Reporting Incidents

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adverse event rqork, these proba-bly represem only a fmction of thesedo us ad verse even& e nco unteredby provide rs A recent review articleI121 found that between 3% and11% of hospita l ad missions c ould beathibuted Io a dve rse drug reac tions.only ab out 1% of serious events arerepotted to the FDA, ac co rding toone study 113).There are probab ly several rea-sons why same selious events arenot reported to e ither the FDA or themenufechne r. FitsI, when co nkontedwith an unexpec ted outcom e o ftrea tmen& physt&ns ma y not con-sider drug-tnduced or device-in-duc ed d&ease. but rather c onsiderthe event to be related to the c ourse0fIhedfsease.Unforhmately, thts may be duo IOthe limited Im ining med ica l studentsreceive n dnical pharmacokgy andtherapeutics A 1985 survey of U.S.med ica schools found tha t only 14%of them ha d requlwd ca uses in co re&Us end prindples of therape uticde-cl&n maldng and c linfcal phatma-co logy. Of the rema inder. 87%taught only a few houn of &&alpharmac ology, and most of theteaching cxc uned in the early yearsof medtcalba lning (14).Another factor Inhibiting p hysicffn

~hk otti& w preped by Dr . Da&dKe.%!er of he FDA for he workingGroup.Leaders4 the WorkingGm,,,lncll&dehe fouo urirw:Shemn

repotting is hat it is not an ingrainedprac tice-- it is not in the cultxe ofU.S. medic ine to notify the FDAabout adverse events or productprob lems. In other co untries such esthe United Kingd om , adverse dntgreporting is more frequent 115). Apa tchwo rk of repoting forms andsystem s ma y ma ke it d ifficult to filerepo rts in the United States and m aydisc ourage even the most c ons&n-tious professionals. Finally, physi-cians may be unclear as to what a d-verse reac tions should be reported tothe FM.

Mindful of these problems, theFDA has co mp leted an overhaul ofthe adverse event reporting systemWe are anno unc ing our new systemcalled MEDWatc h: The FDA Med ialProducts Reporting Program. (Ad-vase OV~IMSaswci&d v.& vac cineswill continue to be repx ted throughthe Vac cineAdverse Event ReportingSystem . a joint p rog ram of the FDAend the Centers for Disease Controlend Prevention (9).)

This new system enc ourag eshealth care professionals to regardrepa ting as a fundamental profes-sional and public heeith reqmnsibil-ity. It was deve loped with the enthu-siastic SuwxI of the med ica l co m-munity, and its succ ess till dependon close coop.mtion amongheFDA, the med ical co mmunih). andindushy to identify and rep&t ed-verse events and p roblems with med-ica tions and devic es.

The FDA rec c@zes tha t the c on-fidentlalky of the identities of bathprovide rs who repat ad verse even&and pa tients is an impo rtant co nce rnof hea lth professiona ls. To enc our-ag e reporting. the FDA ca refully pro-teck the identities of pm vide rS whoreport and p&ants co ntained n FDArecords and w ill no t release suc h in-formation to the public. UnforIu-nately. doting the c ourse of lit&at&ma nufac turers have increasinglybeen asked to reveal Ihe identities ofthose reporting adve rse events end ,in some c ases. even the identitla ofpa ttents. The FDA b elieves that

ma intaining Ibe c onfidentiality ofthese indiv iduals is extreme ly irop or-ten< and t hm participa ted n a nomher of co urt - vigorously opp os-ing release of the na mes of those in-volve d in a dverse event reports. Todate, we have been successful inma intaining he c onfidentiality of &iiinforma tion in all the ca ses n whic hwp have been involved. Neverthe-less, we a r e considering whether ad-diiorlal ac tions may be ap propriateto further strag then our ab ility tosafeg uard the co nfidentiality of thisinformation.

