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Scholars Academic Journal of Pharmacy (SAJP) ISSN 2320-4206 (Online)
Sch. Acad. J. Pharm., 2015; 4(6): 301-307 ISSN 2347-9531 (Print)
©Scholars Academic and Scientific Publisher
(An International Publisher for Academic and Scientific Resources)
www.saspublisher.com
Research Article
Knowledge and Attitudes on Adverse Drug Reaction Reporting of Selected
Hospital-based Health Practitioners in Manila, Philippines
Rogie Royce Carandang
*
, Karen Cao, Nikki Beatrice Jose, Frances Diana Almonte, Ron Michael Tinio
College of Pharmacy, Adamson University, City of Manila, Philippines
*Corresponding author
Rogie Royce Carandang
Email: rrcarandang@gmail.com
Abstract: Adverse drug reaction (ADR) reporting is fundamental in the science of pharmacovigilance. However, under-
reporting still exists and remains a major limitation of the system. This study sought to assess the knowledge and
attitudes of hospital-based health practitioners in Manila towards adverse drug reaction reporting. A convenience
sampling method was used among health professionals in selected hospitals in Manila. Data was collected using self-
administered questionnaires from randomly selected pharmacists (23), physicians (47) and nurses (70). Results indicated
that there is under-reporting of suspected ADRs. Majority of the health professionals (77%) have adequate knowledge on
the ADR reporting. However, there is a significant difference on the level of knowledge of these practitioners. Nurses
have the highest proportion of respondents (86%) with adequate knowledge. In addition, a higher percentage of
respondents (80%) have unfavorable attitude towards ADR reporting. But still, the respondents acknowledged that ADR
reporting is a professional obligation. Only years of practice in the profession appeared to possess a significant
relationship to the practitioners’ knowledge. Meanwhile, only history of ADR reporting exhibited a significant influence
to the attitudes of health practitioners. Those who had experienced reporting ADR are more likely to report ADRs.
Knowledge and attitudes showed a strong influence in the ADR reporting of health professionals. Thus, development of
education strategies which focused on recognition of ADRs as well as altering wrong beliefs and negative attitudes will
hopefully develop a “reporting and learning culture” among the health professionals.
Keywords: knowledge, attitudes, adverse drug reaction, hospital, health practitioners.
INTRODUCTION
Moore once said that, “All drugs are dangerous.
Some may be useful”. This is the current dictum of
many drug safety experts in the world [1]. Such
principle has already been acknowledged by the World
Health Organization (WHO) as early as 1946.
The advent of the Thalidomide scare that
resulted to phocomelia among children of mothers who
were exposed to Thalidomide has brought into the
attention of the global health experts the value of drug
safety; thus, bringing about the science of
pharmacovigilance (PV) [2]. Article 21 of the WHO
constitution in 1946 stipulates that there should be an
adoption of regulations concerning standards with
respect to the safety, purity and potency of biological
and pharmaceutical products moving to international
commerce by world health assembly [3]. Hence, in
1971, there was an emergence of the practice and
science of PV.
In the Philippines, the science of PV has been
recognized by the local health authority and Food and
Drug Authority (FDA; formerly known as BFAD or
Bureau of Food and Drug). In pursuant to the Republic
Act 3720, otherwise known as the “Food, Drugs and
Devices, and Cosmetic Act”, a Memorandum Circular
no. 5 of 1994 was signed by Dr. Quintin Kintanar, the
then Director of BFAD on April 24, 1994. This circular
requires that all serious ADR reports shall be submitted
to BFAD within two weeks after the receipt of the
same. Other ADR reports shall be submitted on or
before the 15
th
of January of each year.
On August 1994, the ADR reporting system in
the Philippines was established and was recognized as a
national center member of the World Health
Organization International Drug Monitoring (currently
known as the Uppsala Monitoring Centre) on February
1995 [4].
This memorandum circular was amended on
16 April 2010 through the FDA Circular 2010-09, and
the amendment includes the change of timeline of
reporting from two weeks to within 72 hours (3
working days) but no later than seven (7) working days
for the serious ADR reports. Meanwhile for other ADR
reports, these will submitted every 30
th
of the first
month of each quarter, and not annually during the 15
th
of January each year as previously stated in the original