This bibliography concentrates on numerous aspects of adverse drug reaction(ADR) reporting. It is divided into 14 sections and covers the literature from 1980 to April 1988. Some earlier articles, written by those considered pioneers in the field, are also included. While most of the articles are primary sources of information on ADR reporting, secondary and tertiary reference articles have been included to present a larger picture of the literature on ADR reporting.
KarchFELasagnaL.Adverse drug reactions—A critical reviewJAMA. 1975;234(12): 1236–1241.
11.
LawsonLAPruemerJMAssessment and management of adverse drug reactions. Am Drug. 1986;(Feb): 129–134.
12.
MyersMGCairnsJASingerJ.The consent form as a possible cause of side effectsClin Pharmacol Ther. 1987;42(3):250–253.
13.
NaranjoCAFornazzariLSellersEMClinical detection and assessment of drug induced neurotoxicityPro Neuro Psychopharmacol Biol Psychiatry. 1981;5:427–434.
14.
NaranjoCAA clinical pharmacologic perspective on the detection and assessment of adverse drug reactionsDrug Inf J.1986;20(4):387–393.
15.
NaranjoCAPontigoEValdenegroCGonzalezGRuizIBustoU.Furosemide-induced adverse reactions in cirrhosis of the liverClin Pharmacol Ther. 1979;25(2): 154–160.
16.
O'DonnellJ.An introduction to adverse drug reactionsInfusion. 1985;9:112–115.
17.
PortaMSHartzemaAGThe contribution of epidemiology to the study of drugsDrug Intell Clin Pharm. 1987;21:741–746.
18.
SellersEMAdverse drug reactions: Uncommon or unrecognized?Clin Med Assoc J.1979; 120:1200–1201.
19.
SwallowRDSwanAJDrug sensitivities in hospital patientsPharm J.1986;236:228–229.
20.
WindhorstDBData on drugs and adverse experiences: Moving from the specific to the generalDrug Inf J.1987;21(1):39–46.
21.
AnelloC.Management of ADR reports at the FDADrug Inf J.1985;19(3):291–294.
22.
Anon. Adverse drug experience reporting requirements for marketed prescription drugs without approved new drug or abbreviated new drug applicationsFed Reg.1986;51(Feb 3): 24476–24481.
23.
Anon. The Food and Drug Administration: How “those regulations” came to beJAMA. 1985;254(15):2037–2039, 2043–2044.
24.
Anon. FDA seeks expanded data base for drug reaction reports. Am Pharm. 1985;NS25(5):14.
25.
Anon. New FDA ADR reporting system provides for quick retrieval. Am Pharm. 1985; NS25(2):11, 13.
26.
BaumCFaichGAAnelloCForbesMBDifferences in manufacturer reporting of adverse drug reactions to the FDA in 1984Drug Inf J.1987;21(3):257–266.
27.
BrolandGVThe FDA adverse reaction report data baseDrug Inf J.1985;19(3):299–303.
28.
FaichGAKnappDDreisMTurnerW.National adverse drug surveillance: 1985JAMA. 1987;257(15):2068–2070.
29.
ForbesMBPerezAEGelbergA.FDA's adverse drug reaction drug dictionary and its role in post-marketing surveillanceDrug Inf J.1986;20(2):135–145.
30.
McKieD.The Federal Drug Administration adverse reaction reporting program. Can Pharm J.1986;700–701.
31.
MooreRCStonecipherBFReynoldsCTThe FDA/USP product problem reporting program. US Pharmacist. 1986;(Jan):35–42.
32.
PerezTHKuritskyJNFaichGAAdverse drug reaction reporting: Comparison of reports received by a specialized registry and the Food and Drug Administration systemDrug Inf J.1987;21(2):133–136.
33.
RossiACKnappDEDiscovery of new adverse drug reactions — A review of the Food and Drug Administration's spontaneous reporting systemJAMA. 1984;252(8): 1030–1033.
34.
SillsJMTannerLAMilstienJBFood and Drug Administration monitoring of adverse drug reactionsAm J Hosp Pharm. 1986;43: 2764–2770.
35.
SillsJMFaichGAMilstienJBTurnerWMPostmarketing reporting of adverse drug reactions to the FDA— An overview of the 1985 FDA guidelineDrug Inf J.1986;20(2):151–156.
36.
