It has been widely reported that hundreds of people in numerous states have been infected with fungal meningitis from contaminated steroid injections, which were illegally mass-produced and shipped across the country by the New England Compounding Center (“NECC”) in Framingham, Massachusetts. The criminal actions of NECC have caused increased scrutiny for all compounding pharmacies. With that scrutiny has come quite a bit of misinformation regarding compounding, which is an essential component of patient care in today’s healthcare continuum.
For that reason, mediStat offers the following fact sheet for patients, customers, medical professionals, and others who may be interested in mediStat’s products and services.
Pharmacy compounding is the art and science of preparing customized medications for individual patients. The practice of compounding dates back to the origins of pharmacy. In the 1930s and 1940s, a majority of prescriptions were compounded. With the arrival of mass drug manufacturing in the 1950s and 1960s, compounding declined as the pharmacist’s role as a preparer of medications quickly changed to that of a dispenser of manufactured dosage forms. However, this “one-size-fits-all” approach to medication meant that some patients’ needs were not being met.
Compounded medications solve numerous problems for patients who have special needs, such as patients suffering from chronic pain or inflammation, men and women suffering from hormone imbalances or infertility, people who are sensitive to additives in manufactured medications, and children with Autism Spectrum Disorder or other developmental, functional or sensory issues. Additionally, pharmacy compounding offers unique delivery systems for a patient’s medications. For patients who find it difficult to swallow a capsule, a compounding pharmacist may instead prepare the drug as a flavored liquid suspension. Other medication forms include topical gels or creams that can be absorbed through the skin, suppositories, sublingual troches, or even lollipops.
Following consultation with a patient’s physician, a compounding pharmacist can:
- Adjust the strength of a medication
- Combine the active ingredients found in two or more medications;
- Offer many medications that are no longer commercially available from pharmaceutical manufacturers;
- Prepare medications using unique delivery systems;
- Add flavor to make the medication more palatable;
- Prepare medications without unwanted ingredients such as dyes, preservatives, lactose, gluten, or sugar.
A compounding pharmacy prepares customized prescription medications pursuant to a prescription written by a physician or other medical practitioner. A drug manufacturer makes FDA-approved prescription drugs for mass markets in predetermined strengths and dosage forms.
No. mediStat prepares customized medications for the special medical requirements of our patients pursuant to a prescription written by a physician or other medical practitioner. mediStat operates according to strict requirements of state boards of pharmacy, as well as the stringent standards of the United States Pharmacopeia (USP).
Just like big pharmaceutical manufacturing companies, mediStat gets its ingredients for medications from suppliers that are registered and inspected by the FDA and DEA. We only purchase ingredients from these trusted suppliers. These suppliers have processes to verify the quality and potency of the ingredients that they send to our facility. Each ingredient arrives to our facility with a Certificate of Analysis. The Certificate of Analysis provides details regarding purity, contaminants, water content, evaporation, and a number of other required tests that insure the ingredient is safe.
mediStat is dedicated to maintaining the highest possible standards in quality. We strictly adhere to the United States Pharmacopeia (USP) Chapter 797, which addresses the preparation of compounded sterile products, and USP Chapter 795, which addresses the preparation of compounded non-sterile products. We also strictly adhere to applicable federal and state laws on sterile and non-sterile compounding.
mediStat uses state-of-the-art equipment, including a Class 100 clean room containing a laminar flow hood in the sterile area, powder hoods, digital computerized weight measurement instruments, and computer bar code technology, in all of our compounding processes. These systems assist us in assuring that all medications are properly prepared. Our digital scales for measuring chemical ingredients are tied to our barcoding system and formula database. After the barcode of an ingredient is scanned, the ingredient is then added to the scale. The system provides the pharmacist or technician the ability to electronically confirm that the weight of the ingredient exactly matches the formula in the database.
Pursuant to USP <795> and <797>, as well as our own standard operating procedures for safe pharmacy practices, mediStat strictly documents and maintains logs for measuring temperature, humidity, pressure, cleanliness, and many other parameters in the pharmacy that track and insure proper facilities for preparation of compounded products. Additionally, mediStat utilizes high risk precautions for our lab staff, which includes shoe covers, hair covers, gloves, scrubs, and protective lab coats.
mediStat trains its staff through intensive courses of study in compounding and continuing education specific to compounding practice. Furthermore, mediStat maintains and strictly abides by detailed standard operating procedures for all compounding activities.
mediStat tests compounded sterile products for potency, sterility, fungal contamination, and endotoxins by a combination of in-house and third party independent analytical laboratories. Additional details regarding product testing, quality assurance, and pharmacist and technician competency may be found in the questions below.
