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New Federal Regulation on Prescription Pain Meds Limits Refills
Healthy You: Hormones and your Bladder Health
Keystone Pharmacy Invests in Patient Safety, First Pharmacy in Michigan to Use Pallchek™ for On-Site Sterility Testing
Grand Rapids, Michigan, July 25, 2014 - In a move to enhance patient safety, Keystone Pharmacy has become the first pharmacy in Michigan to use Pallchek™ technology for on-site sterility testing of compounded medications.
The locally owned, full-service compounding pharmacy has invested nearly $100,000 in the Pallchek™ Rapid Microbiology System, a faster alternative to conventional microbiological quality control methods. Rather than waiting 14 days for an outside lab to perform sterility tests, Keystone can now perform sterility testing in-house and know the results in as little as three days.
Keystone now uses its Pallchek™ system to test the sterility of compounded medications required to be sterile. These include injectable medications such as pain injections or vitamin replacements, medications for the eye such as antibiotics for eye infections and those applied directly to mucous membranes such as inhalers.
Using the same chemical that gives fireflies their glow, Pallchek™ tests for the presence of bacteria, yeast and fungus, giving pharmacists an objective measurement tool for assessing sterility.
Sterility took an uncomfortable position in the national spotlight in 2012, when 64 people – more than a third in Michigan – died and 750+ were sickened by an outbreak of fungal meningitis that was traced to contaminated epidural steroid injections manufactured in Massachusetts. Outcry over the outbreak has spurred changes at the state and federal levels to enhance oversight and ensure pharmacies have the proper safety protocols in place.
"Pallchek™ technology represents a quantum improvement for patient safety and convenience," said Dr. Dave Miller, chief formulation scientist and co-owner of Keystone Pharmacy. "As a pharmacy, we are very strict about not releasing sterile products until they have passed sterility testing. The 2012 meningitis outbreak confirmed the importance of having the right protocols and testing in place.
"Our investment of time and dollars in acquiring, installing, testing and validating this new technology underscores our focus on patient safety. We are committed to producing the highest quality compounded products and, with the help of our firefly friends, we have made another huge leap forward."
Miller explained that past sterility tests relied on the human eye to assess whether a product was sterile or not. A sample of the product would be filtered and then incubated with the addition of a "growth media" to detect the presence of bacteria, yeast and fungus. After 14 days, if the sample turned cloudy, it was deemed not to be sterile. Pallchek™, on the other hand, relies on "firefly chemistry" to objectively assess sterility.
Miller explains the chemistry this way: Fireflies have a unique chemical called luciferin-luciferase. When this chemical binds to adenosine triphosate, or ATP, it emits light and gives fireflies their evening glow.
Since all living organisms produce ATP, adding luciferin-luciferase to a product sample is an effective way to test for the presence of microorganisms. If something is alive in the sample, it will emit light that is detected by the Pallchek™ system after an incubation period of three days.
"Not only is the Pallchek™ system faster than the old method, it is also much more sensitive and leaves no room for interpretation," Miller said. "It is absolutely objective."
Keystone Pharmacy is accredited by the Pharmacy Compounded Accreditation Board for sterile and non-sterile compounding. Keystone was one of the original 50 pharmacies in the national to receive accreditation and was the first in Michigan to go through the reaccreditation process in 2012.About Keystone Pharmacy
Founded more than a decade ago with a commitment to providing individualized medication solutions, Keystone Pharmacy is a locally owned, full-service pharmacy with a strong expertise in compounding. In its state-of-the-art facility, Keystone pharmacists compound medications for many purposes, including pain management and palliative care, cancer treatments, hospice, ophthalmological applications, hormone replacement therapy, wound management, skin conditions and others. Its Nutrition division provides individualized consulting services aimed to harmonize diet, exercise and supplements for a healthier lifestyle. Keystone is accredited by the Pharmacy Compounded Accreditation Board for sterile and non-sterile compounds. For more information, go to www.keystonerx.com or visit us on Facebook.
