Preparing for a damaging medication error

From the Sept. 24,1997 Issue

All practice sites should have a plan of action for responding to serious errors, especially any that result in patient harm or death. The plan should address how, in the event of an incident, the organization should interact with patients, families and outside organizations, including state and federal regulatory authorities and accrediting bodies. Since it is not uncommon for serious medical errors to receive press coverage, the plan should also address this issue. If not handled properly, the health-system's reputation can be severely damaged and may result in a long-lasting adverse effect on community relations. Managers, attorneys, public relations specialists and risk managers need to be involved in the development of the overall plan. Key individuals, such as the CEO, manager of the pharmacy, director of nursing and chief of the medical staff, should be consulted. The following issues need to be addressed:

• How should staff interact with patients and families involved in adverse events?
• What procedures must be undertaken for safeguarding applicable documents and involved containers and equipment?
• How should the risk manager's immediate review and investigation be carried out?
• In the event of inquiry from the news media, how will confidentiality of patient-related information be assured while providing useful and accurate information to the public?
• How will internal public relations activities be conducted so that staff knows the incident is being addressed properly?
• What process will be used to assure that appropriate immediate and long-term remedial actions are taken?
• If a product or device is defectively labeled, packaged or designed, what steps should be undertaken to prevent future errors (i.e., should product be removed, brand or package type be changed, etc.)?
• What is the internal and external notification process (FDA MEDWATCH, USP Medication Errors Reporting Program, manufacturers, state department of health, coroner, professional staff, etc.)?
• What is the internal and external notification process (FDA MEDWATCH, USP Medication Errors Reporting Program, manufacturers, state department of health, coroner, professional staff, etc.)?
• What sort of psychological counseling and other forms of support are available for all involved in the incident?

In the investigation that immediately follows a serious error, it is important to learn as much as possible about the nature of the incident and exactly how it happened. Investigations must focus on system and process deficiencies, not on an individual's knowledge deficit or performance failures.

References: Cohen MR. Responding to a serious medication error. Hosp Pharm 1991;26:1024-5; Heape A. How to neutralize negative publicity. ECRI. Hospital Risk Control 1990.