Bibliography - Springer978-1-349-09887-3/1.pdf · Bibliography Drug-induced Diseases ... Martin us...

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.


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.


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


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):


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

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22. CQNCOI.ITANT DIU:$ NO DATES 01 AOIMSTRA'hON (E•clucM thoH UMd to treat ~t)

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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

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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.

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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

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: b. Do you think the relationship between the suspect drug : andtheadverseeventwas:

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11. REGULATORY AUTHORITY NOTIFIED? Yes 0 No 0 12.

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Appendix 307

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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

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HAEMOGLOBIN

RBC

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t~t1FfET " g 0 T0TALW8C 1-~ NEUTROPHIL$ ~ ~ BASOPHIL$ X

EOSINOPHIL$

LYMPHOCYTES

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Appendix

Laboratory Data Form

FOA OFFICE USE ONLY

309

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COMMENTS:---------------------------------------------------------------------


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


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: ---------------------


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


OJ liT 1.---,

ITIJO OJI I I I I I I I I 1'--' Order


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


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


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


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


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.


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?














'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


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.


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


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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Chapter 3

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Medicine (ed. N. Macleod), Churchill Livingstone, 1978, p. 156 493. !warson, S. Pharmaceutical companies and unexpected drug side effects.

Lancet, 1985, 9 March, p. 580 494. Schwartz. Scrip, no. 1103, 19 May, 1986, p. 19

Chapter 9

495. Rogers, M.L. National abstracts: U.K. hospital pharmacists collaborative computerised database. In The Impact of Computer Technology on Drug Information (ed. P. Morrell and S.G. Johansson), North Holland, 1982, pp. 187-188

496. Rogers, M.L. The Pharmline drug information system. In Current Perspectives in Health Computing (ed. B. Kostrewskil, British Computer Society, 1984, Cambridge University Press, pp. 135-140

497. Simkins, M.A. A comparison of databases for retrieving references to the literature on drugs. Information Processing and Management, 1977, I3, 141-153

498. Anon. Adverse Drug Reactions Advisory Committee Report for 1978. Med. J. Aust., 1980, I, 207-208

499. Morley, D. CAIRS. In Minis, Micros and Terminals for Libraries and Information Services (ed. A. Gilchrist), Haydon, 1981, pp. 78-79

'''500. Jones, J.K. Criteria for journal reports of suspected adverse drug reactions. Clin. Pharm., 1982, 1, 554-555

501. Berneker, G.C. et al. Standards for reporting adverse drug reactions, Br. Med. J., 1983, 287, 1720

'''502. Helling-Borda, M., Mane II, P. and Mandahl, H. Use of computers in drug


monitoring. In Monitoring for Drug Safety, 2nd edition( ed. W.H.W. Inman), 1986, MTP Press, pp. 305-322

503. Wright, P. and Haybittle, J. Design of forms for clinical trials (1). Br. Med. J., 1979, 2, 529-530

504. Idem, 1979, 2, 590-592 505. Idem, 1979, 2, 650-651 506. Rycroft, D. and Smith, D.E. Provision of poisons and safety data. Aslib

Proc., 1980, 32<5), 235-240 507. Talbot, J.C.C. Management of ADR data from different sources. Drug Inf

J., 1986, 20 297-299 508. Ravenscroft, T. and Smith, D.E. The development of Clindata. A clinical

trial management system. J. Inf Sci., 1981, 3, 129-136 ''509. Teal, T.W. and Dimmig, A.L. Adverse drug experience management- A

brief review of the McNeil Pharmaceutical system. Drug Inf J., 1985, 19, 17-25

510. Fisher, M.P. Adverse reaction reporting. Clin. Res. Practices and Drug Reg. Affairs, 1986, 4, 329-343

:511. Herman, R.L. and Jargus, L.Y. Computer generation of the FDA 1639 form. Clin. Res. Practices and Drug Reg. Affairs, 1983, 1, 209-225

':'512. Goldsmith, D.I. et al. A comprehensive system for international pharmaceutical company monitoring of adverse drug reactions. Drug Inf J., 1985 20, 305-310

513. Garbus, S.B. et al. ADEMS: Astra drug experience monitoring system. Third World Conference on Clinical Pharmacology and Therapeutics, Stockholm, 1986, Abstract 411, p. 156

