September 15, 2003


 Reporting adverse vaccine events

Posted Sept. 1, 2003


Veterinarians discuss how to improve the system

It's late at night, the telephone rings, and you answer it. "Hey doc, remember that dog you vaccinated at 2:00 p.m.?" a man on the line asks. "He can't walk." The caller wants to know whether the vaccine did it, but do you know?

"How are you going to know how likely it is the vaccine could do it, if there is no way to collect information from other practitioners about observations, move that information through a system, and get it to you as educational information?" asked Dr. David Hustead, an AVMA Council on Biologic and Therapeutic Agents member-at-large. How, for that matter, do you compare the relative clinical value of similar vaccines?

The current state
According to Dr. Hustead, little or no practical safety information exists on vaccine labels or in the literature, and current adverse event reporting systems need great improvement. The Department of Agriculture requires anaphylaxis warnings on labels, but that is about it, said Dr. Hustead, who spoke about adverse event reporting on July 19 at the AVMA Annual Convention.

In 1993, the U.S. Pharmacopeia developed a system through which you could easily dial a telephone number and report adverse vaccine events. This system, however, ended up ultimately failing because, among other reasons, not enough reports came into the system, which resulted in biased data.

In recent years, the Adverse Event Working Group has been looking into the problem. The group consists of individuals from the COBTA, the USDA, manufacturers, and affiliated groups, including the American Society for the Prevention of Cruelty to Animals, Poison Control Center, U.S. Pharmacopeia, and the Canadian VMA.

Dr. Hustead, who is also a senior director of international technical and biological regulatory affairs at Fort Dodge Animal Health, says multiple parties are to blame for the current system's failure: veterinarians, manufacturers, and the government.

Historically, veterinarians have not demanded information from the USDA or manufacturers, and veterinarians lack the commitment to reporting observations, he said. They think it's too much work for the results, the system is confusing, or that they must know an event is related before they report it. They might also think an adverse event isn't related, so they don't bother to report it. "We have really not pushed anybody in a (position) of authority to get us more information because, to be honest, we didn't really want it," Dr. Hustead said.

Manufacturers and the government also share the blame. Manufacturers are reluctant to share information, because of concerns over liability issues, inappropriate commercial comparisons, or even appropriate commercial comparisons. And, in the past, the USDA hasn't pushed for reform.

Contrary to common knowledge, however, adverse reporting rules do exist. The rules say that, if a user wants to report an event to the USDA, the agency will accept that report but won't necessarily investigate. The rules also say that if a manufacturer creates a record from a complaint, they must maintain those records and make them available upon request. Manufacturers must also tell the government if they collect information that indicates the vaccine is unsafe or worthless.

One of the main problems with this process is that it exists in a vacuum. "It is completely hidden from practitioners," Dr. Hustead said. "They have no idea what goes on between the USDA and the manufacturers. They have no idea about how the data is collected and reviewed. They have no idea how the USDA comes to a decision."

System of the future
Currently, the USDA has proposed new rules to improve the current system. Implementation, however, has been delayed, because of international harmonization efforts. Japan, Europe, and the United States are trying to develop standardized adverse event regulations.

Under the proposed system, the USDA and manufacturers will continue to accept adverse event reports, but companies will be required to document all communications. Manufacturers must document any complaints and subsequent investigation and send this documentation to the USDA. Manufacturers must also submit periodic safety reports.

Although this system is an improvement over the current situation, it still has flaws, according to Dr. Hustead. It doesn't set out guidelines for when safety events will trigger a formal review, the process is still hidden from practitioners, and it's unclear how information will flow to practitioners. In addition, the method of analysis is undefined. "There is still a lot in the detail that has not been covered," Dr. Hustead said. "COBTA is very concerned that, if there are 115 manufacturers out there, there are going to be 115 ways of analysis."

So, is this proposed system the best way? Should other clinical agents, such as drugs, insecticides, and nutraceuticals, be included in a reporting system? Is there a way to develop a less-confusing system or encourage veterinarian participation?

Dr. Hustead says veterinarians need to become involved and provide feedback to the COBTA. To do so, individuals can find their representative's contact information in the front of the AVMA directory. For example, perhaps veterinarians would prefer an independent data collection and analysis center, although this would come with a fairly large price tag.

"We really want to know—where do you want us to go from here?" questioned Dr. Hustead. "Do you want us to play with the system as it exists and accept the fact that we can get incremental improvements over the next few years, or do you want something new and novel?"