503B Outsourcing Facilities – Are You in Compliance?

Pharmacy Inspections 503BThe Drug Quality and Security Act, signed into law on November 27, 2013, created a new section titled 503B in the Federal Food, Drug, and Cosmetic Act. Under section 503B, a pharmacy compounder can become an outsourcing facility by registering with the FDA and paying a fee.

Is Your Facility in Compliance?

Once registered as a 503B, an outsourcing facility must meet specific conditions to be exempt from the Food, Drug & Cosmetics Act’s (FDCA) approval requirements and product labeling requirements. The law requires that all medications and drugs be compounded in compliance with 21 CFR Part 210 and 211 (cGMP), either by or under the direct supervision of a licensed pharmacist in a registered facility.

Are FDA Inspections For 503B Compliance Taking Place?

The FDA began inspecting all 503B facilities based on their risk level assessment. Any deviations from cGMP or other FDA requirements observed during an inspection will be documented on an what’s known as an FDA Form 483 and will lead to further FDA actions (up to and including medication and drug recalls, consent decrees, and formal litigation). Currently, there are seventy-one (71) registered 503B facilities and ALL but two (2) that have been inspected have been issued an FDA Form 483 ( accompanied by recalls of sterile products). The biggest reason for the high level of FDA actions is that the vast majority of compounding pharmacists are not trained in (nor familiar with) cGMP unless they have had significant experience in pharmaceutical manufacturing.

The FDA has recently stated that it intends to continue with their inspections of compounding pharmacies in an attempt to take aggressive actions to protect the public health.

Is Preparing or Responding to an FDA Inspection Complicated?

Preparation for an inspection by the FDA, or corrective action in response to an FDA inspection, requires experts that are well versed in FDA rules and laws, cGMP, and facility design. It is a complicated process that is designed to make sure that medications are safe and effective by making Pharmacies adhere to quality standards when compounding pharmaceuticals.

It is also important to note that the regulations are basically “minimum requirements” and that many Compounding Pharmacies utilize modern technology and documentation approaches that already go well beyond the minimum standards. Equipment, technology and risk management tools in place years ago to prevent errors and contamination may be seen as less than adequate by today’s standards (and by future standards). Basically the Quality Compounding Act of 2013 (QCA) revolves around compliance with the Current Good Manufacturing Practice (CGMP) regulations. The FDA enforces these regulations to assure proper design, monitoring, and control of manufacturing processes and facilities. This then assures the identity, strength, quality, and purity of drugs and medications to the ultimate end-users (patients and consumers). The QCA allows a pharmacy to register as a Section 503B “outsourcing facility” to be exempt from the Food, Drug & Cosmetics Act’s (FDCA) approval and labeling requirements as long as specific conditions are in place and met.

Although this is by no means meant as a comprehensive list, the following basic requirements include:
– Medications must be compounded either by or under the direct supervision of a licensed Pharmacist.
– Medications must be compounded in a registered facility.
– All products and drugs compounded at the facility during any 6 months period must be reported to the FDA.
– A detailed list about the compounded products (including source of ingredients, etc.) must be readily available for inspection.
– Multiple conditions must additionally be met, such as reporting adverse events and labeling products with prescribed information (and must be documented).

Under section 503B, a registered outsourcing facility may only use for compounding a bulk drug substance that is included on an FDA’s established list of bulk drug substances for which there is a clinical need or which are on the FDA’s drug shortage list. Prohibited under sections 503A and 503B is the compounding of drugs that are on a list of drugs that present difficulties for compounding.

Who Can Help With 503B Compliance?

As a national leader in Pharmacy Consulting for over 29 years now, HealthCare Consultants Pharmacy Staffing and Consulting can help you ensure that you are in compliance. This is a team approach and HCC is that team! HCC has experts available with many years of experience in pharmacy compounding, pharmaceutical manufacturing, cGMP design and compliance, and FDA law. Contact HCC to discuss facility and operational assessment, risk mitigation, and corrective action planning.

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

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New Specialty Pharmacy Startup

Specialty Pharmacy ConsultationSpecialty pharmacy startups are again at the forefront of discussions based on a recent article just released by HealthLeaders Magazine (a division of Simplify Compliance). The study states that commercial pharmacy spending in the USA has risen to a new rate that greatly exceeds the five year average of a 14% increase. In fact, the rate increased by over 18%, far exceeding what optimistic economic projection analysts were both expecting and hoping to see. While oncology and immunotherapy drugs were noted in the report as the most significant drivers of the higher spending seen, the most important factor revealed in the new study was this: Specialty drug spend accounted for greater than 91% of the total overall drug spend increase!

