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Important Notice

Original article / research
Year : 2010 | Month : June | Volume : 4 | Issue : 3 | Page : 2427 - 2432 Full Version

Education Sessions For Pharmacy Students On Pharmacovigilance: A Preliminary Study

Published: June 1, 2010 | DOI:

*Department of Pharmacology *** Department of Hospital and Clinical Pharmacy Manipal College of Medical Sciences/ Manipal Teaching Hospital Phulbari-11, Pokhara, Nepal. ***Discipline of Social and Administrative Pharmacy School of Pharmaceutical Sciences Universiti Sains Malaysia, 11800 Penang, Malaysia. ****Department of Clinical Pharmacology KIST Medical College, Imadol Lalitpur, Nepal.

Correspondence Address :
P. Subish M.Pharm
Assistant Professor
Department of Hospital and Clinical Pharmacy/ Pharmacology
Manipal Teaching Hospital/ Manipal College of Medical Sciences
Pokhara, Nepal.
Phone: +977 61 526416 Extn: 130/221,


Introduction: In Nepal, there are no mandatory clinical trials for new products. Drugs are approved based on the data from developed countries. Manipal Teaching Hospital is one of the pioneers in establishing the Pharmacovigilance program in Nepal. For the past three years, the students of Pokhara University visit the Pharmacovigilance center, Drug information center and the Hospital Pharmacy of MTH for a 15 days training program. In the year 2007, the students were also trained in pharmacovigilance.
Objectives: To study the demographical details of the students who participated in the pharmacovigilance training and to obtain student feedback regarding the sessions.
Methodology: The session module was activity based and emphasized the following four areas: sketching out the current National Pharmacovigilance programme, designing an adverse drug reaction reporting form, carrying out the causality assessment and severity assessment. The feedback of the students on the training module was evaluated using the specially designed feedback form.
Results: Altogether, thirty students [males 18 (60%) and females 12 (40%)] were present and all of them participated in the study. The Mean ± SD overall feedback score was 81.5 ± 4.4 (maximum possible score was 100). In general, male students had a higher score (82.29 ± 4.88) than females (80.33 ± 3.75).
Conclusion: Overall, the students liked the session and were interested in having similar sessions in the future. This module can be taken as a model for other researchers who would like to carry out educational sessions in pharmacovigilance for pharmacy students.


Education, Nepal, Pharmacy students, Pharmacovigilance

It is a well known phenomenon that new drugs are marketed widely and are often withdrawn from the market due to the Adverse Drug Reactions (ADRs) which occur once they are used by a larger population than that covered in the clinical trials (1). Modern pharmacists consider Pharmaceutical care as their focus and play an important role in patient care (2). Ensuring the safe use of drugs is a combined responsibility of the healthcare team that includes Doctors, Nurses, Pharmacists and other supporting staff. One of the most importance means of ensuring drug safety is by reporting ADRs by healthcare professionals. Pharmacists being more knowledgeable in drug related aspects, have an important role in ensuring drug safety. The involvement of pharmacists in pharmacovigilance programs is considered to be vital (3),(4),(5). However, contrary to their important role, studies from developed countries have acknowledged either a poor knowledge (6) or less experience among pharmacists regarding ADR reporting (7). Researchers suggest the need for education for the pharmacists on Pharmacovigilance (8). One of the better ways to do this is by providing education when they are still students. The education provided for the Pharmacy students, even in developed countries like the United Kingdom, was found to be inadequate. A study found that both medicine and pharmacy courses differed substantially in teaching about the Yellow Card Scheme (the scheme for spontaneous ADR reporting in UK) and ADRs. There is scope for increased involvement of the Medicines and Healthcare products Regulatory Agency in undergraduate education (9).

In Nepal, there are no mandatory clinical trials for new products and drugs are approved, based on the data from developed countries. This eliminates the possibility of knowing the risks involved in the Nepalese population. Recently, Pharmacovigilance programs have been started in Nepal (10). Manipal Teaching Hospital is one of the pioneers in establishing the Pharmacovigilance program in Nepal and the members of the Department of Hospital and Clinical Pharmacy and Pharmacology were actively involved in establishing the program (10). The members have already carried out Pharmacovigilance sessions for undergraduate MBBS students (11),(12). However, such an initiative was not carried out for the Pharmacy students. Pokhara University runs a four year B.Pharm course. For the past three years, the students of Pokhara University visit the Pharmacovigilance center, Drug information center and the Hospital Pharmacy of MTH for a 15 days training program. The students had their training during the month of June 2007. During that time, the members of the Pharmacovigilance center conducted a voluntary Pharmacovigilance training module for the Pokhara University Final year Pharmacy students. The present study was conducted with the following objectives.