TurnerWMFDA processing of ADR reportsDrug Inf J.1985;19(3):295–298.
37.
TurnerWMMilstienJBFaichGAArmstrongGDThe processing of adverse reaction reports at FDADrug Inf J.1986;20(2):147–150.
38.
FaichGAMilstienJBAnelloCBaumC.Sources of spontaneous adverse drug reaction reports received by pharmaceutical manufacturersDrug Inf J.1987;21(3):251–255.
39.
GriffinJPSurvey of the spontaneous adverse drug reaction reporting schemes in fifteen countriesBr J Clin Pharmacol. 1986;22(Suppl 1):83S–100S.
40.
Koch-WeserJ.International aspects of spontaneous reporting of adverse drug reactionsDrug Inf J.1985;19(3):217–221.
41.
RossiACKnappDEAnelloCO'NeillRTGrahamCFMendelisPSStanleyGRDiscovery of adverse drug reactions — A comparison of selected Phase IV studies with spontaneous reporting methodsJAMA. 1983;249(16): 2226–2228.
42.
SachsRMBortnichakEAEvaluation of spontaneous adverse drug reactions monitoring systemsAm J Med.1986;81(Suppl 5B):49–55.
43.
SternRSSpontaneous adverse drug reporting: Do numbers tell the story?Drug Inf J.1987; 21(2):137–140.
44.
CroutJRIntroduction to causality assessment— Who, what, and why? — The manufacturer's perspectiveDrug Inf J.1986;20(4):395–397.
45.
GoldsmithDIYenCCGreenbergBPA comprehensive system for international pharmaceutical company monitoring of adverse drug reactionsDrug Inf J.1986;20(3):305–310.
MohberzgNRSome observations on the collection of medical event dataDrug Inf J.1987; 21(1):55–62.
48.
NissmanEFThe use of COSTART at Burroughs Wellcome CompanyDrug Inf J.1987; 21(3):295–298.
49.
SaltzmanA.Adverse reaction terminology standardization: A report on Schering-Plough's use of the WHO dictionary and the formation of the WHO Adverse Reaction Terminology Users Group (WUG) ConsortiumDrug Inf J.1985;19(1):35–41.
50.
SchneiweissF.Adverse reaction thesaur is used in the pharmaceutical industryDrug Inf J.1987;21(3):299–302.
51.
SnoddyCSCommunication of ADR information: The Merck experienceDrug J.1985; 19(3):381–384.
52.
StephensMDBAssessment of adverse event data in large-scale clinical trialsDrug Inf J.1986;20(3):327–336.
53.
StrathmanI.Experience with the WHO adverse reaction terminology at SearleDrug Inf J.1986;20(2):179–186.
54.
StreichenweinSMActual aspects of data integration— A view from an international companyDrug Inf J.1986;20(3):301–304.
55.
StreichenweinSMCommunication of ADR information: Views from the pharmaceutical industryDrug Inf J.1985;19(3):367–370.
56.
TalbotJCCManagement of ADR data from different sourcesDrug Inf J.1986;20(3):297–299.
57.
TealTWDimmigALAdverse drug experience management — A brief review of the McNeil Pharmaceutical systemDrug Inf J.1985; 19(1): 17–25.
58.
ThayerC.Communication on ADR information: The experience at HoechstDrug Inf J.1985;19(3):371–374.
59.
VenuletJ.The Ciba-Geigy approach to causalityDrug Inf J.1984;18(3/4):315–318.
60.
WallanderAMPalmerLSA monitoring system for adverse drug experiences in a pharmaceutical company: The integration of pre- and postmarketing dataDrug Inf J.1986;20(2): 225–235.
61.
Anon. Continuing role for viewdata reporting?Pharm J.1985;235:625.
62.
Anon. Freefone to the CSMPharm J.1984; 233:171.
63.
Anon. CSM delays its response to society's “pink card” projectPharm J.1985;234:617.
64.
Anon. Yellow cards defended; place of hospital pharmacistsPharm J.1985;234:617–619.
65.
BegaudB.Standardized assessment of adverse drug reactions: The method used in France —Special workshop-ClinicalDrug Inf J.1984; 18(3/4):275–281.
CastleWBakerA.Communication of ADR information: The viewpoint of a British companyDrug Inf J.1985;19(3):375–380.
68.
