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Cancer Medicines The role that community pharmacists play in supporting their customers

Community pharmacists are uniquely placed to provide patients with education regarding oral anticancer medicines to encourage their safe and effective use, minimise medication errors and avoid preventable adverse effects. INDEX

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General principles Prescriptions and Protocols Handling and related waste

Drug interactions Adverse effects Patient education

Resources Oral anticancer medicines available for treatment Summary Cancer Medicines - General principles

General principles of cancer medicines Cancer medicines classifications

Oral formulations of have been around for Cancer medicines can be classified under the following decades but many of the newer agents available have headings: been developed in oral formulations allowing a patient to be treated in the home setting. • Cytotoxic e.g. () • Targeted therapies e.g. tyrosine kinase inhibitors (imatinib) Advantages and disadvantages of treating cancers with oral anticancer medicines. • Hormonal therapies e.g. aromatase inhibitors (anastrozole) • Immunotherapy e.g. immunomodulators (lenalidomide) Advantages Disadvantages Each classification of cancer medicine has a different Reduced supervision Ease of administration pathway of action and associated risks. By understanding Improved quality of life Patient concordance the mode of action, community pharmacists can appreciate the role of a medicine in cancer therapy, anticipate adverse Patient preference Unpredictable pharmacology effects and potential interactions. This information can then Cost benefits Inappropriate patient selection be used to tailor patient education to optimise the quality and safety of the therapy. The PBS in 2016 reported community pharmacies dispensed in excess of ONE million prescriptions for oral Cancer types and related medicines anticancer medicines. Anticancer medicines can lead to toxicity with even a small increase in dose or failure of The following is a list of cancer types that have oral therapy if they are under-dosed. Incorrect prescribing, anticancer medicines available for treatment: dispensing errors and patient misinterpretation have lead to serious toxicities and fatal outcomes. Rollover a cancer type to view the examples of the related medicines Cancer medicines may be used as a single agent or in combination with other drug therapy to target cancer • Breast cells in the body. This is referred to as a treatment • Colorectal protocol. A treatment protocol is specific to disease type. • Hepatic • Leukaemia • Lung • Lymphoma • Melanoma • Multiple myeloma • Neurological • Gynaecological • Prostate • Renal • Sarcoma • Thyroid • Upper gastrointestinal

Click here for a list of oral anticancer medicines available for printing Summary Cancer Medicines - Prescriptions and protocols

Prescriptions and protocols

Oral anticancer medicines have a high risk of adverse Dispensing and supply effects if used for the wrong indication, at the wrong dose, for the wrong duration or may be less effective if Prior to dispensing it is imperative that the prescription doses are missed. verification process has been completed and signed off by a pharmacist. Errors can arise from: Dispensing and supply of medication requires reviewing • prescribing the process by which a medication is labelled and the total • dispensing quantity supplied. This process also requires ensuring that • administration the patient understands how and when to take the prescribed doses including additional precautions. Similarly A multidisciplinary approach to disease management mistiming administration frequency or duration of that entails communication of current, accurate and treatments can also lead to severe toxicities and comprehensive information reduces the incidence of hospitalisation. Ensuring the patient knows when to return patient adverse outcomes. Verification is a systematic for supplies for their next cycle should also be part of this process a pharmacist can include in their practice to process. Unnecessary interruption in the treatment check on therapy accuracy and to avoid medication process can have negative prognostic outcomes. errors.

Verification is not just a signature, it involves a seven- step process that includes the following: Dispensing and supply recommendations include: 1 Prescription • Label to include clear and unambiguous 2 Protocol dosing instructions 3 Patient • Label with the intended period of treatment • Ensure the total dose required is included on 4 Calculations the label 5 Pathology results • Storage requirements 6 Administration • Cautionary and advisory labels 7 Sign off For more information, see COSA guidelines for the safe prescribing, dispensing and administration of systemic cancer therapy. By verifying a prescription and signing off, the pharmacist acknowledges that the complete and comprehensive process has been undertaken to ensure that the medication given to the patient is as safe and appropriate as possible for them. Summary Cancer Medicines - Handling oral anticancer medicines & related waste