Specialty Pharmacy Growth & Projections

Specialty pharmacies have become the fastest growing segment of the pharmacy industry over the past few decades. This is based on the number of new specialty pharmacies opening up nationally, plus the ever increasing rise in the number of existing pharmacies expanding their operations via the addition of specialty pharmacy services. With a projected annual growth rate of about twenty percent (20%) per year according to the AMCP (American Society of Managed Care), many entrepreneurs are focusing on the continuing success of specialty pharmacies as a lucrative business operation to startup. Yet the industry is still in its infancy according to many experts. Spending on specialty pharmacy and services was almost $87 billion in 2012. However, Drug Channels estimated that in 2014 alone, “retail, mail, and specialty pharmacies dispensed about $78 billion in specialty pharmaceuticals.” Although we must keep in mind that it is virtually impossible to come up with an exact number for pharmacies dispensing specialty medications, estimates project that this will quadruple by the end of next year (2020), with sales reaching above $400 billion (or slightly less than 10% of the total US health spending). Factor into this that of the twenty-seven (27) new drugs approved in 2013 by the FDA, fourteen (14) were specialty medications. Many experts are  calling the phenomena the “Specialty Pharmacy Gold Rush”, reminding many of the famous California Gold Rush of 1848. It is clear that the potential for success regarding starting up a specialty pharmacy obviously exists, but perhaps it may be directly proportional to the number of specialty pharmacies “panning for the gold” that is expanding so very rapidly that caution and planning are definitely required.

An analysis in 2012 by United Healthcare revealed that about fifty-one percent (51%) of all spending on specialty drugs is for the treatments of cancer, rheumatoid arthritis, and multiple sclerosis. These are followed by HIV, hepatitis C, respiratory conditions, anticoagulants, growth deficiency, and transplants. Originally, the pharmacies that were classified with the “Specialty Pharmacy” designation were primarily dealing with the preparation of IV and injectable medications. This however quickly expanded into many other types of specialty pharmacies that have proven to be successful business models (compounding, mail-order, oncology, respiratory, Cystic Fibrosis, etc. to name just a few).

Is Starting Up a Specialty Pharmacy Harder Than Other Pharmacies?

Opening and starting up a specialty pharmacy requires both expertise and experience to result in a successful business operation. Yes, it is similar in many respects to starting up a “traditional” retail pharmacy. However, in addition to the list of steps followed in the planning and execution of more “traditional” pharmacies, there are numerous equipment, policies, procedures and operational considerations. How a business owner chooses to get into the specialty pharmacy market is sometimes a very tough investment decision to make. While more and more pharmacies are entering the specialty pharmacy market, the market is not without its challenges. With more and more pharmacies entering the specialty pharmacy market, many experts are wondering if the marketplace is becoming saturated. Associated with high cost medications and the historical domination of the Specialty Distributors (SD), the startup of a specialty pharmacy is becoming more complicated and challenging than ever before.

Let HCC Help!

Are you considering opening or starting a Specialty Pharmacy? Perhaps expanding or turning a portion of your existing Pharmacy business into a specialty pharmacy? Let a nationally renowned Pharmacy Consulting firm like Healthcare Consultants help you get the most out of your investment and guide you through the entire process.

Healthcare Consultants has helped plan and open more specialty pharmacies nationally than perhaps any other Pharmacy Consulting firm in the industry. Plus HCC offers the additional advantage of Pharmacy Staffing and Pharmacy Management, being in the business for over 29 years and being recognized as one of the premier Pharmacy Consulting agencies in the nation. With a proven track record and a history of success, HCC can plan and execute a strategy to win in the Specialty Pharmacy arena. Contact us online or call us today at 800-642-1652 to discuss how we can help you.

Specialty pharmacy startups require both expertise and experience to result in a successful business operation. Similar in many respects to starting up a traditional retail pharmacy, specialty pharmacy start-ups have additional requirements that must be taken in consideration and present additional challenges in both the planning and the ongoing operations of the pharmacy. In addition to all the steps involved in the starting up and opening of a new pharmacy, there are numerous equipment, policies, procedures and ongoing operational considerations that must be dealt with.




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Choosing Pharmacy Consulting Firm

pharmacy consulting firmThe definition of a true consultant is an individual who is able to give you expert and professional advice. There comes a time in every business when an objective, qualified and experienced third party is necessary to help guide, direct or advise the owner or your management team. This is true for most pharmacy operations, especially when making decisions regarding expansion, increasing efficiency, establishing policies and procedures, or choosing a technology system that will best suit the individual company’s needs. Everyone can agree that when it comes to the practice pharmacy and the dispensing of drugs and medications, pharmacists are the experts. Yet knowing one’s limitations is a key to success for many pharmacy owners or managers. One need only take a moment to remember all of the failed pharmacy businesses in the past few decades to realize that running a profitable operation is NEVER a given. In any business, seeking the advice of a knowledgeable expert is often times the most effective way to solve a problem, get the correct solution and make certain that your operation is running as efficiently and profitably as possible. Try thinking about a pharmacy consultant as a coach. Are there any successful sports teams that don’t have a coach? Even professional golfers like Tiger Woods have a coach. They may be the best professional there is at playing their sport, but only an objective coach (consultant) can see what they can’t and help them keep constantly improving their game (or business operation for a pharmacy owner).

How Do You Select The Right Pharmacy Consulting Firm?

When the time comes to actually reach out and identify the right pharmacy consulting firm, how do you make sure that you are choosing the best one for your individual business’s needs? Here are some tips and actions to consider when interviewing consulting firms to help make your choice the best possible decision.

  1. Document Your Project or Needs –

    Often times being able to communicate your needs, goals and objectives will make all the difference in choosing the right firm. Write out exactly what you think you need, share details of your past experiences, what you think may be some possible solutions, plus identify what you want and expect from the consultant as best you can. Don’t waste too much time trying to document everything perfectly – after all if you can do that, then why do you need a consulting firm and their expertise? Just keep in mind that the consultant cannot “read your mind” and the better job that you do presenting and explaining your situation, the easier your choice will become in selecting the right firm.

