Reporting and monitoring adverse events with cancer treatment [final]
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Transcript of Reporting and monitoring adverse events with cancer treatment [final]
Reporting and Monitoring of Adverse Events of Cancer TreatmentRosalynn L. Pangan, RPhDepartment Manager for Pharmacy Dispensing & CompoundingSt. Luke’s Medical Center – Global City
Objectives
At the end of the presentation, the participant will be able to:▫Have a clear understanding of the
definition of adverse drug events;▫Value the importance of reporting
adverse events;▫Know common adverse events with
cancer treatment; ▫Learn about the FDA Philippines
process of ADR reporting; and,▫Appreciate how to assess ADRs
Outline
• DEFINITION OF TERMS
• COMMON ADVERSE EVENTS WITH CANCER
TREATMENT
• ADR REPORTING PROGRAM IN THE PHILIPPINES
• ASSESSING ADRS
• INTEGRATION
Patient Case•49/F diagnosed with breast CA•Patient presented erythema and dysesthesia on the hands and heels after the 5th session of chemotherapy•HPI:
• Patient underwent mastectomy and two months after patient was started chemotherapy with docetaxel, adriamycin, cylophopshamide
• On the 4th chemo session, patient presented erythema and dysesthesia of the burning sensation type on the hands which improved in 2 weeks
•Treatment given: prednisone 0.2 mg/kg/day for 7 days, mometasone cream and moisturizer
Donati, A. And Castro LGM. Cutaneous adverse reactions to chemotherapy with taxanes. The dermatologist's point of view. An. Bras. Dermatol. vol.86 no.4 Rio de Janeiro July/Aug. 2011
•Did the patient experience an adverse event?
•Is it an ADR?
•Which is the most likely causative agent?
Definition of Terms (WHO)
Adverse Event (AE)
•Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment
Synonym: Adverse experience
Adverse Drug Reaction (ADR)
• A response which is noxious and unintended, and which
occurs at doses normally used in humans for the
prophylaxis, diagnosis, or therapy of disease, or for the
modification of physiological function. (WHO, 1972).
• An adverse drug reaction, contrary to an adverse event, is
characterized by the suspicion of a causal
relationship between the drug and the occurrence,
i.e. judged as being at least possibly related to treatment
by the reporting or a reviewing health professional.
Serious Adverse Drug Reaction (ADR)
- any untoward medical occurrence that at
any dose:
results in death
requires inpatient hospitalisation or
prolongation of existing hospitalisation
results in persistent or significant
disability/incapacity
is life-threatening
Side Effect
•Any unintended effect of a
pharmaceutical product occurring at
normal dosage which is related to
the pharmacological properties of
the drug
Unexpected Adverse Reaction
•An adverse reaction, the nature or
severity of
which is not consistent with domestic
labelling
or market authorization, or expected from
characteristics of the drug
Common Adverse Events with Cancer Treatment
Common ADRs
• Alopecia• Nausea and vomiting• Myelosuppression• Haemorrhagic cystitis• Mucositis• Increased toxicity with
impaired renal function• Cardiac toxicity• Hot flushes• Electrolyte imbalance• Deep vein thrombosis
Beers, M.H. and Berko, R. 1999. The Merck Manual. 17th ed. USA. pp 990-993
ADRs identified in the RADAR Project and no. of reports contained in the database (1998-2007)
RADAR – RESEARCH ON ADVERSE DRUG EVENTS AND REPORTS
Chemotherapy-Induced Dermatological Toxicity
• Alopecia
• Hyperpigmentation
• Nail changes
• Palmar-plantar
erythrodysesthesia
• Extravasation
• Radiation reactionsCassagnol, M. Dermatologic Toxicities of Chemotherapeutic Agents. US Pharm 2008; 33(1):10-
18
Chemotherapy-Induced Dermatological Toxicity
Berger A, Karakunnel J. Adverse effects of treatment. In: DeVita V, Hellman S, Rosenberg S, eds. Cancer: Principles & Practice of Oncology. 7th ed. Philadelphia, PA: Lippincott Williams &
Wilkins; 2005:2556. line B. Prevention of chemotherapy-induced alopecia: a review of the literature. Cancer
Nurs. 1984;7:221-228.