CoulterD.Duplicate prescription pad trial boosts IMP reportingNZ Pharm. 1987;7:30–31.
69.
CrombieIKBrownSVHamleyJGPostmarketing drug surveillance by record linkage in TaysideJ Epidemiol Community Health. 1984; 38(3):226–231.
70.
CuyegkengEIAdverse drug reaction reporting— Philippine experienceMed Tox.1986; 1(Suppl 1):99–104.
71.
DangoumauJLagierGRoyerRJA drug information-ADR collection network: The French systemDrug Inf J.1986;20(3):337–346.
72.
EdwardsIRPost-marketing surveillance in New ZealandMed Tox.1986;1(Suppl 1):83–85.
73.
FeferE.Developing national systems: An overviewDrug Inf J.1985;19(3):345–346.
74.
GoldbergA.Drug safety and the CSMJ R Soc Med.1987;80(2):67–68.
75.
InmanWHYellow cards and green formsPractitioner. 1983;227:1443–1449.
76.
InmanWHPrescription-event monitoring and yellow cardsLancet. 1984;1(8389):1301.
77.
LaporteJRDeveloping national systems: Spain as a modelDrug Inf J.1985; 19(3):351–355.
78.
LawsonDHPost-marketing surveillance in the UK (1984). Br J Clin Pharmacol. 1986;22(Suppl 1):71S–75S.
79.
LeRoyA.Developing national systems: Experience in selected Latin American countriesDrug Inf J.1985;19(3):347–350.
80.
MashfordMLThe Australian method of drug-event assessment — Special workshop-RegulatoryDrug Inf J.1984; 18(3/4):271–273.
81.
McEwenJVrhovacB.Panel on management of ADR reports in selected national centersDrug Inf J.1985;19(3):329–344.
82.
MooreNPauxGBegaudBBiourMLoupiEBoismareFRoyerRJAdverse drug reaction monitoring — Doing it the French way. Lancet. 1985;(Nov 9): 1056–1058.
83.
MoussaMAABayoumiAAl-KharsAAThulesiusO.Adverse drug reaction monitoring in Kuwait (1981–1984). J Clin Pharmacol. 1985;25:176–181.
84.
SihombingMPCanVHSWidyaR.Special problems of adverse reaction assessment in Indonesia. Med Tox.1986;1(Suppl 1):95–98.
85.
SriwatanakulKPothisiriP.Adverse reaction assessment in ThailandMed Tox.1986;1(Suppl 1):105–109.
86.
StrandLMDrug epidemiology resources and the studies: The Saskatchewan data baseDrug Inf J.1985;19(3):253–256.
87.
WiholmBEThe Swedish drug-event assessment methods — Special workshop — RegulatoryDrug Inf J.1984;18(3/4): 267–269.
88.
DunneJ.The World Health Organization viewDrug Inf J.1985;19(3):213–215.
89.
DunneJFThe CIOMS/WHO project on the assessment of adverse drug effectsDrug Inf J.1986;20(3):319–321.
90.
StrandbergK.Experiences from the WHO Collaborating Centre for International Drug MonitoringDrug Inf J.1985;19(3):385–390.
91.
Anon. Doctors favour pharmacy help in reaction reportingPharm J.1985;234:620.
92.
Anon. No reporting for pharmacistsPharm J.1985;235:655.
93.
Anon. Some encouragement for pharmacy involvement in ADR reportingPharm J.1986; 236:174.
94.
Anon. What happened to the “pink card” scheme for pharmacists?Pharm J.1986;236:174.
95.
BerbatisCGPlumridgeRJPublishing adverse drug reactionsMed J Aust. 1984;104:304–305.
96.
BlancSLeuenbergerPBergerJPBrookeEMSchellingJLJudgments of trained observers on adverse drug reactionsClin Pharmacol Ther. 1979;25(5):493–498.
97.
BusseyRAWalkerRMartinAMAdverse drug reactions and the pharmacistPharm J.1985;235:593.
98.
CorreKAAdverse drug reaction processing in the United States and its dependence on physician reporting: Zomepirac (Zomax) as a case in pointAnn Emerg Med.1988; 17(2): 145–149.
99.
CrombieIKBrownSVHamleyJGGeneral practitioners and postmarketing surveillanceDrug Ther Bull. 1984;22(21):83–84.
100.