  2. Do They Listen, Comprehend and Communicate Well?

    If you did your part and communicated your project expectations or needs, now it is their turn! The best consultants are great communicators. They are able to listen, ask the right questions when appropriate and communicate effectively. After explaining your situation and needs (as recommended above), have the firm recap what you said and what “they think that they heard”. This ensures that they understand your situation and project’s scope. Often times you may find that it doesn’t quite match up, and this can be an indicator that you may be interviewing the wrong agency or firm. After all, if they can’t understand from the very start, what makes you think that they can deliver the right advice, solution or advice at the finish line?

  3. View Them as a Partner –

    Honesty is a crucial element in making your selection. However, this is a “two way” street. When you view the hiring of a consulting firm as them becoming a partner, it’s imperative that you give them the total picture in order for the business relationship to be both effective and beneficial for your company. Obviously we expect total honesty from them, so we need to overcome any fear or embarrassment that we may have and give them the total picture. Treating them as a partner and not just as a vendor will ensure that they can achieve the best results on your behalf.

  4. Ask For Evidence –

    Every consulting firm will tell you that they can help you solve your problems or help you to meet your goals and objectives. Ask them for proof! Do they have examples or case studies of similar businesses with the same challenges or in similar situations? Do they have references that you can call and talk to? Although everyone obviously will give you references that are satisfied clients, it’s still a good idea to call them. Even if the references are happy with the results they received, it’s a good chance to ask them some important questions:
    – Were the consultants easy to work with?
    – Did they respond quickly?
    – Was the work finished on time?
    – Did they meet the budget or cost estimates?

  5.  Look For Diversity –

    Many times a consultant will be qualified, experienced and knowledgeable in just one very specific area. The best consulting firms have expertise and experience in all areas of pharmacy. This allows them to “see the total picture” of your business and can often lead to suggestions and improvements in numerous other areas of your operation. Having experience in all types of pharmacies and settings allows the consultant to come up with creative solutions for your business that a more limited firm could not produce.

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.


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Pharmacy Information Systems

pharmacy information systemPharmacy Information Systems (PIS) have evolved over the years to become a core component of any successful pharmacy operation. Whether it’s a hospital setting, a clinic or even a specialty pharmacy business, these complex and sophisticated computer software systems continue to evolve and their functionality is ever expanding. Sometimes they are also referred to as Medication Management Systems, selecting the best PIS for a particular pharmacy has become an extremely complicated process. Keeping in mind that not all pharmacies have the exact same procedures, requirements and needs, choosing the best pharmacy information software system for your particular business may pose several dilemmas and can often be an extremely difficult task. Yet making the correct software system selection is a is critical decision!

What Is a Pharmacy Information System (PIS)?

Pharmacy information systems (PIS) are basically computer software systems that are programmed with the ability to perform the various tasks required to operate a pharmacy. They make the business operate more efficiently, plus allow for digital record storage and fast retrieval of information. Typical uses of a PIS include:
– Prescription management (Rx data entry and dispensing info such as labels and warnings)
– Patient personal profiles and medication history
– Consultation documentation
– Physician monitoring
– Inventory management
– Purchasing management
– Billing and insurance management
– Pricing structure variables
– Reporting
– Clinical screening (allergies, drug interactions, warnings and patient education)
– Drug interaction monitoring
– Staffing and workload management
– Compounding and manufacturing documentation and management

What PIS Best Meets Your Pharmacy’s Specific Needs?

Many pharmacy managers and owners find this to be the hardest business decision that they will ever have to make or be involved in. Selection of the right pharmacy information system takes a lot of time and requires extensive education. As with any computer program or system, choosing the wrong PIS will lead to both wasted money and resources, and eventually to severe pain if the medication management system needs to be totally replaced at some point in the future.

Although all of the major pharmacy information systems contain the core functionality and components described above, some systems are obviously more robust than others. With literally hundreds of systems to choose from, evaluating the different software programs can be an exhausting and challenging task. A list of the “Top Ten” most popular systems usually includes some of the following:
HMS Pharmacy (Healthcare Management Systems Inc.)
PharmNet (Cerner’s pharmacy system)
Meditech’s Pharmacy Solution
Sunrise Pharmacy (Allscripts)
Horizon Meds Manager
Siemens Pharmacy
WORx (Mediware)
Willow (Epic)

Major Considerations in Selecting a PIS

Although they are not listed in any particular order of preference, each PIS listed above has pros and cons associated with it. Some of the key factors that need to be considered as a part of your selection process should include:
1. Price –
Obviously this is a major expenditure for any pharmacy operation or business. Historically, some large hospitals and healthcare systems developed in-house proprietary solutions, but that is no longer typically seen. The cost of development, maintenance and system enhancements make using a third party system the obvious and most economic solution for almost any pharmacy.
2. Integrated Systems versus “Stand Alone” Systems –
There is a critical choice that needs to be made: use a “stand alone” system or product or use an integrated system? Using a “stand alone” system basically makes your business dependent on the vendor for updates and enhancements in the future. Integrated systems mean that you can connect with various other technology and programs that you may utilize, such as CPOE, EMR, RFID and bar-code scanning programs.
3. Your Current Need versus Your Future Needs –
Although your selection may meet you current needs, what about your future needs? Obviously technology changes very rapidly and the future is sometimes very unpredictable. The point is that not all of a system’s capabilities are used by every pharmacy, so it may be critical to know the entire PIS functionality in order to grow your operation at some future point. This can be especially critical if you are planning a future expansion into the specialty pharmacy area, as some systems are specifically geared to specialty pharmacy operations. Conversely, when acquiring and using a vendor’s PIS, you don’t want to pay for features and functionality that are not required to run your business, and that you most likely will never utilize and need.

