By Online Pharmacy

More and more pharmacists are providing vaccinations today. Far from being "bad" pharmacists, as branded by a recent NBC-TV "ER" program, these practitioners are helping the federal government meet its "Healthy People 2010." That goal is to increase to 90% the number of noninstitutionalized elderly who are vaccinated against influenza and pneumococcal disease. ag-guys.com

Pharmacists in 30 states are administering vaccinations to patients, and, in the process, they are moving into a field that's dominated by nurses, nurse practitioners, and physicians. Few, if any, pharmacists are stepping on the toes of pediatricians, who deliver the largest share of childhood vaccinations. Pharmacists say they are professionally satisfied by the increased contact with patients that comes from administering vaccines. As an added bonus, there are no headaches in terms of payment for the immunization service--both patients and health insurance companies are readily paying pharmacists for their time and expertise.

Pharmacists' interest in administering vaccines began with the flu shot--and for good reason. More than 20,000 Americans die from flu-related illnesses each year, and another 40,000 die of pneumonia--mostly seniors over the age of 65. While flu shots account for the majority of vaccinations administered at pharmacies, pharmacists are expanding their services to include vaccines against hepatitis A and hepatitis B, Lyme disease, tetanus, chickenpox, and travel vaccines. As pharmacists broaden their horizons, there are fears that they may encounter problems now that there's growing concern about the safety of some vaccines.

Bart Classen, an immunologist and CEO of Classen Immunotherapies Inc., Baltimore, said in the near future there are going to be huge lawsuits challenging the safety of vaccines. "We'll see more and more class action lawsuits, and it's going to be bad news for pharmacists because if they start giving out these vaccines, they could get caught up in these huge liabilities." Ultimately, he said, pharmacists who own their own pharmacies "could lose their livelihood because vaccine safety is becoming a big national issue, and there are some real problems with adverse reactions."

Classen cautioned that pharmacists should be "very careful with vaccines because many of them can do more harm than good." Pharmacists need to "think about the risks," he said, "because vaccines may kill people." For example, he said, the Haemophilus vaccine can cause an increased risk of developing insulin-dependent diabetes in some pediatric and adult populations. "For most vaccines, there's a significant increase in development of diabetes. With the Haemophilus vaccine, by age seven, it was accounting for a 26% increase in diabetes. And some of the newer vaccines, which are more potent, may be causing a 35% rise in diabetes," he said.

Diabetes, on average, reduces life expectancy by 10 years. Classen explained, "So right there, several people who are getting vaccine-induced diabetes will die from it. They'll start to get serious complications from diabetes about 20 years after the onset of diabetes." Pharmacists, he said, should counsel people seeking a vaccination that "there are real risks to consider, and a vaccine isn't something they should just go and get without thinking."

According to Classen, people today are focused on disease prevention and management, and that type of thinking has created a climate in which there seems to be a vaccine being developed for everything--from AIDS to Lyme disease. However, he noted that "there's a limit to how many vaccines people can take. The problem with vaccines is manufacturers have to study them for only 15 days. In clinical trials, the vaccine is administered to the subject, and if in 15 days the person looks healthy, the vaccine is said to be safe. Well, I think that's completely unacceptable."

Already a class action lawsuit has been filed against SmithKline Beecham, maker of LYMErix, a vaccine that can prevent Lyme disease. The lawsuit claims the vaccine causes an incurable form of autoimmune arthritis in patients classified by genetic type HLA-DR4+. According to the lawsuit, the vaccine could produce symptoms that are much worse than those caused by the actual illness itself. The lawsuit also claims that SmithKline failed to warn doctors and the general public that nearly 30% of the population is predisposed to the degenerative autoimmune syndrome, which the suit claims is triggered by the contents of the vaccine.

SmithKline spokeswoman Carmel Hogan said the company won't comment on the litigation, but it will "vigorously defend the product in this lawsuit." In a prepared statement, SmithKline said clinical trials and commercial use have proven LYMErix to be a safe vaccine that is well tolerated by patients. In a pivotal efficacy clinical trial for LYME-rix, an independent data safety monitoring board reviewed the safety data and found no evidence of an association between LYMErix and autoimmune arthritis. "Neither the independent monitoring board nor SmithKline Beecham found evidence of a higher incidence of arthritis among the recipients of LYMErix compared with the recipients of a placebo," said Hogan.

LYMErix is not the only vaccine causing concern. Several vaccinations have been associated with adverse reactions in children, including increased risk of polio and autism. The American Academy of Pediatrics (AAP) recently voiced concern that oral polio vaccines can actually cause the development of polio. Eight cases of vaccine-associated polio were reported annually, on average, to the Centers for Disease Control & Prevention between 1980 and 1994. AAP now recommends the use of injected polio vaccine instead of oral polio vaccines. "Pediatricians need to move to an all-injected schedule in an expeditious manner," said Jon Abramson, M.D., chair of AAP's Committee on Infectious Diseases.

