Improving pharmacovigilance in EuropeBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1694 (Published 12 April 2010) Cite this as: BMJ 2010;340:c1694
All rapid responses
The National Pharmacovigilance Center in Saudi Arabia was established in early 2009 with special focus on adverse drug reactions detection (ADR), assessment and prevention.1 The aim of this letter to highlight the issues related to improvement of pharmacovigilance in Saudi Arabia.
in 2013 the National Pharmacovigilance Center in Saudi Arabia reported that there was underreporting of ADR and the main reasons were unaware of pharmacovigilance issues, complicating reporting system and lack of motivation.2 Lack of awareness towards ADR and ADR reporting among community pharmacists in community pharmacies as well as health care professionals on hospitals was reported on other studies on Saudi Arabia. 3,4 There is a lack of research about pharmacovigilance issues on Saudi Arabia, there are few studies available with focus only on knowledge and awareness of pharmacists and health care professionals towards ADR.3,5 Many health care professionals mentioned at the first scientific meeting on Medication Safety on 26-27 February 2013. Riyadh, KSA, that there was no feedback to their ADR reports. Counterfeit medicine is an increasing problem worldwide especially on developing countries6; there is a lack of research about counterfeit medicine in Saudi Arabia. Pharmacovigilance program on government and private hospitals either does not exist or the health care professionals not aware of it. There is a lack of awareness among patients about ADR report.1 Lack of training and workshops about ADR is reported.4 There are no data about pharmacovigilance concepts education in pharmacy, nursing and medical education on Saudi Arabia.
The following recommendations are very important to improve pharmacovogilance in Saudi Arabia:
• Marketing the National Pharmacovigilance Center role and activities through media, workshops, general lectures, brochures and distribute of educational materials are needed to increase the health care professional and patients awareness.
• Motivate health care professional and patients to report ADR is required to improve ADR reporting.
• Re-evaluate the reporting system and make it easy for health professionals and peoples are necessary to facilitating ADR reports.
• Collaboration between the National Pharmacovigilance Center and universities to conduct research about pharmacovigilance issues is very important to improve it.
• Send ADR feed back to health care professionals about their reports to motivate them for further collaboration.
• Address all issues of counterfeit medicines to fight it especially if it is at the beginning. Collaboration between Saudi Food & Drug Authority and other authorities on Saudi Arabia are required to fight counterfeit medicines.
• Establish and activate the pharmacovigilance programs on government and private hospitals as critical in improving pharmacovigilance in Saudi Arabia.
• Introduce pharmacovigilance concepts to pharmacy, nursing and medical education to improve pharmacovigilance in Saudi Arabia.
Competing interests: None declared
1.Saudi Food & Drug Authority. National Pharmacovigilance Center. [ Cited 2014 9th May]; Available from:
2. http://www.who-umc.org/graphics/26302.pdf [ Cited 2014 9th May].
3.Khan, Lateef M., Sameer E. Al-Harthi, Omar I. Saadah, Ahmed B. Al-Amoudi, Mansour I. Sulaiman, and Ibrahim M. Ibrahim. "Impact of pharmacovigilance on adverse drug reactions reporting in hospitalized internal medicine patients at Saudi Arabian teaching hospital." Saudi medical journal 33, no. 8 (2012): 863-868.
4.Bawazir, Saleh A. "Attitude of community pharmacists in Saudi Arabia towards adverse drug reaction reporting." Saudi Pharmaceutical Journal 14, no. 1 (2006): 75-83.
5.Mahmoud, Mansour Adam, Yazeed Alswaida, Thamir Alshammari, Tahir Mehmood Khan, Alian Alrasheedy, Mohamad Azmi Hassali, and Hisham Aljadhey. "Community pharmacists’ knowledge, behaviors and experiences about adverse drug reaction reporting in Saudi Arabia." Saudi Pharmaceutical Journal (2013).
6. World Health Organization. Medicines: counterfeit medicines, Fact Sheet 275. [ Cited 2014 9th May]; http://www.who.int/mediacenter/factsheets/fs275/en/. 2010.
