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CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017 1
CALIFORNIA MEDICAL ASSISTANTPublished Bi-Monthly by the California Medical Assistants Association, Inc. for Medical Office Professionals
CM
AA
UNITY IS STRENG
TH
KNOWLEDGE
ISPO
WER
�
SEPTEMBER/OCTOBER2017
________________________CALIFORNIA
MEDICAL ASSISTANTS ASSOCIATION, INC.
P.O. Box 5694Petaluma, CA 94954-5694Toll Free 1.888.464.2622
Fax 208.730.3763www.cmaa-ca.org
Email address: [email protected]
Many volunteers are working along with me in prepartion for CMAA’s upcoming 1-Day
Fall Conference to be held on Saturday, October 28, 2017 at the United Indian Health Services (U.I.H.S.) Potowat Health Village, in Arcata, California. This location is a beautiful place and the building’s design is based on a traditional native redwood built house. It’s surrounded by so much greenery that it can make one forget that the
state freeway is just hundreds of feet away. I was also informed that they have a garden, which is planted and cared for by the nutrition staff, each year. I hope when you come, you can see what I mean about the facility.
From the time I’ve been a CMAA member, I can’t recall when our association held a conference in the Redwood Region. I’m personally get-ting really excited for the conference. Also, it has been such a learning experience in all and I have met a lot of new individuals in the past year.
Again, I would to say that I appreciate the Executive Committee for their continued support, assistance and patience.
Hope to see everyone in Arcata at the 2017 Fall Conference!
Best Wishes,
Debra A. Carpenter, CCMA-AC, NPT 1 PRESIDENT, CMAA, INC.
Presidents’ MessagePresidents’ Message
WHAT’SINSIDE n PRESIDENT’S MESSAGE.................... 1
n 2017 FALL CONFERENCE: Event & Hotel Information ................. 3 Tentative Agenda ................................ 4 Registration Form ................................ 5
n PRESIDENT-ELECT’S MESSAGE ....... 6
n CERTIFYING BOARD UPDATE: Newly Certified CMAs .................. 7-10
n CONTINUING EDUCATION: What Are Biologics/ Biological Medications? ............ 11-14 Self-Assessment Test....................... 15
n CME PERSONAL CERTIFICATE OF PARTICIPATION FORM .............. 16
Come Join Us for the UpcomingFall Conference 2017!
2017 FALL CONFERENCE REGISTRATION FORM & HOTEL INFORMATION
INCLUDED IN THIS PUBLICATION ISSUE.
2 CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017
California Medical Assistant
E D I T O R
KIM JONES, CCMA-CEast Bay Region
Email: [email protected]
P U B L I C A T I O N C O M M I T T E EC H A I R M A N
THERESA HENDERSON, CCMA-ACRiverside Region
Certifying Board Executive Director
ALYSON BRISCO, CCMA-ACSanta Rosa Region
Instructor Empire College
C M A A P R E S I D E N T
DEBRA A. CARPENTER, CCMA-AC, NPT-1Redwood Region
MARGIE HATTOX, CCMA-CSan Diego Region
For Advertising contact:
CALIFORNIA MEDICAL ASSISTANTS ASSOCIATION, INC.
at
CMAA, INC.P.O. Box 5694
Petaluma, CA 94954-5694
Toll Free: 1.888.464.2622
Fax: 208.730.3763
Email: [email protected]
www.cmaa-ca.org
Material contained herein may NOT be used without the permission of the
California Medical Assistants Association, Inc.
ALL ITEMS FOR PUBLICATIONSHOULD BE SENT
DIRECTLY TO THE EDITOR.
MISSION STATEMENT
CALIFORNIA MEDICAL ASSISTANTS ASSOCIATION, INC.
The purpose of the California Medical Assistants Association, Incorporated, is to promote the professional and educational growth of medical assistants.
CM
AA
UNITY IS STRENG
TH
KNOWLEDGE
ISPO
WER
�
California Medical Assistant
— NEXT ISSUE —
NOVEMER/DECEMBER 2017
To submit items to be published in this newsletter, please mail or email:
KIM JONES, CCMA-CEmail: [email protected]
DEADLINE: October 1, 2017All materials must be submitted by the
deadline date to be included in the next issue!