Medication Therapy Management
It is estimated that 1.5 million preventable adverse events due to medications occur each year with a corresponding cost of $177 billion. Many of those events could be prevented by better understanding of the medication and better communication between health care providers and the patient. We are pleased to let you know about a new program at Keystone Pharmacy, called Medication Therapy Management, as our attempt to help fill in those gaps. This program includes a one-on-one meeting with our Pharmacist, Suzi Anthony, to review all your prescription medications, as well as non- prescription, herbal, and dietary supplements. During the consultation, how each medication works, the reason for its use, the timing of the dose, as well as any concerns may be discussed. Any interactions between the medications will be looked at. Appropriate actions to respond to any identified problems will be determined between you and the Pharmacist. An action plan as well as a personal medication list will be generated for you after the meeting. The consultation is covered by some insurance programs, but is available to any of our patients. Our goal is to help you achieve safe and effective results from your medications. Please call us to set up a time for your medication management meeting!
Update of Federal and State Legislation
Last week, I went to Washington DC to attend the International Academy of Compounding Pharmacists (IACP) annual convention. This convention brings together compounding pharmacists from all over the U.S. and Canada. There were many updates, most centered on the federal and states’ response to the meningitis outbreak caused by tainted injections from the New England Compounding Center. Back in November 2013, President Obama signed into law the Drug Quality and Security Act. Among other things, this law:
Currently, IACP is working with the US Congress to ensure that the US FDA does not overstep their boundaries with the new legislation. Also in process through the Michigan legislature is SB704. This legislation would, if passed:
While all of these actions seem good on the surface, what it will mean is limited access to your custom medication. We have already seen the impact in our pharmacy. We can no longer compound 3 key products because of passed legislation and proposed legislation. We estimate that the net impact to our patients is over $1000/month because the difference between the compounded product and the commercial products’ cost is so vast. Also, the imposition of criminal penalties, including up to 15 years imprisonment, for performing some compounding services may force many pharmacies to limit the services they provide. How, in their right mind, would a pharmacist perform services that could land them in prison just for performing their jobs?
This bill has already passed the Michigan senate and is on its way to the house. I will keep you posted as situations progress.
Brandi Grimmer talk with Channel 13 about the benefits of magnesium
David Miller talks with Channel 13 about scar treatments
Pharmacies embrace broader role in shifting health care industry
Already much more than just a place to fill prescriptions, the pharmacy could become an accessible, one-stop center in the delivery of basic health care services. Health care consumers increasingly have the option to walk in and see a pharmacist to get a flu shot, seek advice in managing chronic conditions such as diabetes, and potentially get diagnosed and treated for common ailments.
Keystone Pharmacy Launches Keystone Nutrition, Private Label Supplement Lines
Grand Rapids, Michigan, November 11, 2013 – Keystone Pharmacy has launched Keystone Nutrition, a new consulting division, along with two new lines of privately labeled, pharmaceutical-grade supplements.
Suzanne Anthony talks with Channel 13 about flu vaccines
Congratulations to Brandi on 10 years of dedicated service to our patients. Brandi, you are Keystone!
Brandi Grimmer discusses simple fixes for a healthy gut with Channel 13's Val Lego
Keystone's David Miller Talks to Val Lego and Channel 13's "Healthy You" about Signs and Symptoms of Low Testosterone in Men
Mary PreFontaine Discusses How Hormones Can Affect Weight as We Age, in a Recent Segment of Channel 13's Healthy You with Val Lego.
David Miller Interviewed by WOOD TV Regarding the Recent Meningitis Outbreak and How It Affects the Compounding Industry
David J. Miller Honored as a 2012 Fellow for Practice Excellence and Leadership by IACP
Grand Rapids, Michigan, July 16, 2012 – Keystone Pharmacy announced today that David J. Miller has been honored as a 2012 fellow for Practice Excellence and Leadership by the International Academy of Compounding Pharmacists, or IACP.
Miller received this honor in recognition of his contribution as a specialist in the art and skill of pharmacy compounding. Applicants are selected following an assessment of their credentials against rigorous criteria that includes, contributions to published literature, continuing education, presentations, leadership, professional and civic service as well as professional awards.
IACP fellows must meet stringent requirements designed to demonstrate their commitment to patient care through quality pharmacy compounding and their commitment to the highest ethical and professional standards. In addition, fellows must be registered pharmacists who have practiced pharmacy for at least five years and practiced as a compounding pharmacist for at least three years.
Pharmacy compounding is the long-established tradition in pharmacy practice that enables physicians to prescribe and patients to take medications that are specially prepared by pharmacists to meet patients' individual needs. IACP's Fellowship Program was established in 1997 to distinguish pharmacists who are exemplary in their commitment and professionalism to the practice of pharmacy compounding. The organization has since recognized 70 pharmacists as fellows.
