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The Journal of Emergency Medicine, Vol. 33, No. 1, pp. 81–89, 2007Copyright © 2007 Elsevier Inc.

Printed in the USA. All rights reserved0736-4679/07 $–see front matter

doi:10.1016/j.jemermed.2006.11.017

Public Health inEmergency Medicine

AN INNOVATIVE ADVANCE TO INCREASE THE USE OF THE VACCINEINFORMATION STATEMENT

Richard F. Edlich, MD, PHD,*† Dana M. Olson,‡ Brianna M. Olson,‡ Jill Amanda Greene,‡K. Dean Gubler, DO, MPH,§ Kathryne L. Winters,� Maia J. Poe,‡ L. D. Britt, MD, MPH,¶

and William B. Long III, MD**

*Distinguished Professor of Plastic Surgery, Biomedical Engineering and Emergency Medicine, University of Virginia Health System,Charlottesville, Virginia; †Department of Trauma Prevention, Research and Education, Trauma Specialists, LLP, Legacy Emanuel

Hospital, Portland, Oregon; ‡Vancouver, Washington; §Director, Department of Surgical Critical Care, Trauma Specialists, LLP, LegacyEmanuel Hospital, Portland, Oregon; �Trauma Specialists, LLP, Legacy Emanuel Hospital, Portland, Oregon, ¶Chairman, Departmentof General Surgery, Eastern Virginia Medical School, Norfolk, Virginia; **President and Medical Director of Trauma Specialists, LLP,

Legacy Emanuel Hospital, Portland, Oregon

Reprint Address: Richard F. Edlich, MD, PHD, 22500 NE 128th Circle, Brush Prairie, WA 98606

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Abstract—Because many physicians do not use the Vac-ine Information Statement (VIS), we created a revisedtatement that would alert the physician to the need to usehe VIS. Even though the Centers for Disease ControlCDC) coordinated this evaluation, both the CDC and mostf the State Board of Medical Examiners did not supporthis revision of the VIS. Despite the disinterest of the vastajority of the State Board of Medical Examiners, weould recommend that this updated VIS be implemented

mmediately to educate our society on the information inhe VIS. © 2007 Elsevier Inc.

Keywords—Vaccine Information Statement; Vaccinenjury Compensation Program

INTRODUCTION

he topic of vaccine safety became prominent during theid 1970s with increases in lawsuits filed on behalf of

hose presumably injured by the diphtheria, pertussis,etanus (DPT) vaccine (1). Legal decisions were madend damages awarded despite the lack of scientific evi-ence to support vaccine injury claims (1). As a result ofhe liability, prices soared and several manufacturersalted production. A vaccine shortage resulted and pub-

ECEIVED: 6 July 2006; FINAL SUBMISSION RECEIVED: 17 N

CCEPTED: 29 November 2006

81

ic health officials became concerned about the return ofpidemic disease. To reduce liability and respond toublic health concerns, Congress passed the Nationalhildhood Vaccine Injury Act (NCVIA) in 1986. Thisct was influential in five different ways.First, the National Vaccine Program Office was es-

ablished within the Department of Health and Humanervices. The responsibility of the National Vaccinerogram Office is to coordinate immunization-relatedctivities between all Department of Health and Humanervices agencies, including the Centers for Diseaseontrol and Prevention (CDC), the Food and Drug Ad-inistration, the National Institutes of Health, and theealth Resources and Services Administration.Second, Vaccine Information Statements (VISs) were

eveloped for the vaccine recipients. Vaccine informa-ion pamphlets produced as a result of the Nationalhildhood Vaccine Injury Act mandate were first pub-

ished October 15, 1991. This Law was amended in 1993nd the first, one-page Vaccine Information Statementsroduced under the amended law were published on June0, 1994. These vaccine information statements were foriphtheria, tetanus, pertussis (DTP); tetanus, diphtheriaTD); measles, mumps, rubella (MMR); and polio (IPV)

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accines. As of September 2001, the VISs that must besed are: diphtheria, tetanus, pertussis, (DTaP); diphthe-ia, tetanus (Td); MMR; IPV; hepatitis B; Haemophilusnfluenzae type b (Hib); varicella; and pneumococcalonjugate.

