Pharmacy Business Plans

Pharmacy Business Plan Review ServicesAny new business venture, whether it may be the actual startup of an entirely new pharmacy operation, or simply the addition of a new service line to an already existing business, must begin with a well thought-out business plan. The plan is best developed through a process of careful and thorough consideration of the business’s potential strengths, weaknesses and chances of successfully capturing enough market share to sustain both growth and profitability. To get the most optimal operating results from the very start, plus generate the largest possible return from their investment, the business plan requires both time and effort from the pharmacy owner, who must answer numerous detailed and sometimes difficult questions that will ultimately “frame” the viability and feasibility of the plan. The business plan serves not only as an assessment of the new venture’s feasibility, but additionally serves as both an accounting of the various resources that may be required for the success of the new startup or expansion, and as a tool for measuring the progress along the way. Basically, the business plan is your road map on how best to quickly and efficiently achieve your business’s objectives and ultimately attain your goals.

How Do I Develop My Business Plan?

When initially starting out and “mapping out” your business plan, you must first describe who you are and exactly what it is that you plan on doing. As part of this initial step, the owner should also specify exactly what their business’s USP is (Unique Selling Proposition). In other words, what exactly does your business offer to potential customers that differs from your competition and sets your business apart from the rest of your competitors, resulting in both an increased volume of business, plus ensure customer loyalty and satisfaction.

The next step of the business plan “development process” requires that the owner both identify and quantify several sectors of the local business environment currently existing in each of the possible physical locations that are under consideration for “housing” the business. Some examples of the specific questions that every business owner should be asking include:

  • Who are my potential customers and exactly who is my “Target Audience“?
  • Did I properly assess the proposed location to determine if it’s the very best possible location that’s available?
  • Where do my new customers and clients actually originate? Some examples may include individuals who live &/or work in the local community, referrals, health plans, partnerships, etc. (to list just a few of the numerous possible sources of new customers available to a new business startup).
  • Where are your potential new customers currently receiving their care, services and products from?
  • Who are my competitors and which ones  are more successful than the others? Why are they seeing more success and what exactly are they doing or offering that’s different from the rest of your competition?
  • What advantages do my competitors have (services, pricing, convenience, etc.) that I must meet or beat?
  • What advantages do I have that perhaps my competitors don’t possess or currently know about?
  • What are the potential barriers to “market entry” that may be encountered?Restricted payer plans, access to referral sources, affiliations with hospitals or clinics, represent just a few of the potential barriers that your new venture may be facing.
  • How will I encourage my competitor’s customers to switch over to my business?  (marketing plan)?For those who have ever participated in a SWOT analysis in the past, the process will resemble that exercise and result in a similar outcome. The goal of both strategic planning techniques is to help a business owner or an organization to identifying their existing Strengths, Weaknesses, Opportunities, and Threats (hence SWOT) that are relevant to their business.

Once the business owner thoroughly describes and/or defines the local market and customer profile, a financial assessment is then necessary to project the total anticipated amount of money that will be required in order to achieve the initiation or launch of the plan. Both the optimistic and the pessimistic projections that are received should be thoroughly assessed to determine the financial reserves that are necessary to have on hand (or have access to) in case there’s any deviation from the anticipated performance, projections and/or initial estimates. A comprehensive financial assessment will also provide the business owner with a realistic view of the viability of the plan, the resources needed, plus provide the metrics to measure the business’s performance by.

A summary of the plan and findings is the last step of the process. This summary provides the pharmacy owner with a detailed timeline, including both expenditures (both those already encountered and those still anticipated) and the  dates of the major milestones or event completion dates that can be expected during a pharmacy startup or expansion project. HCC can also present you with details regarding possible exit strategies that may be available to you when you are ready, plus help you to define your future plan for the business.

What are the Basic Considerations for a Pharmacy Startup?

The basic considerations that you will need to focus your attention on when planning to start up a new pharmacy business or expanding your existing pharmacy operation by adding new service lines are listed below. They’re broken down into three (3) categories: Startup Costs, Operating Costs and Cash Flow.

Start Up Costs –
– Facility build out or renovations
– New equipment
– Personnel
– Inventory
– Licensing
– Permitting
– Accreditation

Operating Costs –
– Monthly recurring overhead costs
– Staff salaries and benefits
– Marketing
– Professional fees (legal, consulting, accounting, etc.)

Cash Flow –
– Projected revenue growth – includes both dispensing related and service related revenues (examples include MTM, vaccinations, etc.)
– Inventory levels versus availability – this includes the actual costs of maintaining an inventory of legend drugs, over-the-counters (OTC) goods and numerous other patient supplies
– Anticipated margins
– Costs of providing Outstanding Customer Service – this may include ongoing education for your staff, Rx deliveries, special packaging, plus the time for providing patient counseling and other clinical services
– Anticipated Fees – credit card processing, RX switch fees, anticipated DIR fees, etc.
– Projected or anticipated Break Even (BE) Point
– Total spend (start up plus cumulative burn rate) until BE Point

Although the development of a business plan requires significant time and effort, it’s a MUST DO for starting up any new business! It basically provides the “road map” to be followed in preparing for a successful launch of the business and for measuring the operation’s progress over time. If the business owner is seeking external funding such as banks, investors or partners, then a polished business plan is an absolute must!

Who Can Help With My Business Plan?

Healthcare Consultants has assisted scores of pharmacy business owners and managers like yourself in the planning and assessment of both new or expanded business opportunities. We have in-house experienced specialists and experts in all facets of pharmacy operations – retail, small chain, compounding, mail order, specialty, LTC, hospital, ACO, 340B, etc. – that can provide you with all the relevant details on a “granular level” that you need to be successful. We help our clients to “drill down” into the plan’s key aspects to help them get a better understanding of how to achieve their goals, maximize their ROI (return on investment) and reduce unwarranted expenditures during the implementation of the plan’s. In short, both our experience and expertise allows us to provide our clients meaningful insights and industry metrics, resulting in a more realistic and refined business plan.

If you are considering starting a new pharmacy or simply expanding with an additional service line, contact HCC online now or call us today at 800-642-1652 to discuss how we can assist you in both the planning and the implementation that are necessary in meeting your objectives and attaining your goals.


Share This:
Facebooktwitterpinterestmail

Opening a Successful New Pharmacy Business – What You Need To Know

New Pharmacy ConsultationStarting up and opening a new pharmacy business is really not that much different from starting up any other type of retail operation or business enterprise. Aside from the regulations and laws inherently involved in a new pharmacy startup being planned, built and opened, the basic business startup principles still all apply. Having opened up hundreds of new pharmacies here at Healthcare Consultants, let’s discuss some of the general retail business guidelines that any entrepreneur MUST consider to be the very basics for your investment to become both a successful and profitable endeavor.

