PRACTICE SCHOOL

REPORT ON “PHARMACOVIGILANCE”

Submitted in partial fulfillment for award of the degree of

BACHELOR OF PHARMACY

SUBMITTED BY

ADITYA NARAYAN SAMAL

Regd No: 2003251029

Under the guidance of

MR. NILURAM PARIDA
Asst. Professor, Dept. of Chemistry

KANAK MANJARI INSTITUTE OF PHARMACEUTICAL SCIENCES, CHHEND,

ROURKELA

AFFILIATED TO

BIJU PATNAIK UNIVERSITY OF TECHNOLOGY, ROURKELA, ODISHA

KANAK MANJARI INSTITUTE OF PHARMACEUTICAL SCIENCES,ROURKELA,
ODISHA

CERTIFICATE

This is to certify that the practice school report entitled “PHARMACOVIGILANCE” is a

bonafide research done by “ADITYA NARAYAN SAMAL”, Regd. No- 2003251029,
[Link], 7th Sem in a partial fulfillment for the award of degree of “Bachelor of Pharmacy” .
The work has been carried out at KANAK MANJARI INSTITUTE OF PHARMACEUTICAL
SCIENCES ,ROURKELA, ODISHA under the guidance of Mr. NILURAM PARIDA Asst.
Prof, Department of Chemistry, Kanak Manjari Institute of Pharmaceutical Sciences, Rourkela.

Prof. (Dr.) Biswaranjan Behera

Principal
Kanak Manjari Institute of
Pharmaceutical Sciences, Rourkela

DATE:
PLACE: ROURKELA
 KANAK MANJARI INSTITUTE OF PHARMACEUTICAL SCIENCES,
ROURKELA,ODISHA

CERTIFICATE

This is to certify that the practice school report entitled “PHARMACOVIGILANCE” is a bonafide
research done by “ADITYA NARAYAN SAMAL”, Regd. No- 2003251029, [Link], 7th Sem
in a partial fulfillment for the award of degree of “Bachelor of Pharmacy” . The work has been
carried out at KANAK MANJARI INSTITUTE OF PHARMACEUTICAL
SCIENCES ,RORKELA, ODISHA under the guidance of Mr. NILURAM PARIDA Asst. Prof,
Department of Chemistry, Kanak Manjari Institute of Pharmaceutical Sciences, Rourkela

MR. NILURAM PARIDA

Asst. Professor Department of Chemistry

Kanak Manjari Institute of Pharmaceutical Sciences,

Rourkela

DATE:

Place: Rourkela
 KANAK MANJARI INSTITUTE OF PHARMACEUTICAL SCIENCES,
ROURKELA,ODISHA

DECLARATION

I hereby declare that the practice school report entitled “PHARMACOVIGILANCE” is a

bonafide research work done by ADITYA NARAYAN SAMAL in partial fulfillment for
the award of degree of “Bachelor of Pharmacy”. The work has been carried out KANAK
MANJARI INSTITUTE OF PHARMACEUTICAL SCIENCES, ROURKELA,ODISHA
under the noble guidance of Mr. NILURAM PARIDA, Asst. Prof, Department of
Chemistry, Kanak Manjari Institute of Pharmaceutical Sciences, Rourkela.

ADITYA NARAYAN SAMAL

Regd. No. 2003251029

Kanak Manjari Institute of

Pharmacutical Sciences,Rourkela
 ACKNOWLEDGEMENT

I wish to place my record my indebtedness to Mr. Nilaram Parida Asst. Prof. Department Of
Chemistry, KMIPS Rourkela for her sustained co-operation, interest and encouragement
throughout this project work

I express my deep sense of gratitude and indebtedness to our Principal Prof. (Dr.) Biswa
Ranjan Behera, KMIPS Rourkela for his kind support and facilities in the for the literature
review on carica papaya

I express my sincere thanks to other faculty members of KMIPS, Rourkela for their continuous
encouragement, interest and valuable discussion during the period of project work.

I am indebted to my parents for their moral support and personal sacrifice to see mee through the
project work

Sincerely I express my deep feelings to all my friends who rendered a helping hand in the hour
of need.

I owe my soulful thanks to almighty for endowing his immense blessings that helped me to
wards the successful completion of my literature Review work

ADITYA NARAYAN SAMAL

Regd. No. 2003251029
[Link]

Pharmacovigilance refers to the science and activities relating to the detection, assessment,
understanding, and prevention of adverse effects and other drug-related safety problems. Related
to this general definition, the underlying objectives of pharmacovigilance are to prevent harm
from adverse reactions in humans that arise from the use of health products within or outside the
terms of marketing authorization and in relation to the life cycle of these health products.

The main goal of pharmacovigilance is thus to promote the safe and effective use of health
products, in particular by providing timely information about the safety of health products to
patients, health-care professionals, and the public. Pharmacovigilance is therefore an activity
contributing to the protection of patients and maintaining public health.

Many other issues are also of relevance to pharmacovigilance-related activities and include
medication errors, lack of efficacy reports, off-label use, acute and chronic poisoning, assessment
of drug-related mortality, abuse and misuse of health products, and adverse interactions of
medicines with chemicals and other drugs (see Annex 1).

