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

Pharmacist Jobs Statistics

Statistics regarding the state of the current job market for pharmacists that were released in the most recent report by the US Department of Labor (Bureau of Labor Statistics) on June 17, 2019 show some interesting results when one is considering pharmacy as a career. For those already practicing in the pharmacy profession, it also may help to clarify what segment of the industry a pharmacist should consider practicing in as a future career path. For many this means getting the required training and experience now that may help them get the best position for a job or position in the future.

National Pharmacist Job Statistics in 2018

Pharmacist Job StatisticsThe first thing to note is that there continues to be an increase in the number of pharmacist jobs and positions across the entire nation. Yet the annual percentage increase of new jobs available for pharmacists is definitely slowing down. As a point of reference, comparing the total number of positions for pharmacists in 2014 (297,100) versus 2016 (305,510) shows just a modest gain of 8,410 new jobs available over the two year period (or slightly less than a 3% increase). The statistics just released by the Department of Labor show that in 2018 the total number of positions for pharmacists rose to a new record high of 312,500. Once again, if we compare the next two year period of 2018 versus 2016 we see a very modest gain of 6,990 new jobs available over the two year period (or approximately a 2.2% increase). So, while we still are seeing a steady annual increase in the number of new jobs and total positions available to pharmacists, there is definitely a “slowing down” of the growth.

This increase has been going on for well over a decade now and according to the US Department of Labor (USDL) will continue until 2026. Based on the continuing increase in life expectancy and the growing geriatric population in the United States, the increased demand for prescription drugs will obviously lead to an increase in the demand for pharmacists and thus more jobs. The USDL projects that the number of pharmacist jobs will grow roughly by six percent (6%) over the next ten years.

Too Many Pharmacists Graduating?

Although these statistics indicate a continued and steady positive increase in the growth of the total number of jobs for pharmacists over the next decade in the United States, many are sharing their concern that the number of new pharmacy graduates will at some point outpace that job growth. In the USA, the number of pharmacy graduates has “exploded” due to the significant increase in the number of Pharmacy schools that offer a degree in Pharmacy. In 1987 there were a total of only 72 accredited pharmacy schools in the US. In 2014, according to the AACP (American Association of Colleges of Pharmacy) there are currently 130 accredited pharmacy colleges across the nation. Many experts predict that due to the laws of supply and demand, salaries for pharmacists in certain settings and/or regions of the country will at some point have to adjust and begin to decline.

Regional US Pharmacist Job Statistics

Looking at the USDL numbers on a regional basis reveals some very interesting statistics. As expected, the more populous states such as California, Texas, Florida, New York and Pennsylvania have the most pharmacist jobs. Here are the totals for these highly populated states:
– California 30,950
– Texas 21,250
– Florida 20,790
– New York 20,400
– Pennsylvania 14,610
What is interesting to note is what the USDL calls a “Location Quotient” relative to jobs in a profession. The USDL location quotient (LQ) is basically a way of quantifying how concentrated a particular occupation is in a region when compared to the US as a whole. It can reveal what makes a particular state or region of the country unique or lucrative when compared to the national average. When looking at the “concentration” of pharmacy jobs available by state using the USDL location quotient, some interesting results are seen. Perhaps unexpectedly, the following states show the highest concentration and number of pharmacist jobs per capita:
– Rhode Island
– West Virginia
– Montana
– South Dakota
– Arkansas
The results indicate that, although perhaps the number of total jobs are higher in the more populated states and regions of the country, the “concentration” of pharmacy jobs available are greater in the less populous states. So the conclusion can be made by some that perhaps pharmacists are “more in demand” and jobs more obtainable in these areas and states.

Comparing Pharmacist Salaries by State

Also of interest to many is comparing the average hourly wages for a pharmacist in these different states and geographical areas and regions of the nation. From the USDL statistics one can see that, excluding California, there is actually very little difference in the average hourly wages between these states:
– California: $67.16
– Texas: $60.96
– Florida: $57.55
– New York: $58.19
– Pennsylvania: $55.86
– Rhode Island: $58.12
– West Virginia: $56.93
– Montana: $53.99
– South Dakota: $55.97
– Arkansas: $56.88

Pharmacy Jobs in Retail Versus Hospital Settings

From the USDL statistics, one can perhaps get a pretty clear picture of the retail job vs. the hospital job opportunities for pharmacists over the next decade. Currently, an estimated fifty-eight percent (58%) of all pharmacists in the US work in what is considered a retail setting. Of those retail positions, approximately seven and a half percent (7.5%) work in grocery or supermarket chain stores. The USDL numbers predict that these supermarket and grocery store positions will grow by an estimated four to five percent (4-5%) over the next ten years.