Competing interests: No competing interests
Pharmacovigilance in Yemen (Challenges and recommendations)
I appreciated the letter entitled "New Initiative to Start a Pharmacovigilance Program in Yemen to Ensure Medicine Safety" 1. So, in this letter would like to clarify, correct and update the information mentioned in letter. The author stated that "Yemen has a population of approximately 20 million".1 According to the Yemeni Central Statistics Organization in their Annual report. 2012; the population is about 24 million.2 The author stated that "The statistical report (2003-2004) of the Ministry of Public Health & Population (MoPH&P) shows a total of 136 general hospitals (93 private), 470 polyclinics (341 private), 626 health centres (115 private), 2185 primary health care units, 380 maternity and child health centres, 1768 private pharmacies and a total of 4799 physicians (329 dentists and 974 specialists)" The total numbers of hospitals and polyclinics in Yemen in 2008 were 3,850 public and 3,736 private.; The number of pharmacies increased in 2011 to 3,315 pharmacies and 4,133 drug stores; The number of physicians were (572 dentists and 6469 physicians). 3-5The author stated that "The local pharmaceutical industry is evolving gradually, covering only around 8% of the total market share". The local pharmaceutical industry in Yemen covers approximately 10–20 per cent of the total market.3,6
Pharmacovigilance in Yemen (Challenges and recommendations)
Pharmacovigilance center in Yemen faces major challenges to developing and improving its services. The following list summarises the major challenges to Pharmacovigilance center in Yemen and what can be done to address them:
1. Lack of staff in Pharmacovigilance center in Yemen. To activate the pharmacovigilance role and activities in Yemen. Hire more trained staff are necessary to improve the services of Pharmacovigilance center in Yemen.
2. Lack of awareness among health care professionals about pharmacovigilance center, its role, how they can report ADRs and other activities of medication safety. Marketing the pharmacovigilance center role and activities through media, workshops, general lectures, brochures and distribute of educational materials are needed to increase the health care professional awareness.
3. Introduce pharmacovigilance concepts is very important to pharmacy and all medical education to improve the pharmacovigilance in Yemen.
4. Lack of time among health care professionals. Motivation is the key to overcome this challenge.
5. "Counterfeit medicines in Yemen are a major problem. Steps need to be taken to increase awareness on the part of pharmacists, healthcare professionals, and the public about the dangers and potentially bad outcomes from using these counterfeit medicines"3. Also fight counterfeit medicines by activate the punishment of pharmacies selling counterfeit medicines as well as those smuggling medicines or facilitating enter it to Yemen.
6. Lack of awareness among patients about pharmacovigilance center, its role and how they can report ADRs and other issues related to the medication safety. Marketing the pharmacovigilance center role and activities through media, general lectures, brochures and distribute of educational materials are very important to increase the health care professional awareness.
7. Lack of research about different issues of pharmacovigilance in Yemen. Supports from MoPH&P, universities and policy makers can overcome this challenge.
8. Lack of experience among pharmacovigilance issues in Yemen as pharmacovigilance center was establishe in early 2011. Train the staff and health care professionals and share experience with neighboring countries by conduct the annual regional conferences can overcome this challenge
9. Establish hospitals reporting programmes are needed to improve ADRs-reporting among the health care professionals.
Competing interests: None declared
1.Alshakka MA. New Initiative to Start a Pharmacovigilance Program in Yemen to Ensure Medicine Safety. BMJ2014; 340/bmj.c1694.
2.Central Statistics Organization. Annual report. 2012 [cited 2013 29th September]; Available from: http://www.csoyemen. org/content.php?lng=arabic&id=623.
3.Al-Worafi, Yaser Mohammed. "Pharmacy practice and its challenges in Yemen." The Australasian medical journal 7, no. 1 (2014): 17.
4.Ministry of Public Health and Population. Annual statistical health report 2011 [cited 2013 1st March];
Available from: http://www.mophp-ye.org/arabic/docs/ Report2011.pdf.
5.Al-Worafi, Yaser Mohammed. "Pharmacy education in Yemen." American journal of pharmaceutical education 77, no. 3 (2013): 65-65.
6.Supreme Board of Drugs and Medical Appliances (SBDMA). 2012 [cited 2013 1st March]; Available from: http://www.sbdye.org/.
Competing interests: No competing interests
Every medication is potentially hazardous and can cause substantial harm to the recipient with varying degree of injury. One of the potential hazards that accompany the use of most types of medications is Adverse Drug Reactions (ADRs). ADRs can cause short- and long-term hospitalization, morbidity and even can lead to mortality (WHO, 1972).
