Your drugs- when that magic bullet to health turns toxic
Mar 01, 2009
MICHEAL Kaliisa went to a clinic complaining of a high fever, body weakness and fatigue. “That must be malaria,†the nurse told him as she prescribed some medicine.
By Irene Nabusoba
MICHEAL Kaliisa went to a clinic complaining of a high fever, body weakness and fatigue. “That must be malaria,†the nurse told him as she prescribed some medicine.
“But Kaliisa woke up in the night with difficulty in breathing and by morning, he was dead,†his wife, Mary Kaliisa, says.
Kaliisa had reacted to metacalphin, an anti-malarial in the class of fansider (sulphur drugs).
The post-mortem exonerated the health worker from incompetence and negligence as alleged by the deceased’s survivors, revealing that he was allergic to the drug.
Kaliisa’s is just one of the few reported cases of adverse drug reactions — unwanted, uncomfortable, or dangerous effects that a drug may have.
Dr. Ambrose Talisuna, an epidemiologist (determines what factors cause or contribute to disease) and country representative of Medicines for Malaria Ventures, says adverse drug reactions typically occur soon after a drug is taken.
He explains that an adverse drug reaction may be mild — disappears gradually without major interventions.
It may also call for change in treatment, hospitalisation or treatment to counter the reaction and discontinuation of the drug.
Talisuna says many people always consider medicine a magic bullet because it improves health, not knowing they can react to it. Medicines can be life-threatening, cause a birth defect and disability.
In the early 1960s, an abnormally high number of children in Canada were born with severe deformities: limbs were missing, or only half existed and in some, the fingers and toes were found at the end of what looked like flippers.
It turned out that thalidomide, a tranquilliser, which was marketed as the safest ever, was causing the problems. It was commonly prescribed to pregnant women for morning sickness. The drug was banned.
In Uganda, quinine injections have caused disability to many children with orthopedic departments in major hospitals revealing that they contribute to a third of the admissions.
Studies in developed countries like the US and UK have shown that adverse drug resistance are a major cause of hospital admissions, accounting for 15% (one in every seven people admitted.)
A Canadian-based study published in the Canadian Medical Association Journal also showed that 12% (more than one in nine people) of all emergency room visits were medication-related. The study involved 1,017 patients in a 12-week period.
In Africa, unfortunately, such studies are hard to come by as researchers do not give the problem prominence; neither do the patients, going by the poor reporting habits.
Nonetheless, Helen Byomire, the head of National Pharmacovigilance Centre (NPC) at the Uganda National Drug Authority (NDA), says half of all hospital-related illnesses are a result of adverse drug reactions.
“Since we established a pharmacovigilance centre in 2005 with regional desks in Masaka, Gulu, Lira, Soroti, Kabarole, and Hoima districts, we have received over 300 drug-related illness reports, mostly on anti-malaria treatment and anti-retroviral drugs,†Byomire reveals.
“We fear it is just a tip of the ice burg because not only are our activities not yet popular, but the culture of reporting drug reactions is poor.
The challenge is telling the difference between the drug and the disease,†she adds.
Byomire also notes that many people practice self-medication and may not present the right names of the drug they may have taken.
“Besides, most times, patients go to another healthcare provider when they get adverse drug reactions on assumption that the doctor did not know what he was doing.â€
She says pharmacovigilance (the detection, assessment, understanding and prevention of adverse effects of medicines) is the solution, although it is a new phenomenon.
How adverse drug reactions commonly present
An Internet site on health, www.familyhealth.com reveals that most are relatively mild, and many disappear when the drug is stopped or the dose is changed; some gradually subside as the body adjusts to the drug, while others are severe.
“About 10% of all hospital admissions in the US are for treatment of ADRs, 10 to 20% (2.2 million) of which are severe,†the site adds, noting more that 100,000 deaths are attributed annually to serious adverse drug reactions.
The site reveals that digestive disturbances, loss of appetite, nausea, a bloating sensation, constipation and diarrhoea are particularly common reactions, because most drugs are taken by mouth.
However, almost any organ system can be affected. In older people, the brain is commonly affected, often resulting in drowsiness and confusion.
Byomire says in severe instances, the patient may collapse, suffer shock, or multiple organ failure like kidney and heart failure which is the common cause of death.
Byomire explains that adverse drug reactions may be limited to a certain location, or systemic, where a medication has caused adverse effects throughout the body.
Causes of drug reactions
An advocacy too lkit for patients’ organisations on addressing global patient safety issues reveals that adverse drug reactions may arise from particular diseases and prescribing practices; genetics, diet, and traditions of the people.
They may also arise from the drug manufacturing processes, which can influence pharmaceutical quality and composition and the use of traditional and complementary drugs like herbal remedies which may pose specific toxicological problems when used alone or in combination with other drugs.
“A medical, genetic or allergic condition in the patient may cause a bad reaction to the drug. Various diseases, especially those that cause renal or hepatic insufficiency, may alter drug metabolism,†the kit adds.
Talisuna, also the former commissioner of epidemiology and surveillance at the health ministry, says adverse drug reactions may also be a result of counterfeit and substandard medicines.
