Appendix E Return to the Beginning

National Coordinating Council for Medication Error Reporting and Prevention Recommendations to Health Care Organizations to Reduce Errors Due to Labeling and Packaging of Drug Products and Related Devices

The Council recommends the establishment of a systems approach to reporting, understanding, and prevention of medication errors in health care organizations. The organization's leaders should foster a culture and systems that include the following key elements:

a.an environment that is conducive to medication error reporting through the FDA MedWatch Program and/or the USP Practitioners' Reporting Network;

b.an environment which focuses on improvement of the medication use process;

c.mechanisms for internal reporting of actual and potential errors including strategies that encourage reporting;

d.systematic approaches within the health care organization to identify and evaluate actual and potential causes of errors including Failure Mode and Effects Analysis (FMEA) and root cause analysis;

e.processes for taking appropriate action to prevent future errors through improving both systems and individual performance.

In addition, the Council makes the following recommendations to health care organizations to reduce errors due to labeling and packaging of drug products and related devices:

1.The Council recommends that health care organizations employ machine readable coding (e.g., bar coding) in the management of the medication use process.

2.The Council recommends reevaluation of existing storage systems for pharmaceuticals by health care organizations and establishment of mechanisms to insure appropriate storage and location throughout the organization from bulk delivery to point of use. The following issues should be considered when applicable:

storage and location that will help distinguish similar products from one another;
storage and location of certain drugs, (e.g., concentrates, paralyzing agents) that have a high risk potential;
scope, access, and accountability for floor stock medications;
safety and accountability of access to pharmaceuticals in the absence of a pharmacist (e.g., floor stock, eliminate access to pharmacy after hours);
labeling and packaging of patient-supplied medications.

3.The Council recommends the development of policies and procedures for repackaging of medications that will clarify labeling to help avoid errors.

4.The Council encourages collaboration among health care organizations, health care professionals, patients, industry, standard-setters, and regulators to facilitate design of packaging and labeling to help minimize errors.

5.The Council recommends that health care organizations develop and implement (or provide access to) education and training programs for health care professionals, technical support personnel, patients, and caregivers that address methods for reducing and preventing medication errors.

Appendix F

National Coordinating Council for Medication Error Reporting and Prevention Recommendations for Avoiding Error-Prone Aspects of Dispensing Medications

1.The Council recommends that prescriptions/orders always be reviewed by a pharmacist prior to dispensing. Any orders that are incomplete, illegible, or of any other concern should be clarified using an established process of resolving questions.

2.The Council recommends that patient profiles be current and contain adequate information that allows the pharmacist to assess the appropriateness of a prescription/order.

3.The Council recommends design of the dispensing area to prevent errors. Design should address fatigue-reducing environmental conditions (e.g., lighting, air conditioning, noise level, ergonomic fixtures); minimize distractions (e.g., telephone and personnel interruptions, clutter, unrelated tasks); and provide sufficient resources for workload.

4.The Council recommends that product inventory be arranged to help differentiate medications from one another. This may include use of visual discriminators such as signs or markers. This is particularly important when confusion exists between or among strengths, similar looking labels, and similar sounding names.

5.The Council recommends that a series of checks be established to assess the accuracy of the dispensing process prior to the medication being provided to the patient. Whenever possible, an independent check by a second individual should be used. Other methods of checking include the use of automation, computer systems, and patient profiles.

6.The Council recommends that labels be read at least three times, for example, when selecting the product, when packaging the product, and when returning the product to the shelf.

7.The Council recommends that pharmacists counsel patients. Counseling should be viewed as an opportunity to verify the accuracy of dispensing and the patient's understanding of proper medication use.

8.The Council recommends that pharmacies collect data regarding actual and potential errors for the purpose of continuous quality improvement.