Other VISs that are available are influenza, hepatitis, pneumococcal polysaccharide, meningococcal, lymeisease, and anthrax. Their use is not required by theCVIA, but is strongly encouraged. Copies of the VIS

re available at www.cdc.gov/nip/publications/VIS.opies are available in English as well as many other

anguages. They must be used when giving vaccinesurchased through a CDC contract. VISs should be giveno the vaccine recipient, their parent, or legal represen-ative before each dose. A VIS must be given with everyaccination, including each dose in a multi-dose series.ach VIS contains a brief description of the disease asell as the risks and benefits of the vaccine. VISs areeveloped by the CDC and distributed to state and localealth departments as well as individual providers.ealth care providers shall make a notation in eachatient’s permanent record regarding the time the vac-ine information materials are provided, indicating 1) thedition date of the VIS materials distributed and 2) theate these materials are provided.

This record-keeping requirement supplements the re-uirement of 42 U.S.C. (300 aa-25) indicating that allealth care providers administering these vaccines mustecord in the patient’s medical record (or in a permanentffice log) the name, address, and title of the individualho administers the vaccine, the date of administration,

nd the vaccine manufacturer. Healthcare providershould consult their legal counsel to determine additionaltate requirements pertaining to immunization. The Fed-ral requirement to provide the vaccine information ma-erial supplements any applicable State Laws.

Third, the NCVIA also mandates that all health careroviders must report certain adverse events after vaccina-ion to the Vaccine Adverse Event Reporting SystemVAERS). This system will be described in detail later inhis review.

Fourth, under the NCVIA, the National Vaccine Injuryompensation Program (NVICP) was created to compen-

ate those injured by vaccinations on a “no fault” basis. Thisrogram will also be described in detail later in this report.

Finally, the NCVIA established a Committee from thenstitute of Medicine (IOM) to review the existing liter-ture on vaccine adverse events (health effects occurringfter immunization that may or may not be related to theaccine). This group concluded that there are limita-ions in our knowledge of the risks associated withaccines. Of the 76 adverse events they reviewed forcausal relationship, 50 (66%) had no or inadequate

esearch (2,3). r

VACCINE ADVERSE EVENTREPORTING SYSTEM

he National Childhood Vaccine Injury Act of 1986andated that all health care providers report certain

dverse events that occur after vaccination (4). As aesult, the Vaccine Adverse Events Reporting SystemVAERS) was established by the Food and Drug Admin-stration and the Centers for Disease Control and Pre-ention (CDC) in 1990. VAERS provides a mechanismor the collection and analysis of adverse events associ-ted with vaccines currently licensed in the Unitedtates. Adverse events are defined as health effects thatccur after immunization that may or may not be relatedo the vaccine. VAERS data are continually monitored toetect previously unknown adverse events or increases innown adverse events.

Approximately 10,000–12,000 VAERS reports areled annually, with 20% classified as serious (causingisability, hospitalization, life-threatening illness oreath). Anyone can file a VAERS report, includingealth care providers, manufacturers, vaccine recipientsr, when appropriate, parents. Those who have experi-nced an adverse reaction after immunization are encour-ged to seek help from a health care professional whenlling out the form. VAERS forms can be obtained ineveral ways. Each year the form is mailed to more than00,000 physicians specializing in pediatrics, familyractice, internal medicine, infectious diseases, emer-ency medicine, obstetrics and gynecology. In addition,opies are sent to health departments and clinics thatdminister vaccines. The VAERS form requests the fol-owing information: the type of vaccine received, theiming of vaccination, the onset of the adverse event,urrent illness or medication, past history of adversevents after vaccination, and demographic informationbout the recipient (age, gender, etc.). The form is pre-ddressed and stamped so it can be mailed directly toAERS. To request a VAERS form or assistance inlling it out, call 1-800-822-7967.

UNDERSTANDING VACCINE SAFETYINFORMATION FROM VAERS

n understanding of the system’s defined objectives andnherent drawbacks is vital to the effective use of theAERS data in vaccine safety investigations. In 2004,arricchio et al. featured an article that explains theefined objectives of the VAERS, as well as its strengthsnd limitations (5). The information in VAERS is notecessarily complete, nor is it verified systematically (5).eports are classified as serious or non-serious based on

egulatory criteria. Reports are coded by VAERS in a

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Vaccine Information Statement 83

niform way with a limited number of terms using aerminology called costart. Coding is useful for searchurposes, but is necessarily imprecise. VAERS is usefuln detecting adverse events related to vaccine and mostecently was used for enhanced reporting of adversevents in the national smallpox immunization campaign.AERS data have always been publicly available. How-

ver, it is essential for users of VAERS data to be fullyware of the strengths and weaknesses of the system.AERS data contain strong biases. Incidence rates and

elative risks of specific adverse events cannot be calcu-ated. Statistical significance tests as well as confidencentervals should be used with great caution and not rou-inely. Signals detected in VAERS should be subjected tourther clinical and descriptive epidemiologic analysis.onfirmation in a controlled study is often required.

