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Bibliography
Drug-induced Diseases
Drug-induced Diseases, vols 1, 2, 3 and 4. Editors: L. Meyler and H.M. Peck, Excerpta Medica, 1972. Essential reading providing background information on many different topics from an impressive list of international contributors.
Iatrogenic Diseases, 3rd edition. Editors: P.F. D'Arcy and J.P. Griffin, Oxford University Press, 1986. Will tend to be compared with the Textbook of Adverse Drug Reactions. This edition is a considerable improvement on the second edition with many more contributors, the first hundred pages being given to general topics. I would now class it as essential.
Textbook of Adverse Drug Reactions, 3rd edition. Editor: D.M. Davies, Oxford University Press, 1986. Superb textbook dealing with all aspects. Includes individual drugs (well referenced) as well as a few general chapters.
Pathology of Drug-induced and Toxic Diseases. Editor: R.H. Ridell, Churchill Livingstone, 1982. The majority of contributors are American with a sprinkling from the UK. Excellent, authoritative basic textbook.
Drug Reactions and the Liver. Editors: M. Davis, J.M. Tredger and R. Williams, Pitman Medical, 1981. All the authors originate from the Liver Unit at King's College Hospital. This is an essential book with background discussion on mechanisms of ADR and the liver.
Guidelines for Detection of Hepatotoxicity Due to Drugs and Chemicals. Editors: C.S. Davidson, C.M. Leevy and E.C. Chamberlayne, US Department of Health, Education and Welfare, NIH Publication No. 79-313. An American book with all the world experts participating. This is an essential book.
Drug-induced Disorders, vol. 1, Drug-induced Hepatic Injury, B.H.Ch. Stricker and P. Spoelstra, Elsevier Science Publication, 1985. Details of individual drug reactions as well as general information.
Drug-induced Heart Disease, vol. 5. Editor: M.R. Bristow, Elsevier, North Holland, Biomedical Press, Amsterdam, 1980. Most of the many contributors are from the USA. A lot of physiopathological details. Well produced.
Drug-induced Disorders, vol. 2, Drug-induced Diseases in the Elderly. F.l. Caird and P.J.W. Scott, Elsevier Science Publication, 1986.
291
292 The Detection of New Adverse Drug Reactions
Toxicology of the Eye, 3rd edition. Editor: W. Morton Grant, Thomas, Springfield, Illinois, 1986. Exhaustive tome. Covers disorders of function as well.
Drug-induced Ocular Side Effects and Drug Interactions, 2nd edition. Editor: F.T. Fraunfelder, Lea and Febiger, Philadelphia, 1982. A well-structured textbook on individual drugs. Based on experience of the American National Registry of Drug-induced Ocular Side Effects.
A Guide to Drug Eruptions, 4th edition. W. Bruinsma; De Zwaluw, PO Box 21, Oosthuizen, The Netherlands, 1986. Brief but invaluable. Short 125 pages. Contains lists of drugs causing each type of skin reaction. Useful general text. Annual supplements between frequent editions.
Cutaneous Side Effects of Systemic Drugs. Editors: K. Zurcher and A. Krebs, S. Karger, Basel, 1980. The subtitle 'A commentated synopsis of today's drugs' is very accurate. Well-referenced. All text in German and therefore rarely used.
Drug-induced Nutritional Deficiencies, 2nd edition, D.A. Roe, AVI Publications Co. Inc., Westport, Connecticut, 1985.
Birth Defects Compendium, 2nd edition. Editor: D. Bergsma, Macmillan Press Ltd, 1979. Very comprehensive.
Drugs in Pregnancy and Lactation: a reference guide to foetal and neonatal risk. Editors: G.G. Briggs, T.W. Bodendorfer, R.K. Freeman and S.S. Yaffe. Williams and Wilkins, Baltimore/London.
Allergic Reactions to Drugs. Editors: A.L. de Week and H. Bundgaard, Handbook of Experimental Pharmacology, vol. 63, Springer-Verlag, 1983. Excellent.
Drug Interaction
A Manual of Adverse Drug Interactions, 2nd edition. Editors: J.P. Griffin and P.F. D'Arcy, John Wright and Sons Ltd, Bristol, 1979. A good introduction to interaction mechanisms. Interactions presented in tabulated form in pharmacological groups. The only one with medical authors. The first 50 pages on mechanisms and 307 pages on interactions.
Drug Interactions: a source book of adverse interactions, their clinical importance, mechanisms and management. Ivan Stockley, Blackwell Scientific Publications, 1981. Succinct data on a large number of interactions, each dealt with individually. Easy to read; 447 pages on interactions. This book and the APA book (see below) I found easiest to read.
Evaluations of Drug Interactions, 2nd edition. American Pharmaceutical Association, 2215 Constitution Avenue, NW Washington DC 20037, 1976. Excellent monographs on individual interactions; 458 pages on interactions.
Drug Interactions, 4th edition. Editor: P.D. Hansten, Lea and Febiger, Philadelphia, 1979. Half the book deals with drug effects on clinical laboratory results; 264 pages on interactions.
Bibliography 293
Clinical Trials
Randomised Controlled Clinical Trials. C.J. Bulpitt, Martin us Nijhoff, 1983. One of the very few books which deals adequately with both sides of the cost/benefit ratio. Should become the standard textbook on the subject. Forms, questionnaires and the quality of life are dealt with very fully.
Guide to Clinical Studies and Developing Protocols. Bert Spilker, Raven Press, New York, 1984. A vast number of tables. A valuable reference book.
Guide to Clinical Interpretation of Data. Bert Spilker, Raven Press, New York, 1986. A large number of tables. Very useful.
Reference Books
Meyler's Side Effects of Drugs, lOth edition, 1986 and The Side Effects of Drugs Annual, nos. 4-11, 1987, Excerpta Medica. Absolutely essential. The most exhaustive available text on ADR of individual drugs.
Physician's Desk Reference. Medical Economics Comp. Inc., USA. 3060 pages of USA drug products: Annual.
ABPI Data Sheet Compendium. Datapharm Publications Ltd. 1500 pages on UK drug products. Annual.
Dictionnaire Vidal. OVP, 11 rue Quentin-Bauchart, 75384, Paris. Details of all the French drug products. Annual.
Rote Liste, Bundesverband der Pharmazeutischen lndustrie, V. Karlstr. 21, 6000 Frankfurt am Main. Details of all the German drug products. Annual.
L'informatore Farmaceutico, Organisazione Editorali, Medico-Farmaceutica SRL, Via Edolo 42, 20125, Milano. Two-volume annual giving details of all Italian drug products.
Quick Guide to Japanese Ethical Products. Sept. 1984. JMRC Co., Medical Department, Metatex Co. Ltd., 3-12-41. Komaba Meguro Ku Tokyo 153. Check price before ordering!
Martindale. The Ji:xtra Pharmacopoeia, 28th edition, The Pharmaceutical Press, 1982. Best source of brand names in other countries.
Pharmaceutical Handbook, 19th edition. Editor: A. Wade, The Pharmaceutical Press, London, 1980. A companion volume to Martindale. A 'Pear's Encyclopaedia' of useful pharmaceutical and medical information.
Abbreviations in Medicine, 3rd edition. Karger, Albrecht Scherkl.
A Laboratory Guide to Clinical Diagnosis, 5th edition. R.D. Eastham, Wright PSG, 1983. An excellent reference book.
294 The Detection of New Adverse Drug Reactions
Biochemical Values in Clinical Medicine. R.D. Eastham, John Wright and Sons Ltd, 1978. The subtitle is 'The results following pathological or physiological change'. An excellent reference book.
Drug Effects in Clinical Chemistry, 2nd edition. Editors: N. Tryding and C.-G. Lindblad, Apoteksbolaget, Stockholm, 1981.
A Handbook Synopsis of Laboratory Medicine, 3rd edition. J. Wallach, Little, Brown and Co., Boston, 1978.
General
Adverse Drug Reactions: Their Prediction, Detection and Assessment. Editors: D.J. Richards and R.K. Ronde!, Churchill Livingstone, 1972. Based on a symposium organised by the Association of Medical Advisers in the Pharmaceutical Industry in 1971. A short book (176 pages), now outdated.
Drug Monitoring. Editors: F.H. Gross and W.H.W. Inman, Academic Press, 1977. Proceedings of an instructional workshop in Honolulu in January 1977 sponsored by Ciba-Geigy. Contributions from most of the important men in the field and now somewhat dated.
Drug Monitoring. A requirement for responsible drug use. Editors: R.B. Steward, L.E. Cluff and J.R. Philip, Williams and Wilkins, Baltimore, 1977. Most of the contributors come from Florida and describe the early American experience.
