Side Effects of Drugs Annual 00 - Instructions to Authors
SIDE EFFECTS OF DRUGS ANNUAL 29
Editor: JK Aronson, Oxford
NOTES FOR CONTRIBUTORS
[Even if you are an experienced contributor, please read these notes; they are updated every year; PLEASE NOTE IN PARTICULAR SECTIONS 5 AND 8]
1.INTRODUCTION
The SIDE EFFECTS OF DRUGS ANNUAL (SEDA), begun in 1977, is a yearly critical review of new information on the adverse reactions and interactions caused by drugs. It is compiled by experts in the various therapeutic fields, to provide the reader not only with a summary of the essential new data that have appeared in the literature, but also with a guide as to how this literature may be interpreted and what its repercussions are for medical practice.
Although it is an independent work of reference, the Annual also serves to bring up to date the encyclopedic review of adverse reactions provided by MEYLER'S SIDE EFFECTS OF DRUGS ("Meyler"), the 15th edition of which is soon to be published as Meyler’s Encyclopedia of Adverse Drug Reactions and Interactions.
2.BASIC APPROACH OF THE SIDE EFFECTS OF DRUGS ANNUALS
For your chapter in the Annual you can take as your starting point (a) the corresponding chapters in Annuals 25–28 and (b) the corresponding chapter in the 14th edition of Meyler (2000).
It is suggested that you adopt broadly the same structure as in the corresponding chapter in Meyler, omitting the topics on which there is no new information.
3.SPECIAL REVIEWS
In some fields, in the course of a year, some special themes dominate the literature. It is often more useful to concentrate on these few dominant themes in chapters than to provide equal coverage of the whole subject. This approach is emphasized typographically by printing these "special reviews" in italics and marking them with the prescription sign (the eye of Horus). We should like your chapter to include at least one such review.
4.GENERAL RULES
(a)What is an adverse effect?
Although the book is called "Side Effects of Drugs", all adverse reactions should be covered, including side effects (or collateral effects), toxic effects, and hypersensitivity reactions (see Br Med J 2003; 327: 1222-5), as well as interactions (with other drugs, foods, cosmetics, etc). The emphasis should be placed on effects seen in normal dosage, but new information on the effects of overdosage and on management of toxicity should also be cited.
In dealing with interactions, please try to assess their real clinical importance. Some interactions are demonstrable only in vitro or in animal studies, or, although demonstrable in man, have no repercussions for therapy at all; the text must include guidance on this point.
Addiction and dependence should be regarded as adverse effects and dealt with when necessary.
(b)What is new and worth reporting?
Only a paper that in some way adds to our knowledge and understanding of the field should be dealt with. New papers, however excellent they may be, that simply provide confirmation of data well established, should not be discussed in detail, although it may be useful to reference them in order to keep the text up to date. Please try to stress the evidence base whenever possible.
The following list may be helpful in deciding which new facts should be included:
•New adverse effects of known drugs.
•New information on previously described adverse effects, for example their frequency, the circumstances in which they are most likely to occur, the ways in which they come about, their seriousness, or their severity (intensity).
•New data throwing doubt on earlier information on adverse effects (for example the controversy over the data in CLASS on the adverse effects of the coxibs and subsequent information about rofecoxib).
•Information on adverse effects of drugs that have not previously been dealt with in Meyler or in the Annuals.
•Reference to authoritative reviews of adverse effects or editorials in leading journals. These need not be discussed in detail, but reference to them keeps the text up to date.
•Statements by Government or other agencies on a particular adverse effect, or news of measures taken against a drug because of an adverse effect (warnings, sales restrictions, prohibitions). This may include statements by the manufacturers.
When reporting frequencies of adverse effects in a study please state the total number of patients studied and the number affected. If you give percentages please also give the original numbers.
(c)Should the mechanism underlying an adverse effect be discussed?
When there is evidence pointing to the way in which an adverse effect is produced, it should be cited; relevant animal data may also be briefly referred to (see below). If the mechanism of a drug interaction is known it should be described.
(d)Are doses and dosage regimens important?
