General measures for healthcare centres: training, resources, procedures, continuity of care and risk management

• 1.1.

  The hospital has a procedure for ensuring that all health professionals involved in treating cancer patients have the necessary knowledge and skills and are competent to perform their functions. For this purpose, the following have been established:

  • 1.1.1.

    The educational requirements and competencies of newly joined professionals.

  • 1.1.2.

    The continuing professional development requirements demanded of staff, which should be updated at least once a year.

  • 1.1.3.

    The criteria for accreditation by authorised independent organisations, and how this accreditation is documented.

  • 1.1.4.

    The criteria for assessing the competence of professionals.

  • 1.1.5.

    A full training programme that ensures compliance with the established requirements for initial and continuing training for all categories of staff who prescribe, dispense, prepare and administer cancer therapies.

• 1.2.

  The hospital has sufficient staff to ensure that individuals assigned to each healthcare process are suited to the volume of work, so that established safe practices are followed and high-risk behaviour encouraged by high pressure on care staff is avoided.

• 1.3.

  At least one specialist in medical oncology and one oncology nurse trained in basic life support are at the hospital and are available immediately when the antineoplastic therapy is administered.

• 1.4.

  The hospital has an information and communication technologybased integrated information system for the management of cancer patients (inpatients, outpatients and external patients). It is integrated into the single medical record and the hospital's information systems, so that full information about the cancer patients and their medication is available to all health professionals who provide them with care, including emergency care.

• 1.5.

  The hospital has in place standard operating procedures designed to prevent errors, containing clear definitions of the processes for medical prescribing, pharmaceutical reviewing, preparing, dispensing, administering and monitoring antineoplastic therapy, and staff responsibilities in each process.

• 1.6.

  The hospital has up-to-date, evidence-based treatment protocols, clearly and unambiguously written, and accessible to all health professionals involved in cancer patient care. Those protocols specify at least the following aspects of each treatment regimen:

  • 1.6.1.

    Name of the protocol/regimen.

  • 1.6.2.

    Tumour and stage for which it is intended.

  • 1.6.3.

    The full antineoplastic therapy, including drugs to be administered orally or by other routes, and the order of administration of each drug.

  • 1.6.4.

    Administration route of all drugs.

  • 1.6.5.

    Dose of all drugs and calculation method.

  • 1.6.6.

    Drug diluent and volume, if applicable. Specific filters and tubing, when needed.

  • 1.6.7.

    Rate and duration of administration.

  • 1.6.8.

    Administration frequency and time intervals.

  • 1.6.9.

    Laboratory tests required to monitor toxicity.

  • 1.6.10.

    Dose adjustments for each agent, according to laboratory test results and/or adverse effects.

  • 1.6.11.

    Expected adverse reactions and their treatment.

  • 1.6.12.

    Supportive therapy (hydration, antiemetics, etc.).

• 1.7.

  Before the first cycle of a new treatment regimen is administered, essential information about the patient and the therapy is entered in the medical records, including:

  • 1.7.1.

    Histopathological confirmation or verification of the initial diagnosis.

  • 1.7.2.

    Initial cancer stage and current status.

  • 1.7.3.

    Full medical history (including comorbidities) and physical examination.

  • 1.7.4.

    Weight and height.

  • 1.7.5.

    Full list of the patient's concomitant medication (see 1.12).

  • 1.7.6.

    History of allergy or hypersensitivity reactions.

  • 1.7.7.

    Initial psychosocial assessment and actions taken when indicated.

  • 1.7.8.

    Antineoplastic treatment plan, including at least the patient's diagnosis, drugs, doses, duration of therapy and goals of therapy.

  • 1.7.9.

    Expected frequency of follow-up visits and patient monitoring appropriate for the individual antineoplastic agents.

• 1.8.

  At each clinical consultation or on each day of treatment, healthcare staff carries out an assessment of the patient and documents it in the medical records. This should include:

  • 1.8.1.

    Performance status.

  • 1.8.2.

    Vital signs.

  • 1.8.3.

    Weight.

  • 1.8.4.

    Hypersensitivity reactions and other adverse events that occurred during treatment administration.

  • 1.8.5.

    Adverse reactions experienced with the treatment.

  • 1.8.6.

    Pain assessment.

  • 1.9.

    At each visit, the patient's treatment is reviewed and updated if required by the oncologist and validated by the pharmacist.

• 1.10.

  Oral antineoplastic therapy is subject to the same documentation, prescribing, validating and dispensing procedures as parenteral therapy.

• 1.11.

  Antineoplastic treatments given in clinical trials should follow the same safe practices described in this document as for commercially available treatment, in order to prevent medication errors.