Computer Aid to Drug Therapy and to Drug Monitoring. Editors: H. Ducrot, M. Goldberg, R. Hoigne and P. Middleton, North Holland Publishing Co., 1978. Proceedings of the IFIP Working Conference of the same title, Switzerland, March 1978. The early days of computerised drug data banks.
Drug-induced Sufferings. Medical, pharmaceutical and legal aspects. Editor: T. Soda, Excerpta Medica, 1980. Proceedings of the Kyoto (Japan) International Conference against drug-induced sufferings held in 1979. Contributors worldwide but the majority Japanese. Not as emotional as the title implies. Contains reports on most of the world ADR problems.
Drug-safety Progress and Controversies. Editors: M. Auriche, J. Burke and J. Duchier, Pergamon Press, 1982. The proceedings of the IVth International Congress of Pharmaceutical Physicians, April 1981. Largely given to adverse drug reactions and postmarketing surveillance, especially within the industry.
Assessing Causes of Adverse Drug Reactions. Editor: J. Venulet, Academic Press, 1982. Based on a workshop held at Morges, Switzerland, in June 1981. Almost half the participants were Ciba-Geigy staff but with contributors from most of the world authorities. Dominated by standardised methods with few voices in opposition.
lmmunotoxicology. Editors: G.G. Gibson, R. Hubbard and D.V. Parke, Academic Press, 1983. Comprehensive. The proceedings of the first international symposium on immunotoxicology in 1982. About half of its 500 pages are on drug-
Bibliography 295
related topics. It is well-produced and well-referenced and has a very good chapter on drug allergy.
Clinical Epidemiology. A Basic Science for Clinical Medicine. Editors: D.L. Sackett, R.B. Haynes and P. Tugwell, Little, Brown and Co., Bostonfl'oronto, 1985. Well written- comprehensive.
Monitoring for Drug Safety, 2nd edition. Editor: W.H. Inman, MTP Press Ltd, 1986. An absolutely essential book on postmarketing surveillance with a wide ranging list of international contributors. The bible of PMS.
PAR Pseudo-allergic Reactions. Involvement of drugs and chemicals. 4. Idiopathic, food-induced and drug-induced pseudo-allergic reactions. Editors: P. Dukor, P. Kallos, M.D. Schlumberger and G.B. West. Publication S. Karger.
Medicines and Risk/Benefit Decisions. Editors: S.R. Walker and A.W. Asscher, MTP Press, 1987. This is the proceedings of a centre for Medicines Workshop held in October 1985. An excellent coverage of the situation.
Adverse Drug Reactions. Editor: R.D. Mann, Parthenon Publishing, 1987. A 1986 view of PMS in the UK. Proceedings of a Management Forum Conference. Excellent.
Paperbacks
Postmarketing Surveillance of Drugs. L. Lasagna, Medicine in the Public Interest Inc., 1977; 54 pages on the early American experience.
Postmarketing Surveillance of Adverse Reactions to New Medicines. MedicoPharmaceutical Forum, 1 Wimpole Street, London. Publication No.7, Report of a meeting held in December 1977. Reflecting mainly the British approach to the problem with an excellent paper on the practolol syndrome.
Guidelines for Pre-clinical and Clinical Testing of New Medicinal Products, Part 2: Investigations in Man. ABPI, 1977. Essential basic reading.
Safety Requirements for the First Use of New Drugs and Diagnostic Agents in Man. The Council for International Organisation of Medical Sciences (CIOMS), 1983. Subtitled: A review of safety issues in early clinical trials of drugs. Essential reading for those involved in Phase 1 and 2 studies.
Legal and Practical Requirements for the Registration of Drugs (Medicinal Products) for Human Use, published by the International Federation of Pharmaceutical Manufacturers' Associations in Zurich 1980. Pages 374-409 relate to post-marketing surveillance and the requirements of each nation are given in a tabular form but with little detail.
Monitoring and Assessment of Adverse Drug Effects. Council for International Organisations of Medical Sciences (CIOMS), 1986. The advantages and disadvantages of various methods covered in 28 pages.
296 The Detection of New Adverse Drug Reactions
Journals
Adverse Drug Reactions and Acute Poisoning Reviews. Quarterly journal edited by Professor D.M. Davies, Oxford University Press. Excellent monographs on specific areas.
Reactions. Bi-monthly with quarterly and cummulative annual index. Adis Press, New Zealand. Current adverse drug reaction problems. Fills in the time lag before ADR are published in Meyler's.
Scrip. Editor: Dr P. Brown. PJB Publications Ltd. Published at frequent but irregular intervals. Essential reading to find what is happening in your own company and to your own drugs, as well as the changes in the regulations and practices around the world.
Medical Toxicology. Bi-monthly journal published by Adis. First published January 1986.
Adverse Drug Reaction Bulletin. Bi-monthly. Published by Professor D.M. Davies in English, Italian, French and Spanish editions. Each issue deals with one particular ADR problem area.
Human Toxicology. Quarterly journal published by Macmillan Press Ltd.
Drugs and Therapeutics Bulletin. Fortnightly bulletin published by the Consumers' Association.
Drug Information Journal. Quarterly journal of the Drug Information Association. Excellent source of information on methodology and data management.
Update
Quality of Life: Assessment and Application.Editors:S.R. Walker and R.M. Rosser, MTP Press Ltd, 1988.
Scrip. Post-marketing surveillance. Present problems and future prospects in the UK. PJB Publications Ltd, July 1987. Contains a brief account of the Pharmaceutical Computer Club Malta Meeting (see page 197).
Appendix
297
298 The Detection of New Adverse Drug Reactions
CSM Yell ow Card
IN CONFIDENCE- REPORT ON SUSPECTED ADVERSE REACTIONS
1. Please report all suspected rqctions to recently introduced dru;s (identified by a bl.ck triangle in the British National Fonnulary}. vaccines, dental or surgical materials,IUCD's, ebsorblblesut•Jres, contec:t lenses and associat.::l fluids, and serious or unusuel ructions to all ~nts.
2. Ro!Cord all other drugs etc, including self-medication, taken in the previous 3 months. With congenital ebnormalities, record all drugs taken during pregnancy, and date of liSt menstrual period.
3. Do not be deterred from reporting because some details are not known.
4. Please report suspected drug interactions.
NAME OF PATIENT Family name SEX AGE or WEIGHT (To allow for link-s~~ DATE OF BIRTH (Kg.) with other reports for same ~tient. Please Forenames give record number for hospital patienu.J
DRUGS, VACCINES Inc. Batch o. , DEVICES, DAILY DATE
MATERIALS etc. ROUTE INDICATION (Pleese give Brand Name if known) DOSE STARTED ENDED I Suspected drug, etc. I I I Other drugs, etc. (Pieese stete if no other drug given.)
SUSPECTED REACTIONS STARTED ENDED OUTCOME (q. fatal, recovered)
ADDITIONAL NOTES REPORTING DOCTOR (Block lettars plene) Nama:
Address:
Tal. No: Specialty:
Sign~~tura: Date:
If you would like information about other reports usoc._ted with tha suspected drug, pia ... tick box - I I AR;20 400,000 5:83 5214286 C. BROS INICI Ltd.
Note: This is literally a yellow card with the reverse side in the form of a prepaid and preaddressed 'fold here' envelope.