The bad news is that the USDL estimates indicate that a drop in the total number of retail pharmacy jobs available will be seen over the next decade. Although it is minimal (less than 1%), retail jobs for pharmacists will be stagnant. The good news is that the number of hospital jobs will increase by well over ten percent (10%) during the next ten or so years. Some medical staffing experts predict that a thirteen to fifteen percent (13-15%) increase is not to be unexpected. Currently an estimated thirty-one percent (31%) of all pharmacy jobs are in the hospital, clinical and home health settings, but this will dramatically rise due to several factors. The continuing increase in our country’s population life expectancy and the growing geriatric population in the United States, plus the exponential increase in new medication therapies, all lead to the need of more hospital pharmacists. Additionally, as roles such as Medication Therapy Management (MTM) are expanding, so will the demand for specialized clinical pharmacists increase during the next decade.

About Healthcare Consultants Pharmacy Staffing

Whatever setting or market segment that a pharmacist is looking to work in, we here at HCC can help. Our pharmacy positions and staffing availability cover all aspects of job types: retail, mail-order, hospital, clinical and specialty pharmacies. We offer direct hire, permanent placement and temporary and part-time job solutions in almost every type of pharmacy setting that you may be looking to work in.

Let HCC do the work for you! HealthCare Consultants Pharmacy Staffing is one of the leading pharmacy staffing agencies in the United States. Established in 1989 and owned and operated by pharmacists, we serve all 50 states and have vast experience in relocation, direct hire and permanent placement. We attribute our 28+ years of success to always placing the right pharmacist in the right job.

If you are a pharmacist looking for opportunities to switch jobs or relocate, we urge you to talk with us. With positions immediately available, contact us today online or call us at 800-642-1652 to get started.


Share This:
Facebooktwitterpinterestmail

Emergency Relief Pharmacists

relief pharmacists in FL, GA, AL, NC, SC, TXNeeding temporary pharmacists during emergency situations can sometimes pose what seems like insurmountable obstacles to the pharmacy owner and manager. Last year the hurricanes in both Texas and Florida had brought up numerous discussions with clients regarding situations that can occur when an emergency relief pharmacist can be of critical importance to your drugstore even being open for business. Because a pharmacy can not legally be open for business without a registered pharmacist on duty, sometimes the pharmacy owner or store manager is faced with the dilemma of finding a pharmacist quickly or having to close the pharmacy’s doors and shut the business down until a pharmacist can be found.  Emergencies such as the severe weather that accompanies a hurricane can prevent a pharmacist scheduled to work a certain shift from returning safely from evacuation if required. This also applies if the pharmacist was on vacation and severe weather leads to the closing of airports that will simply impede or delay his or her return to work.

Additionally, the death of a family member, personal illness, accidents and other unforeseen events can lead to emergency situations that can force a pharmacy to shut down. This not only results in lost business, but can cause severe stress and frustration to customers and patients who rely on the pharmacy being open for their medications and health needs. This can be even more critical in rural communities and small towns where sometimes only one pharmacy operates. With no pharmacists to rely on for “back-up”, emergencies from not having a pharmacist available can turn into an escalating crisis for an entire community.

The Trend Is Pharmacy Staffing Agencies

In the past it was often the case that a pharmacist’s coworkers would simply fill in when needed. To cover for illness, vacations and situations like a death in the family, the other pharmacists simply worked overtime or called their friends to fill in. Yet for several reasons this has shifted to the utilization of pharmacy staffing agencies and staffing firms over the past decade.

The first reason is that several recent studies have linked long shifts and hours worked by pharmacists to severe increases in medication errors. In one study published by the National Association of Pharmacy Regulatory Advisers (NAPRA) it was noted that “pharmacists who are overburdened and understaffed present a very real threat of harm to the patients who depend on them”. Another study performed at the Houston Methodist Hospital documented that an exponential relationship can be seen between a pharmacist’s workload and working long shifts to an alarming increase in medication dispensing errors. Some states are even considering legislation over the past several years regarding setting limits on how many hours per shift and hours a week that a pharmacist should be allowed to work.

The second reason cited for the shift to using pharmacy staffing agencies is that overworked pharmacists have been shown to “burn out” and to quickly develop a negative attitude toward their profession. A great article in Pharmacy Times noted that excessive overtime, long shifts and being on-call constantly, all contribute to the extremely high rate of “burn out” seen in the pharmacy profession. The result is that more and more pharmacists are choosing not to work part time jobs or do relief work any longer.