The pharmacovigilance approach can be clinical, epidemiological, experimental (e.g., to

reproduce an adverse effect in animals to better understand the mechanism involved for human
protection), or diagnostic (e.g., imputable methods).

The ultimate goal of pharmacovigilance is to accurately characterize and optimize the

benefit/risk ratio of a health product throughout its life cycle.

Aim of pharmacovigilance:

 To improve patient care and safety relation to the use of medicines and all medical and
paramedical intervension .
 To improve public health and safety in relation to the use of medicines
 To contribute the to the assessment of benefit, harm, effectiveness, and risk of medicines,
encouraging their safe, rational and more effective use
 To promote understanding, education and clinical training in pharmcovigelince and
effective communication to health professionals and the public
Responsibilities:

 Timely collection of data ,recording and notification.

 Appropriate assessments (data completeness ,seriousness).
 Expedited and periodic reporting .
 Creates appropriate structures for communication.

Governing Bodies:

 The pharmaceutical industry

 WHO collaborating center for international drug monitoring
 Regulatory authorities
 CIOMS(Council for International Organization of Medical Science)

2. Pharmacovigilance

Pharmacovigilance is defined as ...the activities involved in the detection, assessment,

understanding, and prevention of adverse effects or any other drug related problems.... All drugs
have the capacity to cause adverse effects and no drug is completely safe. Medication safety is of
particular concern for dermatologists, as most treatment indications involve diseases that are not
life-threatening and are often chronic, requiring years of medical therapy. Although skin diseases
can create substantial morbidity, physicians, regulatory agencies, and society generally have less
tolerance for risk when treating skin diseases. This chapter reviews the eight key principles
related to interpreting information related to drug safety. Knowledge of these principles is
fundamental to making informed treatment decisions and to aid in the discussion of risk with
patients.

Knowledge, Attitude, and Practice of Pharmacovigilance in Developing Countries

Abstract

Pharmacovigilance (Pv) systems are gaining ground in developing countries. The knowledge,
attitude, and practice (KAP) of Pv by different stakeholders are discussed in this chapter to
identify challenges and recommend solutions. The study of Pv KAPS is a trend in developing
countries, Healthcare professionals, including pharmacists, have poor to moderate knowledge, a
positive attitude, and poor practice of Pv. Continuing education will improve their KAP of Pv.
knowledge is easier to change than attitude and practice. The existing knowledge and attitude
will be retained better if it is applied in practice. The increasing involvement of developing
countries in the World Health Organization (WHO) Program for International Drug Monitoring
(PIDM) is promising. Technology and financial challenges hinder Pv incorporated into the
healthcare systems of developing countries. In a developing healthcare system, in addition to its
inherent deficiencies, practitioners are afraid to use Pv, which is indicated as evidence of its
flaws. An efficient healthcare system will facilitate a sustainable Pv practice. The development
of locally relevant patient-centered practice demands a PV culture.

Pharmacovigilance and Risk Management

Qualified Person for Pharmacovigilance in Europe

The QPPV is a required role for all pharmaceutical companies in Europe, but not yet required in
other regions of the world. A named person is responsible for all aspects of pharmacovigilance
for a medicinal product. The QPPV must be a physician or someone acting under the supervision
of a qualified physician. He or she ensures the adequacy of the pharmacovigilance system and
full compliance with meeting regulatory obligations and timelines for safety reporting.
Therefore, the QPPV must be very experienced in clinical trial safety as well as safety
regulations, compliance, and policy. The QPPV oversees the pharmacovigilance plan
development and proactive risk minimization strategies.

Regulatory Process in the United States of America, Europe, China, and Japan.

Pharmacovigilance Risk Assessment Committee

Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and

monitoring safety issues for human medicines. PRAC provides the safety recommendations to
CHMP. PRAC is composed of the following members.
Does Regulation Drive Science or Does Science Drive Regulation?

The Pharmacovigilance System Master File

The Pharmacovigilance System Master File (PSMF) is a mandatory requirement in Europe, as

described in EU GVP Module II.25 The PSMF is a dynamic document which describes the
global PV system of the MAH in a prescribed format, with a focus on how the system affects
products authorized in Europe. It includes how all departments within a company interact with
PV and if any tasks have been delegated to third parties.

The PSMF is maintained and updated at frequent intervals by MAHs. It contains contact details
and the resume of the EU QPPV plus a summary of the PV organizational structure including the
physical site(s) where specific safety information is handled (such as data entry of adverse events
into the global database, signal detection, and safety analysis). The PSMF documents the sources
of safety data, including clinical trials and marketed drug data collection programs.

The purpose of the PSMF is to provide the EMA and EU competent authorities with an overview
of a company's PV system. It is used by EU regulators in a risk-based manner when selecting
companies for PV inspection.