Chemotherapy-Induced Dermatological Toxicity
Alley E, Green R, Schuchter L. Cutaneous toxicities of cancer therapy. Curr Opin Oncol. 2002;14:212-216.
Lindley C. Adverse effects of chemotherapy. In: Koda-Kimble MA, Young LY, Kradjan W, eds. Applied Therapeutics: The Clinical Use of Drugs. 8th ed. Philadelphia, PA: Lippincott
Williams & Wilkins; 2005.
Chemotherapy-Induced Dermatological Toxicity
Lindley C. Adverse effects of chemotherapy. In: Koda-Kimble MA, Young LY, Kradjan W, eds. Applied Therapeutics: The Clinical Use of Drugs. 8th ed. Philadelphia, PA: Lippincott
Williams & Wilkins; 2005.
Chemotherapy-Induced Nausea and Vomiting (CINV)
• Risk factors: ▫ Patient-related: age, sex▫ Drug-related chemotherapy dose, emetogenicity
Hesketh, PJ. Chemotherapy-Induced Nausea and Vomiting. N Engl J Med 2008; 358:2482-2494
Chemotherapy-Induced Peripheral NeuropathySymptoms Drugs linked to CPN• Pain (may be there all the time or come and go, like
shooting or stabbing pain) • Burning • Tingling (“pins and needles” feeling) or
electric/shock-like pain • Loss of feeling• Trouble using your fingers to pick up or hold things;
dropping things • Balance problems • Trouble with tripping or stumbling while walking • Pressure may hurt more than usual • Temperature may hurt more than usual (mostly
cold; this is called cold sensitivity) • Shrinking muscles • Muscle weakness • Trouble swallowing • Constipation • Trouble passing urine • Blood pressure changes • Decreased or no reflexes
• Platinum drugs like cisplatin, carboplatin, and oxaliplatin
• Taxanes including paclitaxel docetaxel and cabazitaxel
• Plant alkaloids, such as vinblastine, vincristine, vinorelbine, and etoposide (VP-16)
• Bortezomib• Eribulin
http://www.cancer.org/acs/groups/cid/documents/webcontent/002908-pdf.pdf
Importance of Monitoring and Reporting ADR
Why is there a need to Watch Out for ADRs?•44,000 to 98,000 deaths occur annually
from medical errors. Of this total, an estimated 7,000 deaths occur due to ADRs (IOM, Jan 2000)
•In a meta-analysis of 39 prospective studies from US hospitals, the overall incidence of serious ADRs was 6.7% and fatal ADRs was 0.32% of hospitalized patients
*Lazarou, J., Pomeranz, BH., Corey, PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.JAMA. 1998 Apr 15;279(15):1200-5.
Misconceptions about ADR Reporting
• It is ALREADY DOCUMENTED
• It is DIFFICULT TO ESTABLISH CAUSAL RELATIONSHIP WITH THE DRUG
• Report ADRs IF ABSOLUTELY CERTAIN
• One case report CAN’T MAKE A DIFFERENCE
NOT ALL ARE DOCUMENTED
TEMPORAL RELATIONSHIP MAY BE USEFUL
ANY SUSPICION SHOULD BE REPORTED
ONE REPORT CAN MAKE A DIFFERENCE
1Figueiras A, Tato F, Fontainas J, Gestal-Otero JJ. Influence of physicians’ attitudes on reporting adverse drug events: a case-control study. Med Care 1999;37(8):809-814. 2Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999;48(4):623–627. 3Chyka PA, McCommon SW. Reporting of adverse drug reactions by poison control centres in the US. Drug Saf 2000;23(1):87–93.