VACCINE INJURYCOMPENSATION PROGRAM

o reduce the liability of manufacturers and health careroviders, the National Childhood Vaccine Injury Act of986 established the National Vaccine Injury Compen-ation Program (NVICP). This program is intended toompensate those individuals who have been injured byaccines on a “no-fault” basis. No fault means thateople filing claims are not required to prove negligencen the part of either the health care provider or manu-acturer to receive compensation. The program covers alloutinely recommended childhood vaccinations. Settle-ents are based on the Vaccine Injury Table, which

ummarizes the adverse events caused by vaccines. Thisable was developed by a panel of experts who reviewed

he medical literature and identified the serious adversevents that are reasonably certain to be caused by vac-ines. Examples of Table injuries include anaphylaxissevere allergic reaction), paralytic polio, and encepha-opathy (general brain disorder). The Vaccine Injuryable was created to justly compensate those injured byaccines while separating out unrelated claims. As morenformation becomes available from research on vaccineide effects, the Vaccine Injury Table is updated (6,7).

Individuals and their families can qualify for compen-ation in three ways. The first is to show that an injuryound on the Vaccine Injury Table occurred in the ap-ropriate time interval after immunization. The other twoays to qualify include proving that the vaccine caused

he condition or demonstrating that the vaccine worsenedr aggravated a pre-existing condition (6,7).

The vaccine injury compensation process begins whenn individual files a petition with the United States Court ofederal Claims. At that point, a physician from the pro-

ram reviews the petition to determine whether it meets S

he criteria for compensation. This recommendation isot binding. A Court attorney then reviews the case andakes an initial decision for or against entitlement to

ompensation. Decisions may be appealed to the Courtf Federal Appeals. This process occurs at no cost to thendividual filing the claim. The NVICP is coordinated byhe Department of Health and Human Services and theepartment of Justice. For more information on therogram or for assistance in making a claim, call 1-800-38-2382 (6,7).

IMPROVEMENTS IN VACCINE SAFETY

n the last decade, numerous changes in vaccine produc-ion and administration have reduced the number ofdverse events and resulted in safer vaccines. A moreurified acellular pertussis (aP) vaccine has been li-ensed for use and has replaced the whole-cell pertussisaccine used in DTP (diphtheria, tetanus, pertussis vac-ine). Several studies have evaluated the safety and ef-cacy of DTaP as compared to DTP and have concluded

hat DTaP is effective in preventing disease and that mildide effects and serious adverse events occurred lessrequently when the DTaP vaccine was given (8). Recenthanges in the schedule of polio vaccines have alsoesulted in fewer reports of serious side effects. In 1997,he Advisory Committee on Immunization Practice recom-ended a change in the vaccination schedule to include

equential administration of inactivated polio vaccine (IPV)nd oral polio vaccine (OPV) (9). This sequential scheduleas expected to produce a high level of individual protec-

ion against the disease caused by wild polio virus, whileeducing by 50–70% vaccine-associated paralytic polioVAPP) that occurs in 8–10 people a year who receivePV (9). Today, only IPV is on the recommended child-ood immunization schedule.

THE VACCINE INFORMATION STATEMENT,A REVOLUTIONARY, BUT NEGLECTED

ADVANCEMENT IN HEALTH CARE

n 2001, Davis et al. courageously reported the results ofnational survey of the childhood vaccine risk/benefit

ommunication in private practice office settings (10).hey pointed out that communication about childhoodaccine risks and benefits has been legally required inealth care for over a decade. Until their study, little wasnow about the actual practice of vaccine risk/benefitommunication. Their study was conducted to identifyurrent practices of childhood vaccine risk/benefit com-unication in private physician office settings nationally.

pecifically, they wanted to determine what written ma-

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erials were given, by whom, and when; what informa-ion providers thought parents wanted/needed to know,he content of nurse and doctor discussions with parents,nd the time spent on discussion. They also wanted touantify barriers to vaccine benefit/risk discussion and torioritize materials and dissemination methods preferreds solutions to these barriers.

They conducted 32 focus groups in six cites, and thendministered a 24-question cross-sectional mail surveyrom March to September 1998, to a random nationalample of physicians and their office nurses who immu-ize children in private practices. Eligible survey respon-ents were active fellows of the American Academy ofediatrics or American Academy of Family Physicians

n private practice who immunized children and a nurserom each physician’s office. After three mailings, theesponse rate was 71%.

