Requiring Vaccines for Children: Are there Limits?

Transcription

1 Requiring Vaccines fr Children: Are there Limits? Lainie Friedman Rss, MD, PhD Carlyn and Matthew Bucksbaum Prfessr Sectin Chief, Cmmunity Sciences, Institute fr Mlecular Pediatric Sciences (IMPS) Assciate Directr, MacLean Center fr Clinical Medical Ethics University f Chicag

2 10/90 Divide* Less than 10% f medical research funds are spent n the diseases that accunt fr 90% f the glbal burden f disease. Selgelid charges that biethics apparently suffers frm a misdistributin f research resurces analgus t the 10/90 divide. Althugh infectius diseases shuld be recgnized as a tpic f primary imprtance fr biethics, it has received little attentin. Three themes: 1) Significant impact f infectius diseases n health histrically (Black Death and small px) and currently (SARS and AIDS) is unrivalled in medicine. 2) Public Health versus Individual Autnmy 3) Justice: Burden is mst heavily shuldered by the pr (in develping cuntries). * MJ Selgelid, Ethics and Infectius Disease Biethics; 2005: 19(3):

3 Universal Vaccinatins and Exemptins State has the authrity t require universal immunizatin fr infectius cnditins (parens patriae), but it is less clear hw aggressively the state shuld use its pwer when the likelihd f infectin is quite lw. Three types f exemptins Medical exemptin: if vaccinatin wuld place the individual at risk (e.g.,immuncmprmised hst) Religius exemptins Philsphical exemptins

4 Whether Failure t Vaccinate is Medical Neglect Failure t immunize children against certain diseases when a safe and effective vaccine exists is medically neglectful. What is meant by safe and effective is nt clear-cut. cut. Medical neglect des nt always merit legal interventin What is the threshld fr legal interventin is nt clear-cut. cut. Treatment is f prven efficacy; has a high prbability f success; and denial f treatment will mst likely result in imminent death r serius mrbidity. Gldstein, Freud and Slnit use the criteria least detrimental alternative t justify state interventin Whether the neglect is due t religius beliefs (r ther sincerely held beliefs) shuld nt matter althugh bth deserve greater respect than neglect due t laziness.

5 Balancing Public Health and Individual Freedm First, state has an bligatin t ensure that all nnexempt children are fully immunized accrding t public health recmmendatins. Requires imprved access t such services. State interventin is justifiable in times f epidemics when nn-immunizatin pses risks t many.

6 Requiring Childhd Vaccines: Case Studies

7 Case 1: Immunizatin Refusals Mr. T brings in his sn Tmmy fr a pre- schl physical exam. Tmmy is 5 years ld and will enter public schl in September. Tmmy recently mved frm Ohi and has nt received any immunizatins. His parents base their refusal n religius grunds. FACTS: Mst states respect religius refusals fr immunizatins unless there is an imminent public health threat. What d yu d next?

8 Flanagan-Klygis, Sharp and Frader, Dismissing the Family wh Refuses Vaccines. Arch Ped Adl Med 2005; 159: pediatricians frm the American Academy f Pediatrics 452 returned surveys (45%) 256 f 302 (85%) pediatricians reprted encuntering partial vaccine refusal during the preceding 12 mnths. 162 f 302 (54%) reprted encuntering a parent wh refused all vaccines. Reasns fr refusals: Safety cncerns T many at ne time Philsphical r religius bjectins

9 Physician Respnse Fr parents refusing specific vaccines, 82 (28%) wuld ask the family t seek care elsewhere. Fr parents refusing all vaccines, 116 (39%) wuld refer the family Reasns: Lack f shared gals Lack f trust Fear f litigatin Sme said the type f vaccine refusal was extremely imprtant. DTAP, HIB, MMR and IPV were mre imprtant than Pneumcccal, Hep B and Varicella-zster vaccine.

10 Diekema & the Cmmittee n Biethics, Respnding t Parental Refusals f Immunizatin f Children. Pediatrics 2005; 115: Cited ther data: 7 f 10 pediatricians reprted they had a parent refuse an immunizatin in the 12 mnths prir t the survey. Usually MMR (fear f autism) Als refused Varicella, then pneumcccal, Hep B 4% f pediatricians refused permissin fr an immunizatin fr their wn children yunger than 11 years. Small percentage said they always (4.8%) r smetimes (18.1%) tell parents they will n lnger serve as the child s s physician.