ADR Monitoring Program in the Philippines
ADR Reporting System
www.fda.gov
ADR Reporting System
ADR Report Form
Submit on a quarterly basisSerious ADRs to be submitted within 48 hours
Assessing ADRs
REACTION TYPE
•Exaggerated pharmacological action
▫Exaggerated, but otherwise normal
pharmacological action of a drug given in the
usual therapeutic doses
•Unpredicted/unexpected reaction
▫not expected from the known pharmacological
actions of a drug given in usual therapeutic doses
SEVERITY
• 0 – Reaction required little or no treatment, no change in therapy, did
not require significant reduction in dosage or discontinuation of the drug
and did not cause harm or extend the stay in the facility
• 1 – Reaction caused no harm to the patient but required significant
reduction in dosage or discontinuation of the drug
• 2 – Reaction contributed or resulted in temporary harm to the patient
and required initial or prolonged hospitalization
• 3 – Reaction contributed to or resulted in permanent patient harm or
disability
• 4 – Reaction required intervention necessary to sustain life
• 5 – Reaction contributed to or resulted in the patient’s death
AVOIDABLE/PREVENTABLE
Likelihood of ADRs according to Edwards and Aronson• Certain
▫ Time frame of the reaction can be linked to the drug▫ Patient responds positively to the removal of the drug
• Probable▫ No rechallenge info is available
• Possible▫ Time frame is reasonably related to the administration
of the drug in question▫ Occurrence might also be the result of other drugs or
diseases• Unlikely
▫ Other chemicals, drugs, and diseases provide likely explanationsEdwards, IR, Aronso, JK. Adverse drug reactions: definitions, diagnosis and management. Uppsala Monitoring
Centre, WHO Collaborating Centre for International Drug Monitoring, Sweden. The Lancet (Impact Factor: 39.06). 11/2000; 356(9237):1255-9. DOI: 10.1016/S0140-6736(00)02799-9
PROBABILITY (NARANJO ALGORITHM)
Six Types of ADR (Edwards and Aronso, 2000)
• dose-related • non-dose-related
•dose-related and time-related
•time-related•withdrawal•failure of therapy
AugmentedBizarreChronic
DelayedEnd of useFailure
Edwards, IR, Aronso, JK. Adverse drug reactions: definitions, diagnosis and management. Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Sweden. The Lancet (Impact Factor: 39.06). 11/2000; 356(9237):1255-9. DOI: 10.1016/S0140-6736(00)02799-9
INTEGRATION
Patient Case•49/F diagnosed with breast CA•Patient presented erythema and dysesthesia on the hands and heels after the 5th session of chemotherapy•HPI:
• Patient underwent mastectomy and two months after patient was started chemotherapy with docetaxel, adriamycin, cylophosphamide
• On the 4th chemo session, patient presented erythema and dysesthesia of the burning sensation type on the hands which improved in 2 weeks
•Treatment given: prednisone 0.2 mg/kg/day for 7 days, mometasone cream and moisturizer
Donati, A. And Castro LGM. Cutaneous adverse reactions to chemotherapy with taxanes. The dermatologist's point of view. An. Bras. Dermatol. vol.86 no.4 Rio de Janeiro July/Aug. 2011
Accomplish the ADR Report Form
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Patient developed erythema and dysesthesia of burning sensation on the hands and heels after the 5th session of chemotherapy
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Details of ADR
Docetaxel
Suspect Drugs
Adriamycin
Cylophosphamide
Suspect Drug: Docetaxel
•ADR (based on lit): Neurosensory symptoms characterized by paresthesia, dysesthesia or pain including burning sensation) were reported in 49% of patients treated with docetaxel as a single agent for various tumor types and in 38% of patients treated for recurrent and/or metastatic SCCHN. Severe reactions were observed in less than 4% of the patients.
Source: Taxotere Package insert
Suspect Drug: Adriamycin/Doxorubicin
•Peripheral neurotoxicity in the form of local-regional sensory and/or motor disturbances have been reported in patients treated intra-arterially with doxorubicin, mostly in combination with cisplatin
Source: Cytoxan package insert
Suspect Drugs: Docetaxel, Adriamycin, Cyclophos-phamide
Slade, JH. Neurological Toxicities Associated with Cancer Chemotherapeutic Agents. US Pharm.2005;4(Onc suppl):3-18.
Management of ADR
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prednisone 0.2 mg/kg/day for 7 days, mometasone cream and moisturizer
ADR Assessment
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ADR Assessment
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ADR Assessment
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Pharmacy Dispensing & Compounding
THANK YOU!