CMAA WANTS TO COME TO
YOUWe need your meeting
space!
Does your company have a meeting room that could be used by CMAA to host an Education Day?
Would you be willing to assist our Education Chairman with planning a seminar in your town?
Please email Carol at CMAA Headquarters so we can schedule a date for this year.
CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017 3
NEARBY HOTELS
1. Best Western Arcata Inn 4827 Valley West Blvd., Arcata, Ca 95521 707.826.0313 n bestwestern.com
2. Hampton Inn & Suites Arcata 4750 Valley West Blvd., Arcata, Ca 95521 707.822.5896 n hamptonarcataeureka.com
3. Days Inn & Suites Arcata 4701 Valley West Blvd., Arcata, CA 95521 707.826.2827 n wyndhamhotels.com/days-inn
4. Super 8 Arcata 4887 Valley West Blvd., Arcata, CA 95521 707.822.8888 n wyndhamhotels.com/super-8
5. Red Roof Inn 4975 Valley West Blvd., Arcata, CA 95521 707.633.6148 n redroofinn.com
6. Motel 6 Arcata 4755 Valley West Blvd., Arcata, CA 95521 707.822.7061 n motel6.com
7. Comfort Inn Arcata 4700 Valley West Blvd., Arcata, CA 95521 707.826.9660 n choicehotels.com
Upcoming Event . . .
UIHS Potowat Health Village – 1600 Weott Way, Arcata, CA 95521
http://www.unitedindianhealthservices.org/
CMAAFALLConference October 28, 2017
Upcoming Event . . .
UIHS Potowat Health Village
Here’s a list of the seven (7) local hotels/motels that are in the Arcata, CA area:
Please note: Hotels are not listed above in any specific order or preference.
4 CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017
“Bringing Awareness to the Redwood Region”Saturday, October 28th 2017
UIHS Potowat Health Village – 1600 Weott Way, Arcata, CA 95521Hosted by the Redwood Region
TENTATIVE AGENDA
SATURDAY, October 28, 2017
8:00 a.m. Registration Opens
8:30 a.m. Welcome & Greeting
9:00 a.m. – 10:00a.m. “Why, Who, What, Where & When” April Smith Physical Therapist
10:00 a.m. – 10:15 a.m. Coffee Break
10:30 a.m. – 12:00 p.m. “Energy Medicine Center” Sandra Freeman Master Quantum Energetics Practitioner
“How it can help in the Medical Community” Kim Anderson
12:00 p.m. – 1:30 p.m. LUNCH
1:30 p.m. – 2:30 p.m. TBA
2:30 p.m. – 4:00 p.m. “Awareness of Rape Crisis” Paula Arrowsmith Jones North Coast Rape Crisis Team
2017 FALL CONFERENCE
C a l i f o r n i a M e d i c a l A s s i s t a n t s A s s o c i a t i o n , I n c .
CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017 5
PLEASE TYPE OR PRINT
Name: ___________________________________________
Credentials: ______________________________________
Address: _________________________________________
Region: _____________________________________
Telephone: __________________________________
Email: ______________________________________
**Check if first timer________
CHECK ONE:
________ Platinum Member
________ Gold Member
________ Silver Member
________ Student
________ Guest
REGISTRATION DEADLINE: 10/10/17
No refunds after October 20, 2017
Mail to: CMAA Inc. P.O. BOX 5694 PETALUMA, CA 94954-5694
Please make checks payable to: CMAA
Additional inquiries or registration by credit card:
Call Headquarters at 1-888-464-2622.
This is a one-day conference withfive CEU’s being offered.
The Humboldt County area is a beautiful place to visit so consider bringing the
family for the weekend and enjoying the rich history and beautiful coastline and
classic architecture.
There will be a lunch break during the day. Attendees are welcome to bring their own
lunch or venture out to several local eateries all within a mile of the
conference location.__________________________________________________
MEETING REGISTRATION FEES:
_____ Members & Students .................................... $25.00
_____ Non-member .................................................. $75.00
TOTAL AMOUNT ENCLOSED $____________
C a l i f o r n i a M e d i c a l A s s i s t a n t s A s s o c i a t i o n , I n c .
Important information on reverse side - please copy this form, complete and mail.
