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<31> 2017 SPCC(전국 약대생 컴파운딩 대회) 참가 수기

기사입력 2017-05-02 09:33     최종수정 2017-05-02 09:57 프린트하기 메일보내기 스크랩하기 목록보기   폰트크게 폰트작게

2017 SPCC 참가 수기

임성락약사▲ 임성락약사
그레이스와 레이첼은 필자와 함께 근무하는 약대 본과 3 학년 인턴 학생들이다.   항상 밝은 성격과 씩씩하게 일하는 인턴들이라 바쁜 약국 업무 중 필자가 많은 도움을 받고 또 아끼는  인턴들이다. 약 한달 전 우연히 그레이스와 레이첼이 궁금해하는 컴파운딩 (pharmaceutical compounding) 질문에 답변을 하다가  이들이 올 3 월 플로리다에서 개최되는 전국 약대생 컴파운딩 대회(National Student Pharmacist Compounding Competition 이하 SPCC) 최종 결선에 참가한다는 반가운 소식을 들었다.

미국 약사의 컴파운딩에 대해서는 몇 해 전 약업신문을 통해 소개한 적이 있다.   Pharmaceutical compounding의 기록은 고대 이집트에서 찾아볼 수  있고 이후 의사 또는 치료자들이 직접  컴파운딩을 통하여 환자 약물 치료가 이루어 지다가 19세기 말에 와서야 본격적 제약산업의 출현과 함께 비로서 유럽과 미국에서 의사와 약사의 분업 역활이 정립되었다.

컴파운딩이란,  환자 개개인을 위한 맞춤형 처방제제를 만들어 치료효과를 극대화시키는 과학이다.   처방자가 자신의 환자 치료를 위해, 기존의 제약시장에 나와있는 처방약 과는 다른 약제가 필요하다고 판단될 때, 컴파운딩 처방전을 발행하고 이에 약사는 법에 규정된 시설을 갖춘 장소에서 허가된 원료물질과 기구를 가지고 만드는 제조공정이다.  예를 들어, 어느 환자의 피부증상이 시중에 나와있는 스테로이드 크림 제제에 치료반응을 나타내고 있으나 유효성분이 아닌 특정 비활성 성분 (inactive ingredient)에 알러지 반응을 나타내어 더이상 제품을 사용할 수 없다면,  처방자는 약사에게 컴파운딩 처방전을 발행하여 알러지를 유발하지 않은 대체 비활성 물질을 가진 컴파운딩 스테로이드 크림 제제를 주문할 수 있다.

처방자는 환자치료에 필요한 유효성분과 원하는 제형, 용량과 사용법을 처방전에 기재할 뿐, 이 맞춤제제를 만드는 공정은 전적으로 약사의 지식과 경험 그리고 제조 노하우에 의존한다.   
컴파운딩을 크게 세가지로 분류하면 (1) 경구형 (알약, 캡슐, 트로키, gummy, 현탁액 등) (2) 비경구형 (topical formulation) 그리고 (3) 멸균(sterile) 제제 (눈약, 주사제, 피부 이식 호르몬제 등) 이고 환자의 종에 따라 분류하면 (1) 인체용 과 (2) 애완동물과 기타 수의과 동물 용으로 분류할 수 있다.

앞서 말했듯이, 컴파운딩은 (1) 의사나 다른 처방자의 처방전에 의거하여 (2) 법규정에 따라 장소, 시설, 화학물질을 가지고 약사가 특정환자를 위해 만드는 맞춤형 제제 공정이다.   이것이 불특정 다수의 환자를 위해 다량 제조된다면 약사나 약국은 제조사의 면허를 신청하여야 하고 더욱 엄격한 FDA 관리 감독하에 제조공정이 이루어 진다.   지난 2012 년 가을, 미국 전역에서64 명의 생명을 앗아간 New England Compounding Center 의 컴파운딩 약화 사고는 약사들의 pharmaceutical 컴파운딩의 엄격한 제조공정과 관리 감독의 중요성을 말해주고 있다.

올해로 7 주년을 맞이한 SPCC 대회는 컴파운딩 제조 물질과 기자재 판매 전문회사인 메디스카 (Medisca) 가 주관한 공식 행사이고 플로리다 주의 어벤추라 도시에서 3월 18 일과 19 일 양일에 걸쳐 진행되었다.   이번 대회는 지역예선을 거친 18 개 약학대학팀들이 결선에 참여하였고 올해 2017년에는 Univ. of Texas at Austin에게 일등의 영예가 돌아갔다.

다음 영문에세이는 인디애나폴리스에 소재한 버틀러 약학대학 (Butler University) 본과 3 학년 그레이스 (사진 오른쪽 긴머리 여학생)가 한국의 약학도들에게 소개하는 대회 참가 경험담으로서 또다른 약학의 매력을 소개하고자 한다.  Happy Reading!!!    <이하 참가수기는 원문> 

The Butler University team in the compounding room at LP3 Network’s new facilty in Aventura, FL. (Left: Rachel Mays, Jake Brown, Grace Lewis)

 

The Butler University team in the compounding room at LP3 Network’s new facilty in Aventura, FL. (Left: Rachel Mays, Jake Brown, Grace Lewis)

As a current P3 Butler University pharmacy student, I always enjoyed compounding during practical lab class.  Despite this, I never anticipated that I would perform much compounding after practical lab ended my P2 year.  However, a classmate approached me about entering the Student Pharmacist Compounding Competition (SPCC).  I was excited at the prospect, because it provided the opportunity to represent my university and participate in my first pharmacy-related national competition. So, I jumped at the opportunity, and entered the competition with two classmates.

