Overexposure of radiation therapy patients in Panama: problem recognition and follow-up measures

Abstract

This report summarizes and analyzes the responses of various organizations that provided assistance to the National Oncology Institute (Instituto Oncológico Nacional, ION) of Panama following the overexposure of 28 radiation therapy patients at the ION in late 2000 and early 2001. The report also looks at the long-term measures that were adopted at the ION in response to the overexposure incident, as well as implications that the incident has for other cancer treatment centers worldwide. In March 2001, the director of the ION was notified of serious overreactions in patients undergoing radiation therapy for cancer treatment. Of the 478 patients treated for pelvic cancers between August 2000 and March 2001, 3 of them had died, possibly from an overdose of radiation. In response, the Government of Panama invited international experts to carry out a full investigation of the situation. Medical physicists from the Pan American Health Organization (PAHO) were among those invited. They ascertained that 56 patients treated with partially blocked teletherapy fields for cancers of the uterine cervix, endometrium, prostate, or rectum, had had their treatment times calculated using a computerized treatment planning system. PAHO's medical physicists calculated the absorbed doses received by the patients and found that, of these 56 patients, only 11 had been treated with acceptable errors of ±5%. The doses received by 28 of the 56 patients had errors ranging from +10 to +105%. These are the patients identified by ION physicists as overexposed. Twenty-three of the 28 overexposed patients had died by September 2005, with at least 18 of the deaths being from radiation effects, mostly rectal complications. The clinical, psychological, and legal consequences of the overexposures crippled cancer treatments in Panama and prompted PAHO to assess radiation oncology practices in the countries of Latin American and the Caribbean. ION clinicians evaluated the outcome of 125 nonoverexposed patients who had been treated in the same time period and for the same cancer sites as the overexposed patients. The clinicians uncovered a larger recurrence of cervical cancers than expected. The finding prompted PAHO to launch an initiative for the accreditation of radiation oncology centers in Latin America and the Caribbean, working in collaboration with professional societies for radiation oncologists, medical physicists, and radiotherapy technologists. The Latin American Association for Radiation Oncology (Asociación Latinoamericana de Terapia Radiante Oncológica) has established an accreditation commission. Accreditation will require that centers implement a comprehensive radiation oncology quality assurance program that follows international guidelines. Statistical data on patient outcomes will be collected in order to document needs in radiotherapy centers in Latin America and the Caribbean and to define future strategies for cancer treatment.

Cancer control in developing countries: using health data and health services research to measure and improve access, quality and efficiency

“…For example, an IAEA audit of radiation machine dosimetry found 16% of audited radiation beams in various developing countries did not meet the +/-5% dose acceptance limit on the first test of radiation dosimetric standards [41]. Doses beyond this +/-5% acceptance limit have been associated with severe and even lethal toxicity [43]. 93% of radiation beams met standards by the second iteration of the audit.…”

History of the radiological health program of the Pan American Health Organization

“…PAHO was also asked to investigate a radiotherapy overexposure incident that occurred in Panama, caused by the improper use of treatment planning software. The details of the Panama exposure are published in this issue of this journal, in a report by Borrás (22).…”

A conceptual framework for lean regulated software development

“…For example, the Enron scandal 2001, which resulted in the loss of over $11 Billion of investors' and employees stocks and pensions, was due to fraudulent financial reporting [1]. In Panama, 21 patients died from overdoses of radiation during cancer treatment as a result of software failure combined with software misuse [2]-and many other risks to public as collected by Neumann et al [10]. As a consequence, regulations have been imposed to help reduce the possibility of such events recurring.…”