Off label and unlicensed drug use in neonatal wards (excluding neonatal ICU) at Tygerberg children's hospital (TBH)
Date
2019-12
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Stellenbosch : Stellenbosch University
Abstract
ENGLISH ABSTRACT: Off label use of medicines is defined as the use of an authorised medicine for a
purpose or in a manner other than that stipulated in the summary of product
characteristics (SmPC) (1), or as approved by the medicine control council or authirity
of a country (1).The off label use can be for an unapproved indication, for dose, for
administering route or, for use in an age group or population not registered during the
approval process (2). Unregisterd medicines are medications that have not been
approved for medicinal use in a particular country.(1) The majority of medication
prescribed to neonates and young infants have not been tested in them and in the
European Union 45% to 60% of medicine are given to children off label (3 ). In the
period before 1995 and 2005, only one third of registered medication in Europe were approved for use in children (4), while 54% are approved in the United States of
America (4). An Estonian study demonstrated that 80-98% of drugs used in neonates were used off label (5).
The regulation of modern medicine started only after breakthrough progress in the
fields of chemistry, physiology and pharmacology (6). This laid a firm basis for
medicine testing and research. Certain events such as the diethylene glycol poisoning
and thalidomide induced congenital abnormalities in history, also led to establishment
of medicine regulatory bodies. In 1937 people in the USA died from diethylene glycol
poisoning, which was used as a solvent with no prior safety testing and this led to the
establishment of The Federal Food, Drug and Cosmetics act (6).
The second important event occurred between 1956 and 1960 and involved the world
wide use of Thalidomide (6). Thalidomide was developed in Germany in 1956 and was
used as a hypnotic and sedative. Thalidomide’s widespread use in more than 46
countries, led to the birth of many babies with phocomelia (6). In 1956, an association
was made between Sulfonamide antibiotics use, kernicterus and high rates of mortality
in the premature neonate, this was higher than in infants receiving a tetracycline (7).
In 1959, a syndrome of sudden cardiovascular collapse was described by Sutherland
in three neonates who had received high dose chlorompenicol (8).
Description
Thesis (MMed)--Stellenbosch University, 2019.
Keywords
Off-label drug use, Unlicensed, Drug use, Neonatal, Tygerberg Children’s Hospital, Hyperbilirubinemia, Neonatal