Our goa l in introduc ing MED-Watch is to underscore the rerpons-bility of p roviders to identify and re-po rt ad verse events that m ay be re-lated to FDA-reg ulate d prod uc ts. Tothat end . we want to 1) maket easierfor p roviders to repo rt s0riou.s events,21 make it c lear to physicians andothers what tvpes of rep orts the FDAwants to receive. 3) mo re widely d ls-semlna te informa tion o n the meactionshathave esultedromd-verse event and product p roblem re-po ting. and 41 increase physicianunderstanding and awareness ofdrug- and de&e-induc ed disease.

How TO REFaRTUnder the MEDWatc h p- m. thesepa rate o rms previously used to re-port adverse dmg reactions, drugquality product problems, devicequality product problems, and ad-verse reac tions to medic al devic eshew bee n co ns&lad into a single,one-pa ge reporting form for healthpro fessionals IPIgure 1). This formca n alzo be used to rqm;: pmb lemswtth other FDA-requlated pmducs.such as d ietary supp lements, cosmet-ics, medic al ood s. and infen! fonnu-las (Tab le 1).

In a ddition to ma ktng reportingeasier for providets. using one formfor both device and dtus mob lemsshould help the health ca~ecom mu-nitv Io detec t and the FDA Io inves-@me, ad verse events.

One exam ple of how this form

&weal d Nurse- w . Vd. 39, No. 6. Novemb aKkce mber 1994


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FIGURE 1.The MEDWatchunifiedreporting orm

404


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TABLE 1Advice ab out Voluntary Repo rting*

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Reporteven f:. Youre not certain he productcaused he event. You dcnt have all the detir

How to report:. Just P in the s&ions that ap ply oyour repcrt. use sec tion c for all produc tsexceMmedical evices

Confidentiality: The pabents idenhty isheld in strict confidence by FDA andprotected to the fullest extent of thelaw. The reponerr idenhty may beshared wit,, the manufacturer unlessrequested othenvise However, FDA tillnot disclose he reporters dentity ii,response o a rquen ham the public.purwant to the Freedom of InformaSar,*_.

. Repon either 1 FDA or themanufacnirer (or both)lmpatant numbers.. I-800.FDA-0178 to FAX rep+,,. I-800.FDA-7737 to report bymodem. I-800.FDA~l088 for more

. 1-800-822-7967 or a AERSformfor vaccinesIf your repoit wolves a seriousadverreevent with a dewce and it occuned in afacility outside a doctois office, thatfacility may be legally required to reportto FDA antior the manufacturer Pleasenotify the person in that facihtywhowould handle such repotting.

might facilitate investiga tion wa s theFDAs diswvey that the latex-c uffedba rium enema tips used to pa formma ny ba rium &ma p&edureswxmk ed life-threatenins affemk re-&INS in som e pa ti& (41. Whenthe problem was first recognized.pracliticmers typically believed thatp&-a nts - reac ting to the ba riumsulfate or to o ther med ica tions usedin the prccedwe. and therefore ad-vase incide nts were inllially repa teda3 ba dlm l sulfate reac tions to theCenter for Drugs The new one-pag efour asks reporters to indic ate co n-co mitant devic es as well a s the suepec t drug a nd other d rugs used in theprocedures. Using the new formmight have decreasedhe f&w-up

time required by FDA officia ls, thetime needed to id entify latex as theproblem. and the time until the med -ical com munity wa s alerted.

The unified reporting form will beava ilable n several publica tions, in-cluding the Physicians Desk Refer-ence, the FDA Medical Bulletin. andAMA Drug Eoaluotions. A 24_hour-a-d ay, 7.da y-a- wek toll-free nun-her. (800) FDA-1088, is also nowava ilable for p roviders who want torequest forms or obtain the new FDADesk Guide to Adverse Event andPmduct Problem Reporting.

Providers till no long er be a-peaed to send different reports fordevic es and med ica tions 10 differentaddresses at the FDA; there will now

be a single ma iling add ress for thesereports In add ition, hea lth profes-sionals will be ab le to report elec tron-ically by com puter by c alling (800)FDA-7737 and responding to thequestions that ap pearcm he screen.Reports can be also sent to the FDAby fax. 1800) FDA-0178, a by regular mail using the self-mailer in-dude d in the form.