Sixty-nine percent of the pediatricians and 72% ofamily physicians self-reported that their offices gavearents the CDC VISs, whereas 62% and 58%, respec-ively, gave it with every dose. In 70% of immunizationisits, physicians and nurses reported initiating discus-ion of the following: common side effects, when to callhe clinic, and the immunization schedule. However,hysicians reported rarely initiating discussions regard-ng contraindications (� 50%) and the National Vaccinenjury Compensation Program (� 10%). Lack of timeas considered the greatest barrier to vaccine risk/benefit

ommunication. Nurses reported spending significantlyore time discussing vaccines with parents than pedia-

ricians or physicians. Both physicians and nurses felt andditional 60–90 s was needed to optimally discussmmunization with parents under current conditions.

Stratified analysis indicated that nurses played a keyole in immunization delivery and risk/benefit commu-ication. To improve vaccine risk/benefit communication,0% of all providers recommended a pre-immunizationooklet for parents and approximately half recommended acreening sheet for contraindications and poster for immu-ization reference. The learning method most highly en-orsed was use of practical materials (80%). The authorsourageously concluded that there was a mismatch be-ween the legal mandate for VIS distribution and thectual practice for private office settings.

Appreciating the risks/benefits of VISs, the giftedmergency physician, Dr. Marcus Martin, the visionarymergency nurse practitioner, Leslie Buchanan, and thealented medical student, Alfa Diallo, provided a copy ofhe VISs to the parent or legal representative of any childo whom the provider intended to administer a vaccine,r to any adult to whom the provider intended to admin-ster such vaccine at the Emergency Department at the

niversity of Virginia Health Science Center (11). Their c

fforts are now being replicated in other Emergencyepartments in the Commonwealth of Virginia. The VISas been supplemented with visual presentation or oralxplanation as appropriate. These gifted health care pro-essionals have also been lobbying for computerizedmmunization records for patients in the Commonwealthf Virginia. Dr. Philip F. Parshley, medical director ofhe Oregon Board of medical examiners, has also taken atrong stand for the use of Vaccine Information State-ents by the practicing physicians in Oregon. He points

ut that although “there are no specific State rules/lawsddressing this issue, failure to do so may result in disci-linary action, but only if a complaint is received notifyinghe Board of the occurrence.” His eloquent comments stresshe need to educate the public on the availability of Vaccinenformation Statements as well as the valuable informationhey provide for the immunized patient.

Ball et al. have outlined effective vaccine risk commu-ication strategies (12). These strategies have four compo-ents. First, they communicate existing knowledge, takingnto account what individuals already know. Second, suc-essful risk communication recognizes factors influencingarental risk perception and addresses vaccine decisioneuristics. Third, they acknowledge potential risk commu-ication pitfalls. Finally, effective risk communication en-ages parents appropriately, which, for active concernedarents, means a decision-making partnership with theirhysician. As previously noted, vaccine administrators areequired by law to provide Vaccine Information Statementsor vaccines covered by the NVICP. However, it is impor-ant to find out that the Vaccine Information Statementhould not be construed as informed consent because in-ormed consent requirements are determined by State laws.tate laws dictate whether informed consent is requiredefore vaccination, whether informed consent must be oralr in writing, and whether additional vaccine informationust be provided (Kevin Malone, CDC, Office of Generalouncil; personal communication). While the VISs can beonsidered to be a revolutionary educational advance, theyust be modified to fit the reading level for some parents.

t is important to emphasize that Vaccine Information State-ents and other vaccine information materials cannot be a

eplacement for the dialogue between the physician andarent, legal representative, or those who are being immu-ized. The physicians who do not emphasize patient edu-ation and provider-communication have been found to beusceptible to a higher litigation rate (13).

EXEMPTIONS FOR VACCINATION

n every state, parents with religious objections to im-unization may apply for an exemption for their child or

hildren from the state’s immunization requirements for

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Vaccine Information Statement 85

chool entry. All states offer medical exemptions (indi-iduals who are immunocompromised, have allergic re-ctions to vaccine constituents, have moderate or severellness, etc.). Religious exemptions are allowed in 48tates (not allowed in West Virginia and Mississippi),nd 15 states offer philosophical exemptions (14). Theequirements for documentation of medical, religious, orhilosophical exemptions vary.

In some states, parents with philosophical exemp-ions may apply for an exemption for their children

igure 1. Letter to the Board of Medical Examiners.

rom the state’s immunization requirements for schoolntry.