What is a hazardous substance? Safety precautions for patients and Medicines are considered hazardous if they exhibit one or more of the following six characteristics in humans carers at home or animals: Advice for patients taking oral anticancer 1. Carcinogenicity medicines: 2. Genotoxicity • When storing your medication at home be sure 3. Teratogenicity to keep out of the reach of children and pets 4. Reproductive toxicity or fertility impairment • Medications that require refrigeration should be 5. Serious organ toxicity or adverse health effects stored away from food, preferably on a separate at low doses in experimental animal models or shelf where possible treated patients • Carers should wear two pairs of disposable 6. Structure and toxicity profiles of new medicines gloves when administering the medication and that mimic existing medicines determined to be hazardous when cleaning up any spills of vomit, urine or faeces To prevent and minimise occupational exposure to • Swallow oral anticancer tablets or capsules hazardous substances during the dispensing and whole (never break, crush or chew and do not supply of oral anticancer medicines the following open capsules or dissolve tablets unless precautions should be considered: directed to by your doctor, pharmacist or cancer • Personal protective equipment (PPE) nurse) • Health and safety • Wash your hands after handling these • Do not crush medicines • Dose administration aids (DAA) • Anyone who is pregnant or breast feeding • Managing spills should avoid touching anticancer medicines and related waste or if necessary use protective

precautions Disposal of anticancer medicines • Always flush the toilet on full flush with the Pharmacy Board of Australia Guidelines for the toilet lid down dispensing of medicines have adopted the • Men should sit on the toilet to urinate to avoid Environmental Protection Authority (EPA) requirements, splashing which specify that anticancer medicine waste must be incinerated in a facility approved by the EPA for the • Wash soiled linen straight away. Wash destruction of hazardous waste. separately, hot or cold wash at the maximum cycle, then line dry The RUM (Return of Unwanted Medicines) Project is a national scheme enabling the collection and disposal of • Seal any waste like incontinence pads, stoma or consumers’ unwanted and out of date medicines by catheter bags in two plastic bags (double community pharmacies. Oral anticancer medicines in bagged) before placing in the household solid dose formulation (i.e. tablets and capsules) and rubbish empty bottles can be disposed of in the RUM container. However, liquid products should not be placed in the • A patient (on chemotherapy or a hazardous RUM container, but in a container specifically designated substance) and/or their partner should wear for such waste. condoms when having sex. This is because low amounts of medication may be passed in semen or vaginal secretion. Summary Cancer Medicines - Drug interactions

Did you know?

Drug interactions are estimated to account for Identifying interactions approximately 4% of deaths among patients with cancer.1 Since medicine interactions can lead to clinically significant outcomes (both beneficial and adverse), it is When a drug-drug interaction is recognised in important to identify any potential interactions before cancer patients, it is classified as moderate or they occur. Pharmacists are ideally placed to identify major in the majority of cases (82% and 15% possible interactions. respectively).1 The following is a stepwise method that can be Up to 58% of ambulatory cancer patients had incorporated into practice to help identify potential 1 at least one potential drug-drug interaction. interactions and course of action to be taken:

1. Take a comprehensive medication history from the patient Drug interactions occur when one medicine alters the pharmacological effect of another medicine. The 2. Check for potential interactions pharmacological effect may be increased or decreased or an adverse effect may occur. 3. Determine if any administration instructions may minimise interaction and Drug interactions can be classified according to the advise the patient accordingly mechanism by which they occur: pharmacodynamic, pharmacokinetic or a combination of mechanisms. 4. Determine any recommendations and Specific interactions with oral anticancer medicines discuss with the prescriber where involving these mechanisms, include interactions with the appropriate gastrointestinal environment/food and beverages and interactions with complementary and alternative 5. Counsel patient medicines (CAM). 6. Follow up 1. van Leeuwen RW, Brundel DH, Neef C, et al. Prevalence of potential drug-drug interactions in cancer patients treated with oral anticancer drugs. Br J Cancer. 2013;108(5):1071-8. Summary Cancer Medicines - Adverse effects

Adverse effects and supportive therapies Although oral anticancer medicines are effective Recognise when to immediately refer patients treatments for many types of cancer, like other cancer to the nearest hospital emergency department: treatments, they have the potential to cause adverse effects. The type and intensity of these adverse effects • temperature 38oC or above vary from person to person and may be influenced by the individual anticancer agent/s, the dose, the type and • shivers, sweats, chills or shakes location of cancer, and the patient’s overall health. • uncontrolled vomiting or diarrhoea