On average the owner of an independent retail community pharmacy makes an estimated two-hundred and fifty thousand dollars annually (~ $247,000). Keeping in mind that the independent community pharmacies still hold roughly a thirty percent (30%) share of the overall retail prescription market, one can easily see why so many new drugstores are constantly being opened up. Yet the entrepreneur must also take into consideration the most recent reports from the National Community Pharmacists Association (NCPA). The NCPA reported that there’s actually been approximately a ten percent (10%) decline since 2001 in the total number of independent pharmacies that are operating in the United States. According to the NCPA statistics released, there are currently an estimated 22,000 independent community pharmacies versus the 25,000 retail independents operating nationally in 2001. The point is, that while starting up a new pharmacy business can be very rewarding financially, like any other retail business it must be properly planned and executed correctly to wind up as a profitable business investment and venture in the end.

Start With a Written Business Plan

Any successful entrepreneur will tell you that a written business plan is the key to success when starting up a new business of any kind. Basically, your business plan should contain your business goals, the reasons that they are achievable and a detailed plan for reaching them within a certain time-frame. Most entrepreneurs look at a business as they would a map. Would you set out driving a long distance without a map or knowing the fastest and safest route to get to your ultimate destination? Of course not. The same is true for starting up a new pharmacy – outline the fastest and safest route to achieving a profitable,stable and well run pharmacy operation. Keep in mind that, like the example of the map we used, your business plan must be flexible and allow for changes and contingencies. As with driving, the roads may be under construction or blocked, so sometimes even the best laid plan needs some ongoing adjustments or modifications made to it. The same holds true with a new pharmacy start-up. Being flexible and prepared to make business adjustments or changes when certain conditions call for them is the key to achieving a profitable venture in the end. I think that most can agree on the fact that no businesses change as fast and as consistently as is seen in the pharmacy profession. Additionally, a solid business plan can greatly assist you in obtaining the support and funding from banks and other lenders that may be required to meet your goals and objectives.

Is a Pharmacy’s Location a Critical Consideration?

As with any retail business, the three most important factors that will need your consideration are: location, location and location! It is imperative that you first determine who your target market and audience is, and then select a location where they frequently shop for goods and services. Your new pharmacy startup may offer customers the very best of everything – great service, low prices, excellent product selection – but if your target market doesn’t frequent the location that you’ve chosen,  you will likely not be open for very long.

Most entrepreneurs view choosing their business’s retail location as they would fishing. To be successful while fishing you must throw your line and bait where the fish are. There’s no use fishing where the type of fish you’re trying to catch don’t swim and eat! The best fishermen put in the time and energy to research the best fishing spots. The same holds true for determining where to start your new pharmacy. Intensive research should be performed before choosing your pharmacy’s location. Economic data such as average family income in a specific zip-code or neighborhood is readily available these days. You may want to consider hiring a professional market research firm to provide you accurate data before you select a location. Additionally, look for retail outlets that are already thriving with business and shoppers. You may have to pay a higher rent, but the rewards and results will be worth it.

Design – Both the Outside and the Inside

Design of both the inside and outside of your new pharmacy can be a major key in the business becoming a successful venture. In order to determine what would be the best possible presentation and appeal for prospective customers, think about forming what the large advertising agencies and marketing companies refer to as “marketing focus groups” before making up your mind. Try and remember that you are not your own target audience and that it’s extremely hard to be objective about your own business. Consider hiring a professional store designer and then enlisting a sampling of people that represent your ideal customer base. You may be shocked to find out that what you had in mind may not be in alignment with the feedback you may receive. So be open minded and remember that becoming a profitable business is your goal, not satisfying your ego!

How Much Money Does It Take To Start a Pharmacy?

Your answer to this “dangerous” question will become much clearer after your business plan is written and finalized. Obviously, you will need to include all of the potential and possible initial startup costs, plus take into consideration such ongoing costs as staffing (if necessary) and marketing. Additionally, a brand new pharmacy takes time to start generating any profit, so a realistic operating budget is a must. Acquiring a credit line and researching how best to obtain additional funding should you need it are both highly suggested steps to execute at the very beginning of the start-up process.

Should Your Marketing Begin Before You’re Open For Business?

Don’t make the mistake of waiting until your pharmacy is ready to open up to initiate your marketing! Have your website and Google Business Listing already completed and fine tuned before you actually fill your first prescription. Explore the use of direct mail and social media prior to the “Grand Opening” to create a buzz. Additionally, consider some form of an initial promotion to get those curious shoppers to stop by and hopefully become customers of your business. We have seen some owners of new pharmacies experimenting and trying various different offers, but the “time tested” promotion that often times is seen to work the best is to offer a major incentive for each prescription that is transferred into your pharmacy by your customers.

Enlist the Experts!

You may have already talked with an attorney or accountant, BUT the most important expert of all is a seasoned Pharmacy Consultant on your team. Healthcare Consultants is known as the leader in helping pharmacy owners plan, purchase, setup and staff their pharmacies nationwide. Having opened hundreds of new pharmacies and pharmacy startups, HCC will ensure that all aspects of the business are covered and done right the first time.

If you are truly considering starting up a new pharmacy business, we strongly urge you to get in touch with us today for a free consultation. We offer you the support of an experienced staff who have been through the process numerous times and know the business inside and out!  With over 30+ years of experience, Healthcare Consultants Pharmacy Staffing has helped hundreds of business owners (both pharmacists and non-pharmacists alike) establish successful businesses over the years.  Contact us now online or call us today at (800) 642-1652 to discuss how we can help you.

 


Share This:
Facebooktwitterpinterestmail

340B Pharmacy Consulting

340b pharmacyManagement of an in-house 340B pharmacy by a hospital is often times more complex and complicated than the hospital’s administrators may had initially anticipated. On the “surface” a hospital or healthcare system administrator can easily see the potential profitability that the specialty pharmacy can generate for them. Ever since the creation of the federal 340B Drug Discount Program in 1992, the program has been seen as the primary catalyst for the rapid growth and expansion of specialty pharmacies in hospitals and healthcare system facilities that’s been occurring over the past decade or two.

The 340B Program was actually a section of the Public Health Service Act (PHSA) that was signed into law by then President George Bush and was intended by the HRSA (U.S. Department of Health and Human Services, Health Resources and Services Administration) to allow covered entities to “stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The new program was aimed at both maintaining the levels of services provided to patients, while at the same time lowering the patient’s medication costs.