Who Can Help You Select The Correct PIS?

Selection of the right PIS is a critical, yet time consuming business decision. The process of evaluating each system independently to meet both your immediate and future needs can be both exhausting and overwhelming. Perhaps consider hiring an expert that is both objective and experienced with the various PIS programs.

Healthcare Consultants has helped more pharmacies choose a PIS and successfully run their business than any other pharmacy consulting firm in the nation. We have in-house experts that have the experience to help you and know the pharmacy business “inside and out”.

From major hospitals and healthcare systems to individual community retail and specialty pharmacies, HCC has been the nationally renowned pharmacy consulting firm of choice for over 29 years now. HCC can assist with expert advice in any area of your pharmacy business or practice. With a full-time staff of in-house Pharmacy Consultant specialists, we 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.







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Pharmacy Consulting

Why A Pharmacy Consulting Firm?

Pharmacy Consulting ServicesIn a traditional independent retail pharmacy setting, many pharmacy owners, Prescription Department Managers (PDM) and Pharmacists in Charge (PIC) ask themselves this question: “Perhaps I could use some expert advice on some of the business decisions that are being made here?”. The use of an objective and experienced third-party pharmacy consulting firm in larger pharmacy organizations is much more widely accepted these days. Most large hospital systems, governmental and institutional pharmacies and large healthcare systems are much more likely to seek outside pharmacy consultants to assist them in their decision making process. They realize that two major absolutes exist in today’s pharmacy environment: Specialization and Objectivity. Many would agree that specialization and objectivity are “keys to success” in almost any industry, but nowhere is this more important than in healthcare and pharmacy.

The Age of Specialization

The complex nature of our society that exists today as the information age began in the early 1990’s and has peaked now according to experts, means that no individual alone could possibly operate a business when it comes to areas such as technology, human resources, legal requirements and finance. This is true not only for pharmacy, but for almost every field of industry (healthcare related or not). A friend who operates a large Internet company shared that over 20 years ago he employed one IT professional on his staff full-time. Now he has five full time IT employees: specialists in website hosting and email, VM & cloud solutions, IT infrastructure, database administration and programming.

Nowhere is specialization seen more than in the businesses of healthcare and the profession of pharmacy. Just understanding the technology in pharmacy alone takes quite an education and is an extremely time consuming undertaking. In one of our previous blog posts several years ago we took a good look at Medication Therapy Management (MTM), which included a discussion of Health Information Exchanges (HIE’s). Yet we didn’t really even touch on the majority of recent technological advancements in pharmacy such as e-prescribing, mobile health apps, and electronic health records (EHRs). When you add in the complexity of keeping up with and understanding the additions and changes in federal and state laws and regulatory agencies (DEA, FDA & State Boards of Pharmacy), it is clear that sometimes the help of an an expert is absolutely necessary. Lastly, let us just make a short list of additional areas that a pharmacy business may have to deal with and it’s pretty easy to see why having a pharmacy consulting firm as a business “partner” may be a really good idea:
– PBMs and insurance networks
– Sterile and non-sterile compounding <USP 795 & 797>
– Accountable Care Organizations (ACOs)
– Integrated Delivery Networks
– Security
– Internet pharmacies


Perhaps the famous Danish philosopher Søren Kierkegaard was correct in his observation that it is impossible for a human being to be objective about themselves. Many experts agree that this is especially true when it comes to being totally objective regarding your business or pharmacy operation. Large pharmacy business organizations, hospitals, government institutions and major healthcare systems know this to be true. They all internally have systems of checks and balances in place, yet consistently utilize objective third party pharmacy consulting firms such as Healthcare Consultants to take an unbiased look at their operations in order to maximize their operation’s efficiency and increase their revenue. Additionally, they receive vitally important feedback on operational policies and procedures, industry best practices and emerging technologies.

The need for objectivity for “smaller” clients is just as crystal clear. Sometimes it is even more necessary in an independently owned and managed retail or specialty pharmacy operation because the owner is emotionally tied to the business. We have all heard the phrase “making a decision based on your heart and not your head”. Sometimes an objective third party taking a look at your situation can make the difference between growing your business or closing it down.

The Nation’s Leading Pharmacy Consulting Firm

HCC is known to be 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. Some of the services we most commonly provide include:

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. HCC 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 and 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 or call us today at 800-642-1652 for a free consultation.