Some non-European regulators still use the Detailed Description of the PV System (DDPS)
(referred to in superseded EU PV legislation), meaning that MAHS must maintain both
document formats. To complicate matters, other countries have duplicated the EU PSMF
requirements and have added extra requirements. For example, countries following the Arab
GVPS accept the EU PSMF but also require an additional document referred to as the
Pharmacovigilance System Sub- File, which focuses on the national PV system. More recently,
the Eurasian Economic Union has requested a separate Eurasian Union PSMF. This is clearly an
area that lacks harmonization
3. Pharmacovigilance planning:

Abstract:

The pharmacovigilance plan describes how the safety profile of a medicine is further
characterised. Companies must perform routine, ongoing PV activities for their products such as
benefit-risk monitoring and managing spontaneous reports. These may be sufficient to address
some, or even all, of a product's safety concerns. However, additional PV activities are often
needed, which are usually classified as post-authorisation safety studies (PASS). These can
include further clinical trials as well as non-interventional approaches, such as observational
studies or patient registries. This chapter summarises the contents of a PV plan and the range of
available routine and additional PV activities. It also discusses how to assess the need for
additional actions and select the most appropriate options.

4. Methods

Literature Review and Survey Development A comprehensive literature review of English

language literature to inform the project background was conducted in pertinent electronic health
databases (PubMed, EMBASE, IPA, CINAHL: 1990-December 2010) and the Google and "side
Google Scholar search engines using combination of predetermined key words and phrases,
"pharmacovigilance"; "postmarketing surveillance"; "adverse reactions"; "adverse events";
effects"; "safety"; "monitoring"; "reporting"; "pharmacist"; "attitudes"; "perceptions";
"experiences"; "barriers"; "survey"; and "questionnaire". Online resources of multinational
organizations, such as the World Health Organization, the International Society of
Pharmacovigilance, and the European Union Expert Group on Safe Medication Practices were
verified. Hand-search of references of retrieved articles was also performed. Retrieved reports
that describe or contribute new data pertaining to pharmacovigilance activity of health
professionals were reviewed (n=45) and papers reporting findings from survey methodology
(questionnaires) (n=37) were evaluated and potentially adapted in the development of our own
survey. Relevant studies reporting results of health professional survey of pharmacovigilance
activity were summarized to explore patterns of questions [Link] themes emerged and
our questionnaire was developed according to the domains of interest evaluated in this existing
literature: subject demographics; ability to detect suspected ADRs (knowledge); experiences
reporting suspected ADRs; attitudes towards pharmacists" role in ADR reporting, perceived

barriers and facilitators to suspected ADR reporting: recommendations for improvements in this
process locally; as well as questions encompassing the "seven deadly sins" or factors associated
with under-reporting of suspected ADRs, as described by Inman (Appendix A).A draft
questionnaire was then reviewed for face and content validity by a small working group of
members of Qatar University (QU) College of Pharmacy (CPH) faculty and staff.

The survey was translated into Arabic by two undergraduate pharmacy students under the
supervision of specific small working group members. Native Arabic speakers fluent in English
translated the survey into Arabic (forward translation) and then the document was back-
translated into English by the first group (who were hence familiar with English content) and a
third native Arabic speaker fluent in English who was blinded to the original English version.
Any discrepancies were then reviewed, discussed, and corrected. Questionnaire piloting was
undertaken by a small randomly selected group of Qatar pharmacists, after which any necessary
design changes were made. The decision to include this pilot group in the final data was
dependent on the magnitude of modifications made to the pilot questionnaire, which were few.
The pilot sample group was separate from the small working group. Both closed- and open-
ended questions were posited in the survey (Appendix B). Knowledge of suspected ADR were
ascertained by giving short scenarios (1 sentence G2127 12 each) and asking respondents to
correctly identify whether or not a suspected ADR has been described (binary response)
Suspected ADR scenarios were developed according to internationally recognized definitions
(Appendix C).1,2,4,5 Respondents were asked to rate their level of agreement (5-point likert
scale) with statements outlining specific attitudes, experiences, barriers and facilitators of
suspected ADR reporting, most of which were extracted from prior literature surveying
pharmacist pharmacovigilance elsewhere. Survey Sample and Deployment Qatar is an emerging
economy but its infrastructure for health professionals lags considerably behind that of
developed countries. In the absence of a national pharmacy regulatory body, there is no complete
database of pharmacists working in Qatar.45 The QU CPH Community Outreach Committee
maintains an independent internal database of 568 pharmacist contacts (which according to best
estimates, represents 70-75% of all pharmacists practicing in the country). This convenience
sample of pharmacists employed within documented public and private health care facilities
were invited to participate in the survey. Inclusion Criteria: Pharmacists employed in private and
public health care settings in Qatar who are recorded in the QU CPH Community Outreach
Database. The questionnaire was formatted as an electronic survey (SurveyMonkey program).
Using workplace contact information (email, fax) documented in the QU CPH database,
pharmacists were invited by email to participate in the anonymous web-based survey that
remained open for response over a 2-month period.

