Importance of Product Label in Risk Management

 

The regulatory world is rapidly evolving to shorten the review and approval process, moving toward more conditional approvals with restricted and controlled drug use. The field of combination products, with the limitless possibilities of smartphones, device technology, sensors and drug delivery systems is exploding. The ability to access massive datasets across different systems and populations is disrupting the existing approaches to data mining and pharmacoepidemiology.

The customization of benefit-risk at the individual level brings patient engagement activities and risk communication to a totally different way of thinking about benefit-risk and risk communication. In the meantime, the ever increasing dis-harmonization of safety requirements across regions and countries obliges pharmacovigilance organizations to constantly look for innovation, productivity and performance gains. These are some of the significant but very exciting challenges that makes pharmacovigilance such a fascinating domain, more than ever. The ability to understand the current trends and to brainstorm with key opinion leaders and colleagues are critical to preparing our minds and practices to this changing world.

Countries maintain different requirements for medicine labels; the differences may be mostly formatting, but there may also be unique content requirements. Also, the threshold for including safety information in product label may differ among local health authorities.

 

The Fleming. team sits down with Debra Feldman to explain us more about the importance of product labeling in risk management.

  • Debra Feldman
  • Vice President, Global Pharmacovigilance and Epidemiology
  • Bristol-Myers Squibb, United States

1. What are the important elements to consider when building the safety section in product labeling?

The product label is where pharmaceutical companies (Sponsors) communicate the information needed for the effective and safe use of the medicine. To build the safety sections of the label, the Sponsors consider pre-clinical studies, clinical studies, post-approval data, and mechanism of action to describe both on target and off target effects of the medicine. After assessing these sources of information, the Sponsor constructs the set of core safety information that will be included in product labels. Constructing product label content requires input from many expert groups within a Sponsor company.

Countries maintain different requirements for medicine labels; the differences may be mostly formatting, but there may also be unique content requirements. Also, the threshold for including safety information in product label may differ among local health authorities.

 

2. What role does the product label play in risk management?

Risk identification is the first step in risk management. Once risks have been identified, the product label serves as the cornerstone for communication of identified risks. Labels can be complicated to read, even for health care providers. Communication materials beyond the product label are based on the safety and risk content included in the product label.

 

3. What are some of the challenges in building the safety section of product labels?

Constructing product label content requires input from many expert groups within a Sponsor company; experts in building product labels can facilitate this process, along with scientific subject matter experts, Regulatory affairs, pharmacovigilance and others. The frequency for introducing safety labeling updates is challenging, given that the creation of new labels generally require local regulatory approval for updates and must be closely coordinated with product manufacturing.

The product label is where pharmaceutical companies (Sponsors) communicate the information needed for the effective and safe use of the medicine. To build the safety sections of the label, the Sponsors consider pre-clinical studies, clinical studies, post-approval data, and mechanism of action to describe both on target and off target effects of the medicine. After assessing these sources of information, the Sponsor constructs the set of core safety information that will be included in product labels. Constructing product label content requires input from many expert groups within a Sponsor company.

Countries maintain different requirements for medicine labels; the differences may be mostly formatting, but there may also be unique content requirements. Also, the threshold for including safety information in product label may differ among local health authorities.