Pharmacovigilance

 Programme Director:  Dr Kyle Perrin

The role of drug therapy in the development of Churg-Strauss syndrome

The Churg-Strauss Syndrome is a rare disease in which there is inflammation of the blood vessels (vasculitis). It occurs in patients with asthma and is associated with significant risk of morbidity and mortality. Recently there has been an increase in reports of Churg-Strauss Syndrome in patients with asthma who have received leukotriene receptor antagonists (LTRA), a new class of asthma medication. The Adverse Event Reporting System (AERS) database maintained by the FDA was examined to investigate the association between Churg-Strauss Syndrome and LTRA therapy. This database is the key resource used to identify adverse events for marketed medical products in the United States, containing over 2 million spontaneous reports of adverse reactions for more than 2000 products spanning nearly a 35 year time period. The analyses identified that an association between LTRA use and Churg-Strauss Syndrome was present irrespective of the use of other asthma drugs suggesting a causal association and highlighting the need for further research.

Risk of adverse cardiovascular events with COX-2 inhibitors

The magnitude of risk of serious adverse cardiovascular events associated with the use of specific COX-2 inhibitors has been a matter of considerable debate. To clarify this uncertainty, a series of systematic reviews and meta-analyses of clinical studies which reported data on cardiovascular events with different COX-2 inhibitors was undertaken. This identified that celecoxib, etoricoxob and parecoxib/valdecoxib were associated with an increased risk of cardiovascular events. These findings, which have now been replicated, have attracted considerable international interest and have challenged the FDA’s assessment of the relative risks of COX-2 inhibitors.

The PHARMAC series

The Pharmaceutical Management Agency’s (PHARMAC) primary function is to manage the national pharmaceutical schedule. Decisions on subsidy levels and prescribing guidelines are undertaken by PHARMAC with input from independent medical experts on the Pharmacology and Therapeutics Advisory Committee (PTAC) and its specialist sub-committees. Since its inception there have been concerns about the strategies employed by PHARMAC, and the negative impact that may have resulted, in terms of provision of pharmceuticals for health care. To consider these issues the MRINZ coordinated and edited a series of articles on PHARMAC, which were published in the New Zealand Medical Journal. In total there were twenty articles written by prominent specialists throughout New Zealand, who examined in detail the strengths and weaknesses of PHARMAC, using a case based approach. PHARMAC contributed to the series by writing one of the articles and by responding to all the other articles. This series has been widely acclaimed as an authoritative academic review of PHARMAC, and has contributed to the government decision to review its operation.

A new look at the oxyhaemoglobin dissociation curve

The oxygen haemoglobin dissociation curve represents one of the key physiological relationships in medicine. In a commentary published in The Lancet we took a new look at the oxygen/haemoglobin dissociation curve and proposed that a different orientation of the curve might better illustrate its relevance to clinical practice. This formed part of a broader review in which it was recommended that oxygen be regarded as a drug that is prescribed for defined indications, in which its benefits outweigh its risks, that the prescription specifies the dose, method and duration of delivery, and that the patient’s response to oxygen therapy is monitored.

Risks of high flow oxygen therapy

This review represented part of the research programme determining the optimal use of oxygen therapy in acute medical disorders. It put into clinical perspective the potential risks of the routine use of high flow oxygen therapy in breathless patients. Physiological modelling was used to demonstrate how, in the situation of a deteriorating cardiovascular or respiratory condition, high flow oxygen therapy may lead to a delay in recognising the worsening clinical condition and result in delay in seeking medical help. These findings have been incorporated into the recent British Thoracic Society Guidelines on Oxygen Therapy.

High flow oxygen therapy and myocardial infarction

An historical review of the effects of high flow oxygen therapy in myocardial infarction was published. This review suggested that the current practice of routinely administering high flow oxygen therapy in patients experiencing a heart attack may be harmful, leading to worse outcomes in this clinical situation. This has led to an international collaboration to undertake a multi-centre randomised controlled trial of oxygen therapy in myocardial infarction, in an attempt to determine the preferred therapeutic regime.

