution of medications during the time of drug shortages increased medication errors1–3 and intensity of patient monitoring.2 During a shortage of remifentanil, substitution of alternative opioids, to improve tolerance of mechanical ventilation in the intensive care unit, substantially increased the length of mechanical ventilation, the intensive care unit stay, and the hospital stay.21 The increased popularity of multimodal pain management using nonsteroidal anti-inflammatory agents, acetaminophen, neuroleptic modulators, ketamine, intravenous lidocaine, local anesthesia, and neuraxial analgesia or peripheral nerve blocks with enhanced recovery or perioperative surgical pathways can optimize postoperative pain management using nonopioid techniques.22 Use of these adjuncts can mitigate the adverse effects of shortages of opioids. INFORMED CONSENT AND DISCLOSURE OF RISKS Informed consent is an ethical obligation in the practice of medicine and a legal requirement per statute and case law in most countries. The ethical principles of informed consent are derived from respect for patient’s autonomy to voluntarily make decisions to achieve their goals, preferences, and values.14 Informed consent involves threshold elements (ie, determining the competence, decision-making capacity, and voluntariness to decide), informational elements (ie, disclosure of relevant information, making recommendations, and assessing understanding of information and recommendations), and consent elements (ie, decision and autonomous authorization).13 Informed consent for medical treatment involves a thoughtful dialog between the physician and patient wherein sufficient information concerning risks, benefits, and alternatives is presented so that the patient can make an educated decision. What constitutes “sufficient information” varies across the world due to different legal requirements and patient/family expectations regarding informed consent. Court decisions guide legal precedents in “common law” countries. These former colonies of the British Empire (eg, England, Wales, Ireland, Scotland, United States, Canada, Australia, New Zealand, India, Kenya, among others) form a third of the world population.23 In the United States, half of the states use a “reasonable person” standard (ie, what a reasonable patient would consider pertinent in making an informed decision) and half use “professional practice” standard (ie, what a reasonable physician would disclose under similar circumstances).24 Material risks are those that a reasonable person would want to be made aware before deciding to undergo the proposed treatment. Material risks include those that occur frequently but have little long-term consequence, as well as those that are rare, but may result in serious, long-term morbidity or mortality. The risks disclosed under a “professional practice” standard may not include rare risks. In the European Union, the Oviedo Biomedical Convention in 1997 approved a legal framework to protect patient rights in medical care.25 This agreement, signed by 35 European states, supported patient autonomy and struck down a medical paternalist approach that allowed clinicians to decide on what patients should be told.25 It required that patients should receive free and informed consent for medical treatments. In the United Kingdom, a 2015 landmark Supreme Court decision (Montgomery versus Lanarkshire Health Board) changed the legal requirements for informed consent for medical treatments.23 This court decision underscored that patients must be provided with adequate information concerning material risks and alternatives presented in a dialogue to ensure patient understanding. In 2017, the Association of Anesthetists of Great Britain and Ireland (AAGBI) updated their guidelines on consent for anesthesia to reflect the increasing emphasis on consumerism and patient-centered care.26 The guidelines emphasized that patients should be provided information about anesthesia and risks to patients at preassessment or when the surgery is scheduled, preferably via an evidenced-based online or written materials.26 The guidelines stated that consent for elective procedures just before induction of anesthesia was not acceptable, except in unusual circumstances.26 The guidelines also recommended that the amount and nature of the information presented be determined by “what this patient wants.” Unfortunately, the real-world application of the ethical guidelines during the informed consent discussion is a major challenge during anesthesia care.11–14 Multiple system, anesthesiologist, and patient factors contribute to inadequate informed consent for anesthesia care (Figure). When informed consent is obtained immediately before the surgical procedure rather than in a preoperative assessment clinic or on the surgical ward, the patient has already made the decision to undergo surgery. In addition, the patient and their family are not allowed time to reflect on the risks, benefits, and alternatives of the treatments. The paucity of preoperative anesthesia clinics and scheduling problems for both ambulatory patients and anesthesiologists contribute to the less than optimal practice of obtaining consent just before surgery. Anesthesiologists also face other challenges that lead to inadequate informed consent, including deciding on the amount of information to provide, allowing adequate time to permit patient and family discussion, communication barriers, and language/cultural challenges with patients.11–14Figure.: Factors contributing to inadequate informed consent.It is also our assumption from clinical experience that some anesthesiologists may refrain from disclosing information out of concern that it may increase patient/family anxiety. However, disclosure of rare risks during informed consent for anesthesia does not increase anxiety and might actually alleviate the anxiety.27,28 A majority of patients, 61%, surveyed in preoperative clinic disagreed that the disclosure of anesthesia risks produces more anxiety than benefit.27 Nearly 80% of the 411 patients believed that rare yet severe complications should be discussed.27 In another survey, Tait et al28 found that only 1 parent out of 263 parents preferred not to know about anesthesia information, while 51% preferred to receive verbal information and 58% preferred both verbal and written information from a doctor or nurse. While these studies pertain to the broad area of anesthesia risks, disclosure of drug shortages that may affect anesthesia care is also likely to be desired by patients. Obtaining informed consent with a critical drug shortage challenges existing dogma with regard to how much patients wish to know and to what physicians wish to share. In a survey of 106 adult patients undergoing general, orthopedic, and urological surgeries, most patients (88%) desired information on treatment of postoperative pain.29 Most patients wanted to be informed of a medication