It is the self-control that recognizes all the tasks that are performed to check the results of medicines on humans. Surveillance tasks must be carried out in all House phases of a drug's life, consisting of the duration of the medical growth – site.
Internationally, the term drug safety monitoring is much more correctly used, defining whether it is pre- or post-marketing.
“A set of missions whose aim is to provide, on a continuous basis, the best possible information on the safety of medicines, thus allowing to take the right measures and consequently to guarantee that the medicines proposed on the market exist, under the authorized conditions of use, a positive record benefit for the population” (1).
In 2002, it was defined by the Globe Wellness Company (WHO) as “the science and activities associated with the identification, examination, understanding as well as prevention of adverse reactions or various other drug-related disorders”.
It is thus specified “any type of unwanted medical circumstance, which occurs in a person or in a subject included in a clinical study to which a drug is administered and which does not necessarily have a causal relationship with the therapy”.
This interpretation, therefore, as can be recognized, includes a wide range of events that could develop during drug therapy, such as adverse drug reactions, failure of restoration as well as overdose. ADR (Adverse Medicine Response):.
A reaction to a drug that is harmful, unintended and occurs at doses normally used by people for the treatment, diagnosis or therapy of a disease, or to modify its physiological functions (2) (WHO – Globe Health Organization- 1972).
Dangerous and unpleasant reaction of a particular degree due to the use of a drug, which represents a threat to further administration, which requires prevention or special treatment or a change in dosage or suspension of the element itself” (3) (Aronson and Edwards) .
A reaction to a drug that is dangerous
Unintentional as well as occurring at doses normally used by humans for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify their physiological functions” (EU Directive 83/2001).
This de facto meaning is practically the same as that of the WHO in 1972 and does not include the harmful effects resulting from abuse, overdoses, medication errors as well as uses outside accredited indications (the so-called off-label use ). :.
Lately, the new European regulation has in fact modified the definition of negative response, now understood as “Dangerous and undesirable result resulting from the use of a drug” (EU Instruction 84/2010) (4) which includes drug damage resulting from :
- Use Not Based on Instructions Included in Advertising Consent.
- Medicine errors, including accidental overdose.
- Inappropriate use.
- Drug abuse.