Reporting and monitoring adverse events with cancer treatment [final]

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  • 1. Reporting and Monitoring of Adverse Events of Cancer Treatment Rosalynn L. Pangan, RPh Department Manager for Pharmacy Dispensing & Compounding St. Luke’s Medical Center – Global City
  • 2. 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
  • 3. Outline
  • 4. 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
  • 5. 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
  • 6. 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.
  • 7. 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
  • 8. Side Effect • Any unintended effect of a pharmaceutical product occurring at normal dosage which is related to the pharmacological properties of the drug
  • 9. 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
  • 10. 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
  • 11. ADRs identified in the RADAR Project and no. of reports contained in the database (1998-2007)
  • 12. Chemotherapy-Induced Dermatological Toxicity • Alopecia • Hyperpigmentation • Nail changes • Palmar-plantar erythrodysesthesia • Extravasation • Radiation reactions Cassagnol, M. Dermatologic Toxicities of Chemotherapeutic Agents. US Pharm 2008; 33(1):10-18
  • 13. 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.
  • 14. 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.
  • 15. 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.
  • 16. 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
  • 17. Chemotherapy-Induced Peripheral Neuropathy Symptoms 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
  • 18. 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.
  • 19. 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.
  • 20. ADR Reporting System
  • 21. ADR Reporting System
  • 22. ADR Report Form Submit on a quarterly basis Serious ADRs to be submitted within 48 hours
  • 23. 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
  • 24. 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
  • 25. AVOIDABLE/PREVENTABLE
  • 26. 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 explanations 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
  • 27. PROBABILITY (NARANJO ALGORITHM)
  • 28. Six Types of ADR (Edwards and Aronso, 2000) • dose-related • non-dose-related • dose-related and time-related • time-related • withdrawal • failure of therapy Augmented Bizarre Chronic Delayed End of use Failure 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
  • 29. 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
  • 30. Accomplish the ADR Report Form
  • 31. Patient developed erythema and dysesthesia of burning sensation on the hands and heels after the 5th session of chemotherapy
  • 32. Docetaxel Adriamycin Cylophosphamide
  • 33. • 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
  • 34. • 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
  • 35. Slade, JH. Neurological Toxicities Associated with Cancer Chemotherapeutic Agents. US Pharm.2005;4(Onc suppl):3-18.
  • 36. Pharmacy Dispensing & Compounding