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BCOP(Board Certified Oncology Pharmacist)

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BCOP(Board Certified Oncology Pharmacist)

문진영 국립암센터

1. 자격 요건

BCOP 시험은 아래의 조건을 만족하면 응시할 수 있으므로, 병원 약사로서 3년 이상의 경력이 있으면 시험에 지원할 수 있다.

1) ACPE(American Council on Pharmaceu- tical Education)에서 인정하는 약학교육프로 그램 이수

· 국내의 경우 약학대학 졸업증명서 제출 2) 약사 자격증 소지 및 현재 실무 종사자

· 국내의 경우 약사면허증 사본 및 재직증명서 제출

3) 해당 분야(oncology pharmacy)에서 3년 이 상의 실무 경험

· 실제 해당 분야에서의 근무 여부를 증명하 기 힘들므로 경력증명서나 재직증명서에 보이는 근무 년수로 대체

2. 시험 문항

총 200문항으로 오전, 오후 각각 100문항씩 치른다.

recertification의 경우 오전 시험 100문항만 치르면 되는데, 개인적으로는 오후보다 오전이 더 어려웠다.

3. 시험 내용

종양약학에 대한 실무와 그에 대한 최신 지견, 논 문에 게재된 임상시험 결과를 해석하거나 통계에 관 한 부분, 신약개발에 관련된 내용 등이 포함되며 암

종별 치료 방법 뿐만 아니라 예방 방법 및 검진 지침 등에 대해서도 출제된다. 공부를 해 보면 알겠지만 BPS 자격 취득이라는 목적 외에도 종양 관련 업무 를 하고 있다면 실제 업무에도 크게 도움이 된다. 출 제 영역은 크게 4영역으로 분류되어 있으나, 시험문 제는 영역을 따로 구분하지 않고 전체적으로 분포되 어 출제된다.

1) Domain 1 : 임상 능력과 치료적 관리(60%) 암 환자의 약물치료 계획 및 모니터, 조정 등을 통 한 약물 치료의 최적화에 관한 부분

* 관련 지식 01 병리학 02 해부, 생리학 03 분자생물학

04 암의 원인과 병리생리학, 암 치료와 관련된 합병증

05 항암요법(chemotherapies, biologic ther- apies, hormonal therapies 등)

06 비약물요법(방사선치료, 수술, 관찰 치료, 방 사성의약품)

07 조혈모세포이식

08 대체치료(herbals, vitamins, acupunc- ture)

09 약물상호작용 10 임상시험

11 암의 병기, 진단, 예후

12 환자별 인자에 따른 치료에 대한 예상 반응율 13 암 또는 암 치료의 합병증

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14 부작용 평가 및 등급

15 치료 결과에 영향을 줄 수 있는 인자(연령, 주 요 장기 기능, 유전적 특징 등)

16 항암제와 보조 치료 약제의 약리학/약동학, 약력학

17 약물전달기술(Drug-delivery technology) 18 약물 투여 방법과 투여 경로

19 진단 및 모니터 방법

20 치료와 결과에 영향을 줄 수 있는 사회적, 문 화적 인자

21 통증 조절, 완화 치료

22 보조적 치료(growth factors, chemopro- tectants, anti-emetics, anti-infectives 등)

2) Domain 2 : 정보의 생성, 해석, 교육(20%) 연구, 연구 결과의 적용, 교육 등을 통하여 환자 care에 기여

* 관련 지식

01 문헌과 정보 검색 시스템 02 연구 디자인 및 연구 방법

03 연구 목적 (반응율, 부작용, 경제학, 삶의 질, 약동학, 약력학, 약물유전학)

04 연구결과의 해석 및 적용 05 통계 방법

06 교육 및 상담 방법

07 교육 및 상담에 대한 정보원

08 임상시험과 관련된 윤리학적인 문제들 (환자 비밀 보장, 동의서, 환자 권리 등)

09 신약 개발 과정

3) Domain 3 : 가이드라인, 정책, 표준지침(15%) 가이드라인의 이행과 약제 서비스의 개선을 통해 암 환자에서의 안전하고 효과적이며 적합한 약물 사 용에 관한 부분

* 관련 지식

01 임상진료지침(예: ASCO, ASHP, NCCN) 02 임상진료지침의 개발 또는 평가에 대한 방법 03 전문적인 실무 표준지침(예: ASHP, USP,

ASCO)

04 National accreditation and regulatory standards(JCAHO, CMS, HIPAA, NIOSH, USP 797, OSHA, OBRA, DEA, ASHP Oncology Pharmacy Practice Residency Standards)

05 Reimbursement policies of federal and private agencies

06 투약 오류를 예방하기 위한 QI 활동 방법(항 암제 처방 방법, 프로토콜 검토)

07 항암제 취급 방법(투여 방법, 조제 방법, 폐 기)

08 임상시험약품 관리

4) Domain 4 : 공중 위생(5%)

