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Letter from the Editor |
What a year for IJPC and compounding! |
Loyd V. Allen, Jr., Ph.D |
Looking back over 2004 it is amazing at the changes in the quality of compounding that have occurred. USP standards for nonsterile (USP Chapter <795>) and sterile (USP Chapter <797>) have made a definite impact on our profession. No longer is compounding just �throwing a few things together� but is becoming more and more scientifically based; which is the way we were taught and the way it should be in practice. Compounding areas in all practice sites (community pharmacy, hospital pharmacy, home healthcare, etc.) are being upgraded and equipment is being purchased by most compounding pharmacists to do the job correctly.
PCAB is well on its way to having an impact on community pharmacy compounding facilities and JCAHCO is implementing pharmacy compounding accreditation standards for health care organizations.
The Pharmacists Pharmacopeia (actual name to be decided soon) is under development by USP and should be available this spring (it has been ten years in the making so a few more months shouldn�t matter). This will enable pharmacists to have their own official book of standards without all the industrial/manufacturing information.
Suppliers of pharmaceutical grade (USP, NF, BP, etc.) chemicals, materials, equipment, etc. are expanding and serving the profession well. Pharmacy compounding support companies are providing assistance in physical facilities, laboratory testing, consulting and other vital activities.
One ongoing problem however is that information to support pharmacy compounding is �here and there and everywhere� and requires effort and time to obtain. Our goal at IJPC is to continue what we have initiated this year in providing to you whatever information you will need to compound quality preparations. We hope that CompoundingToday.com will ultimately be your �Information Central� for data and information that will be accessible from anywhere in the world.
Thank you for your support over the years and we look forward to continuing our trip together.
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Regulatory Update |
The International Academy of Compounding Pharmacists provided this regulatory update.
USP to Publish Pharmacists� Pharmacopeia � Seeks Input
USP is currently developing an annual hard copy reference publication for practicing pharmacists and would like your input in helping to shape the content of this publication. To participate in a brief electronic survey, which should take no more than 20 minutes to complete, please visit http://www.usp.org/survey/SM/P2GC
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Drug Shortage Information |
Current Drug Shortage:
Drug: Methotrexate injection with preservative 25mg/mL/2mLvials
Company Information: Mayne Pharma
Customer Service #302-266-7510
Related Information: Mayne is now distributing this product under
allocation. The product will temporarily be distributed with a Canadian
label (with both English and French text). Please contact the company
for additional ordering information.
Resolved Drug Shortage:
Drug: Folic Acid injection
Company Information: American Pharmaceutical Partners (APP)
Customer Service #1-888-386-1300
Related Information: APP is now distributing Folic Acid Injection -
please call APP for additional availability information
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SOPs on CT.COM |
There are 94 SOPs on CompoundingToday.com that can be downloaded and customized for your pharmacy practice. Here is the current list. More are being added every week.
Employment Procedure
Authorization to Input and Modify Data on Computer Systems
Recalling Sterile and Nonsterile Compounded Preparations
Developing and/or Evaluating Written Tests for Knowledge of Compounding Skills
Fire Prevention Measures
Eyewash Station - Use and Maintenance
Safety Shower - Use and Maintenance
First Aid Administration
Handling of Syringes and Needles
Sharps Containers
Broken Glass Discard
Exhaust System Air Flow Monitoring (Individual capsule stations)
Use of the Biohazard Containers
Safety for Employees in the Compounding Work Area
Emergency Safety Shower Use
Hazardous Drugs
Compressed Gases - Use, Storage and Transportation
Use of Acid Saf-T-Spill Kit
Use of Caustic Saf-T-Spill Kit
Use of Biobloc - Blood and Body Fluid Spill and Clean-Up kit
Use of Chemo-Bloc Spill Kit
Air Temperature and Humidity Monitoring
Refrigerator Temperature Monitoring
Freezer Temperature Monitoring
Incubator Temperature Monitoring
Air Return / Pre-filter Changing
HEPA Filter Changing
Clean Room Certification
Laminar Flow Hood Certification
Cleaning and Disinfection
Tacky Mat Maintenance
Room Cleaning Procedures - Clean Room
Environmental Testing for Laminar Flow Hoods and Isolation Barriers-Paddle Method
Room Cleaning Procedures - Compounding Room
Room Cleaning Procedures - Vial Washing Room
Use of Anteroom to Clean Room
Disposable Gowns, Masks, Gloves, Shoe Covers, etc.