2017 FALL CONFERENCE
“Bringing Awareness to the Redwood Region”
Saturday, October 28th 2017UIHS Potowat Health Village – 1600 Weott Way, Arcata, CA 95521
6 CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017
United Indian Health Services Building • Arcata, CA
CMAA 2017 FALL CONFERENCESaturday, October 28, 2017
Hello CMAA members. Unfortunately summer is over and kids are going back
to school, which means fall will be upon us soon. I hope everyone had a good
summer with fun and exciting trips with or without their kids. Now is it time to get
back to the grind — work and running kids around for their sports and activities
along with getting ready for the change in weather for fall.
Don’t forget, our Education Day is right around
the corner. We will be holding our Education Day
on October 28th at our 2017 Fall Conference in
Arcata with some great speakers. Please join us
as the CMAA gets together for this event. ❧
Don’t miss Education Day!
Bryon Clinton, CCMA-C President-Elect, CMAA Inc.
President-elect’s cornerPresident-elect’s corner
CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017 7
NAME SPECIALTY HOMETOWN
• RECERT ++ ADDING 2ND SPECIALTY
C E R T I F Y I N G B O A R D U P D A T ECongratulations to the newly California Certified Medical Assistants
Certification Codes: A = Administrative C = Clinical AC = Administrative and Clinical
NAME SPECIALTY HOMETOWN
ABREU, JESSICA AC CORNING
AGNISH, SIMPY C YUBA CITY
AGUADO, DEANNA MARIE AC GUALALA
AGUILAR, MARIA D • C DESERT HOT SPRINGS
ALAM SAFEE, RABIA • A NEWARK
ALVAREZ, JASMINE GABRIELLE AC BAKERSFIELD
ANTILLON LOPEZ, DIANA RUBI AC OXNARD
ARANDA, TIFFANY LISSETTE AC SACRAMENTO
ARELLANO, RYANNE-NICOLE CARRERA C WATSONVILLE
ARGUELLES, ARACELY • C BAKERSFIELD
ARRIAGA, SALLY C REDWOOD CITY
ASHTON, WENDY • C PERRIS
BARAJAS, OFELIA C BAKERSFIELD
BARAJAS, ROCIO J C MOSS LANDING
BARAJAS REYES, ELVIRA C SANTA ROSA
BARBOSA, CINDY K C LA PUENTE
BARRERA, MARCO • C SAN FRANCISCO
BARRON CRUZ, JOCELINE TANIA AC SOQUEL
BECK, LINDSEY • C SONORA
BEGA, KIMBERLY MARIE C RANCHO CORDOVA
BELTRAN JR, JOSE LUIS • A LOS ANGELES
BENTZ, KIMBERLEY AC STOCKTON
BORROWMAN, LAURA JANAE A CHICO
BRIAN, MELISSA AC CROCKETT
BRONSERT, NICOLE C SAN JOSE
BROOKSHIRE, SHARON KAY C POLLOCK PINES
BUNCE, JAIMEE A SHASTA LAKE
CABUNTALA, AILEENE VIDA AC SAN JOSE
CALDERON, ALYSSA J C WATSONVILLE
CALLES, BRENDA C CAPITOLA
CALLES, LAURA C. • C SANTA CRUZ
CAMARA, KAREN YORK • C HAYWARD
CAMPBELL, CHELSEA AC CAMERON PARK
CAPESIUS, KATHLEEN MARIE AC SACRAMENTO
CARNELL, KACIE • A PASO ROBLES
CARPENTER, MELANI C WEAVERVILLE
