Being an oncology pharmacist demands precision and carries with it immense pressure and responsibility, yet, with no set legislated guidelines to follow, the health risks associated with the job increase. With oncology pharmacy not being recognised as a specialty in South Africa, Carien van der Merwe shares the eye-opening reality of the situation faced by herself and her colleagues every day.
The second the pain hit, I knew I could be in trouble. I felt angry with myself for making the mistake. I knew this should not happen. But it did. The blood dripped from my finger so I got up from where I was mixing chemo – in the biosafety cabinet – to go change my gloves, wash my hands and to find a plaster. I had a needlestick injury mixing paclitaxol.
Oncology pharmacy is not a speciality in pharmacy in South Africa. There are, as yet, no guidelines set by the South African Pharmacy Council (SAPC), displaying the fact that they still don’t recognise the important role we play. I have been fortunate to learn from peers like Michael Conidaris.
As I stand washing my hands and apply pressure on my finger, concerned staff gather, asking “Are you ok?” The tone of their voices echoes my frustration. My stress levels rise as I know we are now behind in mixing. Like most oncology practices there is only one person to mix, and time is of the essence.
To make things worse, a patient’s mother appears at the pharmacy window looking grey and sombre. I knew her well, as with most patient’s family she was there with her son practically every week. He had testicular cancer and the regime brought him back for chemo daily in the first week of treatment.
“He passed away last night,” she said. The shock hit me like a brick. Giving her a long hug, I knew I couldn’t replace her loss, but only comfort her. I knew time was ticking and we were falling far behind our mixing schedule. I quickly said a few words and rushed to don my gown, gloves and mask. I sat mixing with tears in my eyes.
Thoughts rushed through my mind – “What went wrong? Did we miss something?” I tried to calm myself and concentrate as I couldn’t be distracted while mixing. I blinked repeatedly to stop the tears obstructing my view. I pacified myself while putting the diluent in the second vial of trastuzumab to make up the dose for the patient, who was now probably upset as she was waiting too long for her treatment.
I stopped abruptly. This script was for a new patient. I remembered her well from three weeks back; she mentioned she was worried about her finances as trastuzumab was so expensive and she was out of funds. This must then be her second dose…but why the high dose? I looked up. I could see her waiting in the treatment room. Yes, it was her. Why am I mixing two vials for her? The dose is wrong. There is a mistake. Her dose on the second cycle should be less. I got rid of my protective clothing once again, walked out of the clean room and phoned the oncologist. “Yes, the dose should be less…Yes, please change it…Yes, just keep the vial. Thank you.”
As a pharmacist in an oncology unit you’re an integral part of the team. Like a trapeze artist having safety nets, we act as safety nets for our patients. If the doctor makes a mistake, the pharmacist should pick it up. If we both miss the mistake, usually the oncology nurse will pick it up before the patient gets the wrong dose or drug. Oncology drugs have a narrow therapeutic window, thus a small mistake could have serious negative effects on the patient.
Pharmacovigilance and accountability rests on the shoulders of the pharmacist. Double-check systems are part of our daily work lives. We look at international standards such as QuapoS (Quality Standard for the Oncology Pharmacy Service), issued by the European Society of Oncology Pharmacists (ESOP). The other standards are from the International Society of Oncology Pharmacy Practitioners (ISSOP).
In the US, the U.S. Pharmacopeia Convention (USP) launched the USP Chapter 800. USP is a scientific non-profit organisation that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. Since its founding in 1820, USP has helped secure the quality of the American drug supply. The USP Chapter 800 deals specifically with ‘Handling of Hazardous Drugs’.
But none of the above laws apply here. We do have the South African Oncology Consortium (SAOC) that accredits oncology practices. There is a strict code of compliance and oncology practices are accredited each year.
With trial data out, showing abortion rates of 31% among non-compliant staff handling chemotherapy, we need legislated guidelines in place for safe-handling for the wellbeing of staff.
With trial data out, showing abortion rates of 31% among non-compliant staff handling chemotherapy, we need legislated guidelines in place for safe handling for the wellbeing of staff. Abnormalities of either chromosome 5 or 7 were significantly increased per hazardous drug handling event in staff handling chemotherapy without gloves and appropriate PPE (personal protective equipment).
A safety cabinet class 11 (type A2,B1, or B2) is minimum standard for mixing hazardous oncology drugs according to all international oncology standards. The mustard gas molecule used in World War 1 is utilised today for certain cancers – and international guidelines protect the staff, the product and the environment. We still mix with needle and syringe, while most overseas countries use safety devices. Staff who are pregnant, breastfeeding or want to father a child should not be in contact with chemotherapy.
The process is simple. Once the patient is diagnosed, an authorisation is sent to the medical aid. On approval, the appropriate drugs are ordered. Once delivered, the patient will come in for treatment. It is up to every oncology pharmacist to check that it is the right drug, for the right patient, at the right dose. Each drug has stability data and criteria for handling once mixed. Certain drugs have very short stability and need to be infused within a few hours after mixing. Monoclonal antibodies, such as trastuzumab and rituzimab, cannot be agitated as it will degrade the molecule and alter stability.
I currently train oncology pharmacists in South Africa and Sub-Sahara Africa on safe-handling techniques so that we align with international standards. Until SAPC introduces an accredited oncology pharmacy course, it is up to the oncology pharmacists to ensure that they comply with international standards, to not only ensure their own safety and that of the nurse, but most importantly the safety of the patient. The patient is the focus of our attention. The right drug, at the right dose, to the right patient. It sounds so simple, but without systems in place it becomes incredibly complicated.