Is Pharmacy needed in Clinical Trials?
In my years as a research pharmacist over the last 5 years, I've had numerous questions and the biggest and most frequent one has always evolved around the role of Pharmacy in Clinical Trials.
I remember the first time I had an interview at Southampton General Hospital and the presentation I had to put together was the role of Annex 13. Now to people who have a background in clinical trials, this seems such an easy task. Now backtrack to day one of your clinical trials career and you picked up a protocol...that's how I felt - what am I looking at? Luckily - I researched enough and self-taught sufficiently to be successful at my interview.
Subsequent clinical trial job interviews have always, without fault, set the task of presenting on the role of Pharmacy in Clinical Trials. Having attended as many interviews as I have, this has somewhat become my area of expertise! I could reel off the roles and responsibilities of Pharmacy in Research with my eyes closed.
In order to answer the question succinctly, it's best to highlight the role of Pharmacy and medicines, as essentially, Pharmacy is useful for the management of clinical trials involving investigational medicinal products (IMPs), or CTIMPs as the type of trials.
March 2017, NHS England published a paper "NEXT STEPS ON THE NHS FIVE YEAR FORWARD VIEW", which highlighted the pharmacy department as needing to work as a multidisciplinary unit in a consolidated manner by moving forward with the NHS in this new vision. The Paper also highlights the need to "create a more fertile environment for clinical trials". Pharmacy, along with the NHS, is changing dramatically. The rise of prescribing pharmacists, electronic prescribing and the strong emphasis on value and evidence based medicines management enhances the role of Pharmacy even further from just ordinary 'pill-pushers' and 'dispensers'. Sandra Gidley (RPS England Board Chair) in response to the NHS Paper understands that NHS needs to make use of pharmacy skills and stated that "Pharmacists are the third largest healthcare profession...and can make a huge difference to patient care".
The best way to describe what pharmacy does, is to start off with the role of a pharmacist.
This is an excerpt from the General Pharmaceutical Society:
Pharmacists are responsible for:
the quality of medicines supplied to patients
ensuring that the supply of medicines is within the law
ensuring that the medicines prescribed to patients are suitable
advising patients about medicines, including how to take them, what reactions may occur and answering patients' questions.
Pharmacists also:
supervise the medicines supply chain and ensure pharmacy premises and systems are fit for purpose
advise other healthcare professionals about safe and effective medicines use, and safe and secure supply of medicines
respond to patients' symptoms and advise on medicines for sale in pharmacies
provide services to patients, such as smoking cessation, blood pressure measurement and cholesterol management
supervise the production and preparation of medicines and assessments of quality of medicines before they are supplied to patients from pharmaceutical manufacturers.
One must remember though, pharmacy is made up of a massive support team consisting of pharmacy technicians, pharmacy assistants, pharmacy and pharmacy technician students, and pre-registration pharmacists. These roles are vaguely similar to pharmacists, with a shift in responsibilities. But ultimately, pharmacy is there to ensure the quality of medicines supplied to patients and that medication is prescribed correctly, safely and appropriately.
The keywords that help put Pharmacy on the map for clinical trials are: SAFEGUARD, SAFETY, and QUALITY.
Especially in CTIMPs when using drugs that are novel products, pharmacy background and knowledge on drug handling is vital in ensuring the clinical trial drug (the IMP) is safely stored, handled and dispensed correctly to the correct trial patients at the safe and recommended dose and the IMP is handled by the nurses and any other staff or patients in a safe manner. All to ensure the quality of the IMP, but most of all the integrity and quality of the clinical trial.
Would you want to run a trial without Pharmacy input? Can you guarantee the expertise that Pharmacy can offer? I certainly would not. Both as a sponsor, patient and pharmacist, I would continue to advocate the addition of Pharmacy in the involvement from design, setup, management all the way to close down of a clinical trial involving investigational medicinal products.