As a healthcare professional, it is vital that you provide • flu-like symptoms advice and counselling to the patient to help them • shortness of breath manage their adverse effects and to know when to refer • chest pain or discomfort them back to their oncologist, haematologist or nearest hospital emergency department. Adverse effects can be • pain or tingling in arms life threatening in some situations. Less critical adverse effects that go unidentified can lead to permanent effects Recognise when to advise the patient to contact for a patient. This may affect their quality of life and may their doctor or nurse within 24 hours of exclude them from future treatment options. symptom onset:

Cytotoxic medicines, specifically, are not able to Unable to eat or drink for 24 hours distinguish between normal cells that are actively dividing and cancer cells that are actively dividing. The damage to • Dizziness, thirst, dry mouth normal cells, particularly the hair follicles, gastrointestinal • Not passing urine for 12 hours tract, oral mucosa and bone marrow, during treatment results in some common adverse effects and toxicities. Non-cytotoxic medicines are also associated with adverse • That stops the patient eating effects which may be serious. • Not relieved by medications Vomiting • Not relieved by medications Common adverse effects: • More than 5 times in 24 hours The following are some of the more common Bleeding categories of adverse effects with anticancer • Black or tarry stools medicines: • Blood in the patient’s urine or stools • Haematological: , neutropenic Swelling of hands or feet sepsis, , anaemia • Tingling, burning, redness or swelling • Gastrointestinal: nausea, vomiting, • Skin peeling diarrhoea, constipation, mucositis Diarrhoea • Dermatological: acneiform rash, hand-foot syndrome, cutaneous squamous cell (except or immunotherapy which carcinoma requires immediate management) • • 4 to 6 times in 24 hours • Pulmonary toxicity • Not relieved by medications • Peripheral neuropathy • Fatigue Summary Cancer Medicines - Patient education

Patient education Communicating with patients using both verbal and written information is crucial to support the safe and effective use of oral anticancer therapy. It is vital this Pharmacists should explain: information is simple, clear and concise. All patients and/ or carers must be educated on how to take their medication to ensure they receive optimal benefit to • The medication name and indication minimise medication administration errors. • The duration of treatment Written information may be provided in multiple forms • How and when to take the medication including Consumer Medicines Information leaflets and • The need to swallow tablets/capsules eviQ Patient Information Sheets whole and not to break, crush or chew Counselling points for oral anticancer medicines • What to do in the event of missing a dose or vomiting after taking a dose Education of patients and/or carers is vital to ensure the • Expected adverse effects safe use of oral anticancer medicines. Adherence to cancer treatment is crucial to obtain optimal health • Important drug interactions outcomes, such as cure or improvement in quality of life. • Supportive medications Some factors associated with non-adherence may include disease complexity, denial of illness, poor communication • The need for and how to obtain further leading to lack of understanding of the medication, supplies forgetfulness, swallowing issues and intolerance to side • Principles of safe handling, storage and effects. Patient education is an essential tool for disposal combating poor adherence. • Expected tests during treatment A step by step method, as explained below, should be • Useful resources used when counselling patients taking oral anticancer medicines. Resources Cancer Medicines

eviQ https://www.eviq.org.au/ eviQ Education https://education.eviq.org.au/ eviQ patient information sheets https://www.eviq.org.au/patients-and-carers/anticancer-drug-treatments eviQ treatment protocols https://www.eviq.org.au/Category/tabid/65/categoryid/1/Default.aspx eviQ supporting document - Safe handling and waste management of https://www.eviq.org.au/Protocol/tabid/66/id/188/Default.aspx eviQ Patient fact sheet: Information on cancer medicines taken as tablets, capsules or liquids https://education.eviq.org.au/getmedia/1ebe10c9-667e-40e2-8c26-8b5f3d3161d7/eviQ-PatientFactsheet- CancerMedicines.aspx eviQ Community pharmacist fact sheet: Cancer Medicines, The role community pharmacists play in supporting their customers https://education.eviq.org.au/getmedia/c9e61170-ad22-487a-a397-8aa634ee6702/eviQFactsheet-Community- pharmacist-2017.pdf.aspx eviQ fact sheet: Information to assist community pharmacists in managing common adverse effects https://education.eviq.org.au/getmedia/5fe8da26-98e3-4025-90bb-bca042a1f4c0/eviQFactsheet- Info2AssistCommPharmacists-V2.pdf.aspx eviQ Patient information sheet on oral cancer medicines https://www.eviq.org.au/LinkClick.aspx?fileticket=RX7TyBU-Elg%253d&tabid=60) eviQ Pharmacy professional standards competency https://education.eviq.org.au/getmedia/a95316c3-412d-41fe-bb34-d4b9aa3d6606/PharmCompStand.pdf.aspx eviQ Education Cancer information videos for patients https://education.eviq.org.au/videos/cancer-information-for-patients Safe use of oral cytotoxic medicines https://www.nps.org.au/australian-prescriber/articles/safe-use-of-oral-cytotoxic-medicines Society of Hospital Pharmacists of Australia (SHPA) Don’t Rush to Crush https://www.shpa.org.au/dont-rush-to-crush-2nd-edition Drug interactions in cancer therapy https://www.nature.com/scitable/content/Drug-interactions-in-cancer-therapy-27632 National Competency Standards Framework for Pharmacists in Australia https://www.psa.org.au/download/standards/competency-standards-complete.pdf NPS Medicine Wise Medicines List https://www.nps.org.au/medical-info/consumer-info/keeping-a-medicines-list Australian Adverse Drug Reaction Reporting System https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabase COSA guidelines for the safe prescribing, dispensing and administration of systemic cancer therapy https://wiki.cancer.org.au/australia/COSA:Cancer_chemotherapy_medication_safety_guidelines Oral anticancer medicines