CEJA, LUZ MARIA C SUISUN CITY
CHAIKEN, TAYLOR ALEXIS AC HENDERSON NV
CHAO, TIFFANY C SAN PABLO
CHAVEZ, DESTINY NICOLE AC BAKERSFIELD
CHOI, STACY AC SACRAMENTO
COATS, JENNIFER R AC NORTH HIGHLANDS
CONTRERAS, ALEJANDRA AC ANTELOPE
COPELAND, STACY C SACRAMENTO
CORONADO, ADRIANA M C CAMARILLO
COVEY, DEBORAH A • C LEBANON OR
CRESPO, MAYRA A. • C HIGHLAND
CROWELL, JACKIE M. AC REDDING
DE LA ROSA, FERNANDO AC STOCKTON
DE LEON, ALEXANDREA KEANE AC DALY CITY
DEAL, AMANDA R C ROSAMOND
DECUSEARA, MARGARETA • C HAYWARD
DEHONESTIS, JEANETTE D AC SAN JOSE
DEXTER, ARLA AC PLUMAS LAKE
DOWNEY, DEIRDRE LAUREEN-HARPER AC HUNTINGTON BEACH
DURFEE, HEATHER ELAINE AC SACRAMENTO
ESCALANTE, CRISTY AC LOS ANGELES
ESSER, JENNIFER ANNE • AC LAKEPORT
continued on page 8
8 CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017
C E R T I F Y I N G B O A R D U P D A T E
NAME SPECIALTY HOMETOWN
• RECERT ++ ADDING 2ND SPECIALTY
NAME SPECIALTY HOMETOWN
– continued from page 7 –
Certification Codes: A = Administrative C = Clinical AC = Administrative and Clinical
ESTERNON, MA SHIERLA O AC SACRAMENTO
FUENTES, LAURA AC CORNING
FUERTE, HILDA • C SANTA CRUZ
GABRIEL, TERRY C DIXON
GALIPEAUX, DANIELLA ++ AC SAN JUAN BAUTISTA
GARCIA, MARIA ISABEL • AC TALMAGE
GARCIA, MONICA A BAKERSFIELD
GARZO, HEIDI M. • AC VALLEJO
GENTALEN, MELISSA A FREEMONT
GEPALAGA, CHRISTINE MELINA • C SAN BRUNO
GOMEZ, WALTER URIEL AC WOODLAND
GONZALEZ, ALEJANDRA AC COLUSA
GONZALEZ, JESSICA C OXNARD
GOUVEA, GERRET E C ANDERSON
GRAFFMAN, SHANA AC ORANGE
GRANADOS, MARIA G AC SACRAMENTO
GRIFFITHS, KRISTINA MAE MARIE C LODI
GUERRA, ESMERALDA • AC FOUNTAIN
GUERRA, GUADALUPE AC UKIAH
GUERRERO, ANA JACQUELINE • AC WATSONVILLE
HAGEDON, KADIE R AC ROSEVILLE
HARMON, CANDACE M AC LONG BEACH
HARSHMAN, ERIN AC SACRAMENTO
HEER, DILPREET KAUR C YUBA CITY
HENRY, CHANDRA • C RICHMOND
HERNANDEZ, CRYSTAL MARIE C FILLMORE
HERRERA, NICOLE RENEE AC RED BLUFF
HIGHTOWER, LAKISHA A AC WOODLAND
HUANG, GUIZHEN C SAN LEANDRO
IROD, PETER AC SACRAMENTO
JACKSON, CASANDRA AC SACRAMENTO
JENKINS, TERRI • C KING CITY
JIMENEZ, BRITTNEY A RANCHO CORDOVA
KAMONDY, MELISSA C CLOVERDALE
KHANAM, AFROZA • AC PALMDALE
KISLING, LAUREN O C MODESTO
KRIEB, CYNTHIA C DESERT HOT SPRINGS
LA GRANDE, ALICIA A • AC SANTA ROSA
LANG, KRISTI AC ROSEVILLE
LARA, EMILY C NORTH HOLLYWOOD
LARSEN, HANNAH AC CARMICHAEL
LATAG, BONNIEBELLE LAMALU C OXNARD
LEE, SHERRY C MERCED
LEYVA, PATRICIA C WHITTIER
LOBAUGH, CASSIDY C ACAMPO
LODHA, MADHU • AC SANTA CRUZ
LOLAR, SABRINA DANIELLE A SACRAMENTO
LOPEZ, NIKKIE C CASTRO VALLEY
LOPEZ, REBECCA ++ AC TULARE