• 1.12.

  At the first consultation, before each treatment cycle begins, a structured procedure is used to obtain a full list of medication being taken by the patient, including prescription and non-prescription drugs, vitamins, herbal medicines and substance abuse, and that list is compared and reconciled with drugs prescribed during the consultation and upon any subsequent transition of care. At the following consultations, a procedure will be used to learn of subsequent changes in treatment, and they will be reviewed by the pharmacist.

• 1.13.

  The hospital has in place a standard procedure for reconciling treatment at discharge, which ensures appropriate education of patients or carers and good communication with professionals who care for the patient, to ensure suitable treatment monitoring.

• 1.14.

  The hospital has a full-time emergency department for dealing with treatment-related adverse reactions and emergencies in cancer patients. If required, an oncologist can be consulted, and there is the option of transferring the patient to a site with specialist oncology services.

• 1.15.

  The hospital has rules in place for recording and reporting adverse drug reactions.

• 1.16.

  The hospital has an interdisciplinary patient safety or risk management committee, which has set up a reporting system enabling health professionals to report adverse events, potential events and medication incidents that occur at the site. The committee analyses these incidents in order to introduce measures designed to prevent their recurrence. It also reviews external errors and published information about new safe practices and develops and implements effective practices for improving the safety of cancer therapy.

• 1.17.

  The hospital has a general or specific quality management system for oncology procedures, which is accredited or certified by an external body.

Treatment planning, patient consent and information

• 2.1.

  The hospital has a standard procedure for obtaining informed consent from patients and documenting it before they receive cancer therapy.

• 2.2.

  Before each treatment regimen begins, the existence of informed consent to treatment is verified.

• 2.3.

  Patients are provided with verbal and written information (supported by applications or websites) before the first treatment administration, and at subsequent visits if required or if changes occur. The information consists of at least:

  • 2.3.1.

    The patient's diagnosis and treatment objectives, i.e. curing disease, prolonging life or reducing symptoms.

  • 2.3.2.

    Expected treatment duration and dosing schedule.

  • 2.3.3.

    Names of antineoplastic drugs and supportive medication, and possible interactions with drugs or food.

  • 2.3.4.

    Expected adverse effects of treatment and specific measures for minimising them. Patients of reproductive age must be informed about the risks of sterility and resources for preserving fertility.

  • 2.3.5.

    Procedures for handling drugs, excreta and waste at home.

  • 2.3.6.

    Monitoring plans and hospital contact details.

  • 2.3.7.

    Warning symptoms that may require urgent medical attention.

• 2.4.

  Information is provided to family or carers, depending on the patient's decision and ability to take responsibility for treatment management. Information materials should be suited to the understanding of the patient or carer. Provision of information should include feedback from the patient or carer, that shows understanding and commitment to follow instructions appropriately.

• 2.5.

  When the hospital pharmacy department dispenses drugs intended for cancer therapy to patients, specifically trained pharmacists provide the patients or carers with verbal and written information about the following issues concerning their medication:

  • 2.5.1.

    Safe handling of the medication and additional precautions (treatment of excreta and waste).

  • 2.5.2.

    Storage conditions.

  • 2.5.3.

    Administration instructions.

  • 2.5.4.

    Dosage and advisability of adhering to treatment.

  • 2.5.5.

    What to do in the event of forgotten doses or vomiting.

  • 2.5.6.

    Dose adjustments, as prescribed by the oncologist, when applicable.

  • 2.5.7.

    Additional information about adverse effects and how to manage them, especially dose-limiting effects.

  • 2.5.8.

    Potential interactions with other drugs, food or alternative therapies.

  • 2.5.9.

    Contact details for contacting the site if necessary.

  • 2.5.10.

    Returning unused medication to the pharmacy.

  • 2.6.

    When home treatment dosage is intermittent or changed because of toxicity, proper understanding by the patient or carer must be ensured.

• 2.7.

  It is important to define and coordinate in each hospital, both for parenteral and oral treatments, the complementary roles of the various health professionals (medical oncologists, pharmacists and oncology nurses), and their responsibility for the patient's health education and follow-up, reinforcing key information while avoiding redundancy and inefficiency.

• 2.8.

  The hospital has comprehensive, up-to-date resources and information sources. Verbal and written information provided must be comprehensible and updated regularly. A translation system must be available, if necessary, to enable the patient to understand the treatment plan. The use of patient diaries is recommended, to assist with adherence and to record incidents or adverse effects.

• 2.9.

  The hospital encourages the development of new technologies designed for good patient education, which facilitate better access to information about medication and the patient's active involvement in his cancer therapy.

