Pharmacists matter in pandemic response

Federal policymakers have declared that pharmacists must be high on the priority list for receiving protective vaccine during an influenza pandemic.

A guidance document from the Department of Health and Human Services (HHS) specifically lists 150,000 pharmacists among the second-priority tier of professionals whose services will be necessary to maintain the country’s safety during a severe influenza pandemic. This categorization places pharmacists with utility and communication workers, military support staff, and other critical professions and populations that together account for about 15 million Americans.

First in line to receive vaccine are about 24 million people in critical occupations or high-risk populations. These include deployed military personnel; frontline health care workers; fire, emergency, and law enforcement professionals; pregnant women; and young children.

In all, the prioritization scheme divides the U.S. population into five tiers based mostly on occupation or health risk factors. The fifth tier, those last in line for vaccine, consists of healthy adults 19–64 years of age in the general population, a group numbering about 123 million.

Pharmacists were not specifically named in a preliminary version of the prioritization plan but were added to the final document, along with mortuary workers, after HHS held public forums about the plan.

Charles C. Thomas, state pharmacy director for the Alabama Department of Public Health, was among those who urged HHS to specifically recognize pharmacists in the guidance document.

“Pharmacy always seems to be an afterthought in any kind of planning [for] disasters,” Thomas explained in an interview. He said he and other Alabama pharmacists participated in an HHS-convened forum to give the department input on problems that the pharmacy profession would face during an influenza pandemic.

“I do believe that pharmacists, both in hospitals and the community, will be among the first people that will get exposed” to pandemic influenza, he added.

The development of a vaccine for a pandemic-causing strain of influenza can begin only after a pandemic starts, and several months are expected to pass before any vaccine becomes available.

The federal government is funding projects to help the vaccine industry shift from egg-based influenza vaccine production to modern cell-culture systems and is also funding experiments with adjuvants and other dose-sparing strategies. According to the prioritization guidelines, the goal of these projects is to foster the production, within six months after a pandemic starts, of enough vaccine to protect every American who wants to be vaccinated.

Thomas cautioned that even if the six-month production timeline for vaccines is achieved, supply-chain disruptions and other issues will affect pharmacists early during a severe pandemic.

“I don’t think that they fully think about all of the significant things that could happen in a pandemic influenza as far as shortage of drugs, sickness of their personnel, and things like that,” he said of his pharmacy colleagues.

If pharmacies close down for as little as a week or two for lack of supplies or staff, he said, people who need maintenance medications like insulin or anticoagulants could suffer.

“I can foresee a very serious situation where many people may possibly get really sick or die just because they can’t get their regular maintenance medication, which will only exacerbate the problem of the pandemic influenza sickness and death,” Thomas said.

Planning for the possibility of an influenza pandemic has become a public health priority since the first known outbreak of H5N1 avian influenza occurred in geese in China in 1996. The virus was blamed for several human deaths during the next year.

Eradication efforts caused a lull in H5N1 cases, but the virus reemerged in 2003 in domestic poultry and humans. From 2003 through mid-June of this year, the World Health Organization had reported 385 confirmed H5N1 infections in humans, including 243 fatal cases.

Thomas said the high death rate underscores the need to decide, well in advance, what to do if a pandemic caused by H5N1 or another deadly avian influenza variant strikes.

“The main thing that pharmacists need to do is to plan, not only personally but for their pharmacy as well,” he said.

The vaccine-prioritization document does not address the use of antiviral medicines for influenza prophylaxis or treatment during a pandemic. These issues were discussed in a draft guidance document from HHS that was announced in the June 3 Federal Register.

According to HHS, antiviral drug allocation during a pandemic should be driven by medical need and not allocated to specific priority groups. This strategy “better meets the ethical principle of fairness and recognizes the significant uncertainty in estimating stockpiling requirements” for antivirals, the draft document states.

The draft guideline states that treatment is preferred over prophylaxis when antiviral supplies are scarce, although postexposure prophylaxis may be appropriate in health care settings to maintain critical functions.

The federal government has purchased 50 million treatment courses of antivirals in advance of an influenza pandemic, according to the draft document. About 80% of the stockpile is oseltamivir, sold by Roche as Tamiflu, and the rest is GlaxoSmithKline’s zanamivir, or Relenza. The federal stockpile also contains substantial amounts of rimantadine, an antiinfluenza drug that is ineffective against recently circulating strains of seasonal influenza but may be of use during a pandemic.

Federal pandemic-response planners have encouraged states to purchase their own stockpiles or antivirals, with the goal of acquiring 81 million total treatment courses between federal and state purchasers.

Thomas noted that pandemic- response plans should address the ethically charged issue of determining who should get antiviral drugs if they are in short supply.

For example, he said, a pharmacist could receive two orders for antiviral medication when only one treatment course is available. In such a case, the patient’s age, health, or even occupation could factor into the decision to allocate the medication, and the decision should be made in accordance with already-established procedures.

“Your simple solution at that point is, we’re going follow the plan. We’ve already agonized over it, gotten that over, we have a plan,” Thomas said. “That takes the emotion of the moment out of that decision, so you feel good about the decision you made.”