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Medication Errors

Medication errors occur in a pharmacy under the best of conditions. However, a previous Missouri court ruling regarding a pharmacy medication dispensing error clearly shows that a lack of proper supervision, documentation and up-to-date policies and procedures will not be tolerated when the public’s safety is placed in jeopardy as a result. In an excellent article just released in the Australian Journal of Pharmacy, an extremely valid point is made: the owner of the pharmacy is always ultimately responsible! The point was well made that although many pharmacies are owned by pharmacists (or non-pharmacists) who do not actually work in them, in the end it is the owner’s responsibility to make certain that current and up to date Policies and Procedures are maintained and followed by all of the pharmacy’s staff. Being an “absentee” owner will not stop the legal ramifications of dispensing errors and other mistakes by employees that could (and should) have been prevented.

The Missouri Case and Ruling

The Missouri Court of Appeals (Western District) reversed a lower court’s decision in late October that centered around a medication dispensing error by a pharmacist in Missouri. The dispensing error occurred when a pharmacy technician took several prescriptions over the phone from a Registered Nurse on behalf of the physician who was discharging his patient from the hospital. Although several mistakes were actually made by the technician, the most significant medication dispensing error was that the prescription phoned in by the RN for the patient’s metolazone was transcribed incorrectly to read methotrexate. The directions given to the patient for “once daily” administration of the drug inherently led to the patient’s death less than three weeks later (after she followed the directions on the Rx bottle and took a dose each day).

The family sued after the patient’s death and was awarded $2,000,000 in damages by a jury after a trial. Even though gross negligence was proven and admitted by the defendants in the initial trial, the damages awarded were reduced by a lower Missouri appeals court to $125,000 (based on Missouri statutory caps and limits to damages awarded by a jury). The victim’s family further pursued the ruling, which eventually led to the recent reversal by the higher court. The court upheld the jurors’ decision to award the patient’s family the additional damages that they initially awarded for pain and suffering caused by “aggravating factors and circumstances” resulting from the medication dispensing error by the pharmacy.

The Four (4) Medication Dispensing Errors as Noted By The Missouri Court

What makes this case so noteworthy is that the Missouri Court of Appeals actually broke down the case into four separate incidences of medication errors occurring in the pharmacy’s process of dispensing the prescription.
1. The first error cited by the court was that the technician took the prescription verbally over the telephone. Although currently Missouri is one of the seventeen (17) sates that allows pharmacy technicians to take prescriptions verbally by telephone, the court noted that the pharmacy’s own policies and procedures actually prohibited this practice and state that only RPh’s are allowed to accept prescriptions via verbal phone communication.

2. The second error was that the pharmacist did not question the methotrexate being administered once daily. In conjunction was the fact that the pharmacy’s computer system failed to “flag” the daily methotrexate dose. The court’s opinion stated that the pharmacist failed to properly review the medication and its administration, plus the court noted that there was a lack of a computerized “hard stop” for methotrexate prescriptions prescribed to be administered once a day.

3. The third error cited by the court was the failure by the pharmacy to provide the patient with the necessary education and the required patient counseling when dispensing a new Rx to a patient. Especially when the prescription is for a high risk medication (such as methotrexate is).

4. The fourth and perhaps most significant error cited by the court was the fact that the pharmacy “had made no meaningful changes to its procedures as a result of the patient’s death.” The court noted that in the twenty (20) months since the original verdict in February of 2016, the pharmacy had failed to update and document any changes to their policy and procedures manual. This included any documented updates to their procedures regarding a pharmacy technician’s role in the prescription dispensing process.

Minimizing Medication Errors and Pharmacy Dispensing Errors

The FDA defines a medication error as “any preventable event that may cause or lead to inappropriate medication use or harm to a patient”. A study released back in 2006 by The Institute of Medicine (a part of the US National Academy of Sciences) showed that medication errors result in harm to at least 1.5 million patients annually. Another study showed that over 400,000 patient injuries take place in hospitals in the US alone due to medication errors.  Medication errors occur for a variety of reasons. and everyone agrees that no one is perfect. Yet in today’s society of consumers having more access to drug information than ever before, medication dispensing errors by pharmacists are being reported much more frequently. As a pharmacy owner and/or practitioner, we all need to take a hard look at this and ensure that best practices are always being followed to the best of our abilities. As the National Institute of Health (NIH) points out: “Errors will always occur in any system, but it is essential to identify their causes and attempt to minimize the risks”.

As a pharmacy owner or manager, ask yourself the following questions:
– Do you ensure that if a mistake is made that you have documentation that will prove that you made changes to your written Policy and Procedures to show that you take every step possible to avoid medication dispensing errors?
– Is your staff properly trained and able to document situations where a mistake is made? Do you have job descriptions for your technicians and support personnel?
– When was the last time that your pharmacy took a good look at how it dispenses prescriptions and medications, plus how you document patient counseling?
– Are you following “best practices” and limiting the chance for potential medication dispensing errors (and therefore reducing your risks of potential lawsuits and bad publicity)?
If your answers are “not lately”, then we strongly advise that you get a qualified pharmacy consultant to take an objective look at your policies and procedures. An objective third party review may mean the difference between a court ruling like the damaging case seen in Missouri and your pharmacy maintaining its good reputation.

Pharmacy consulting is an area that most pharmacy owners don’t take advantage of until it is too late. At HCC we stress that addressing and preventing issues before they occur is the key to avoiding future problems, lawsuits and bad publicity. The old cliché that “an ounce of prevention is worth a pound of cure” has never been more relevant than it is today.