The cover letter outlined the survey purpose, instructions on and estimated time for completion,
as well as how G2127 results will ultimately be shared with respondents (Appendix D). Email
and fax reminders were sent at designated intervals at 2, 4, 6, and 8 weeks. Planned efforts to
increase the response rate included the random selection of one sample subject at 4, 6 and 8 week
intervals to receive a pharmacy book prize. Winners were announced by email and fax to the
sample population and coincided with the survey reminders. In addition, two live continuing
professional pharmacy development (CPPD) events were conducted on-site at QU CPH during
the study period where hardcopies of the survey were distributed to attending pharmacists and
collected at the end of the event. Any subject indicators were separated from the body of this
hardcopy questionnaire and responses manually entered into the SurveyMonkey® program by
the investigator. Ethical Considerations.

This research project posed no risk to participants. There was no medical intervention or invasive
procedure and no adverse effect on rights or welfare. Electronic responses were anonymous and
no attempt made to collect IP addresses. Any respondent indicators (e.g. consent signature and
contact information) on manual survey submissions (e.g. by fax or by hardcopy) were physically
separated from the questionnaire content before data entry. The research proposal was submitted
and approved by both the QU and London School of Hygiene and Tropical Medicine
Institutional Review Boards (IRB) (Appendix E). Statistical Analyses Survey questions were
coded according to domain: subject demographics; ADR knowledge; suspected ADR reporting
experiences; attitudes; and perceived barriers and facilitators (Appendix F). Incomplete surveys
were analyzed provided a response to the G2127 14 dependent variable question (history of
suspected ADR reporting in Qatar) was given. Frequencies of correct and incorrect answers to
ADR knowledge questions were assessed. Categorical data is presented as percentages of
frequency or occurrence and continuous data is presented as means with standard

deviations. Responses are further stratified according to categorical demographic parameters of

age, gender, years in practice, and practice setting, as well as comparisons between ADR
reporters and nonreporters. Statistical comparisons of frequencies utilized x 2 -tests with an alpha
of less than or equal to 0.05 considered statistically significant.

Univariate and multiple logistic regression analysis was used to examine differences in ADR
reporting (dependent variable) among pharmacists according to a priori defined criteria including
independent variables: age; gender; years in practice; and practice setting. Results are expressed
as odds ratios and 95% confidence intervals. All data analyses was conducted using IBM SPSS®
for MAC release 19.0. Results Characteristics of Study Group The survey remained open for two
months between April 30 and June 30, 2011.

At the end of this time, 130 (22.9%) pharmacists had accessed the survey online and 12 were
completed manually at the live CPPD events. Of the 142 (25%), total responses 116 (81.6%)
surveys were completed beyond demographic data and included information about prior
suspected ADR reporting experiences. No survey was completed in Arabic. Half of respondents
were female (52.6%) and the mean age was 36.2 years (range 23- 60) (Table 1). Seventeen
different countries of origin were represented with the majority of pharmacists from either Egypt
(34.5%) or the Sudan (18.1%). Most had G2127 15 attained a Baccalaureate as the highest
pharmacy degree (87.9%) from various Arab (60.2%), South Asian (12.9%), or African (12%)
program. The median interval length of time since graduation from their highest pharmacy
degree program was between 1-10 years. One-third had held their highest pharmacy degree to
practice for 10-20 years and 12.1% had obtained their initial degree more than 20 years ago. The
majority (77.6%) had practiced in the country for less than 10 years, and among these 41.4% for
less than 5 years. More respondents represented in-patient pharmacy practice sites (64%) while
onethird described their workplace as serving ambulatory patients (community pharmacy site or
public/private outpatient clinic). The remainder (7.8%) stated employment in government,
industry, or academic positions. Only fourteen (12.1%) had never worked in a hospital
pharmacy. ADR Knowledge Pharmacist knowledge of ADR terminology was assessed. Over
90% identified the WHO description of an ADR; however, approximately 1 in 5 selected
statements inconsistent with accepted ADR descriptions, in addition to another 1 in 5 who were

unable to choose (Table 2). Many correctly identified that prolonged hospitalization (78.4%) or
death (65.5%) associated with use of a medication would be categorized as a severe ADR, but
less (39.7%) did so for hospital admission to investigate a recognized, but uncommon ADR.
Most pharmacists were able to correctly distinguish an ADR (Scenarios 1 and 3) from a
medication error (Scenarios 2, 4, and 5), but approximately 10% mischaracterized or were unable
to offer an answer for each scenario (Table 3), Suspected ADR Reporting Experience G2127 16
Forty-nine (42.2%) made suspected ADR reports in the past, of whom thirty-four (29.3%)
reported doing so in Qatar. Twenty-nine (85.3%) of these reports were by hospital pharmacists, 4
(11.7%) from ambulatory clinics and 1 from a non-direct patient care position. No community
pharmacist surveyed had ever made a suspected ADR report in Qatar. Reporters mostly
submitted their documentation to the hospital pharmacy and therapeutics (P&T) committee
(97%), but also directly to the SCH (14.7%) or drug manufacturer (5.9%). Eighteen (53%)
described receiving some form an acknowledgement for their submission. When asked to
describe the ultimate fate of a submitted suspected ADR report in Qatar, over half of all surveyed
(54.3%) were unsure (Figure 1). If faced with a patient experiencing a serious ADR, most
respondents said they would investigate further, including consulting the literature for
information concerning the reaction (90.5%), taking the responsibility to alert the prescriber
(97.1%), and directing the patient for further emergent care (84.6%). The majority (90.5%)
thought they would initiate a suspected ADR report (Table 4). Attitudes Towards Suspected
ADR Reporting Most believed pharmacists (88%) and physicians (81%) were qualified to report
suspected ADRs, but less confidence was expressed for nurses (57%) and other health
professionals or students in pharmacy or medicine (Figure 2). Pharmacists were asked to offer
opinions regarding the purpose of pharmacovigilance and their roles in this regard (Table 5).
Respondents uniformly agreed with aims of pharmacovigilance activity to promote new
understanding of medication; patient safety; and transparency of reporting (e.g. only 14.7% and
23.8% G2127 17 agreed that the reporter and prescriber, respectively, should not be indicated on
the documentation).