Appendix
In Confidence - Report on Suspected Adverse Reactions
IN CONFIDENCE - REPORT ON SUSPECTED ADVERSE REACTIONS
1. lteport all rooct lono Ofld off octo oo lnotruc:tocl b)' WAll 41. 2. llrocord all othor c:lrugo, Including oolf-dlcotlono, tokon In tho previous J -nths. With contenltol obnor-lltles. record oil drup t•«~ ctur lnt pregnoncy. 3. P'loooo do not bo dot erred tr .. report Jng bocouos OOM dotollo ore not llnown. 4. tto. tl'llo potlent'o rooctiOfl boen reported to uo provlouoly [ YE:S I NO]: P'revlouo Adverse lleoctlon ltoglotrotlon Mo:
299
5. Ple"o ototo tho llconolng otohlo u1uMr wtllcfl the drue reactions occurred (rlftg rolovont ototuo bol ond gin Identifying n\lll'bor):
uctos••• STATUS• D D D I I D ..•. , ........... I (CTX, CTC, CT .. ,
II'L, P'MS, ate.) I I I I 1/1 I I I ID IWir MD ADOitlSI or COMPAMY DOCTOR or other representative of product I leones holder -
------Oats:
FAMILY NAil!:
IWI( Off PATIENT'S OIM DOCTOI (orul oddre•• If known):
... DJtuet. VACCIIIll (Inc. latch Na.), OAT( DtVICI:S. IMTtltiAL.I etc. ltOUT( DAILY DOS( AMO UNITS (f'lea•e give I rand N- If known) STARTED [N0[0
SU$f'[CTU DRUG, etc,
SUSf'[CTU R[ACT I OMS STARTED [N0[0
ADDITIONAL MOTU
COWANY'S lt!:ACTION UPOftT NUM!IEit
AG( or OAU OF llltTH I
l INDICATION
WEIGHT (kg)
5. Ple"o ototo tho llconolng otohlo u1uMr wtllcfl the drue reactions occurred (rlftg rolovont ototuo bol ond gin Identifying n\lll'bor):
300 The Detection of New Adverse Drug Reactions
The CIOMS Report Form
INTERNATIONAL EVENT REPORT
I I I I II II I I I I I I '· [V[HT N'()Rt.IA. TIOfrt
1. PATIENT NTIAl$ I'·· """"'"' 12 .•••• ., "'"" 2o. A«. 13. S<X I. -•. [V[Nf ..... I - 12. Qt[CK ALL _ .. ro ......
7 + 1J. DESCRK EVENTS
lXI PAOOIT 01!D
o ........... flftQlOHQED IPAT'DfT 110SPJTAUZAf1DN
o ............... mu ., ....,.,.,.. OISAI1UfY DR ICAPADTY
0 Lft ,....,.._
I. DRUG N"OftWATION
14. UNTFIED DIIIIJG(,S) 20. DO [Y[NT AIM Tf AfTO STOPf'IG ....,.
OY<S 0.0 DNI• 15. DAILY DOSE: ,, •• lOUT! OF ADIMSTitATJQN 21. DO EVENT .............. 17, ICliCATo.(S) FOit US(
.........., ..... ta. THERAPY DATtS (P1te»r~VTO) r·· Tt£RAPY DUitAllON
OY<S 0.0 ON/A
•. C()trCOMTANT DMIGS AIG HISTORY
22. CQNCOI.ITANT DIU:$ NO DATES 01 AOIMSTRA'hON (E•clucM thoH UMd to treat ~t)
23. OTHER ftfl.£VAHT ttSTOftY
rv. Ofri.Y FOR IIEPORTS SWWJT£1) IY IIWU'ACT1JROI
21. NAME AND ADMESS OF WAN# ACTlJIEJt (IC:LUD£ lP CODE)
1240. WO CDHfOOl NO.
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Appendix
Form 1 INTERNATIONAL DRUG SURVEILLANCE DEPARTMENT
GLAXO GROUP RESEARCH LIMITED
ADVERSE EVENT REPORT FORM
CONFIDENTIAL
~ PLEASE CROSS APPROPRIATE BOXES AND WRITE CLEARLY OR PRINT
PLEASE COMPLETE ALL SECTIONS
1. PATIENT DETAILS: Patten! tden!lftcatton
Wetght Hetght Male
• -riJ~J ,9 [il]'m' D
2. RELEVANT MEDICAL HISTORY (Please include previous surgery and medical details where relevant)
3. HISTORY OF ALLERGY: (Including drug allergy) Yes 0 No 0 Deteils:
303
~D_R_U_G-S:-,-,,.-,,,-.. ,-.,"-~-."-''"-,-----.---,-~~u-,-,-,------~-------,-----------------1 l·•st tnctu<lf'b.otch num~• wherek.,ownl Route l,~u.;;~·:'f.,~,.,0::;o=.,~~~l:rt~";"~O =,=,.~, ~o=.,~~~~
5. ADVERSE EVENT: (P$ease give full description, including frequency, severity, duration and diagnosis, if possible). Use additional sheet or space overleaf for Laboratory Data.
Time
Date of onset U_.I~"--L_l__J lftimetoonsetis<24hrs rn hrs
Time
lfdurationis<24hrs rn hrs
Descrtplton
·······.·c·"'"'······················ ·······"'= .. ··········•c·.=···· 6. TREATMENT OF ADVERSE EVENT:
0 Suspect drug withdrawn due to event
0 Dose reduced (please state new dose) ....
D No change in drug therapy
Was treatment prescribed? Yes D No 0 Was hospital treatment required/prolonged? Yes D No 0
7. OUTCOME: Resolved Improved but completely 0 st1fl present D Unchanged 0
8. CAUSAUTY: •· Could the p•tient's origin•l condition or other illness account for the adverse event?
~~~~~tly 0 Probably 0 Possibly 0 Unlikely 0 No 0
9. COMMENTS: I Further space on back if necessary)
10. REPORTING DOCTOR:
Name.
Address ..
Tel. No ...
Did the symptoms resolve?
Was the patient rechallenged?
Did the reaction recur?
If 'Yes' please specify .
Worse 0 Fatal 0
Yes 0 Yes 0 Yes 0
NoD
No 0 No 0
Date L[ -'----'---"....LT_" .....__'..._j"-'
: b. Do you think the relationship between the suspect drug : andtheadverseeventwas:
: Alma:stD Probable D Possible 0 Unlikely D Nreola'ted 0 : certa.n
11. REGULATORY AUTHORITY NOTIFIED? Yes 0 No 0 12.
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Appendix 305
Form 2
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306 The Detection of New Adverse Drug Reactions
RElEVAN t LABOR.IlTOR'I' FINDINGS
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Appendix 307
Tyt>f Ve,•.en' New~ Reeord ~o.
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BIOPSY AN010R POST~ RESUlTS
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308 The Detection of New Adverse Drug Reactions
INSTRUCTIONS FOR COMPLETING LABORATORY DATA PAGE
The protocol for this study outlines the need for venous blood samples to be taken:
Please enter the results of the laboratory tests on the following pages and assess the data when the results of ALL samples have been recorded. If any additional samples are required please make an overall assessment of the data when the results of these samples have been recorded. Consider clinical chemistry, renal function, liver function and haematology as separate aspects. Make an overall assessment of each aspect and grade as follows.
0 { Normal Abnormal, but of no clinical significance. Abnormal, due to laboratory error.
1 Abnormal, UNLIKELY to be due to DRUG. 2 Abnormal, POSSIBLY due to DRUG. 3 Abnormal, PROBABLY due to DRUG. 4 Abnormal, ALMOST CERTAINLY due to DRUG.
...
...
Further blood samples must be taken until the assessment can be classified as normal or allows you to establish a cause for the abnormal assessment.
I!ATCHFOAMA.T I c==JA.T1ENTHO CODE
I I 1· 1 l
SODIUM
POTASSIUM
TOTAL PROTEIN'
> ALBUMIN' a:
CALCIUM' .. "' ~
UREA X (J
~ CREATININE· (J
z BILIRUBIN :::;
u SGOT IASTI
SGPTIALTI ALKALINE PHOSPHATASE
GGT
HAEMOGLOBIN
RBC
MCV >
t~t1FfET " g 0 T0TALW8C 1-~ NEUTROPHIL$ ~ ~ BASOPHIL$ X
EOSINOPHIL$
LYMPHOCYTES
MONOCYTE$
Appendix
Laboratory Data Form
FOA OFFICE USE ONLY
309
r-----
0
'---
COMMENTS:---------------------------------------------------------------------
310 The Detection of New Adverse Drug Reactions
Adverse Skin Reaction Report Form
INSTRUCTIONS
Please: 1. Complete all sections 1-10.
2. ~ Mark appropriate boxes and write clearly or print.
3. Do not write in any shaded areas.
4. If space in any section is insufficient, continue
under "Additional Comments" (section 9), stating to
which section the continuation refers.
Appendix 311
ADVERSE SKIN REACTION FORM
CONADENTIAL
1. PATIENTDETAILS Patient Identification:. .. Hospital Number:
Date of I Day I Month I Year I Sex 0 Female Weight I I kg Birth
I I I I I I I • I
0 Male 0< c:J st. c:J lbs
Ethnic Origin Was the patient?
D Caucasian 0 Negroid 0 Mongoloid 0 An in-patient 0 An out-patient
0 Other (please specify) D In general practice
D Other (please specify).
Occupation
Pregnant 0 Yes 0 No If yes, period of gestation at time of adverse event CJ weeks
2. MEDICAL HISTORY
Previous medical history (excluding allergy)
Current d1agnoses and any concurrent conditions
H1story of Atopy 0 Yes 0 No History of Allergy 0 Yes 0 No
Personal Family
0 0 If yes, please give details
Asthma
Hay Fever 0 0 Eczema 0 0 Other 0 0 (please specify) .....
