Reprinted from The Scope: Medical Edition, Issue 16 (First Quarter 2024)
by Shelly Kriete, Risk Management Consultant
The current resource challenges facing healthcare organizations are unprecedented. Issues related to limited resources – including drugs, supplies and labor – impact overall costs, access to products and services and, ultimately, patient health outcomes. As a long-standing problem for healthcare providers, our focus in this article will be drug shortages, which can have a negative impact on appropriate therapy regimes and access to needed surgical procedures and also may contribute to medication-related errors and poor patient outcomes.
Drug Shortage History
While drug shortages have been a systemic problem for over 20 years, they have become a recent hot topic for patient safety. In 2013, the FDA published its first annual drug shortages report following the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA), which effectively requires an annual report to Congress on drug shortages.
Concerns related to drug and drug product shortages continue. A post on August 18, 2023, titled “Reforms Needed to Alleviate Persistent Drug Shortages,” notes,
“The AMA Council on Science and Public Health (CSAPH) is charged with evaluating the factors driving national drug shortages and reporting on progress toward solutions… The Council’s 2022 report on this subject found that, while the number of new drug shortages has trended downward in recent years, the overall number of active drug shortages has remained relatively steady, suggesting that individual shortages are taking more time to resolve.
“Unfortunately, a surge in new drug shortages in 2023, combined with the complexity of resolving even a single drug shortage, has resulted in severe stress to the supply chain. The University of Utah Drug Information Service, which has tracked drug shortages since 2001, reported that active drug shortages in 2023 were at their highest level in a decade.
“Its data on real-time shortages are posted regularly on a website hosted by the American Society of Health-System Pharmacists (ASHP), the largest professional association of pharmacists in support of safe medication practices. The five classes of drugs most frequently in short supply are central nervous system drugs, fluids and electrolytes, antimicrobials, chemotherapies and hormones.”
As of December 28, 2023, ASHP’s website listed 248 items on the drug shortage list. In a recent MLMIC-moderated panel discussion at the Association for Healthcare Risk Management of New York’s Fall Conference, one of the panelists stated that her facility’s pharmacist mentioned that he had not seen shortages like we are currently experiencing in the last 20 years.
Factors Contributing to Drug Shortages
Pharmaceutical production and distribution is a complex, worldwide system that faces many variables for supply volume. Given these variables, to solely describe drug shortages as supply not meeting demand would be an oversimplification.
All areas along the vast continuum of the pharmaceutical supply chain have ample opportunity to contribute to the risk of supply imperfections, reductions, production losses or distribution delays. One or more of these aspects of supply can impact drugs and drug products reaching the patient. Some examples include:
- production of raw materials;
- technical and quality issues in the manufacturing systems;
- new or modified regulation(s);
- distribution processes;
- vendors and/or group purchasing organizations;
- healthcare organizations’ procurement practices; and
- unique attributes of the drug product market, such as the specific challenges of the generic drug sector.
Each of these areas offer potential complications with product availability and quality, production capacity (including labor force availability), distribution and business decision-making (e.g., budget constraints) and can be exacerbated by natural disasters or other public health emergencies, such as the recent coronavirus pandemic.
As we will note later, being aware of the potential for shortages and being proactive in assessments are key to effective medication management programs.
Assisting in that preemptive approach is the 2012 FDASIA requirement that manufacturers notify the FDA of production changes for some drugs and biologicals. The elements to be reported include interruptions or the permanent discontinuation of drugs or biologicals, any of the active pharmaceutical ingredients necessary and the reason for the interruption. The notification to the FDA should occur six months prior to changes or as soon as possible if less than six months.
This requirement was updated by the Coronavirus Aid, Relief, and Economic Security Act in 2020 to further mitigate the effects of shortages.
Concerns and Risks for Patient Safety from Drug Shortages
Not only do providers and their practices and facilities need to be concerned with disruptions to the operational workflows and administrative burdens when planning for current or anticipated drug shortages, the potential negative impacts related to clinical patient safety should be at the forefront. It is well known that patient safety and medication management initiatives are directly related, and changes to medication management processes, from procurement to administration, can increase medication error rates.
In October of 2023, ECRI, a patient safety organization, and the Institute for Safe Medication Practices, both associates in patient safety, announced information from a survey on the supply shortages and their impact on harm to patients. As noted in their report,
“Most respondents reported that shortages have compromised patient care, with half saying shortages have delayed patient treatments and one-third reporting they were unable to provide patients with optimally recommended drugs or treatments. A quarter of respondents said they were aware of at least one error related to a drug, supply or device shortage.”
Additionally, changes in available drug substitutes may impact treatment routines by creating delays or complete interruptions in planned care; making errors in instructions to patients or caregivers more likely; and making prescribing errors more frequent as prescribers are forced to use dosing parameters they are not accustomed to.
In addition to process risks, clinical risks related to shortages and alternative therapies must always be considered. Much uncertainty and the potential for liability concerns come with choosing an alternate medication regime. Is there an alternative option available? Will the new therapy be as effective and meet the current standards of care? Will patients be able to tolerate the available substitution drug? These issues may not only affect the care provided but may also have a tremendous impact on the patient’s overall mental well-being, particularly if life-saving treatment is at stake.