Adults main target

Most pharmacists who offer immunizations work with adult rather than pediatric populations, but because pharmacists are becoming credentialed to deliver all manner of vaccinations, there's the opportunity to serve pediatric populations. Two years ago, for example, Walgreens offered a childhood immunization program called Shots for Tots in the Chicago area. In keeping with Walgreens' role as a facilitator of vaccinations, the shots were administered by nurses rather than pharmacists. Yvette Venables, a Walgreens spokeswoman, said that while the Shots for Tots program was a success, it has been discontinued.

Holly Whitcomb Henry, R.Ph., co-owner of View Ridge Pharmacy and three other pharmacies based in Seattle, noted, "Our role as pharmacists on childhood immunization is to provide information--but we leave the administering of vaccines to pediatricians."

While there is concern about the safety of some vaccines, there is also encouraging news about the benefits of hepatitis B vaccination. Two recent studies found that hepatitis B infection is linked to the development of primary liver cancer. In a study in Taiwan, universal childhood immunization against the hepatitis B virus actually decreased the occurrence of liver cancer among children by 49% from 1981 to 1994.

In a Korean study, adults who were vaccinated against hepatitis B decreased their risks of developing liver cancer by 42%. William Schaff-ner, M.D., professor and chairman of the department of preventive medicine at Vanderbilt University, said, "Widespread immunization against hepatitis B is the most effective means to prevent the hepatitis B infection and, subsequently, liver cancer."

The Food & Drug Administration has already recognized the hepatitis B vaccine as the first anticancer vaccine. In keeping with that, the FDA authorized changes to the labeling of SmithKline's Engerix-B, a leading hepatitis B vaccine. The labeling changes highlight a clear link between chronic hepatitis B infection and development of liver cancer.

Pharmacists who are developing vaccination services say they are not put off by some of the adverse publicity surrounding vaccine safety. Whitcomb Henry said, "We'd be very hard-pressed to say vaccines are more dangerous than the diseases they prevent because we have virtually wiped out pertussis and measles in this country, and many children used to die of these diseases before we had vaccines."

Chad Shedron, Pharm.D., an assistant professor of pharmacy at Butler University and director of clinical services at Family PharmaCare Center Inc., a disease management-centered pharmacy based in West Lafayette, Ind., said, "The good of the public health at this point says that we will save more lives by vaccinating people, and the incidence of adverse events is actually higher with the disease than with the vaccination."

Rod Shafer, R.Ph., executive director, Washington State Pharmacists Association, said pharmacists' level of commitment to administering vaccinations is "very high," and the patient response to getting shots from a pharmacist has been overwhelming." For many patients, getting a flu shot is "almost like an impulse buy when they walk into the pharmacy and see the sign saying 'Get your flu shots here,' " he said.

The fact that pharmacists now administer vaccinations has had a positive impact on what other health professionals are doing. "In smaller communities, experience shows that when the pharmacist began delivering vaccinations, physicians also began to do more," Shafer said. Doctors became more aware that people needed to be vaccinated, he said. "I think there was a knee-jerk reaction of, Hey, wait a minute. This is something we should have been doing ourselves." Most physicians are supportive of pharmacists doing adult immunizations but, said Shafer, "The caveat is that nobody is too keen on our doing the pediatric vaccinations as well."

Shedron explained, "Up to 30% of a pediatrician's income is derived from delivering childhood immunizations, and as pharmacists move into the immunization field, we have to be careful in establishing our programs that we don't step on pediatricians' toes or get off on the wrong footing. Mostly, we steer clear of childhood immunizations."

Shedron founded a vaccination clinic at Family PharmaCare in October 1998 after reviewing data that suggested Indiana had one of the lowest vaccination rates--particularly for pneumococcal vaccinations. "I was personally embarrassed by the figures," he noted. "I felt I had to do something to make a difference." Shedron took a training course in administering vaccinations that is offered by the American Pharmaceutical Association, and, working on referral from Family PharmaCare's medical director, he began administering flu shots to customers aged 18 and above.

Shedron is trained to deliver vaccinations for hepatitis B, tetanus, and chickenpox. Because the pharmacy offers a variety of disease management programs, he said, "We were already set up with Medicare Part B coverage to bill Medicare for flu shots and for pneumococcal vaccines." In Indiana, the Pharmacy Practice Act authorizes pharmacists to administer drugs, but the act is not as specific as those of other states, such as Iowa and Texas, that have rewritten the practice act and listed specific steps for pharmacists to follow. Shedron said he is looking forward to the day when that happens "because it will give us more freedom."