340B Hospital Pharmacy Medication Management Review – Case Study

Recently Healthcare Consultants was hired for our nationally renowned Pharmacy Consulting Services by a hospital located in the Northeastern US that’s a part of a large community healthcare system with multiple locations. Initially engaged by the hospital’s administration to perform reviews of the facility’s medication security and accountability (with a focus on CS), we were additionally tasked with identifying any other areas of risk exposure that currently existed (or could potentially arise sometime in the foreseeable future).

The Medication Management Review that HCC performed identified several existing areas of risk that were present at the hospital:
– Significant gaps were identified in the controlled substance monitoring program in place.
– Ineffective Medicaid billing practices were in place.
– Poor data management within the 340B system was seen, leading to a large potential for inaccurate billing.
– A high potential for diversion existed (ineligible prescription dispensing).
– The potential of medication use that is outside of the scope of the 340B program existed.
– An increased risk of potential regulatory actions and recoupment demands (potentially in the millions of dollars).
– Pharmacy management concerns were identified and documented.
– Poor communication (both vertically and horizontally) with the hospital’s senior leadership team was identified (as relating to increased pharmacy risks being present).
– A lack of transparency within the pharmacy department was documented, enabling the operation’s staff to practice “siloing” and isolate from one another.
– Inadequate forecasting and planning processes were in place.
– No accountability system in place that would allow the hospital’s administrators the ability to measure their pharmacy’s performance.

The outcome of our findings and report resulted in several key middle and senior management changes, a complete recasting of their 340B program management, a thorough review of their billing procedures, plus a complete pharmacy department “overhaul” under a brand new leadership team. Healthcare Consultants additionally has provided the hospital with both ongoing support and guidance in several key areas afterwards.

Summary of this 340B Case Study

For entities that are currently considering adding a 340B program (or expanding their existing 340B program), proper attention must be given to the structure, scope, and data management that’s required. Inattention at any point of your planning process in any of these areas can easily lead to improper program utilization, which can potentially result in some extremely large recoupment demands being made following an audit. Paybacks in the range of several hundreds of thousands to even several millions of dollars are not unusual. HCC has health system pharmacy experts and 340B program experts that can help you to identify your hospital’s areas of risk exposure and provide remedial solutions to better protect a healthcare system from adverse regulatory and payer outcomes.

About HealthCare Consultants

From major hospitals and healthcare systems to individual community pharmacies, HCC has been the nationally renowned pharmacy consulting firm of choice for over 30+ years now. We work with businesses of every size – from the corner drug store to national corporations and organizations – with our primary goals being: improve your business’s operations and help increase your company’s profitability. We can help assist you with expert advice in any area of your pharmacy business or practice.

We urge you to contact us today to see how our Pharmacy Consulting services can help you improve your business now, plus be ready for the future. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.

 


Share This:
Facebooktwitterpinterestmail

340B and Hospital Specialty Pharmacies

340BCreated all the way back in 1992 as a federal program, the 340B Drug Discount Program required that all drug manufacturers provided their medications and treatments on an outpatient level to eligible HCOs (Health Care Organizations) at appreciably reduced prices. Although many people don’t connect the two, the 340B Program was actually a section of the Public Health Service Act (PHSA) that was signed into law by then President George H. W. Bush.

The intent of the program according to the the HRSA (U.S. Department of Health and Human Services, Health Resources and Services Administration) was to allow covered entities to “stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The intended purpose of the new program was aimed at both maintaining the levels of services provided to patients, while at the same time lowering the patient’s medication costs. Although, as numerous “program non-eligible” independent pharmacy owners have been telling everyone for many years now, perhaps some additional adjectives regarding the program’s pricing discounting should include “extraordinary, seriously, crucially, notably, remarkably, strikingly, glaringly, exceptionally and unusually” when describing the pricing reductions and what has resulted. To fully comprehend what the results of the 340B Drug Discount Program really are, many simply point to what’s been referred to as the “Hospital Specialty Pharmacy Explosion” that’s been seen in most major hospitals and healthcare centers across the nation the past decade.

Did the 340B Program Cause the Increase of Hospital Specialty Pharmacies?

Since its inception in 1992, the 340B Pricing Program has been “accused” to be the primary catalyst for the rapid growth and expansion of specialty pharmacies in hospitals and healthcare system facilities. Let’s take a quick look at a few of the primary reasons this growth trend will continue to accelerate across the USA:

– The potential for sizable profits through the acquisition of discounted specialty medications via the 340B Drug Pricing Program.
– The potential increase in revenue that having a specialty pharmacy allows the hospital to generate by being able to offer new services to potential patients that are afflicted with complex and chronic diseases & disorders that are typically treated with specialty drugs and medications.
– Use of the specialty pharmacy by the hospital’s own staff of employees helping to reduce the hospital’s overall internal benefits costs.
– Increased revenue through the integration of the hospital’s own specialty pharmacy services with Accountable Care Organizations (ACOs), which thus provides incentives for increased services such as patient monitoring and adherence coverage.

The point is that the 340B Drug Pricing Program has always been the catalyst for the growth (or explosion!) of specialty pharmacies at hospitals. And it will continue to be doing that for quite a while in the future according to all projections by experts. The reality is that the hospital that owns its own specialty pharmacy avoids paying any of the fees to a 340B contract pharmacy. Instead, by operating their own specialty pharmacy, the 340B hospital can purchase the required specialty drugs at discounts of seventy to one-hundred percent (70% to 100%!) off the list price. These potential profits from 340B prescriptions essentially provide all the encouragement that a hospital would ever need to invest in owning and expanding its own specialty pharmacy.

If one reads the latest national survey regarding hospital pharmacy practices that was recently released by the ASHP (The American Society of Hospital Pharmacists), the undeniable primary goal of all hospitals and healthcare systems is to maximize their potential ROI (return on investment) in regards to the “capture” of the potentially lucrative specialty pharmacy dispensing revenues. When one looks at it like that, it’s pretty easy to see why in early 2019 almost three-quarters (or seventy-five percent) of all of the major US hospitals (with 600+ beds) already owned their own specialty pharmacy. It’s currently estimated that roughly about twenty percent (20%) of all US hospitals owned a specialty pharmacy. Compare this to the ASHP survey released back in 2016, when approximately only nine percent (9.1%) of all hospitals had a specialty pharmacy in-house. To help keep everything in its proper perspective, it’s important to note that currently it’s estimated that only approximately a little over 30% (or one-third) of all US hospitals actually participates in the 340B Drug Pricing Program. However, drugs sold at 340B pricing now accounts for over five percent (5%) of all medications purchased in the USA annually. Lastly, spending on 340B drug purchases in the year 2016 alone was estimated to be approximately $16.2 billion.