암과 관련된 문제들에 관해 대중들의 인식을 고양

* 관련 지식

01 American Cancer Society, National Cancer Institute 등과 같은 단체 또는 조직 을 통해 얻을 수 있는 자료들

02 암 발생 위험 인자 03 암 예방 방법 04 암 검진 지침 05 암 치료 방법

06 Clinical trial options 4. 교재

국내에 BPS에 대한 공식적인 교육프로그램은 없지 만, 한국병원약사회에서 BPS 시험 응시와 관련하여 응시원서 접수 및 시험 장소 신청 등의 행정적, 재정 적 지원을 적극적으로 해 주고 있다. 또 2006년과 2007년에는 삼성서울병원에서 주최한 Oncology Pharmacy Symposium이 있어 시험을 준비하는 약사들에게 도움을 주었다.

기본이 되는 교재로는 Oncology Pharmacy Preparatory review Course Book과 Pharma- cotherapy Self Assessment Program(PSAP) : Hematology and Oncology)이다. 교재들은

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ACCP web site(www.accp.com)에서 구입 가능하 다.

이 책 외에도 ASCO나 NCCN guideline에 대한 공부와 최신 약물요법을 익히기 위해 최신 저널을 읽 는 것이 필요하며, 이미 자격을 획득한 약사들로부터 시험 유형 및 출제 경향 등을 파악하면 도움이 될 것 이다.

5. Recertification

자격을 취득한 이후 자격의 유지를 위해서는 7년마 다 갱신 시험을 보거나, 매년 보수교육을 받는 방법 이 있다. 보수교육은 Oncology Pharmacy Preparatory Review Course(20시간, 적어도 한 번은 반드시 이수해야 함), BCOP Recertification Home Study Syllabus(15시간), Oncology Pharmacy Specialty Sessions(5시간) 등을 통해 7년 동안 100시간 이상을 이수해야 한다.

6. 시험문제 예시

1) On day 14 after allogeneic stem cell transplant, the patient complains of right-upper-quadrant pain. He has gained 10 kg over the past 3 days. The preparative regimen for his AML was cyclophosphamide and busulfan. What is the most likely cause of the pain?

A. Cytomegalovirus hepatitis B. Graft-versus-host disease C. Veno-occlusive liver disease D. Acute cholecystitis

2) A 50-year-old male presents to the emergency department with a tempera- ture of 39.4°, severe hypotension, and chills. The patient has a history of hypertension, diabetes, and coronary artery disease. He received paclitaxel and carboplatin 9 days ago for non-small-cell

lung cancer. His absolute neutrophil count is 56 cells/mm? Which of the fol- lowing interventions would be most appropriate for this patient?

A. Cefepime

B. Imipenem and filgrastim C. Ceftriaxone and filgrastim D. Ciprofloxacin and aztreonam

3) Which of the following chemotherapy agents has been associated with severe extravasation injury?

A. Bleomycin

B. Cyclophosphamide C. Methotrexate D. Vincristine

4) A 68-year-old female has been recently diagnosed with stage IV breast cancer.

Her tumor is found to be estrogen-and progesterone-receptor positive. Which of the following is recommended for initial hormonal management?

A. Anastrozole 1 mg PO q.d.

B. Aminoglutethimide 250 mg PO q.i.d.

C. Tamoxifen 40 mg PO b.i.d.

D. Exemestane 25 mg PO q.d.

5) Which of the following is the most appro- priate treatment for Helicobacter pylori - associated low- grade lymphoma of mucosa-associated lymphoid tissue (MALT)?

A. Omeprazole, amoxicillin, DICE B. ProMACE cytaBOM

C. Omeprazole, amoxicillin, clarithromycin

D. CHOP, rituximab

6) Which of the following combination

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chemotherapy regimens is considered first-line treatment for adults with acute nonlymphocytic leukemia?

A. Mitoxantrone and cytarabine B. Cytarabine and doxorubicin C. Mitoxantrone and daunorubicin D. Cytarabine and daunorubicin

7) Questions 7 and 8 refer to the same patient. S.I. is a 65-year-old female with metatstic colon cancer. Her treatment plan includes irinotecan,leucovorin, and flourouracil (IFL). You have been asked to discuss potential side efects and manage- ment of them with her. Which of the fol- lowing describes the proper management plan for diarrhea that occurs greater than 24 hours after treatment?

A. Take two atropine tablets at the onset of diarrhea and then repeat after each loose bowel movement. Continue tak- ing atropine tablets on this schedule until you are diarrhea free for 12 hours.

B. Drink at least eight 8-oz. glasses of water a day to prevent dehydration. If symptoms persist for more than 48 hours, call your physician.

C. Take two loperamide capsules at the onset of diarrhea and then take one capsule every two hours. Continue taking loperamide on this schedule until you are diarrhea free for 12 hours.