Yemen is an Arab country located in the southern Arabian Peninsula. The Kingdom of Saudi Arabia, Oman, the Red Sea and the Arabian Sea border it. Yemen has a population of approximately 20 million, with more than 70% live in rural areas. The illiteracy rate is still high at about 55.7%. Yemen is a low-income country with a per capita Gross Domestic Product (GDP) of USD 659. The total expenditure on health is not available at the present time, but the governmental contribution is about USD 256 million a year or $13 per capita and represents only 2% of the GDP . In general, the health services (either public or private) mainly focus major cities; though primary health centres/units and polyclinics are scattered throughout the whole country, including some rural areas. The statistical report (2003-2004) of the Ministry of Public Health & Population (MoPH&P) shows a total of 136 general hospitals (93 private), 470 polyclinics (341 private), 626 health centres (115 private), 2185 primary health care units, 380 maternity and child health centres, 1768 private pharmacies and a total of 4799 physicians (329 dentists and 974 specialists). In addition, there are a few non-governmental organisations (NGOs) and foreign medical missions.
The local pharmaceutical industry is evolving gradually, covering only around 8% of the total market share. Medicines are imported via private sector agents and cover most of the country’s needs. A small percentage of medicines are imported by the MoPH & P for the public health facilities.
There are critical health challenges in Yemen, including the high incidence of both communicable diseases (such as malaria, tuberculosis, schistosomiasis, sexually transmitted infections and vaccine-preventable diseases) and noncommunicable diseases (such as cardiovascular diseases, renal problems, cancer, and eye diseases). In addition, Yemen exhibits higher prevalence of lifestyle risk factors (including tobacco use, ‘qat’ chewing, malnutrition, injuries and accidents) and lacks the necessary sanitation (especially water sanitation).
Pharmacovigilance in Yemen
Adverse drug reactions, medication errors and other drug-related problems are expected to be among the leading causes of hospitalisation and are associated with a huge economic burden and significant human suffering. This serious issue of medication therapy also contributes to morbidity and mortality. At present, the monitoring of adverse drug reactions was started in Yemen by establishing a pharmacovigilance centre in 2011. Till now there is no published information about its work , number of reports and how they process it. The country and public are facing with many safety problems related to drug smuggling, counterfeit drugs, improper and irrational use of drugs, importation of unnecessary drugs and medical errors. Therefore, it is necessary to make serious steps and active regulations in Yemen to ensure patients and public safety in relation to medicines use.
In Yemen, health services focus major cities with primary health centers and polyclinics are scattered throughout the whole country. Local pharmaceutical industry is growing at a slow rate and most of the country’s needs are catered by imports. The scenario in Yemen is somewhat contrasting with other countries where it does not own a nationwide coverage of ADRs reporting systems as well as systematic plan to monitor drug reactions and related problems. A pharmacovigilance center was established in 2011 by the Supreme Board of Drugs and Medical Appliances (SBDMA). However, there are no official data or reports released by the SBDMA on the number of ADRS being reported and how they processed it . In Yemen, the major problem faced by consumer is the poor framework of pharmacovigilance programs. Currently, Yemen is way behind other developing countries in terms of improving the effectiveness of ADRs reporting system. Another contributing factor is the lack of nationwide coverage of pharmacovigilance centers, as well as hospitals. This might probably originate from the lack of legislation and clear policy on pharmacovigilance. The situation exacerbates after studies have found that 60% of all imported medicines in Yemen were originated from illegal channels . As a result, the occurrence of fake medicine and drugs is rampant which poses serious threat to the health of the public.
In addition, the lack of ADRs monitoring in Yemen might lead the consumers to believe that all their reports will fall into deaf ears and eventually deter them from filing reports. This, added with the high illiteracy rate of the Yemeni population ,might make it impossible to establish a proper and effective ADRs reporting system in this country .
New Initiative to initiate a pharmacovigilance program in Yemen
Academics from Faculty of Pharmacy in Aden University decided recently with responsible officers from SBDMA in Aden new Initiative to initiate a pharmacovigilance program in Yemen , to activate the pharmacovigilance centre of SBDMA to cover the whole country and to establish plan to implement the basic steps for the establishing pharmacovigilance program according to Uppsala Monitoring Centre (UMC) Guidelines.
Yemen is facing many medicine-related problems. Therefore, it is necessary to implement strategies to ensure patients and public safety in relations to medicines use. In developing countries generally there is limited coverage and under-reporting of ADRs. In Yemen despite the presence of a pharmacovigilance centre there is no published information about its work and no reports.
The effectiveness of pharmacovigilance activities in a country is directly dependent on the active participation of health professionals, patients and consumers. The more information about ADRs collected will definitely be useful for creating a national database. Therefore all should be briefed regarding the ADRs reporting system and encouraged to report ADRs even suspected ones.