Previous Adverse Drug Reactions
Drug Reaction
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Appendix 313
5. MANAGEMENT OF ADVERSE REACTION
(a) Wasthesuspecteddrugwithdrawn? (b) Did the adverse event continue?
0 Yes 0 No 0 Yes 0 No .... Was suspected drug withdrawn by
D Patient 0 Doctor
Was the patient rechallenged with the suspected drug?
0 Yes 0 No
If yes, did the symptoms or signs recur?
0 Yes 0 No
Tre•tment of •dverse reaction
Hno
Was the dose of the suspected drug
0 Reduced 0 Unchanged
If reduced, new dose .....
6. INVESTIGATION OF ADVERSE REAC'nON
SKIN TESTS
Yes No Positive
Patch tests 0 0 0 Prick test 0 0 0 Intra-dermal test 0 0 0 Biopsy of a lesion 0 0 Immunofluorescence of a lesion 0 0 Other (please specify) ..
7. CASUAL RELATIONSHIP
.... were the symptoms or signs
0 0 0 0
Considerably improved
Slightly improved
Unchanged
Wo""
Could the adverse event have continued even if the suspected drug had been withdrawn?
0 Yes 0 No
Results
Negative
0 0 0
Could the original conditions or other illnesses have accounted forth is skin reaction?
D Yes 0 Possibly D No Please give details ....
Do you think the relationship between the drug and adverse event was
D Almost certain 0 Probable 0 Possible 0 Unlikely
Nno
do you think this improvement was due to:
0 0 0
Stopping suspected drug
Treatment of adverse reaction
Not known
314 The Detection of New Adverse Drug Reactions
Type' V•riwtt• New7 -No. ~ D [[]~' 0~·=1=1=1=1=1~~------~-----------··~··~
Special
12lii:=D1• 1sl I I I I l1a
I I I I I I
Report
120:JJ1·
I j59
I lea j&r
,.1 I I I I 119
8. RELEVANT lABORATORY RNDINGS
Please specify any significant laboratory findings before, during and after the adverse skin reaction.
9. SPECIAUST OPINION
Was a further specialist opinion sought?
If yes, please give date·
Name of specialist ...
Appointment ..
Opinion ...
10. ADDITlONAL COMMENTS
Have you notified your drug regulatory authority (e.g. F.O.A., C.S.M.)?
11. REPORTING DOCTOR
Name ....
Appointment ...
Address ...
Country ...
Signature ...
0 Yes 0 No
Day I Month I Year I
0 Yes 0 No
. ...... Telephone No ..
Day Month Year
Appendix
ADVERSE EVENT DATA TRANSFER FORM
080 No I I I I I I I I I 0
Patient Details : PallentldentHicallon Ll ..~....1 ..J...-L-' ooa I I I I I orAGEITIJ
Petlent No.: Ptotocol code: ___ lnvwllgetor code :'-------Study code : __ _
Weight I I 1·1 I kg Sex (M,F,U)D Preg 1 (V,N,U) D
Weight I I I 1•1 I lba
Height ITO cme Date of lui manatrual period I I I I I I I I Haight ITO In
Medical History :
T erma for coding
I I I I I I I I I II I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I
315
Text (Including previous adverse reactions to drugs): ------------
History of Allergy : History of allergy? (Y.N.U) 0 Allergies
1 2 3 4 5
I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I 2 3 4
Drug allergies
1 2 3 • 5
I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I ll I I I t I I I I I 13 1 I I I I t I I I I I .-t.,..l-.--1 ..-1-.1-1
Atlergytext: ---------------------
316 The Detection of New Adverse Drug Reactions
Adverse Event Data Transfer Form (Part 2)
Drugs :(Suspect Drug first) (DSONO
Dooage Deleo
Drug Unh Free
[Tot. ~~lng Route Dooe Do•• Slon Flnlohed ni.Chk lndlcollon
I I I I I I I I I I I I I I I Durell on
liT rn 0 OTIO 0 Order
I I I I I I Durell on
rn liT b CITJO OJ I I I I I I I I I Order
I I I I I I Duration
o::J to 0 ITIJO OJ I I I I I I I I I Order
f I I I I Duration
II I h ITDO OJ r f -1 I I I I I Order
I I I I I I Duration
OJ liT 1.---,
ITIJO OJI I I I I I I I I 1'--' Order
I I I I I I Duration
OJ I lr- ITDD OJI I I I I I I I I Order
I I I I I I Duro lion
OJ OJ b OIJD OJI I I I I I I I I I
(DSONO
Appendix 317
Adverse Event Data Transfer Form (Part 3)
DSD No Signature Counlry
Adverse Event : Data of onoat rl-l,--,lr-rl-,-1..,..1-,-1 ..,1 Tlmo to onoot (M.H,Dm=J QDurotlon (M.H.D)o::J] O Tormslorcodlng --------------------------
I I I I I I I I I I I I I I I I I I I I II I I I I II I I I I I I I I I II I i I I I I I I I I I I I I I II I I I I I I I I I I I I I I I I I I I I I I I I I I ~~~-----------------------------------------------
laboratory D.ta
Treatment: Adlon Resolved Rochallonged Recur
Suspect drug action : CodingOnty D D D
A Withdrawn 10 R- 0 Rochallenged 0 Recur D (Y,N,U) (Y,N,U) (Y,N,U)
B Dose Reduced R- Rochallenged 0 Recur D 20 (Y,N,U) D (Y,N,U) (Y,N,U)
n reduced new-C No Chango 30 Roaolved
D (Y,N,U)
D Not Applicable
Was avant lre.ted (Y,N,U) 0 Hospital troatmont 0 Drug treatment 0 H YES spocify
D
Outcome : Dale
Resolved Q lmprovedQUnchangod q Worao ct Fatal Q Dlsabilhy 9 CodlngOI I I I I I I \ Causality: 2 3 4
Condition: AlmoatConainly 0 Probably O PoaablyO UnlikolyQ No O
Drug: AlrMsl Conalnly O Probably O PoaablyO UnlikelyO No 0 Physician's Comment :
form Date
Coding 0 Coding O
I I I I I I I I
318 The Detection of New Adverse Drug Reactions
Working Causality Algorithm for Drug-event Associations (from Dr A. Ruskin)
Drug-causal relation
[Temporal association reasonable I no----+1 REMOTE
l yes
Known same event follows yes----.1 same drug (class) and is PROBABLE
biologically plausible
I and unique I yes__., HIGHLY PROBABLE I 1 no
I Dechallenge present I no _____.1 POSSIBLE
I yes
I Event abates on dechallenge I no--+[ POSSIBLE J 1 yes
I
I I
I
I
I Rechallenge present and yes I HIGHLY PROBABLE I same event reappears
1 no I Sllght H I PROBABLE Contribution of host factors/
disease/other therapy I Great t---+1 POSSIBLE I to known event I Overwhelming H REMOTE I
Appendix
Working Causality Algorithm for Drug-death Associations (from Dr A. Ruskin)
Drug-causal relation
[Temporal association reasonable L no~
l yes
Overdose/ confirmed by no J POSSIBLE I
treatment yes___. toxicologic or error pathologic data yes
PROBABLE I "I
1 no
Rapid anaphylaxis, L ye» .I PROBABLE I dysrythmia, etc. J .I
1 no
319
I Premortal event (s) on 1 yes ·:HIGHLY PROBABLE I previous drug challenge 1
l no
I Autopsy done I no~ J yes
no~ Pathology compatible with drug death yes~
l no
Contribution of host I Slight I .. , PROBABLE I factors/disease/ I Great I .. I POSSIBLE I
other therapy I Overwhelr.1ing ~ REMOTE I
320 The Detection of New Adverse Drug Reactions
Adverse Event Scoring
There are six factors and each has a variable basic score between 1 and 10:
1-4 are against it being due to the drug. 5 and 6 are neither very much for or against it being due to the drug. 7-10 are in favour of it being due to the drug.
Additional scoring has been added to increase the range in special circumstances.
Since descriptions cannot fit all the circumstances exactly, the score can be moved up or down one value.
Alternative drug candidates should be scored using this table.