LOPEZ, ZULMA VERONICA • AC SOUTHGATE
LOPEZ-VALENCIA, CLAUDIA A C CORNING
LOYA, STEPHANIE G • AC FORTUNA
LUEVANO, ERNESTO URIEL C HEALDSBURG
LUEVANO-GUZMAN, GABRIELA C HEALDSBURG
LUNA, KARLA Y • C LOS ANGELES
LUNA-PEREZ, DAISY AC SANTA CRUZ
LUQUIN-JIMENEZ, ALEJANDRA C SANTA MARIA
LUVIANO, MARIA VICTORIA C ESCONDIDO
CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017 9
• RECERT ++ ADDING 2ND SPECIALTY
NAME SPECIALTY HOMETOWN NAME SPECIALTY HOMETOWN
– continued from page 8 –
Certification Codes: A = Administrative C = Clinical AC = Administrative and Clinical
MACIAS-DELEON, YOSELIN C SAN MATEO
MANUEL, CHRISTINA MARIE AC VICTORVILLE
MARTIN, ALANA SERAFINA AC SANTA ROSA
MARTINEZ, KEELI • C SHINGLE SPRINGS
MARTINEZ, MAYRA C OXNARD
MATTEONI, YVETTE C. C ROSEVILLE
MCCAIN, JILL RAE C VALLEY CENTER
McHUGH, ANTOINETTE • C YUBA CITY
McLANE III, JAMES L AC HESPERIA
MCNAIRY, ANDREA • C MARYSVILLE
MEDINA, JOANNA A. AC LIVE OAK
MEFFORD-CAVAZOS, JUDY AC SACRAMENTO
MENDEZ, JAYANNA D C UNION CITY
MOMOKO, ITO • C SANTA ROSA
MOORE, JASMINE C STOCKTON
MORALES, MAYRA V. AC BAKERSFIELD
MORENA, JAMIE AC SACRAMENTO
MORENO-SERNA, ROSA • C NAPA
MUNOZ, VANESSA M • C WATSONVILLE
NAGLEE, JENNIFER AC YUBA CITY
NELSON, MEGAN NICOLE AC OAKLAND
NEUO-CHANTAVONG, CHENDA • - DNR C SAN PABLO
NUNEZ, BERENICE ++ AC CLOVERDALE
O’GRADY, CASEY • C PASO ROBLES
OLSON, TINA A OLIVEHURST
OMAR, SANA AC BAKERSFIELD
ORCUTT, CHRISTINE ANNE C CAMARILLO
PARRY, AMANDA ANNSELLA • AC SANTA ROSA
PEREZ, CAITLIN N C CHULA VISTA
PEREZ, SOPHIA • C SUNNYVALE
PEREZ-RODRIGUEZ, JESSICA AC WEST COVINA
PETERSON, BRANDI A REDDING
PETERSON, ELIZABETH AC SACRAMENTO
PINA, JUANITA C VICTORVILLE
PORROVECCHIO, CHRISTINA MARIE AC SAN JOSE
POTTS, KAREN • C SUTTER
RAGADIO, DALE M • C SAN JOSE
RAMOS, DARLA K A ROSEVILLE
READ, CAITLIN C FORTUNA
REESE, KARI L • C IRVINE
REGALA-ORTIZ, ROCHELLE PLACIDO • AC SAN MATEO
REVUELTA, MARISOL ++ AC BRAWLEY
REYES, CHRISTI L. • C PACIFICA
RIVAS, ZYGRIDH J • AC LOS ANGELES
RIVERA, IVANA GODINEZ C EL CENTRO
RODRIGUEZ, CHRISTINE O A CAPITOLA
RODRIGUEZ, IVON C ARBUCKLE
RODRIGUEZ, PERLA • C LA QUINTA
RODRIGUEZ LEGUIZAMO, AURORA A LAKE FOREST
ROWLAND, KAREN • C RIVERBANK
RUIZ, ANNA C OJAI
RULAND, MIKYEONG C WILLOWS
RUSSELL, MELINDA CAYE C SANTA CRUZ
RUYBAL, MARIA ADELA • C UNION CITY
RYNOTT, TAYLOR JOSEPH C DUBLIN
SAMANIEGO, ADAM MICHAEL AC BELLFLOWER
SANCHEZ, BRENDA AC LA PUENTE
SAUCEDO, MARGARITA C CORONA
C E R T I F Y I N G B O A R D U P D A T E
continued on page 10
10 CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017
Congratulations to each of these medical assistants.