Medicines are made of ‘potent-active ingredients’ and need to be taken in the correct dose and frequency as prescribed by a health professional.
“For instance missed doses of glucoma medicine can lead to optic nerve damage or blindness and missed doses of heart medication can lead to cardiac arrest, while an overdose of some medicines can lead to death,†he says.
“If a patient is taking a different medicines at the same time, there is risk that they could interact with each other or with certain types of food or supplements in a harmful way,†she explains.
The route of drug administration — topical, intramuscular (injections) and intravenous administrations (drips) are more likely to cause hypersensitivity reactions.
“Oral medications are less likely to result in serious drug hypersensitivity,†he says. “Nonetheless, how you eat, how much you weight and your age may cause an adverse drug reaction.
But many people pick drugs over the counter and do not read the information insets.
“Some ignore the precautions like “do not take on a hungry stomach, take after a meal, drink lots of fluids and don’t consume alcohol or diary products’.
This information is important. If you take flagyl and drink alcohol, you could die,†Talisuna stresses.
Recommendations on how medical personnel can reduce cases of adverse drug reactions
Dr. Ambrose Talisuna, the country representative of Medicines for Malaria Ventures, says for developing countries, especially in Africa, the scope for pharmacovigilance needs to be broader because of the growing problems with substandard and counterfeit drugs.
He also advises that once a medicinal product has been placed on the market, there is still need to monitor the effects of the medicine when taken by individuals because adverse effects will only become apparent when the medicine is used extensively in large numbers of patients.
“Information about rare but serious adverse reactions, chronic toxicity, use in special groups like children, the elderly or pregnant women, or interactions between drugs is often incomplete or not available.
Unfortunately, manufactures do not invest heavily in post-marketing pharmacovigilance,†he says.
The director general of health services, Dr. Sam Zaramba, says there should be awareness on drug reactions.
He says the Uganda National Expanded Programme on Immunisation has a ‘visible programme on pharmacovigilance.
“Emulate them.
Work closely with professionals like nurses and midwife associations to combat adverse drug reactions,†he advises.
Zaramba urges nurses to go the extra mile to ask patients to report adverse reactions.
“This helps us document the medicine so that we can withdraw it, caution health providers or recommend an anecdote to counter the medicine.â€
He says they have developed forms that doctors should fill when a patient returns, with complaints of possible drug reactions.
But the WHO says with the disparities in the doctor-patient ratios, physicians tend to concentrate on the primary cause, than pay attention to drug reactions.
Training institutions also do not emphasise drug reactions, the reason governments should include pharmacovigilance in their health programmes.
Talisuna, however, notes that poor regulation of drug outlets and over-the-counter medication pose a big challenge in Uganda.
MICHEAL Kaliisa went to a clinic complaining of a high fever, body weakness and fatigue. “That must be malaria,†the nurse told him as she prescribed some medicine.
“But Kaliisa woke up in the night with difficulty in breathing and by morning, he was dead,†his wife, Mary Kaliisa, says.
Kaliisa had reacted to metacalphin, an anti-malarial in the class of fansider (sulphur drugs).
The post-mortem exonerated the health worker from incompetence and negligence as alleged by the deceased’s survivors, revealing that he was allergic to the drug.
Kaliisa’s is just one of the few reported cases of adverse drug reactions — unwanted, uncomfortable, or dangerous effects that a drug may have.
Dr. Ambrose Talisuna, an epidemiologist (determines what factors cause or contribute to disease) and country representative of Medicines for Malaria Ventures, says adverse drug reactions typically occur soon after a drug is taken.
He explains that an adverse drug reaction may be mild — disappears gradually without major interventions.
It may also call for change in treatment, hospitalisation or treatment to counter the reaction and discontinuation of the drug.
Talisuna says many people always consider medicine a magic bullet because it improves health, not knowing they can react to it. Medicines can be life-threatening, cause a birth defect and disability.
In the early 1960s, an abnormally high number of children in Canada were born with severe deformities: limbs were missing, or only half existed and in some, the fingers and toes were found at the end of what looked like flippers.
It turned out that thalidomide, a tranquilliser, which was marketed as the safest ever, was causing the problems. It was commonly prescribed to pregnant women for morning sickness. The drug was banned.
In Uganda, quinine injections have caused disability to many children with orthopedic departments in major hospitals revealing that they contribute to a third of the admissions.
Studies in developed countries like the US and UK have shown that adverse drug resistance are a major cause of hospital admissions, accounting for 15% (one in every seven people admitted.)
A Canadian-based study published in the Canadian Medical Association Journal also showed that 12% (more than one in nine people) of all emergency room visits were medication-related. The study involved 1,017 patients in a 12-week period.
In Africa, unfortunately, such studies are hard to come by as researchers do not give the problem prominence; neither do the patients, going by the poor reporting habits.
Nonetheless, Helen Byomire, the head of National Pharmacovigilance Centre (NPC) at the Uganda National Drug Authority (NDA), says half of all hospital-related illnesses are a result of adverse drug reactions.