Pharmacovigilance

 Programme Director:  Dr Kyle Perrin

The role of drug therapy in the development of Churg-Strauss syndrome

The Churg-Strauss Syndrome is a rare disease in which there is inflammation of the blood vessels (vasculitis). It occurs in patients with asthma and is associated with significant risk of morbidity and mortality. Recently there has been an increase in reports of Churg-Strauss Syndrome in patients with asthma who have received leukotriene receptor antagonists (LTRA), a new class of asthma medication. The Adverse Event Reporting System (AERS) database maintained by the FDA was examined to investigate the association between Churg-Strauss Syndrome and LTRA therapy. This database is the key resource used to identify adverse events for marketed medical products in the United States, containing over 2 million spontaneous reports of adverse reactions for more than 2000 products spanning nearly a 35 year time period. The analyses identified that an association between LTRA use and Churg-Strauss Syndrome was present irrespective of the use of other asthma drugs suggesting a causal association and highlighting the need for further research.

Risk of adverse cardiovascular events with COX-2 inhibitors

The magnitude of risk of serious adverse cardiovascular events associated with the use of specific COX-2 inhibitors has been a matter of considerable debate. To clarify this uncertainty, a series of systematic reviews and meta-analyses of clinical studies which reported data on cardiovascular events with different COX-2 inhibitors was undertaken. This identified that celecoxib, etoricoxob and parecoxib/valdecoxib were associated with an increased risk of cardiovascular events. These findings, which have now been replicated, have attracted considerable international interest and have challenged the FDA’s assessment of the relative risks of COX-2 inhibitors.

The PHARMAC series

The Pharmaceutical Management Agency’s (PHARMAC) primary function is to manage the national pharmaceutical schedule. Decisions on subsidy levels and prescribing guidelines are undertaken by PHARMAC with input from independent medical experts on the Pharmacology and Therapeutics Advisory Committee (PTAC) and its specialist sub-committees. Since its inception there have been concerns about the strategies employed by PHARMAC, and the negative impact that may have resulted, in terms of provision of pharmceuticals for health care. To consider these issues the MRINZ coordinated and edited a series of articles on PHARMAC, which were published in the New Zealand Medical Journal. In total there were twenty articles written by prominent specialists throughout New Zealand, who examined in detail the strengths and weaknesses of PHARMAC, using a case based approach. PHARMAC contributed to the series by writing one of the articles and by responding to all the other articles. This series has been widely acclaimed as an authoritative academic review of PHARMAC, and has contributed to the government decision to review its operation.

A new look at the oxyhaemoglobin dissociation curve

The oxygen haemoglobin dissociation curve represents one of the key physiological relationships in medicine. In a commentary published in The Lancet we took a new look at the oxygen/haemoglobin dissociation curve and proposed that a different orientation of the curve might better illustrate its relevance to clinical practice. This formed part of a broader review in which it was recommended that oxygen be regarded as a drug that is prescribed for defined indications, in which its benefits outweigh its risks, that the prescription specifies the dose, method and duration of delivery, and that the patient’s response to oxygen therapy is monitored.

Risks of high flow oxygen therapy

This review represented part of the research programme determining the optimal use of oxygen therapy in acute medical disorders. It put into clinical perspective the potential risks of the routine use of high flow oxygen therapy in breathless patients. Physiological modelling was used to demonstrate how, in the situation of a deteriorating cardiovascular or respiratory condition, high flow oxygen therapy may lead to a delay in recognising the worsening clinical condition and result in delay in seeking medical help. These findings have been incorporated into the recent British Thoracic Society Guidelines on Oxygen Therapy.

High flow oxygen therapy and myocardial infarction

An historical review of the effects of high flow oxygen therapy in myocardial infarction was published. This review suggested that the current practice of routinely administering high flow oxygen therapy in patients experiencing a heart attack may be harmful, leading to worse outcomes in this clinical situation. This has led to an international collaboration to undertake a multi-centre randomised controlled trial of oxygen therapy in myocardial infarction, in an attempt to determine the preferred therapeutic regime.