1. To study the demographic details of the students who participated in the pharmacovigilance training,

2. To study the student feedback regarding the sessions, and

3. To compare the scores of the students based on their demographic status.

Material and Methods

For the past three years, the final year B. Pharm students were trained in various aspects of Hospital and Clinical Pharmacy at the Manipal Teaching Hospital (MTH). The total training period of 15 days is divided into small slots of 2-3 days at the Drug Information center, Pharmacovigilance Center, Inpatient Pharmacy, Outpatient Pharmacy, Bulk Pharmacy and the Medication Counseling center. Besides running the hospital pharmacy, the Department of Hospital and Clinical Pharmacy, with the help of the Department of Pharmacology, also runs a medication counseling center, a drug information center and a pharmacovigilance center. The Pharmacovigilance activities have been going on since September 2004 and now MTH is the regional Pharmacovigilance Center for ADR monitoring for the Western region of Nepal.

During the 15 days training program, the students were also provided training in Pharmacovigilance. The module was activity based and focused on the following four areas: sketching out the current National Pharmacovigilance programme, designing an adverse drug reaction reporting form and carrying out causality assessment and severity assessment of ADRs. Students were divided into groups of five students each. The details are listed below.

Part I: Sketching out the current National Pharmacovigilance programme: The students were asked to sketch out the National Pharmacovigilance programme of Nepal.

Part II: Designing an adverse drug reaction reporting form: Students were encouraged to design an ADR reporting form by themselves. They were instructed that the form should be brief, concise and should have all the essential information required for an ADR reporting form.

Part III: Carrying out the causality assessment: Students were asked to carryout the causality assessment of four ADRs that were reported to the Phamacovigilance center. Naranjo algorithm (13) was provided to the students to carry out the causality assessment.

Part IV: Carrying out the severity assessment: Students were also asked to carry out the severity assessment of four ADRs that were reported to our PV center. Modified Hartwig and Siegel scale (14) was provided to the students to carry out the severity assessment. These four ADRs were the same as those used for causality assessment.

The feedback of the students on the training module was evaluated using the specially designed feedback form (Table/Fig 1).


Altogether, thirty students were present and all of them participated in the study. The demographical characteristics of the students are listed in (Table/Fig 2) .

Student Feedback on the Sessions
The median scores of the individual statements are listed in (Table/Fig 3). The Mean ± SD overall score was 81.5 ± 4.4 (maximum possible score was 100). We also compared the scores with the demographical status of the respondents and the details are listed in (Table/Fig 4).


Pharmacovigilance, previously more often referred to as adverse drug monitoring or drug surveillance is now regarded as the quality control system of the society regarding the use of medicines. Its broader aim is to check if medicines fulfill their intended role in alleviating human suffering and reducing disease related economic loss, with the best acceptable safety in use. The ultimate aim of pharmacovigilance is to attain the safe and rational use of medicines, once they are released for general use in the society. A very important outcome of pharmacovigilance is the prevention of patients being affected unnecessarily by the negative consequences of pharmacotherapy (15). In order to protect consumers from the negative consequences of drug therapy, the healthcare professionals including the Pharmacists should be aware of the concept of pharmacovigilance. Data from Nepal clearly suggest vast amount of irrational use of medicines. Some examples of the irrational use of drugs still in evidence in Nepal are: polypharmacy, use of expired drugs, the irrational fixed dose combination of drugs and overuse of antibiotics, vitamins / herbal remedies, brand prescribing, retail shop prescribing and unethical dispensing. Such irrational practices, combined with lack of patient information on proper handling and use of drugs, can lead to wastage of medicine as well as other serious consequences like adverse drug reactions and drug interactions (16). In Nepal, retail pharmacists are considered as the first point of contact for healthcare problems. However, they are often less qualified and do not have adequate sources of information and knowledge about drug related matters.

Moreover, in Nepal the pharmacy curriculum is more ‘product oriented’ and there is less emphasis on Social Pharmacy, Pharmacoepidemiology and other aspects of medicine use. The curriculum prepares the students for a job in the pharmaceutical industry than for a job in a Hospital or as a Community Pharmacist (17),(18).

We included four areas in our Pharmacovigilance training module. The first area, ‘Sketching out the current National Pharmacovigilance programme’ is very essential for the students. The students should know about the ongoing Pharmacovigilance program in Nepal. They were able to sketch out the current pharmacovigilance program. They also emphasized the need for more regional centers and peripheral centers. As of now, in Nepal there is a national centre and four regional centers.

The second area, ‘Designing an adverse drug reaction reporting form’ was well received by the students. The student designed forms had all the essential features like patient demography, drug history and drugs responsible for the ADR, contact details of the reporter, etc. In a previous session conducted for medical students, the students were creative and enjoyed the sessions (12). Similarly, the present study also clearly reflects that students liked the sessions.

The third area, ‘Carrying out the causality assessment’ using the standard method, is one of the best ways to establish the causal relationship between the drug and the effect. The Naranjo algorithm is used widely in carrying out the causality assessment of ADRs. It is based on the score calculated on the basis of the points given for each of the ten questions that comprise the table. The maximum possible score was 13. If the score was 9 or greater than 9, then the adverse reaction was categorized as ‘definitely’ caused by the particular drug. A score of 5-8 was categorized as ‘probably’ caused by the drug, while a score of 1-4 was categorized as ‘possibly’ caused by the drug.