11 AAP Cmmittee n Biethics First respnse f mst pediatricians Attempt t educate Dcument Cnsider 3 types f cases Cases in which refusal risks harming the child sufficiently that the decisin cnstitutes medical neglect and justifies DCFS invlvement. (Refusal f tetanus after sustaining a deep and cntaminated puncture wund.) Cases in which refusals puts ther children at risk f harm sufficient t justify public health interventin (Measles immunizatin requirements fr schl entry.) All ther cases (e.g., hepatitis B in newbrns)

12 AAP Respnse t Parental Refusals Listen carefully and respectfully t parents cncerns recgnizing that parents may nt use the same decisin criteria and may weigh evidence differently. Educate Risks f encephalpathy frm measles vaccine is 1 in 1 millin Risk f encephalpathy frm measles disease is 1000X greater. Negtiate (sme parents want t delay MMR until 3 years because f fear f autism) Cntinued refusal after adequate discussin shuld be respected unless the child is put at significant risk f harm (e.g., during an epidemic). In general, pediatricians shuld avid terminating the relatinship. This allws fr cntinued discussin Child still needs and deserves access t medical care fr ther health prblems.

13 Case 1: Reslutin I accepted Tmmy int my practice. I explained t the parents the limits f my willingness t respect treatment refusals. Public health threats If their decisins placed Tmmy at serius risk f imminent harm. I cntinue t engage parents in discussins abut immunizatins. Presently have begun the DTaP series because f plans fr camping vacatins.

14 Case 2: Immunizatin Refusals Mrs. V. brings in her daughter Vilet wh is 7 years ld. Vilet has been hme-schled and Mrs. V. has avided all immunizatins because she wanted her daughter t be part f the decisin making prcess. Vilet has agreed t at mst tw needles tday. Questins 1) Shuld yu wrk with this family? 2) Can yu wrk with this family? 3) What questins abut Vilet and the family d yu want t ask? 4) What immunizatin(s) d yu recmmend?

15 Case 2: Which Immunizatins? AGE: At age 7 years, HIB and PREVNAR are less necessary (risk highest in yunger children). Hepatitis B vaccine can surely wait until the child is a teenager. TRAVEL/freign expsure If the family lives in the US and des nt plan t travel utside f the US, and des nt have an internatinal nanny, ne can prbably wait n the IPV. Recent utbreak in an unimmunized cmmunity in Minnesta. If ne is nt planning t g n a camping trip r walk bareft in city parks, tetanus can be safely withheld. And if necessary, can be given up t 72 hurs pst injury. Health f Family members If a husehld member has severe COPD r asthma, thught shuld be given t influenza.

16 Case 2: Which Immunizatins? Which immunizatins wuld I chse fr a healthy 7 year ld child, given a histry f unremarkable risks and expsures? (in rder f imprtance) MMR DPT Want t cmplete a series. Secnd dse can be as sn as ne mnth; as lng as years (in cntrast with Hepatitis A that must be cmpleted in ne year, fr example).

17 Case 3: Immunizatin Delay Ms H brings in her twin children, Helen and Henry. They are bth 2 mnths ld. They were brn at a birthing center and received n immunizatins, but did receive vitamin K. When Ms H learns that yu want t administer DTaP, Hib/HepB, IPV, and Prevnar, she becmes quite distressed. She asks yu hw many vaccines will her children need by age 2 years? Answer: 20 +7; DTaP 4; HIB 4: Prevnar 4; IPV 3; MMR 1; Varicella 1; Hep B 3; and pssibly Hep A 2 and 2 dses f influenza (and we will be re-intrducing RV vaccine [3 dses]) If yu cunt DTaP as 3 different diseases, the answer is 11 disease (+3) If yu cunt the number f times each disease requires an immunizatin 30 (+7)

18 Case 3: Immunizatin Delay Ms H is willing t authrize the immunizatins fr her children, but asks if they can be delayed because f her fear that her children, particularly her sn, might develp autism. The media has described an assciatin f autism and thimersl; and autism and MMR. What are the risks and benefits f delay? Which nes wuld yu be mre willing t delay? Answer: If I culd nly immunize fr certain diseases in infants under ne year, I wuld pick in this rder DTaP (fr the diphtheria and pertussis); HIB; Prevnar

19 Case 4: Schl Entry Ms C is the principal f a private schl in yur area. She asks t have a meeting with yu. The Mntessri-type type schl admits children frm age 1 year ( mmmy( and me r mre crrectly caregiver and child ) ) and int the nursery prgram at 2 years. The principal wants t knw whether she shuld allw unimmunized children int the prgram.