Lastly is the expense and cost. By using a pharmacy staffing agency for relief pharmacists, the pharmacy can save on all of the following:
– Hiring expenses and the time required
– HR expenses such as criminal background checks, license verification, drug screening and paperwork
– Payroll taxes
– Accounting expenses
– Insurance
– Overtime pay
Some accounting experts estimate that all of the above expenses can add up to an increase of over 60% per hour when compared to hiring a pharmacist on staff paid by the hour.

Choosing an Emergency Pharmacy Staffing Agency

As with all other vendors, choosing the right pharmacy staffing agency is critical. You want one that is not too small as to be geographically constrained and that has a limited number of viable pharmacists that meet your specific needs. You also want one that is not too large and therefor is not service oriented when dealing with a “smaller” clients immediate needs.

The perfect choice if you’re pharmacy business is located in the Southeastern United States is HealthCare Consultants Pharmacy Staffing. Our emergency pharmacist staffing service is available 24 hours a day, 365 days a year. HCC maintains one of the largest active pools of emergency pharmacists in the nation, thus allowing us to quickly locate available, qualified and reliable pharmacists in the following states: Florida, Georgia, Texas, North Carolina, South Carolina and Alabama. Our proprietary online system allows us to match your needs with the most qualified candidate to work relief during your emergency. HCC also ensures that all of our emergency pharmacists comply with all HIPAA requirements and maintain professional liability insurance. As always, with HealthCare Consultants Pharmacy Staffing, your satisfaction is guaranteed!

Please also note that HCC can fill all of your emergency relief staffing needs regarding pharmacy technicians (in Florida only). HCC has been the leading provider of qualified, registered, licensed and professional pharmacy technicians (CPhTs) in Florida since 1989. As with emergency pharmacists, satisfaction with our emergency pharmacy technician staffing is guaranteed!

We strongly urge you to be proactive regarding establishing a relation with us now (this way all required paperwork is completed before an emergency situation actually occurs). Then, when you require an emergency relief pharmacist, HCC will be ready to meet your needs so that you can relax and rest easy. Call us now at (800) 642-1652 or take a moment and Contact Us Online and an HCC in-house staffing consultant will contact you as soon as possible to discuss all of your emergency and staffing needs.

 


Share This:
Facebooktwitterpinterestmail

Pharmacy Staffing, Recruitment and Placement Services

Pharmacy Staffing ServicesHealthcare Consultants Pharmacy Staffing is recognized as a national leader in regards to pharmacy staffing, recruitment and placement services, plus has been known as a “full service” pharmacy staffing company since 1989 now. With more than 30+ years in the pharmacy staffing, recruitment and placement business, HCC is acknowledged throughout the USA for our ability to always correctly match the best possible potential candidates to the right job or employment opportunity, plus suit the exact needs of the potential employer! We are able to accomplish this by utilizing our own proprietary candidate database system that we’ve developed internally over the past three decades, and that no other company has access to or can match. This system, plus our experienced in-house staff of experts, allows us to match a pharmacist’s skill sets, experience and other considerations (such as geography and lifestyle) with whatever criteria the employer and job description may require.

Pharmacist Recruitment, Placement and Staffing Services

With all the various pharmacy consulting services that we provide to both pharmacies and pharmacists, it’s sometimes easy to overlook the fact the we are one of the nation’s most successful and respected pharmacy staffing and placement firms. HealthCare Consultants Pharmacy Staffing deals with all aspects of matching pharmacists to jobs and open positions in every type of possible situation. This includes filling short term pharmacy positions and temporary jobs, as well as permanent and long term placements. We also can help with temp-to-permanent situations.

Pharmacist Recruitment and Placement

A national leader in pharmacy staffing since 1989, HCC is able to bring an employer the correct pharmacy candidates who are fully qualified for placement in permanent, full-time, direct-hire, or contract positions. In this manner we act as the “liaison” between the employer and the qualified professionals to fill a pharmacy position with the best possible match. Our recruitment experts take the time to build a relationship with you and learn about your business. This helps us to locate the best possible candidates for your company – now and in the future – plus gives you immediate access to a far broader and more talented pool of candidates than you would be able to reach on your own. Our 30+ years of pharmacy recruitment and placement experience ensures that the right pharmacist is a perfect fit regarding geographical considerations, skill sets and, of course, company culture.
Of course HCC is also able to find you the perfect PDM (Prescription Department Manager) &/or PIC (Pharmacist in Charge) should the need arise. During this critical selection of a PDM or PIC, HCC provides you with immediate access to a far broader and more talented pool of candidates than you would be able to reach on your own. We also offer a six month pro-rated satisfaction guarantee!

