Strategies for avoiding product-related errors in investigational drug usage, focusing on guidance for drug sponsors, the Food and Drug Administration (FDA), and clinical sites (Part II)

Strategies for avoiding product-related errors in investigational drug usage, focusing on guidance for drug sponsors, the Food and Drug Administration (FDA), and clinical sites (Part II)

In the realm of pharmaceutical research, ensuring the safety and efficacy of investigational drugs is paramount. A recent focus has been placed on the responsibilities of drug sponsors in maintaining the highest standards for labeling, packaging, and nomenclature of these drugs.

According to guidelines, sponsors should package oral investigational drugs in patient-ready unit-of-use packaging and establish good manufacturing practices and quality control testing standards. This ensures that the intended number of tablets or capsules are packaged in each container.

Moreover, sponsors are advised to initiate a timely and coordinated name change in the protocol, pharmacy manual, product labeling and packaging, and other product-related information when the investigational drug's name or standardized identifier changes. It is also essential for sponsors to select and approve a unique, standardized identifier for a new investigational drug before Phase II trials.

Despite the existing guidelines and standards, there are few recommendations specific to sponsors' responsibilities for safe investigational drug labeling, packaging, and nomenclature. The Code of Federal Regulations (CFR) requires a warning on the immediate package of investigational drugs: "Caution: New Drug-Limited by Federal (or United States) law to investigational use."

Sponsors should label all investigational drugs before providing them to clinical sites and standardize investigational drug shipping invoices/packing lists to include all information required on the product labels, including expiration/retest dates and site-specific protocol number.

In addition, sponsors should perform a risk assessment on the new investigational drug's name, labeling, and packaging. They should also package parenteral investigational medications in vials/containers in the size and volume that best corresponds to the dosing.

To prevent medication errors, specific error mitigation strategies have been recommended for sponsors. These strategies focus on ensuring accuracy, clarity, and cross-functional collaboration in the development and quality assurance processes. Key strategies include thorough Root Cause Analysis (RCA) and Corrective/Preventive Actions (CAPA), cross-functional collaboration and early integration, attention to details in labeling and packaging, early and continuous hazard analysis and verification, training and competency development, label stock and equipment management, use of clear nomenclature and consistent labeling, and standardizing investigational drug shipping invoices/packing lists.

The Joint Commission's (TJC) Medication Management Standards require accredited hospitals to manage investigational drugs safely by addressing review, approval, supervision, and monitoring of these drugs, as well as controlling storage, dispensing, labeling, and distribution. The American Society of Health-System Pharmacists (ASHP) and the Hematology/Oncology Pharmacy Association (HOPA) have also published best practices for investigational drugs, including recommendations for storage, dispensing, labeling, and tracking expiration dates.

These strategies emphasize a system-based approach combining technical, human, and procedural controls to mitigate medication errors related to investigational drug labeling, packaging, and nomenclature. By adhering to these recommendations, sponsors can contribute significantly to the safety and success of clinical trials.

1. In the realm of pharmaceutical research, maintaining the highest standards for data related to labeling, packaging, and nomenclature of investigational drugs is crucial.
2. Sponsors should ensure health-and-wellness by packaging oral investigational drugs in patient-ready unit-of-use packaging, establishing good manufacturing practices, and implementing quality control testing standards.
3. News about hazards can arise if sponsors do not initiate a timely and coordinated name change in the protocol, pharmacy manual, product labeling, and packaging when the investigational drug's name or standardized identifier changes.
4. Support for sponsors in these responsibilities can come from guidelines that suggest selecting and approving a unique, standardized identifier for a new investigational drug before Phase II trials.
5. The Code of Federal Regulations (CFR) requires a warning on the immediate package of investigational drugs: "Caution: New Drug-Limited by Federal (or United States) law to investigational use."
6. Sponsors should review all investigational drugs before providing them to clinical sites and standardize investigational drug shipping invoices/packing lists to include all required information, such as expiration/retest dates and site-specific protocol numbers.
7. To prevent errors, specific strategies have been recommended for sponsors, focusing on accuracy, clarity, and cross-functional collaboration in the development and quality assurance processes.
8. These strategies include thorough review of root causes and implementation of corrective/preventive actions, cross-functional collaboration and early integration, attention to details in labeling and packaging, early and continuous hazard analysis and verification, training and competency development, label stock and equipment management, use of clear nomenclature and consistent labeling, and standardizing investigational drug shipping invoices/packing lists.
9. The Joint Commission's (TJC) Medication Management Standards require accredited hospitals to manage investigational drugs safely by addressing review, approval, supervision, and monitoring of these drugs, as well as controlling storage, dispensing, labeling, and distribution.
10. Research has shown that a system-based approach combining technical, human, and procedural controls can significantly mitigate medication errors related to investigational drug labeling, packaging, and nomenclature.
11. Adherence to these recommendations can contribute significantly to the safety, quality, and success of clinical trials and various medical-conditions treatments.

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