Introduction - Uppsala Monitoring Centre

any active principle that influences the body then it is called a drug and that active
principle may, if given in the wrong dose, cause an adverse event or if the person is
allergic to it they may suffer an allergic drug reaction. The official definition of a drug:
‘Any substance or mixture of substances destined for administration to man for use
in the diagnosis, treatment, investigation or prevention of disease or for the
modification of physiological function’. Safety can only be discussed in the context of
the balance between the chance that it will do good and the chance that it will do
harm–the so-called risk/benefit ratio. The choice of drug to be used must depend on
the balance of the cost/benefit ratio of one drug compared with the cost/benefit ratio
of all the other treatments that might benefit the patient.
Part 1. Chronicles of Drug Safety
Chapter 1: Pre-biblical Era: Inserts: Alchemy
Chapter 2: Biblical Era: Inserts: Adulteration of drugs, and Medical Philosophies
Chapter 3: 1200 to 1500 AD: Inserts: The Age of Pharmacopoeias, Herbals and
Dispensatories, Apothecaries
Chapter 4: 16 th Century: Inserts: Dose, Dichotomy
Chapter 5: 17 th Century: Inserts: Journals, Tracts and Monographs. 18 th Century:
Inserts: Terminology, and Self-experiments
Chapter 6: 18th Century: Inserts: Vaccines, Terminology, and Self-experiments
Chapter 7: 19 th Century: Inserts: Secret remedies, Placebo, Disease
nomenclature, Adverse Reaction Committees, Interactions, and
Health Insurance schemes
Chapter 8: 20 th Century: Inserts: Type B allergic reactions, Poison, Demise of
drugs, Persistence of drugs, Panaceas, The strength of the evidence
that an adverse event was caused by a drug, Books on the sideeffects
of drugs, and Regulations and laws
The events mentioned in this part are those that have affected drug safety over the
years:
1. Communication of information on adverse reactions to the prescribers
a. Printing. The development of different materials and the production of script
b. Types of publication – manuscript, pharmacopoeias, books, journals and
the internet
c. Terminology. The descriptions of symptoms change over time as well as
the meaning of words.
d. Translations