Mention the exact dose or dosage regimen whenever possible, and especially if an adverse effect is clearly dose-related, or appears to be elicited by an unusually low dosage, or if excessive dosage could explain the reaction. Do not discuss new information on pharmacokinetics unless it is directly relevant to an adverse effect.
(e)Should animal studies and in vitro work be included?
As a rule, no. However, animal and in vitro work sometimes throws light on mechanisms underlying a possible adverse effect, and thereby helps in the evaluation of clinical observations. In such cases it can be briefly mentioned.
(f)Should case histories be given?
A case history may be summarized (including the age and sex of the patient) if it provides a clear illustration of the type of case that the physician is likely to meet, or if it has unusual features. The description should be as brief as possible, including only those elements that appear to be relevant to the adverse effect.
(g)How critical should the text be?
This is not a volume of abstracts, but a book written by experts to inform their colleagues about what information is available on the topic concerned, how reliable this information appears to be, and what conclusions can be drawn from it. If the information appears to be unreliable, or if the authors of a paper appear to have drawn incorrect conclusions, say so. In other words, help the reader to distinguish fact from fiction; if a matter is not yet settled, outline the pros and cons. Please do not hesitate to point out new material that discredits older material. These volumes must not become a cumulative repository of errors, and when it becomes evident that earlier reports of an adverse effect have not been confirmed in later work on a larger scale, we must say so. It is sometimes necessary to include a misleading or a poor paper (especially if it has appeared in a widely read journal) simply in order to indicate to the reader that the information is indeed misleading (for example a supposed interaction of digoxin with warfarin; see SEDA-26, 200).
(h)Should the repercussions of an adverse effect for the therapeutic role of a drug be discussed?
Yes, if these are important. For example, when it was found that practolol could cause sclerosing peritonitis, it was obvious that it could easily be replaced by other betablockers, and that its use should therefore be restricted.
If a particular finding has no clinical repercussions, it may be better to say so than to leave the reader in doubt.
- CLASSIFYING ADVERSE DRUG REACTIONS
At least for major reactions, authors should try to classify the reaction according to the DoTS system (see Br Med J 2003; 327: 1222-5). In this system adverse reactions are classified according to the Dose at which they usually occur, the Time-course over which they occur, and the Susceptibility factors that make them more likely, as follows:
- Relation to dose
- Toxic reactions (reactions that occur at supratherapeutic doses)
- Collateral reactions (reactions that occur at standard therapeutic doses)
- Hypersusceptibility reactions (reactions that occur at subtherapeutic doses in susceptible patients)
- Time-course
- Time independent reactions (reactions that occur at any time during a course of therapy)
- Time dependent reactions
- Rapid reactions (reactions that occur only when a drug is administered too rapidly)
- First-dose reactions (reactions that occur after the first dose of a course of treatment and not necessarily thereafter)
- Early reactions (reactions that occur early in treatment then abate with continuing treatment)
- Intermediate reactions (reactions that occur after some delay but with less risk during longer term therapy, owing to the “healthy survivor” effect)
- Late reactions (reactions the risk of which increases with continued or repeated exposure)
- Withdrawal reactions (reactions that occur when, after prolonged treatment, a drug is withdrawn or its effective dose is reduced)
- Delayed reactions (reactions that occur some time after exposure, even if the drug is withdrawn before the reaction appears)
- Susceptibility factors
- Genetic
- Age
- Sex
- Physiological variation
- Exogenous factors (for example drug–drug or drug–food interactions, smoking)
- Diseases
5.CLASSIFYING ADVERSE DRUG REACTIONS
At least for major reactions, authors should classify the reaction according to the DoTS system (see Br Med J 2003; 000: 000-000). In this system adverse reactions are classified according to the Dose at which they usually occur, the Time-course over which they occur, and the Susceptibility factors that make them more likely, as follows:
Relation to dose
oToxic reactions (reactions that occur at supratherapeutic doses)
oCollateral reactions (reactions that occur at standard therapeutic doses)
oHypersusceptibility reactions (reactions that occur at subtherapeutic doses in susceptible patients)
Time-course
oTime independent reactions (reactions that occur at any time during a course of therapy)
oTime dependent reactions
Rapid reactions (reactions that occur only when a drug is administered too rapidly)
First-dose reactions (reactions that occur after the first dose of a course of treatment and not necessarily thereafter)
Early reactions (reactions that occur early in treatment then abate with continuing treatment)
Intermediate reactions (reactions that occur after some delay but with less risk during longer term therapy, owing to the “healthy survivor” effect)
Late reactions (reactions the risk of which increases with continued or repeated exposure)
Withdrawal reactions (reactions that occur when, after prolonged treatment, a drug is withdrawn or its effective dose is reduced)
Delayed reactions (reactions that occur some time after exposure, even if the drug is withdrawn before the reaction appears)
Susceptibility factors
oGenetic
oAge
oSex
oPhysiological variation
oExogenous factors (e.g. drug–drug or drug–food interactions)
oDisease
6.PERIOD COVERED
Side Effects of Drugs Annual 29 will in principle deal with the material published during the year 2004. If, after you submit your manuscript, very important new information reaches you which substantially affects your conclusions, please summarize it briefly and we shall try to include it during production.