Parents should be aware that withholding vaccinationseaves their child vulnerable to vaccine-preventable dis-ases in the event of an outbreak. As a matter of personalealth, children without immunizations should remainome during outbreaks of the diseases for which theyave not received vaccination. Also, as a matter of re-ponsibility to the community, unvaccinated childrenhould be kept at home if there is an outbreak of a

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accine-preventable disease within the family. Such ill-esses should be reported to the pediatrician or familyhysician.

If you are considering a philosophical or religiousxemption for your child, you should be aware thatutbreaks tend to occur in waves: One group becomes ill;second group becomes ill within a week or two, and son. This means that the time an unvaccinated child mustiss school can run into months.For clarification of the laws of your State, contact

our State Health Department. Some states haveosted their school entry immunization requirementsnline. You can check your state’s home page byoing to the Centers for Disease Control and Preven-

igure 2. Proposed updated VIS.

ion home page. o

A REVISED VACCINE INFORMATIONSTATEMENT DESIGNED TO INCREASE THE

USE OF VACCINE INFORMATIONSTATEMENT BY ALL PHYSICIANS WHO

ADMINISTER VACCINES

ealizing that many physicians do not use the Vaccinenformation Statement, we created a revised statement thatould alert the physician to the need to use the Vaccine

nformation Statement. We added the following statemento the bottom of the Vaccine Information Statement: “Fed-ral Law 42 U.S.C. 300aa-26 requires that healthcare pro-iders distribute this to the patient, or to the patient’s legalepresentative, prior to administering this vaccine.” It was

ur goal to alert the health care provider, the patient, or the

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Vaccine Information Statement 87

atient’s legal representative that a Federal Law mandatese use this Vaccine Information Statement.

RESPONSE OF THE BOARD OFMEDICAL EXAMINERS IN EACH STATE

TO THIS REVISED VACCINEINFORMATION STATEMENT

ecause there was going to be a proposed change inhe Vaccine Information Statement, we sent a letter to theoard of Medical Examiners in every state that had the

ollowing components. First, we outlined the goals of theevised Vaccine Information Statement (Figure 1). Sec-

igure 2. (continued).

nd, we included in the letter a question that allowed t

ach Board of Medical Examiners to express their advicend guidance about this revision in the Vaccine Infor-ation Statement. A copy of the updated Vaccine Infor-ation Statement was included (Figure 2).

RESPONSES OF THE STATE BOARD OFMEDICAL EXAMINERS TO THE REVISED

VACCINE INFORMATION STATEMENT

irst, we were surprised that the majority (35) of Stateoard of Medical Examiners did not respond to this

urvey. Only 15 responded (Table 1). We were furtherisappointed that only three states supported the use of

his updated Vaccine Information Statement. One state

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pposed the use of the revised Vaccine Informationtatement.

DISCUSSION

n a recent report to be published, we discussed in detailhe enormous cost to the Federal Government for theaccine Injury Compensation program (15). The Na-

ional Childhood Vaccine Injury Act of 1986, asmended, established the Vaccine Injury Compensationrogram (VICP). The VICP went into effect on October, 1988 and is a Federal “no-fault” system designed toompensate individuals or families of individuals, whoave been injured by covered childhood vaccines,hether administered in the private or public sector. For

he consumer, health care professional, as well as attor-ey, it is important to refer to the following website:ttp://www.hrsa.gov/osp/vicp/INDEX.HTM. This out-ine of the information on the website includes the fol-owing important components: 1) Information about fil-ng claims, program statistics, and other pertinent issues;) How to file a Vaccine Injury Compensation Programlaim; 3) How is the eligibility for the Vaccine Injuryompensation Program determined? 4) What is themount of an award under the Vaccine Injury Compen-ation Program? 5) Can claims from injuries from thio-erosal (mercury) be filed with the Vaccine Injury Com-

ensation Program? 6) How does the Vaccine Injuryompensation Program work? 7) Are there any age

able 1. Vaccine Information Statements Responses

State Support No Comment No Support

issouri Xregon Xtah Xlabama Xolorado* Xawaii Xaine Xinnesota Xississippi Xhode Island Xouth Carolina Xirginia Xashington X

owa Xontana† X

otals 3 11 1

We have no authority or role in taking a position on this issue.The Board voted to oppose revising the Vaccine Informationtatement because it creates a need to document when thetatement is actually handed to the patient, and by whom, toiminish the potential for litigation. The Board feels that the CDChould notify physicians twice a year about the need to provideatients with the statement before administering vaccines.

