Developing guidelines for the safe handling of cytotoxic drugs in academic research laboratories

The bench-to-bedside approach to healthcare involves a continuous iterative process whereby practice-based challenges are examined, researched and addressed in an effort to optimise patient care. This is supported through fostering collaborations and partnerships between healthcare professionals and academic researchers.

In oncology, the research work ensuing from these collaborations ranges from studying the stability of anti-cancer medicines to the characterisation of novel natural or chemical molecules for potential anti-tumour activity. These usually take place in cytotoxic academic research laboratories (CARL). This has been our experience at Kingston University where we collaborate with oncology pharmacists at the Royal Marsden Foundation Trust and University College London Hospital to address practice-based challenges^[1],
[2]
.

As the work progressed, it was clear that the handling of cytotoxic drugs needed to be organised with dissemination of good practice. The pharmacists within the research group took responsibility to train and supervise researchers to ensure safe handling of cytotoxics in the CARL and university premises.

In the absence of specific guidelines for the safe handling of cytotoxics in academic research laboratories, the pharmacists used guidelines issued by professional bodies for clinical settings (International Society of Oncology Pharmacy Practitioners^[3]
and American Society of Healthâ€System Pharmacists^[4]
).

Nevertheless, owing to the variability in the setting and practice in CARL, some activities were not covered by the aforementioned guidelines. For instance, there is no reference to the precautions for handling cytotoxics in laboratories not intended or designed for cytotoxic manipulation, and the required maintenance of analytical equipment used (e.g. high performance liquid chromatography). Furthermore, some recommendations were not reflected in university policies, such as the specific receipt and storage procedures of cytotoxic drug parcels.

This triggered the pharmacists to look into the practice at other research establishments through a survey of the corresponding health and safety officers. Statistical analysis of the results revealed a gap between the guidelines set for healthcare settings and real practice, implicating the needless exposure of researchers to cytotoxic drugs.

A total of 39 health and safety officers participated in this UK national survey; 19 of the 39 officers mentioned that the top two personnel groups that access the CARL are researchers and cleaning staff. Also, 19 of them disclosed that the latter are not aware of any special cleaning procedures required for these laboratories. There were 17 officers who reported that the staff at the reception point for cytotoxic drugs is neither aware of their risk nor notified of the content of the delivery. The required personal protective equipment (PPE) reported by the officers in these laboratories was as follows: gloves (n=37), impermeable gown (n=23), mask (n=10), shoe cover (n=16), goggles (n=34)^[5]
. This highlights a shortfall in guideline implementation, as full PPE donning is required when handling cytotoxic drugs.

In light of these results and the lack of available guidelines dedicated to CARL, the authors decided to formulate a working group to adapt the existing guidelines to develop standards that promote safe cytotoxic handling in academic institutions. Stakeholders with expertise on the subject matter from academic, clinical, and research settings were invited to participate.

So far, the CARL working group has met three times and is expected to issue the first draft ready for peer review in September 2017.

The working group will then seek endorsement by professional bodies, international implementation of an updated survey on CARL practices, and adoption of guidelines to fit international CARL.

This was an exciting opportunity for pharmacists to take a leading role in a national strategic initiative.

Racha Sabbagh Dit Hawasli

PhD researcher

Stephen Barton

Associate professor

Shereen Nabhani-Gebara

Senior lecturer

School of Pharmacy and Chemistry

Kingston University