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.
Conclusion
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.
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Re: Improving pharmacovigilance in Europe
Dear Editor,
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.
Conclusion
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
Aden University
Competing interests: No competing interests