FACTOR 1: Historical Evidence (Maximum score is 10)
Type of Adverse Reaction Previous Inte~l OnUC:
Reports or Not on lkrket IncUvidual Type A Type B lkrket <5 years
Published Cases Pharwaco 1 ovi cal Occurrence know .achani .. vi th other drug
of s- class .Type
Known +2 A 3 NO REPORTS or they Hypothesis not proven 0 Known +1 5 are "UNLIKELY" No hypothesis -2 Not known -2
B 5
Known +2 A 5 ONLY "POSSIBLES" Hypothesis not proven 0 Known +1 6 and "UNLIKELYS" No hypothesis -2 Not known -2
8 6
Two or 1t0re Known +2 A 7 "PROBABLES" (if Hypothesis not proven 0 Known +1 8 only one, No hypothesis -2 Not known -2 subtract 1) B 8
Two or lftOre Known +1 "ALitlST CERTAIN" Known +1
(if only one, Hypothesis not proven 0 Not known -2 9 9 subtract 1) No hypothesis -1
For the other drugs use published reports:
If in UK Data Sheet If in USA Data Sheet
Almost certain Probable Possible
OnUC: lkrket
>5 years
1
3
3
5
4
6
9
If in Committee on Safety of Medicine printout If in Meyler's Side Effects of Drugs Probable - if there is
extensive information it may change assessment to almost certain or possible.
Appendix
FACTOR 2: Time to Onset
MECHANISM
/TYPE A TYPEB ~
Very unusual for the event
Reaction occurred after stopping the drug - delay 1110re than 48 hours
Reaction occurred after stopping the drug - delay less than 48 hours
Tille to onset rather unusual for this event
Time to onset not known
Only rough estimate of ti111e to onset? Acceptable?
Just within time to steady state or just about acceptable
Well within time to steady state or acceptable timing
Approximate ti111e of peak levels or exactly correct timing
If other simultaneous drugs -5 Check each separately
Event so unusual, onset tiN not known
Within wide normal limits for the event (months)
Within the normal limits for this event (weeks)
Exactly correct timing for this event (<one week)
321
Score
2
3
4
5
6
7
8
9
No other simultaneous drugs, i .v. drug Onset <5 minutes
Type 1 allergy. Immediate onset. (<1 hour) 15 No other simultaneous drugs
If adverse event started before drug administration but became worse whilst on drug, subtract 2 from score.
2
322 The Detection of New Adverse Drug Reactions
FACTOR 3: Evolution of Event and Drug Withdrawal
A usually revers;ble react;on but cont;nues despHe stopp;ng the drug
Event d;sappears desp;te cont;nu;ng the drug. Tolerance to drug unl;kely
A poss;ble ;rrevers;ble event wh;clf cont;nues despHe stopp;ng drug
Event already ;mprov; ng when drug stopped, ;mprovement cont; nues
Treatment and stopp;ng drug s;multaneously. Improvement m;ght be due to treatment OR no ; nformat; on after onset of adverse event I dent; cal response as non-drug event ( durat; on normal for spontaneous d; seas e)
A def;nHely ;rrevers;ble event OR event dhappears despHe cont;nu;ng the drug. Tolerance to ADR occurs OR drug stopped before react; on date
Drug stopped. No treatment g;ven. Unusually slow, sHght or fast ;mprovement on stopp;ng drug
Drug stopped. Event regressed. No other ;nformat;on
Score
2
3
4
5
6
7
8
Drug dose reduced. No treatment g;ven. Improvement occurs wHMn reasonable Hme 9
Drug stopped. No treatment g;ven. Dhappearance exactly correct for th;s event 10 (No exact t;me g;ven -1)
'Irreversible' in this context means that, if the drug had caused the event, stopping the drug would not be expected to stop the event from continuing, i.e. myocardial infarction. It does not mean that with or without treatment the event would not resolve.
2
Appendix 323
FACTOR 4: Rechallenge - if not performed, add 5
Score
No response - dose and durat;on sh1nar to odg;nal - no other change ;n treatment _2 OR same response on placebo
If event ;s a rash - negaHve patch test
Odg;nal reducHon ;n dose and rechallenge equals re-estabHshment of odg;nal dose - no response
Lower dose than odg;nal or shorter durat;on of treatment - no response (Type A only) 4
DHf;cult to judge due to changes ;n underly;ng dhease - no response 5 OR negat;ve rechallenge - no response. Tolerance known to occur
DHHcult to judge due to changes ;n underly;ng d;sease - some response 6
Odg;nal reducHon ;n dose and rechallenge equals re-estabHshment of or;g;nal 7 dose - ; ncrease ; n event
Other drugs conHnued - ;denHcal response on rechallenge 8 OR pat; ent says return of symptoms wHh each dose (no placebo control)
Rechallenge wHh smaller dose - SOME response but not ;denHcal 9 OR on other drugs cont;nuously. PosH;ve rechallenge (symptomat;c only -1)
No other drugs, no change ;n treatJnent - ;denHcal response on rechallenge 10 (If response on stopp;ng rechallenge exactly correct for drug ;nvolved +2) (If event h subject;ve symptoms only and no placebo control -2) (If double posH;ve rechallenge +5)
4
5
324 The Detection of New Adverse Drug Reactions
FACTOR 5: Alternative (disease) Candidate
Event convincingly diagnosed or treated as naturally-occurring disease (depending on strength of evidence)
Patient has a history of si11ilar event without drug involv-nt
Event !llJ1iW of c0111110n complication of underlying disease or connon new disease
Event !llJ1iW of rare complication of underlying disease or rare new disease
Event 22lli.!1Jj( due to complication of underlying disease or new disease
Changes in other drugs/treatllentldisease/ci rt..,stances could be the cause
Insufficient infor..ation to judge
Situation confused by IIUltiple therapies/disease but they are .ll!!l.i.!ttlJl cause
Score
-2 to 0
0
3
4
5
No change in other drugs/treatment/diseases/ci rcUIIstances. Unlikely due to underlying 8 disease or new disease
No other drugs given. Unlikely due to underlying disease or new disease 9
No other drugs given. Not known with any underlying or new disease 10
3
4
8
Appendix 325
FACTOR 6: Odds and Ends
Further investigations, laboratory, biopsy, post mortem. If none done or noncontributory, add 5 (i.e. specific tests for drug involvement)
Very mrh against drug involvement
No help at all
Investtations strongly in favour of drug involvement
2
(interpolate where 1 necessary) !
Reaction at site of application only Additional score +10
Patient has had exactly similar reaction with a previous drug Additional score + 3
Scores Unlikely Possible Probable Almost certain
< 30 30-36 37-42 > 42
Should be reported with date and drug with scores i.e.- 7.7.1983- drug name- 6, 4+1, 3, 2, 5, 5+3 = 29 =unlikely
If two drugs are both rated as probable or almost certain and if one score exceeds the other by two or more, then the higher becomes probable and the other becomes unlikely. If they are the same or differ by less than two, then it indicates a probable/almost certain drug reaction with two possible candidates. If two drugs are rated possible and one is more than four greater than the other, then the higher remains possible and the lower becomes unlikely.
326 The Detection of New Adverse Drug Reactions
ALGORITHM FOR ASSESSING CAUSALITY OF ADVERSE REACTIONS
ALESSANDRO E.l4A.lWEU, MD
START p
! Was there a temporal assoc•a~
NO UNRELATED tlon between agent and event?
YES
"" The possibility that clinical condition may explain the NO event can be ruled out?
DOUBTFUL o.so
YES
NO
YES 1 NO-I POSSIBLE 0.70
YES
Old the avant disappear upon
NO -1 dechallanga and reappear upon PROBABLE 0.90 rachallange (reintroduction of agent)?
! YES DEFINITE 0.99
NO
YES 1 NO-! PROBABLE 0.90
YES
NO -!HIGHLY PROBABLE I 0.95
YES DEFINITE 0.99
NO 'HIGHLY PAOIAILEi 0.95
YES
NO" 0.97
YES DEFINITE 0.99
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
"" The possibility that clinical condition may explain the event can be ruled out?
'HIGHLY PAOIAILEi
'HIGHLY PAOIAILEi
Update
Chapter 2
A comparison of a seven-point scale and a VAS was published in J. Chron. Dis., 1987, 40, 1129-1133, by Guyatt, G.H., Townsend, M., Berman, L.B. and Keller, J.L.
The seven alternatives, in response to a question concerning the frequency of an event, were:
1. All of the time 2. Most of the time 3. A good bit of the time 4. Some of the time 5. A little of the time 6. Hardly any of the time 7. None of the time.
The seven-point scale and the VAS results were similar but the VAS required more patient training and they recommend the seven-point scale. Their reservations concerning the study were that it was used in an uncontrolled study in respiratory disease and therefore further studies would be required in other conditions.