In addition to reporting adverseevents to the FDA repo ;ts can besent to ma nufac turers, whic h a re re-quired by law to fotward reports tothe FDA l10.111. If the event has oc -curred n a health ca re zxilihl. ravxtsof problems with med ical de&esshould also be filed with that fac ility,which legally must report deviceproblems to the FDA and/or themanufacturer Ill).

The Joint Commission cmAcaed-Nation of Hea lthcare Organizationsalso has standards for monitoringand reporting adverse medicationand deviceevenis (161. Individua l n-stih~tians may have their own pnxe-dures and guide lines for monitoringand rep&ing ad verse ever& w ithinthe in&it&lo& physicians ca n ob tainthat information from the pharmac yand therapeutia com mittee for theinstitutional dsk m ana ge r at their in-stihdion.

WHAT TO RKORTPhystciansshould report when thereis a suspicion that a drug or devicemay be related to a smious adverseeffect they are not expected to es-tablish the connec6on oreven to waitun6l evidence seem compelling. Re-ports should be alert of possible as-sociations. Combined with other re-wrts. follow-un. and resultsof wide-miolbgic s&es or new &diesundertaken. the FDA can evaluatethese initial suspicions.

On the other hand, the FDA doesnot went pwidezs to report everyadverse reaction observed; thiswould Dot be prac tica l or the pract-tioner or useful to the FDA. TheFDAS gall is to increase reporting


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of serious events, not all adverseevents Whet should be reported arethose cases in which the Physiciansospeck hat e FDA-regulated prod-uct was assakted with a seriousout-come-death, a life-threatening con-dition, initial or prolonged hospital-k&ion, disability, or congenitalanomaly, or when intervention wasrequired to prevent permanent im-pamwnt or damage.Although traditionally problemswith devices are associated withproduck that are defective or mal-fontion, adverse evenk can occurwith e device eve when no malfunc-tion or defect k recognized, for ex-ample, hypersensitivity o latex (4) ordtalyzer germicides (17).

Especially important to report areadverse effeck from medlcattons ordevices hat have been on the marketfor a relatively short time-about 3years or &-because that is whenthe most critical problems are dkcov-ered. Because most sertous adversewenk are obsenred in the hospitalsetting (18), pi-actitioners should beespecially diligent about reportingthese events.The FDA should also be informedpromptly of product quality problemssuch as defective devices, inaccumteor unreadable product labeling,packwpng or product mix-up, con-Laminationor stebilitv rrroblem4. andparticulateatter n-i;jeaable prod-ucts. In 1990, a total of 38 drug re-calls resulted from reporting of suchproblems (19). Althoush vhammciskbr isk managersare oiien the ones ina position to obsewe these problems,physicians who become aware ofsuch problems should bring them tothe FDAs attention by calling (800)FDA-lo%3 and submittlnq a report.One recent example 0% he impor-knee of thtt type of report is the pas-sible link reported between hyper-kelemk observed in two patients in amedica! center intensive care unitand two enteral feeding products.The universitys laboratory analysisdemonstrated that the pmduck hada potassium content about twice that

specified on the t&l. The FDA fol-low-up of this report revealed that ellproduct lines of the maufxtorercontained potasstumvalues of 150%to 250% oftheeclared mnout Be-cause these pmduck are frequentlyused as a sole sorw of nutrition,and sometimes in patients with cam-promked renal function, the FDA ini-tiated a recall of the product

PROVfDE PHYSICLANrn~oubworvMEDWatch k aimed et facilitating re-porting by providers. but we alsowant to better inform providers aboutregulatory actions taken by the FDAI rosponso to reports. we believethis information will not only be use-ful to physicians ad others, but thatit wtll eke encourage serious adverseevent reporting by demonstreting thevalue of the information. The FDAwill therefore take a more aggressivestance n reporting back to providers.