Pharmacovigilance

 Programme Director:  Dr Kyle Perrin

The role of drug therapy in the development of Churg-Strauss syndrome

The Churg-Strauss Syndrome is a rare disease in which there is inflammation of the blood vessels (vasculitis). It occurs in patients with asthma and is associated with significant risk of morbidity and mortality. Recently there has been an increase in reports of Churg-Strauss Syndrome in patients with asthma who have received leukotriene receptor antagonists (LTRA), a new class of asthma medication. The Adverse Event Reporting System (AERS) database maintained by the FDA was examined to investigate the association between Churg-Strauss Syndrome and LTRA therapy. This database is the key resource used to identify adverse events for marketed medical products in the United States, containing over 2 million spontaneous reports of adverse reactions for more than 2000 products spanning nearly a 35 year time period. The analyses identified that an association between LTRA use and Churg-Strauss Syndrome was present irrespective of the use of other asthma drugs suggesting a causal association and highlighting the need for further research.

Risk of adverse cardiovascular events with COX-2 inhibitors

The magnitude of risk of serious adverse cardiovascular events associated with the use of specific COX-2 inhibitors has been a matter of considerable debate. To clarify this uncertainty, a series of systematic reviews and meta-analyses of clinical studies which reported data on cardiovascular events with different COX-2 inhibitors was undertaken. This identified that celecoxib, etoricoxob and parecoxib/valdecoxib were associated with an increased risk of cardiovascular events. These findings, which have now been replicated, have attracted considerable international interest and have challenged the FDA’s assessment of the relative risks of COX-2 inhibitors.

The PHARMAC series

The Pharmaceutical Management Agency’s (PHARMAC) primary function is to manage the national pharmaceutical schedule. Decisions on subsidy levels and prescribing guidelines are undertaken by PHARMAC with input from independent medical experts on the Pharmacology and Therapeutics Advisory Committee (PTAC) and its specialist sub-committees. Since its inception there have been concerns about the strategies employed by PHARMAC, and the negative impact that may have resulted, in terms of provision of pharmceuticals for health care. To consider these issues the MRINZ coordinated and edited a series of articles on PHARMAC, which were published in the New Zealand Medical Journal. In total there were twenty articles written by prominent specialists throughout New Zealand, who examined in detail the strengths and weaknesses of PHARMAC, using a case based approach. PHARMAC contributed to the series by writing one of the articles and by responding to all the other articles. This series has been widely acclaimed as an authoritative academic review of PHARMAC, and has contributed to the government decision to review its operation.

A new look at the oxyhaemoglobin dissociation curve

The oxygen haemoglobin dissociation curve represents one of the key physiological relationships in medicine. In a commentary published in The Lancet we took a new look at the oxygen/haemoglobin dissociation curve and proposed that a different orientation of the curve might better illustrate its relevance to clinical practice. This formed part of a broader review in which it was recommended that oxygen be regarded as a drug that is prescribed for defined indications, in which its benefits outweigh its risks, that the prescription specifies the dose, method and duration of delivery, and that the patient’s response to oxygen therapy is monitored.

Risks of high flow oxygen therapy

This review represented part of the research programme determining the optimal use of oxygen therapy in acute medical disorders. It put into clinical perspective the potential risks of the routine use of high flow oxygen therapy in breathless patients. Physiological modelling was used to demonstrate how, in the situation of a deteriorating cardiovascular or respiratory condition, high flow oxygen therapy may lead to a delay in recognising the worsening clinical condition and result in delay in seeking medical help. These findings have been incorporated into the recent British Thoracic Society Guidelines on Oxygen Therapy.

High flow oxygen therapy and myocardial infarction

An historical review of the effects of high flow oxygen therapy in myocardial infarction was published. This review suggested that the current practice of routinely administering high flow oxygen therapy in patients experiencing a heart attack may be harmful, leading to worse outcomes in this clinical situation. This has led to an international collaboration to undertake a multi-centre randomised controlled trial of oxygen therapy in myocardial infarction, in an attempt to determine the preferred therapeutic regime.

 
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