The Extent of Pharmacovigilance Awareness among Pharmacy Senior Students ofCentro Escolar University, Manila, Philippines

The Philippine Pharmacists’ Association (PPhA) Code of Ethics for Pharmacists defines Pharmacists as Health Professionals who help individuals protect themselves against diseases, maintain good health and make the best use of their medications. They promote rational use of drugs and ensure the provision of safe, effective and quality drugs for improved patient care and quality of life [1].The Pharmacist roles have truly evolved from their traditional roles of filling prescriptions to the management of medication therapy of their patients through Pharmaceutical Care, a concept introduced by Heplerand Strand [2] in the late 1980s. The Pharmacist, as part of the Healthcare Team is committed to place the well being of the patient at the centre of professional practice. The pharmacist’s knowledge and expertise is important to the application of the safety profile of a medicine to the needs of a particular patient. Maintaining and monitoring of drugs safety and efficacy is an integral part of clinical practice. Thus, pharmacovigilance being part of the clinical discipline will play a vital role in assessing clinical practice standards in each country.The World Health Organization (WHO) [3] defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse affects or any other possible drug-related problems.”


Introduction
The Philippine Pharmacists' Association (PPhA) Code of Ethics for Pharmacists defines Pharmacists as Health Professionals who help individuals protect themselves against diseases, maintain good health and make the best use of their medications. They promote rational use of drugs and ensure the provision of safe, effective and quality drugs for improved patient care and quality of life [1].The Pharmacist roles have truly evolved from their traditional roles of filling prescriptions to the management of medication therapy of their patients through Pharmaceutical Care, a concept introduced by Heplerand Strand [2] in the late 1980s. The Pharmacist, as part of the Healthcare Team is committed to place the well being of the patient at the centre of professional practice. The pharmacist's knowledge and expertise is important to the application of the safety profile of a medicine to the needs of a particular patient. Maintaining and monitoring of drugs safety and efficacy is an integral part of clinical practice. Thus, pharmacovigilance being part of the clinical discipline will play a vital role in assessing clinical practice standards in each country.The World Health Organization (WHO) [3] defines pharmacovigilance as "the science and activities relating to the detection, assessment, understanding and prevention of adverse affects or any other possible drug-related problems. " Since, Adverse Drug Reactions (ADR) are common causes of morbidity and mortality in different healthcare settings, Pharmacists are more likely to detect ADRs than other healthcare professionals. According to US Food and Drug Administration [4], a serious Adverse Reaction is one in which the patient outcome is death, life threatening (real risk of dying), hospitalization (initial or prolonged), disability (significant, persistent or permanent), congenital anomaly, or required intervention to prevent permanent impairment or damage.Even if the Practice of Pharmacovigilance varies from country to country, the pharmacists' prime responsibility is the welfare of each individual.
The primary objective of this study was to"Determinethe Extent of Pharmacovigilance Awareness" among Pharmacy Senior Students ofCentro Escolar University, Manila, Philippines.

Objectives
• To determine the awareness of the Centro Escolar University (CEU), Manila Pharmacy Senior Students' Knowledge about Pharmacovigilance, Adverse Drug Reaction (ADR) and Adverse Drug Events (ADE).
• To assess the respondents' familiarization regarding ADRmonitoring, reporting, and documentation.
• To measure the respondents' perception on pharmacovigilance education or training as part of Pharmacy Curriculum and Practice.

Methods
A Descriptive Type of Research was used to determine the Extent of Pharmacovigilance Awareness among Pharmacy Senior Students of Centro Escolar University, Manila, Philippines between January 2013 to March 2013 (Appendix 1). A validated questionnaires (Appendix 2) was administered to 336 Pharmacy Senior Students using a Five-Point Liker Scale ranging from 1 (not aware/very low level) to 5 (very much aware/very high level) [5].

Results
To determine the awareness of the Centro Escolar University (CEU), manila pharmacy senior students' knowledge about pharmacovigilance, adverse drug reaction (ADR) and adverse drug events (ADE) ( Table 1) The results showed that the respondents have high level of awareness about Pharmacovigilance activities and knowledge on adverse drug reactions and adverse drug events (Table 2).
To assess the respondents' familiarization regarding ADR monitoring, reporting, and documentation (Table 3) The computed general weighted mean of 3.52 suggest that respondents have high level of familiarity when it comes to the Existence    of National Pharmacovigilance Center. Likewise, with a mean of 3.24, the respondents are undecided on whether they are familiar or not with regards to where to report a suspected ADR/ADE. On the other hand, 3.93 implied that they have high level of familiarity with regards on who to report a suspected ADR/ADE. Lastly, the respondents have high level of familiarity with regards to the adverse drug online reporting system with a mean of 3.53.

Journal of Pharmacovigilance
Furthermore, the general weighted average of 3.27 showed that respondents have neither high nor low level of familiarity with regards to the national policy and program on pharmacovigilance [6]. Moreover, the general computed mean of 3.61 means that respondents have high level of familiarity with regards to the existence of an adverse reaction forms used in making reports to FDA [7]. Additionally the general weighted average of 3.34 indicates that respondents have neither high nor low level of familiarity when it comes to the minimum criteria for a valid ADR report (Table 4).
To measure the respondents' perception on pharmacovigilance education or training as part of pharmacy curriculum and practice (Table 5) The respondents have a very high level of perception with 4.47 weighted mean with regards to the inclusion of Pharmacovigilance in a 4-year BS Pharmacy Curriculum. The respondents also strongly agree that it should be discussed in different Pharmacy subjects particularly on Internship 2 (Hospital) with a weighted mean of 4.50 (Table 6). Furthermore, a general weighted mean of 4.56 implies that they have a very positive perception with regards to ADR monitoring, reporting, documentation and 4.69 on Pharmacists participation in different areas of specializations regarding the said activities (Table 7 and Figure 1).

Conclusions
Pharmacy Senior Students of Centro Escolar University, Manila, Philippines have high level of awareness about Pharmacovigilance activities and knowledge on adverse drug reactions (ADR) and adverse drug events. However, even if the respondents have a very high level of perception with regards to the inclusion ADE). Also, a high level of familiarity by the respondents regarding ADR monitoring, reporting and documentation of Pharmacovigilance in a 4-year BS Pharmacy Curriculum, in terms of level of perception, the overall extent obtained from the respondents response resulted to neither positive nor negative perception. Considering the results obtained from this study, Pharmacist Educators should ensure that the curriculum include the pharmacists' importance in pharmacovigilance. By doing so, future pharmacists would be more informed and aware of the vital role they      play in drug safety and thereby potentially help enhance the level of ADR monitoring, reporting , documentation and preventing ADR and ADE.