We are committed to maintaining the highest possible standards in quality by having our products tested by an independent analytical laboratory. This third party testing demonstrates that we take the training of our people and the quality of our products seriously, and insures that our patients receive the best product possible. In addition to potency testing for our sterile and non-sterile medications, we also test our sterile medications for sterility, fungal contamination, and endotoxins. mediStat currently uses Dynalabs as the independent analytical lab that receives compounds from our pharmacy and performs tests to insure the compounds meet the required criteria for quality.
We have a policy in place for generating and maintaining detailed patient information associated with every compound. In the event of a recall, the prescribing practitioner and patient would be contacted via telephone by one of our pharmacists.
Yes. mediStat is certified by Dynalabs, an independent analytical laboratory, as a Continuous Quality Improvement (“CQI”) pharmacy. The CQI Program focuses on establishing and maintaining quality systems in a compounding pharmacy, which results in the highest level of quality assurance possible. This is done by a rigorous process of product testing and careful scrutiny of the compounding process. In addition to testing of products and scrutiny of lab processes, each of our pharmacists and pharmacy technicians are individually tested on the competency by which she or he prepares compounded products.
The CQI Program measures quality in terms of objective measures such as accuracy, precision, and product testing. Data collected by the Program verifies that the product was made accurately, that it is stable, and that the container is appropriate for the product. The CQI Program also:
- Validates the compounding process to insure that a quality product is consistently produced;
- Confirms that the training of pharmacists and technicians is effective;
- Qualifies vendors of active pharmaceutical ingredients and packaging materials used for compounding as reliable quality suppliers; and
- Verifies that the facilities and equipment used to compound medications are certified and are in excellent working condition.
Additionally, members of our lab staff have been tested and received certification as “Subject Matter Experts” by Dynalabs. During the testing process, a mediStat lab staff member prepares the same product on three different occasions. A sample from each batch is then sent for testing. If the samples meet the strict quality standards set forth by Dynalabs, the lab staff member receives the Dynalabs Continuous Quality Improvement certification as a “Subject Matter Expert.”
The following mediStat team members have achieved the title of “Subject Matter Experts” by Dynalabs:
- Carrie Blair, CPhT, for capsules;
- Ashley Copeland, CPhT, for creams and troches;
- Tim Fickling, CPhT, for injections and suspensions; and
- Brehia Hare, CPhT, for injections and aliquots.
How do I know that my compounded medications are safe? How do I know that the compounded medications I’m getting from you are safe for my patients?
The best way to know that your compounded medications are safe is to talk with one of our pharmacists. We welcome your questions about our policies and procedures for quality assurance and product testing
For close to a decade, mediStat has provided compounding pharmacy services and solutions to thousands of patients and physicians. In May 2012, owners Mark Acker and Tim Fickling opened a new, 21,000 sq. ft. state-of-the art pharmaceutical compounding facility, retail pharmacy and corporate office at 110 E. Azalea Avenue in Foley, Alabama. With over 70 years of combined compounding experience, mediStat’s pharmacists have established an outstanding reputation among physicians by providing medications and advice that make a difference in the lives of their patients.
In addition to providing high quality compounded medications, mediStat is a complete health and wellness resource, carrying pharmaceutical-grade over-the-counter vitamins and supplements. mediStat may be reached by calling (855)737-2550 or by visiting the pharmacy between 8:00 and 5:00, Monday through Friday. Also, please visit mediStat on Facebook at www.facebook.com/mediStat <http://www.facebook.com/mediStat>.
mediStat currently ships medications to Alabama, Florida, Mississippi, Georgia, Texas, South Carolina, North Carolina, Ohio, and Pennsylvania. mediStat is currently working with numerous other states to obtain appropriate licenses and permits to ship medications into those states. Please check back frequently to learn of new states in which mediStat is permitted to ship medications.
The United States Senate will soon vote on legislation (S.959) that would unduly restrict access to personalized compounded medications. S.959 is an attempt to find a legislative solution to address the tragedy caused by the illegal actions of the New England Compounding Center (NECC), which mass-produced contaminated injectable medication and shipped it across the country. NECC’s illegal activity, as well as the failure of state and federal regulators to stop that illegal activity, led to a meningitis outbreak that resulted in patient illnesses and deaths. While well-intended, S.959 negatively impacts you and your doctor’s access to important compounded medications prepared by reputable, professional, and law-abiding compounding pharmacies, such as mediStat. Even if you are not currently using compounded medications, S.959 will likely limit your future options and your physician’s ability to prescribe the best solution for you.