Patient response very positive

Patient response to getting the flu shot and other vaccinations from their pharmacist has exceeded Shedron's expectations. In 1998, he expected to do about 100 flu shots but ended the season administering 500. Last year, he expected to administer 1,000 shots but ended up doing 1,800. "People from all walks of life are really eager to protect themselves from the flu, and other vaccine-preventable illnesses. Given the chance, they are more than willing to let their pharmacist handle their vaccinations," he said. He also believes that national groups are doing a much better job of increasing public awareness about flu and pneumococcal shots and noted that "CDC has done its part by sponsoring a campaign saying one of the most undervaccinated groups are patients under 55 years of age who have diabetes."

Shedron uses the pharmacy's database to review patient populations that could benefit from immunizations. "As far as pharmacists are concerned, one of the great things we have is a built-in database of who needs a shot," he said. Pharmacists can readily create a report on patients who are on medications for congestive heart failure, draw up information on diabetes patients, and identify patients who are 65 and older.

"We have done that for a range of specific groups, and we've followed up by sending them letters, reminding them that they have not received the pneumococcal vaccination," he said. The letters include leaflets about the vaccination and its benefits. He said his goal is to provide patients with as much information as possible so that the patient can make an informed decision about whether they should have the vaccination or not. "We basically tell them, 'Here's some information about it. Here's what the CDC information sheet says. Think about it and talk to your physician. You can get the vaccination from him, or if you want to come to the pharmacy to get it done, we can take care of it for you,' " he said.

Shedron charges patients for his services. "Last year, our flu shots cost $12, while other places were charging up to $18. For pneumococcal vaccinations, we charged $26, and for hepatitis B shots, we charged $180 for the entire series. Patients pay out of pocket, and that seems to work great for them and for us," he said.

Service takes to the streets

While Shedron is building a thriving vaccination business at the pharmacy, he is also taking the service beyond the site and into local school districts and companies that used to be served by visiting nurses. To get the business, Shedron simply telephoned several school districts, described his program, and offered to administer flu and pneumococcal vaccinations to the schools' staff members. Succeeding there, he next approached a local employer that hosts an annual health fair at which Family PharmaCare pharmacists perform cholesterol screenings. "I told the company that we could do their vaccinations as well, and they took us up on it," he said. Another local employer hired him to administer flu shots to its employees and asked him to bill the company's health insurer directly. "This season, we did 100 shots in a couple of hours, sent a single bill to the medical insurance company, and so patients didn't have to pay out of pocket," he said.

Today, Shedron's patients include a local physician who has started referring her patients to him for flu and pneumococcal shots. "Initially, I did her hepatitis B shots, and I did her flu shot for her, and then she asked me to vaccinate her staff," he said. Physicians support his involvement in administering shots, he said, "because they know I can handle it; it's convenient for them to send patients to me. And because I keep the vaccines at the pharmacy, it means the physicians don't have to stock them. They don't have to worry about vaccines going out of date; they don't have to worry about the handling requirements of vaccines, such as which ones have to be kept refrigerated and which ones don't. Physicians tell me they appreciate the fact that they can leave all that to the pharmacist because we are kind of used to doing all of that."

For each shot administered, Shedron keeps a record of the date the shot was given, the site of administration, and the vaccine's lot number. If the vaccine requires notification or has to be entered into the patient's medical record, like the pneumococcal vaccination, he sends a letter to the patient's physician.

Giant offers flu shots

Last year, Eleni Anagnostiadis, R.Ph., manager of pharmacy support services at Giant Food, Landover, Md., launched a pilot flu vaccination campaign involving pharmacists at 10 of the chain's 174 stores. Giant is a wellness-oriented food-pharmacy chain serving customers in Delaware, Maryland, New Jersey, Virginia, and Washington, D.C. The majority of flu shots administered at 160 of the chain's food-pharmacy stores are delivered by an outside vendor who employs nurses and licensed nurse practitioners to administer the shots. With Giant's pharmacists administering vaccines, Anagnostiadis said, "We definitely see the nurses as competition now, because they have done this for years, and now our own pharmacists are administering vaccines."

The food-pharmacy chain has operated a flu vaccination campaign for the past five years, advertising the service in the Washington Post, the Baltimore Sun, on local radio, and using in-store signs and banners. For the pilot program, pharmacists at Giant were trained by APhA to administer vaccines to customers. The pharmacists are approved to deliver hepatitis A and B, tetanus, pneumonia, measles, mumps and rubella, influenza, and varicella--but only in Virginia where pharmacists are authorized by law to administer vaccines. "We are not doing all of those vaccinations yet, but we asked for approval so that when we want to proceed with them, we are already certified," Anagnostiadis said.