Even-AdinD.Information for the physician and the nursePharmakon. 1984;57:15–17.
101.
GoldsmithMFPostmarketing follow-up: Physicians have key roleJAMA. 1985;254(16): 2217.
102.
HaramburuFBegaudBPereJCMarcelSAlbinH.Role of medical journals in adverse drug reaction alerts. Lancet. 1985;(Sept 7):550–551.
103.
Koch-WeseJSidelVWSweetRKanarekPEatonAEFactors determining physician reporting of adverse drug reactionsN Engl J Med.1969;280(1):20–26.
104.
KramerMSAssessing causality of adverse drug reactions — Global introspection and its limitationsDrug Inf J.1986;20(4):433–437.
105.
LeiperJMLawsonDHWhy do doctors not report adverse drug reactions?Neth J Med.1985;28(12):546–550.
106.
MilstienJBFaichGAHsuJPKnappDEBaumCDreisMWFactors affecting physician reporting of adverse drug reactionsDrug Inf J.1986;20(2):157–164.
107.
MiwaLJRandallRJAdverse drug reaction program using pharmacist and nurse monitorsHosp Formul. 1986;21:1140–1146.
108.
NoycePRThe role of the hospital pharmacist in the introduction of new medicines I. Clinical trialsPharm J.1985;235:367–369.
109.
RandhawaHKSmithJCIrvinLEHospital doctors attitudes to adverse drug reaction and their reportingPharm J.1987;238:793–795.
110.
RobinsAHWeirMBierstekerEMAttitudes to adverse drug reactions and their reporting among medical practitionersS Afr Med.1987; 72(2):131–134.
111.
RogersASAdverse drug events: Identification and attributionDrug Intell Clin Pharm. 1987; 21:915–920.
112.
SalbergDJRecognizing and reporting adverse drug reactionsHosp Formul. 1986;21:539.
113.
ScottHDRosenbaumSEWatersWJColtAMAndrewsLGJuergensJPFaichGARhode Island physicians' recognition and reporting of adverse drug reactionsRI Med J.1987;70(7):311–316.
114.
SmithJMThe role of the hospital pharmacist in the introduction of new medicines II. New drug evaluationPharm J.1985;235:369–372.
115.
SofferA.The practitioner's role in detection of adverse drug reactions. Chest. 1984;86(6):808–809.
116.
SpencerMGThe role of the hospital pharmacist in the introduction of new medicines III. Postmarketing surveillancePharm J.1985;235: 372–375.
117.
VeitchGBATalbotJCCThe pharmacist and adverse drug reaction reportingPharm J.1985; 234:107–109.
118.
VenuletJ.Role of medical journals in adverse drug reaction alerts. Lancet. 1985;(Oct 12): 836.
119.
VenuletJ.Incomplete information as a limiting factor in causality assessment of adverse drug reactions and its practical consequencesDrug Inf J.1986;20(4):423–431.
120.
Anon. ADR reporting system: Some improvements suggested. Am Pharm. 1984;NS24(12): 21–22.
121.
BustoUNaranjoCASellersEMComparison of two recently published algorithms for assessing the probability of adverse drug reactionsBr J Clin Pharm. 1982;13:223–227.
122.
CaseRLGuzzettiPJA survey of adverse drug reaction reporting programs in select hospitalsHosp Pharm. 1986;21:423–426, 431–434.
123.
CastleWMAssessment of causality in industrial settings — Special workshop — IndustrialDrug Inf J.1984;18(3/4):297–302.
124.
EmanueliA.A simple algorithm for assessing causality of adverse reactions — Special workshop-IndustrialDrug Inf J.1984;18(3/4): 303–306.
125.
EmanueliASaccettiG.An algorithm for the classification of untoward events in large-scale clinical trialsAgents and Actions. 1980;73: 318–322.
126.
HutchinsonTAStandardized assessment methods for adverse drug reactions: A review of previous approaches and their problemsDrug Inf J.1986; 20(4):439–444.
127.
HutchinsonTALeventhalJMKramerMSKarchFELipmanAGFeinsteinARAn algorithm for the operational assessment of adverse drug reactions II. Demonstration of reproducibility and validityJAMA. 1979;242(7):633–638.
128.
JeffreyLPRevised ADR report permits internal review of drug experiencePharm Times. 1986;52:48–50.