Each participating pharmacy college, of which there were 18, held a local competition to determine which team of three pharmacy students would represent the college at the National SPCC.  The local competition consisted of two rounds.  The first round was the compounding competition, during which each team had three hours to complete three compounded preparations: niacinamide topical gel, diltiazem transdermal PLO gel, and clotrimazole oral troches.  Teams were provided with a list of ingredients to be used, and students had to assign each ingredient to a formulation and calculate the amount of each ingredient needed.  In addition to compounding each preparation, associated paperwork had to be completed, which included calculations, a Master Formula Record, prescription labels, quality testing, and chemical sensitivities.  Because of the amount of paperwork, this competition required time management and good teamwork.  Although we were unable to complete all of the paperwork within the allotted time, my team completed the most paperwork out of all of the competing teams; this, combined with the correct compounding of all three preparations, placed us as a top three team after the first round.

The top three teams from the first round moved on to the second round, a regulatory challenge.  Each team had to create and present a business plan for an on-campus compounding pharmacy with the goal of securing funding from an investment firm.  The pharmacy would be a 503a compounding pharmacy.  This regulatory competition required us to thoroughly understand USP <795>, <797>, and <800> and to be able to fit these regulations together to make one compliant pharmacy.  Additionally, we had to set ourselves apart by emphasizing measures we would take that exceed current regulations and anticipate future regulatory updates.  After a few days, we received the good news that we would be traveling to the National SPCC as the Butler University team!

My team met with various Butler University College of Pharmacy faculty each week to prepare for the national competition.  The faculty explained improvements to be made with regard to compounding paperwork, and they tested our knowledge on the role of various chemicals by having us examine different dosage form sample formulations.  Additionally, we received tips on which elements of USP <797> and <800> are especially important to competition judges.  Finally, my team worked together to finalize information and references that we brought with us to the national competition.

The 2017 National SPCC, sponsored by Medisca, Medisca Network, and LP3 Network, was held March 18-19 in Aventura, Florida.  Every team from the 18 colleges participated in three different challenges – compounding, game show, and regulatory.  On day one, my team started with the compounding challenge.  We had three hours to prepare two non-sterile compounded preparations, which were dextromethorphan lollipops and ketoprofen capsules.  

The two compounds were not revealed until the challenge began, so it was critical that teams brought relevant references because internet access was not allowed.  All of the ingredients were already assigned to one of the two formulations, except for sodium chloride.  Teams had to decide in which formulation to use sodium chloride.  Similar to the local competition, we had to fill out extensive paperwork for each formulation.  Because we revised our team strategy based on the local compounding competition, we were able to complete all required paperwork.  Ranking for the compounding challenge was based on observation during the challenge, paperwork, and quality testing of the final products performed by judges.

The three hours spent compounding passed quickly.  Next, we moved on to the second component of the competition, the game show.  Teams had 45 seconds to record an answer to each of 36 questions.  These questions covered a wide range of compounding knowledge, including USP <800> and compounding preparations, techniques, tests, and equipment.
Immediately following the game show challenge, teams were given two hours to prepare a poster for the regulatory portion of the competition.  Each team had to create a poster based on the premise of opening a 503a compounding pharmacy equipped for non-sterile and sterile, non-hazardous and hazardous preparations.  This was very similar to the local competition regulatory challenge.  Thus, our preparation before and after the local competition aided us greatly in creating a successful poster.  

The poster included the pharmacy layout, airflow, workflow, and technology used in the pharmacy.  Once the two hours ended, day one of the competition came to a close.
 
The Butler University team with their poster for the regulatory portion of the National SPCC. (Left to right: Rachel Mays, Jake Brown, Grace Lewis)
On day two of the competition, every team’s regulatory poster was displayed, and team members answered questions from students, faculty, and judges.  It was a great opportunity for my team to demonstrate our knowledge of USP regulations.  After the poster presentation concluded and points were tallied, The University of Texas at Austin College of Pharmacy was announced as the overall winner of the 2017 National SPCC.  

The Butler University team with their poster for the regulatory portion of the National SPCC. (Left to right: Rachel Mays, Jake Brown, Grace Lewis)


In the end, the Butler University team did not place in the top five overall.  However, we did achieve 5th place in both the game show and regulatory challenges.  Although we did not walk away with the trophy, my team is grateful for our experience at SPCC.  The competition furthered the appreciation that we have for compounding pharmacists and the challenges posed by continually strengthened regulations.  Most importantly, were able to utilize and improve our compounding, problem-solving, presentation, and teamwork skills.  I look forward to providing advice to Butler University’s 2018 SPCC team next year.

Special thanks to my teammates, Jake Brown and Rachel Mays, and Drs. Margaret Stratford, Nandita Das, Hala Fadda, and Angela Ockerman.

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