 |
 |
 |
 |
 |
 |
 |
|
|
|
|||||||||
|
|||||||||||
PhD Research Pharmacist Department of Pharmacy Practice Monash University 381 Royal Parade Parkville VIC 3052 Australia FAX 613/990-39629 E-mail phyllis.lau{at}vcp.monash.edu.au
Senior Lecturer Department of Pharmacy Practice Monash University
Director of Pharmacy Peter MacCallum Cancer Institute Senior Lecturer Department of Pharmacy Practice Monash University
Published Online, January 13, 2003. www.theannals.com
In a study at the Peter MacCallum Cancer Institute (February 28–June 2, 2000), we randomly selected admissions for review of patient medical records and further selected a subset for interviews about ADRs. All adverse events were assessed for relationship to drugs using the Naranjo algorithm.2 A total of 577 ADRs were identified.
To realistically assess preventability, we modified the criteria of Schumock and Thornton3 to categorize ADRs into definitely, probably, and not preventable (Table 1). Where a history of allergy or adverse reaction to a drug is present or the drug, dose, route, or frequency of administration is inappropriate, an ADR was regarded as definitely preventable (Section A).
|
We omitted the factor of toxic serum drug concentration. With advances in cancer supportive therapy and transplant technology, antineoplastics are increasingly administered at high dosages, often resulting in blood concentrations beyond traditionally recognized toxic levels. This factor, therefore, does not necessarily identify preventability.
We added 2 questions (4, 5; Section B) on the use of preventive measures because many ADRs are predictable and preventable.4 When a predictable ADR occurs, questions should be raised about whether known prevention has been used in an appropriate, adequate, and timely manner.
Where an ADR could have been avoided if there had been laboratory monitoring, no drug interaction or compliance problems, or appropriate and adequate prevention, it was regarded as probably preventable (Section B).
Like Schumock and Thornton,3 we agree that there will ultimately be ADRs that occur, even with all necessary precautions. These were regarded as not preventable (Section C).
Using the modified scale, we found that <2% of ADRs were definitely preventable, less than half were probably preventable, and just over half were not preventable.
In oncology practice, where a patient's general health status is heavily compromised, many factors and influences determine patient management. More often than not, there is little choice between giving a life-preserving drug that would likely elicit an undesirable reaction and not giving it at all. The challenge in these circumstances becomes how well we can prevent predictable ADRs. Our results show that few ADRs in oncology practice are definitely preventable. There are, however, many occasions where improved use of preventive measures has the potential to reduce the incidence and severity of ADRs. The vigilant prevention of ADRs is therefore an important issue in the quality use of medicine.
Conclusions regarding the preventability of adverse events in oncology must be qualified with the degree of preventability to enable robust estimations or extrapolations of potential impacts of interventional strategies.
References
Related articles in The Annals:
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
 |
 |
 |
 |
 |
 |
 |