From the
California Certifying Board for Medical Assistants
• RECERT ++ ADDING 2ND SPECIALTY
NAME SPECIALTY HOMETOWN NAME SPECIALTY HOMETOWN
– continued from page 9 –
Certification Codes: A = Administrative C = Clinical AC = Administrative and Clinical
C E R T I F Y I N G B O A R D U P D A T E
SEPTIMO, SARA • AC SAN JOSE
SIBAL, SIMMONNE CARPIO AC SACRAMENTO
SIERRA, ALECIA • C HIGHLAND
SMITH, BREANA AC YUBA CITY
SOLANO, LUZ ELENA • A LOS ANGELES
SOLOMON, BETH LYNN C ESCONDIDO
SOLORIO, ANNABEL C YORBA LINDA
SORIANO, BERNADETTE C UNION CITY
SULLIVAN, KORINNE ELIZABETH A RIDGECREST
SURBER, ASHLEY NICOLE C CHICO
SUTTON, MARIA AC SACRAMENTO
SWEARINGEN, BOBBI J AC SACRAMENTO
TARVERDYAN, EMMA C RANCHO CORDOVA
TERRY, DONNA • AC LUCERNE
THERIEN, JULIE C SAN FRANCISCO
THOMPSON, AMANDA LYNN • AC DEL MAR
TINAJERO, KIMBERLY C PATTERSON
TOLENTINO, CHARMAINE GAY DELA CRUZ C CATHEDRAL CITY
TOMODA, RINA C FOSTER CITY
TONG, YOKO ONO C OAKLAND
TORRES, DAYLE C C REDDING
TORRES, KARLA AC CONCORD
TORRES, MELISSA C SACRAMENTO
TOVAR, KATRINA M • C BELLFLOWER
TROTTER, ASHLEY A OAKLAND
TRUJILLO, JENNA AC APPLE VALLEY
VAID, REENA C ELK GROVE
VALLE, TRACY ELAINE • AC LAKESIDE AZ
VANBEZOOYEN, HILLARY PAIGE A WILLITS
VANG, MALI C STOCKTON
VEGA, DANIELA C EL SOBRANTE
VELASCO-ESQUIBEL, VERONICA LETICIA • C UNION CITY
VENEGAS, ABIGALE C MORGAN HILL
VILLARINO, KRISTIELYN MARZAN AC ELK GROVE
VO, JIMMY VAN • C SAN JOSE
WAGNER, HAYLI AC PALMDALE
WEATHERMAN, TONI C MARYSVILLE
WEBERG, MARILYN JEAN AC PENN VALLEY
WINCHESTER, SUSAN • AC PARADISE
WOOD, MARGARET E • AC CAMERON PARK
WOODRUFF, ASHLEY M C DUBLIN
YBARRA, JENNIFER C MERCED
YUN, JESSICA C SEAL BEACH
ZAMAN, SANNA C LODI
ZEPEDA, BIANCA YESENIA C YUBA CITY
CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017 11
Biologics have quickly become one of the fastest growing class of pharmaceuticals today. But what are biologics? Biologics or biological drugs are a pharmaceutical product made from living organisms or contain components of living organisms. Chances are many of us are using biologics in our offices and may not even realize it.
When a patient hears the word medication, they typically think of a pill or capsule that is usually taken by mouth. Those pills or tablets are chemically synthesized and considered small molecule medicines. Biologics differ from small molecule drugs, in that biologic drugs are large molecule medications that are extracted from or semi synthesized from a living organism (biological sources). This process uses recombinant DNA technology (the joining together of DNA molecules from two different organisms) from sugars, proteins, nucleic acids or complex combinations extracted from actual living cells or tissue from humans, animals or other organisms to create biological drugs.
Biologics do tend to be heat sensitive and susceptible to microbial contamination making it necessary to use aseptic principles from the start of the initial manufacturing steps. This is in stark contrast to most conventional chemically synthesized drugs.
Biologic drugs can be used to treat numerous diseases and conditions while others are used to prevent or diagnose diseases. These drugs are the most advanced therapies
available. In fact, biological drugs have revolutionized cancer treatment, delayed or reversed immune related conditions and offered hope for many patients who previously had no effec-tive treatment options available.
Biologics are regulated by the Food and Drug Administration (FDA,) Center for Biologics Evaluation and Research (CBER). Approval can require several years of research including clini-cal trials. Biologics, like most drugs that are released, will con-tinue to be monitored for performance and safety risks.