A high proportion (84.4%) felt that suspected ADR reporting was a professional obligation and
60% disagreed with a voluntary reporting model. Suspected ADR Reporting Barriers and
Facilitators Tables 6 and 7 show potential factors which may discourage or conversely ease the
process of suspected ADR reporting. Although more respondents identified that lack of access to
a reporting form and remuneration were problematic, a larger proportion disagreed that these
issues were barriers (46.2% and 45.5%, respectively). Time constraints were also rated low
(21.2%) as a potential impediment. Inability to recognize a suspected ADR was a barrier stated
by 39.4%. Pharmacists identified an increased likelihood to report a suspected ADR if the
reaction were: serious for the patient (96.2%); novel (90.2%), or associated with a new
medication (88.8% ); and if some feedback was offered (e.g. acknowledgment of submission
($3.4%) or intended response to report (75.2%). Many (81.6%) felt more pharmacovigilance
training and an ability to submit online (68.6%) would facilitate reporting. When asked to
express any suggestions to improve pharmacovigilance activity in Qatar, 24 (20.6%) offered a
range of comments describing a desire for more training in the identification of suspected ADRs;
wider accessibility to a common form; and an efficient means for submission. Factors Associated
with Suspected ADR Reporting When stratified according to gender, age, practice setting and
years in practice, there were no significant differences in responses for suspected ADR reporting
knowledge, attitudes or perceived barriers and facilitators. Only availability of an ADR G2127
18 form was considered a greater barrier for ambulatory care pharmacists when compared with
their hospital-based colleagues (11.4% vs 40.3%, p=0.002). Univariate analysis found that
hospital pharmacists were 5 times more likely than ambulatory care pharmacists in this sample to
have submitted a suspected ADR report in Qatar (OR 5.23, 95% CI 1.6-16.38), p=0.002), No
statistically significant effect of gender or age was found when independently assessed (Table 8).
Stratum specific analysis demonstrated increased odds (OR 6.46, 95% CI 1.2-21.4, p=0.02 and
OR 13.3, 95% 3.5-84.9, p=0.006) of suspected ADR reporting in Qatar when years of practice in
Qatar were 6-10 and >15 years, respectively, but these confidence intervals are wide. Direct
logistic regression was performed to assess the impact of the four independent variables on the
likelihood that respondents would report having made a suspected ADR submission in Qatar.
The full model containing all predictors was statistically significant, x 2 (7. n-103)-27.42, pl5
years categories) independent variables made a unique statistically significant contribution to the
model. When controlling for all other factors in the model, respondents working in hospital
settings were now over 7 times more likely to have reported a suspected ADR in Qatar. When
the results of Qatar suspected ADR reporters and non-reporters were compared, there were no
differences in ADR knowledge, attitudes, experiences, or G2127 19 identified facilitators to

pharmacovigilance activity. Non-reporters more often cited unavailability of ADR forms or

patient encounters as impediments to participation (48% vs 22%, p=0.021 and 21% vs 6%, p-
0.039, respectively), but more reporters described lack of payment as a barrier (26% vs 51%, p-
0.041). Discussion This is the first study to evaluate knowledge, experiences and attitudes about
spontaneous suspected ADR reporting among pharmacists in Qatar. As anticipated, a diverse
group of respondents emerged with respect to country of origin and education. The paucity of
Qatari pharmacists is mainly due to the historic absence of a domestic pharmacy college (Qatar
University graduated its first class (18 women) in June 2011) and cultural factors which often
hinder female students" capacity to study abroad. Few advanced pharmacy degree opportunities
(non-distance-based) exist in the region and so most have presently peaked at baccalaureate-
training.26 While just under half of survey respondents had worked as a pharmacist for over a
decade, less than 25% have done so this long in Qatar. Like many other occupations and
professions, it is possible that pharmacists have also migrated from countries nearby to capitalize
on Qatar's emerging economy. 46 ADR Knowledge Knowledge of ADR classification was
assessed, through recognition of definitions and patient descriptions, as it is follows that poor
knowledge would lead to low declared reporting rates. Correct identification of ADRs was high
in our sample and greater than that reported elsewhere recently. 18,39 Still, a good proportion of
pharmacists gave incorrect answers or indicated they were unable to determine an answer. It is
possible our scenarios could be misinterpreted by pharmacists as definitions of an adverse drug
G2127 20 event, "an injury resulting from the use of a drug" which would encompass ADRs as
well as incorrectly prescribed drug or an intentional overdose.2 It is also likely that formal
classifications of the seriousness of a suspected ADR (by WHO, for example) are not widely
known, although most pharmacists intuitively knew prolonged hospitalization and death possibly
associated with a medication were grave outcomes for the patient. It is worthwhile noting that
"serious" and "severe" are not synonymous in ADR nomenclature. "Severe" is often used to
describe the intensity of a specific event, but the event itself may be of relatively minor medical
significance (e.g. a severe headache). Conversely, "serious" is rated on the patient outcome or
action criteria usually associated with events posing a threat to a patient's life or well-being;
seriousness and not severity serves as a guide for defining regulatory reporting obligations. 47 It
is unknown if this pharmacist population regards adverse outcomes associated with use of herbal
or complementary and alternative medicine

reportable in the same manner as those reactions arising from other medications, although two-
thirds correctly identified that death from hepatic complications associated with an herbal
product described in one of the questionnaire's patient scenarios was a serious ADR. The
Pharmacy and Drug Control Department of the SCH in Qatar is active in issuing warnings
through lay media to increase public awareness and safety with regard to use of herbal products,
but this is principally in instances where they may surreptitiously contain harmful substances.48
Pharmacist distinction between ADRs and medication errors is also important as the implications
for reporting processes and response differ. Medication errors, either potential or actual are
considered preventable events that may cause or lead to G2127 21 inappropriate medication use
or patient harm. They may occur at multiple points of the drug use process during, transcribing,
dispensing, administering, adherence, or monitoring a drug and examples include misreading or
miswriting a prescription. Safeguards to minimize risk of medication error in drug use processes
hinge principally on technological advances (computerized physician order entry, point-of-care
unit dosedispensing cabinet, bar-code technology) and do not apply to mitigation of
[Link] ADR Reporting Experience One-third of responding pharmacists had submitted
a suspected ADR report while practicing in Qatar, slightly less than the proportion that stated
they had submitted one ever. This rate is higher than others documented recently in the region
(approximately 10% in Saudi Arabia, 21% in Turkey), but these investigations were all
conducted in community pharmacist populations only. 18,23 Conversely, our findings are within
reported ranges when surveys among hospital pharmacists in the past decade are considered,
(14.6% China, 23% Saudi Arabia, 25% and 61% in UK studies) 29,30,39,40 As the majority of
suspected ADR reporters in our study were in-patient pharmacists, it is not surprising that
submitted reports largely went to the hospital P&T committee. Having said this, health care in
Qatar is a mixed-model, provided by both public and private facilities and currently only public
hospitals are internationally accredited. Four of the 5 private hospitals lack policies and
procedures for pharmacovigilance activity and so these pharmacists would need to report to an
alternate authority 24 Uncertainty exists related to how submitted suspected ADR reports are
handled in the country. In Qatar, there is no directive that reports be automatically advanced to
the SCH from patient care sites and there is no indication that reports received by the SCH
G2127 22 are consistently or systematically addressed. This ambiguity is detrimental to
coordinated and collaborative medication safety monitoring and likely hinders reporting activity,

especially for pharmacists whose practice site is not affiliated with a hospital P&T. Local
(hospitals, primary care centers) and national (SCH) bodies alike could also enhance
pharmacovigilance awareness and reporting with implementation of a feedback mechanism; only
half of our respondents described receiving some form an acknowledgement for their
submission.51-53 When faced with a hypothetical patient experiencing a serious reaction that
could be attributed to a medication, most pharmacists indicated they would look up information
and offer clinical guidance, but community pharmacies in Qatar generally do not have internet
access and hard copy references are poor. 54 There is no information as to the number of
community pharmacist who can overcome this technological hindrance with personal handheld
wireless devices or smartphones. Attitudes Towards Suspected ADR Reporting This study
illustrates a good understanding of purpose and positive attitude towards suspected ADR
reporting by pharmacists in Qatar. Not all countries permit ADR reporting by non-physician
healthcare providers, but reassuringly the majority of our responding pharmacists considered it a
professional obligation as advocated by international pharmacy bodies. 25,55 Healthcare
providers should be considered partners in improving patient outcomes, as well as in
pharmacovigilance activities, and our respondents largely felt physicians and nurses were
qualified to make report suspected ADRs, but not students. The value of pharmacy student
participation during experiential training is worthy of promotion as it has been shown to increase
suspected ADR G2127 23 documentation in reporting programs and enhance patient care, as
well reinforce their future roles in medication safety monitoring. 56 Patient reporting of
suspected ADRs is also gaining momentum worldwide, but we did not ask pharmacists"
perceptions of this in our survey.57 Suspected ADR Reporting Barriers and Facilitators
Unavailability of a reporting form has been a stated constraint to voluntary participation in
pharmacovigilance activities in other studies, but this was not a collective barrier in our
population; this may be due to the large number of hospital practitioners responding who may
have a standard form in place at their site. Unlike a number of other reports, the time required to
report a suspected ADR was not considered a major barrier either, but Qatar pharmacists did
express sentiments similar to both community and hospital pharmacists elsewhere in the Middle
East, Asia and Europe who are unsure if a patient reaction is truly an ADR.11, 17,19,
27,31,39,40 This diffidence has also been expressed by physicians and is perhaps surprising