shortage if the substituted treatment might have different side effects that might affect their health care.9 Disclosure of a drug shortage by physicians is largely guided by ethical guidelines based on the assessment of whether it is a significant risk. In the United States, guidelines from the American Society of Anesthesiologists specifically address drug shortages, including consideration of postponing an elective procedure when the risks of proceeding may outweigh the risks of using medications that are alternative to those in short supply or unavailable.30 While not directly addressing drug shortages, the AAGBI guidelines recommended that any information that might lead a patient to cancel or defer a procedure should be discussed with the patient.26 In practicality, the guidelines leave the assessment of risk up to the judgment of the individual anesthesiologist. If he/she evaluates the increased risk of using an alternative medication to be negligible, then there is no need to discuss this with the patient when obtaining informed consent. However, if the risk is deemed to be significant, then the informed consent should include a discussion about alternative treatments. While these are ethical guidelines for populations, the interpretation by an individual anesthesiologist is nuanced. The application of the guidelines may differ among 2 anesthesiologists. It is unclear how 2 anesthesiologists judge the risks of using an alternative medication. One anesthesiologist may deem it safe, while another considers it dangerous. One may argue to postpone elective surgeries. However, another may weigh this decision against the psychological impact to the patient who is left waiting. What one anesthesiologist deems to be a “must have” medication, another anesthesiologist may be more facile with an alternative and thus proceed. Disclosure of more information may not be better and optimal timing is critical.31 Disclosure of a particular drug shortage immediately before surgery when the decision to proceed has been made may be extremely upsetting to patients/families and may do more harm than good. SHARED DECISION-MAKING Shared decision-making is a formal strategy of patient-centered care that empowers the patient to make an active evidence-based treatment choice.15,16 The elements of shared decision-making include nature, alternatives, pros/cons, uncertainty of the treatment, the patient’s role, context, and understanding of the treatment, patient’s values and preferences, input from others, and a teach back to assess patient understanding (Table 1). Shared decision-making uses formal decision aids which provide scientific evidence concerning treatment choices and probability of outcomes.15 Decision aids help patients understand treatment options, scientific probabilities of outcomes with various treatment options, and clarify their individual preferences and values.Table 1.: Key Elements of Informed Consent and Shared Decision-MakingAlthough informed consent ethically involves decision-making that is shared between the physician and the patient, shared decision-making is different from informed consent (Table 1). Informed consent provides a minimal legal standard to discuss risks, benefits, and alternatives to a treatment that the patient may accept or reject.16 In contrast, shared decision-making is a 2-way patient–physician dialog that actively empowers and engages patients by stimulating them to consider multiple treatment options.16 Informed consent confirms the patient’s decision to proceed with the treatment, while shared decision-making facilitates the patient’s choice of optimal treatment.16 The framework of shared decision-making is directed at the specific patient, as opposed to informed consent where the legal standard applies to reasonable patients and clinicians.16 Informed consent generally provides disclosure primarily aimed at the patient accepting or rejecting the proposed treatment plan, as opposed to shared decision-making where multiple choices are seriously discussed.16 Shared decision-making provides probabilities of the outcomes based on current scientific evidence using vetted decision aids15 (eg, pamphlets, videos, or interactive computer programs) and then incorporates patient values or preferences into the decision process. Shared decision-making improves patient understanding, satisfaction of their decision, and trust in the physician.32 A Cochrane Systematic Review of 105 studies found that patient knowledge regarding treatment options was improved and decisional conflict was reduced with the use of decision aids.33 In addition, in studies that measured patient–provider communication, decision aids improved satisfaction with the decision and the decision-making process.32 Patients took a more active role in decision-making and had improved risk estimates with decision aids compared to usual care.33Table 2.: Theoretical Clinical ExamplesTreatment of acute postoperative pain is a prime area for shared decision-making, due to a variety of options for effective pain treatment. Shared decision-making aids can be made available online to patients when elective surgery is scheduled. Discussion of treatment alternatives should ideally occur in preanesthesia clinic. The content should be based on the level of expected postoperative pain, on whether the patient already has, or is at increased risk of developing, chronic pain, and whether the surgery carries a high-risk postoperative pain probability. Discussion of the “drug shortage du jour” could be incorporated into the discussion, with clear alternative treatment options for patients, including the possibility of postponement of surgery if a particular pain medication is not available. Table 2 illustrates theoretical clinical examples of patients confronted with elective surgery during a drug shortage. Due to the success of shared decision-making strategies in other preference-sensitive choices,15,16 we believe that shared decision-making is also optimal for patients facing choices about postoperative pain treatments. SUMMARY We recommend use of a shared decision-making process to ethically inform patients of drug shortages for analgesic medication. Shared decision-making incorporates patient values and preferences in choosing pain management alternatives after surgery, including the possibility of delaying elective surgery until the shortage abates. Conventional informed consent often fails to honor the patient’s perspective and preferences and can be biased by the opinion of an individual anesthesiologist. DISCLOSURES Name: Daniel S. Orlovich, MD, PharmD. Contribution: This author helped research, write, and edit the manuscript. Name: Shawn L. Mincer, MSW. Contribution: This author helped research, write, and edit the manuscript. Name: Karen B. Domino, MD, MPH. Contribution: This author helped research, write, and edit the manuscript. This manuscript was handled by: Ken B. Johnson, MD.