Temp & Relief Pharmacy Staffing Services

Once again, with over thirty years of experience, HCC is nationally renowned for being a “full service” pharmacy staffing company since 1989. Many times a pharmacy owner or manager is in immediate need of a temporary pharmacist to fill in coverage and shifts at their business or operation. This sometimes may be a planned absence of an employee, such as time off for a vacation or a wedding as examples. Yet more often than not, it is more of an “emergency” situation, such as an unexpected illness, leave of absence, or perhaps simply an employee quitting unexpectedly and without any warning.

HCC specializes in providing relief pharmacists in Florida, Alabama, Georgia, North Carolina, South Carolina and Texas. Whatever your requirements and needs may be pertaining to getting pharmacist relief, our automated matching and scheduling services allow us to quickly recruit, screen and locate the perfect pharmacist with the perfect capabilities to meet your every need – guaranteed.

Emergency Pharmacist Staffing

Every pharmacy owner has faced an emergency situation where the only solutions were to either find an emergency pharmacist to quickly fill their need or to shut their pharmacy’s doors. Emergencies such as an illness, death of a loved one, accidents or severe weather preventing an employee’s return happen much more frequently than most think or expect. In such situations, finding an emergency relief pharmacist who is licensed, experienced and professional becomes a task that can seem impossible to accomplish.

Our emergency pharmacist staffing service is available 24 hours a day, 365 days a year. We maintain one of the largest active pools of emergency pharmacists in the nation, allowing us to quickly locate available, qualified and reliable personnel in or around your local area. Our proprietary online system allows us to match your needs with the most qualified candidate to work relief during your emergency. HCC also ensures that all of our emergency pharmacists comply with HIPAA requirements and maintain professional liability insurance. As always, here at HCC your satisfaction is guaranteed!

Specialty Pharmacist Staffing

Whatever special needs a pharmacy may be searching for, HCC can help. Our pharmacy staffing services cover all aspects of job types: retail, hospital, clinical and specialty pharmacies. We offer solutions for almost every type of pharmacist you may require:
– Compounding pharmacy (both sterile and non-sterile)
– Nursing Home & Long Term Care pharmacy
– Institutional (prisons and jails) pharmacy
– Hospice pharmacy
– Mail-order pharmacy
– Home health pharmacy
– Respiratory pharmacy
– IV pharmacy
– Nuclear pharmacy
– Home infusion pharmacy

Pharmacy Technician Staffing

At HCC we also place licensed and certified, highly trained Pharmacy Technicians throughout the State of Florida. Our large technician database allows us to place the right experienced and trained pharmacy technician to suit your needs throughout the entire state of Florida, including the Miami, Tampa, Orlando and Jacksonville areas. Our Pharmacy Technician Staffing Department offers you trained professionals with the premium skills and experience needed to help you best serve your patients and customers.

As required in the State of Florida, all of our pharmacy technicians are registered with the Florida Board of Pharmacy and have completed a Florida Pharmacy Board Approved Pharmacy Technician training program. Our experienced in-house pharmacy consultants have placed thousands of pharmacy technicians throughout Florida and are able to find you the right technician based on your pharmacy’s individual needs and the skill-sets required.

About Healthcare Consultants Pharmacy Staffing

If you are a pharmacy requiring temporary or permanent staffing help, HCC Pharmacy Staffing can help you! We have a professional staff who can find you the right pharmacist or technician to match your needs, whether it be in a retail, hospital or a specialty pharmacy area. 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.

Keep in mind that while specializing in pharmacy jobs, staffing and placement services for over 30+ years now, HCC can help you with all of your pharmacy needs. HCC is recognized as a national leader as a Pharmacy Consulting Firm and a sample of some of our additional services include:
– Equipment needs assessment
– Policy & Procedure Manual review, recommendations and customization
– Medicaid/3rd party review
– Moving a pharmacy to a new location
– Out of state licensing
– Exit strategies
– Audit, surveys & mock inspections
– Expanding, redesigning and overhauling your pharmacy
– Compliance review for compounding pharmacies (USP 795 & 797)

We urge you to contact us today to see how our Pharmacy Staffing services and 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

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