In addition to the APhA training, the pharmacists followed up by gaining certification in cardiopulmonary resuscitation (CPR) and took a training program offered by the Occupational Safety & Health Administration (OSHA) on what to do in emergency situations. "They were trained in how to handle situations in which blood spills or someone is bleeding profusely," Anagnostiadis said.

Pharmacists at Giant closed the flu season by administering about 1,500 flu and pneumonia vaccines. "The customer response was tremendous," Anagnostiadis said, "We actually had some customers say, 'Wow, that's my pharmacist doing this for me.'" Customers readily accepted that the person who filled their prescriptions was now also their flu care provider, she added. The pharmacists also felt rewarded. "Watching our pharmacists participate in this--the joy that they got out of the customer contact and answering questions about flu and pneumonia or whatever else the patients wanted to talk about--it was like we gave them a million dollars. They got a lot of personal satisfaction," she said.

Documentation very important

Before administering flu shots, pharmacists asked each patient to sign a consent form, documenting the date and the type of vaccination being performed. For its files, the pharmacy keeps a record of the patient's name, the vaccine's manufacturer, lot number, and the expiration date. "That's important because if, down the road, there are a lot of adverse reactions that would need to be reported, or if a manufacturer had a recall on a certain lot, we would have to be able to track it and notify the patient," Anagnostiadis said.

"Our pharmacists charged $10 for a flu shot, and people just paid. They didn't have a problem with that and so reimbursement wasn't an issue," Anagnostiadis said. To follow up on patient response to pharmacists administering vaccinations, Giant has conducted a patient satisfaction survey asking how people feel about their pharmacists administering vaccines. The results are due in March.

Giant Foods is now preparing for the next flu season and Anagnostiadis said she already has plenty of volunteers. "I'm getting calls from pharmacists who are asking, 'When is the next training session because we definitely want to participate?' " she said. With pharmacists showing that level of interest, Giant will likely expand its pharmacist-driven flu shot campaign. "What we do next depends on what action is taken to rewrite the pharmacy practice acts in the District of Columbia, Maryland, and New Jersey, the three other states where Giant Foods has stores," she said.

Whitcomb Henry, with her four pharmacies in Seattle, operates a busy flu shot program that delivered more than 2,000 flu shots last season "just on a walk-in basis in two retail pharmacies." In addition to serving patients through the retail outlets, Whitcomb Henry provides flu and pneumonia, hepatitis A and B, and tetanus shots to hundreds of residents of assisted-living facilities and adult family homes. "They really like the service of a pharmacist coming in to give them their shots," she said. Typically, an adult family home has four to six residents, and "for them to pay a visiting nurse to come in and do flu shots is prohibitive. But we'll come in and do it for them, and we bill Medicare because most of those people are seniors or they are disabled persons who also have Medicare benefits," she said.

Whitcomb Henry has run the flu shot program for four years and markets the program using the pharmacy newsletter, which is mailed to 1,300 households. "We run factual articles about the flu and what a flu vaccine does for you. We include statistics, and we outline the recommended populations that really should get flu shots, like health-care workers, anybody over 65, and people with chronic respiratory problems, such as asthma, emphysema, or bronchitis," she said. Flu shots are also recommended for "anybody who wants to avoid the flu and the loss of work and loss of time in school that's associated with it, " she said.

Other marketing strategies include "hold messages on our phones informing callers that we do flu shots, and we have in-store signage and a banner in our window," she said. "One of our locations is a pretty high traffic corner, so lots of people walk by every day and see our signs. We've also done some outreach marketing--giving flu shots to workers at various businesses in the area and immunizing the teachers at some of the schools." Patient response has been overwhelming, she said. "People like the convenience. One of our retail stores is open from 9 a.m. to 8 p.m. seven days a week, and literally any hour we are open, they can get a flu shot." People who have health insurance that would pay for the shot if they went to their doctor "just come into our pharmacy and pay us to do it instead," she said.

Clearly pharmacists who offer immunization services are making headway, but nurses and nurse practitioners are not going to give up the immunization business they have dominated for years without resorting to novel vaccine promotions. Nurses at Huntington Memorial Hospital in Pasadena, Calif., now offer flu shots free of charge on a drive-through basis to people waiting in cars.

"We delivered more than 2,000 flu shots in less than three hours," noted Connie Matthews, director of public relations at Huntington Memorial Hospital. "One year, our nurses administered flu shots while wearing rollerblades to speed things up," she said. Pharmacists have yet to don skates, but they are nonetheless succeeding in gaining the attention of patients who want the protection provided by vaccines.