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Drug Safety
Defining ‘Surveillance’ in Drug Safety
Aronson JK, et al.
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Defining “surveillance” in drug safety
Appendix
The main paper to which this is an appendix describes the evolution of a definition of
‘surveillance’ in pharmacovigilance, using a combination of four approaches: etymology,
usage, previous definitions, and the Ramsey-Lewis method (in which the characteristics
of the system being described is used to derive the definition). Much of the material on
the first two of these (etymology and usage) was omitted from the main body of the
article for the sake of brevity; that material is given here.
A.1. Etymology
A.1.1. “Surveillance” and “monitoring”
“Surveillance” comes from Old French, sur (over) + veiller (to watch). The transitive
verb from “surveillance” is the back-formation “surveil”, “to exercise surveillance
over” * . The original Indo-European root of “veiller” is UEG, from which the Latin words
vigor and vigilare (to watch or stay awake) derive, with their connotations of
watchfulness and liveliness; indeed, “watch” and “wake” have the same root. Metathesis
of vigilare gives velox, speedy, from which we derive “velocity”. Thus, “vigilance” and
“surveillance” have the same etymology; their origins imply both watchfulness and
speedy action.
“Monitoring” derives from the Latin word monere, to bring to the notice of, remind,
advise, recommend, warn, tell. It is defined as “overseeing; surveillance, listening in”.
A.1.2. “Active”
The word “active” derives from the Indo-European root AG, to drive, push, or do. The
Greek words
and observance) and
(agōgē; meaning, among other things, freight, seizure, guidance,
(agōn, assembly, contest, and struggle) give English words
such as pedagogue, demagogue, hypnagogue, agonist, antagonist, and protagonist, in
*
All the definitions given here are taken from the Oxford English Dictionary, which cites literature from
the English-speaking world, including British and American English.
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which some of these meanings are implied. The Latin derivative, agere, and its supine
form actum, give us words such as act, stratagem and strategy, agenda, and exigency, in
which the doing aspects of the root are evident.
Thus, driving and guiding are, when relevant, essential aspects of being active.
A.1.3. “Passive”
The word “passive” comes originally from the Indo-European root PAEN, meaning
“almost”, implying near death and therefore sufferance or patience. From the Latin
derivative, the deponent verb patior (I undergo, suffer, or be subjected to), and its supine
form passus, we derive passion, patience, and compatibility, among others. Penance,
repentance, and pain are also related.
Thus, waiting is an essential part of being passive. In the phrase “watchful waiting”,
“watchful” implies activity (see above) and “waiting” implies passivity [1]. If
surveillance is in any sense watchful waiting, it combines both active and passive
elements, making these qualifiers redundant.
A.2. Usage
Etymology need not, and often does not, dictate usage. However, the usages of these
words closely reflect their etymologies and have changed little over the centuries.
A.2.1. “Surveillance”
“Surveillance” appeared at the end of the 18th century, meaning “watch or guard kept
over a person; supervision for the purpose of direction or control, superintendence.” Its
meaning has not changed since then. Below we discuss the distinction between
monitoring and surveillance.
A.2.2. “Active”
The Latin terms “activus” and “passivus” are found in Anglo-Saxon and early English
texts. However, the earliest written examples of the English forms date from the 14th
century. “Active” originally meant “given to outward action rather than inward
contemplation or speculation”, and soon afterwards “opposed to passive: originating or
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communicating action, exerting action upon others; acting of its own accord,
spontaneous” Shakespeare used it to mean “abounding in action; energetic, lively, agile,
nimble; diligent, busy, brisk”, and its meanings have hardly changed since then, apart
from some technical usages, such as in grammar and physics.
A.2.3. “Passive”
Since its appearance in written English at the end of the 14th century, “passive” has been
used to refer to something “that is acted upon or is capable of being acted upon from
outside”. At the start of the 17th century it came to mean “not acting, working, or
operating on anything else; not exerting force or influence; inert, quiescent” and “that
makes no response or offers no resistance; yielding readily to external force or influence,
or to the will of another; submissive”. Later (19th century) it acquired the meaning “of
movement or motion of (part of) the body: produced by an external agency” (for
example, passive movements). No other general meanings have emerged since, although
there are many specialized uses in fields such as grammar, law, immunology, chemistry,
electronics, banking, linguistics, and psychology.