Once this proposal succeeds, a plan of action should be developed to to establish similar centres in order to extend the services to other governorates in Yemen.
Mohamed Ahmed Alshakka
Competing interests: No competing interests
We read with great interest the editorial by Moore and
Begaud on improving pharmacovigilance in Europe . Nepal
is a developing country in South Asia. Though small in area
the country has the greatest altitude variation of any
country on earth and a diverse population. In Nepal a large
percentage of the drugs are imported and clinical trials on
the Nepalese population are not required before approving a
drug. Facilities for testing drug quality are limited. A
strong pharmacovigilance program is of vital importance to
promote safe use of medicines in Nepal. Recognizing this
government of Nepal decided to join the WHO Programme for
International Drug Monitoring in October 2004 and appointed
Department of Drug Administration (DDA), the national drug
regulatory agency as the national centre to communicate with
Uppsala Monitoring Centre (UMC). Nepal became a full member
of the programme in July 2006.
In Nepal at present health professionals report adverse drug
reactions (ADRs) to regional pharmacovigilance centers and
from there reports are forwarded to DDA and further to UMC.
The four regional centers are Manipal Teaching Hospital,
Pokhara, Tribhuvan University Teaching Hospital in
Kathmandu, Nepal Medical College Hospital in Kathmandu and
KIST Medical College in Lalitpur. The present system in
Nepal has limitations which need to be addressed. Only
limited number of centers from selected geographical regions
is involved, communication and feedback systems between
regional and the national center and reporters and the
center have to be strengthened. Many centers operate in
private medical schools and depend on institutional funding
which may be unreliable. There are problems in training
people to run a center and provide impartial, objective
information to reporters and prescribers. To promote ADR
reporting it is better to link pharmacovigilance with
provision of independent medicine information. In Nepal
spontaneous reporting by prescribers is the major source of
To strengthen Nepal’s program more regional centers have to
be established especially in underrepresented areas. All
medical schools in Nepal should be encouraged to join the
national program. At present in Nepal there are fourteen
zones and a center should be established in each. In zones
with no medical schools centers can be developed in
secondary care hospitals. Running a center requires training
and expenditure of time and effort and personnel involved
should be rewarded.
Awareness of pharmacovigilance among healthcare
professionals and the general public should be increased. A
study conducted in a Nepalese hospital had found knowledge,
attitude and practice (KAP) scores among healthcare
professionals to be low and had recommended educational
programs . The benefits of ADR reporting and procedure to
report ADRs should be stressed. Developing a consumer ADR
reporting program as has been developed in Malaysia can be
considered. Pharmacovigilance should be introduced in the
curriculum of health professionals. Practical aspects of ADR
reporting should be stressed. Teaching will be easier if
there is a functioning pharmacovigilance center in the
Community pharmacists are often the first contact of
patients with the healthcare system and can be trained to
report ADRs. In western Nepal, a pilot project to improve
ADR reporting by community pharmacists was initiated
successfully . The project can be expanded to other
regions. Reporting ADRs can be made mandatory for drug
companies like in many developed nations. Making it
mandatory for all health professionals to report ADRs can be
considered. We personally believe that reporters should gain
something from reporting an ADR and from the ADR database at
a regional and national level. At both Manipal College of
Medical Sciences, Pokhara and KIST Medical College, Lalitpur
we share information on managing a particular ADR with
reporters and encourage them to publish rare ADRs. We also
share overall ADRs reporting statistics and interesting
individual reports with clinicians every six months.
Nepal faces enormous challenges in its pharmacovigilance
program. Considering its vital importance to medicine safety
and public health concerted efforts to overcome these are
1. Moore N, Bégaud B. Improving pharmacovigilance in
Europe BMJ 2010; 340: c1694.
2. Subish P, Izham MM, Mishra P. Evaluation of the
knowledge, attitude and practices on adverse drug reactions
and pharmacovigilance among healthcare professionals in a
Nepalese hospital: a preliminary study. The Internet Journal
of Pharmacology 2008; 6 (1).
3. Subish P, Mohamed Izham MI, Mishra P, Alam K,
Poudel A, Khanal S. ADR reporting by community pharmacists
in Nepal. J Pharm Pract Res 2008; 38: 331-2.