514. Anello, C. Management of ADR reports at the FDA. Drug Inf J., 1985, 19, 291-294

515. Turner, W.M. FDA processing of ADR reports. Drug Inf J., 1985, 19, 295-298

516. Brolund, G.V. The FDA adverse reaction report data base. Drug Inf J., 1985, 19, 299-303

517. National Adverse Drug Reaction Directory COST ART (Coding Symbols for Thesaurus of Adverse Reaction Terms), US Dept. of Health, Education and Welfare, F.D.A

518. COST ART !Coding Symbols for Thesaurus of Adverse Reactions Terms), 2nd edition, Dept. of Health and Human Services, FDA, 1985

519. Streichenwein, S.M. Actual aspects of data integration- a view from an international company. Drug Inf J., 1986, 20, 301-304

520. WHO International Classification of Diseases. Manual of the International Statistics Classification of Diseases, Injuries and Causes of Death, vols 1 and 2, Alphabetical index, 9th revision (1975), HMSO, 1977

521. National Library of Medicine, Bethesda, Medical Subject Headings <MeSH). Annotated alphabetical list, 1986

522. Perry, J. (ed.). OXMIS Problem Codes, Oxmis Publications, Oxford, 1978 523. Perry, J. A primary care morbidity code based on the international

classification of diseases. In Medical Data Processing (ed. M. Laudet, J. Anderson and F. Bregon), Taylor and Francis, 1976, pp. 719-725

524. Cote, R.A. (ed.L Systematised Nomenclature of Medicine <SNOMED), vol. I, 2nd edition, College of American Pathologists, 1979 (numeric index)

525. Cote, R.A. (ed.). Systematised Nomenclature of Medicine rSNOMEDJ, vol. II, 2nd edition, College of American Pathologists, 1979 (alphabetic index)

526. Cote, R.A. and Robboy, S. Progress in medical information management. Systematised Nomenclature of Medicine (SNOMEDL J.A.M.A., 1980 243,

References 359

756--762 527. Anon. International monitoring of adverse reactions to drugs. Adverse

reaction terminology 1980. Collaborating Centre for International Drug Monitoring, Uppsala, Sweden

528. Saltzman, A. Adverse reaction terminology standardisation: A report on Schering-Piough's use of the WHO Dictionary and the formation of the WHO adverse reaction terminology user's group <WUGl consortium. Drug lnf J., 1985, 19, 35-41

529. Herman, R.L. System integration of an adverse experience thesaurus -experience with a new computer methodology. Drug lnf J., 1986,20,351-355

530. Monthly Index of Medical Specialities <MIMSl. Haymarket Publishing, London (published monthlyl

531. British National Formulary, No. 12, 1986. Pharmaceutical Press, London (updated 6-monthlyl

532. Dendy, P.R. Indexing Medicines for Monitoring Adverse Reactions. Oxford Drug Monitoring Conference- Workshop on Drug Information System, 1977, Oxford Community Health Project, A1-A4

533. Dunleavy, J. and Perry, J. Appendix B. In OXMIS Problem Codes and Drug Codes (ed. J. Perryl, Oxmis Publications, Oxford, 1978, B24-B25

534. Strathman, I. Experience with the WHO adverse reaction terminology at Searle. Drug Info. J., 1986, 20, 179-186

535. Walker, S.R. and Lumley, C.E. Reporting and under-reporting. In Adverse Drug Reactions (ed. R. Mannl, Parthenon Publishing, 1987, pp. 115-126

536. McDevitt, D.G., Beardon, P.H.G. and Brown, S.V. Record linkage in Tayside: an assessment of present development. In Adverse Drug Reactions (ed. R. Mannl, Parthenon Publishing, 1987, pp. 107-114

537. Lawson, D.H. Post-marketing surveillance: the problems in practice. In Adverse Drug Reactions (ed. R. Mann), Parthenon Publishing, 1987, pp. 159-164

538. Myers, M.G., Cairns, J.A. and Singer, J. The consent form as a possible cause of side effects. Clin. Pharmacal. Ther., 1987, 42, 250-253

539. Levine, R.J. The apparent incompatibility between informed consent and placebo-controlled clinical trials. Clin. Pharmacal. Ther., 1987, 42, 247-248

540. Chalmers, D., Dombey, S.L. and Lawson, D.H. Post-marketing surveillance of captopril (for hypertension): a preliminary report. Br. J. Clin. Pharmac., 1987, 24, 343-349

541. Barnett, D.B. and Woods, K.L. Post-marketing surveillance or drug acceptability study? Br. J. Clin. Pharmac., 1987, 24, 281-282

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

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