Pharmacovigilance of drug quality deviation in the public health system
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Universidade Federal de Minas Gerais
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Background: Drug quality deviation (DQD) is
defined as the disagreement with the parameters
established for a pharmaceutical preparation at the
registration process. Pharmacovigilance programs
should be notified of DQD to support patient safety.
Objectives: To describe DQD from public health
system and its impact on the pharmaceutical care.
Methods: Descriptive analysis of DQD recorded in
public health care facilities at primary and secondary level in Belo Horizonte, Brazil. All notifications (n =
271) of quality deviations of drugs from the Municipal
List of Essential Medicines recorded from April to September 2016 were analysed. Variables selected were
type of DQD, pharmaceutical product, therapeutic
class, notifying health unit, risk classification (potential
consequences for drug, patient and pharmaceutical
care), and reply of DQD notification by private and
public drug suppliers and by Brazilian Health Surveillance Agency (ANVISA). Variables were described
by estimating absolute and relative frequencies.
Results: A total of 329 DQD was recorded, which led
to a loss of 9,311 preparations, representing on
average 0.2% of the acquired lot. Most DQD came
from the primary health care level. Drug-related problems included deviations in package content (47%),
package integrity (26%), label (5%), and pharmaceutical product itself (e.g. change in colour) (22%). DQD
involving solid preparations was the most recorded
(68.3%). Anti-infectives for systemic use and nervous
system drugs accounted for 21.0% and 20.3% of
DQD, respectively. Approximately, 70% of the DQD
could lead to transient and reversible harm to patients
(intermediate risk). Drug suppliers replied 83.6% of
notifications, being the pharmaceutical manufactures
more effective and faster in solving the complaints.
None notification has been completely analysed by
ANVISA until the end of the study.
Conclusions: Pharmacovigilance is an important tool
to minimize potential patient harm by managing
DQD and improving the quality of dispensed drugs.
The results highlight the need to strengthen this
activity as well as extend it beyond the hospital
settings where this practice is best established.
Abstract
Assunto
Farmacovigilância, Desvio da qualidade do medicamento
Palavras-chave
Farmacovigilância, Desvio da qualidade do medicamento
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https://onlinelibrary.wiley.com/doi/full/10.1002/pds.4275