While RxE2 continues promoting the practice of pharmacy and community-based pharmacists in clinical trials in the United States, the European Association of Hospital Pharmacies (EAHP) is encouraging the involvement of hospital pharmacists in European clinical trials. RxE2 applauds the EAHP for taking a position on clinical trials and their recognition of the valuable contributions pharmacists make to clinical trials.
The EAHP Position Paper on Clinical Trials raises several excellent points relevant not only to Europe but also to the US. While most clinical trials still occur at the level of the academic institution, diversifying the clinical trial patient base by tapping into pharmacies is a necessity long overlooked. This is especially true as diversity, equity, and inclusivity (DEI) initiatives are implemented across the board. Additionally, as decentralized clinical trials (DCTs) become the norm, patient recruitment must be done locally. Community pharmacies, including hospital and clinical pharmacies in many locations, have established community relationships and patient trust that promote ease of recruitment and retention, two areas where many clinical trials struggle and often fail.
RxE2 would like to add to the EAHP statement that, like the US, there is a gray area in the regulations—the dispensing of investigational drugs is not addressed. This is the purview of pharmacists globally, yet pharmacists, the medication experts, are often relegated by the regulations to accountability and recordkeeping.
In the US, state law requires that drugs are dispensed only by a state-licensed pharmacist according to the regulations of that state. This fact is commonly overlooked during clinical trial packaging, shipping, and dispensing. RxE2 is bringing the pharmacist back into dispensing, following state regulations, and simplifying the process. This is a paradigm shift that will revolutionize clinical trials and is applicable across the globe.
While RxE2 builds clinical trial connections in community pharmacies in the US, the EAHP is unifying hospital pharmacies in the European Union (EU) with the same clinical trial recommendations. In the European Statements of Hospital Pharmacy, the EAHP identifies how hospital pharmacists contributed to clinical trials during the COVID-19 pandemic and that by adhering to the Statements, medicines and medical device safety and efficacy can be improved. Concluding the Statements, Section 6 Education and Research says, “Hospital pharmacists should be actively involved in clinical trials of medicines.”
As we create momentum, it’s time to think bigger. This is a call for the International Pharmaceutical Federation (FIP) to lead the global positioning of pharmacists and pharmacies in clinical trials. It’s here that FIP can apply its strength to further its mission of supporting global health by advancing the practice of pharmacy and its vision of a world where everyone has accessible, effective, and affordable medicines, technology, and care, including access to clinical trials.
The globally unifying International Council for Harmonisation (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (Guidelines) must also be amended to reflect the role of pharmacies and pharmacists. This is a strategic step for clinical trials. The Guidelines can describe Good Clinical Practice (GCP), but dispensing of investigational drugs still must be done under local, state and federal regulations by a licensed pharmacist. More than drug accountability and documentation, as indicated in the ICH guidelines, pharmacists are the link between investigational drugs and patient-centric dispensing via local regulations. The gray area of US, EU, and global regulations must be illuminated to put pharmacists in their rightful place as medication experts. They have community connections and trust, patient knowledge, and accessibility to the diverse participants often missing from clinical trials.
The Federal Drug Administration (FDA) understands that state and local regulations apply to investigational drugs, especially when working with DCTs. The recent DCT guidance document states that investigators and delegated individuals must perform activities and tasks according to the investigational plan, applicable regulations, and relevant laws. This encompasses state and local laws pertaining to the practice of pharmacy and the dispensing of medication.
This is further illustrated under the DCT guidance Section G Packaging and Shipping of Investigational Products (IP), “Sponsors and investigators must comply with applicable Federal, State, and international laws and regulations that address shipping IPs in their respective jurisdictions.”
Shipping investigational product falls under the practice of pharmacy in most countries, which requires state-licensed pharmacists to label, dispense, and counsel the patients receiving investigational drugs.
In the DCT guidance, the FDA must reconsider the alternative of shipping investigational drugs to a patient’s local pharmacy rather than their home. This should be considered DCT best practice. Local pharmacists have the expertise to receive, dispense, and counsel patients properly on drugs (even investigational drugs) that involve specialized handling, shipping, and storage conditions.
Finally, this is a call to the pharmaceutical companies. The world is changing; pharmacists have a role in clinical trials that has yet to be fulfilled. RxE2 encourages pharma to create Chief Pharmacy Officer positions to ensure patient recruitment, retention, and accountability issues are addressed. Moreover, the Chief Pharmacy Officer would have the expertise and background to ensure patient-centricity is finally incorporated into clinical trials, starting with packaging, labeling, and dispensing investigational supplies.
Imagine where your trials can go.
