Ten years ago, almost all chemotherapy drugs were delivered intravenously at a hospital. Today, many cancer treatments are taken orally by patients, in their homes. The trend means patients enjoy the comfort of being in their own homes and avoid parking and transportation costs.  It is also much less costly for hospitals. But taking oral chemotherapy at home can be risky and some question whether health systems are doing enough to protect cancer patients.

When patients take powerful medications like chemotherapy outside of the hospital, it’s more difficult to ensure they take the correct dose at the prescribed times for the right length of time. Taking more than the intended dose of chemotherapy can be fatal and taking an amount lower than the intended dose means a cancer isn’t effectively treated.

While oral chemotherapy medications have been on the market since the late 1990s, the use of oral chemotherapy has risen greatly over the last five years. More than 20 oral chemotherapy drugs were approved for use in North America during this time, and the amount of oral chemotherapy drugs currently in development far outpaces the amount of intravenous chemotherapy drugs in development, according to research by Rick Abbott, an oncology pharmacist from Newfoundland.

This shift from IV chemotherapy delivered in the hospital to oral chemotherapy taken at home “transfers responsibility for the administration and assessment of ongoing side affects and toxicities from a group of trained health professionals directly to the patient and their family,” says Heather Logan, executive director of the Canadian Association of Provincial Cancer Associations (CAPCA).

In her yet-to-be-published research with HumanEra, a University Health Network project, Rachel Gilbert has interviewed community pharmacists, physicians and other health providers about oral chemotherapy safety in eastern provinces. Because patients are taking their oral chemotherapy drugs on their own, she says providers are worried that patients could suffer harm or death due to a dosing mistake. “It’s a giant black box,” says Gilbert.

In their interviews with health care providers and pharmacists, Gilbert heard anecdotes of patients purposefully self-adjusting doses at home. “Maybe they felt really unwell yesterday so they’ve lowered their dose on purpose. Or maybe they’re really scared and they figure more must be better so they take more on purpose.”

Patients can also incorrectly take their chemotherapy drugs at home because they don’t understand the instructions, adds Melissa Griffin, who also researches oral chemotherapy safety issues with the HumanEra project. Exemplifying how complicated the instructions can be, she brings up the drug Temozolomide, a brain cancer drug. “There are multiple different strengths of the pills that patients have to put together to make up the dose,” she says.

Another reason dosing errors can occur is that patients can be given the wrong dose due to an error by the prescriber or pharmacist distributing the drug.

Education for patients and family members, along with better standards to avoid prescribing errors, reduce the risk of over- or under-doses of chemotherapy. But the safety standards, as well as the level of support patients on oral chemotherapy receive, differs vastly depending on where they live.

How oral cancer treatments are currently delivered in Canada

In British Columbia, Alberta, Saskatchewan, Manitoba and Quebec, provincial governments pay for oral chemotherapy, whereas in Ontario and the eastern provinces, patients have to find third party funding or pay out of pocket, as a recent Healthy Debate article makes clear. Likewise, standards around education, quality and safety tend to be controlled at the provincial level in the west, while in the eastern provinces, most standards are set at the hospital level.

In Alberta, for example, all patients starting oral chemotherapy are invited to a standardized day-long educational session and receive follow-up phone calls after commencing their medications, explains Carole Chambers, director of cancer services at the pharmacy division of Alberta Health Services.

In Ontario and other eastern provinces, meanwhile, some hospitals have robust educational and follow up programs, while others do not, explains Gilbert. A study published in 2014 found that the majority of regional cancer hospitals in Ontario had “few requirements in place as to what education should be completed by each member of the health care team.”

Another important difference is that in the western provinces and Quebec, oral chemotherapy prescriptions are, for the most part, only available at oncology pharmacies. “No chemotherapy that is publicly funded goes through a retail drug store,” explains Chambers. The oncology, or cancer, pharmacist who fills the prescription has received specialized chemotherapy training and only distributes cancer drugs – so they are very familiar with the normal dosing ranges. Through a computerized system, oncology pharmacists also have access to information like the patient’s height, weight, treatment plan, and the patient’s laboratory results, which can help the pharmacist double check that a dosage is appropriate. Meanwhile, because of their specialized training, the pharmacists are comfortable counselling patients on what side effects will occur when, and what toxic reactions to look out for. “That’s a guarantee that we have that the patient receives counselling,” says Chambers, who explains the session usually lasts 15 to 30 minutes and takes place in a private area.

In Ontario, Manitoba and the Atlantic provinces, meanwhile, oral chemotherapy prescriptions can be filled by retail pharmacists in the community. “That pharmacist may have never had any specialist training in chemotherapy medications. They may only see a chemo order once a week or once a month,” says Gilbert. Furthermore, the retail pharmacists don’t have access to other information like the patient’s weight and laboratory results that can indicate if a given dose or medication is appropriate or not. When Abbott conducted a survey of over 350 community pharmacists in Ontario, Manitoba, New Brunswick, PEI and Nova Scotia, he found only 9% felt comfortable educating patients on oral chemotherapy medications.