About Healthcare Consultants

Healthcare Consultants has been in the business of Pharmacy Consulting for over 29 years now. Known as one of the nation’s leading full service pharmacy staffing companies, HCC is also one of the industry leaders in providing a full range of professional pharmacy consultation services to its vast array of clients. Owned and operated by pharmacists, Healthcare Consultants can provide proven expertise and experience in all facets of pharmacy operations, including retail, hospital and specialty pharmacy venues. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all areas of your business. Contact us online or call us today at (800) 642-1652 for a free consultation to see how we can help you.




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New Pharmacies and Ownership

New Pharmacy ConsultationNew pharmacy startups and the opening of brand-new pharmacy operations are occurring at a faster rate this year than ever before seen. Just reviewing the first two weeks of November this year reveals a staggering number of new retail community pharmacy businesses being opened and successfully established all across the entire fifty United States. Considering the 2018 “explosion” of new drug stores, plus the recent national economic growth and positive forecasts for 2019, one can only conclude that the number of new pharmacy start-ups will continue and even, probably, accelerate at a rate never before seen.

Examples of Recent Pharmacy Startups

Just as examples of the startup trend, consider the following recently opened retail community pharmacies that have been in the news in just the past few weeks.

  1. In Clarksville, Tennessee – Hilltop Supermarket is adding a brand new pharmacy department. Owner of the supermarket (Cody Jackson) said that he will actually not own the pharmacy, but will partner with a local RPh. who has vast experience running retail community pharmacies in the area. For Hilltop Supermarket, having a pharmacy as an addition to his grocery store will be “breaking new ground”. “I know about the grocery business, but I don’t know a lot about running a pharmacy,” Jackson said. “The pharmacy will occupy space in our store, but it will be run and managed by someone else who has been successful with other pharmacies in the area.”
  2. In Ellensburg, Washington – Whole Health Pharmacy was recently opened by two local pharmacists who saw a tremendous opportunity after the local Downtown Pharmacy closed their doors this past October. Both of the new pharmacy’s owners had previously worked at the now defunct Downtown Pharmacy and knew that this was the “chance of a lifetime” to both help their community and open up a successful retail community drugstore.
  3. In Dayton, Ohio – Wright-Patt’s Kittyhawk Pharmacy opened its doors for business (although the official “ribbon cutting” will actually take place on December 12th). The new $10 million facility was actually upgraded with a modernized drive through lane, plus new dispensing apparatus that will enhance  both dispensing safety and double the prescription processing space. While focusing on diabetic supplies, the owners are hoping that the increased efficiency alone will pay for the upgrades over time (plus increase their local market share of customers).

    Changes in Ownership Also Rapidly Increasing in Pharmacy

    In addition to the rapid pace of new pharmacy practices being recently started and established, there is also an increasing frequency of established pharmacies being sold, bought and reorganized under new ownership and management. Once again, simply scanning the past several weeks reveals numerous examples to consider.

    1. In Cleveland, Ohio – Dave’s Mercado Pharmacy (owned by Dave’s Supermarket Inc.) was sold to Neighborhood Family Practice. The new owners have announced that they will be expanding the pharmacy’s business hours, plus adding several new services. Currently the pharmacy is undergoing an extensive remodeling, but will reopen in January of 2019 under the new name of the Neighborhood Family Practice Pharmacy. Interestingly, the store was originally founded all the way back in 1930 and renamed Dave’s Mercado in an effort to attract the Hispanic population in the area as customers.

    2. In Bull Shoals, Arkansas – Lake Side Pharmacy was purchased from previous owner Steve Thomas (who owned the drugstore for approximately thirty years) Thomas sold the pharmacy in order to retire, and the new owner (Layne Hawkins) has a PharmD degree and vast previous experience as an independent pharmacist.

    Starting a Drugstore or Buying an Existing Pharmacy

    If you are considering a pharmacy startup or the purchase of an existing drugstore in 2019, then consider asking yourself several basic questions. Your answers may make the difference between your pharmacy becoming a successful business venture versus it being a disappointing failure and a loss of money.
    1. How much money and funding will I need and where will it come from?
    Your answer should include all of the possible initial startup or acquirement costs, plus take into consideration such ongoing costs as staffing (if necessary) and marketing. If this is your first business venture, are there additional costs that you may not have thought of? How much debt or equity are realistic? How best to obtain funding should you need it?
    2. Do I need a written pharmacy business plan?
    The answer is YES! Whether starting up a pharmacy business or purchasing an existing drugstore, every successful entrepreneur knows that in order to become successful one must write a solid business plan. In addition to being a “road map to success”, a solid business plan can help you get the funding from lenders that may be required.
    2. What experts will I need?
    You may have already considered an accountant and an attorney, BUT the most important expert of all is a seasoned Pharmacy Consultant on your team. HCC is known for being a national leader in helping pharmacy owners plan, purchase, setup and staff their pharmacies nationwide. Having helped open hundreds of new pharmacies and pharmacy startups, HCC ensures that all aspects of the business are covered and done right.