Find a Pharmacy Consulting Firm With Experienced 340B Experts On Staff to Help You!

If you’re considering adding to or expanding your 340B program, then you would probably agree from previous experience that a large portion of your attention must be focused initially on the structure, scope, and data management required. Any inattention now can easily lead to unwanted results such as improper program utilization, which then can obviously result in some extremely large reimbursement and repayment demands following an audit. Paybacks of several hundreds of thousands to even several millions of dollars are not unusual. HCC has health system pharmacy experts and 340B program experts in-house that can identify all of your existing and potential areas of risk exposure, plus provide you with the remedial solutions required to best protect a healthcare system from adverse regulatory and payer outcomes.

About HealthCare Consultants

From major hospitals and healthcare systems to individual community pharmacies, HCC has been the nationally renowned pharmacy consulting firm of choice for over 30+ years now. We work with businesses of every size – from the corner drug store to national corporations and organizations – with our primary goals being: to improve your business’s operations and help increase your company’s profitability. We can help and assist you with expert advice in any area of your pharmacy business or practice.

We urge you to contact us today to see how our Pharmacy Consulting services can help you improve your business now, plus be ready for the future. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.

 


Share This:
Facebooktwitterpinterestmail

Pharmacy Exit Strategy

Exit Strategies For Pharmacy OwnersExit strategies in any business are a critical requirement. Every business owner needs to think through and document exactly what their plan is regarding selling their business when it reaches a certain level or it’s perhaps time for them to finally retire. Perhaps this is even more critical to do if you own an independent retail pharmacy than in most other businesses. Recently we discussed how the opening of new retail community pharmacies and specialty pharmacies was dramatically on the rise across the nation. Yet a review of recent pharmacy related news stories over the past several weeks also reveals that numerous small independent pharmacies were closing, shut down or suddenly went out of business at an increasing and alarming rate.

Pharmacies Suddenly Closed or Shut Down

A recent article from Fox News discussing the issues that many independent pharmacy owners are facing today may help educate the public as to why their local pharmacy suddenly closed its door and the business was unexpectedly shut down. The current situation that the independent pharmacy owner now faces includes having to compete with the large national chains, plus also having to try to make a profit while adhering to policies that were put in place by the insurance companies and hospitals. Some of these policies put the independent pharmacies at a severe disadvantage to be able to do business profitably, plus still perform the critically vital role of serving their customers by filling their prescriptions and provide counseling. Eventually, the beloved corner drugstore may be a memory from the past, just like the typewriter and rotary telephones have sadly become.

Let’s take a closer look at some recent examples of pharmacies suddenly going out of business, closing down or being sold in just the past two weeks!

  1. In Addison, Michigan, the Addison Pharmacy and Gifts in downtown Addison suddenly announced that they were closing their doors and then closed permanently just this past week (August 2nd of 2019). This leaves the City of Addison without an independent pharmacy for the first time since the pioneer era. After eighteen (18) years of owning the pharmacy, Doug and Karol Heidbreder sent a letter to their customers letting them know that the pharmacy was intending to shutdown and close its doors. It’s important to note that the Heidbreder’s did have an exit strategy in place and were able to sell the business to a competitor located in nearby Hudson, Michigan (a drive of approximately fifteen miles from Addison, or thirty miles for the “round-trip”).
  2. The NY Post announced that the Metropolitan Pharmacy, located in Queens, New York and the Metro Pharmacy II, located in Forest Hills, both closed their doors after serving local residents for well over forty years. Owner Ira Lisogorsky who, according to the pharmacies’ customers “had selflessly served the neighborhood” for the past 40 years, stated that “problems with drug companies, as well as regulatory and city policies” led to his decision to shut the two businesses down for good. Lisogorsky also noted that the ever increasing popularity of online ordering combined with “the drug companies screwing us so I make almost nothing on prescriptions” ultimately made the decision easy. So far, according to the article, no buyers for the pharmacies have been identified.
  3. In Richmond, Virginia, the Grove Avenue Pharmacy announced that they were shutting their doors and closing down at the end of August this year according to NBC News. After 73 years at their current location, the family-owned pharmacy announced that they had been purchased by CVS and that all of the prescriptions and patient files would be transferred to the CVS Broad Street location. The owners stated that the “shrinking” prescription volume had caused “financial pressures” and that they simply could not continue to stay open and operate the pharmacy profitably any longer.

Exit Strategies For Pharmacy Owners

Having an exit strategy is a must for all pharmacy owners. The very best of business plans that must be written when a company or corporation is initially being started all include a detailed strategy regarding the “exiting” of the owner of the business at some point in the future. The specifics of challenges, issues and situations that the pharmacy faces obviously may change, however the exit strategy can change right along with them. Every pharmacy business owner should be asking themselves the following questions (or similar ones):
– Will I be able to sell my my business when I’m ready to finally retire?
– Will it be a hard or an easy thing to do?
– How can I project what my business will be worth?
– Should I periodically have an outside third-party perform a valuation of my business?
– Will my wife and/or children be able to run my business if something should happen to me? Are they really prepared for such an occurrence?
– Should I hire a 3rd party to take an objective review of my pharmacy operation and efficiency to give me an unbiased opinion and perhaps get some constructive feedback?
– Do I want to expand my business and if yes, what are the best ways to accomplish that?
– Do I want to consider employee ownership for my valued and key staff members?
– What do I need to change or upgrade in order to make my business more attractive to a potential third-party buyer?

Most pharmacy owners love what they do and work hard everyday to best service their customers and patients and make their business a success. Yet, as an owner of a business ourselves, we strongly urge you to plan ahead and consider developing an exit strategy for your pharmacy business or enterprise.

How Should a Pharmacy Owner Proceed?

A successful exit strategy takes a considerable amount of time, thought and planning. The fact is that the sooner you plan and document your possible exit strategies, the more prepared you will be and the more you will be able to focus on the actual running of your business. A good way to think of an exit strategy is to look at it like you would a map. You know where you want to travel to and eventually end up, but how will you get there? What’s the fastest way to get there, taking into consideration that all of the roads need to be reliable A person would never drive a long distance without consulting a map for the best route (plus their navigation system to see the current conditions on their proposed route), so why would a business owner not “map out” their “business journey”.  As noted above, the best plans and strategies are always flexible and allow you to be able to respond to changes. As most can agree, the practice of pharmacy is perhaps one of the fastest changing environments there is when compared to most other businesses.

HCC Has the Experience to Help You!