Chapter 4
Two further papers have been published on the assessment of adverse events using the Bayesian approach. The first entitled 'The causality assessment of adverse drug reactions using a Bayesian approach' by D.A. Lane, M.S. Kramer, T.A. Hutchinson, J.K. Jones and C. Naranjo in Pharmaceut. Med., 1987, 2, 265-283 gives a good explanation of the method with two examples whilst the second paper 'A Bayesian approach to causality assessment' by J.K. Jones and published in Psychopharmacology Bulletin, 1987, 23, 395-399 is a shorter version with a further example.
327
328 The Detection of New Adverse Drug Reactions
Chapter 6
A clinical pharmacy-Driented drug surveillance network has been set up for PMS in the USA. It includes 383 clinical pharmacists from all 50 states. Specifically designed forms are sent out for investigation of potential problems. Participation in any particular survey is voluntary. A pilot study was carried out in early 1987. (A clinical pharmacyoriented drug surveillance network: Part I Program description, Grasela, T.H. and Schentag, J.J. Drug Intell. Clin. Pharm •. , 1987, 21, 902-908, Part 2 Results of a pilot project, Grasela, T.H., Edwards, B.A., Raebel, M.A., Sisca, T.S., Zarowitz, B.J. and Schentag, J.J., Drug Intell. Clin. Pharm., 1987, 21, 909-914).
Under the title 'Pharmacovigilance internationale' Vaissere, J., Cremiers, F. de, Auriche, M. and Juillet, Y. give details of the national systems of PMS in the USA, Canada, Australia, Norway, Denmark, Sweden, Finland and Japan in Therapie, 1987, 42, 373-378.
'Post-marketing surveillance of new drugs' by E.G. Buckley in the Journal of the Royal College of General Practitioners, 1987, 37, 337-340 gives the latest information on PMS as it affects GPs in the UK.
A critique of the Squibb Captopril PMS Studl40 (see page 196) was published in Br. J. Clin. Pharmac., 1987, 24, 281-282. The authors, D.B. Barnett and K.L. Woods, point out the problems arising from the lack of a control group. In a subsequent letter (Br. J. Clin. Pharmac., 1988, 25, 404), R.H. Robson stresses the 'opportunities for promotional activity' inherent in company schemes.
The problems involved in the comparison of the ADR within a therapeutic class using the national spontaneous reporting systems are illustrated by R.M. Sachs and E.A. Bortnichak in an article: 'An evaluation of spontaneous adverse drug reactions monitoring systems' in Am. J. Med., 1986, 81 (suppl. 5B), 49-55 and also in an editorial in Human Toxicol., 1988, 7, 3-5 by D.H. Lawson entitled 'More about spontaneous reports of suspected adverse drug reactions'.
Essential reading for anybody contemplating a large cohort study is 'Review: post-marketing surveillance of the safety of cimetidine - the problems of data interpretation' by D.G. Colin Jones, M.J.S. Langman, D.H. Lawson and M.P. Vessey in Alimentary Pharmacology and Therapeutics, 1987, 1, 167-177 (see pages 172 and 195). Their conclusion: 'Cohort studies should be capable of detecting all events occurring within a defined group of individuals, but interpretation is difficult or impossible for the majority of events which mimic those occurring in the ordinary community' should deter company schemes. They also found that their comparison group taken from the ordinary community emphasised the pre-existing differences between the takers and the ordinary population rather than solving the problem of detecting an increase in ordinary
Update 329
disease caused by drug toxicity if a consistent time relationship is not observed.
The guidelines agreed by the APBI, the BMA and the RCGP (see page 184) were published in the BMJ, 1988, 296, 399-400 and are as follows.
Post-marketing Surveillance
Introduction
These guidelines are intended for company-sponsored post-marketing surveillance studies, whether carried out by a company directly, or indirectly through an agency or other intermediary. They have been formulated and approved by: the Association of the British Pharmaceutical Industry; the British Medical Association; the Committee on Safety of Medicines; and the Royal College of General Practitioners.
Any departure from these guidelines, which gives cause for concern that a PMS study appears to be promotional in intent, may be submitted to the Code of Practice Committee of the ABPI for adjudication as a possible breach of that Code.
Guidelines
1. These guidelines are intended for post-marketing surveillance (PMSl observational cohort studies sponsored by pharmaceutical companies.
2. Post-marketing surveillance involves the collection of clinical data, primarily on drug safety, on marketed medicines used in everyday clinical practice.
3. PMS studies will normally entail the use of the product in accordance with the Summary of Product Characteristics (Data Sheet). However, information collected about marketed medicines used at the discretion of clinicians outside the terms of the Product Licence should not be excluded from the analysis of the results of a PMS study, but should be separately reported.
4. The following features are essential in the design of company sponsored PMS. There should be a valid medical reason for undertaking the study. The design and methods used must permit the achievement of the stated scientific and medical objectives. The study must not be designed for, or conducted as, a promotional exercise.
330 The Detection of New Adverse Drug Reactions
5. Before the start of such a PMS study, a document must be drawn up explaining the aims and objectives of the study, the methods to be used and the record keeping which is to be maintained.
6. The plans of all PMS studies by pharmaceutical companies will be filed in a register held by the medicines division of the DHSS. The ABPI will hold a voluntary register.
7. It is useful to distinguish between prospective and retrospective PMS studies. In prospective studies the patient is recruited from the day the qualifying prescription is written and clinical experience is monitored from that time onwards. In retrospective studies, the patient is identified at some point after the medicine has been prescribed. The clinical record will be studied from the date of the qualifying prescription. Studies on these patients can be continued thereafter by further monitoring, either on or off the treatment.
8. In prospective studies patients should be identified for inclusion in the study only after the decision to prescribe a particular medicine has been taken. The clinical justification for prescribing the particular medicine for each individual patient must be recorded at the outset by the prescribing doctor in the study documents for that patient.
9. The Committee on Safety of Medicines (CSM) has indicated the type of drugs on which PMS will normally be expected. Detailed proposals regarding such studies should be produced when a product licence application is originally submitted to the Licencing Authority. Any subsequent proposed variation in the study plan should be reviewed prior to implementation with the Adverse Drug Reactions Unit of the CSM Secretariat.
10. Any PMS study which gives cause for concern because it appears to be a sales promotion may also be reported to the Code of Practice Committee of the ABPI for adjudication regarding a possible breach of the Code of Practice.
11. The medicines used in company sponsored PMS studies shall be prescribed and supplied to patients by prescription in the normal way, e.g. in NHS practice by an FP10 form written by the GP or by the usual hospital methods.
12. The company must not indicate that a study has been 'approved' or 'requested' by the CSM in any literature or communication which is not confidential to the CSM and/or DHSS.
13. Responsibility for the design, conduct and analysis of the study shall be vested in a company medical department under the supervision
Update 331
of a medical practitioner registered in the UK, and whose name will be recorded in the documents.
14. Company representatives should not be involved in such a way that the study can be seen as a promotional exercise.
15. Interim and final reports should be made available without undue delay to participating doctors and lodged with the CSM. A final report should be made available for publication.
16. Doctors must be reminded of their commitment to notify adverse drug reactions to the CSM. Any reporting requirements of adverse drug reactions imposed by the CSM or Medicines Division, DHSS, or the industry must be observed. Participating companies should ensure that doctors taking part in sponsored PMS studies notify the company's Medical Department immediately of any serious suspected adverse drug reaction which occurs during the course of the study.
17. Normal standards of professional confidentiality must be exercised.
Remuneration
18. No inducement to undertake a study shall be offered to, requested by, or given to a doctor participating in a company sponsored PMS study.
19. Subject to compatibility with NHS guidance and terms of service, reasonable payment may be offered to the doctor as a recompense for completing record forms and expenses incurred in the work involved in a company sponsored PMS study. A scale of fees appropriate for this purpose shall be drawn up between the ABPI and BMA.
There are moves afoot to institute an 'umbrella' organisation to oversee post-marketing surveillance within the UK. Hopefully we will hear more of this before the end of 1988.
Chapter 10
The changes foreseen on page 279 are now published. Article 9 of the Law Decree n. 531, 30.12.1987, contains the new
procedures on drug surveillance which are now operating. The article states that the Local Health Authorities are obliged to
transmit to the Ministry of Health, by the end of June and December each year, a report on prescriptions and on the nature and frequency of any
332 The Detection of New Adverse Drug Reactions
toxic or side effects, as reported by doctors over the previous six-month period.
Fatal cases and cases which prove life-threatening for the patient or which are capable of causing a permanent lesion must be the subject of a special report to be transmitted to the Ministry of Health within a fortnight of the occurrence of the event. In all cases, the report must be accompanied by the clinical records compiled by the medical practitioners concerned in accordance with the next paragraph.
