Attached
Introduction
Package inserts (Pis) provide information
about medicines to health professionals.
Incomplete or inaccurate information may
lead to medication errors.
Objectives
Aim of the study was to assess the accuracy
and availability of key information in Pis of
medicines used in Sri Lanka. Method
Two samples of 100 Pis each were used to
assess availability and accuracy of information
respectively. Pis were randomly selected from
a government hospital and a private
pharmacy. Availability of essential information
was checked against criteria specified in the
regulations of the Cosmetics, Devices and
Drugs (CDDA) Act No. 27 of 1980.Clinical facts
in Pis were matched against the British
National Formulary and/or Australian
Medicines Handbook for accuracy. Pis were
categorized as 'compatible' when information
was identical, 'partially compatible' if there
was at least one mismatch, and 'not
compatible' if completely unmatched against
references.
Results
Nine types of clinical information
(Indication/s, contraindications, precautions,
adverse effects, drug interactions, average
dose, dose regimen for adult/child, dosing
interval and average duration of treatment)
were matched with the reference in 100 Pis,
resulting in 900 cross-matches. Among them,
61 incompatibilities and 179 partial
compatibilities were identified.
Contraindications (16%) and precautions
(11%) had the highest percentage of
incompatibilities. 82% of Pis had at least one
deviation from the CDDA regulations. The
most frequently missing information was
pharmacokinetic data, duration of treatment,
overdose, and dosage information in special
situations.
Conclusions
Information provided in Pis is inadequate and
not completely accurate. Regulatory
authorities need to urgently and continuously
review Pis prepared by drug manufacturers.