Although not directly clinical, the potential negative impacts on clinical treatment plans should be concerning. These include the possibility of a payor not covering the costs of available alternative therapies; ethical dilemmas and emotional struggles created for patients, their families, and staff stemming from distribution or rationing parameters; and issues surrounding the informed consent (e.g., drug alternatives now being considered may warrant an update or a totally new consent process and form).
Strategies for Managing Drug Shortages
On a national level, both the FDA and AMA are leading supporters in reducing the negative effects drug shortages have on patient care through proactive reporting requirements, exploring options to expand investment in production capacity, early notification of impending shortages, ongoing regulatory review and analysis of contracting practices related to organizations in competition (e.g., GPOs).
A November 14, 2023, article in Medical Economics, “AMA Pushes for Action on Drug Shortages,” is calling the shortage of drugs a “growing public health crisis.”
Even with their continuous efforts to find longer-term solutions, healthcare organizations must be actively vigilant and prepared by establishing a well-defined plan to inform their management of impending or actual disruptions in the drug or drug product supply chain. It is not “if” but “when” the next shortage will occur.
As recent as December 31, 2023, an article titled, “Lessons From The Chemotherapy Shortages: Invest in Generics,” authored by Elenora Teplinsky, M.D., a medical oncologist, reflected on the 2023 shortages of chemotherapy agents and the difficulties in managing life-saving therapy regimes for many cancer patients. She, too, indicated the need for the early identification of potential/imminent shortages, clear paths to address actual shortages and improvements in production and pricing for the generic drug sectors.
What COVID Taught Us
As we have heard multiple times, if we’ve learned anything from the COVID pandemic, it is that we have to be prepared for the next one. The variables are complicated, with many along the drug and drug product supply chain continuum requiring proactive and ongoing attention and investment, both financial and from a human capital perspective.
Creating a management plan and structure involving a multidisciplinary team with decision-making authority is critical to an organization’s success in navigating the challenges created by interruptions and shortages in the supply chain. Preemptively addressing the following areas and proactively monitoring for impending shortages are essential as ongoing organizational assessments could identify actions to be taken prior to the formal announcement of a shortage, which could then reduce the stress on an already burdened system.
Oversight
A multidisciplinary team reviewing the impact of drug shortages should have decision-making capabilities from:
- Purchasing and Finance — to leverage relationships with vendors and also have the liquidity to act quickly when necessary to secure resources as they become available.
- Pharmacy Processes — to secure the appropriate physical space and environmental requirements related to storage and preparation needs.
- Information Technology (IT) and Security — to manage data collection and monitoring that includes medication error rates before, during and after shortage activities. Information gained from data analysis can be helpful in anticipating future requirements or addressing issues that may arise during a shortage.
- Risk Management — to address impacts on patient safety.
- Nursing — to provide insight into workflow, staffing and training needs.
- Communications and Education — to expedite cross-functional training plans and provide all stakeholders with contemporaneous situational updates related to the shortage and process changes made in response to the shortage.
Distribution of Medicines During Drug Shortages
Drug shortages that require decisions related to rationing limited pharmaceutical resources may necessitate a collaborative group specifically focused on managing drug and drug product distribution, as well as determining the clinical stratification parameters needed to prioritize distribution. These decisions are complicated and, in many instances, emotionally charged. The group established should be multidisciplinary, with delegates from pharmacy, nursing, social services/care management, medical expertise, patient advocates, ethics, human resources, legal/risk management and other disciplines, if necessary.
Patient Communication and Documentation
Effective communication skills for both internal and external conversations related to drug shortages are a critical part of setting and managing realistic expectations and fostering a culture of collaboration and will assist in leveraging existing relationships.
Internally, sharing information with practitioners may alleviate stress by reducing the number of unknowns related to shortage details, such as current inventory status and active substitutions or alternative treatments, what the distribution priorities and rationing protocols are and any cancellations of or changes to routine operations. Outside of the organization, plans to communicate with patients and their families, including conversations about difficult situations, must be considered, in addition to how an organization will respond to the local community or media with an appropriate spokesperson.
As always, detailed documentation related to patient care, treatment and services, as well as other processes related to business interruption, will be necessary to accurately reflect and “tell the story” in a detailed and accurate manner, regardless of the subject matter. How the patients respond to alternate therapies, as well as details of the informed consent discussion resulting in the chosen care plan, must be reflected in the medical record. Dates and details of decisions related to changes in services, protocol adjustments or any new clinical practices implemented should be archived for future reference, accompanied by evidence of staff education related to these changes. Tracking the specifics of actions is an important part of accountability and responsibility and will always be your best defense in a legal action.
Looking Ahead
While large-scale efforts to support changes to drug manufacturing, supply chain processes and issues with the generic drug market are in progress, there are no real solutions in the immediate future. With that, we must enhance our organizational framework, allowing for proactive monitoring, and foster nimble, creative and collaborative decision-making related to our pharmaceutical products and supplies. Thorough documentation of attempts to address drug shortages, as well as communication to patients and staff of these efforts, will be essential should a patient experience an untoward outcome related to care due to the shortage of essential drugs.
This document is for general purposes only and should not be construed as medical or legal advice. This document is not comprehensive and does not cover all possible factual circumstances. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors for any questions related to legal, medical or professional obligations, the applicable state or federal laws or other professional questions.
Featured image courtesy of Karolina Grabowska/Pexels.
Share:
