health professionals’ awareness about pharmacovigilance system in bulgaria

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Petkova et al. World Journal of Pharmacy and Pharmaceutical Sciences

HEALTH PROFESSIONALS’ AWARENESS ABOUT

PHARMACOVIGILANCE SYSTEM IN BULGARIA

Tatyana Benisheva-Dimitrova¹, Petya Trendafilova¹, *Valentina Petkova², Dobriana

Sidjimova¹, Emilia Naseva¹

¹Faculty of Public Health, Medical University –Sofia, Sofia, Bulgaria.

²Faculty of Pharmacy, Medical University –Sofia, Sofia, Bulgaria.

ABSTRACT

Statistics show that about 6% of hospital admissions are due to adverse

drug reactions (ADRs) and over 50% of them could have been

avoided. In accordance with European and national regulatory changes

related to the pharmacovigilance system since 2012, the issue of

medical professionals’ awareness on the given topic is extremely

important. The annual reports of the BDA website for the period 2000-

2012 refer to the low average of ADRs reporting among health

professionals and it proves thatmedical specialists in Bulgaria do not

realize the importance and necessity of ADRs reporting in order to

ensure and maintain safe and effective medicinal products. A pilot

study has been undertaken in order to investigate medical professionals’ awareness in

Bulgaria about the importance of adverse drug reactions reporting. Pharmacovigilance is

defined as a system for collecting, monitoring, researching and evaluating information by the

healthcare professionals, marketing authorisation holders and patients. In this survey

undertaken in 2013 among 143 health professionals regarding pharmacovigilance system, a

significant awareness of 61.5% of the respondents was found. More than half of the surveyed

health professionals are familiar with the reporting rules and regulations, regardless the low

frequency of reporting for the country, published in the annual reports of the Bulgarian Drug

Agency (BDA) The highest share of pharmacovigilance knowledge is among the

pharmacists, followed by assistant pharmacists and the medical doctors. Regarding the

procedure for adverse drug reactions reporting the proportion of respondents who answered

correctly was 85.3% or 122 participants in the study indicated that this is by completing the

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Article Received on 28 May 2013, Revised on 29 June 2013, Accepted on 27 July 2013

*Correspondence for

Author:

* Dr V. Petkova,

Faculty of Pharmacy, Medical

University – Sofia.

[email protected]

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“Yellow card” provided by the BDA. Nevertheless the propotion of the health professionals

who reports is only 6%. On the other hand, the low level of reporting of adverse drug

reactions suggested that the health personnel do not realize the importance and necessity of

adverse drug reactions reporting, which is extremely important for the public health

protection. This requires major initiatives in the health and in the education system of the

medical professionals for continuous and systematic education in the pharmacovigilance rules

as a discipline for understanding the meaning and importance of the issue. The results show a

great need of further health professionals’ training on ADRs reporting in order to be able to

understand the nature of the pharmacovigilance system, optimize the use of scarce health

resources and prevent potential tragedies. This study has been funded by Medical University

– Sofia, Council of Medical Science under project № 26 on 'Reporting of adverse drug

reactions among medical specialists', "Grant – 2012", Contract №53/2012.

Keywords: Pharmacovigilance, health professionals, adverse drug reactions,awareness.

1. INTRODUCTION

Pharmacovigilance is defined as “the science and activities relating to the detection,

assessment, understanding and prevention of adverse effects or any other possible drug-

related problems”. [1]

It aims at making the best use of medicines for the treatment or prevention of disease. Good

pharmacovigilance practice will identify the risks and the risk factors in the shortest possible

time so that harm can be avoided or minimized. When communicated effectively, this

information allows for the intelligent, evidence-based use of medicines and has the potential

for preventing many adverse reactions. This will ultimately help each patient to receive

optimum therapy and, on a population basis, will help to ensure the acceptance and

effectiveness of public health programmes. [1]

In line with Article 57 (1)(d) of Regulation (EC) No 726/2004 which provides the legal basis

for thedissemination of information on adverse reactions (as well as, Directive 2001/83/EC,

as amended, andDirective 2001/20/ECthe EMEA is in the process of developing a

EudraVigilance Access Policy.Which should provide stakeholders such as National

CompetentAuthorities (NCA), healthcare professionals, patients, consumers, and the

pharmaceutical industry withinformation on adverse reactions to medicinal products derived

from the EudraVigilance database.(2-6)

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Avoidable adverse drug reactions and medications errors are leading cause for morbidity and

mortality and there arepatients’ needs which are for good rug information and for better

understanding of the medicinal product choices. One of the reasons why pharmacovigilance

systems are not fully functional and effective is that many stakeholder groups do not

participate sufficiently in the reporting of ADRs. In most countries, only health professionals

are currently encouraged to report ADRs. it has been demonstrated that health professionals

only forward a small minority of all reports Increasingly, therefore, more according to the

current EU Legislation [7-12].

In Bulgaria,in 2011,only 327 reports have been received by the Bulgarian Drug Agency

(BDA) and 258 of these are valid reports for serious 182 (56%|) and 76 (23%) are for serious

and unexpected ADRs, which proves that the non-serious substantial ADRs are not a

substantial part for 2011 but the health professional reorting is still limited . [13]

Pharmacovigilance incorporates and provides training in the identification of adverse

reactions, data collection, processing and analysis. Importantly, these activities allow for the

identification of previously unsuspected adverse reactions as well as identification of their

effects in pregnant women and in the very young or old, which, for new medicines, are

generally unknown. The information collected also provides the tools for the effective

management of problems. These include communication and minimization of risk. [1]

In accordance with European and national regulatory changes related to the

pharmacovigilance system since 2010, the issue of medical professionals’ awareness on the

given topic is extremely important. Moreover, according to the Bulgarian legislation since

2012, health professionals are obliged to report adverse reactions. This applies to risk

management plans and leads to risk minimization actions between health workers and

patients. In many articles like Cox and Butt stress that the prescribers prefer to highlight the

benefit than the risk and the trust of patient and their health workers must be fundamental.

The aim of the study is to survey the understanding of the pharmacovigilance system and also

the report system for risk minimization of medicinal productsamong the health professionals

2. MATERIALS AND METHODS

The purpose of this study is to present the importance of integrating pharmacovigilance as an

essential component of health professionals’ every day work, as well asraising awareness

https://www.researchgate.net/publication/6982173_Which_drugs_cause_preventable_admission_to_hospital_A_systematic_review?el=1_x_8&enrichId=rgreq-baa1959652133b7273fdef04d38c4cbc-XXX&enrichSource=Y292ZXJQYWdlOzI2NzAyNjY4ODtBUzoxNTMzMDgxMzYyMTg2MjRAMTQxMzU2MjkxNjI2Mg==

https://www.researchgate.net/publication/232248817_Adverse_Drug_Reactions_When_the_Risk_Becomes_a_Reality_for_Patients?el=1_x_8&enrichId=rgreq-baa1959652133b7273fdef04d38c4cbc-XXX&enrichSource=Y292ZXJQYWdlOzI2NzAyNjY4ODtBUzoxNTMzMDgxMzYyMTg2MjRAMTQxMzU2MjkxNjI2Mg==

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about medical specialists’ important role in reporting of adverse drug reactions of prescribed

medicinal products, and optimize the use of scarce health resources and prevent potential

tragedies.

A pilot study has been undertaken among 143 health professionals living in Bulgariain order

to investigate medical health workers ’awareness in Bulgaria about the importance of adverse

drug reactions reporting, and the legislative initiatives in the pharmacovigilance area after

2010.

Methods used

documentary method,;

developed questionnaire of 20 anonymous questions on multiple choice

sociological method;

methods for analyzing and processing of the data;

graphical, statisticalSPSS 16.0 software

mathematical methods also have been used.

A total of 143 health professionals (response rate: 87.24 %) filled in the questionnaire.

A specially developed questionnaire of 20 anonymous questions on multiple choice has been

used among medical specialists with different background – medical doctors, pharmacists,

and assistant-pharmacists were also included because of their central role in drug dispending

and information. The rest of the respondents like nurses, midwifes, laboratory assistants,

paramedics are part of the study due to their close communications to the patients. The

developed questionnaire was completed at three different hospitals in Sofia, the Transport

Hospital and the Pediatric Hospital at the Alexanrovska University Hospital and one country

hospital in Samokov. The surveyed pharmacists were mainly in Sofia.

3. RESULTS AND DISCUSSIONS

The results show that 70 (49%) out of 143 medical professionals who took part in the survey

have a Master degree (in medicine or pharmacy, almost equally distributed), and 73(51%) of

them have a bachelor degree (nurses, midwifes, laboratory assistants, paramedics and

assistant-pharmacists with predominant involvement of nurses). Their distribution is shown

оn Figure 1.

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Figure 1: Distribution of participants according to their background (%).

Only 49 (34.3%) participants answered correctly to the question "What is the nature of drug

safety?" The correct answer representsdetection, assessment and prevention of adverse

reactions to pharmacologicaltreatment. The rest of 65.7%chose one or another wrong or

incomplete answers. Although one third of the responding healthcare professionals are

familiar with the safety issue, a substantial part do not considered the risk information on

drug safety issue to be important.

The proportion of correct answers was highest among pharmacists 21 ( ), followed by

,medical doctors 19 nd nurses 32 (Fig. 2).

Figure 2: Distribution of participants by their background and their responses to the

question "What is the nature of drug safety?"(Absolute number)

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Participants were asked whether they are aware of the pharmacovigilance system. Positive

response gave 88 (61.5%). respondents The highest percentage of them is pharmacists,

followed by assistant-pharmacists, and the lowest awareness isamong the laboratory

assistants. (Fig.2)

When respondents have been asked if they know where the pharmacovigilance rules are

being published and could be found, almost all of them (134 persons or 93.7%) answered

correctly that the rules are available on the website of the Bulgarian Drug Agency (BDA).

Others gave wronganswers(the website of the Ministry of Health or the website of the

National Health Insurance Fund – NHIF) - Fig. 3., which is not proportion in the survey and

this proves that the respondents are familiar with the liable source of information for the

issue.

Figure 3: Distribution of participants according to whether they know where the

pharmacovigilance rules are published (percentage)

Participants were asked if they know what an adverse reaction (ADR) is. A very large

proportion of them (137 health professionals or 95.8%) responded correctly, that this is any

undesirable and unintended response to a medicinal product which occurs during the

application of the product at doses normally used for treatment, prevention or diagnosis of a

disease for human use or to restore, correct or modifya physiological function.

According to one of the surveyed directions 'When can a side effect occur?'. Answering this

question, 76.9% gave correct responses- when the drug is used for indications and in dosages

given in the Summary of the Product Characterstic (SmPC)and package leaflet, or misuse

(PIL) (Fig. 4).

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Figure 4: Distribution of participants according to whether they know when an adverse

drug reaction might occur

The proportion of correct answers was highest among pharmacists, followed by laboratory

assistants and assistant-pharmacists, and the lowest was among paramedics, midwives and

nurses.

Participants were asked whether they know what theSummary of the Product Characteristics

SmPC is. The correct answer gave 97 persons or 67.8%, namely "a summary of the approved

information about use of the product", while the rest participants in the survey have chosen

some of the wrong answers. Highest share of correct answers is again among pharmacists,

followed by medical doctors. Nevertheless that the different information resourcesmay

confused patients and health professionals due to the information, need regular update and to

the healthcare professionals should consider which is the valid information.

The question about where they receive product information from, the largest proportion is of

those who have chosen the site of the BDA, where the most complete information on all

medicinal products registered in the countrycan be find. This response is indicated by almost

half of the participants - 67 health professionals (46.9%). One third (43 of the questionnaired

health workers or 30.1%) gave the answer paper-printed medicinal guides, where the

information is out of date. Every fifth respondent (27 people or 18.9%) has been informed by

scientific journals, and 4.2% (6 participants) - from Internet sources which are not always

known. The distribution of responses is shown in Fig. 5.

Obviously, the SmPC is the main source for regular safety information and health workers

need to be familiar with liable databases and websites where that updated information is

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provided.

Risk communication is important as the authors from Netherlands Plening at al. pointed out

and suggested a mix of tools for disseminating safety information to impact on more

healthcare professionals for patient safety.The regulators should provide clarity on their

communication objectives . Fischhoffs propose a framework for the benefit-risk balance with

integrated statistics and calculations, with judgments on the quality and transparent value, and

criteria. [14|]Same lessons can be understand in the Philippines, where the risk management

and the communication regarding drug safery should be accepted as culture within

governments, healthcare and pharmaceutical industry [15]. Surprisingly, the highest

percentage of correct answers is among laboratory assistants, paramedics and nurses. The

total share of the questionnaire assistant-pharmacists is 4% only and but nevertheless more

than 50% of them provided the answer “drug reference books” which proves that the SmPC

paper information is still important for them.

Figure 5: Distribution of participants by their background depending on where they get

information about medicinal products fro

Among the surveyed physicians,pharmacists and assistant-pharmacists we found out much

more professionals who work with current summaries of the product characteristics

(SmPCs)compared with medical staff with a bachelor degree.

Almost all respondents (93%) wereaware that the current summaries of the product

characteristics can be found on the BDA website, while the Ministry of Health’s website has

been chosenby6.3% of all the participants in the survey, and the NHIF’s website – by 0.7%

(only 1 person).

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Participants were asked which legal documents regulate pharmacovigilance system in

Bulgaria. Almost all of them (90.2%) indicated the correct answer – Bulgarian Law on

Medicinal Products for Human Use and its regulations). Nevertheless that the question is

based on multiple choice that provide information that the health workers are orientated for

the source of pharmacovidgilance information,

Respondents were asked about who is the inspection authority who collects and summarizes

adverse drug reactions (ADRs) for medicinesauthorisedfor use in Bulgaria. The proportion of

correct answersthe Bulgarian Drug Agency (BDA) is significant - 84.6%.

Again the proportion of correct answers to the question “who is the inspection authority,

which has the same functions, as BDA butat EU level”, wasquite significant – 90.9% selected

the European Medicines Agency (EMA). (Fig. 6). The high proportion of the respondents

shows that the health workers in Bulgaria are familiar where the phramacovidgilance

information is placed- on the website of the regulatory authority (BDA and/or EMA) in order

to apply social marketing approach for promoting the safe use of medicines. The trust is

better when the information is provided by the regulatory authority than by the industry.

Figure 6: Who is the inspection authority who collects and summarizes ADRs in the

European Union?

Respondents were asked about who can report ADRs under this legislation. Over half of them

(58.7%) indicated the correct answer - the authorization holder, as well as health

professionals and patients. Reasonably, the highest percentage of correct answers wasamong

pharmacists and at the contrary – the lowest wasamong nurses, midwives and paramedics

(Fig. 7).

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Figure 7: Distribution of participants by their background and their awareness about

who can report ADRs

Participants were asked whether they know which ADRs are unexpected. A substantial

percentage of the respondents (79%) gave the correct answer – ADRs that are not listed in the

summary of product characteristics.

The proportion of participants who said they have reported ADRs wastoo low - only 6.3% (9

health professionals). The othershave neverreported ADRs. Respondents were been asked

about where the ADRs should be reported. The proportion of respondents who answered

correctly to this questionwas very high (93.7%). These were the regulatory body (BDA) or

the marketing authorization holder. A small proportion of health professionals have chosen

the wrong answer "at the hospitals."

Only 40.6%saidthey were familiar with the methodological guidelines for reporting of

suspected ADRs by health professionals. Most of them rerefamiliar with the methodological

guidelines, including assistant-pharmacists, followed by medical doctors, while the less

familiar was the group of midwives. Similar results were presented Lauren T Lee et al., 29%

of the respondents stated that they were not familiar with the current medications guidelines.

Only a quarter of respondents (24.5%) reported that they have already participated in training

for knowledge acquiring and health professionalsencouragement to report ADRs.

The largest share of those who participated in training during the last two years, consists of

pharmacists, followed by assistant-pharmacists which proves that had resulted from the direct

medicines supply to patients. (Fig. 8).

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Figure 8: Distribution of participants by their background and whether they have

participated in a training to acquire knowledge and encourage reporting of ADRs

among healthcare professionals

Apparently, two-thirds or 75% of the health professionals who took part in this surveydidnot

have access to ADRs reporting trainings or were unaware of the need for this type of training.

Medical specialists in this country do not realize the importance and necessity of ADRs

reporting in order to ensure and maintain safe and effective medicinal products on the

Bulgarian market. This is also evidentfrom the annual reports of the BDA referring to the low

average of ADRs reporting amonghealth professionals.