Shankar PR, Subish P
Dr. P. Ravi Shankar
Dept. of Clinical Pharmacology
KIST Medical; College
Dr. P. Subish
Discipline of Social and Administrative Pharmacy
Universiti Sains Malaysia
Competing interests: No competing interests
One member of the ISoP Executive Committee - Ugo Moretti - was not
included in the list of co-authors for this response. This was an
accidental ommission and we hope that his name can now be added to this
Executive Committee of the International Society of Pharmacovigilance
Competing interests: No competing interests
Malaysia is a developing country located in Southeast Asia with a national
centre for Pharmacovigilance, namely the ‘National Adverse Drug Reaction
Monitoring Centre’ that services the entire country. Some major hospitals
and pharmaceutical companies also operate ADR monitoring systems, but the
national centre consolidates all of their reports. Normally, reports from
doctors, pharmacist and dentists are completed on a voluntary basis, but
reports from marketing authorization holders are mandatory. These
personnel monitor drugs for human use, vaccines, biological and herbal
remedies. 12 The National Drug Reaction (ADR) centre uses prepaid postage
report forms or report cards that are updated every month. The national
centre has an advisory committee that assesses the casualties reported in
the ADRs. The Malaysian Adverse Drug Reaction Advisory Committee (MADRAC)
was established under the Drug Control Authority (DCA) to monitor the
safety profiles of drugs registered for use in Malaysia. MADRAC provides
the DCA with information regarding drug safety both locally and
internationally. The National Drug Safety Monitoring Centre, which is the
secretariat to MADRAC, was accepted as the 30th member of the World Health
Organization (WHO) Safety Monitoring Program in 1990. Under the monitoring
programme, all ADR reports that are received and screened by MADRAC are
submitted to the Uppsala Monitoring Centre in Sweden for inclusion into
the WHO database.
MADRAC also promotes ADR reporting in Malaysia, provides information
and advises the DCA such that regulatory action can be taken based on ADRs
that are received both locally and internationally. It also provides
information to doctors, pharmacists and other health care professionals
regarding ADRs and participates in the WHO ADR monitoring programm.
Limitations of the current drug safety system in Malaysia
Even though the Malaysian system and programme have been established more
than 20 years, it still has few drawbacks.. The major weaknesses of the
drug safety system in Malaysia are as follows:-
1. Lack of awareness about drug safety among health professionals
2. Lack of awareness about the existence, function and purpose of national
3. Difficulty of signal generation due to the lack of a national
computerized database on the drug prescribed.5
4. Inability to involve pharmaceutical industries in drug safety issues.4
5. Lack of information on genetic effect, social practices and drug
interaction and indication contra associated with drugs.4
6. Presence of only a few reports on traditional and herbal drugs, which
are widely used.4
7. under reporting – major weakness of all spontaneous reporting
8. No involvement of nursing staff and consumers in the ADR monitoring
9. Limited role of NGOs in drug safety issues.
10. Limited role of mass media in public drug safety education.
11. Selective reporting among healthcare professionals (reporting bias).
12. Poor at detecting delayed ADRs.
Ideas on how to improve the drug safety system in Malaysia
A. Strategies to improve the drug safety system 9 in Malaysia:
1. Enhancing, strengthening and empowering the role of the MADRAC.
There is an urgent need to increase the ability of MADRAC to regulate
drugs after they reach the market and to conduct long-term post marketing
studies for all drugs available in the Malaysian market.
MADRAC also needs to develop active new pharmacoepidemiological methods
and tools, train new staff and increase their resources and funds to
improve its role in the lives of healthcare professionals and public.
2. Starting awareness programs for healthcare professionals to explain the
importance, function and purposes of the national drug safety monitoring
program in Malaysia. MADRAC should increase the role of health care
professionals in this program and in particular, include nurses, community
pharmacists and private general practitioners in the reporting of ADRs.
This can result in increased knowledge about the harmful effects of drugs
currently used in the country.
3. Development of a consumer reporting program, 8 which would be
beneficial to the existing program available in Malaysia and increase the
information and knowledge regarding ADRs. This will allow MADRAC to
overcome the main problem of under reporting while improving consumer
rights, which will eventually improve the quality of life and patient
safety in Malaysia.
4. Strengthening the role of pharmacovigilance by developing new
methods for risk analysis and risk management. This will strengthen the
methods for safety surveillance and allow enhanced detection,
understanding, prediction and prevention of ADRs.
5. Improving communication and information flow between healthcare
professionals and the public.
