National Consultative meet on Cytotoxic Drugs

7th Aug’2012

Venue: Willow Hall, IHC, Lodhi Road, Delhi

Mr. Satish Sinha, Associate Director, Toxics Link, introduced the topic of cytotoxic drugs across the table. He pointed out that every hospital in India follows its own set of SOPs (standard operating

procedures) to handle cytotoxic drugs because of the lack of any National Guideline. There is a lot of ambiguity in the handling of this waste as the rule just states that the entire quantum of the waste is to be incinerated. But the question remains of how this waste is to be classified, how the spill needs to be managed and how the vials are to be disposed off. Thus, he invited the suggestions and recommendations from the participants and requested everyone to come up with a practical and feasible plan to combat

the problem.

Mr. Vinod Babu (Scientist E, CPCB) addressed the meeting with an overview on the threat posed by cytotoxic drugs and the waste thus generated. CDs act as mutagens and many a times because of the mishandling of the drug, the issue gets manifolded.The lack of a credible national guideline adds to the negative impacts of the drug.

CPCB highlighted the disposal of cytotoxic drugs by incineration in the BMW Rules (1998). CPCB looks forward to some

guidelines for the handling of this waste. It also visited some of the hospitals last year to monitor the ways used by the hospitals to deal with the cytotoxic waste.

It also sent letters to the leading cancer hospitals asking information about their usage and handling of CDs to gather more info on the issue.

He acknowledged Toxics link’s effort in initiating discussion on the issue and offered CPCB’s full support in framing of the document.

Dr. T.K. Joshi (Head, Centre for environment and occupational health, Maulana Azad Medical College), remarked that most doctors don’t recognize it as a problem. He also emphasized on the need for having a

centralized guideline for the hospitals similar to those in countries like US, New Zealand and Australia. He said that the Ministry of Labor should be more sensitive about the occupational safety issues in hospitals and should not shrug off its duty as is being observed presently.

He elaborated that chemical waste in the hospital forms around 3% of the total waste stream. Hospital should have careful planning on exposure control, training and handling of such waste. Blood tests, urine, yearly X-rays or any other type of surveillance system should be in place to monitor occupational exposure.

Ms. Kankana Das,Sr. Programme Officer, Toxic Link, in her presentation reflected on the direct and indirect exposure of the staff in pharmacy and nursing healthcare and gave us an alarming count of 32% of healthcare workers being exposed, of which 8% are exposed through the direct involvement and 24% are exposed indirectly. She further corroborated the need for introducing the guidelines for the safe handling

and disposal of cytotoxic drugs by citing a study that highlighted the manifold increase in genetic damage among nurses of oncology department of a hospital in South India. (A study done by Indian Institute of Chemical Technology, Hyderabad)

She cited various parties concerned with the broader umbrella under which cytotoxic drugs fall and stressed on the need for greater attention to the issue than they are being given. She opined that Institutes like ICMR (Indian Council for Medical Research), CDSCO (Central Drugs Standards Control Organisation) need to grill the issue more and should come up with their guidelines.

Presentations were also made by Dr. Sushma Bhatt from Dharamshila Hospital, Dr. Neelam Sachdeva from Rajiv Gandhi Hospital, and Dr. Rohini Kelkar from Tata Memorial hospital, highlighting the preparation, handling and transfer of cytotoxic drugs in their respective hospitals and the problems faced by them.

Dr. Sushima Bhatt, Head, Quality Control, (Dharamshila hospital):

Hospital follows ISO standards and NABH Standards for high risk medicines as no other guidelines are available for handling of cytotoxic waste.

They have installed chemo preparation hood in chemo preparation room. As was there were complaints of headache and nausea before its installation. Once the hood has been installed no such complaints are there.

Drug Spillage kits are available at all concerned locations. For safe Transport, Dum Waiters are being used from pharmacy

store to shop. Nurses and Staff are well trained and equipped to handle the

cytotoxic waste. Hospital has started maintaining records since2007 on some

health/ general parameters like -Birth Defects (No fetal abnormalities and abortions reported)

Spills (few minor spills) Quantum of CDs handled (250kg of cytotoxic waste is sent

for incineration every month, it also includes infected plastic)

Surveillance mechanism is there which includes- blood testing, which is carried out once in three months, although urine testing is not a routine check up with the hospital. X-rays are also done once in a year.

No special attention is given to the cytotoxic waste generated in the form of urine/ vomit by patients administered with the drugs.

Rotation of staff is a practice which limits the exposure of the staff to the toxic environment.

