Drug shortages in anesthesia care: ethical challenges and patient safety impacts

¶ … Drug Shortage on Anesthesia Providers

The rate of drug shortage has risen from 70 (2006) to 211 (2011). In the year 2012, the American Food and Drug Administration (FDA) reported over 225 drug shortages. These shortages affect anesthesiologists, in particular. According to the GAO (Government Accountability Office), central nervous system (CNS) drugs and anesthetics constitute 17% of total shortages; they also come under the categories of drugs regularly experiencing highest shortage frequency (Orlovich & Kelly, 2015). Eventually, drug shortage adversely impacts patients' safety. Numerous factors contribute to drug shortages, including disrupted supply of raw materials, lean inventory from producers to hospitals, and increasingly complicated international supply chain. FDA-implicated reasons for shortage include the novel Unapproved Drugs Initiative and failed inspections. A recent House Oversight Committee blamed FDA overregulation considerably. Critical supply producers are shut down due to insufficient documentation and technical breaches having marginal impact on safety. Clearly, the resultant medication shortage has threatened patient safety more than violation of regulation, which led to closing of manufacturing units. Industry consolidation, reduced profitability, variable demand and reduced manufacturing capacity have all played a role in causing specific shortage (Campbell, n.d).

Ethical Issue/Challenge

i. How drug shortage challenges "non-maleficent" and "beneficent" health care delivery

With regard to non-maleficence and beneficence, compelling evidence now exists of the fact that health systems, individual patients, and whole populations may suffer harm on account of drug shortages. A patient may be harmed when no equally effectual alternative drug can be found for his/her care, leading to compromised, precluded, or delayed care (Lipworth & Kerridge, 2013). Besides causing harm to individual patients, a shortage of drugs threatens public health. In fact, some regard this to be a public health emergency, as it threatens society's ability of preventing and treating acute as well as chronic illnesses (Singleton et al., 2013, 42).

Moreover, drug shortages endanger evidence creation as well as use of evidence-based drugs, as they hinder clinical research, making trials smaller, or halting or modifying them. Hence, clinicians find it hard to abide by evidence-based medical practice guidelines. Lastly, drug shortages cause harm to health systems, resulting in organizational and governmental commitment to considerable resources for supervision and management of the situation, as well as potential increased costs for alternative drugs that aren't normally used. Such expenditures constitute opportunity costs for the community and patients (Lipworth & Kerridge, 2013).

ii. How shortage of drugs challenges "just" care delivery

Shortage of drugs forces clinicians and pharmacists to make tough choices among patients, when allocating scarce resources. Sometimes, they are required to give priority to the youngest patient, or one who is most ill, or one who is on clinical trial, or is suffering from a rapidly progressing disease, or who will most likely benefit from the medication. The necessity of this sort of triage, together with its ethical consequences, is recognized by several organizations that have endeavored to come up with resource allocation guidelines in times of drug shortage. Further, it has been observed that organizations are ethically-obligated to be ready for situations of drug shortage. This can be done by conservation of supplies as well as ensuring the institution is set to respond effectively to all shortages that arise (Lipworth & Kerridge, 2013).

Recommendation and justification of how best one can respond to this challenge

ii. Identify Therapeutic Equivalents/Alternative Drugs

A key task in drug shortage management is identification of alternative medications to substitute unavailable drugs. Decisions with this regard must be made by collaborating with medical, pharmacy, and nursing representatives, and must receive the approval of relevant medical committees. Subsequent to decision-making, the chosen therapeutic alternative must be inventoried as well, for ensuring its adequate supply. Additionally, pharmacists might have to alter or establish bar-coding procedures; sound-alike, look-alike drugs; impacts on automation; distribution paths; preparation of final product; and contract compliance. Healthcare facilities must also be ready to deal with potential subsequent shortage of alternative agent (Ventola, 2011; Fox et al., 2009; Fox & Tyler, 2013).

Follow Sound Inventory-Management Practices

In times of drug shortage, inventory management may pose a challenge. Healthcare centers need to resist the inclination to stockpile medication in preparation for shortages, as this may lead to additional problems. Drug-hoarding before a predicted shortage might deplete available inventory and aggravate the shortage issue, by diverting supplies from other needy patients and facilities. Drug-stockpiling may also prove to be costly, and can leave a medical facility with excessive inventory, which isn't only costly, but may also not be absorbed in case the shortage gets averted or is less severe than predicted (Fox et al., 2009; Fox & Tyler, 2013).

Shortages might not materialize if glitches that pose a genuine potential threat surface, but never end up reaching end-users (consumers). This may occur when sufficient inventory is present in the supply chain for providing adequate supply and meeting routine demand, enabling the problem, which may have resulted in shortage to get solved within the intervening time. Furthermore, in times of shortage, distributors and manufacturers commonly allocate products based on usage history; hence, an unexpected stockpiling order normally has no impact upon increased drug allocation (Ventola, 2011; Fox et al., 2009).