Miller, chief formulation scientist and co-owner of Keystone Pharmacy, has 21 years of experience as a pharmacist and 10 years as a compounding pharmacist. He launched Keystone Pharmacy 10 years ago, and it has since grown significantly, completing a large expansion in 2011 to meet the increased demand for compounded medications.
About Keystone Pharmacy
David Miller, our owner and Chief Formulation Specialist, was invited to be on "Healthy You" this month to address common questions and concerns about Sleep Aids
Watch the video below, or read the story at www.wzzm13.com.
Keystone Pharmacy Approved for Reaccreditation by the Pharmacy Compounding Accreditation Board
Grand Rapids, Michigan, May 16, 2012 – Keystone Pharmacy is proud to announce that it has been approved for reaccreditation by the Pharmacy Compounding Accreditation Board, or PCAB, for sterile and non-sterile compounding through Feb. 1, 2015.
Keystone Pharmacy is one of only five pharmacies in Michigan that has received this accreditation and is the first to go through reaccreditation. It was also among the original 50 pharmacies in the nation to receive the accreditation; today there are approximately 140 pharmacies that are PCAB accredited.
PCAB was created by eight of the leading organizations in the pharmacy profession for the purpose of recognizing those compounding pharmacies that have demonstrated their outstanding commitment to quality. Accreditation means that the pharmacy ranks among the best in the nation for compliance with quality standards.
"We are exceptionally pleased to receive re-accreditation from the PCAB," said Dave Miller, chief formulation scientist and co-owner. "Demand for compounded medications continues to increase and quality remains of the utmost importance. We are committed to providing the highest quality compounding services to our patients and are proud to be acknowledged for our efforts once again."
About Keystone Pharmacy
Keystone Pharmacy Introduces "Pocket Rx" Smartphone App
Grand Rapids, Michigan, April 2012 – Keystone Pharmacy has launched a mobile pharmacy app, Pocket Rx, allowing users to refill and manage current pharmacy prescriptions from their smartphones, regardless of location.
The free app takes only a few minutes to download from the App Store (keyword – Keystone Pharmacy) and is currently available for Android and iPhone platforms.
"Keystone Pharmacy has long been known for our commitment to customer service that exceeds the expectations of our clients," said David J. Miller, chief formulation scientist and co-owner. "Pocket Rx brings technical convenience to our 'on-the-go' customers, saving them valuable time on the management of their prescriptions."
Pocket Rx provides a simplified data entry system, including bar code scanning, that is completely integrated with the Keystone Pharmacy's prescription management system. The new app provides customers the tools to create a separate profile for each family member or pet that has a current prescription with Keystone Pharmacy.
About Keystone Pharmacy
Our pharmacist and Anti-Aging Specialist, Mary PreFontaine was invited to be on 'Healthy You' on March 26 as Val Lego's resident expert on HRT
Watch the video below, or read the story at www.wzzm13.com.
Keystone Pharmacy is mixing drug combos to combat the nationwide shortage of Ritilin & Adderal
December 2nd, 2011 - GRAND RAPIDS TOWNSHIP - In the laboratory at Keystone Pharmacy, white-clad technicians carefully weighed, measured and mixed to the whirring sound of an electronic mortar-and-pestle blender.
This is where medications are compounded, and it is an especially busy place these days. A record number of drug shortages is prompting customers to seek pharmacies that can make their medications or alternatives that will do the job.
"One of the unique niches we fill as compounders is helping out with drug shortages," said David Miller, a pharmacist and the owner of Keystone, 4021 Cascade Road SE. Adderall, a stimulant often prescribed for attention deficit disorder, is one of the most recognized examples.
In many cases, doctors have switched patients to Ritalin or Dexedrine. Manufacturers have been unable to keep up with the increased demand, so shortages have developed for those drugs. That's where the compounding pharmacists come in: They mix the medications for customers with Ritalin or Dexedrine prescription. They are unable to provide Adderall, however, because the ingredients are in scarce supply. Federal limits on the controlled substances are blamed by some for the shortage. Tetracycline, an antibiotic commonly prescribed for skin, urinary tract and respiratory tract infections, is another drug that is in scarce supply. So is methylprednisolone, an anti-inflammatory. In both cases, medications can be compounded at a pharmacy.