Prescribing, preparing, dispensing and administering treatment

• 3.1.

  Medical prescriptions for antineoplastic therapies are signed by hand or electronically.

• 3.2.

  The hospital has a specific policy for prescriptions for antineoplastic therapies, which ensures that:

  • 3.2.1.

    Verbal orders are not permitted, except to discontinue or cancel the administration of antineoplastic drugs.

  • 3.2.2.

    Any change or new treatment is documented in the medical records, as are any dose adjustments to oral treatments communicated directly to the patient.

• 3.3.

  The hospital has a computer physician order entry system integrated into the medical records, equipped with clinical decision support systems that minimise prescribing errors (dose calculation alert systems based on body measurements or biomarkers, adjustments according to clinical situations, allergies, maximum doses and disease-specific decision trees).

• 3.4.

  The hospital uses standard, pre-printed or electronic forms for each cancer therapy regimen.

• 3.5.

  Medical prescriptions for antineoplastic therapies state at least the following elements:

  • 3.5.1.

    Patient's full name.

  • 3.5.2.

    A second unambiguous patient identifier (medical record number or date of birth).

  • 3.5.3.

    Weight, height and body surface area.

  • 3.5.4.

    Prescription issue date.

  • 3.5.5.

    Diagnosis and name of the regimen or protocol.

  • 3.5.6.

    Cycle number and day, when applicable.

  • 3.5.7.

    Full generic drug names (including trade name in the case of biosimilars).

  • 3.5.8.

    Drug dose according to the protocol: theoretical dose according to the regimen and resultant dose for the patient, dose adjusted according to pharmacokinetic or laboratory parameters, and correction factor used for any dose increase or reduction.

  • 3.5.9.

    Administration date.

  • 3.5.10.

    Route of administration.

  • 3.5.11.

    Vehicle used and final volume of solution prepared.

  • 3.5.12.

    Allergies.

  • 3.5.13.

    Supportive care treatments appropriate for the treatment regimen: pre-medication, hydration, growth factors, drugs to prevent hypersensitivity reactions, and antiemetic therapy when applicable.

  • 3.5.14.

    Sequencing of drug administration, when applicable.

  • 3.5.15.

    Administration rate, when applicable.

  • 3.5.16.

    Prescriber's ID, including his signature or corresponding electronic ID.

• 3.6.

  Prescriptions for oral antineoplastic drugs state the following:

  • 3.6.1.

    Patient's full name.

  • 3.6.2.

    A second unambiguous patient identifier (medical record number or date of birth).

  • 3.6.3.

    Weight, height and body surface area.

  • 3.6.4.

    Prescription issue date.

  • 3.6.5.

    Diagnosis and name of the regimen or protocol.

  • 3.6.6.

    Full generic drug name.

  • 3.6.7.

    Drug dose according to the protocol: theoretical dose according to the regimen and resultant dose for the patient, dose adjusted according to pharmacokinetic or laboratory parameters, and correction factor used for any dose increase or reduction.

  • 3.6.8.

    Route of administration and special instructions, if any.

  • 3.6.9.

    Amount of drug to be dispensed.

  • 3.6.10.

    Dosing schedule.

  • 3.6.11.

    Duration of treatment, when applicable.

  • 3.6.12.

    If appropriate, the instructions should state how drugs should be taken as regards food intake, and whether certain food types can affect the efficacy or toxicity of the medication.

  • 3.6.13.

    Prescriber's ID, including his/her signature or corresponding electronic ID.

• 3.7.

  All prescription orders for cancer therapies, including oral medication, must be validated by a hospital pharmacist specifically dedicated to cancer therapy.

  • 3.7.1.

    Validation is mandatory as an independent preliminary step in treatment preparation.

  • 3.7.2.

    In order to validate the treatment order, the pharmacist checks the patient's previous treatment (paying attention to cumulative maximum doses), and verify all drugs and administration routes, scheduling, if all doses are correct according to patient weight, BSA and renal and liver function, potential interactions, the patient's allergies, dose adjustments related to previous adverse effects, compliance with site protocols, and whether patient blood counts and other laboratory results allow the treatment to be administered.

  • 3.7.3.

    If any discrepancies are found in the validation process, they must be resolved with the prescribing physician before the preparation process continues.

• 3.8.

  The hospital has a system for ensuring that preparation is safe and traceable, covering all stages from the prescribing to the administration of antineoplastic drugs.

  • 3.8.1.

    Antineoplastic therapies must be prepared under the control and supervision of the hospital pharmacy department.

  • 3.8.2.

    When antineoplastic therapies administered on-site are prepared off-site, the external site must satisfy all the general requirements for quality, safety and traceability.