129.
KichelsonPAShieldsK.Adverse drug reaction reporting: A working systemHosp Pharm. 1987;22:682–684.
130.
KilarksiDJZieglerBCoarseJBuchananC.Adverse drug reaction monitoring system: Developing a well-monitored programHosp Formul. 1986;21:949–952.
131.
KramerMSHutchinsonTAThe Yale algorithm— Special workshop — ClinicalDrug Inf J.1984;18(3/4):283–291.
132.
KramerMSLeventhalJMHutchinsonTAFeinsteinARAn algorithm for the operational assessment of adverse drug reactions I. Background, description, and instructions for useJAMA. 1979;242(7):623–632.
133.
KramerMSHutchinsonTARudnickSALeventhalJMFeinsteinAROperational criteria for adverse drug reactions in evaluating suspected toxicity of a popular scabicideClin Phamacol Ther. 1980;27(2): 149–155.
134.
LeventhalJMHutchinsonTAKramerMSFeinsteinARAn algorithm for the operational assessment of adverse drug reactions III. Results of tests among cliniciansJAMA. 1979; 242(18):1991–1994.
135.
LouikCLacouturePGMitchellAAKauffmanRLovejoyFHYaffeSJShapiroS.A study of adverse reaction algorithms in a drug surveillance programClin Pharmacol Ther. 1985;38(2):183–187.
136.
LundberG.Decision tables — Their use for the presentation of clinical algorithmsJAMA. 1975;233(5):455–457.
137.
MaistrelloIGrassiGBertolinoAValerioPPistollatoGSoveriniS.Unwanted symptoms in depressed patients treated with viloxazine: An algorithm for identification of illness-related symptomsEur J Clin Pharmacol. 1983;24: 277–281.
138.
MichelDHKnodelLCComparison of three algorithms used to evaluate adverse drug reactionsAm J Hosp Pharm. 1986;43:1709–1714.
139.
NaranjoCABustoUSellersEMSandorPRuizIRobertsEAJanecekEDomecqCGreenblattDJA method for estimating the probability of adverse drug reactionsClin Pharmacol Ther. 1981;30(2):239–245.
140.
StephensM.Assessment of causality in industrial setting — Special workshop — IndustrialDrug Inf J.1984;18(3/4):307–313.
141.
SwanGTJonesANHughesJDPlumridgeRJAdverse drug reactions: A systematic approach to documentation and reporting in hospitalsAust J Hosp Pharm. 1983; 13(4):137–141.
142.
TallaridaRJMurrayRBEibnC.A scale for assessing the severity of diseases and adverse drug reactions — Application to drug benefit and riskClin Pharmacol Ther. 1979;25(4):381–390.
143.
TurnerWMThe Food and Drug Administration algorithm — Special workshop — RegulatoryDrug Inf J.1984;18(3/4):259–266.
144.
VenuletJCiucciAGBernekerGCUpdating of a method for causality assessment of adverse drug reactionsInt J Clin Pharmacol Ther Toxicol. 1986;24(10):559–568.
145.
BastinCWertheimerPVenuletJ.Adverse drug reactions — A computer-assisted application of correspondence analysis for automatic causality assessmentMeth Inform Med.1984; 23:183–188.
146.
FisherMPAdverse reaction reportingClin Res Practices and Drug Reg Affairs. 1986;4(5):329–343.
147.
GabrieliERGabrieliJDERoseTJAutomated monitoring of adverse drug reactionsDrug Inf J.1985;19(3):305–317.
148.
HermanRLSystem integration of an adverse experience thesaurus — Experience with a new computer methodologyDrug Inf J.1986;20(3): 351–355.
149.
LemeshowSPastidesHAvruninJPTeresD.Epidemiologic programs for computers and calculatorsAm J Epidemiol. 1985;122(4):710–716.
150.
PalmerKRDatabase development of a clinical trialDrug Inf J.1985;19(1):43–47.
151.
SpiegelhalterDJComputers, expert systems, and ADRs: Can causality assessment be automated?Drug Inf J.1986;20(4):543–550.
152.
WindhorstDBElectronic records of adverse drug reactions — Should they be pooled?Drug Inf J.1985;19(3):223–225.
153.
GrohmannRDirschedlPSchererJSchmidtLGWunderlichO.Reliability of adverse drug reaction assessment in psychiatric inpatientsDrug Inf J.1986;20(3):357–361.