Lori DeCou, communications manager at the Ontario College of Pharmacists argues, however, that checks are already in place to protect patients. If pharmacists have “a gap in their individual competency around a prescription,” they are required to take appropriate action, which may mean referring a patient. She adds that pharmacists are also obligated to take professional development courses to ensure they stay current with new drugs and protocols. Ben Shenouda, a pharmacist in Brampton and president of the Independent Pharmacists Association of Ontario, adds that community pharmacists are expected to always check the minimum and maximum dosing limits of a drug to ensure they’re dispensing the proper amount.

Yet, according to a report released last month by the Institute for Safe Medication Practices (ISMP) Canada, the lack of specialized training in oral chemotherapy among both pharmacists and other doctors who see oral chemotherapy patients in the community is contributing to dosing errors. At one community pharmacy, for example, a chemotherapy drug was prescribed at 1500 mg and dispensed at 150mg. “That’s a 10-fold under dose,” says Roger Cheng, project lead at ISMP Canada, who adds the error could have rendered the chemotherapy ineffective. “We felt if the pharmacist had specialized knowledge with this particular oral chemotherapy medication, he or she would have realized this is way too low a dose.”

It doesn’t help that in the retail pharmacies (where oral chemotherapy is available in most eastern provinces), chemotherapy is often given to patients in the amount provided by the company, not the amount on the prescription. So a pharmacist may give a patient a box of 30 pills, even if their prescription is for 20 pills. In Alberta, BC and Saskatchewan, however, “the pharmacist gives the patient exactly what they need to take home,” explains Chambers.

“We’ve seen reports going into ISMP where the patient doesn’t understand and they take all of the drugs,” Chambers explains.

How to deliver cancer treatments safely in the home

The Ontario government may be reconsidering its delivery model of oral cancer treatments. A Cancer Care Ontario think tank report on the issue, released in 2014, summarized recommendations from cancer care experts and patient advocates from across the country, highlighting that, “system oversight for take-home cancer medications should be consistent with the one in place for hospital-administered drugs.”

Kathy Vu, CCO’s clinical lead of Systemic Treatment Safety Initiatives, said her organization has sent recommendations for standards on oral chemotherapy to the Ministry of Health. Both Vu and David Jensen, spokesperson at the Ministry of Health, were unable to disclose the nature of those recommendations, however. “The Ministry has been discussing the findings with CCO,” Jensen said.

CCO has also been working to improve the model currently in place. CCO partnered with the Ontario Pharmacists Association to roll out a voluntary online course on oral chemotherapy for community pharmacists last year. They also developed standardized patient education tools that are currently under review. In addition, CCO has established a goal of having no handwritten oral chemotherapy prescriptions by the end of June of this year. Computerized prescriptions and pre-printed prescriptions reduce the risk of dosing errors.

Meanwhile, CAPCA has been working on oral chemotherapy safety standards, which will include a list of information that should be available on every chemotherapy prescription. Among many other recommendations, CAPCA is also recommending that pharmacists should never distribute more pills than are required by the patient for a given time period. And standards around education include that patients not simply be provided information, but that health providers evaluate whether the patient has understood the information, by asking such questions like, “What will you do if you miss a dose?” Logan explains. The standards should be released sometime this spring or summer.

The system in Alberta and other western provinces is not perfect. Chambers says her organization is still figuring out how often and when patients on various drugs should be followed up with, according to when errors and toxicities are most likely to occur. Also, having chemotherapy delivered only at cancer care centres means, in some cases, patients travel more than 100km to access their drugs.

Abbott thinks that, provided they’re given the right education and have access to oncology pharmacists over the phone, community pharmacists can safely dispense chemotherapy drugs. Plus, he says, community pharmacists can be best positioned to “do the drugs interactions check” to ensure patients’ chemotherapy isn’t interfering with another medication they are taking. Shenouda agrees and points out that better educating and supporting community pharmacists to dispense oral chemotherapy makes sense for pragmatic reasons. “This is a new trend in medicine and this is only the start,” he says. Shenouda argues oral chemotherapy prescriptions will grow due to an aging population and the convenience of the drugs, and cancer pharmacists won’t be able to keep up. “If you go and see the cancer pharmacies in different hospitals, you will see how busy those guys are.”

It is likely, that due to patient preference and cost, we will see even more oral chemotherapy taken at home in the years ahead. But doctors, nurses, pharmacists and patients need to be better supported to ensure safety in using these drugs. Collectively, we have an opportunity across the country to ensure that regardless of where patients are getting their chemotherapy medication, all patients receive the same quality of education and follow-up, all pharmacists delivering chemotherapy feel comfortable doing so, and all prescriptions include the same information. Together, these actions could save lives.