More than 200 prescription drugs are listed on the Food and Drug Association shortage list. President Barack Obama has urged the FDA to work with drug companies on increasing medication supply and has asked the Justice Department to intensify its investigation into price-gouging claims. In the meantime, customers are turning to pharmacists who can create the pills, capsules, liquids or creams they need by hand.
"It's very labor intensive," Miller said. "It takes an average of 45 minutes to fill a compound versus three to four minutes for a traditional prescription." The pharmacy employs eight technicians to make medications. The equipment they use includes built-in safeguards. The bar code of each ingredient must be scanned by computer to ensure it is the right one. And the scale is connected to a computer to double-check that the correct amount is measured. But not every tool is high-tech. Miller picked up an old-fashioned glass mortar and pestle, long a symbol of pharmacists. It is still used to mix some compounds, particularly suspensions, such as creams and ointments and liquid versions of medications given to children.
"You can get a lot of energy into the particles. There's nothing really better than this," he said. "You can get things to mix a lot better." A mortar and pestle are used to create many of the medications created for pets. Miller uncapped a bottle of a foul-smelling liquid and offered a whiff.
"That's our fish-suspension base we make for kitties," he said. "It's real salmon, sardines and tuna." Medication is added to the fishy liquid goes down much easier with cats than pills, he said.
The cost for compounded medications is usually not much higher for customers, Miller said. In some cases, prior authorization is needed from the insurance company, or the higher, brand-name co-pay charge instead of the generic co-pay. And sometimes, the compounded medication costs less than an expensive brand name drug. Miller advised patients unable to find a prescribed medication to talk to their doctor and pharmacist.
"If they call four or five pharmacists and can't find it, it's time the doctor, the patient and the pharmacist come together to find an alternative," he said.
Megan Meyering, a certified technician at Keystone Pharmacy, does capsulating of powder medications as part of compound medications. As shortages develop for Adderal, Ritalin, tetracycline and other drugs, pharmacies are seeing an increased demand for them to compound those medications.
Nicolle Holzgen, left, and Lynn Berry, certified technicians at Keystone Pharmacy, dose capsulating of powder medications as part of compound medications.
Certified Technicians at Keystone Pharmacy (front to back) Lynne Spiller, Debbie Martinson, Nicolle Holzgen (left) and Lynn Berry work at different stations for preparing a variety of compound medications.
Nicolle Holzgen, a certified technician at Keystone Pharmacy, does capsulating of powder medications as part of compound medications.
Compounds are heated up and melted to make troche sublingual tablets as part of compound medications.
Keystone Pharmacy expands on Cascade Road
GRAND RAPIDS TOWNSHIP – While other independent drug stores keep dropping off the scene, Keystone Pharmacy is completing a building expansion and taking on a new venture. The pharmacy took over another 1,600 square feet in the plaza at 4021 Cascade Road SE, creating 40 percent more space, with a seminar room, expanded lab and two consultation rooms. The $130,000 expansion also includes a sterile lab that few other pharmacies outside of hospitals ever add.
Read More Here...
Keystone Pharmacy Expands, Celebrates 10th Anniversary
Grand Rapids, Michigan, October 5, 2011 – Fueled by strong demand for its compounded medications, Keystone Pharmacy is putting the finishing touches on a significant expansion of its Grand Rapids store – just in time for its 10th anniversary.
The locally owned, full-service pharmacy will celebrate its anniversary and the grand "re-opening" of its store at 4201 Cascade Road SE on Wednesday, Nov 2. The new store, which has increased square footage by 62 percent, will feature:
"Keystone is extremely pleased to be celebrating our 10th anniversary in West Michigan by unveiling our expanded store," said David J. Miller, chief formulation scientist and co-owner. "We opened our doors a decade ago with a strong commitment to providing individualized medication solutions, and this formula continues to resonate with our patients. We have grown nine-fold over that time and are continuing to grow.
Read More Here...
Linking Cortisol Production to Stress By Mary PreFontaine, R.Ph, FAAFM
Andropause: Male "Menopause" By Mary PreFontaine, R.Ph, FAAFM
Testosterone: Prescription for Passion By Mary PreFontaine, R.Ph, FAAFM
West Michigan doctors offer tips to improve your sex life
An article written by Paul R. Kopenkoskey and published in The Grand Rapids Press. View the article here
Congratulations to our winners of our Christmas Angel Coloring Contest!
Keystone Pharmacy would like to congratulate our two winners of our Christmas Angel Coloring Contest, Emily Beidler & Brett Holzgen. They both will receive a webkinz of their choice.