Biological Drugs/Therapy
• Blood factors (Factor VIII and Factor IX)
• Thrombolytic Agents (tissue plasminogen activator)
• Hormones (Insulin, glucagon, growth hormone, gonadotropins)
• Haematopoietic growth factors (erythropoietin, colony stimulating factors)
• Interferons
• Interleukin
• Vaccines
• Monoclonal Antibodies
• Tumor necrosis factors
• Therapeutic Enzymes
What Are Biologics/ Biological Medications?
continued on page 12
CONTINUING EDUCATIONAa Bb Cc224
12 CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017
What Are Biologics/Biological Medications? – continued from page 11
CONTINUING EDUCATIONAa Bb Cc224
molecules. Most cells in your body only reproduce a limited amount of times before they stop however cancer cells are “immortal” in the sense that they will reproduce indefinitely. Cells from tumors are an important source of cell lines for biotechnology. An example of this biotechnology can be found in the book The Immortal Life of Henrietta Lacks, cells cultured from Ms. Lacks’ cancer tumor are “immortal” in that they will reproduced indefinitely. Cells can also be made to be “immortal” by changing their DNA to make them more like cancer cells. Using genetic engineering techniques on cells such as those from the Chinese hamster ovaries, fetal human retinas, or bacteria cells like E.coli, cells can be made to be “immortal” cells.
Some forms of biologicals such as Infliximab, neutralize inflammatory cytokines, Cytokines (including interferons and interleukins cytokines) are signaling proteins that are produced by white blood cells, they help to mediate and regulate the immune responses like inflammation, pain and blood cell formation.
Once the types of cells needed have been determined, the next step is changing those cells to make the appropriate antibodies. Non- human cells make non-human antibodies, therefore extra DNA is introduced to the cell to make the correct antibodies. This process can produce fully human antibodies from not-fully human cells. Choosing the best cells produce the “cell Line’ which is then frozen and serve as the “master cell bank” so that future batches maybe cloned from the master cell producing identical cells to the master cell.
The cells are then thawed and put into bioreactors (stainless steel containers). The bioreactors create the exact environ-ment, nutrition, temperature, PH, oxygen, etc. for the cells to grow and produce the desired protein antibodies. This process requires around the clock monitoring, then after about two weeks the cells are harvested.
The living systems used to produce biologics can be sensitive to very minor changes in the manufacturing process. The smallest change could significantly affect the nature of the finished product and the way it functions in the human body. This ensures the stability of the manufacturing process, many checks and extremely tight controls being put into place.
The bioreactors are then processed to purify the cells. No living cell should make it through to the finished product. The Center for Biologics Evaluation and Research (CBER) is the organization within the FDA that regulates biological products for human use. CBER protects the public’s health by ensuring that biological products are safe and effective and available to those who need them.
As of 2013, US pharmaceutical companies account for 80% of the world’s research and development of biotechnology.
A few examples of how biologics are being used today are:
A medication for the treatment of metastatic colorectal cancer was developed using a process called angiogenesis (the devel-opment of new blood vessels). By creating an antibody that prevents the formation of new blood vessels that provide oxygen and nutrients to tumors.
Some biologics are made from proteins found in the human body, they work by targeting and blocking the effects of protein in the body called TNF (tumor necrosis factor-alpha). TNF-alpha is made by the immune system. In certain auto-immune diseases such as RA, there is too much TNF-alpha, which can cause the immune system to attack parts of the body. Anti-TFN biologics such as golimumab, target and bind with the excess TNF-alpha.
A treatment for psoriasis, was developed using the ovary cells of a Chinese hamster. These hamsters are used because of their low number of chromosomes. Etanercept is a common biologic used to treat psoriasis.
The first new class of medication approved to treat adults with active lupus in over 50 years, Beliumab, is a BLyS-specific inhibitor. This new monoclonal antibody binds to the BLyS and prevents it from stimulating B cells, reducing the abnormal immune system activity that contributes to the disease.
Another example is omalizumab, a biologic that works by blocking Immunoglobulin E (IgE). Patients with severe allergic asthma often have high IgE. By blocking the IgE they have less asthma exacerbations.