6. Involvement of Non-Governmental Organizations (NGOs) in drug
safety issues to utilise the important role of NGOs at the local level. In
addition, NGO such as Consumer Association of Penang (CAP) and Federation
of Malaysian Consumers Associations (FOMCA) have extensive experience in
dealing with public interests. They can understand public needs and
choices, as well as advocate for the rights of the people.
7. The full involvement of drug industries in drug safety issues in
Malaysia. There are 76 licensed local manufactures and 136 licensed local
manufacturers of traditional medicine. One hundred seventy two companies
are involved in the development and production of medicine and traditional
medicine. However, the Pharmaceutical industry in Malaysia has little
regard for safety monitoring. The full involvement of drug industry as key
player in drug safety can improve pharmacovigilance in Malaysia. The
companies should regularly report the ADRs associated with their products
to the national center.
8. Inclusion of providers of local and herbal medicine into the drug
safety program in Malaysia. The national drug safety system should monitor
and evaluates ADRs associated with herbal medicine. This is very rare, but
in rapidly developing countries, there are local officials that offer
these activities. There is a lack of methodological uniformity for
identification and measurement of herbal medicines, which is widely in
Malaysia. Moreover, there are very few ADR reports about these compounds
9. Increase the role of the mass media in public drug safety
education. The media will remain a key provider of drug information and a
key player in drug safety issues. It can also play an important role in
educating the public about the harmful effects of drug and strengthening
consumers’ views about medicines by having a weekly column and inviting
healthcare professionals to contribute.
10. Teaching pharmacovigilance. Pharmacovigilance should be taught to
undergraduate students of Medicine, Nursing, Pharmacy and other healthcare
related studies. Thus, these students will be aware of the program when
they start their practices. Pharmacovigilance modules must be linked to
courses on the rational use of medicines (RUM). The Uppsala Monitoring
Centre (UMC), the international collaboration centre for ADR monitoring,
has suggested a number of basic components of a pharmacovigilance course
for pharmacologists and other healthcare personnel. Currently in Malaysia,
education programs for Pharmacovigilance for undergraduate students are
lacking. For example, in the School of Pharmaceutical Sciences at
Universiti Sains Malaysia, Penang, students are given less than two hours
of instruction regarding pharmacovigilance during their four-year Bachelor
of Pharmacy course.
1. MADRAC Web site available:
2. Drug, device and cosmetic regulation in Malaysia: 2005 Update
Pacific Bridge Medical. Available at
3. Annual report of Malaysian Adverse Drug Reactions Advisory
Committee, 2007. Available at http://www.bpfk.gov.my
4. Hag ASM. Pharmacovigilance initiatives in Malaysia. Drug
Information Journal 2003; 57: 143- 8.
5. Olsson S. National pharmacovigilance systems, 2-edition,
Uppsala Monitoring centre, 1999.
6. Palaian S, Alshakka M, Mohamed Izham. Developing a consumer
reporting program in Malaysia: a novel initiative to improve
pharmacovigilance. Pharm World Sci 2010; 32(1):2-6.
7. Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug
reactions: predictors of under-reporting in Malaysia. Pharmacoepidemiol
Drug Saf 2007; 16(2):223-8.
8. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting
of suspected adverse drug reactions: a review of published literature and
international experience. Br J Clin Pharmacol 2006; 63(2):148-156.
9. The Future of Drug Safety – Promoting and Protecting the Health of
the Public. FDA’s Response to the Institute of medicine’s Report, 2006.
Competing interests: No competing interests
It was encouraging to read the editorial by Moore and Begaud 
explaining how pharmacovigilance is being enhanced in Europe. Improving
monitoring of the safety of medicines is one of the founding principles of
the International Society of Pharmacovigilance (ISoP)  and we applaud
any improvements to European and global pharmacovigilance systems.
The important developments of the European system which have been
under discussion by European regulators should lead to strengthening of
science-based, rapid and robust assessments of safety issues. Simplified
procedures should speed up decision making, improve focus for post-
authorisation safety studies, make more effective use of limited resources
and increase transparency. However, there remains a need to explore,
develop and fund new pharmacovigilance activities so that safety data
sources available in many different countries can be used effectively.
Looking beyond Europe, pharmacovigilance is an important public
health issue worldwide and those of us in this field recognise the need to
improve patient safety in all countries. ISoP began as a European group,
but since 2000 has become increasingly a more global organisation with
regional Chapters in many parts of the world, including the Western
Pacific  and South America as well as a nascent one in Africa. We
recognise a need for wider understanding and better application of
existing methodologies for pharmacovigilance and ISoP carries out training
and education in this field.