given these professionals must often take action despite medical ambiguity (e.g. differential
diagnoses).20-22 Our survey's ADR knowledge-oriented questions did not assess pharmacists"
suspected ADR recognition through causality exercises (e.g. dechallenge and rechallenge
principles) to help determine if difficulties might instead lie with low confidence and not poor
ability. Communication and education from regulatory and health professional bodies should
emphasize that clinical certainty is not prerequisite for report submission as causality assessment
can be performed by the pharmacovigilance authority according to documentation of the
suspected ADR provided by the reporter. G2127 24 Our results indicate that financial
compensation is not a stated incentive for spontaneous ADR reporting among these pharmacists,
which is in keeping with our findings of positive attitudes in our sample population towards the
professional responsibility of pharmacovigilance. Pharmacists preferred a singular and accessible
suspected ADR reporting form with web-based submission capability. Clarity of suspected ADR
reporting forms and ease of submission essential components for any are
pharmacovigilanceprogramme. Even the most motivated pharmacist will likely abandon the
reporting process for other patient care priorities when faced with a frustrating search for an
unavailable form. On the other hand, forms developed in isolation unnecessarily generate
multiple discrepant documents, some potentially overlooking collection of relevant information,
and make it less straightforward for reporters in multiple patient care sites. A singular national
suspected ADR reporting form modeled from an ideal sample (e.g. WHO) would simply
reporting and enhance data collection and causality analysis, both locally and globally. 58,59
Factors Associated with Suspected ADR Reporting Hospital pharmacists in Qatar were far more
likely to have made a suspected ADR report than community pharmacists and this is consistent
with low reporting rates of community pharmacists encountered elsewhere. 11,13,18,23,27,28
Factors for such in-patient site-related differences in reporting have been previously proposed:
greater familiarity with pharmacovigilance; constant contact with patients experiencing serious
ADRS; and close relationships with physicians who may delegate reporting of ADRs they have
identified to the hospital pharmacist. G2127 25 Hospital pharmacists may have greater abilities
to recognize suspected ADRs. Pharmacists with additional clinical training are usually employed
in the hospital sector in Qatar and any pharmacovigilance education is more likely to be
conducted here.

Local pharmacovigilance activity may be promoted by the medication safety standards

prescribed by international agencies which have recently accredited the country's public
hospitals, but no policies and procedures are yet implemented at the majority of private sites in
the country. 24 The development of a local written hospital policy is certainly a positive
administrative step to facilitate spontaneous ADRs reporting; however, ability for clinical
recognition as a barrier persists among a large proportion of the hospital pharmacist survey
respondents and has been previously described for other groups of hospital and community
pharmacists. 11, 17,19, 27,31,39,40 Pharmacists" lack of clinical confidence in diagnosis of
ADRs and its causality should be further addressed. Before the pharmacist can detect and report
an ADR, they must have opportunity to encounter them. It has been demonstrated that
participation in ward rounds improves pharmacist suspected ADR reporting rate, but hospital
pharmacists in Qatar are not necessarily at an advantage in this regard.60 Our questionnaire did
not explicitly inquire about hospital participation in ward rounds, but it is known that currently
less than 20 pharmacists in these large practice sites have de-centralized roles. Ambulatory
carebased pharmacists might actually then have an advantage with respect to daily volume of
patient interactions. 18,28 Indeed the role of community pharmacists in spontaneous ADR
reporting is crucial in the pharmacovigilance system since it allows for medication and patient
monitoring under actual conditions.

To be accomplished, however; patients must first present to the pharmacist who then needs to
elicit the existence and circumstance of G2127 26 the untoward reaction. In Qatar, there is
ongoing work to determine and elevate both the level of pharmacist interview skills and public
perceptions of pharmacist roles.61,62 In many countries worldwide, community pharmacists as
recognized as accessible and reliable health providers and Qatar is highlighting these attributes
under its recently launched health care reform which emphasizes a shift towards a preventative
and community-based model anchored by primary care settings.63 Hospital pharmacists are still
more likely to espy the serious ADRs (as these patients have required admission) and have
processes in place for reporting; unlike in hospitals, if ambulatory care-based pharmacists do
identify suspected ADRs, no national reporting form is available, nor is the submission process

outside a hospital pharmacy framework clear. The multivariate analysis found women two-thirds
less likely to have submitted a suspected ADR report in Qatar. Gender-based differences have
not been previously described and it is unclear why this report would differ. This finding requires
further exploration as women are in fact at greater risk of experiencing ADRs to many
medications and cultural preferences for same gender care delivery often arise in the country.64
When controlling for other variables in our model, increasing age was also associated with
decreased reporting, contrary to other findings. 27 Older pharmacists in Qatar may have
graduated from product-centered education models historically offered in the Middle East region
as opposed to more contemporary patient-oriented programs and despite greater practical
experience, have less clinical confidence in detecting potential ADRs.26 Pharmacists with longer
practice history in the country in theory have had greater opportunities to encounter, detect, and
report suspected ADRs in Qatar. The study's crude and adjusted analyses did show significant
increases in the odds of G2127 27 reporting within stratum-specific practice durations but with
suitably wide confidence intervals reflecting the smaller respondent samples in these categories.
Limitations There are a number of limitations to our survey warranting discussion. The absence
of a formal national pharmacist registry means our study sample is incomplete. Our internal
College of Pharmacy records estimate 200 retail pharmacies are operating in Qatar and so our
corresponding community pharmacist respondents under-represent pharmacists at these practice
sites. Survey invitation was by fax and email, but actual survey completion was by internet-based
questionnaire; no faxed hardcopies were returned during the data collection period. Community
pharmacies in Qatar do not generally have internet access and so pharmacists with limited or no
internet access at home may have been disadvantaged 45,54 Non-response error (occurring with
survey response rates.

5. Recommendations

National Perspectives Resource constraints have proven a significant barrier to building and
optimizing pharmacovigilance systems in many countries.67 Fortunately, this is not the case in
Qatar where the government has recently committed significant funds towards the
reconfiguration and strengthening of health care processes and infrastructure over the next
decade. The political and financial climate is ideal to capitalize on opportunities to: 1. Earmark a
portion of new health care funding to the creation of a Qatar Pharmacovigilance Center. This
center could be a new subdivision of the Supreme Council of Health or a singular subsection of
the existing Pharmacy and Drug Control Department subdivision. Qatar is a small enough in
geography and populace that decentralized regional centers are presently unnecessary. Allocate
devoted staff and budget national funds annually for its operations and personnel training. 2.
Develop national pharmacovigilance strategic plans: form an advisory committee; adopt and
disseminate reporting tools (e.g. a national suspected ADR reporting form); establish and
promote mechanisms for submission to a national central repository; determine
acknowledgement and feedback systems; produce multimedia materials to inform health
professionals about definitions, aims, and methods of the system; determine program evaluation
criteria and processes. 3. Obtain membership with the World Health Organization (WHO)
Programme for International Drug Monitoring. This programme can further guide and inform
strategy and roles for a Qatar Pharmacovigilance Center, provide training and software support
G2127 32 and resources, and offer access and contribution rights to VIGIbase, the largest and
most comprehensive individual case safety report database in the world. 4. Develop and maintain
a national database for documentation and analysis of submitted suspected ADR reports. 5.
Generate formal mechanisms to share medication safety information regionally. The Middle
East, and the GCC in particular, are made up of small countries with similar demographics and
population genetic and cultural make-ups that influence medication and patient safety. It is of
value then for ADR submissions to ultimately end up in one data repository for meaningful
analysis of the accumulated data to inform priority needs and relevant solutions in these
countries.67 The GCC DR is an existing vehicle for this enterprise with Saudi Arabia serving as
a leader within the group, having worked to develop their national pharmacovigilance program
for five years prior to its 2009 launch. Saudi Arabian experience and expertise coupled with
additional collaborative efforts across other GCC countries could build technical capacity in the
region and consolidate reporting back to a global database.

6. Local Perspectives - Public and Private Hospitals

1. Generate and implement written pharmacovigilance policies and suspected ADR reporting
procedures in private hospital settings.

2. Increase ease of suspected ADR reporting within all hospital settings. Online report form
access and submission would facilitate reporting as could other technological vehicles, such as
the capacity to transmit via mobile device (e.g. short message service, or SMS). Web-based
placement of all aspects of the pharmacovigilance program (including description and
participation) would further promote awareness. G2127 33

3. Enhance (public hospital) and create (private hospital) immediate feedback processes and
periodic summative reports in all hospital settings. Acknowledgement is vital to maintain health
professional motivation and participation in a pharmacovigilance program. A simple automated,
yet customized response should be sent to acknowledge every individual who submits an ADR
report and offer feedback on the fate of the submission. Quarterly or semi-annual publication of
an ADR bulletin would regularly inform health care provider staff of pharmacovigilance
activities and further promote awareness of suspected ADR reporting in the hospital
[Link]

Pharmacovigilance is part of healthcare systems worldwide. The WHO leads pharmacovigilance

operations and provides technical support in reporting ADRs. Many countries have well-built
pharmacovigilance systems, but actual incidence of ADRs is much nigher than what is reported.
Underreporting of ADRs is a major problem as well as the quality of reports. The basic objective
of pharmacovigilance is the safe use of drugs, patient safety, and, ultimately, safeguarding public
health. To achieve this goal, national regulators and international organizations should empower
healthcare professionals and the public to report more ADRs.
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