Meeting unique pharmaceutical needs of physicians and patient through custom prescription compounding

By John Waclawski and Monica Zatarski PharmD
JPSW - Practice Spotlight March-April 2007

Monica Zatarski’s interest in pharmacy began when she was quiet young. At the age of 14, she started working at Ye Olde Pharmacy, owned by her dad, John Waclawski. She helped with checking in orders, cleaning the shelves and vacuuming the carpet. As time went on, Zatarski’s duties progressed to assisting in filling prescriptions and serving as the delivery person. Her interest in pharmacy grew with her increased exposure to the various unique niches Ye Olde Pharmacy served. A niche which was particularly appealing to her was prescription compounding. It was this interest which influenced her decision to become a pharmacist, graduating from the UW School of Pharmacy in 2004.

From pharmacy school, Zatarski went to work for her dad at Ye Olde Pharmacy as the compounding pharmacist. In her words, "My father has always been my mentor. He has not only taught me how to be a great pharmacist but also the importance of providing patient care, running a business, being a problem solver and instilling a love for the art and science of prescription compounding. I have always been fascinated with prescription compounding. It truly makes the pharmacist an invaluable asset in solving medication problems. I learn something new every day."

By the summer of 2005, Zatarski had increased the compounding business as well as the patient consultation sessions to the point where the lab at Ye Olde Pharmacy was inadequate to handle the demand. She and her dad decided that they needed to open a compounding-only pharmacy. On Nov. 1, 2005, MD Custom Rx opened its doors with Zatarski as the owner.

MD Custom Rx, located in Glendale, Wis., occupies 1,500 sq ft and boasts a 450 sq ft USP<795> compliant general compounding laboratory, a 400 sq ft USP <797> compliant clean room facility, a physician’s office, business office, patient consultation office, and reception area. The décor is very warm and inviting, which provides an extremely professional environment. The patient waiting area, which is shared by both physician and pharmacy patients, is furnished with winged backed chairs and decorative end tables. The laboratories are enclosed in glass, so patients can observe their prescriptions being compounded.

The staff of MD Custom Rx consists of a full-time pharmacist, Zatarski, a part-time pharmacist, a compounding technician, a receptionist and clerk. John Waclawski helps out with the pharmacist duties especially on days that Monica has patient consultations scheduled. The general laboratory is stocked with over 1,000 different pharmaceutical grade ingredients used in compounding. Unique compounding equipment such as electronic balances with attached printers, an ointment mill, a commercial blender, 100 and 300 count capsule machines, incubators, a calibrated refrigerator and freezer and a powder containrnent safety hood are used to prepare customized prescriptions.

MD Custom Rx boasts a state-of-the-art USP<797> compliant clean room facility used for the preparation of sterile products. This area consists of a prep room housing materials and ingredients used in sterile compounding as well as a convection oven used to sterilize oil-based injectables, an ante room where the gowning and scrubbing procedures are carried out, and a buffer room housing the laminar flow hood where the actual sterile compounding work is performed. Positive pressure keeps the prep room at IS0 class 8, the ante and the buffer rooms at ISO class 7 and of course, the laminar flow hood insures an IS0 class 5 environment. "We are very proud of our clean room facility it puts us ahead of most other facilities in the area in terms of USP compliance" states Zatarski. Standard operating procedures (SOPs) have been written and closely adhered to. The SOPs cover procedures involved with cleaning, environmental monitoring, equipment calibration, employee technique validation and much more.

MD Custom Rx currently is filling an average of 65 compounded prescriptions per day and is projected to be filling 90 per day by December 2007. The scope of the type of prescriptions compounded is endless: sustained released capsules, troches, suppositories, PLO gels, vanishing creams, vitamin blends, flavored suspensions and medicated lollipops. Therapeutic categories that MD Custom Rx services include bio-identical hormone therapy, topical analgesic therapy, unique medications for the treatment of autism, veterinary meds (including medicated "animal treats"), and vaginal preparations. Zatarski explains, "The sky is the limit on what we can do. Give me a problem and some time for research and I can guarantee a proposed solution.

"Bio-identical hormone therapy is the most popular service provided by Zatarski and her team."Two years ago I started 'It's All About Balance - A Hormone Consultation Program.' Patients - men and women alike -were demanding a way to learn more about bio-identical hormones as a treatment option." Since starting the program, Zatarski has met with over 1,000 patients. "Patients schedule 45-minute appointments with me and pay an office visit fee for my time. I will typically meet with a patient twice by appointment. First, to collect background health information and provide a test kit to measure hormone levels and then a second time to go over the test results together. I share their results as well as a SOAP note summarizing my recommendations with their physician," explains Zatarski. "I have seen that restoring hormone balance can make a night and day difference in a person's life, male or female, young or old." The practice of pharmacy is very rewarding at MD Custom Rx. In Zatarski's words, "I am able to apply all I learned about patient consulting and pharmaceutical care to my practice. Physicians call me daily asking for my opinion on therapy options for their patients. There is a physician who has office space within the pharmacy and we consult and collaborate on a daily basis as well. It is also very rewarding to meet with patients who are seeking my advice in regard to health care issues.” MD Custom Rx does not bill insurances for the services it provides. Upon request patients are given an insurance claim form which they can submit for reimbursement. As Zatarski says "By not doing insurance billing, it allows me the time I need to spend with the patients I serve to help them get better."

The future of MD Custom Rx is very bright. "We're still new, we have to spread the word and remind physicians of the usefulness of individualized treatment options," says Zatarski.

In the next year, MD Custom Rx will be applying for accreditation with the Pharmacy Compounding Accreditation Board (PCAB). "I'm looking forward to the accreditation process and being the first accredited compounding pharmacy in Wisconsin," says Zatarski.

MD Custom Rx has the goal of expanding with three additional sites in southeastern Wisconsin. "We are always looking for pharmacists who are interested in the art and science of prescription compounding,” says Zatarski.