An article “Cytotoxic drug – reliever to cancer patients or an agent for cancer!” published recently in the newsletter of Toxics Link has raised serious concern over lack of clear cut guidelines to be followed for safe handling of these drugs in the best interest of the patients, concerned health professionals and environment. Toxics Link is a civil society working on environmental issues attempting to achieving freedom from toxics.
Cytotoxic or anticancer medicines are chemotherapeutic agents used in specialized centres for the treatment of cancers. They have the capacity to kill or stop the growth of living cells. The terminology ‘cytotoxic medicines’ are being replaced by the antineoplastic medicines. Now extremely effective regimens are available for cancer treatment. There are equal risks of occupational hazards for the healthcare professionals handling these medicines. If not handled safely, these medicines can cause variety of harms to the handling professionals. Some early reports like development of second cancers in patients treated with these medicines, discovery of mutagenic substances in persons who handled these medicines and cared for the treated patients raised the issue of safety of these medicines. Increase in fetal abnormalities, fetal loss and fertility impairment are reported as occupational hazards of the persons handling antineoplastic medicines.
There are some shocking facts as being practiced by the health facilities. The unused or leftover drugs and the containers are handed over to the patients or their representatives. The patients are completely unaware of the risk of exposure and the need of protection. The workers are exposed for long period of time, no training or health checkup of the staff, and no written system for disposal including spill management.
The healthcare professionals especially the pharmacists or nurses are involved in the preparation and administration of antineoplastic medicines. In absence of appropriate controlled procedure to minimize the risk of exposure, the pharmacists and the nurses are often at high risk of occupational exposures. The exposure is usually through skin contact, skin absorption, inhalation of aerosols and drug particles, ingestion and needle sticks injuries resulting from the following activities: drug preparation, drug administration, handling patient waste, transport and waste disposal, or spills.
Adherence to correct and perfect preparation and handling techniques prevent drug particles or droplets from escaping from their containers while they are being manipulated. Perfection is near impossible and the policy, education and training become the key to reduce risks of occupation exposure. Few basic steps are advocated for reducing the harm: Using vertical laminar air flow hoods or biological safety hoods for the preparation and reconstitution of antineoplastic medicines; Wearing protective gloves and masks during product preparation; Having the centralized disposal system with designated waste containers and high temperature incineration; Periodic health checkup of persons handling admixtures to ascertain any harmful effect; Training and sensitizing the involved persons on exposure risk on their health and prevention; And adopting specialized labels to ensure proper handling and disposal. There is need of not just reducing the risk of exposure to drugs or containers or the wastes, there is equal need of preventing exposure to other cytotoxic wastes. These include used catheters; vomits, blood or excreta or drained fluids; bedpans, urinals, colostomy or urostomy bags, vomit bowls, wet nappies, incontinence pads, and wet dressing materials; bed linen or clothing soiled with patient’s waste or drug product; and other exposed materials. Though primarily the antineoplastic drugs are eliminated by renal or hepatic excretion, all body substances may be contaminated with the unchanged drug or with the active metabolites.
The patients too require proper counseling in order to reduce risk for their own safety and for the safety of their caretakers. The patients should be instructed to wash hands before and after handling the product or bottle; wear disposable gloves while handling; appropriately manage spilled ingredients and expired medicines; and keep away the products from children and pets. The key point is that people who are not taking or using should not be exposed.
Disposal of antineoplastic medicines, both unusable and expired, needs special care. Their exposures to environment have serious consequences and the same has been realized even in early 1980s. The World Health Organization has developed guidelines for safe disposal. The best way of disposal is to return the wastes in a safe packaged to the suppliers or manufacturers as they may have facilities for proper disposal. If the option of returning to the suppliers is not feasible, they must be destroyed in a two chamber incinerator which operates at a temperature of at least 1200°C in the secondary chamber and fitted with gas cleaning equipment. Without the functioning of high temperature secondary chamber, degraded antineoplastic materials may get emitted from chimney. Processing in secondary chamber ensures complete destruction. They should never be disposed of directly in a landfill without processing like encapsulation or inertization. They should not be disposed into sewers and water courses.
With increasing incidences of cancer, which is estimated at around 7 lakh new cases in India every year, the use of antineoplastic medicines too would substantially increase. There would also be more number of hospitals often exclusively for cancer treatment. There are chances of increasing occupational and environmental hazards too for the persons handling these extremely toxic medicines and for others. The Government should come out with safe handling guidelines including waste disposal and mechanisms for monitoring the adherence of the guidelines by the health facilities without much delay. In the meantime, the pharmacy programmes of the various universities should also initiate inclusion of the subject matter in the curriculum to sensitize and train the future hospital or oncology pharmacists.
(The authors are with Department of Pharmacy, Annamalai University, Annamalai Nagar, Tamil Nadu 608 002)