20 Case 4: Schl Entry Can the schl require immunizatins fr schl entry? YES Must the schl respect religius r philsphical refusals? This depends upn state laws. If the schl des allw children wh are unimmunized, d ther parents have a right t knw? Des it matter if it is ne child wh is nt immunized r if it is 25% f the children? Issue f herd immunity Issue f greater likelihd f spread with larger pckets f unimmunized children.

21 Case 4: Schl Entry What recmmendatins wuld yu have fr Ms C if she decides t allw unimmunized children t attend her schl? A clearly written plicy wuld be ideal. Plicy shuld address: What will be dne if a child cmes dwn with any f these cnditins? T whm will cases be reprted? Will there is a maximal number (r percentage) f unimmunized children wh can attend? What rights d parents (bth refusers and nn- refusers) have t knw abut the plicies and abut the percentage f unimmunized children wh attend the schl? What happens if a child, r child s s sibling develps an underlying cnditin like cancer and the treatment leaves him immuncmprmised?? Will the schl defend the right t refuse r the right t cmmunity prtectin?

22 Case 5: Adlescent Vaccines CURRENTLY Tdap (r at least dt) [ne dse bster] Menactra (previusly fr children entering cllege, nw being recmmended fr children entering middle schl) [ne dse] Hep B (if nt previusly given) [series f 3; pssible need fr a bster in thse immunized in infancy] Varicella (if nt previusly given and n immunity) [series f 2] (Influenza in teens with chrnic health cnditins r wh live in husehlds with at risk members) [yearly] IN THE NEAR FUTURE HPV vaccine fr Sexually transmitted infectins (STI) [series f 3] Herpes vaccine

23 Case 5: Adlescent Refusal Ms M cmes in with her teenage sn Mark. Mark is a natinally-ranked squash player and is being recruited t attend barding schl n the East Cast. The schl requires that all entering students have received Menactra in the past 5 years and Tdap; and that they be tested twice fr TB. He needs 2 vaccines and the first f 2 TB tests. Ms M cnsents but Mark says n. What d yu d?

24 Case 5: Adlescent Refusal Why is Mark saying n? Fear f needles? Use EMLA cream Philsphical r religius belief? Mark states he is a vegetarian and believes in meditatin t achieve hlistic well-being. Hw strng are these cnvictins? Is he willing t freg Barding Schl? Are yu willing t call the schl and see if an exceptin can be made? D yu need Mark s s cnsent t administer these vaccines? D yu need his active assent? Or will yu administer if he says I d d rather nt but sticks ut his arm and des nt fight when the nurse cmes in with the needles? Hw is this different than hlding a fur year ld child dwn? Hw is it different if the vaccine were experimental?

25 Case 5: Reslutin Mark and his parents went hme with numerus references and website addresses. I specifically recmmended the AAP website and hand-uts. I specifically discussed the Waksman scandal in the Lancet. Mark and his parents called fr a nurse visit apprximately 3 weeks later. EMLA was rdered and applied prir t the appintment. Schl frm updated at that time.

26 Childhd Vaccinatins: Are there limits?

27 Childhd Vaccinatins: Are Mre Better? Are there Limits? Frm a public health perspective, mre seems better. Frm the perspective f the individual patient s medical well-being, mre seems better althugh sme individualizatin may be apprpriate. Frm the perspective f the prvider, unifrm plicies are needed (e.g., what ppulatin, what age, timing if the vaccine requires multiple dses). Prs and Cns f vaccinating infants rather than teens may be based n severity f illness (HiB mre likely in a yung child) r based n cnvenience (Hep B series).

28 Childhd Vaccinatins: Are there Limits? Limits based n abslute risk; risk: benefit t the child risk: benefit t the cmmunity Parents can refuse prvided it is nt seriusly neglectful f the child. Balance between respect fr parents t raise their children accrding t their wn values and the well-being f the child Parents can refuse prvided it des nt pse serius risk t the cmmunity. Balance between respect fr family autnmy and cmmunity well-being. Sincere cnvictins (whether religius r philsphical) shuld have greater weight than bjectins due t incnvenience

29 Future Cnsideratins regarding Childhd Vaccinatins: Are there Limits? If the state is ging t mandate these immunizatins, d they have an bligatin T ensure safety (vaccine databases)? Phase IV clinical trials Stricter reprting laws t VAERS T prvide the immunizatins free-f f-charge? T prvide cmpensatin if an adverse event ccurs (VAERS)? T cntinue t track ptential lng-term risks f bth individual vaccines and multiple vaccines.