Methodological clarity should facilitate communication between all stakeholders with the

view why the pharmacovidgilance issues are so important.The experts in that field both

regulators and industry may enable the communication between healthworkers and patients to

be more effective and to improve the drug safety. An integrated approach of risk assessment,

evaluation, risk minimization plans and regular monitoring of the public concerns are

important. The risk communication need to be improved in this country in order risk

assessment, minimization and decision upon benefit-risk balance of the medicinal products to

be a national policy. The low frequency of reporting in thia country needs general policy

update, like are better communication between health workers and patients and industry may

achieve improved patients outcomes.Due toserious concerns about inadequate

communication among the stakeholders in this field that may be a serious risk for avoiding

unsafe medicinal products.

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4. CONCLUSION

The results of the study shows that 85% of pharmacists and 55% of medical doctors were

aware of the pharmacovigilance system. Still, medical doctors don’t know in general what

the purpose of the system is Health professionals werenot active in reporting of suspected

ADRs - only 40% of doctors know what pharmacovigilance and werefamiliar with the

guidelinesof ADRsof the regulatory authority BDA. Only 6% of respondents have reported

ADRs, which is consistent with BDA’s reports about the low frequency of ADRs reporting

by medical specialists in Bulgaria which may lead to serious risks for the minimization of the

use of unsafe medicines.

. BDA is well known as a competent authority and often used as a source of information

regarding pharmacovigilance and regulatory information. Nevertheless, only 46% wereaware

about the fact that they can look forupdated information in the SmPC register for each

medicinal product on the regulatory website.

Apparently, more than 50% of health professionals used other sources of medicines

information and no one couldsay how reliable those sources werewhich may place a serious

risk for working with irrelevant and not updated information.

Only 25% of medical specialists have participated in training on ADRs. Health professionals

have a great need of further education and training onADRs reporting in order to be able to

understand the nature of the pharmacovigilance system. This training should be implemented

in the higher medical education curriculum. The low percentage of training is in

correspondence with the low frequency of reporting in this country.

Implementing regular trainings in the educational process, aiming to raise awareness and

knowledge of health professionals on pharmacovigilance issues and ADRs reporting is

particularly important for the effective functioning of the pharmacovigilance system leading

to risk minimization and good communication between health professionals and patients.

ACKNOWLEDGEMENTS

The authors wish to acknowledge the financial support of Medical University – Sofia,

Council of Medical Science under project № 26 on 'Reporting of adverse drug reactions

among medical specialists', "Grant – 2012", Contract №53/2012.

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https://www.researchgate.net/publication/7090916_Under-Reporting_of_Adverse_Drug_Reactions_A_Systematic_Review?el=1_x_8&enrichId=rgreq-baa1959652133b7273fdef04d38c4cbc-XXX&enrichSource=Y292ZXJQYWdlOzI2NzAyNjY4ODtBUzoxNTMzMDgxMzYyMTg2MjRAMTQxMzU2MjkxNjI2Mg==

https://www.researchgate.net/publication/7090916_Under-Reporting_of_Adverse_Drug_Reactions_A_Systematic_Review?el=1_x_8&enrichId=rgreq-baa1959652133b7273fdef04d38c4cbc-XXX&enrichSource=Y292ZXJQYWdlOzI2NzAyNjY4ODtBUzoxNTMzMDgxMzYyMTg2MjRAMTQxMzU2MjkxNjI2Mg==

https://www.researchgate.net/publication/12690658_Underreporting_of_Adverse_Drug_Reactions_Attitudes_of_Irish_doctors?el=1_x_8&enrichId=rgreq-baa1959652133b7273fdef04d38c4cbc-XXX&enrichSource=Y292ZXJQYWdlOzI2NzAyNjY4ODtBUzoxNTMzMDgxMzYyMTg2MjRAMTQxMzU2MjkxNjI2Mg==

https://www.researchgate.net/publication/12690658_Underreporting_of_Adverse_Drug_Reactions_Attitudes_of_Irish_doctors?el=1_x_8&enrichId=rgreq-baa1959652133b7273fdef04d38c4cbc-XXX&enrichSource=Y292ZXJQYWdlOzI2NzAyNjY4ODtBUzoxNTMzMDgxMzYyMTg2MjRAMTQxMzU2MjkxNjI2Mg==

health professionals’ awareness about pharmacovigilance system in bulgaria

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