Oral anticancer medicines available for treatment include:

Breast Lung Prostate anastrozole (Arimidex®) afatinib (Giotrif®) abiraterone (Zytiga®) capecitabine (Xeloda®, Xelabine®) alectinib (Alecensa®) bicalutamide (Cosudex®, Bicalox®, ® (Endoxan®) ceritinib (Zykadia®) Calutex ) ® ® exemestane (Aromasin®) crizotinib (Xalkori®) cyproterone (Androcur , Cyprocur , Procur®) lapatinib (Tykerb®) erlotinib (Tarceva®) enzalutamide (Xtandi®) letrozole (Femara®) (Vepesid®) flutamide (Flutamin®) (Methoblastin®) gefitinib (Iressa®) nilutamide (Anandron®) (Ibrance®) osimertinib (Tagrisso®) (Kisqali®) (Navelbine®) Renal tamoxifen (Nolvadex-D®) axitinib (Inlyta®) ® Lymphoma vinorelbine (Navelbine ) ® (Leukeran®) everolimus (Afinitor ) ® cyclophospamide (Endoxan®) pazopanib (Votrient ) Colorectal ® ibrutinib (Imbruvica®) sorafenib (Nexavar ) capecitabine (Xeloda®, Xelabine®) ® (Zydelig®) sunitinib (Sutent ) regorafenib (Stivarga®) trifluridine/tipiracil (Lonsurf®) Melanoma Sarcoma ® cobimetinib (Cotellic®) imatinib (Glivec ), Hepatic ® dabrafenib (Tafinlar®) pazopanib (Votrient ) sorafenib (Nexavar®) ® trametinib (Mekinist®) regorafenib (Stivarga ) ® vemurafenib (Zelboraf®) sunitinib (Sutent ) Leukaemia (Myleran®) Multiple Myeloma Thyroid ® chlorambucil (Leukeran ) cyclophosphamide (Endoxan®) lenvatinib (Lenvima®) ® dasatinib (Sprycel ) dexamethasone (Dexmethsone®) pazopanib (Votrient®) ® (Fludara ) lenalidomide (Revlimid®) sunitinib (Sutent®) ® hydroxyurea (Hydrea ) (Alkeran®) sorafenib (Nexavar®) ® ibrutinib (Imbruvica ) prednisolone (Panafcortelone®, vandetanib (Caprelsa®) (Zavedos®) Predsolone®) imatinib (Glivec®) pomalidomide (Pomalyst®) Upper Gastrointestinal (GI) (Puri-Nethol®, thalidomide (Thalomid®) Allmercap®) capecitabine (Xeloda®, Xelabine®) methotrexate (Methoblastin®) Neurological (Brain) (Astromide®, Temizole®, Temodal®) nilotinib (Tasigna®) (CeeNU®) everolimus (Afinitor®) ponatinib (Iclusig®) (Natulan®) imatinib (Glivec®) ruxolitinib (Jakavi®) temozolomide (Temodal®, Astromide®, ® regorafenib (Stivarga®) tioguanine (Lanvis®) Temizole ) (Vesanoid®) Ovarian (Venclexta®) (Lynparza®) medroxyprogesterone (Provera®)