A.2.4. “Active surveillance”
A.2.4.1. “Active surveillance” in politics
The term “active surveillance” was originally used in political contexts, dating from the
19th century, for example in an 1828 Lancet annotation [2]: “There has been established
in Paris a journal [La Clinique], [one] object of which is ... to exercise an active
surveillance on the medical officers of [Parisian hospitals]”. An early reference, albeit
political, to adverse drug effects occurred in an 1893 pamphlet on the effects of opium:
“The Bombay opium officials, who seem to drive their trade hard, and to keep an active
surveillance over the opinions of medical men on the subject, encourage the sale of
children’s pills at the Government opium shops” [3].
A.2.4.2. “Active surveillance” in epidemiology and pharmacovigilance
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Active surveillance of infectious diseases (cholera and tuberculosis) was first mentioned
in the 1890s [ 4,5,6]. However, the term “surveillance” was not used in drug safety until
the 1950s and 1960s, with different nuances of meaning [7,8,9]. The term “active
surveillance” in this context was introduced soon afterwards; in one example it was
contrasted with spontaneous reporting of adverse drug reactions [10].
After that, apart from a single instance of active surveillance of neonates in a 1970
French paper [11], the term first appears in a Pubmed search in 1979 in relation to
surveillance for infection. Papers on active surveillance of toxic shock syndrome in
relation to tampons [12] or barrier contraceptives [13,14,15,16] appeared in the 1980s; it
is not surprising that this was an early application, since almost all of the previous work
on active surveillance had involved infectious diseases. Active surveillance for drug
effects was mentioned in a review of the beneficial effects of antiepileptic drugs in 1986
[17] and active surveillance for adverse effects in a Bulgarian paper in 1987 [18].
Other sporadic reports of the use of active surveillance appeared in 1993 on the
adverse respiratory effects of shoe sprays [19] and injuries related to fireworks [20], but
the first occasion on which the term “active surveillance” was used in relation to a
specific therapeutic drug was in 1994, in a description of adverse events in elderly
patients taking digitalis [21].
Active surveillance for the adverse effects of vaccines was first reported in 1995 [22],
again illustrating the importance of infectious diseases in the history of the adoption of
this term in describing the detection of adverse drug reactions. The authors had
previously described the failure of passive surveillance in the UK to detect an
unacceptably high risk of aseptic meningitis with measles/mumps/rubella (MMR)
vaccines that contained the Urabe mumps strain [23].
In addition to studies on vaccines, studies on appetite suppressants [24], missed doses
of medications [25], general adverse drug reactions in hospital [26], and the safety of
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cyproterone acetate [27] followed in the 1990s. The terms “active surveillance” and
“pharmacovigilance” both appeared in the same paper for the first time in 1996 [28].
A.2.5. “Passive surveillance”
The term “passive surveillance” has been in use in different areas for many years, since at
least the 1950s [29]. However, it was not used in the context of drug therapy or vaccines
until the 1980s [ 30]. Most of the papers yielded by searching Pubmed for “passive
surveillance” are about infectious diseases; about 18% deal with surveillance of the
adverse effects of vaccines. In only about 20% of cases were active and passive
surveillance mentioned in the same paper.
A.2.6. Postmarketing surveillance
The term “postmarketing surveillance” first appeared in the 1960s and was attributed
to Bill Inman [31], who defined it as “techniques for detecting and measuring the
incidence of adverse drug reactions… [including] all kinds of schemes for generating or
testing hypotheses” [32]. It has also been defined (translating from the Dutch) as “the
systematic surveillance [toezicht] and scientific study of all intended and unintended
effects of medicines on human health, after their release for marketing” [33,34], which in
effect circularly defines “surveillance” as “surveillance”.
Postmarketing surveillance refers to analysis of data accumulated typically for the
purpose of detecting adverse effects after a medicinal product has been given a marketing
authorization by a regulatory body [35,36]. The term normally refers to the processes of
signal detection and signal evaluation, but it may be confused with the term
“pharmacovigilance”, which first appeared in French in the late 1960s, when the terms
“pharmacovigilance intensive” and “pharmacovigilance spontanée” were contrasted [37].