    Pharmacy Startup Experts

    There are many factors to consider in the planning, execution and the long-term success of starting up or purchasing an existing pharmacy business. Planning and execution are the keys to a drugstore being opened and becoming a successful business. Some of the considerations and tasks that Healthcare Consultants Pharmacy Staffing can provide include:

    – Creation and review of a business plan
    – Evaluation of proposed business location
    – Design recommendations
    – Obtaining financing
    – Assistance and guidance in the application process
    – Provide a Pharmacy Manger for both the application process and inspection
    – Provide a list of equipment and supplies (both for the Board of Pharmacy inspection and the actual Pharmacy operations)
    – Make arrangements for the final inspection of the facility (including a mock-inspection)
    – Suggestions for vendors
    – Provide legal support
    – Provide staffing

    If you are considering starting up or purchasing a pharmacy in 2019, 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 29 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.

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

New Pharmacy ConsultationOpening up a new pharmacy business is really not that much different from starting up any other type of retail enterprise. Aside from the regulations and laws inherently involved in a new pharmacy operation, the basic business startup principles still all apply. Having opened up hundreds of new pharmacies at HCC, here are the general retail business guidelines that any entrepreneur should consider as the basics for 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 keep being opened up. Yet the entrepreneur must also consider the most recent reports from the National Community Pharmacists Association (NCPA). The NCPA reported that there’s actually been roughly a ten percent (10%) decline since 2001 in the number of independent pharmacies 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.

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 operation. Keep in mind, that like the example of the map, your business plan must be flexible and allow for contingencies. As with driving, the roads may be under construction or blocked, so sometimes even the best plan needs some 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. Additionally, a solid business plan can greatly assist you in obtaining funding from lenders that you may require.

Location Is the Critical Consideration

As with any retail business, the three most important factors that need 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 marketing companies refer to as “focus groups” before making up your mind. Try and remember that you are not your own target audience and that it’s 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 receive. So be open minded and remember that becoming a profitable business is your goal.

How Much Money Does It Take To Open a Pharmacy?

Your answer will be much clearer after your business plan is written. Obviously you will need to include all of the 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. Initially acquiring a credit line and researching how best to obtain additional funding should you need it are both highly suggested to do at the very beginning of the start-up process.

Start Marketing Before You’re Open For Business

Don’t make the mistake of waiting until your pharmacy is open to begin the marketing! Have your website and Google Business Listing in place before you actually fill your first prescription. Use 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.

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.

If you are truly considering starting up a new pharmacy operation, 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 29 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.


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Pharmacy HIPAA Compliance Policies Procedures

Pharmacy HIPAA compliance policies and proceduresDo you have Pharmacy HIPAA compliance policies and procedures at your pharmacy? Are your employees HIPAA certified? HIPAA (Health Insurance Portability and Accountability Act) is always a topic of discussion when patients start asking their pharmacists and physicians for the receipts of their medical expenditures for tax purposes. This usually starts happening in late November and December, plus continues all the way to April 15th. These receipts are considered to be a part of a patient’s medical records and their release (what information and to whom it is released) should be covered in your pharmacy’s policies and procedures manual. Additionally, it is wise to get your staff training on dealing with patient confidentiality and even have them become HIPAA certified. Now is the time to make sure that your employees understand exactly what HIPAA compliance really is, plus gives you the time to update your P & P manual and get your staff properly trained and certified in regards to your pharmacy operation being HIPAA compliant.

Verdict Against Walgreens Upheld by the Indiana Court of Appeals

It has been almost three years now since the $1.4 million dollar verdict against Walgreens was upheld by the Indiana Court of Appeals. The court had ruled against Walgreens Pharmacy and one of its pharmacists who shared confidential medical information regarding a patient. The court based the award on the fact that they had violated HIPAA restrictions and broken the patient’s rights to privacy and confidentiality, thus resulting in harm to the individual and his family. That ruling was the initial decision handed down by an Indiana State Court holding a healthcare company or provider liable for an employee violating the Health Insurance Portability and Accountability Act, but there have since been others. Many Pharmacists still remember back in 2009 when the CVS drug chain agreed to pay $2.25 million to settle for HIPAA violations regarding the inappropriate disposal of prescription bottles and receipts that were considered to be violations of HIPAA standards and rules.

Patients Own Their Medical Records

It must also be pointed out that legally patients own their medical records. More and more patients and consumers are aware of this right and requesting their medical records from their doctors, hospitals and pharmacies. Previously, in the “paper age”, obtaining them was a costly, time consuming process. However, in this age of electronic medical records (and digital data storage and retrieval), obtaining one’s medical records is easily accomplished. A recent survey reported that over 97 percent of hospitals and over 82 percent of physicians utilize electronic records for their patients. So the public’s expectation is that they are “quickly” entitled to this information, plus it should be provided without hesitation and inexpensively (as compared to just a decade ago). In a good article in The Peoples Pharmacy, patients are encouraged to obtain their medical records and can even download and print a free “drug safety questionnaire” to take to their pharmacists and physicians to fill out.

Pharmacy Operations and HIPAA

HIPAA’s Privacy Rule basically was put in place to safeguard a patient’s protected healthcare information (PHI). Additionally it mandates that a patient has access to their own medical records and that patients have the right of ownership regarding their own healthcare information. These HIPAA Privacy Rules apply to everyone who “manages health care transactions”, and the point to be noted is that this includes pharmacies, pharmacists and the entire pharmacy staff.