The fourth area, ‘Carrying out the severity assessment’ is an important step in Pharmacovigilance. In order to take appropriate initiatives towards management of the ADR, it is necessary to study the severity of the ADRs. Hartwig scale is widely used for the purpose. This scale categorizes the reported adverse drug reactions into different levels as mild, moderate or severe, based on the treatment and whether or not hospitalization was required for the management of the ADRs.

The feedback of the students was positive. The students agreed that the sessions made them aware of the concept of Pharmacovigilance. With regards to the success of the current Pahrmacovigilance program in Nepal, they had a negative response. This response suggests the students’ concern regarding the program. One of the most striking findings was that the students wanted Pharmacovigilance to be incorporated in their curriculum.

While going through the feedback forms, we got some interesting responses from the student participants. One of the female respondents wrote, ‘The session was entirely new and helpful for me. It has made me feel aware of my responsibility as a Pharmacist in some way’. Another female respondent wrote, ‘This type of session must be given to the first semester students of B.Pharm and also to the general public.’ A male student wrote, ‘The information obtained during the session was very informative. Pharmacovigilance was quite a new term for me. So, it was informative for me’.

Our study had a few limitations. It was a preliminary study and included only 30 students. Moreover, only one batch of students was included in the training program. We also did not evaluate the improvement of knowledge of the students regarding Pharmacovigilance, following the training program.

Practice Implications
To the best of our knowledge, the present study is one of the first to introduce activity-based learning of pharmacovigilance to pharmacy students in South Asia. Pharmacovigilance is an important area of practice for pharmacists. We hope our experience will be of interest to researchers and teachers from South Asia and other developing regions.


The study was successful in evaluating the students’ feedback on the educational sessions about pharmacovigilance. Overall, students liked the session and were interested in having similar sessions in the future. In a country like Nepal, where Pharmacy students are not taught much about the negative consequences of drug therapy, this study gains attention. This module can be taken as a model for other researchers who are willing to carry out educational sessions for pharmacovigilance for pharmacy students.


The authors acknowledge all the students who participated in the study spending their valuable time.


Alastair J J W. Adverse Reactions to Drugs In: Braunwald etal. Harrison’s principles of Internal medicine (pp 430-438). 15th edition Mc Graw-hill, 2001.
Hepler CD. Clinical pharmacy, pharmaceutical care, and the quality of drug therapy. Pharmacotherapy 2004; 24: 1491-8.
van Grootheest A C, de Jong-van den Berg L T. The role of hospital and community pharmacists in pharmacovigilance. Res Social Adm Pharm 2005; 1:126-33.
van Grootheest A C, van Puijenbroek E P, de Jong-van den Berg L T. Contribution of pharmacists to the reporting of adverse drug reactions. Pharmacoepidemiol Drug Saf 2002; 11: 205-10.
van Grootheest, K, Olsson S , Couper M, de Jong-van den Berg L. Pharmacists' role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf 2004; 13, 457-64.
Toklu, H Z, Uysal M K. The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharm World Sci 2008; 30:556-62.
Granas, A G, Buajordet M, Stenberg-Nilsen H, Harg P, Horn AM. Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf 2007; 16: 429-34.
Green C. F, Mottram D R, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol 2001; 51: 81-6.
Cox AR, Marriott JF, Wilson KA, Ferner RE. Adverse drug reaction teaching in UK undergraduate medical and pharmacy programmes. J Clin Pharm Ther 2004; 29: 31-5.
Nepal joins programme. Uppsala reports. 2007; 36: 5-6. (Available on
Shankar PR. Pharmacology at the Manipal College Of Medical Sciences, Pokhara, Nepal : new roles and new challenges. The Internet Journal of Pharmacology, 2006 , 4.
Shankar PR, Subish P. Designing a spontaneous adverse drug reaction reporting form: an exercise for medical students. The International Journal of Risk and Safety in Medicine 2006; 18: 115 –9.
Naranjo CA, Busto U, Sellers EM. et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239- 45.
Hartwig SC, Siegel J, Schneider P J. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992; 49: 2229- 32.
Olsson S. The need for pharmacovigilance. In: Gupta SK. Pharmacology and therapeutics in the new millennium, 2001, pp.502-508. Narosa publishing house, New Delhi.
Blum NL. Drug information development. A case study from Nepal, 2002 [Online]. Accessed 9th February 2008]. Available from World Wide Web
B.Pharm curriculum of the Kathmandu University, Kathmandu, Nepal, 2004.
B.Pharm curriculum of the Pokhara University, Pokhara, Nepal, 2004.

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  • Embase
  • EBSCOhost
  • Google Scholar
  • HINARI Access to Research in Health Programme
  • Indian Science Abstracts (ISA)
  • Journal seek Database
  • Google
  • Popline (reproductive health literature)