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(Learning about USP Chapter <800> in 10 minutes a week.)
18. MEDICAL SURVEILLANCE
Personnel handling HDs regularly SHOULD be enrolled in a medical surveillance program (MSP).
The MSP includes:
- Assessment and documentation of symptom complaints
- Physical findings and
- Laboratory values
Tracking these individuals over time allows comparison of health variables which may facilitate early detection of a:
- Change in a laboratory value or
- Change in a health condition
The individual's data can be:
- Compared over time
- Compared with others with the HD exposure group and
- Compared with those with no exposure
Elements of the MSP SHOULD include:
- Organized identification of workers potentially exposed to HDs due to their job
- Use of an entity-based or contracted employee health service to perform the MSP
- Initial baseline assessment to include
- Medical (including reproductive) history
- Work history
- Physical examination and
- Laboratory testing
- Methods used to assess exposure history include a review of:
- Records of HDs handled, quantities and dosage forms
- Estimated number of HDs handled per week
- Estimates of hours spent handling HDs per week and/or per month
- Performance of a physical assessment and laboratory studies linked to target organs of commonly used HDs
- Maintain MSP records according to OSHA regulations
- Prospective monitoring of workers' health
- Data monitoring to identify prevention failures leading to health effects
- Follow-up plan development for workers showing health changes
- Exit examination when a worker ceases to work at the facility
Next week, we will look at Section 18.1 Follow-Up Plan.
QUESTIONS
Questions received on the Medical Surveillance Program section.
- In a medical surveillance program, what can a PIC do if the employee does not want the employer to see their medical records?
- In a medical surveillance program, what "health variables" should be followed over time for individual workers? (How detailed?)
- In a medical surveillance program, who pays for all the tests, etc.?
- In a medical surveillance program paid for by the employer, does the employer have access to and/or own the data?
- In a medical surveillance program, how does an employer obtain data from the "unexposed workers" for comparison to the "exposed workers"?
- What are the limitations on "potentially exposed" to HDs?
NOTE: USP responses to these questions are nearing completion and will soon be posted on the USP website. We will announce this as soon as it happens. For a complete list of questions asked so far, please go to: http://www.ijpc.com/USP800Questions
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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