ENHANCE PHYSICfANUNDERSTANDINGAs part of MEDWatch, the FDAhopes to heighten physlctan aware-nessof drug- and device-fnduced dk.ease. Our educational effork wfll tn-crude a focus on issues such as theimportance of the problem, mecha-nkms of adverse drug and device re-actions, and how to evaluate possibleadverse events. As part of that effortwe plan to hold a conference forhealth care professionals and FDAofftdals to help poise practitioners torecognize drug- and device-inducedproblems when they occur, andthereby Increase participation in theMEDWatch program.MEDWatch is a m~pvrtent pro-gram that we hope will slgntftcantlyimprove ox ability to monitor thesafety of products we regulate and tot&e neceeeay actions suirtly and ef-fectively. Perhaps m,st important,we hope MEDWatch will encouragean increased sense of responsibilityamog physicians and other health

cae providers about reporting ad-verse evenk and product problems.We are eager to work closely with themedical community to ensure theprogmls scce..%.

REFERENCES1. Peck CC. Temple R, CoihnsJM.Understanding oNeqUeceQ f COcuI-rent therapies.JAMA 1993;26931550-52.2. Honig PK, Wortham DC, LmantK. Conner DP. MutltnJC. CantilanaULTerfenadine-ketoconazole nteraction:pharmacohie;:i: 2-d etrtrocardto-~~~iwquences. JAM4 lS93:2w3. Rossi AC, Bosco L, Fatch GA,Tanner A, TemPteR. The importaxe ofadverse paction qorLin9 by Physktrmr

swrofen and the tlank pain syndrome.JAMA 1988259:1~.4. Stehltn D. When rubber rubs thewrong way. FDA Gasumer. 199226:17-21.5. Gelb LN. ed. Denoea of ACE to-htbiton dudng &od &I third tttmes.krr of preqeancy.FDA Mod ButI 1992:222.b. Rh&stetn PH. Rep&kg of ad--eWlb:ekqrtoportmaacoangdrugwfety. Am Fern Phys. 1992;46:873-7.5.7. Rerr RI. PeeblesCf_ Rum@ \;Ckhs RL, Ten EM. Antinudoareutoaott.baiks In women with &one breast m-Ptenb Lancet 1992$?&134&7.8.DennRW.HaUPN,Rhc0CTKUreart imptent matertats: sense andsafe&t.Br J PtastSwg 1992:4&31%.21.9. Nightin& SL. New sqtem o,reporttng of vaccine adverse evenk.JAM4 1%xXx4:2863.

10. JohnsonJM. Bamh D. A reviewof pastmarketingadveme drug ewxrt.

11. Medkal Devkes;Me&al Dwke.User Fe&y. mbutor, and Menukc-turersRe~orKg,CetiftcaUon,and Rss_istmtion.Ro&viUe, t.fd: Dept ot Healthand Human Sewices. Fmd and DmaAdmkiskatio: lY91:Mx)2Moa39.2iCFR parts SO3 and SO7 (docket No.YlN-0295).

12. Beard K Adwax reactiwa as a


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causeof hospital admissions n tbe aged. 15. Neirenberg DCU Clinical pharma- dialyzer germicides. FDA Med Bull.Drugs Agag. 1992:2%5&67. C0lOg.j ,nEtNCbo lrrr all medxal stw 1993.23:7.13. Scott HD. Rasenbaum SE. waters denb Gun Pharm Ther. :986.40. %?%W et al Rhcde Island plwiciws recog- 87. 18. Kennedy DL. Johnsan JM. Night-nition and reporting of adverse drug re- ingale SS. Monitollng of adverse d;ug&ions. R IMed J 1987;70.311-16. 16. Accredltabo Manuai. 1993 Oak- events in hospitals. JAMA 1991:2x%brook Tenace. 111 oint Comm~~on on 2878.14. Gdfffn JP, Weber JCP Voluntatysystems of adverse reaction repoting. Accreditation of Healthcare Organiza-tions: 1993. 19. Eca&r G. Goeecb R ?.ionitoangpar, I,. Adv Drug React Ac Pas Rev drug product quality. Am Pharm1986;1:w5. 17. Gelb LN. Precautions needed far 1992.NS32:47-50

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Reporting Incidents