Owners Mark Acker and Tim Fickling drafted a detailed letter to Senators Richard Shelby and Jeff Sessions regarding mediStat’s concerns with S.959, a copy of which may be found here ( Shelby letter; Sessions letter)
To learn more about this important issue, please visit www.protectmycompounds.com<http://www.protectmycompounds.com> (produced by our friends at the Professional Compounding Centers of America) and www.myhealthmycompounds.com<http://www.myhealthmycompounds.com> (produced by our friends at the International Academy of Compounding Pharmacists).
These websites also provide an easy mechanism to contact your Senators and Representatives, including form letters and emails that you may customize to tell your personal story. mediStat will also keep you updated about this and other important issues at www.mediStat.com<http://www.mediStat.com> and on Facebook at www.facebook.com/mediStat<http://www.facebook.com/mediStat>.
In May and June of 2013, TriCare, the federal health benefit program for active military and their families, began sending letters to plan participants informing them that any compounded medicine prepared with “APIs” (that is, Active Pharmaceutical Ingredients, which are used in a vast majority of compounded products) would no longer be covered as of July 24, 2013. The International Academy of Compounding Pharmacists (“IACP”), the international organization of which Medistat is an active sponsor and participant, recently released the following statement to its members regarding this decision:
TriCare, the federal health benefit program for active military and their families, began sending letters to plan participants informing them that effective July 24, 2013 any compounded medicine prepared with APIs would no longer be covered. These letters, issued by TriCare’s contracted pharmacy benefit management company Express Scripts (ESI), claim that the plan does not cover “non-FDA approved drugs.” This in spite of an internal document which IACP obtained which shows that TriCare and ESI have been reimbursing for compounded medications based on APIs for the past ten years.
“Denying access to necessary medications — based on the decision of a patient’s physician and individual health needs — is bad enough,” said IACP President Wade Siefert upon hearing the news. ”To have that burden be placed upon a man or woman serving our country is shameful. Congress needs to know how our military and their families are being treated.”
And that’s exactly the tact which IACP has taken. In addition to reaching out to select members of the Washington DC media to educate them about this issue, IACP’s lobbying team has already met with both Senators and Congressmen to call attention to this sudden and unprecedented change. ”The response we’ve had in our meetings has been one of both surprise and determination,” said IACP Vice-President of Government Affairs Sarah Dodge. ”That TriCare can make such a drastic change without considering the financial impact on their beneficiaries or what additional costs the federal government will have to pay as patients have hospital and physician visits to unnecessarily change their medicines is troubling. Especially in these times of tight budgets.”
Neither TriCare nor ESI appear to have considered how unbalanced their decision is. The program continues to reimburse for non-FDA approved manufactured products such as thyroid hormone, codeine, digoxin and the more than 200 medicines that predate the existence of the 1938 Food Drug and Cosmetic Act that established an FDA review process. More importantly, rather than acting as a benefit management plan, ESI appears to have abandoned that responsibility entirely instead of establishing commonplace processes like prior-approval or step-care. Instead, it has advised TriCare to simply stop paying for medicines without regard to patient needs.
While IACP will continue to raise this issue at the federal level, every member who provides services to TriCare patients can do their part as well. Watch for a special IACP Member Alert tomorrow with tools and resources to use in helping your TriCare enrollees reach out and express their own concerns to Congress.
As President Siefert says: ”They’ve protected us… now we have to protect them.”
Due to the overwhelming patient and physician outcry for this abrupt and unnecessary change in policy, TriCare postponed the implementation of this coverage decision for 90 to 180 days. TriCare is currently assessing its position on this issue. We hope that ALL of our patients, customers and friends would consider letting their Senators and Representatives know how important compounded medicines are to your healthcare needs. Please encourage your friends and family to contact their representatives, as well.
To learn more about this important issue, please visit www.protectmycompounds.com/tricare/<http://www.protectmycompounds.com/tricare/> (produced by our friends at the Professional Compounding Centers of America) and www.iacprx.org<http://www.iacprx.org> (produced by our friends at the International Academy of Compounding Pharmacists). These websites also provide an easy mechanism to contact TriCare representatives, as well as your Senators and Representatives. mediStat will also keep you updated about this and other important issues at www.mediStat.com<http://www.mediStat.com> and on Facebook at www.facebook.com/mediStat<http://www.facebook.com/mediStat>.
We would love that! We are extremely proud of what we do. We are open Monday through Friday, 8:00a.m. – 5:00p.m.