• 3.9.

  It must be ensured that antineoplastic therapies are prepared by specifically trained staff.

  • 3.9.1.

    Antineoplastic therapy must be prepared by health professionals trained to prepare such treatments, and under the direction of a specifically dedicated hospital pharmacist.

  • 3.9.2.

    Health professionals (nurses, technicians) involved in preparing antineoplastics must know the rules of cytotoxic drug management and receive specific training before they start work and regularly thereafter.

• 3.10.

  The material resources available must allow antineoplastic medication to be prepared under conditions of safety for both patient and healthcare staff, according to legislation and good manufacturing practice.

  • 3.10.1.

    Cancer drugs should be prepared in clean rooms, under negative pressure and using aseptic technique.

  • 3.10.2.

    Specific Class II Type B2 biosafety cabinets are used for preparing cytostatics, and personal protective equipment is worn, in accordance with current regulations.

  • 3.10.3.

    Only authorised staff is allowed in the preparation area.

  • 3.10.4.

    Each site should assess whether it is cost-effective to use robots for preparing cytostatics. These devices improve the accuracy of preparation and provide additional elements of safety.

• 3.11.

  There should be a safety policy for selecting and storing antineoplastic drugs, aimed at preventing errors with drugs that have similar names or packaging, and to avoid the coexistence at the hospital of presentations of different concentrations. If the usual presentations are changed, staff must be informed, and the computer program updated.

• 3.12.

  The pharmacy department has standard guidelines or protocols specifying the composition, reconstitution, dilution, stability, labelling, etc. of each drug used in cancer therapies at the site.

• 3.13.

  Antineoplastic therapy is prepared in the cabinet for one patient at a time, and each drug is prepared individually.

• 3.14.

  Antineoplastic therapy is prepared in such a way that no further preparation is required by the health professional responsible for administering the treatment. Priming of intravenous tubing and syringes is performed inside the safety cabinet.

• 3.15.

  A standardised labelling method is available for ensuring easy identification of patient, medication, route and dose. Labels are printed BSA: body surface area; ID: identifier. (not handwritten). Mixtures are labelled as soon as they are prepared. The label is checked against the physician order and the worksheet. Labelling for injections includes:

  • 3.15.1.

    Patient's full name.

  • 3.15.2.

    A second unambiguous patient identifier (medical record number or date of birth). Location if applicable.

  • 3.15.3.

    Generic drug name.

  • 3.15.4.

    Drug dose expressed in terms of total content (total dose/total volume).

  • 3.15.5.

    Diluent.

  • 3.15.6.

    Route of administration.

  • 3.15.7.

    Administration rate and duration of infusion.

  • 3.15.8.

    Preparation date and administration date.

  • 3.15.9.

    Expiry date and storage conditions.

  • 3.15.10.

    Instructions for administration (e.g. needs a filter), if applicable.

  • 3.15.11.

    Additional warning label about handling cytotoxics.

• 3.16.

  Cancer drugs dispensed at hospital for external patients can be labelled individually per patient or provided in their commercial packs.

  • 3.16.1.

    When medication is dispensed individually labelled for a patient, the labelling includes:

    • 3.16.1.1.

      The patient's name a second unambiguos identifier.

    • 3.16.1.2.

      Generic drug name.

    • 3.16.1.3.

      Pharmaceutical form and dose.

    • 3.16.1.4.

      Route of administration.

    • 3.16.1.5.

      Batch number, expiry date and storage conditions.

  • 3.16.2.

    When medication is provided in its commercial forms of presentation, the labelling includes items 3.16.1.2 to 3.16.1.5.

  • 3.16.3.

    The pharmacy department uses bar codes or other systems to verify all medication dispensed to patients or carers for cancer therapies.

• 3.17.

  In the case of cancer medication pertaining to a clinical trial, as well as the above-mentioned points, the guidance for the trial protocol is followed. The clinical trial protocol and the time of preparation are stated on the labelling.

• 3.18.

  The components of intravenous mixtures of cancer drugs are verified using bar codes or a similar system. Additionally, a gravimetric method is used to verify correct preparation of the mixture. If this is not possible, the filled syringes and vials are independently double-checked by staff other than the person who prepared them, before they are added to the final solution. The check performed is recorded in writing.

• 3.19.

  After the prepared mixture has been verified, the antineoplastic drug is inserted into a plastic bag with a leak-proof closure. Transparent bags facilitate identification by nursing staff, with no need for unpacking. Bags are transported in an easily washed, rigid container, identified with the cytotoxic hazard symbol, containing an absorbent plastic pad at the bottom.

• 3.20.

