High-Tech Meets High-Touch.

• We are non-sterile and sterile accredited through PCAB.
• Our lab spaces are USP <795> <797> and <800>  compliant.
• We are a Verified Pharmacy Program (VPP) through the National Boards of Pharmacy (NABP).

U.S. Pharmacopeia guidelines classify sterile compounding from non-sterile ingredients as the highest risk category, and recommend, among other things, procedures to take place in a class 100 cabinet inside a class 10,000 clean room.

O’Brien Pharmacy is serious about sterile compounding. That is why we use Class 10 barrier isolators located in a Class 10,000 HEPA filtered environment.  This is ten times cleaner than required.

In addition, while most compounding pharmacies use technicians for compounding, O’Brien Pharmacy uses only pharmacists who are specifically trained and experienced in aseptic compounding. Technicians do not possess the knowledge base in pharmacology, dosing and calculations necessary for consistently accurate compounding. Confidence comes from knowing an experienced pharmacist is making your medicine and can distinguish seemingly identical white powders based on subtle color difference, smell, solubility, and pH.

In fact, our entire sterile compounding environment and related chemicals are isolated from all other compounding and pharmacy activities. This greatly reduces the possibility of the wrong medication being used or unauthorized activity in the lab. And virtually all compounds are made only on demand, minimizing any question of shelf life or stability.

Comprehensive product testing assures the doctor and patient of the quality of each preparation.  Testing includes multi-point sterility testing, endotoxin testing and independent laboratory analysis for potency.

It has been said, “If it isn’t documented, it didn’t happen.” The heart of our 150-page policy and procedure manual is documentation. Everything from temperature and humidity to daily calibration of our balances is documented. In addition, compounding software in the lab facilitates documentation of all formulas, procedures, chemicals, lot numbers and expiration dates.  Printers or software are attached to all balances for verification of quantities weighed, and this data is saved with the lot number of each chemical for verification and retrieval – documentation unrivaled by other pharmacies. 

Here Are Just a Few of Our Quality Assurance Procedures:

• Sterility testing of preparations, retained for 1 year.
• Continuous laboratory temperature/humidity monitoring with email/text alerts.
• Additional in-house monitoring of the air and surfaces.
• Continuous refrigerator/freezer monitoring/calibration with email/text alerts.
• Bi-monthly validation of autoclave.
• Daily monitoring of incubator temperatures and samples.
• Ongoing training/testing/evaluation of aseptic personnel.
• Ongoing endotoxin testing program.
• Bi-annual certification of sterile cabinet.
• Scheduled verification of sterile environment.
• Continuous cleaning of compounding environments.
• Extensive policy and procedures and standard operating procedures.
• Compounding software with backup for continuous record keeping.
• Complete recall and reporting ability on any ingredient of any product or prescription at any time.

QUALITY CHEMICALS:

Quality compounding begins with quality chemicals that meet or exceed stringent pharmaceutical specifications. Inexpensive chemicals without independent verification are available but unacceptable to O’Brien Pharmacy.

Selection of chemical grade:  USP>NF>FCC>ASC>Stop, with distinctions made for route of administration and risk to benefit.

Our chemicals come from a FDA-inspected chemical supplier with the following quality control process:

• Upon receipt, all chemicals are visually inspected for product and container integrity, and placed into quarantine.
• The chemical’s documentation is examined for completeness and accuracy.
• A sample is taken to the quality control lab where its physical properties are compared with the certificate of analysis, United States Pharmacopoeia, British Pharmacopoeia, or other reference documents.
• Chemical identity is verified by IR spectra, UV-VIS spectra, meltpoint, specific gravity and other chemical tests.
• If the chemical meets necessary criteria, the lot number is activated and released from quarantine.
• Prior to repackaging, the bulk container’s barcode is scanned against the package labels to verify the information.
• After repackaging is complete, a random sample is pulled and identity is again confirmed.
• While filling an order, the chemical’s barcode is scanned to insure the correct chemical, size and lot number has been pulled for the corresponding order.
• A final quality control audit is performed by again scanning all barcodes to validate order completeness.

Only one chemical supplier has this extensive quality-control program.  The chemicals are more expensive, but anything less is an unnecessary risk.

