Meditation over serialization in pharmaceutical supply chain and opportunities for pharmacovigilance and quality control

20. december 2016 at 16:32 | Veronika Valdova, ARETE-ZOE
New serialization legislation required for pharmaceutical products has the potential to transform how we think about pharmacovigilance and quality control, and help connect information relevant for these industry functions.

New serialization legislation, package-level identifiers and safety features

The Falsified Medicines Directive of 2011 introduces new harmonized, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. These new measures include:

  • Obligatory safety features on the outer packaging of the medicines (Commission Delegated Regulation (EU) 2016/161)
  • A common, EU-wide logo to identify legal online pharmacies.
  • Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients,
  • And strengthened record-keeping requirements for wholesale distributors.
In March 2010, the FDA issued recommendations in the Standard Numerical Identifier (SIN) Guidance explaining the FDA's current thinking on the structure, format, and content of uniquely labeled package-level identifiers. The guidance is intended to assist with the development of standards and systems for identification, validation, authentication, and tracking and tracing of prescription drugs at package level.
The Drug Quality and Security Act (DQSA), was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act, outlines critical steps to build an electronic, inter-operable system to identify and trace certain prescription drugs as they are distributed in the United States. Ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain.
Historically the U.S. Pharmacopeia has worked to ensure their standards and General Chapters complement regulatory documents such as the FDA Title 21 of the Code of Federal Regulation Part 211 on current Good Manufacturing Practices. USP 1083 covers all areas of sourcing and distribution of packaging materials, active pharmaceutical ingredients, excipients and final products, including clinical trial materials. The guideline applies to not only pharmaceuticals, but also medical devices, combination products, and dietary supplements.

So what is the impact of this new legislation on the way how we go about pharmacovigilance?

Traditional understanding of pharmacovigilance by the industry is that it is a purely compliance function. Main vulnerabilities are internal and external inter-dependencies stemming from organizational structure, outsourcing, reorganizations due to acquisitions and mergers, and (in)compatibility of systems used before and after change.
Threats include incompetence resulting from inability to appropriately train staff on pharmacovigilance as a result of ambiguity in process, human error caused by improvisation and inconsistent application of regulations, and inconsistent quality of information that meets the minimum reporting requirements but does not provide any other useful information.
In pharmacovigilance and clinical research context, adverse consequence typically means regulatory action for non-compliance (See MHRA inspections report for 2015-16 and EMA metrics).

But ... what if the Priority Information Requirements (PIR) change?

Minimum information requirements for ADR reporting include identifiable reporter, identifiable patient, drug involved, and event. This dataset satisfies regulators but provides no meaningful information to the Market Authorization Holder - except for satisfying compliance.
Safety reports are only as good as the information received. MAH may wish to know other attributes to be able to asses quality and make meaningful assessment of the eventProperly designed process that accounts for newly defined PIRs translates into SOPs and working instructions for own staff, vendors and service providers.
Information about the product such as history of storage conditions, batch numbers, or expiration date, can be included by simply scanning the product code in an electronic report. Accurate identification and other information relating to the drug allows the collector to distinguish between:

  • Adverse drug reactions
  • Quality issues, expired or improperly stored product
  • Suspected counterfeit drugs in legitimate supply chain
  • Diversion of legitimate products for illicit use
  • And products obtained through illicit channels
Additional information collected about the context of use of certain drugs may include diagnosis, off-label use, medication error, misuse/abuse, and overdose.
Inclusion of various quality indicators as re-defined in Priority Information Requirements in data collection would make data collection pharmacovigilance data operationally meaningful.

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