154.
HollandBMarcusS.Monitoring adverse drug reactions using a state poison control center data baseDrug Inf J.1987;21(3):331–334.
155.
JonesJKAdverse drug reactions in the community health setting: Approaches to recognizing, counseling, and reportingFam Community Health. 1982;5:58–67.
156.
JonesJKAdverse drug reaction considerations in geriatric drug researchDrug Inf J.1985; 19(4):459–468.
157.
JueSGClarkBGArakiMAInservice teaching and adverse drug reactions in a nursing homeDrug Intell Clin Pharm. 1985; 19:483–487.
158.
KehoeWAA multidisciplinary approach to monitoring adverse drug reactions in a long-term care facilityHosp Pharm. 1985;20:518–521, 525.
159.
MichelDJKnodelLCProgram coordinated by a drug information service to improve adverse drug reaction reporting in a hospitalAm J Hosp Pharm. 1986;43:2202–2205.
160.
SoonJAAssessment of an adverse drug reaction monitoring program in nursing homesCan J Hosp Pharm. 1985;38(4):120–125.
161.
Anon. Using math to assess cause-and-effect in ADRs. Am Pharm. 1986;NS26(6):10, 12.
162.
FeinsteinARClinical biostatistics XXVIII. The biostatistical problems of pharmaceutical surveillanceClin Pharmacol Ther. 1974;16(1): 110–123.
163.
FeinsteinARClinical biostatistics XLVII. Scientific standards vs. statistical associations and biologic logic in the analysis of causationClin Pharmacol Ther. 1979;25(4):481–492.
164.
FeinsteinARLII. A primer on quantitative indexes of associationClin Pharmacol Ther. 1980;28(1):130–145.
165.
HutchinsonTAA Bayesian approach to assessment of adverse drug reactions: Evaluation of a case of acute renal failureDrug Inf J.1986; 20(4):475–482.
166.
HutchinsonTADiscussion panel: Model 2 — Acute renal failureDrug Inf J.1986;20(4):483–485.
167.
JonesJKEvaluations of a case of Stevens-Johnson SyndromeDrug Inf J.1986;20(4): 487–501.
168.
JonesJKDiscussion panel: Model 3 — Stevens-Johnson SyndromeDrug Inf J.1986;20(4): 503–504.
169.
KramerMSA Bayesian approach to assessment of adverse drug reactions: Evaluation of a case of fatal anaphylaxisDrug Inf J.1986; 20(4):505–517.
170.
KramerMSDiscussion panel: Model 4 — AnaphylaxisDrug Inf J.1986;20(4):519–521.
171.
KramerMSHutchinsonTALaneDAJonesJKNaranjoCAA Bayesian approach to causality assessment of adverse drug reactions: Analysis of a case of exfoliative dermatitisDrug Inf J.1986;20(4):523–533.
172.
LaneDAThe Bayesian approach to causality assessment: An introductionDrug Inf J.1986; 20(4):455–461.
173.
NaranjoCAA Bayesian approach to assessment of adverse drug reactions: Evaluation of a case of cholestatic jaundiceDrug Inf J.1986; 20(4):465–471.
174.
NaranjoCADiscussion panel: Model 1 — Cholestatic jaundiceDrug Inf J.1986;20(4):473–474.
175.
O'NeillRTStatistical analyses of adverse event data from clinical trials — Special emphasis on serious eventsDrug Inf J.1987;21(1):9–20.
176.
PeaceKEDesign, monitoring, and analysis issues relative to adverse eventsDrug Inf J.1987; 21(1):21–28.
177.
PereJCBegaudBHaramburuFAlbinH.Computerized comparison of six adverse drug reaction assessment proceduresClin Pharmacol Ther. 1986;40(4):451–461.
178.
SchneiweissFUthoffVASample size and postmarketing surveillanceDrug Inf J.1985; 19(1): 13–16.
179.
SellersE.Discussion on how and when can this approach be applied and initial reactionsDrug Inf J.1986;20(4):535–541.
180.
SoxHCProbability theory in the use of diagnostic testsAnn Intern Med.1986;104:60–66.
181.
VenuletJ.Aspects of standardization as applied to the assessment of drug-event associations —Keynote addressDrug Inf J.1984; 18(3/4): 199–210.