If you are considering selling your pharmacy business in the future,or simply want to prepare and explore your options, we strongly urge you to get in touch with us today for a free consultation. We offer you the support of an experienced staff who have been through the process many times and know the business inside and out! With 29+ years of pharmacy consulting experience, HCC has helped hundreds of business owners (pharmacists and non-pharmacists alike) get prepared by evaluating their business and exploring their possible exit strategy options.  Contact us on line or call us today at 800-642-1652 for a Free Consultation to find out how we can help you too.

 

 

 

 

 

 

 

 

 

 

 


Share This:
Facebooktwitterpinterestmail

Infusion Partners Received an FDA Warning Letter

warningAfter the 483 Form that we previously discussed is responded to by the outsourcing facility, the FDA has the option to then send an FDA Warning Letter if they’re not satisfied with the response and/or action plan that’s presented to them. In March of 2019 the FDA issued such an actual Warning Letter to Infusion Partners LLC located in Canfield, Ohio (Please note that Infusion Partners, LLC is actually part of the BioScrip Inc. “family”, BioScrip being the largest independent national provider of infusion and home care management solutions in the country, with over seventy locations across the USA).

What Actually Transpired With Infusion Partners to Warrant an FDA Warning Letter?

Beginning on January 22nd of last year, the U.S. Food and Drug Administration (FDA) investigators inspected the Infusion Partners facility that’s located at 4137 Boardman-Canfield Road, Suite L104, in Canfield, Ohio. They spent almost four full days observing the operation’s procedures and staff routines and left on January 26th of 2018. The FDA investigators documented what they considered to be “serious deficiencies” in the policies and practices for the manufacture and production of sterile medications and drug products by the outsourcing facility, which they deemed “put patients at risk”.

Pursuant to the inspection, the FDA issued a 483 Form to the facility and acknowledged the receipt of the facility’s two responses (dated February 15, 2018 and August 8, 2018). Based on the initial inspection observations and the facility’s responses, the FDA concluded that they were not satisfied and that Infusion Partners was producing medications and drug products that violated the Federal Food, Drug, and Cosmetic Act (FDCA).

What Does the FDA Warning Letter Actually Say and Include?

On March 20th of 2019, the FDA’s Division of Pharmaceutical Quality Operations issued an actual Warning Letter to Infusion Partners. You can click here to actually view the Warning Letter to Infusion Partners in its entirety, but let’s take a quick look at several of the important points noted by the FDA within the actual Warning Letter.

  1. Even though it is labeled simply as a Warning Letter, the reality is that the FDA actually opens what’s called a “Case” against the facility receiving the letter. In this example the Case number is #575451 and everything is published openly on the FDA’s website. Anyone can easily follow the case and watch how the process works as this case progresses in the future.
  2. The FDA included a specific list of the violations of the FDCA that they had observed during their inspection. This list basically matches the initial 483 Form that was previously sent, but now specified that the facility was “accused” of preparing and distributing what the FDA classified as “Adulterated Drug Products”. The FDA investigators noted that “drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing the products to be adulterated under section 501(a)(2)(A) of the FDCA”. The Warning Letter then listed five (5) specific issues that had been observed and documented during the inspections, such as deficiencies in the actual design of the ISO 5 area, problems with the HEPA Filter itself, plus poor aseptic technique practices by the facility’s staff.
  3. Also included in the Warning Letter was a review of the “Corrective Actions” already taken and/or proposed by Infusion Partners in their two responses to the 483 Form. However, in three (3) separate violations, the FDA found the facility’s corrective actions and/or their future plans aimed at corrective actions to be inadequate. Once again, reading the actual Warning Letter may help an owner or manager better comprehend the level of detail that the FDA is documenting during their inspections and the extent of actual changes that they are requiring to be initiated at compounding pharmacies and outsourcing facilities throughout the USA.

    What Happens Next Now That Infusion Partners Has Received an FDA Warning Letter?

It’s extremely clear that the message that the FDA is sending is simple: They are seriously letting everyone know that patient and consumer safety is their primary goal and that they intend to continue (and perhaps even intensify) their efforts to make compounding pharmacies and outsourcing facilities throughout the nation strictly adhere to “Best Practices” in all areas of their operations.

The Warning Letter is also extremely clear regarding what the FDA expects Infusion Partners to do next:
– They expect a written response to the Warning Letter within fifteen (15) days of receipt by Infusion Partners. They expect a detailed plan of the specific steps that have already been taken by the facility to correct existing violations, plus an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
– If the corrective actions cannot be accomplished within fifteen (15) working days, they require a detailed explanation of the reasons for the delays, plus a proposed  date and time-frame which the facility will meet to complete the corrective actions required.
– They stress “Prompt Action”! They point out very clearly that the failure to promptly correct these violations “may result in legal action without further notice, including, without limitation, seizure and injunction”.

It must also be noted that the FDA places the burden of not only fixing the problems that they documented during their observation and inspection, but that it is in their view the facility’s responsibility to investigate and prevent the occurrence of any other violations in the future. As they clearly stated to Infusion Partners within their Warning Letter: “It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations”.

Lastly, it’s important to note that the FDA strongly recommends that all facilities initiate and undergo a comprehensive assessment of their facility’s current operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. As the FDA actually states: “A third-party consultant with relevant sterile drug production expertise should assist you in conducting this comprehensive evaluation”. 

About Healthcare Consultants

Healthcare Consultants has been known as a national leader in pharmacy consulting for over 30+ years now. Since 1989, our network of experienced pharmacy consultants and in-house specialists have provided expert guidance across all sectors of the pharmacy industry. We work with pharmacies of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations.

One of the services that HCC specializes in is the development and customization of both 503A and 503B Policies and Procedures. We have nationally renowned in-house experts and consultants with proven “track records” and successful results in responding to both FDA 483 Forms and Warning Letters.

We urge you to contact us today to see how our Pharmacy Consulting services can fit your needs and help you improve your business now, plus be ready for the future. With a full-time staff of experienced in-house Pharmacy Consulting specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online now or call us today at 800-642-1652 for a free consultation.

 

 

 


Share This:
Facebooktwitterpinterestmail

FDA 483 Actions

FDA 483 ActionsAfter discussing the difference between an FDA Form 483 and an FDA Warning Letter, it may perhaps be worthwhile to take a closer look at some of the most recent actions that have occurred (including new FDA 483 Forms and Warning Letters). Although perhaps a couple of months have already passed, but March of 2019 makes a great example for looking at exactly how aggressively the FDA is proceeding with their efforts on these facility inspections.

How Many FDA 483’s and Warning Letters Were Issued in March of this Year?

In just the month of March, the FDA issued a total of eleven (11) 483 Forms (including FMD 145 letters) and one (1) Warning Letter. Let’s take a closer look at some of these examples and take a closer look at what the FDA observers and inspectors are actually concentrating on when they visit a facility.