In fact, the World Health Organization’s definition of pharmacovigilance is “the science
and activities relating to the detection, assessment, understanding and prevention of
adverse effects or any other possible drug-related problems” [38].
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For other details on the usage of the term “postmarketing surveillance” see the main
paper.
A.2.6.1. Spontaneous reporting in postmarketing surveillance
“Spontaneous reporting”, a term that emerged in the 1960s in relation to adverse drug
reactions [39], is accepted as referring to adverse events or suspected adverse drug
reactions submitted voluntarily by a reporter to a centralized organization that focuses on
receipt, data cleaning and structuring, analysis, follow up of reports with the aim of
maximizing the value of the enclosed data, and further dissemination of the data or the
results of analysis. For other details on the usage of the term “spontaneous reporting” see
the main paper.
References
1.
Penson DF. Active surveillance: not your father's watchful waiting. Oncology
(Williston Park) 2009; 23 (11): 980, 982
2.
Anonymous. Strictures on the conduct of the Professor of Clinical Medicine at the
Hotel Dieu, Paris. Lancet 1828; 10 (250): 327
3.
Rowntree J. The opium habit in the East: a study of the evidence given to the Royal
Commission on Opium, 1893-4. LSE Selected Pamphlets, 1895
4.
Anonymous. The cholera in France. Lancet 1892; 140 (3606): 852-5
5.
Alleger WW. Some remarks on the limitation of tuberculosis, illustrating the value of
the microscope in preventive medicine. Proc Am Microscop Soc 1895; 16(2): 101-11
6.
Anonymous. The prevention of tuberculosis. Br Med J 1899; 2(2012): 247-8
7.
Peyman MA. The value of a chemical test for the detection of blood in the urine
during anticoagulant therapy. Lancet 1956; 268 (6941): 496-7
8.
Cluff LE, Thornton GF, Seidl LG. Studies on the epidemiology of adverse drug
reactions: I. Methods of surveillance. JAMA 1964; 188: 976-83
7
9.
Slone D, Jick H, Borda I, Chalmers TC, Feinleib M, Muench H, Lipworth L, Bellotti
C, Gilman B. Drug surveillance utilizing nurse monitors. An epidemiological
approach. Lancet 1966; 2 (7469): 901-3
10. Anonymous. Adverse reactions to drugs. Br Med J 1969; 1 (5643): 527
11. Canet J, Bouhanna A. Conditions pratiques d'une surveillance active du nouveau-né
maternité dans les premières heures et les premiers jours. Son efficacité. Bull Inst
Natl Santé Rech Méd 1970; 25 (4): 667-72
12. Osterholm MT, Forfang JC. Toxic-shock syndrome in Minnesota: results of an
active-passive surveillance system. J Infect Dis 1982; 145 (4): 458-64
13. Schwartz B, Gaventa S, Broome CV, Reingold AL, Hightower AW, Perlman JA,
Wolf PH. Nonmenstrual toxic shock syndrome associated with barrier
contraceptives: report of a case-control study. Rev Infect Dis 1989; 11 Suppl 1: S438
14. Reingold AL, Broome CV, Gaventa S, Hightower AW. Risk factors for menstrual
toxic shock syndrome: results of a multistate case-control study. Rev Infect Dis
1989; 11 Suppl 1: S35-41
15. Gaventa S, Reingold AL, Hightower AW, Broome CV, Schwartz B, Hoppe C,
Harwell J, Lefkowitz LK, Makintubee S, Cundiff DR, et al. Active surveillance for
toxic shock syndrome in the United States, 1986. Rev Infect Dis 1989; 11 Suppl 1:
S28-34
16. Broome CV. Epidemiology of toxic shock syndrome in the United States: overview.
Rev Infect Dis 1989; 11 Suppl 1: S14-21
17. Beghi E, Di Mascio R, Tognoni G. Drug treatment of epilepsy. Outlines, criticism
and perspectives. Drugs 1986; 31(3): 249-65
18. Petrov A. [Complications in the cardiovascular system from neuroleptic treatment.]
Vutr Boles 1987; 26 (5): 72-6
8
19. Centers for Disease Control and Prevention (CDC). Severe acute respiratory illness
linked to use of shoe sprays – Colorado, November 1993. MMWR Morb Mortal
Wkly Rep 1993; 42 (46): 885-7
20. Centers for Disease Control and Prevention (CDC). Fireworks-related injuries during
the new year period – Naples, 1992-93. MMWR Morb Mortal Wkly Rep 1993; 42
(11): 201-3
21. Warren JL, McBean AM, Hass SL, Babish JD. Hospitalizations with adverse events
caused by digitalis therapy among elderly Medicare beneficiaries. Arch Intern Med
1994; 154 (13): 1482-7
22. Farrington P, Pugh S, Colville A, Flower A, Nash J, Morgan-Capner P, Rush M,
Miller E. A new method for active surveillance of adverse events from
diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet 1995; 345
(8949): 567-9
23. Miller E, Goldacre M, Pugh S, Colville A, Farrington P, Flower A, Nash J,
MacFarlane L, Tettmar R. Risk of aseptic meningitis after measles, mumps, and
rubella vaccine in UK children. Lancet 1993; 341: 979-82
24. Abenhaim L, Moride Y, Brenot F, Rich S, Benichou J, Kurz X, Higenbottam T,
Oakley C, Wouters E, Aubier M, Simonneau G, Bégaud B. Appetite-suppressant
drugs and the risk of primary pulmonary hypertension. International Primary
Pulmonary Hypertension Study Group. N Engl J Med 1996; 335 (9): 609-16
25. Nettleman MD, Bock MJ. The epidemiology of missed medication doses in
hospitalized patients. Clin Perform Qual Health Care 1996; 4 (3): 148-53
26. Wu FL, Yang CC, Shen LJ, Chen CY. Adverse drug reactions in a medical ward. J
Formos Med Assoc 1996; 95 (3): 241-6
9
27. Heinemann LA, Will-Shahab L, van Kesteren P, Gooren LJ; Collaborating Centers.
Safety of cyproterone acetate: report of active surveillance. Pharmacoepidemiol Drug
Saf 1997; 6 (3): 169-78
28. Jonville-Bera AP, Autret E, Galy-Eyraud C, Hessel L. Aseptic meningitis following
mumps vaccine. A retrospective survey by the French Regional Pharmacovigilance
centres and by Pasteur-Mérieux Sérums & Vaccins. Pharmacoepidemiol Drug Saf
1996; 5 (1): 33-7
29. Rosenfeld E. Social research and social action in prevention of juvenile delinquency.
Soc Probl 1956; 4 (2): 138-48
30. Roberts WN, Liang MH, Stern SH. Colchicine in acute gout. Reassessment of risks
and benefits. JAMA 1987; 257 (14): 1920-2
31. Inman WH. Don’t Tell the Patient. Behind the Drug Safety Net. Los Angeles:
Highland Park Productions, 1999: 143
32. Inman WH. Editor’s introduction and commentary. In: Inman WH (editor):
Monitoring for Drug Safety. 2nd edition. Boston: MTP Press Limited, 1986: 3-11
33. Gezondheidsraad: Commissie Postmarketing Surveillance. Postmarketing
Surveillance in Nederland. 's-Gravenhage: Gezondheidsraad, 1991:
Publicatienummer 1991/12
34. Meyboom RHB. Good practice in the postmarketing surveillance of medicines.
Pharm World Sci 1997; 19 (4): 186-90
35. Roeser HP, Rohan AP. Post-marketing surveillance of drugs. The spontaneous
reporting scheme: role of the Adverse Drug Reactions Advisory Committee. Med J
Aust 1990; 153 (11-12): 720-6
36. Praus M, Schindel F, Fescharek R, Schwarz S. Alert systems for post-marketing
surveillance of adverse drug reactions. Stat Med 1993; 12 (24): 2383-93
10
37. Organisation mondiale de la santé. Série de rapports techniques. No. 425. Pharmacovigilance internationale: rôle de l’hôpital. Rapport d'une réunion de l'OMS. Genève:
Organisation mondiale de la santé, 1969
38. World Health Organization. The Importance of Pharmacovigilance. Safety
Monitoring of Medicinal Products. WHO, 2002 [online]. Available from URL:
http://apps.who.int/medicinedocs/en/d/Js4893e/.
39. Witts LJ. Adverse reactions to drugs. Br Med J 1965; 2(5470): 1081-6
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