7.EDITORIAL COMMENTS
After submitting your manuscript you will receive the Editor's comments, questions, and suggestions. This may include moving some text from your chapter to another or vice versa. Although the editor often suggests changes to the manuscript, the final version is subject to the approval of the author.
8.SOURCE MATERIAL
Elsevier will send you the results of a literature search from its Excerpta Medica Database (EMBASE) to assist you in selecting articles for your chapter. Photocopies of articles from this search that are relevant for the compilation of your chapter but are not electronically available from ScienceDirect will be sent to you on receipt of your request. However, since most Universities and Institutes nowadays have access to Science Direct, we ask authors to retrieve copies of the other articles themselves via ScienceDirect. If you need any help with this please contact Ms Zwetsloot (see below).
Elsevier will send you the results of a literature search from its Excerpta Medica Database (EMBASE) to assist you in selecting articles for your chapter. Photocopies of articles from this search that are relevant for the compilation of your chapter but are not electronically available from ScienceDirect will be sent to you on receipt of your request. Please retrieve the other articles yourself via ScienceDirect. If you need any help with this please contact Ms Zwetsloot (see below).
Although Elsevier tries to be as comprehensive as possible in its literature search, it is hoped that you will supplement this with material to which you yourself have access. If you notice that important publications have been missed in the selection, please let us know, giving examples. This makes it possible for us to look into the causes and to correct them.
9.PUBLICATIONS IN UNFAMILIAR LANGUAGES
Unlike many other texts, the Annual covers literature written in many languages. If you come across a paper that seems to be important but is written in a language that you do not read, try to get help. English language abstracts (for example in on-line databases) may help. If necessary, ask the Editor for help.
10.ENQUIRIES AND SUGGESTIONS
These notes are intended to cover the most important aspects. If you have queries or problems with regard to the concept of your chapter, please address them to:
Dr JK Aronson
University Department of Clinical Pharmacology
Radcliffe Infirmary
Woodstock Road
Oxford OX2 6HE
United Kingdom
e-mail:
Tel: (+44 1865) 224626
Fax: (+44 1865) 791712
For information of a more general nature, please contact Elsevier:
Side Effects of Drugs Annual 00 - Instructions to Authors
Ms.Drs. JCM Zwetsloot
Elsevier
Life Sciences
PO Box 1527
1000 BM Amsterdam
The Netherlands
e-mail:
Tel: (+31 20) 485 3573
Fax: (+31 20) 485 3342
MANUSCRIPT REQUIREMENTS
Please give this information to your secretary.
1.PRESENTATION OF MATERIAL
To attain a standardized presentation of the data reviewed in your chapter, we ask you to keep the following points in mind when preparing your manuscript:
(a)Drugs should appear in alphabetical order within each section or subsection.