Please take note that you should probably download each of the 483 forms discussed in the examples below and take a closer look when time permits (we’ve included a link for each individual 483 form for downloading the actual PDF posted on the FDA’s website). In both of the first two examples that we’ll take a look at there are nine (9) observations total, but a closer look reveals that each observation may have numerous additional points “attached” to it that also need to be addressed by the compounding facility.

  1. QuVa Pharma Inc. in Temple, Texas is known for providing 503B outsourcing services and concentrates on compounded drug formulations and medications for obstetrics, OR, anesthesia, general medicine, cardiovascular, ER, and pain management. QuVa received a 483 Form after an observational inspection on March 14th of 2019. Click here to download a full copy from the FDA that you can review, but the operation was listed with a total of nine (9) “observations” on the 483 Form. The majority were based on a lack of procedural documentation and the lack of written Policies and Procedures specific to how they perform their compounding services.
    Two that summed up the observations are definitely worth noting here:
    – “Written procedures are lacking which describe in sufficient detail the receipt, identification, approval, and rejection of components”.
    – “There are no established written methods of cleaning or methods of processing to remove pyrogenic properties”.
  2. ACRx Specialty Pharmacy located in Las Vegas, Nevada performs both sterile and non-sterile compounding of products, specializing in Women’s Health products, Ophthalmology, Thyroid Dysfunction and Weight Loss. ACRx retrieved a 483 Form on 3/20/2019. The 483 listed a total of nine (9) “observations”, and as in the QuVa example above, the majority were based on a lack of procedural documentation and the lack of written Policies and Procedures specific to how they actually perform their compounding services. Click here to download the entire 483 Form that they received.
    Just to point out quickly again what the FDA was concentrating on while observing the operation of the compounding facility, let’s use the exact verbiage from the form:
    – “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established”.
    – “Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, instructions for protection of clean equipment from contamination prior to use and parameters relevant to the operation”.
  3. Customceutical Compounding located in Phoenix, Arizona received a 483 Form on March 8th of 2019 (Click here to download the entire 483 Form that they received). Known primarily for the compounding of Injectable Medications, Ophthlamics (eye drops & ointments), Inhalation Solutions and Intrathecals, they had a total of five (5) documented observations noted. Again, the observations centered around the fact that the facility’s “procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not adequate”.
  4. Front Door Pharmacy (DBA Pure Pharmaceuticals) in Houston, Texas received their 483 Form on March 20th this year. (Once again, click here to download the entire 483 Form that they received as a PDF from the FDA website.) Front Door Pharmacy had a “whopping” eleven (11) documented observations that included a lack of documented policies and procedures as noted in the examples discussed above. However, the specificity of some of the observations that were noted make a great example of the level of actual “scrutiny” that the FDA is exhibiting:
    – Personnel engaged in aseptic processing were observed with exposed skin.
    – Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves.
    – Equipment and materials or supplies were no disinfected prior to entering the aseptic processing area.

How Do You Prepare For the Inevitable FDA Inspection?

Once again, these are just a few examples of the detailed level of observation and documentation that the FDA is exhibiting. An actual discussion of each noted observation for each 483 Form would take several hours, but we recommend that you actually take a very close look at at least one of these forms that were issued to get an accurate idea of the depth of the the detail involved. Keep in mind that the FDA will thoroughly review the facility’s response and revisit to see whether or not the operation is doing their utmost to be in compliance. Also consider that if the response is found to be lacking, then the next step is the “dreaded” Warning Letter!

The answer is to take action now and be prepared! In other words, take a look now and don’t wait for the inevitable inspection that is certain to come! The FDA strongly recommends that you undertake a comprehensive assessment of your facility’s current operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. As the FDA actually states: “A third-party consultant with relevant sterile drug production expertise should assist you in conducting this comprehensive evaluation”. The FDA also points out very clearly that “It is YOUR responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations”.

Which Third-Party Pharmacy Consulting Firm Can Help Me?

Healthcare Consultants has been known as a national leader in pharmacy consulting for over 30+ years now. Since 1989, our network of experienced pharmacy consultants and in-house specialists have provided expert guidance across all sectors of the pharmacy industry. We work with pharmacies of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations.

One of the services that HCC specializes in is the development and customization of both 503A and 503B Policies and Procedures. We have nationally renowned in-house experts and consultants with proven “track records” and successful results in responding to both FDA 483 Forms and Warning Letters.

We urge you to contact us today to see how our Pharmacy Consulting services can fit your needs and help you improve your business now, plus be ready for the future. With a full-time staff of experienced in-house Pharmacy Consulting specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online now or call us today at 800-642-1652 for a free consultation.

 

 


Share This:
Facebooktwitterpinterestmail

Recent FDA 503 Actions

FDA 503 ActionsLast month the The FDA (U.S. Food and Drug Administration) was extremely busy taking actions in regards to 503B outsourcing facilities and 503A compounding pharmacies. A review of many of these FDA 503 actions indicates an increased and aggressive program aimed at both outsourcing facilities and compounding pharmacies that included numerous onsite inspections, warning letters, recalls, and other actions such as the issuing of Compounding Risk alerts. However, one case in particular may be worth taking a closer look at and discussing further. This is the conviction of pharmacy owner Paul Elmer, the founder of Indiana’s only Outsourcing Facility, who was found guilty on April 11th of 2019 in federal court on ten (10) counts that he was charged with: nine (9) for adulterating compounded drugs and one (1) for conspiracy. Note that Mr. Elmer was acquitted on an Obstruction of Justice charge, plus his sentencing date has not yet been set.

The Events Leading To The Conviction

Mr. Elmer was the founder of Pharmakon Pharmaceuticals in 2003, which was initially located in Indianapolis, but was moved to Carmel, Indiana in 2008 and then finally to Noblesville in 2014. As we noted above, Pharmakon Pharmaceuticals (based out of Noblesville) was the only 503B Registered Outsourcing Facility in the State of Indiana. Many have pointed out, however, that the company shared ownership of the facility with a larger and successful LTC pharmacy named Pharmakon Long Term Care Pharmacy, Inc. (which is also based out of Noblesville, Indiana).

Basically the charges centered around the pharmacy’s history of manufacturing and selling medications and drugs that were both either more potent and/or less potent than what they should have been. Pharmakon compounded medications such as morphine and fentanyl at its Noblesville facility and then shipped them to hospitals throughout the USA. Examples of major hospitals that Pharmakon Pharmaceuticals supplied included the Walter Reed National Military Medical Center in Washington, D.C. and the Community Health Network in Indiana.