All primary-care medical practitioners are obliged to communicate to the territorially competent Local Health Authority all adverse drug reactions in accordance with the paragraph above within ten days of discovery of such reactions, or within 24 hours in fatal cases and in other particularly serious cases as described above. The medical practitioners must use the form detailed in Attachment A.
Failure to comply with the provisions of the above-mentioned paragraph shall lead to the institution of proceedings for the application of disciplinary sanctions.
Now Local Health Authorities are obliged to inform citizens under the National Health Service of the provisions contained in this Law. Citizens may report side effects resulting from, or in any way related to, the use of drugs directly to the territorially competent Local Health Authority.
The previous obligations imposed on pharmaceutical companies by the Ministry of Health Decrees, 20.3.1980 and 28.7.1984, shall remain in force.
In a specific para, the Ministry of Health states that all medicines, the use of which presents a high degree of risk, will be submitted to special forms of drug surveillance.
The Ministry of Health lays down the modalities of execution of the drugs or groups of drugs.
The drug surveillance data obtained on the basis of the provisions of this article, and all additional reports of adverse drug reactions of whatever origin, are submitted by the Ministry of Health at least once a year to the Supreme Council of Public Health for its opinion with a view to the possible adoption of precautionary measures regarding products available on the market.
Ciba-Geigy Ltd
In April 1988 Ciba-Geigy Ltd had a compendium prepared by the Pharma Corporation and the Degge Group entitled A Handbook of International Data Sources for Drug Benefit-Risk Assessment. The compendium was distributed to the invited attendees of a Ciba-Geigy-
Update 333
sponsored conference in Wolfsberg, Switzerland entitled The Perception and Management of Drug Safety Risk. The first volume covers the major data resources available in the USA, UK and Canada. Subsequent volumes will cover the Far East, Europe and Scandinavia. The first twenty pages describe the state of the art of pharmacoepidemiology and drug-risk assessment. An updated version is also planned.
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534. Strathman, I. Experience with the WHO adverse reaction terminology at Searle. Drug Info. J., 1986, 20, 179-186
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537. Lawson, D.H. Post-marketing surveillance: the problems in practice. In Adverse Drug Reactions (ed. R. Mann), Parthenon Publishing, 1987, pp. 159-164
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Index
Aberdeen-Dundee Medicines Codes, 236 Aberdeen-Dundee PMS, 163 ABPI
guidelines for PMS, 1H3--84, 192-93 surveys of company-munitored
release schemes, 183 ADR (adverse drug reaction(s)),
definition of, 15-16 ADR classifications, 16-21 ADR data, computerisation, see
Computerisation of ADR data ADR data sources, 216-17 ADR detection
in PMS, 184--88 long-term reactions, 149 rare reactions, 148-49 separation from placebo reactions,
32 with background incidence, 13 with multiple reactions, 12 with no background incidence, 13
ADR profile elements of, 21-22 establishment of, 116 output from clinical trial data, 240
ADR report forms CIOMS form, 222, 267, 300 data transfer form, 226, 315-17 design of, 222-23 Form 1, 179, 223, 303 Form 2, 180 laboratory data, 56, 223, 304, 308--9 major events in clinical trials, 134,
305 minor events in clinical trials, 132,
306 skin form, 223, 310--14 spontaneous reports, 179-81 see also FDA 1639; Yellow card
ADR reporting national systems, 151, 153-56 necessary elements, 221-22
published literature, 140--42, 156-59, 182--83,218--21
ADRIAN (Adverse Drug Reaction Interactive Advice Network), 109-110
Adverse event, 22 definition of, 15 recording in clinical trials, 131-35 reporting in clinical trials, 137-38
Adverse event data collection coverage in protocols, 29 different stages of clinical studies,
30-31 potential problems, 28--29 symptomatic events, 32-50, 129
Advertisements and pharmaceutical physician, 212
Algorithms in causality assessment, 78--107
APWI, 95-96 Australian Probability Rating, 87--88 Blanc, 82--83 CIBA-Geigy, 89 comparisons of, 98--107 Cornelli, 92-93 Dangoumau, 81--82 Emanueli, 90--92, 326 FDA, 87 French Pharmacovigilance, 86 Irey, 78--79 Karch and Lasagna, 79--81 Kramer, 83--84 laboratory data, 70--71 Lagier, 85--86 Loupi, 98 Maistrello, 97 MDBS, 94-95, 320-26 Naranjo, 84--85 Ruskin, 98, 318, 319 Sandoz, 93 Stricker, 97-98 Sweden, 88 UK, 88--89
361
362 Index
AMG <Arzneimittelgesetz-Medicines Act-West Germany), 262-64, 268-72
APWI (Active Permanent Workshop of lmputologists), development of algorithm, 95-96
Assessment of laboratory investigations, 53-69
Australian Probability Rating (algorithm), 87-88
BARDI (Bayesian Adverse Reaction Diagnostic Instrument), 96, 194
Bayes Theorem, 85, 86, 95, 194 Benefits of drug treatment, 2 Benoxaprofen, 1 BGA (Bundesgesundheitsant), 155
and ADR reporting, 262-73 Blanc algorithm, 82-83 Blinding, in rechallenge, 206--7 BNF (British National Formulary)
ADR with newer drugs, in, 284 use as drugs coding system, 239
Boston Collaborative Drug Study Programme, 162-63, 195
Bronchodilating aerosols, underreporting of deaths, 1
CAIRS, 221 Case control studies, 174-75, 193 Causality assessments, see Algorithms Causality classification (Karch and
Lasagna), 16. 18 Centre for Medicines Research, see
underCMR CHAMPUS PMS scheme, 166 Checklists, 33-34
advantages and disadvantages, 36 Chloramphenicol-induced agranulo
cytosis, 4, 145 CIBA-Geigy algorithm, 89 Cimetidine, post-marketing surveil
lance of, 172-73, 193, 195 CIOMS (Council for International
Organisation of Medical Sciences), 199-200, 267
report form, 222, 300 Classification of ADR, 16--21 'Clin-Alert', 219 Clinical trials
major events in, 133-35 protocol design for adverse event
collection, 30-31
recording of adverse events, 131-35 source of ADR data, 217 see also Pre-marketing clinical trials
Clinical trial certificate, see CTC Clinical trial exemption scheme,
see CTX Clofibrate, 5 CMR PMS scheme, 196--97 Coding systems
for adverse events and diseases, 229-34
for drugs, 234-39 in-house development, 234
Cohort studies in PMS, 162-74, 193 involvement of pharmaceutical
companies, 183 Compass (Computerised On-line
Medicaid Pharmaceutical Analysis and Surveillance System), 163-64
Computerisation of ADR data, 224-27 input, 226 output, 239-42
Contraceptive pill pulmonary thromboembolism study, underreporting of deaths, 1
Controlled trials, 127-35 in PMS, 162 protocol design, 127-31
Cornelli algorithm, 92-93 COSTART, 229-30 Cost/benefit ratio of drug treatment,
2 see also Quality oflife
measurement Costs of drug treatment, statistical
background to ADR, 3-5 Council for International
Organisation of Medical Sciences, see CIOMS
CSM (Committee on Safety of Medicines)
drug codes, 239 evaluation of Debendox, 6 working party on ADR, 154-55,
167 CTC (Clinical Trial Certificate), 279-
80,285-86,288-89 CTX (Clinical Trial Exemption
Certificate), 280, 285-86, 288-89
Dangoumau algorithm, 81-82
Index 363
Data input, 226 Data outputJanalysis, 239--42 Data sheets and pharmaceutical
physician, 212 Data transfer form, 226, 315-17 Data validation, 226 Deaths, numbers associated with
drugs, 11 Debendox-induced teratogenicity as
false-positive reaction, 6-7, 12 Dechallenge, 205 Design of ADR report forms, 222-23 DHSS Drug Master Index, 237 Diary cards, patient, 33 Diethylstilboestrol, 4, 150 Drop-outs from clinical trials, 130 Drug interactions, see Interactions Drugs, coding systems for, 234-39 Dunedin Programme PMS scheme,
166
ECDEU (early clinical drug evaluation unit), questionnaires for pyschiatric drug trials, 39-41