TESTING PROTOCOLS:

• Sterility Testing Includes (one or more of the following):
  • Soybean casein digest medium (aerobic, fungal)
  • Potato dextrose agar (increased fungal sensitivity)
  • Fluid Thioglycollate medium (anaerobic)
  • Two incubators plus room temperature
• Endotoxin Testing
• Potency Testing
• Bi-monthly surface and air quality testing of sterile isolator chamber
• Random cross check of potency and sterility by second laboratory
• Annual validation of procedures
• Semi-annual validation of personnel

Many investigational drug or nutrient studies require the distinctive abilities and flexibility of a compounding pharmacy.  O’Brien Pharmacy is a sterile and non-sterile PCAB accredited pharmacy and an experienced, cost-effective supplier of matching active and placebo dosage forms for clinical studies. In addition, O’Brien Pharmacy provides consultation, compounding, and dispensing services for FDA-approved clinical drug trials, including storage, randomization, dosing, and documentation required for study validation. We have identified and resolved procedural, material, equipment, and calculation issues for clients, increasing accuracy and efficiency.  

We also know the importance of fulfilling these orders on a timely basis, with proper packaging, labeling, and independent laboratory verification of both active and placebo.  And we have worked with clinicians studying drugs and nutrients in both humans and animals from a few hundred to tens of thousands of doses.

O’Brien Pharmacy is uniquely qualified and experienced to satisfy the individualized requirements of many study investigations including:

• Special dosage forms including sterile
• Matching active and placebo
• Special flavorings
• Proper excipient selection
• Appropriate laboratory documentation
• Storage, handling, and expiration issues
• Budget considerations

For more information, please call or email the O’Brien Pharmacy Consulting Group.

Our Experience

1.   University of Kansas Medical Center, Kansas City, KS
Sirolimus, 2021-Present

2.    Kansas City Veterans Association, Kansas City, MO
PPI study, 2019-Present

3.   University of Kansas Medical Center, Kansas City, KS
IBM study, 2019-Present

4.   Children’s Mercy Hospital, Kansas City, Mo
Ketotifen, 2018-Present

5.   University of Kansas Medical Center, Kansas City, KS
Budesonide, 2016

6.   Children’s Mercy Hospital, Kansas City, MO
IV Glucose Isotope, 2015-16

7.   Children’s Mercy Hospital, Kansas City, MO
Ketotifen, 2015-16

8.   University of Kansas Medical Center, Kansas City, KS
SPARQ Statin Study, 2011-12

9.   GlaxoSmithKline
Proprietary, 2011-12

10.  Cleveland BioLabs, Cleveland, OH
Sterile Buffered Drug Diluent, 2008-15

11.  HHT Foundation International, Monkton, MD
FDA Application for Topical Nasal Therapies for HHT, 2009-16

12.  University of Kansas Medical Center, Kansas City, KS
Aspirin/Niacin/Pectin/Placebo, 2009

13.  Consulting Pharmacy, Johnson County Clin-Trials, Lenexa, KS
2005

14.  Inotek Pharmaceuticals, Beverly, MA
Ophthalmology, 2008

15.  Acambis Pharmaceuticals, Cambridge, MA
Flu Vaccine, 2007-08

16.  Shire Pharmaceuticals, Wayne PA
Proprietary, 2007

17.  University of Missouri, Kansas City, School of Dentistry Kansas City, MO; Children’s Mercy Hospital, Kansas City, MO
Ibuprofen/Acetaminophen/Placebo, 2007

18.  Metro Health Medical Center, Division of Gastroenterology, Cleveland, OH
Zelnorm/Placebo, 2003

19.  St. Luke’s Hospital Lipid and Diabetes Research, Kansas City, MO
Nicotinic Acid/Placebo, 2003

20.  Ohio State University, Department of Veterinary Clinical Sciences, Columbus, OH
Glucosamine 750mg and 350mg/Placebo

21.  University of Missouri, Kansas City, School of Pharmacy, Drug Information Center, Kansas City, MO; The Neuropathy Association Greater Kansas City Support Group
Actives/Placebo, 2001

22.  Novartis Pharmaceutical Corporation, East Hanover, NJ
Proprietary, 2000

23.  University of Kansas Medical Center, Kansas City, KS
Bio-identical Hormone Replacement troches/Placebo troches, 1998

24.  Member of Hunkeler Eye Centers Institutional Review Board, Kansas City, MO

25.  Oversaw 95 FDA studies on ophthalmic research, including refractive surgical procedures and new drug therapies, 1993-96