Dr. Neelam Sachdeva, Senior Consultant Microbiologist (Rajiv Gandhi Cancer Institute and Research Centre):

Dr. Sachdeva gave a detailed account of cytotoxic waste handling in the hospital and acknowledged some of the grave problems which needed special attention:

Patients ask for the leftover drugs (the drug is very expensive and they do not want to waste any amount- thus the hospital is forced to give the drugs in the hands of common man who are least aware of the problems with the drug they are carrying)

Sometimes one person does mixing of drugs continuously for 8 hrs. as there is no time limit set to it. (Sometimes these pharmacist are young pass outs and in child bearing age, with very little experience and thus more prone to making mistakes. Most of the time this work is being done by contract workers)

Staff keeps on changing, making it impossible to maintain record for chronic effects.

Spills: The hospital performed an in-house experiment using a fluorescent liquid and found that the traces of drugs were almost everywhere (tray carrying the injection, on floor, water taps, and phone receiver).This experiment highlighted the indirect exposure to the entire hospital staff and visitors who are not in the suspected exposed group.

No check can be kept on preparation and transfer of the drugs as this work has been outsourced by the hospital

Rooms allotted for preparation of drugs are small and inconvenient. Thus the guideline needs to highlight on the minimum space requirement in addition to basic minimum infrastructure required

No regular monitoring related to specific exposure level.

Dr. Rohini Kelkar (HOD, Microbiology, Tata Memorial Hospital): Dr. Kelkar started off by highlighting the problem with incineration of Cytotoxic Drugs. Her hospital got a complaint from the Municipal Corporation that there are waste damages the lining of the BMC’s incinerator. The other issues that needed immediate attention are reconstitution and administering of CDs and disposal of used vials/items. The third important aspect she elaborated on was safety precautions like bio-safety cabinets and rigorous training of nurses.

The hospital decided not to send IV pouches for incineration, because these IV pouches are made of PVC (which is responsible for the generation of dioxins and furans). They instead started neutralizing the CDs with Sodium hypochlorite and sending the glass/ PVC containers for recycling. Even the outdated drugs are now being neutralized with hypochlorite and drained, and the container is then sent for recycling. The speaker opined that implementation of a take back policy of unused/ expired drugs by the manufacturer are the best option.

Recommendations

A National guideline should be issued by the Ministry of Health and Family Welfare which should detail out the method of preparation, administration, transportation and spill management of CDs. Specifications should be issued for dimensions of the room for preparation of drug, exposure time; number of mixings to be done by a person /day etc.

Standards needs to be set for the Bio-safety cabinets and gloves/gowns/and all other protective equipments used while preparations, administration, transfer of the drugs.

Leftover drugs should not be allowed to be carried back by the patient and his relatives under any circumstances whatsoever. Strict instructions should be issued to the insurance companies and hospitals not to allow the drug vials in the hands of any patient attendant.

Pharmacy staff and nursing healthcare should be well trained and aware of the harmful effects due to the mishandling of cytotoxic drugs.

The Indian Nursing and Pharma Council should think of starting short specialized courses on Onco- Nursing and Onco- Pharmacy.

Computerized prescriptions should be made mandatory, in order to avoid transcription errors.

Doctors should be more sensitive of the issue and should not shrug off their duty to biomedical waste team as CDs are toxic waste and not just any other waste.

Expired drugs should be taken back by the manufacturers and should be disposed off properly.

Multi specialty hospital also use cytotoxic drugs (like for arthritis etc.), hence they must come under surveillance.

The following authorities were suggested to be consulted in making of the guidelines: i. Ministry of Health: can be consulted to ensure drug

movement. ii. Ministry of environment and forest iii. Central Drugs Standards Control Organization (CDSCO):

more intervention in clinical research. iv. Ministry of labor: Occupational safety issues should be

addressed by the ministry. v. Indian Council of Medical Research (ICMR): Can be

consulted about regulations for usage of drugs. vi. National Cancer Drug Institute vii. Central Pollution Control Board (CPCB): It can be consulted

for the regulations for handling and disposal of cytotoxic waste (onsite segregation). Role of these organizations was discussed in brief.

SUMMARY and CONCLUSION

India is in dire need of a composite, comprehensive and national guideline which should be made mandatory to be followed by all the hospital.

All the three stages: preparation, administration and safe disposal should be given equal importance

Screening tests are to be devised. Surveillance mechanism needs to be strengthened: indicative

parameters to be identified for carrying out surveillance and monitoring on a regular basis.

More ways are to be devised for safe disposal of cytotoxic waste besides incineration, which are more beneficial and cost effective at the same time

Liquid cytotoxic waste in the form of urine/ vomit from patients needs special attention as there are no methods in place to deal with it.

Dharamshila, Rajiv Gandhi, Tata Memorial, CCSMU, Sir Gangaram’s Hospital would like to be a part in the making of the draft.

TL would do the documentation and co ordination part of the entire exercise.

It was also decided that after consolidating on the momentum gained through this meeting, a similar one with much more participation and representation would be convened in the near future.