182.
WeintraubM.The general clinical pharmacology “bias elimination” method — Special workshop-ClinicalDrug Inf J.1984;18(3/4):293–296.
183.
Anon. Development in clinical trialsPharm J.1986;236:58–59.
184.
CarsonJLStormBLTechniques of postmarketing surveillance — An overviewMed Tox.1986;1:237–246.
185.
CastleWMNichollsJTDownieCCProblems of postmarketing surveillanceBr J Clin Pharmacol. 1983;16(6):581–585.
186.
ChenD.Discussion panel: International issues in postmarketing surveillanceDrug Inf J.1985; 19(3):285–290.
187.
CrombieIKThe role of record linkage in postmarketing drug surveillanceBr J Clin Pharmacol. 1986;22(Suppl 1):77S–82S.
188.
FaichGAInternational drug surveillanceDrug Inf J.1985;19(3):227–229.
189.
FaichGAPostmarketing surveillance of prescription drugs: Current status. New York: Clinical Medicine Research Institute; October 1986.
190.
FisherSBryantSGKlugeRMMeasuring adverse drug reactions in a postmarketing surveillance systemPsychopharmacol Bull. 1986; 22(1):272–277.
191.
FisherSBryantSGKlugeRMDetecting adverse drug reactions in postmarketing surveillance: Interview validityDrug Inf J.1987; 21(2):173–183.
192.
FisherSBryantSGSolovitzBLKlufeRMStatewide test of a new postmarketing drug surveillance systemTex Med.1987;83(8):59–62.
193.
GirardM.Post-marketing surveillance: An art or a science?Drug Inf J.1986;20(3):347–349.
194.
GraselaTHSchentagJJA clinical pharmacy-oriented drug surveillance network: I. Program descriptionDrug Intell Clin Pharm. 1987;21: 902–908.
195.
GraselaTHEdwardsBARarbelMASiscaTSZarowitzBJSchentagJJA clinical pharmacy-oriented drug surveillance network: II. Results of a pilot projectDrug Intell Clin Pharm. 1987;21:909–914.
196.
HartzemaAGPortaMSTilsonHHIntroductions to pharmacoepidemiologyDrug Intell Clin Pharm. 1987;21:739–740.
197.
HollisterLEOverallJEExperience with a failed post-marketing drug surveillance programJ Clin Pharmacol. 1984;24:3–5.
198.
JickHMadsenSNudelmanPMPereraDRStergachisA.Postmarketing follow-up at Group Health Cooperative of Puget SoundPharmacotherapy. 1984;4(2):99–100.
199.
JohnsonA FPostmarketing surveillance: Statistics and auguryJ Chron Dis.1984;37(12): 949–952.
200.
LortieFMPostmarketing surveillance of adverse drug reactions: Problems and solutionsCan Med Assoc J.1986;135(1):27–32.
201.
LuscombeFAMethodologic issues in pharmacy-based postmarketing surveillanceDrug Inf J.1985;19(3):269–274.
202.
PetrieWMLevineJ.The assessment of adverse drug reactions in clinical trialsInt Pharmacopsychiat. 1978;13:209–216.
203.
SchiffG.Monitoring of drugs after market releaseInfusion. 1985;9(6):168–172.
FeinsteinARTheoretical perspectives in causality assessmentDrug Inf J.1984; 18(3/4):219–225.
215.
FinchamJEPilot projects to stimulate adverse drug reaction reportingJ Clin Pharm Ther. 1987;12(4):243–247.
216.
GambleDEHusseyJMMonitoring adverse drug reactions effectivelyMed Mark Media. 1985;20:12,14, 16–17.
217.
GambleDEHusseyJMMonitoring adverse drug reactionsDrug Cosmet Ind.1986; 138:35–36, 38, 42, 77–78.
218.
GriffinJPAdverse reaction monitoring using cohort identificationBr Med J.1987;294:576.
219.
IreyNSCase report methods for assessing causalityDrug Inf J.1984;18(3/4):241–249.
220.
JeffreyLPRevised ADR report permits internal review of drug experiencePharm Times. 1986;52:48–50.
221.
JonesJKUses of drug-event assessmentDrug Inf J.1984;18(3/4):233–240.
222.
KramerMSAssessing the causal relationships between drugs and their adverse effects. Drug Inf J.1981;(July-Dec):146–152.