Testing of Employees for Chemical Hormone Levels
Hand Washing Procedure - Non-Sterile Phase
Hand Washing Procedure - Sterile Phase
Conduct for Clean Room Personnel
Use of Ante Room and Clean Room
Prescription Order Intake (New and Refill)
Withdrawing Medication from Vials
Assignment of Prescription / Invoice Number
Assignment of Batch Number
Packaging of Compounded Sterile and Non-Sterile Preparations
Packing Material for Transport
Labeling of a Compounded Preparation
Shipping of a Compounded Preparation
Compounding Record - Electronic or Paper Trail Documentation for Compounded Preparations
Basic Compounding Documentation - The Master Formula Form
Basic Compounding Documentation - The Compounding Record or Batch Control Sheet
Patient Counseling for Compounded Prescriptions
Assignment of Beyond-Use Date for Non-Sterile Compounded Preparations
Compounding Sterile Solutions
Compounding Sterile Suspensions
Extemporaneous Compounding (No Master Formula Record)
Handling Drugs in the Dry State
Handling Drugs in the Liquid State
Handling Drugs in the Semisolid State
Assignment of Beyond-Use Date for Sterile Compounded Preparations
Filling a Syringe with a Sterile Compounded Preparation
Cleaning, Sterilizing and Depyrogenating Vials
Cleaning, Sterilizing and Depyrogenating Septa
Capping Filled Vials
Washing Glassware and Equipment To Be Used in Compounding Nonsterile Preparations
Washing and Sterilizing Glassware and Equipment Used in Compounding Sterile Preparations
Establishing and Maintenance of Standard Formulations and Dilutions for Medications in Ambulatory Infusion Pumps
Use of Autoclave Indicating Paper and Tape
Handling Spills of Cytotoxic Agent
Transporting Cytotoxic Agents
Developing a Capsule Formulation
General Aseptic Procedures Used at a Laminar Airflow Workbench
Using the Pass-Thru (Either from Anteroom to Cleanroom or with Glovebox)
Using a Vented Needle
Filtering of Ampules
Filling of Ambulatory Pumps
Homepump Filling
CADD - Pharmacia Deltec Medication Cassette Filling
Filling a Syringe with a Non-Sterile Compounded Preparation
Compounding All-In-One or 3-In-One TPN
Sterile Vacuum Filtration
Steam Sterilization by Autoclave
Particle Size Reduction - Pill Tile & Spatula
Geometric Dilution Pulverization by Intervention with Manual Mortar and Pestle
Dry Heat Sterilization
Geometric Dilution Pulverization by Intervention with Electric Mortar and Pestle
List of Potentially Hazardous Chemicals - Drugs
Method of Inventory Control (Manual or Computerized)
Entry of Received Items
Annual Controlled Substances Inventory
Purchasing Chemicals for Pharmaceutical Compounding
Inventory - Vet
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Abstracts added to CompoundingToday.com |
The theme this week is general reviews/position statements on HRT (post-WHI) and specific treatments for menopause symptoms. In the coming weeks CT.COM will be adding many abstracts related to this topic as well as abstracts dealing with osteoporosis and alternatives to HRT in menopause.
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Albertazzi P, Bottazzi M, Purdie DW. Gabapentin for the management of hot flushes: a case series. Menopause 2003; 10(3): 214-217.
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American College of Obstetricians and Gynecologists, Women's Health Care Physicians. ACOG practice bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 50, January 2003 [Hormone replacement therapy]. Obstet Gynecol 2004; 103(1): 203-216 [No abstract available].
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Archer DF; EstroGel Study Group. Percutaneous 17beta-estradiol gel for the treatment of vasomotor symptoms in postmenopausal women. Menopause 2003; 10(6): 516-521.
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Boothby LA, Doering PL, Kipersztok S. Bioidentical hormone therapy: A review. Menopause 2004; 11(3): 356-367.