estrictions on who may file a claim with the Vaccine

njury Compensation Program? 8) What is the deadlineo file a Vaccine Injury Compensation Program claim? 9)

hat vaccines are covered by the Vaccine Injury Com-ensation Program? 10) What adverse events are healthare providers required to report? From 1998 until July005, a total of 2401 non-autism/thimerosal and 4087utism/thimerosal claims were made to the VICP. Theompensation paid for the non-autism/thimerosal claimsrom 1988 until 2005 were $661,777,117.94. On theasis of the deaths and extensive suffering to patients andamilies from the adverse reactions to vaccines comple-ented by the cost of compensation from society to the

njured individuals, their families and attorneys, it shoulde a wake-up call to all health care professionals torovide detailed information to the patient or the parentr legal representative of the child about the potentialangers of vaccines as well as the Vaccine Injury Com-ensation Program. This revised Vaccine Informationtatement must be implemented immediately to ensure

hat the patient or the legal representative realizes theangers of vaccines as well as the Vaccine Injury Com-ensation Program.

Before publication, this report was sent to Mr. Charles. Wolfe of the Centers for Disease Control and Preven-

ion. He made the following comment in an e-mail sento the first author on November 4, 2005. “Like you, Iope we will be able to increase knowledge and use ofhe VISs, so it won’t be such a well kept secret any more.

e will try to do this, at least in part, through moreggressive distribution of the VIS instruction sheet. Theecision to not add the statement to the VISs themselvesppeared to be final.” This decision was obviously veryisappointing to all authors of this article.

cknowledgments—This report was made possible through guid-nce of the Health Education and Information specialists, Charles. Wolfe of the Centers for Disease Control and Prevention.

REFERENCES

1. Freed GL, Katz SL, Clark SJ. Safety of vaccinations: Miss Amer-ica, the media, and public health. JAMA 1996;276:1869–72.

2. Chen RT, Hibbs B. Vaccine safety: current and future challenges.Pediatr Ann 1998;27:445–55.

3. Brink EW, Hinman AR. The vaccine injury compensation act: thenew law and you. Contemp Pediatr 1989;6:28–32,35–6,39,42.

4. Chen RT, Rastogi SC, Mullen JR, et al. The Vaccine AdverseEvent Reporting System (VAERS). Vaccine 1994;12:542–50.

5. Varricchio F, Iskander J, Destefano F, et al. Understanding vaccinesafety information from the Vaccine Adverse Event ReportingSystem. Pediatr Infect Dis J 2004;23:287–94.

6. U.S. Department of Health and Human Services, Health Resourcesand Services Administration. Vaccine Injury Compensation Pro-gram. Available at: http://www.hrsa.gov/osp/vicp.

7. National Immunization Program, Satellite Course on VaccineSafety and Risk Communication. February 26, 1998.

1

1

1

1

1

1

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8. Centers for Disease Control and Prevention. Epidemiology andprevention of vaccine-preventable diseases, vaccine safety (chapter15). Washington DC. Government Printing Office, 1997.

9. Advisory Committee on Immunization Practice (ACIP). Polio-myelitis prevention in the United States: introduction of asequential vaccination schedule of inactivated poliovirus vac-cine followed by oral poliovirus vaccine. MMWR Recomm Rep1997;46:1–25.

0. Davis TC, Fredrickson DD, Arnold CL, et al. Childhood vaccinerisk/benefit communication in private practice office settings: anational survey. Pediatrics 2001;107(2):E17.

1. Edlich RF, Diallo AO, Buchanan L, Martin ML. Hepatitis B virus:a comprehensive strategy for eliminating transmission in the

United States. J Long Term Eff Med Implants 2003;13:117–25.

2. Ball LK, Evans G, Bostrom A. Risky business: challenges inVaccine Risk Communication. Pediatrics 1998;101:453–58.

3. Levinson W, Roter DL, Mullooly JP, Dull VT, Frankel RM.Physician-patient communication. The relationship with malprac-tice claims among primary care physicians and surgeons. JAMA1997;277:553–9.

4. National Vaccine Advisory Committee. Report of the NVACworking group on philosophical exemptions. Atlanta, GA. Na-tional Vaccine Program Office, Centers for Disease Control andPrevention; 1998.

5. Edlich RF, Olson DM, Olson BM, et al. U.S. Department ofHealth and Human Services, Health Resources and ServicesAdministration. National injury vaccine compensation. J Emerg

Med; in press.