Prosecutors presented voluminous documentation and third-party evidence that showed that over a four (4) period (between July 2013 through February of 2016), the company had received seventy (70) potency-test failure notices, proving that the drugs they shipped out (such as morphine sulfate and fentanyl) were either compounded “under dosed” or “overly potent”. In one third party potency test the medications were as documented as being as much as twenty-five (25) times more potent than what they should have been. Many concerned citizens feel that the fact that the drugs were dispensed at the hospitals for use in the treatments of infants, children, geriatric and elderly patients (plus many military veterans) in affect made the case against Pharmakon take on an “elevated profile and urgency” by the FDA. Another point that was frequently discussed was the fact that Pharmakon had previously received greater than half a million dollars ($500,000) in tax breaks and other incentives from both state and local governments. The prosecutors in this case actually cross examined over 10 witnesses that primarily included former Pharmakon employees, some who testified that Mr. Elmer was always aware that his company was actually shipping dangerous drugs to many hospitals.

A Closer Look At the FDA’s 503 Processes

To help everyone have a better understanding of the steps undertaken by the FDA in this process, let’s take a chronological review of what took place between the FDA and the outsourcing facility before Pharmakon Pharmaceuticals was finally shut down in 2016 (and owner Paul Elmer finally being found guilty in April of this year).

  1. The FDA issued 483 Forms to Pharmakon on 3/13/2014 and again on 4/8/2014.
  2. These were followed up with an FDA Warning Letter on 5/21/2015.
  3. Pharmakon initiated a voluntary recall of batches of “super-potent” morphine sulfate on 2/11/2016 that they had already previously shipped to hospitals across the nation. In one instance occurring in 2016, Pharmakon had shipped and distributed morphine sulfate compounded at their facility that had a potency level of over 2,400% to several hospitals in both Indiana and Illinois. One infant who received the medication actually had to be taken by an emergency helicopter to the Riley Hospital for Children in Indianapolis for care.
  4. A team of four FDA investigators initiated an onsite inspection of Pharmakon Pharmaceuticals on 2/18/16, which ended on 3/16/2016 with the issuance of an FDA 483 Form to the facility as the result.
  5. The FDA then issued an Amended 483 again to the facility on 3/21/2016.
  6. On 4/11/2016, the FDA recommended a recall of all unexpired products and a cessation of Pharmakon’s sterile compounding operations until appropriate corrective actions had been undertaken and demonstrated. The very next day (4/12/2016) Pharmakon informed the FDA that it would neither perform the recall, nor cease their sterile operations.
  7. On 4/15/2016, the FDA alerted health care practitioners throughout the US to NOT utilize any sterile drug products distributed from Pharmakon Pharmaceuticals, Inc. to any patients under any circumstances.
  8. On 4/18/2016, the FDA additionally began an inspection of the Pharmakon Long Term Care Pharmacy, Inc.
  9. Finally, on 4/19/2016, Pharmakon issued a voluntary nationwide recall of all sterile compounded products and totally ceased compounding operations temporarily.
  10. On 5/11/2016, Pharmakon Long Term Care Pharmacy was issued a 483 Form pursuant to the FDA inspection.
  11. On 5/20/16, Pharmakon Pharmaceuticals resumed production of sterile compounds and medications once again.
  12. On 6/16/16, a PDF of the Pharmakon Long Term Care Pharmacy 483 Form was posted to the FDA website.

About HealthCare Consultants

HCC is known as a national leader in pharmacy consulting. Since 1989, our network of seasoned advisers and in-house specialists have provided expert guidance across all sectors of the pharmacy industry. We work with businesses of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations.

One of the services that HCC specializes in is the development and customization of both 503A and 503B Policies and Procedures. We have nationally renowned in-house experts and consultants with proven “track records” and successful results in responding to both FDA 483 Forms and Warning Letters.

We urge you to contact us today to see how our Pharmacy Consulting services can fit your needs and help you improve your business now, plus be ready for the future. With a full-time staff of experienced in-house Pharmacy Consulting specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online now or call us today at 800-642-1652 for a free consultation.

 

 

 


Share This:
Facebooktwitterpinterestmail

FDA Form 483

483 FormMany compounding pharmacies have been asking “what is the difference between an FDA Form 483 and an FDA Warning Letter?”. The FDA (U.S. Food and Drug Administration) has been extremely busy and is dramatically stepping up their efforts at inspecting 503A compounding pharmacies across the nation. Officially named by the FDA as a Notice of Inspectional Observations, it is usually referenced as simply a 483 Form by most people. The 483 Form is the result of an FDA onsite facility inspection where the FDA inspector has observed any existing irregularities, potential problems and/or any deficiencies in your processes and systems that could result in unsafe conditions present that potentially could violate the FDCA (Food, Drug, and Cosmetic Act).

What Is an FDA Warning Letter?

After an onsite inspection, the FDA inspector will submit a final 483 Form to both your business and to their supervisors. It is then the compounding pharmacy’s option to submit a response within fifteen (15) working days documenting any corrective actions taken, plus all future actions that they plan on initiating to achieve compliance. However, it’s important to note that if your response to the 483 Form is determined to be lacking or insufficient, an FDA Warning Letter may be issued to your firm. Additionally, if the onsite inspection turns up with deficiencies that are serious enough in nature to warrant it, the FDA will not wait for your response, but may instead choose to almost immediately issue you an FDA Warning Letter.

This FDA Warning Letter is considered to be the FDA’s notice that you have been found to be significantly violating FDA rules and regulations. It usually lays out the FDA’s most serious concerns, but always states that the list is not all-inclusive and almost always encourages the cited firm to retain a “third party consultant with relevant sterile drug processing expertise”. The FDA attempts to make it extremely clear what is expected of your facility by the FDA to correct the existing and potential problems. It also stipulates a time period that requires you to inform the FDA of your specific corrective actions and plans for correcting the issues asap, plus it must also include any future plans that are to be established to prevent the issue from reoccurring. The FDA will thoroughly go over each response individually to make sure that both the immediate actions taken and any future actions planned at your facility are adequate to satisfy them and that the proposed corrections are deemed as sufficiently acceptable.

How Best To Respond to an FDA 483 Form or Warning Letter

Your response to a 483 Form or Warning Letter is critically important! It is best to respond as promptly as possible, thus establishing the fact that you are taking the form &/or warning as seriously as the FDA does. However, you don’t want to be reactive and state something in your response that can be misconstrued – so it’s best to take your time and get your response as perfect and concise as is possible.

You must clearly identify a “course of action” that lists each specific procedural adjustment that you are instituting immediately, plus all future actions that you intend to pursue to correct the inspector’s findings. This must be completed  within the FDA’s specified time frame (which many times differs from case to case). A comprehensive response to each documented observation &/or violation that was noted is also mandatory. These factors mean that BOTH the quality and the promptness of your response to the 483 Form or Warning Letter are both critically important.