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Burger H. Hormone replacement therapy in the post-Women's Health Initiative era. Report a a meeting held in Funchal, Madeira, February 24-25, 2003. Climacteric 2003; 6 Suppl 1: 11-36.
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Deady J. Clinical monograph: Hormone replacement therapy. J Manag Care Pharm 2004; 10(1): 85-86.
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Bhatt R, Whittaker KW, Appaswamy S, Desai A, Fitt A, Sandramouli S. Prospective survey of adverse reactions to topical antiglaucoma medications in a hospital population. Eye 2004;
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Ficicioglu C, Gurbuz B, Tasdemir S, Yalti S, Canova H. High local endometrial effect of vaginal progesterone gel. Gynecol Endocrinol 2004; 18(5): 240-243.
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Flynn CA. Calcium supplementation in postmenopausal women. Am Fam Phys 2004; 69(12): 2822-2823.
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Guttuso T Jr. Hot flashes refractory to HRT and SSRI therapy but responsive to gabapentin therapy. J Pain Symptom Manage 2004; 27(3): 274-276.
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Haskell SG. After the Women's Health Initiative: Postmenopausal women's experiences with discontinuing estrogen replacement therapy. J Womens Health (Larchmt) 2004; 13(4): 438-442.
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Kaplan B, Aschkenazi-Steinberg S, Yogev Y, Nahum R, Sulkes J, Phisher M. Gynecologists' trends and attitudes toward prescribing hormone replacement therapy during menopause. Menopause 2002; 9(5): 354-359.
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Keenan NL, Mark S, Fugh-Berman A, Browne D, Kaczmarczyk J, Hunter C. Severity of menopausal symptoms and use of both conventional and complementary/alternative therapies. Menopause 2003; 10(6): 507-515.
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Mircioiu C, Perju A, Griu E, Calin G, Neagu A, Enachescu D, Miron DS. Pharmacokinetics of progesterone in postmenopausal women: 2. Pharmacokinetics following percutaneous administration. Eur J Drug Metab Pharmacokinet 1998; 23(3): 397-402.
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Mircioiu C, Perju A, Neagu A, Griu E, Calin G, Miron DS. Pharmacokinetics of progesterone in postmenopausal women: 1. Pharmacokinetics following intravaginal administration. Eur J Drug Metab Pharmacokinet 1998; 23(3): 391-396.
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Modelska K, Cummings S. Female sexual dysfunction in postmenopausal women: Systematic review of placebo-controlled trials. Am J Obstet Gynecol 2003; 188(1): 286-293.
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Na N. Recommendations for estrogen and progestogen use in peri-and postmenopausal women: October 2004 position statement of The North American Menopause Society. Menopause 2004; 11(6): 589-600.
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Nappi C, Di Spiezio Sardo A, Guerra G, Di Carlo C, Bifulco G, Acunzo G, Sammartino A, Galli V. Comparison of intranasal and transdermal estradiol on nasal mucosa in postmenopausal women. Menopause 2004; 11(4): 447-455.
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North American Menopause Society. The role of calcium in peri- and postmenopausal women: Consensus opinion of The North American Menopause Society. Menopause 2001; 8(2): 84-95.
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North American Menopause Society. Treatment of menopause-associated vasomotor symptoms: Position statement of The North American Menopause Society. Menopause 2004; 11(1): 11-33.
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Nothnagle M, Taylor JS. Vaginal estrogen preparations for relief of atrophic vaginitis. Am Fam Physician 2004; 69(9): 2111-2112.
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Odmark IS, Backstrom T, Jonsson B, Bixo M. Long-term effects of two different continuous combined regimens of hormone replacement therapy on well-being. Gynecol Endocrinol 2004; 18(6): 305-317.
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Ohsfeldt RL, Gavin NI, Thorp JM. Medical care costs associated with postmenopausal estrogen plus progestogen therapy. Value Health 2004; 7(5): 544-553.
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Shanafelt TD, Barton DL, Adjei AA, Loprinzi CL. Pathophysiology and treatment of hot flashes. Mayo Clin Proc 2002; 77(11): 1207-1218. [Erratum in Mayo Clin Proc 2004; 79(8): 1088.]