Outside Europe there are many different pharmacovigilance systems,
which range from established and well-developed systems in countries such
as New Zealand , Australia and the USA, to countries with emerging
pharmacovigilance systems like Ghana and Uganda in Africa; Brazil and Peru
in South America; and P.R. China and India in Asia. This year the annual
ISoP meeting will be held in Ghana, where the first WHO-recognised
national pharmacovigilance system in West Africa was established in 2001.
Pharmacovigilance in sub-Saharan Africa is, with a few exceptions, still
poorly developed but the emergence of countries like Sudan, Sierra Leone,
Senegal , Namibia and Botswana as full members of the WHO Programme for
International Drug Monitoring gives hope for the future.
Most would agree that Europe continues to be a world leader in
pharmacovigilance and many countries are likely to adopt Europe’s
practices and follow European guidelines. This puts a huge responsibility
upon the Europeans to get improvements to pharmacovigilance systems right.
We hope that new regulation in Europe will lead to more effective safety
surveillance, improved support for decision-making by regulators on safety
issues and ultimately reduction in risk to patients. However, we would
urge all involved not to be too Euro-centric. There is a world of
medicines safety monitoring experience outside Europe and a network of
people with expertise to contribute to global improvements in
pharmacovigilance. Developments in many countries across the globe
indicate that in pharmacovigilance - as in all other aspects of modern
living - it is still a small world.
Alex Dodoo (President)and the Executive Committee of the
International Society of Pharmacovigilance (ISoP)
1. Moore N and Begaud B. Improving pharmacovigilance in Europe. BMJ
2010; 340: c1694
2. International Society of Pharmacovigilance. Available at:
3. Kunac DL, Harrison-Woolrych ML and Tatley MV (2008) Pharmacovigilance
in New Zealand: The role of the New Zealand Pharmacovigilance Centre in
facilitating safer medicines use. NZ Medical Journal 121; 1281: 76-89
a. (available at: www.nzma.org.nz/journal/121-1283/3286)
4. Uppsala Reports 46, July 2009: p.6-8
Competing interests: No competing interests
The development of databases derived from
records and hospital administration systems could help to
improve the detection
of ADRs. In England, these databases include the General
Database (GPRD), The Health Improvement Network (THIN) and
QResearch, all of
which are derived from electronic primary care records; and
Episode Statistics (HES) database, which is derived from
hospital patient administration
systems and hospital discharge records. To illustrate
this potential, we
used one primary care database (THIN) to investigate the
association of myopathy
and myalgia with the use of statins. Using a case-
crossover design (in which
each patient acts as their own control and side-effects are
examined in the
period while a patient is on a drug compared when they are
not), it may have
been possible to detect the association with statins as
early as 1996
exposure period then
allows more precise quantification of the size of the effect
with narrowing of
For ADRs that result in hospital
admission, Hospital Episode
Statistics, which cover all inpatient and day case activity
in England, offer a
method for identifying these admissions. For example,
between 1998–2005, the
total number of hospital episodes for all diagnoses
increased by 14% but the
total number of hospital episodes associated with ADRs
increased by 45%. The
increase in admissions associated with ADRs may have due to
a number of
factors: improving record keeping from increased awareness,
a general increase
in ADRs against a background of an increasingly elderly
introduction of new drugs, and poly-pharmacotherapy because
pressure to prescribe medication for long-term illnesses
such as diabetes,
heart disease and hypertension. More detailed coding, and
better use of HES
data and of similar systems elsewhere in Europe, could
considerably improve our
surveillance of ADRs, as well as allowing the evaluation of
improve the safety of prescribing.
Health systems throughout Europe are
in information and communication technologies, such as the
for Information Technology in England's NHS. One consequence
of this investment
could be substantially improved methods of
pharmacovigilance, allowing pan-European
studies building on the many national studies we have seen
to date. Coverage of larger
populations than allowed by
single country and single database studies also increases
study power with the
potential benefit of earlier and more effective detection of
Senior Lecturer in Epidemiology, Non-communicable Disease
Epidemiology Unit, LHSTM,
London WC1H 7HT; Vasa
Research Fellow, Department of Computing, Imperial College,
London SW7 2AZ; Azeem Majeed,
Professor of Primary
Care, Department of Primary Care & Public Health,
Imperial College, London
A. Sources, uses, strengths and limitations of data
collected in primary care
in England. Health Statistics Quarterly 2004; 21: 5-14. http://bit.ly/bQgASl
M, Curcin V, McKeigue P, Majeed A. Statin induced myopathy
and myalgia: Time
trend analysis and comparison of risk associated with statin
1991-2006. PLoS One 2008; 25;3(6):e2522.