EEC (European Economic Community) regulations on ADR, 286-87, 290
Electronic Prescribing and Therapeutic Information System, see EPI'IS
Emanueli algorithm, 90-92 Encephalopathy, pertussis vaccine
induced, 6 EPI'IS (Electronic Prescribing and
Therapeutic Information System), 197-98
Ethics of drug rechallenge, 202 European Economic Community, see
under EEC Excerpta Medica, 220 Excipients, 27 Eye damage, investigation, 135
FDA algorithm, 87 definition of adverse reaction, 15-16 literature reports of ADR, 182 review of phase 4 studies, 185 US regulations, 244-55 see also FDA 1639
FDA 1639, 222, 254-55, 301-2 France
Pharmacovigilance algorithm, 86 regulations on ADR, 258-62
Frequency classification of ADR, 20
Grahame-Smith adverse reaction working party, 154-55, 167
ICD-9 coding system, 230 IFPMA (International Federation of
Pharmaceutical Manufacturers' Association)
definition of adverse event, 15, 20 definition of ADR, 16 recommendations on PMS, 198-99
IND (Investigational Exemption for a New Drug), 245-50
In-house coding systems, development of, 234
'lnpharma' (ADIS), 219 Interactions
identification in PMS, 149 investigation by rechallenge, 207-8
International Federation of Pharmaceutical Manufacturers' Association, see IFPMA
Investigational Exemption for a New Drug, see IND
Irey algorithm, 78-79 Italy, regulations on ADR, 273-79
Japan, regulations on ADR, 255-58
Kaiser-Permanente PMS schemes, 165 Karch and Lasagna algorithm, 79-81 Karch and Lasagna causality
classification, 16, 18 Kramer algorithm, 83-84
Laboratory investigations algorithm for assessment, 70-71 assessment, 53-55, 57, 60-65, 68-69 choice of, 52 classification of abnormalities, 66-67 forms for recording, 56, 223, 304,
308-9 individual assessment, 64-65, 68-69 large-scale studies, 60-65, 68-69 overall assessment, 61-64 summary, preparation of, 69-72 timing of, 57-60
Lagier algorithm, 85-86 Literature, ADR reports in, 140-42,
182-83,218-21 advantages and disadvantages,
156-59 Loupi algorithm, 98
364 Index
MAIL 41 <Medicines Act Information Letter), 285
MAIL 46,285 MAIL 49, 285--86, 288-89 Maistrello algorithm, 97 Major events in clinical trials, 133-35
ADR report form, 134, 305 Marketing aims of PMS, 146 Mechanism classification, 21
in rechallenge, 206 Medical Subject Headings, see MeSH Medicines Act Information Letter, see
under MAIL Medicines Act <UKl and regulations on
ADR, 279-86 Medline, 220 MeSH <Medical Subject Headings),
231-32 Meyler's Side Effects of Drugs, 219 MHW <Ministry of Health and
Welfare, Japan), 256--57 MIMS <Monthly Index of Medical
Specialities) ADR with newer drugs in, 284 use as drug coding system, 237-38
Minor events in clinical trials, 131-33 ADR report form, 132, 306
Naranjo algorithm, 84--85 National Abstracting Scheme, 220 National Registers in PMS, 160-61 National systems for ADR reporting,
151, 153-56 NDA <New Drug Application) USA,
246--47, 250-54 approval for foreign studies, 123
OXMIS disease codes, 232 drug codes, 239
Oxygen-induced retrolental fibroplasia, 6
Patient(s) diary cards, 33 involvement in rechallenge, 204 numbers needed to assess risks, 10,
12 numbers needed to detect ADR, 14,
124-26 selection for clinical trials, 128
PEM (Prescription Event Monitoring), 15, 168-72
Performance impairment of drugs, 135-36
Pertussis vaccine-induced encephalopathy, 6
Pharmaceutical companies adverse event assessment, 89-90,
92-98 ethics, 213 monitored release, ABPI surveys, 183 PMS, effectiveness of, 184--89, 192 PMS, role in, 175--96 spontaneous reporting to, 175, 177--82
Pharmacological classification of ADR, 16
Pharmacovigilance centres <France), 259-60
Pharmline, 220 Phase 1 studies, 117
involvement of women in, 119 Phase 2 studies, 122-23 Phase 3 studies, 123-26 Phase 4 studies, review by FDA, 185 Physician (pharmaceutical)
and advertisements, 212 ethical problems, 210-15 involvement in rechallenge, 209
Placebo-induced ADR, 23, 25--26 in rechallenge, 207, 208 separation from drug-induced ADR,
239-40 PMS (Post-marketing surveillance)
aims of, 146--50 CHAMPUS scheme, 166 cimetidine, 172-73, 193, 195 CMR scheme, 196--97 cohort studies, 162-74, 193 comparison with pre-marketing
clinical trials, 190-91 computerisation, 196--98 Dunedin programme, 166 effectiveness of company schemes,
184--89, 192 Kaiser-Permanente schemes, 165 marketing aims, 146 medical aims, 146, 148 National Registers, 160-61 numbers required, 10, 12 pharmaceutical industry
involvement, 175-96 political aims, 146 Royal College of General
Practitioners, I 73 Saskatchewan Database, 166
Index 365
see also Phase 4 studies, review by FDA
Post-marketing surveillance, see PMS Power (probability of detecting a real
toxic effect), 58 Practolol, 1, 4, 12 Pre-marketing clinical trials
comparison with post-marketing surveillance, 190-91
establishment of ADR profile, 115-42 see also Phase 1, Phase 2 and Phase
3 studies; Volunteer studies Prescription Event Monitoring, see PEM Probability terminology, 110 Protocols for clinical trials
design for different stages of clinical studies, 30-31
in controlled trials, 127-31 Puget Sound PMS scheme, 164, 195
Quality of life measurement, 44-4 7, 195 Questionnaires, patient, 33-50
advantages and disadvantages, 35 collection of symptomatic adverse
events, 33 Questions, standard, in detection of
symptomatic adverse events, 47-49
'Reactions' (ADIS), 219 Rechallenge, 201-9 Record linkage schemes
Finland, 168 London School of Hygiene and
Tropical Medicine, 167 Oxford, 167 Sweden, 168 Tayside, 166-67
Regulations on ADR, 244-90 interpretation of, 211 see under EEC, France, Italy, Japan,
UK, USA, West Germany Regulatory authorities
ADR reporting to, 211-12 algorithms for causality assessments,
86-89 see under EEC, France, Italy, Japan,
UK, USA, West Germany Reserpine-induced breast cancer, as
false-positive ADR, 12 Retrolental fibroplasia, oxygen
induced, 6 Retrospective assessment of drug
safety (RADS), 168 Rhode Island Health Services Research
Inc., 166 Ringdoc, 220 Risks
acceptability of, 7 drug treatment, 10 involuntary occurrences, 9 numbers of patients for assessment,
10-12 voluntary activities, 8
Royal College of General Practitioners PMS, 173
Ruskin algorithm, 98, 318, 319
SAFTEE (Systematic Assessment for Treatment Emergent Events), 41-43
Sandoz algorithm, 93-95 Saskatchewan Database (PMS), 166 SEDBASE, 219 Seriousness classification, 19 Severity classification, 19 Shift table, use in laboratory data
assessment, 61-62 Skin form (Giaxo), 223, 310-14 SNOMED, 232-33 Spontaneous reporting, as source of
ADR data, 151, 217-18 report forms, 179-81 to pharmaceutical companies, 175,
177-82 Statistical background to ADR
detection, 3-&, 12-15 in pre-marketing trials, 124-26
Statistical classification of ADR, 19 Stricker algorithm, 97-98 Swedish algorithm, 88 Symptomatic complaints, 22-23, 24 Systematic Assessment for Treatment
Emergent Events, see SAFTEE
Tayside Record Linkage System, 166-67 Tennessee Medicaid Database, 164 Teratogenicity induced by Debendox,
6-7, 12 Thalidomide, 1 Timing of laboratory investigations, 57,
60 TRIMIS PMS scheme, 165 Type A (augmented) reactions, 16, 17
and laboratory data, 53 Type B (bizarre) reactions, 16, 17
366
and laboratory data, 53
UK algorithm (Weber), 88-89 UK National Registers, 160 UK regulations on ADR reporting,
279-86, 288-89 post-marketing, 281 pre-marketing, 279-80
Uncontrolled studies, 126--27 USA
National Registers, 160 regulations on ADR, 244---55 spontaneous reporting, 155
Venulet classification, 19 Visual analogue scales, 37-38 Volunteer studies, 117, 193
improvement of ADR collection, 121 rarity of serious ADR, 118-19 screening, 120-21
Index
West Germany, regulations on ADR, 262-73
spontaneous reporting, 155 WHO
Adverse Reaction Terminology, 233-34
definition of ADR, 15 Drug Reference List, 238 international drug monitoring
system, 151, 153 Women, involvement in phase 1 studies,
119
Yellow card, 222, 298 Glaxo version, 299
Yellow card system, 153-55
Zomepirac, 1