What Should YOU Do After Receiving an FDA 483 Form or Warning Letter?

Your response to an FDA 483 Form or Warning Letter is critically important. You will have fifteen (15) working days to submit your response and it should lay out your detailed plan to remedy each observation, including an expected timeline. Never set yourself an unrealistic timeline, because the FDA will hold you to it.

Consult an expert! Although these inspections are going to continue (and probably increase in frequency), the truth is that your response is the first step in “pleasing” the FDA and it needs to be both complete and accurate. Responding to such FDA forms and letters is not a skill that most business owners or pharmacists have any expertise in, yet the response is far too important to be neglected or taken lightly. Another way to look at your response is that it needs to be customized to your individual operation’s environment, policies and procedures, so a response using a generic template is discouraged and obviously not recommended. If you do not already have an active ongoing relationship with an established and experienced Pharmacy Consulting Firm, NOW is the time to find the right one. For some tips and advice on helping you choose the best pharmacy consulting company for your specific needs, please visit our previous blog post: How To Choose a Pharmacy Consulting Firm.

About HealthCare Consultants

HCC is known as a national leader in pharmacy consulting. Since 1989, our network of seasoned advisers and in-house specialists have provided expert guidance across all sectors of the pharmacy industry. We work with businesses of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations.

One of the services that HCC specializes in is the development and customization of both 503A and 503B Policies and Procedures. We have nationally renowned in-house experts and consultants with proven “track records” and successful results in responding to both FDA 483 Forms and Warning Letters.

We urge you to contact us today to see how our Pharmacy Consulting services can fit your needs and help you improve your business now, plus be ready for the future. With a full-time staff of experienced in-house Pharmacy Consulting specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online now or call us today at 800-642-1652 for a free consultation

 


Share This:
Facebooktwitterpinterestmail

GHRP

GHRPGHRP is short for “Growth Hormone Releasing Peptide” and is in the category of drugs known as Growth Hormone Secretagogues (GHS). These peptides actually stimulate the body’s natural release of the naturally occurring growth hormone (GH), primarily by stimulating the pituitary gland to produce more GH. The GHRPs of most interest are GHRP-2, GHRP-6, Hexarelin, and Ipamorelin. These GHS drugs differ in their receptor binding affinities and clinical effects.

Almost everyone can agree that they do not want to suffer the bodily decay associated with aging. Growing older is accepted as a natural part of  our lives, so long as we still are able to feel and act youthful. This basic human desire is as old as mankind itself and has led many to search for the so called “Fountain of Youth” throughout human history. This age-old conundrum has spawned many industries, mostly legitimate, but some obviously a bit “shady”, that basically target our desire to maintain our youth. Recently, an increase has been taking place in the use of these Peptides medications and drugs (GHRP drugs) by anti-aging and men’s health clinics across the USA to achieve this end.

What is the Background and History of these GHRPs?

GHRPs were first described and documented in scientific literature in 1984,  highlighting their GH releasing effects on human pituitary tissues. Soon after, studies identified many non-pituitary derived effects suggesting tissue specific receptors. GHRPs have been shown to be potent ghrelin receptor agonists. Ghrelin, a peptide hormone mainly secreted by the stomach, has been identified as the endogenous ligand of the GH secretagogue receptor (GHS-R) and has a potent GH releasing effect. In addition, ghrelin stimulates food intake and promotes an increase in body mass by a GH-independent action. All of this data suggests that ghrelin plays an important role in the regulation of an individual’s metabolic balance.

Additionally, early cell culture and animal studies identified non-GH related cytoprotective effects of GHRP that included cardioprotective effects with Hexarelin and GHRP-6, plus additional anti-inflammatory effects associated with GHRP-2. Other animal studies have linked the GHRPs with hepatoprotective effects as well. This class of drugs has demonstrated what’s been called “tantalizing potential” in numerous treatment areas, but so far there remains a lack of any conclusive efficacy and safety results derived from well designed human trials. Currently, GHRP6 and its synthetic analogs are only approved for uses in the clinical diagnosis of different forms of Dwarfism.

What are the Current Clinical Uses of GHRPs?

There is currently no approved therapeutic use of GHRPs in the United States. The anabolic and cytoprotective effects demonstrated in animal models, plus the anecdotal human use reports, have caught the attention of many with an interest in the body building and anti-aging arenas. A market for injectable GHRPs has rapidly grown with the incorporation of these drugs into men’s health clinics and websites. Many websites promote GHRPs to “help reduce undesirable symptoms of aging such as decreased libido, hormone imbalance, decreased metabolism, increased cholesterol and weight gain.” The prescribers in these clinics often order a combination of GHRPs customized to the client’s particular needs. These prescriptions /orders are often filled by compounding pharmacies that utilize bulk ingredients (APIs) in this process.

What Is the FDA’s Current View on GHRPs?

The FDA, although both being aware and concerned of this activity, had not, up until recently, taken any action. That has changed dramatically in the past few months. Recently, a few 503a pharmacies have received warning letters from the FDA regarding the compounding of Growth Hormone Releasing Peptide 2 (GHRP-2), Growth Hormone Releasing Peptide 6 (GHRP-6) and chromium picolinate (aka Peptides) as these APIs are (as stated in the FDA warning letter) “not the subject of an applicable USP or NF monograph, are not components of an FDA-approved human drug, and do not appear on the 503A bulks list.” In other words, the FDA is stating that these bulk ingredients are not FDA approved for human use as a drug and, therefore, are not permitted to be prescribed, compounded, or dispensed within the USA as such.

Most experts expect that the FDA will “ramp up” and increase their enforcement and subsequently expand the number of administrative actions taken against compounding pharmacies. So far there have been two FDA warning letters issued to date. The concern is that this can escalate to litigation and, potentially, consent decrees.

Who Can Help With GHRP Related Issues?

If your pharmacy compounds GHRP related drugs (aka Peptides), we urge you to contact Healthcare Consultants now to discuss both your risk exposure to FDA actions and the potential risk mitigation strategies that are available. Our team includes experts in sterile and non-sterile compounding, FDA law, and 503b cGMP.

About HealthCare Consultants

From major hospitals and healthcare systems to individual community pharmacies, HCC has been the nationally renowned pharmacy consultant firm of choice for over 29 years now. We work with businesses of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations. We can assist with expert advice in any area of your pharmacy business or practice.

We urge you to contact us today to see how our Pharmacy Consulting services can help you improve your business now, plus be ready for the future. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.


Share This:
Facebooktwitterpinterestmail