A Letter of Thanks!
We recently received these kind words wanted to share them with you.
Dear Dr. David Miller,
Keystone Pharmacy Donates Children's Items to Metro Health Child Life Program
Wyoming, Michigan, April 7, 2011 - Keystone Pharmacy has donated more than 400 stuffed animals and accessories to the Metro Health Hospital Foundation for use in the Metro Health's Child Life Services program.
After reading an article describing Child Life Services in The Grand Rapids Press, pharmacy employees wanted to contribute to this important service. Marie Woodard, director of marketing at Keystone Pharmacy, worked with the team to gather the items and deliver them to the hospital.
Child life specialists at Metro Health are experts in child development who provide support and help children cope with the emotional stresses of healthcare and the hospital. Working with children who are patients or family members, child life specialists try to take the unknown out of the hospital experience for many young patients or family members.
As a compounding pharmacy Keystone also provides special services to children by formatting medications into flavored liquids or gummies, which make the medications easier for kids to take, according to Woodard.
"It's exciting to see that our community supports the important work of our child life specialists," said Metro Health Hospital executive vice president of foundation and community outreach Laura Staskiewicz. "Donors make this program possible. Metro's Child Life Services program is fully funded through generous gifts from our community."
Keystone Pharmacy Team CPR Training Class
On September 14th, the entire team participated in the optional CPR training, obtaining CPR certification as well as valuable life-saving skills!
Congratulations to our pharmacist, Dave Miller for being elected to another 3 year term after completing a 4 year term!
July 19, 2010 PIPCo NEWS
The Annual Meeting of Shareholders was held on July 19, 2010 in Milwaukee, WI. At the meeting the Board of Directors election took place. Steve Felkey, Dave Miller, and Gregg Russell were all elected to serve a three-year term on the board. Matt Mallinson will fill the role as the alternate board member. The next board meeting will be Saturday September 18 in Milwaukee WI. Congratulations to Steve, Dave, Gregg and Matt.
Keystone Meets with Senator Stabenow
Keystone Pharmacy Working for your rights to continue to have compounded medications as prescribed by your healthcare professional. Dr. Dave Miller and Senator Debbie Stabenow recently met to discuss her support for compounded medication legislation. We are working diligently to protect your rights in this area of healthcare as some would like to limit, or altogether end, your doctors ability to prescribe compounds.
Pharmacists Head to Washington, D.C. to Protect Your Access to Compounded Meds!
More than 250 community pharmacists, including Keystone Pharmacy owner, David J. Miller, RPh, PhD, and pharmacy technicians from across the United States traveled to Washington, D.C., to meet with their federal House and Senate delegations as part of the International Academy of Compounding Pharmacists (IACP) 2011 Compounders on Capitol Hill 17th annual conference and legislative event held, June 11-14, 2011.
Read More Here...
Pharmacy Compounding Accreditation Board Teams Up With the Society for Maternal-Fetal Medicine
Pharmacy Compounding Accreditation Board was recently asked to prepare a question and answer document for the Society For Maternal-Fetal Medicine. SMFM has been very active in advocating the use of 17-hydroxyprogesterone for prevention of preterm labor, and compounding the drug for patient convenience. You will note that it alerts physicians to use PCAB accreditation as a way to identify quality compounding pharmacies. Keystone Pharmacy is proud to be West Michigan's first and only PCAB Accreditated pharmacy! How can we help you today?
PCAB's Q&A has been posted on the SMFM homepage
Team Keystone ran in the West Michigan Urgent Care 5K
"For being a first time race I am really impressed with how they had it organized. From a real race timer to race bibs, to a great spread of food, and medals for the top 3 in different age groups. Lily and I even scored some cool swag from Keystone Pharmacy, Xenergy, and Quiznos Subs. If you are looking for a inexpensive $25/$15 race day 5K for next spring to stretch your muscles out after the Fifth Third River Bank run, this would be it."
These are pictures from the medical mission trip of Christopher Van Ryn PA-C to Haiti in January 2010. Keystone Pharmacy once again was able to help out by donating $5500 in medications to Chris that helped him see over 1000 patients! Best wishes to Chris on his upcoming trip back to Haiti along with fellow Doctors from Riverwood Family Medicine. Check our more photos and the store on our Facebook page.
We are happy to answer questions for our current & future patients and prescribers. If your question is urgent, please call us!