223.
LaneDAA probabilist's view of causality assessmentDrug Inf J.1984;18(3/4):323–330.
224.
LasagnaL.Discovering adverse drug reactionsJAMA. 1983;249(16):2224–2225.
225.
McEwenJ.Improving adverse drug reaction monitoringMed Tox.1987;2:398–404.
226.
MillerRRInterpretation of studies on adverse drug reactionsAm J Hosp Pharm. 1977;34: 753–754.
227.
RoujeauJCGuillaumeJCRevuzJTouraineR.Reporting adverse drug reactions. Lancet. 1985; (Nov 30): 1244.
228.
SeidlLGThorntonGFCluffLEEpidemiological studies of adverse drug reactionsAm J Pub Health. 1965;55(8): 1170–1175.
229.
TurnerP.Long-term assessment of drug safety and efficacyJ R Soc Med.1984;77:93–94.
230.
VenuletJ.Critical reflection on the collection and evaluation of adverse drug reaction dataInt J Clin Pharmacol Ther Toxicol. 1985; 23(Suppl 1):S48–S53.
231.
VenuletJ.Informativity of adverse drug reactions data in medical publicationsDrug Inf J.1985;19(3):357–365.
232.
VenuletJCiucciABernekerGCStandardized assessment of drug-adverse reaction associations — rationale and experienceInt J Clin Pharmacol Ther Toxicol. 1980; 18(9):381–388.
233.
WoodhouseRJMonitoring adverse drug reactionsDrug Cosmet Ind.1986; 139:37, 38, 40.
234.
ZillerueloIEspinozaERuizI.Influence of the assessment of the severity on the frequency of adverse drug reactions (ADRs)Int J Clin Pharmacol Ther Toxicol. 1987;25(6):328–333.
235.
BennettBSLipmanAGComparative study of prospective surveillance and voluntary reporting in determining the incidence of adverse drug reactionsAm J Hosp Pharm. 1977;34: 931–936.
236.
GordonAJNumerators, denominators, and other Holy Grails: Management and interpretation of worldwide drug safety dataDrug Inf J.1985;19(3):319–328.
237.
JonesJKDiscussion panel: The future of causality assessment: Is it wise: Will it help? What effect could it have on the analysis of clinical trial data or in pharmacoepidemiology?Drug Inf J.1986;20(4):551–562.
238.
KarchFELasagnaL.Toward the operational identification of adverse drug reactionsClin Pharmacol Ther. 1977;21(3):247–254.
239.
KarchFESmithCLKerznerBMazzulloMWeintraubMLasagnaL.Adverse drug reactions — A matter of opinionClin Pharmacol Ther. 1976;19(5):489–492.
240.
Koch-WeserJGreenblattDJThe ambiguity of adverse drug reactionsClin Pharmacol Ther. 1976; 19(1): 110.
241.
Koch-WeserJSellersEMZacestR.The ambiguity of adverse drug reactionsEur J Clin Pharmacol. 1977;11:75–78.
242.
KramerMSDifficulties in assessing the adverse effects of drugsBr J Clin Pharmacol. 1981;11:105S–110S.
243.
LaneDAThe logic of uncertainty: Measuring degree of beliefDrug Inf J.1986;20(4):445–453.
244.
LasagnaL.Bias in the elucidation of subjective side-effectsBr J Clin Pharmacol. 1981; 11: 111S–113S.
245.
ShapiroS.Problems in the detection and quantification of adverse drug reactionsDrug Inf J.1984;18(3/4):251–254.
246.
VenningGRValidity of anecdotal reports of suspected adverse drug reactions; the problem of false alarmsBr Med J.1982;284:249–252.
247.
VenningGRIdentification of adverse reactions to new drugs. III: Alerting processes and early warning systemsBr Med J.1983;286:458–460.
248.
VenningGRIdentification of adverse reactions to new drugs. IV — Verification of suspected adverse reactionsBr Med J.1983;286:544–547.
249.
VenuletJ.Monitoring adverse drug reactions —The problem of integration of heterogeneous dataInt J Clin Pharmacol Biopharm. 1979; 17(9):383–386.
250.
VenuletJBlattnerRvon BulowJBerknekerGCHow good are articles on adverse drug reactions?Br Med J.1982;284:252–254.