M. The case-crossover design: a method for studying
transient effects on the
risk of acute events. Am J Epidemiol 1991; 133: 144–153.
H, Bell D, Molokhia M, Srishanmuganathan J, Patel M, Car J,
Majeed A. Trends in
hospital admissions for adverse drug reactions in England:
Analysis of national
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Pharmacology 2007; 7: 9.
P, Mougin F, Joubert M, Thiessard F, Pariente A, Dufour JC
et al. A semantic
approach for the homogeneous identification of events in
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Stud Health Technol
Figure. Relative risk
of myopathy & myalgia by year in 16,591 patients using
statins or fibrates
from 1991–2005: results from a case-crossover
Source: Molokhia M et al. Error bars
Mariam Molokhia is funded
by an NIHR postdoctoral
award and is an
investigator for the EU-
ADR FP7 and Serious
Adverse Events Consortium
(SAEC) projects on
adverse drug reactions.
The Department of Primary
Care & Public Health at
Imperial College London
is grateful for support
from the NIHR Biomedical
Research Centre scheme
and the NIHR
Leadership in Applied
Health Research & Care
Competing interests: Nicholas Moore and Bernard Begaud outline initiatives toimprove pharmacovigilance in Europe. Such initiatives are essential toimproving the safety of healthcare because current approaches to detection ofserious adverse drug reactions (ADRs) have major limitations. Serious ADRs areoften too rare to be detected in early clinical trials, and may not be detectedthrough post-marketing surveillance for many years. This delay in identifyingADRs leaves clinicians unaware about the potential risks of the drugs they areprescribing, puts patients at risk of iatrogenic harm, and increases bothhealthcare costs and the costs of drug development.
N.Moore and B. Bégaud  described in their editorial the situation
of postmarketing pharmacovigilance. Psychotropic drugs are widely used in
clinical practice. The introduction of new drugs (atypical
antipsychotics,SSRI,SNRI) has changed psychopharmacological treatment
drastically, drug safety has become increasingly relevant over the last
years.The AMSP("Arzneimittelsicherheit in der Psychiatrie" recorded
systematically psychotropic drug use and adverse drug reactions (ADR) of
in-patients in 55 psychiatric hospitals in Austria, Germany and
Switzerland. Since 1993 until 2008 about 311.000 in-patients were
monitored. It corresponds to a dynamic cohort study meaning the cohort -
the patient population of the participating clinics - is changing over
time.Incidence for severe ADR of 1.5% about have been found . In
contrast to the autors, we observed most ADR associated with newer
drugs, but with another ADR profil than the old drugs.In accordance with
other authors(4), off -label use and combination treatments are increasing
. These polypharmacy has a high risk for pharmacodynamic and
pharmacokinetic drug interactions and ADR.
Pirmohamed et al.reported about ADR as cause of admission to hospital.
In our study  the mean hospitalisation length of the surveyed
psychiatric patient population was compared to that of the serious ADR
cases. The length of hospitalisation for serious ADR cases showed to be
more than doubled.The costs of treatment of ADR are increasing .
An efficient network of the different national and international
postmarketing surveillance projects in a fair cooperation with drug
companies can help to detect and to prevent ADR and to improve the
awareness of physicians. Only a supranational organisation like ENCePP at
the EMA in all European countries can coordinate this.
1)Moore N,Bégaud B.Improving pharmacovigilance in Europe
BMJ 2010; 340: c1694
2) Grohmann R et al. Psychotropic drug use in psychiatric inpatients:
recent trends and changes over time-data from the AMSP study.
3)Rüther E et al.Safety aspect of psychotropic drugs: future perspective
of AMSP. Europ Arch Psychiatry Clin Neurosci.2009; 259(Suppl1):44-45
4) Mojtabai R,Olfson M. National trends in psychotropic medication
polypharmacy in office-based psychiatry. Arch Gen Psychiatry.
5)Pirmohamed M et al. Adverse drug reactions as cause of admission to
hospital: prospective analysis of 18 820 patients. BMJ 2004;329:15-9
6)Pattanaik S et al.Evaluation of cost of treatment of drug-related events
in a tertiary care public sector hospital in Northern India: a prospective
study.Br J Clin Pharmacol. 2009;67(3):363-9
Competing interests: No competing interests