Over the past year, financial headwinds from rising costs for consumers and manufacturers, high inflation, and the constant churn of regulatory changes have added to the challenges pharmaceutical industry leaders typically face.
But every year brings the promise of new innovations and more opportunities to help patients, and 2024 will be no different. Here are some trends and developments to watch for in the year ahead:
Ongoing drug shortages
In the U.S., the pharmaceutical industry has long been affected by the tides of supply and demand of drugs, so changes in drug supply and price have always been trends to monitor. Factors like clinical study results, pricing, legislative decisions, industry marketing to clinicians and direct to consumer marketing campaigns have historically shifted supply and demand for drugs. As demand increases, the resulting decrease in supply or increase in drug price could potentially become a problem for patients.
Today, social media and the always-online presence of celebrities are powerful drivers of consumer awareness of drug. One interesting example to watch closely in 2024 is the supply crunch and skyrocketing consumer demand for glucagon-like peptide 1 (GLP-1) receptor agonist and GIP and GLP-1 receptors drugs such as Ozempic and Mounjaro. Typically prescribed for diabetes patients struggling with their chronic illness, celebrities and influencers are showcasing stellar results on social media from using Ozempic for weight loss. This has artificially increased the demand for these drugs, creating a shortage of medications that fall within this drug class.
In this case, like with any high-demand drug, pharmacists and clinicians should watch the research closely as they compare popular name-brand drugs with generic or new to the market medications that become available. As the FDA does not require head-to-head trials for new drugs in the same class, it falls on the clinician to both identify how the effectiveness of existing high-demand drugs compare to new alternatives, as well as evaluate the patient’s specific needs and whether they will benefit from a new treatment. Clinicians must keep in mind to look at patients holistically when evaluating alternatives to in-demand drugs, especially if comorbidities exist.
Another best practice with drug shortages is to keep an eye on regulatory changes, especially as state and federal legislative sessions reconvene in January. Certain states are working on legislation focused on creating new boards to evaluate and control drug pricing. Certain drug shortages may also impact workers’ compensation cases, such as with popular name-brand drug Humera, used to treat arthritis. In many cases when the demand for certain drugs skyrockets, patients’ Medicaid or workers compensation plans covers the cost and the consumer isn’t affected, but the onus falls on clinicians to do the due diligence to ensure that patients are getting the treatments they need at an affordable cost.
The growing community impact of pharmacy closures
Over the last several years, retail pharmacy chain stores have oversaturated cities and towns to the level where they’re starting to close locations in underperforming areas. More recently, RiteAid filed for bankruptcy in October and shared plans to close 400-500 of their approximately 2,000 locations. Other chains, like CVS and Walgreens, also have plans to close locations as brick and mortar stores face challenges and competition, particularly with their front-store items.
From a pharmacy perspective, store closures at this volume will have a serious and direct impact on the communities they serve, particularly rural and underserved communities. In many cases, these types of communities lack easily accessible physicians. Pharmacists are the easiest – or only – accessible healthcare providers. When communities lose their pharmacists, they stop receiving medications, vaccines, urgent intervention, education and consultation resources, and many other essential commodities that retail pharmacies provide. Adherence is another risk: a study published in JAMA in 2019 showed a direct link between pharmacy closures and adherence to cardiovascular medication in adults.
Interestingly, a reverse shift has happened for independent pharmacies in the wake of these big retail pharmacy closures. A decade ago, independent pharmacies suffered a similar setback in closures as national retail pharmacies gained momentum, benefitted by insurance contracts and reimbursements. Today, independent pharmacies are starting to make a comeback, especially in underserved communities and in certain states where Medicaid reimbursement is higher. This will be an interesting area to watch as major retail pharmacy locations continue to close nationwide.
Telehealth flexibilities and the Ryan Haight Act
As part of regulatory adaptations during the COVID-19 pandemic, the Drug Enforcement Administration (DEA) granted flexibilities for clinicians and psychotherapists to remotely prescribe controlled substances and waived a requirement, as mandated by the 2008 Ryan Haight Act, that an in-person visit occur prior to prescribing controlled drugs via telehealth.
But this past year has seen changes to these telehealth flexibilities as the federal government lifted the COVID-19 public health emergency declaration in May. After receiving feedback from healthcare providers and telehealth industry groups, in October, the DEA decided to extend these telehealth flexibilities through 2024 as it considers more permanent policy changes.
For clinicians and pharmacists, especially those regularly prescribing and dispensing controlled substances, this will be a crucial area of legislation to monitor in 2024 as the end of the extension approaches.
Psychedelic drug therapies
Since 1985, the psychedelic drug MDMA has been classified as Schedule 1 illegal substance with the highest level of control. But in 2024, psychedelics will be a big area of legislation to watch as FDA regulators consider an application to market MDMA, for Psychedelic-Assisted Psychotherapy, as a treatment for post-traumatic stress disorder.
This is particularly exciting for the clinical community because the likely approval, even under strict guidance, of this drug as a treatment option for patients has been hard-fought by psychedelic therapy advocates.
PTSD is also a complicated and costly condition to treat through the whole lifecycle of intervention, and current therapies and medications available aren’t universally successful for patients. The Phase 3 trial for MDMA-assisted therapy for PTSD concluded with great outcomes and other studies have been equally promising.
A decision on approval and guidance for MDMA is expected in mid-2024 and would open the door for more funding, research, and trials for other psychedelic-assisted therapies for stress-triggered conditions.
As with many trends in the pharmaceutical space, monitoring for updates and awaiting the guidance from regulatory authorities is a best practice pharmacists and other clinicians should heed. Pharmacists are leaders in upholding public health and patient safety standards, and the communities they serve will certainly depend on their expertise in the next year as drugs and regulations continue to change.