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Shulman LP. The menopausal transition: how does route of delivery affect the risk/benefit ratio of hormone therapy? J Fam Pract 2004; Suppl: S13-17.
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Skouby SO, Barlow D, Samsioe G, Gompel A, Pines A, Al-Azzawi F, Graziottin A, Hudita D, Rozenberg S; European Menopause and Andropause Society (EMAS). Climacteric medicine: European Menopause and Andropause Society (EMAS) statements on postmenopausal hormonal therapy. Maturitas 2004; 48(1): 19-25.
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Smith NL, Heckbert SR, Lemaitre RN, Reiner AP, Lumley T, Weiss NS, Larson EB, Rosendaal FR, Psaty BM. Esterified estrogens and conjugated equine estrogens and the risk of venous thrombosis. JAMA 2004; 292(13): 1581-1587.
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Swegle JM, Kelly MW. Tibolone: A unique version of hormone replacement therapy. Ann Pharmacother 2004; 38(5): 874-881.
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Takiya L, Umland E. MenoPAUSE: Taking a second look at the role of HRT. J Am Pharm Assoc (Wash DC) 2003; 43(5 Suppl 1): S34-35.
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Varner RE. Menopausal hormone replacement therapy. Curr Womens Health Rep 2003; 3(5): 410-417.
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Wren BG. Do female sex hormones initiate breast cancer? A review of the evidence. Climacteric 2004; 7(2): 120-128.
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Wren BG, Brown LB. A double-blind trial with clonidine and a placebo to treat hot flushes. Med J Aust 1986; 144(7): 369-370.
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Wren BG, Champion SM, Willetts K, Manga RZ, Eden JA. Transdermal progesterone and its effect on vasomotor symptoms, blood lipid levels, bone metabolic markers, moods, and quality of life for postmenopausal women. Menopause 2003; 10(1): 13-18.
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Wren BG, Day RO, McLachlan AJ, Williams KM. Pharmacokinetics of estradiol, progesterone, testosterone and dehydroepiandrosterone after transbuccal administration to postmenopausal women. Climacteric 2003; 6(2): 104-111.
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Compounding Pharmacy in the News |
Burke's pharmacy denies lawsuit's claims of medication mix-up
Published Sunday, December 5th, 2004 |
BEAUFORT -- Burke's Main Street Pharmacy has denied the major allegations in a lawsuit brought by a Hilton Head Island man who says he suffered permanent
brain damage from a medication mix-up. The pharmacy agrees that it compounded and dispensed the prescription pain medication in February to the 43-year-old plaintiff, Christopher M. O'Leary, according to an answer filed Nov. 23. It also concedes that a doctor who was treating O'Leary contacted pharmacist David Burke with concerns about the medication, but it denied that Burke gave any assurances about it.
For full story,http://www.islandpacket.com/news/briefs/story/4273067p-4068099c.html |
Healthbeat: Kid-Friendly Pharmacy |
Last year, Americans filled more than 3.2 billion orders for prescription medications, spending more than 203 billion dollars. Many of those prescriptions are for children. Children are not simply small adults. They may have some unique medical needs and require different types or doses.
For full story,http://www.hoinews.com/news/features/4/1101482.html |
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New Products |
EPS® Steri-Dropper™ Bottles
EPS®, Inc. is pleased to announce our line of Steri-Dropper™ bottles. It�s yet another enhancement to our extensive array of bottles and containers.
Steri-Dropper™ was designed for the extemporaneous packaging of sterile ophthalmic solutions. It consists of 3, 7 and 15 ml polyethylene vials, manufactured from a special zinc stearate-free resin. This special plastic minimizes the risk of particulate forming in solution with certain ophthalmic preparations.
We package the bottles, tips and caps in blisters of 2�s rather than 12�s or 20�s so that you can just prepare whatever you need. You don�t need to expose or use 12 or 20 bottles when you only need to make a couple of solutions!
For samples, to order or for more information, please contact us at EPS®, INC
E-mail : info@medidose.com Website : www.medidose.com.
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