(b)When adverse effects are discussed in detail in relation to individual organs or systems, overdosage, interactions, etc., please keep to the following sequence:
Side Effects of Drugs Annual 00 - Instructions to Authors
ORGANS AND SYSTEMS
Cardiovascular <includes heart and blood vessels>
Respiratory
Ear, nose, throat
Nervous system <includes central and peripheral nervous systems>
Neuromuscular function
Sensory systems <includes eyes, ears, balance, taste>
Psychological
Psychiatric
Endocrine <includes hypothalamus, pituitary, thyroid, parathyroid, adrenal, pancreas, sex hormones>
Metabolism
Nutrition <includes effects on amino acids, essential fatty acids, vitamins, micronutrients>
Electrolyte balance <includes sodium, potassium>
Mineral balance <includes calcium, phosphate>
Metal metabolism <includes copper, iron, magnesium, zinc>
Acid base balance
Fluid balance
Hematologic <includes blood, spleen, and lymphatics>
Mouth and teeth
Salivary glands
Gastrointestinal <includes esophagus, stomach, small bowel, large bowel>
Liver
Biliary tract
Pancreas
Urinary tract <includes kidneys, ureters, bladder, urethra>
Skin
Hair, nails, and sweat glands
Serosae <includes pleura, pericardium, peritoneum>
Musculoskeletal <includes muscles, bones, joints>
Sexual function
Reproductive system <includes uterus, ovaries, breasts>
Immunologic <includes effects on the immune system and hypersensitivity reactions>
Infection risk
Body temperature
Multiorgan failure
Trauma
Death
LONG-TERM EFFECTS
Drug abuse
Drug tolerance <includes bacterial drug resistance>
Drug dependence
Drug withdrawal
Gene toxicity
Mutagenicity
Carcinogenicity
SECOND-GENERATION EFFECTS
Fertility
Pregnancy <includes labor, cesarian section>
Teratogenicity
Fetotoxicity
Lactation
SUSCEPTIBILITY FACTORS <relates to features of the patient>
Genetic factors
Age
Sex
Altered physiology
Kidney impairment
Liver impairment
Other features of the patient
DRUG ADMINISTRATION
Drug formulations
Drug additives
Drug contamination <includes infective agents>
Drug dosage regimens <includes frequency and duration of administration>
Drug administration route
Drug overdose
DRUG INTERACTIONS
INTERFERENCE WITH DIAGNOSTIC TESTS
DIAGNOSIS OF ADVERSE DRUG REACTIONS
MANAGEMENT OF ADVERSE DRUG REACTIONS
REFERENCES
<Use the Vancouver system (see below)>
Side Effects of Drugs Annual 00 - Instructions to Authors
2.REFERENCES
Number the references consecutively in the order in which they are cited in the text and tables, by Arabic numerals within square brackets, thus: [3tag] (for the tags see below). All references cited in the text must be included in the reference list and vice versa; do not include unpublished observations in the reference list. Please use the Vancouver system and include all authors' names and the first and last pages of cited articles. Please do not use any kind of automatic referencing system.
To help the reader, please include in the main drug or drug group headings crossreferences (with page numbers) to the corresponding sections in recent volumes (for example SED14, 385; SEDA22, 215; SEDA26, 196).
3.TAGGING REFERENCES
The system of tagging references used in the Annuals tells the reader about the quality of the information in the original paper.
The tags are as follows:
CA major randomized controlled trial or observational study
cA minor randomized controlled trial or observational study or a non-randomized study
RA major review, including non-systematic statistical analyses of published studies
rA brief commentary (e.g. an editorial or a letter)
EAn experimental study (animal or in vitro)
AAn anecdote or set of anecdotes (i.e. case histories)
MA meta-analysis or other form of systematic review
SOfficial (e.g. Governmental, WHO) statements
Use your judgment to distinguish between C and c. Remember that small effects need large trials to demonstrate them with a reasonable degree of certainty.
The references given in the text might therefore read:
"There have been various reports of allergic reactions . . . [24A], [26C], [35R], [36M]."
This means that in reference 24 the author mentions allergy in one or a few patients (with clinical details), that reference 26 is a large RCT or observational study, that reference 35 provides a broad review, and that reference 36 is a systematic rreview.
4.REFERENCE LIST
The list of references should be typed in numerical order (the order in which they are cited in the text).