There has been a lot of news about the shortage of testing and personal protective equipment, for good reason. But we are already in the midst of another massive and devastating shortage: medications of all kinds that are critical in the COVID-19 response.
As with every other health care resource encountered thus far in this crisis, we are approaching or exceeding capacity in terms of our vital medicine supply. Ordinary supply chains, mechanisms and administrative processes will not be adequate to respond.
As with every other healthcare resource encountered thus far in this crisis, we are approaching or exceeding capacity in terms of our vital medication supply.
Anticipated shortages include medications that are the most promising as effective therapies against COVID-19, like azithromycin and hydroxychloroquine. However, many other medications are being used up rapidly that are essential to caring for all patients, including — and especially — those with respiratory illnesses like COVID-19, and those who go on to respiratory failure and require intensive care and ventilatory support.
This means that like with so many problems we’re seeing right now, the stress put on our hospital system is going to quickly have consequences not only for our care of COVID-19 patients, but also for other patients with one of the many other respiratory problems that require specific and critical care.
For example, albuterol, used for wheezing illnesses like asthma, is already experiencing a national shortage. Hospitals with high volumes of critically ill patients are also reporting shortages of basic standbys like midazolam and propofol — drugs needed to induce and maintain sleepiness and comfort while on a ventilator. Without those medications, being on a mechanical ventilator can be agonizingly uncomfortable.
With the peak demand on health care systems projected in just a few weeks, we need to increase our supply of multiple medicines now. Efforts started today will be too late for many hospitals to practice at usual standards of care; further, availability of medications outside of the hospital will also be in short supply.
This effort starts with the Food and Drug Administration, which can either be a bottleneck or a facilitator during this crisis. Many of the shortages are going to be generic drugs, where unlike the rest of the world, we have only a limited number of authorized versions available. The FDA must institute a 24-hour turnaround for approving the importation of generic drugs that are in short supply from established manufacturers in other countries. Such an ultra-fast approval time has already been used in this pandemic, for approval to start using plasma from patients recovering from COVID-19 to help very ill patients. The FDA can also institute reciprocal approval for selected generic drugs manufactured in other countries.
The federal government must work with major pharmaceutical companies to boost mass manufacturing of approved drugs that are in short supply. If the companies do not agree to do this voluntarily, or if the two parties are not able to come to terms, then the administration must default to the Defense Production Act to compel mass production.
Nonprofit and generic drug manufacturers have a role here as well. Most active pharmaceutical ingredients — the chemicals that are turned into FDA-approved drugs — are currently manufactured in China. As well as negotiating to increase the supply, the U.S. must consider increasing the manufacture of active ingredients within the country to decrease production times of important drugs.
And any state or federal government stockpiles of critical medications should be mobilized, now, to hospitals experiencing surges in patients.
But even as we increase the amounts of available drugs, we must take steps to keep costs down.
But even as we increase the amounts of available drugs, we must take steps to keep costs down. Making treatment (and vaccines, as they become available) accessible and affordable is a key component of boosting supply. This means Medicare must be allowed to negotiate a single price for COVID drugs and companies could be given a “Netflix” option, in which they receive a fixed contract for an unlimited supply.
As a last resort, the federal government should institute compulsory licensing if companies are not responsive to reasonable financial terms that would allow immediate needs to be met
Once the drugs are made, distribution channels need to step up their game. Pharmacy benefit managers, or PBMs, the middle men between drug manufacturers, pharmacies and insurers, play a large role in the distribution and availability of — and spending on — medications. These managers often favor expensive drugs so they can take full advantage of rebates and large deductibles. Lower-priced COVID-related medications, therefore, are at risk of being pushed out in this system in favor of higher priced alternatives. PBMs also contribute to higher retail prices that disproportionately affect the uninsured and under-insured public. To prevent these problems, the federal government must prohibit deductibles and rebates for COVID-specific drugs and ensure that large pharmacy chains sell these medications at manufacturer price.
For critical hospital medications, the government should establish centralized systems to track need, based on patient caseload, inform manufacturing needs, and shift supply rapidly and equitably. And states and cities should sustain testing and containment measures as they pass the peak of the disease; doing so will allow them to share supplies of vital medicines with other states as the disease passes.
Like many at-risk resources in this crisis, medication shortages will be invisible until it is virtually too late. No matter how quickly we move on this front, we are heading into a deficiency that will be felt deeply by many who fall ill with COVID-19, and many who do not.