“Since we established a pharmacovigilance centre in 2005 with regional desks in Masaka, Gulu, Lira, Soroti, Kabarole, and Hoima districts, we have received over 300 drug-related illness reports, mostly on anti-malaria treatment and anti-retroviral drugs,†Byomire reveals.
“We fear it is just a tip of the ice burg because not only are our activities not yet popular, but the culture of reporting drug reactions is poor.
The challenge is telling the difference between the drug and the disease,†she adds.
Byomire also notes that many people practice self-medication and may not present the right names of the drug they may have taken.
“Besides, most times, patients go to another healthcare provider when they get adverse drug reactions on assumption that the doctor did not know what he was doing.â€
She says pharmacovigilance (the detection, assessment, understanding and prevention of adverse effects of medicines) is the solution, although it is a new phenomenon.
How adverse drug reactions commonly present
An Internet site on health, www.familyhealth.com reveals that most are relatively mild, and many disappear when the drug is stopped or the dose is changed; some gradually subside as the body adjusts to the drug, while others are severe.
“About 10% of all hospital admissions in the US are for treatment of ADRs, 10 to 20% (2.2 million) of which are severe,†the site adds, noting more that 100,000 deaths are attributed annually to serious adverse drug reactions.
The site reveals that digestive disturbances, loss of appetite, nausea, a bloating sensation, constipation and diarrhoea are particularly common reactions, because most drugs are taken by mouth.
However, almost any organ system can be affected. In older people, the brain is commonly affected, often resulting in drowsiness and confusion.
Byomire says in severe instances, the patient may collapse, suffer shock, or multiple organ failure like kidney and heart failure which is the common cause of death.
Byomire explains that adverse drug reactions may be limited to a certain location, or systemic, where a medication has caused adverse effects throughout the body.
Causes of drug reactions
An advocacy too lkit for patients’ organisations on addressing global patient safety issues reveals that adverse drug reactions may arise from particular diseases and prescribing practices; genetics, diet, and traditions of the people.
They may also arise from the drug manufacturing processes, which can influence pharmaceutical quality and composition and the use of traditional and complementary drugs like herbal remedies which may pose specific toxicological problems when used alone or in combination with other drugs.
“A medical, genetic or allergic condition in the patient may cause a bad reaction to the drug. Various diseases, especially those that cause renal or hepatic insufficiency, may alter drug metabolism,†the kit adds.
Talisuna, also the former commissioner of epidemiology and surveillance at the health ministry, says adverse drug reactions may also be a result of counterfeit and substandard medicines.
Medicines are made of ‘potent-active ingredients’ and need to be taken in the correct dose and frequency as prescribed by a health professional.
“For instance missed doses of glucoma medicine can lead to optic nerve damage or blindness and missed doses of heart medication can lead to cardiac arrest, while an overdose of some medicines can lead to death,†he says.
“If a patient is taking a different medicines at the same time, there is risk that they could interact with each other or with certain types of food or supplements in a harmful way,†she explains.
The route of drug administration — topical, intramuscular (injections) and intravenous administrations (drips) are more likely to cause hypersensitivity reactions.
“Oral medications are less likely to result in serious drug hypersensitivity,†he says. “Nonetheless, how you eat, how much you weight and your age may cause an adverse drug reaction.
But many people pick drugs over the counter and do not read the information insets.
“Some ignore the precautions like “do not take on a hungry stomach, take after a meal, drink lots of fluids and don’t consume alcohol or diary products’.
This information is important. If you take flagyl and drink alcohol, you could die,†Talisuna stresses.
Recommendations on how medical personnel can reduce cases of adverse drug reactions
Dr. Ambrose Talisuna, the country representative of Medicines for Malaria Ventures, says for developing countries, especially in Africa, the scope for pharmacovigilance needs to be broader because of the growing problems with substandard and counterfeit drugs.
He also advises that once a medicinal product has been placed on the market, there is still need to monitor the effects of the medicine when taken by individuals because adverse effects will only become apparent when the medicine is used extensively in large numbers of patients.
“Information about rare but serious adverse reactions, chronic toxicity, use in special groups like children, the elderly or pregnant women, or interactions between drugs is often incomplete or not available.
Unfortunately, manufactures do not invest heavily in post-marketing pharmacovigilance,†he says.
The director general of health services, Dr. Sam Zaramba, says there should be awareness on drug reactions.
He says the Uganda National Expanded Programme on Immunisation has a ‘visible programme on pharmacovigilance.
“Emulate them.
Work closely with professionals like nurses and midwife associations to combat adverse drug reactions,†he advises.
Zaramba urges nurses to go the extra mile to ask patients to report adverse reactions.
“This helps us document the medicine so that we can withdraw it, caution health providers or recommend an anecdote to counter the medicine.â€
He says they have developed forms that doctors should fill when a patient returns, with complaints of possible drug reactions.
But the WHO says with the disparities in the doctor-patient ratios, physicians tend to concentrate on the primary cause, than pay attention to drug reactions.
Training institutions also do not emphasise drug reactions, the reason governments should include pharmacovigilance in their health programmes.
Talisuna, however, notes that poor regulation of drug outlets and over-the-counter medication pose a big challenge in Uganda.