  Until they are transported, prepared mixtures are stored, in accordance with the storage conditions, in a properly identified, purposedesigned area, bearing in mind the stability data for the mixture.

• 3.21.

  Prepared mixtures are transported by properly trained healthcare staff. The use of mechanical transport systems such as pneumatic tubes is not recommended.

• 3.22.

  Antineoplastic therapy is administered by a qualified member of nursing staff.

• 3.23.

  Before antineoplastic therapy is first administered, an expert nurse must check for the presence of risk factors for extravasation. If several factors are present, prior insertion of a central line should be evaluated.

• 3.24.

  Before each administration of antineoplastic therapy, patient ID is verified by an expert nurse in the presence of the patient, using at least two identifiers: full name, and a second unambiguous identifier (medical record number, date of birth, or verification by national ID card when administration takes place outside the hospital).

• 3.25.

  Before the start of each administration cycle, an expert nurse confirms the treatment with the patient: drug name, infusion time, route of administration, and infusion-related symptoms that must be reported, stipulating which symptoms must be reported urgently by the patient.

• 3.26.

  Before each administration of cancer therapy, the following are verified and documented by an expert nurse:

  • 3.26.1.

    Drug name.

  • 3.26.2.

    Dose.

  • 3.26.3.

    Route of administration.

  • 3.26.4.

    Volume to be infused.

  • 3.26.5.

    Administration rate.

  • 3.26.6.

    Expiry date and time.

  • 3.26.7.

    Appearance and physical integrity of the drugs.

  • 3.26.8.

    Integrity and suitability of chemotherapy delivery devices: medical devices and infusion pumps.

• 3.27.

  The patient's clinical status is documented by nursing staff during treatment and after it ends.

• 3.28.

  Whenever possible, technologies are introduced to improve patient safety, such as traceability by bar code, data matrix, radiofrequency identification (RFID) or other system, with data transfer to smart infusion pumps.

• 3.29.

  Systems for recording administered medication are available, so that medication errors can be more easily prevented, and full details can be kept of treatment given.

• 3.30.

  Extravasation management procedures are defined and antidotes with protocols for using them are available.

• 3.31.

  Hospitals ensure that home administration of antineoplastic drugs meets the same requirements as at hospital.

• 3.32.

  At hospitals where intrathecal medication is prepared and/or administered, specific procedures exist to prevent treatment-related errors. They include at least the following:

  • 3.32.1.

    Intrathecal chemotherapy is prepared separately from intravenous chemotherapy.

  • 3.32.2.

    The labelling of medication for intrathecal use clearly states “for INTRATHECAL use only”, written out in full, in bold capital letters.

  • 3.32.3.

    Prepared mixtures are stored separately from intravenous chemotherapy.

  • 3.32.4.

    Drugs for intravenous use and for intrathecal use are not dispensed together for the same patient.

  • 3.32.5.

    Intrathecal chemotherapy is administered after having been independently double-checked by the physician and by the nursing staff involved in administering it.

• 3.33.

  All vinca alkaloids are prepared in the pharmacy department in ready-to-administer minibags. The following warning is displayed: “For intravenous use only. Fatal if administered by other routes”.

Follow-up after antineoplastic drug administration: adherence, toxicity and complications

• 4.1.

  The hospital has specific procedures for monitoring treatment response, defining the appropriate timing for assessing the treatment regimen and the necessary functional tests.

• 4.2.

  The hospital has a defined policy for new treatments for patients, which considers:

  • 4.2.1.

    The availability of new treatments.

  • 4.2.2.

    Monitoring procedures and care plan.

• 4.3.

  The hospital has a procedure for evaluating, at each visit by the patient, his treatment adherence as well as the toxicity associated and its treatment.

• 4.4.

  The hospital has a procedure for evaluating and documenting treatment-related adverse reactions and dose adjustments required, and for reporting them before subsequent administration.

• 4.5.

  For drugs associated with cumulative toxicity, the doses administered are monitored.

Staff safety

• 5.1.

  Health professionals are adequately trained in safety procedures and updated in hazardous drugs handling, and wear personal protective equipment suitable for preparing, dispensing and administering cancer drugs, and for handling the patient's body fluids.

• 5.2.

  The hospital employs standard operating procedures for preparation and administration, which ensure the safety of people handling cancer drugs, including the use of closed system transfer devices (CSTD) to reduce the risk of vapours and aerosols being released.

• 5.3.

  The hospital has a protocol to manage accidental exposures and a spill kit is available, with appropriate instructions for use, for those cases, which are registered

• 5.4.

  The hospital has policies and procedures regarding cytotoxic waste management, in accordance with current legislation.