D. Take two diphenoxylate/atropine tablets at the onset of diarrhea and then take two tablets after each loose bowel movement. Continue taking diphenoxylate/atropine tablets every 4 hours until you are diarrhea free for

12 hours.

8) On day 18 of her treatment course she calls complaining of severe mouth pain and dizziness. When she arrives at the clinic, she reports that she has been unable to eat or drink for the past 2 days and for two days prior to that her intake was minimal. Lab values are as follows:

Na 136, K 4.3, CO2 27, C1 102, BUN 34, SCr 1.8, WBC 1800/mm? Hgb 10.5, Hct 37, Plt 90/mm? neutrophils (%) 42, lympho- cytes (%) 45, monocytes(%) 12, eosinophils (%) 0.7, basophils (%) 0.3. The fellow asks you if you think it is going to be neces- sary to adjust the patient next cycle of chemotherapy. Which of the following represents the most appropriate dosing recommendation to make at this time?

A. This patient is not going to be able to tolerate further treatment with chemotherapy. She should be enrolled into an investigational protocol or receive symptomatic and supportive care.

B. Treatment will need to be delayed.

When the patient fully recovers from the treatment- related toxicities, reduced doses of flourouracil, and irinotecan will be necessary.

C. Treatment will need to be delayed.

When the patient fully recovers from the treatment-related toxicities, reduced doses of irinotecan will be necessary. Flourouracil and leucovorin can be resumed at the original dose.

D. This patient is not going to be able to tolerate further treatment with this regimen. She should be treated with only flourouracil and leucovorin when

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she fully recovers from these treat- ment-related toxicities.

9) Which of the following most accurately characterizes the neurotoxicity profile of oxaliplatin?

A. Acute neurotoxicity can be triggered by exposure to cold

B. Acute neurotoxicity usually does not recur with further dosing.

C. Chronic neurotoxicity can be triggered by exposure to cold

D. Chronic neurotoxicity does not limit further treatment

10) With regard to treatment trials, the pri- mary purpose of the informed consent process is to provide:

A. information regarding the treatment and the financial costs associated with trial participation.

B. liability coverage for the institution and the participating investigators.

C. a contract between the investigator and a person participating in the trial.

D. sufficient information for a potential subject to make a decision about par- ticipating in a trial.

11) When an investigational drug is being studied in a phase II clinical trial which of the following choices best character- izes the appropriate endpoints of the study?

A. Efficacy and dose limiting toxicity (DLT)

B. Pharmacokinetic and pharmacody- namic parameters

C. Response rate and safety

D. Overall survival or clinical benefit

response

12) You have been asked to write a depart- mental policy to ensure that all thalido- mide capsules are dispensed consistent with the revised S.T.E.P.S. Program.

Which of the following accurately char- acterizes compliance with this program?

A. Subsequent prescriptions can only be filled if fewer than 7 days of therapy remain from the previous prescrip- tion.

B. A prescription for thalidomide is valid and can be filled up to 14 days after it is written.

C. Up to a 2 month supply of thalidomide can be dispensed at one time with no refills.

D. Capsules can be removed from the blister packs prior to dispensing if the patient requests this.

13) A new physician joins the Oncology Division at your hospital. He has several research protocols that involve the use of gene transfer products and he has submitted these to the IRB for approval.

You sit on the IRB and have concerns about the safety and proper handling of these agents. Which of the following publications would provide the best information about the dangers involved in handling these gene transfer agents and precautions that should be taken to ensure the safety of those preparing them?

A. CDC/NIH publication - Biosafety in Microbiological and Biomedical Laboratories

B. ASHP Technical Assistance Bulletin on

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Handling Cytotoxic and Hazardous Drugs

C. OSHA Technical Manual - Controlling Occupational Exposure to Hazardous Drugs

D. JCAHO publication - Comprehensive Accreditation Manual for Hospitals

14) It is recommended that patients who have had basal cell carcinoma of the skin or those who are at high risk for skin cancer use a minimum sunblock of SPF:

A. 5.

B. 15.

C. 30.

D. 45.

15) You are participating in an annual patient education program sponsored by your employer. You have been asked to help staff the booth focusing on current cancer screening guidelines. A woman asks you about the latest recommenda- tions for the screening of gynecologic cancers. Which of the following state- ments accurately represents the American Cancer Society(ACS) cervical cancer screening guidelines

A. At age 30 or after, women who have a single normal or negative cytology result can receive subsequent screen- ing every three years.

B. All women of screening age should receive human papillomavirus (HPV) DNA testing in conjunction with cytology smears.

C. Women should begin cervical cancer screening no later than age 21 or within 3 years of becoming sexually

active, whichever occurs first.

D. All women who are 70 years of age or older with an intact uterus no longer require cervical cancer screening.

1) C 2) B 3) D 4) A 5) C 6) D 7) C 8) B 9) A 10) D 11) C 12) B 13) A 14) B 15) C

집필자 : 문진영(국립암센터 약제과), 2006년 BCOP 취득 정답

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