Now that we have an understanding of what constitutes a bio-logic, let’s look at the way they are produced. As you would have guessed, biologics are developed through very arduous and time-consuming processes. Biologics are based on very complicated molecules, usually antibodies, which are used by the immune system. The immune system is a complex net-work of organs, tissues, and specialized cells that recognize and destroy foreign invaders, such as bacteria or viruses, as well as some damaged, diseased, or abnormal cells in the body. Biologics create counterfeit antibodies to trick the immune system hence blocking, changing, or killing cells to stop or prevent a disease or condition.
Monoclonal Antibodies (mAb) are antibodies produced by cloning a single cell or cell line consisting of identical antibody
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What Are Biologics/Biological Medications?– continued from page 12
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The development of new biologics is a long and complex endeavor. It takes about 10-15 years to bring a biologic pharmaceutical through the development process to clinical trials. The cost of developing and manufacturing the biologic drugs is astronomical.
Some biologics on the market are about to have their patents expire. By definition, a generic version of a brand drug must have the same active ingredient, strength, dosage form and route of administration. The complexity of biologics may redefine this definition. The generic version of a biologic is called a Biosimilar. Biosimilars have their own set of challenges besides that of the complex processing steps involved in the production of the original biologics without the original master cell.
Biologic products may be vulnerable to extreme temperatures and light, they may need refrigeration or frozen storage, and the shelf life may be limited. Always read the pharmaceuti-cal inserts and know how to handle and store medications. Biologics are often administered by infusion or injections.
As with any medication, biologics can have side effects. Most common are pain, swelling, soreness, redness itchiness and rash at the site of infusion or injection. Less common but more serious side effects tend to be more specific to the type of biological therapy used. Therapies intended to promote an immune response to cancer can cause flu-like symptoms, allergic reaction, tumors, and life-threatening alterations in blood chemistry, heart failure, liver problems, anaphylaxis and cancer.
The Future of Biologics
As many as 1500 new biologic medications and vaccines are currently in clinical trials and more are in the pipeline. The growth in biologic discoveries is expected to increase over the next 10 years especially in the fields of cancer research, regenerative therapy (rejuvenation, replacement and regen-eration) and personalized medicine/ precision medicine. The high costs and the rigorous regulatory environment do pose challenges to researchers and the pharmaceutical industry but the FDA’s CBER is working on granting more Biologic Licenses to the pharmaceutical companies in the near future.
continued on page 14
14 CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017
Read the Continuing Medical Education Article
What Are Biologics/Biological Medications?
located on page 11-14
then complete the Self-Assessment Test on page 15 for CME credit.
What Are Biologics/Biological Medications? – continued from page 13
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RESOURCES
Medicines in Development Biologics presented by Americas Biopharmaceutical research companies PHRMA 2013 report, www.phrma.org
The Making of Biologics 9.10.15 Nation Psoriasis Foundation, www.psoriasis.org/advance/making-biologics
How do Drugs and Biologics Differ? www.bio.org
Arthritis Foundation, Biologics Overview, www.arthritis.org/living-with-arthritis/treatments/medication/drug-types/biologics/drug-guide-biologics.php
How Biologic Drugs are Made, 10.8.2015, blog.crohnology.com/2015/10/08/how-biologic-drugs-are-made/
What is a biological product? 5.31.2016, www.fda.gov/aboutfda/transparency/basics/ucm194516.htm
New Biologic Drug Tackles Hard to Control Asthma, 9.7.2016, health.usnews.com/health-care/articles/2016-09-07/ new-biologic-drug-tackles-hard-to-control-asthma
What are “biologics” Questions and Answer, 9.5.2015, www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsand tobacco/cber/ucm133077.htm
National Cancer Institute Biological Therapies for cancer, www.cancer.gov/about-cancer/treatment/types/immunotherapy/ bio-therapies-fact-sheet
About the Center for Biologics Evaluation and Research (CBER), www.fda.gov/aboutfda/centersoffices/officeofmedical productsandtobacco/cber/ucm471141.htm
What is a Biologic? Simponi, www.simponi.com/rheumatoid-arthritis/biologics
CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017 13
CONTINUING EDUCATION
What Are Biologics/Biological Medications? – Self-Assessment TestAa Bb Cc
224
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SELF-ASSESSMENT TEST AVAILABLE FOR DOWNLOAD SEPARATELY.
16 CALIFORNIA MEDICAL ASSISTANT — SEPTEMBER/OCTOBER 2017
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