The Rules

Suffice it to say that the rules are complex regarding a patient’s protected healthcare information (PHI). The basis of HIPAA and the HIPAA Privacy Rules simply stated is that pharmacies must get signed authorization from patients prior to service that allows the pharmacy to use their PHI during their care, plus allows the patient to access their PHI. Yet there are exceptions, exclusions, provisions from other acts (such as the Clinical Laboratory Improvement Act) that have turned the good intentions of HIPAA into a legal “quagmire” for the pharmacy and pharmacist. Just a few that were noted in some excellent articles (including a well explained discussion in Pharmacy Times):
–  Exclusions to a patient’s PHI (when it could harm the individual or others) include psychotherapy notes, legal documents, or laboratory results prohibited under the Clinical Laboratory Improvement Act (CLIA).
– Another exclusion is if the patient is not able or unavailable to agree or object in instances where disclosure is required by law, public health oversight, or child abuse or neglect.
–  PHI must be disclosed regardless of patient’s authorization to the U.S. Department of Health and Human Services (HHS) during an investigation.
– Additionally there are situations when a pharmacy or a pharmacist may disclose a patient’s PHI without the patient’s consent under certain treatment, payment or operations “instances”.

Reporting Violations and Possible Fines

HIPAA violations must be reported to the Department of Health and Human Services (HHS). If a violation affects more than 500 patients, then HHS must be notified within sixty (60) calendar days. If less than 500 patients are affected by a violation, you may notify HHS no later than sixty (60) days after the end of that calendar year. Fines range from a minimum of $100 per violation up to $1.5 million.

What Should You Do Regarding HIPAA Compliance

The answer is simple: Develop good Policies and Procedures. Don’t delay – do it now! Then educate your staff on how to implement and follow them. Train yourself and your staff on the law and do not tolerate violations of your Policies and Procedures.
In the past, it was common practice for a pharmacist or pharmacy staff member to share the personal prescription records of patient with the patient’s family members or even friends out of concern or in an attempt to help. Yet now such actions are violations of laws and can result in lawsuits, fines and negative publicity for your pharmacy business operation. Perhaps it’s time to have a comprehensive Pharmacy Business Review of your entire operation by an objective and experienced third-party pharmacy consulting firm.

About Healthcare Consultants

As always, please contact us here at HCC if you have any questions regarding development of policies and procedures related to HIPAA Compliance. If you already have HIPAA policies and procedures in place, perhaps a review by an objective (and experienced) third party is a good idea? With over 29 years in the pharmacy consulting business, HCC can assist you with expert advice in any area of your pharmacy business or practice. 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.

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Dispensing Error Liability

dispensing errorsDispensing errors in pharmacy are a fact of life. Even with the very best policies and procedures in place, an educated and well trained pharmacy staff performing the necessary steps to ensure safe Rx dispensing, plus an experienced pharmacist performing and overseeing the actual prescription dispensing, the process involves human beings and they are not robots. The point is that humans make mistakes, and dispensing errors occur even when a pharmacy has the very best of systems and professionals in place.

New Dispensing Error Legislation Proposed In The UK

Interestingly enough there is currently new legislation being proposed in the United Kingdom in regards to dispensing errors made by pharmacists and the associated liability to the pharmacy. The problem that the proposed UK legal changes attempts to address is quite simple: Remove the fear of prosecution that pharmacists face when they discover that a dispensing error has been made. By removing the impediment that discourages pharmacists from reporting dispensing errors and mistakes that have been made, the result of increased error reporting can only result in learning from the errors and a vast improvement in patient and consumer safety.

It is important to note that the proposed legislation for exemption from legal liability applies only when an inadvertent medication dispensing error takes place or occurs. As long as the pharmacy had in place proper and up-to-date written Policies and Procedures, plus the pharmacist involved did not intentionally make an error or knowingly break a law, then the proposed legislation would prevent any liability as a result of being reported. In other words (keeping in mind that we here at HCC are not attorneys or lawyers), if the RPh acted in the expected and best standard practices of their profession when a dispensing error was made, the pharmacist would be exempt from both criminal and civil legal liability.

The Estimated Reduction Of Errors In The UK

The assessment that was performed in the United Kingdom to substantiate the legislative changes was based on several basic estimates. Determining whether the estimates are accurate or not is not the intent of this discussion. The reasoning that was used, however, does seem to be logically sound and leads to a dramatic result in the potential economic savings, and, perhaps more importantly, an increase in patient welfare and safety.

The Impact Assessment Estimates

The Impact Assessment conducted and released by the UK Department of Health and Social Care estimated the following:
1. In 2016 alone there were almost twenty-one thousand (20,820) estimated dispensing errors reported by pharmacists throughout the UK.
2. There were almost five-hundred thousand (499,651) additional dispensing errors that were NOT reported by pharmacists during the same year (2016).
3. This means that only about four percent (4%) of all errors were actually reported.
4. The assessment estimated that over sixty percent (62%) of the dispensing errors could be eliminated with a major increase in the sharing of information and an increase in education and discussion regarding the errors.
5. The proposed new UK legislation would then result in an estimated thirty percent (30%) reduction in medication errors in a four year time period. This means that over one-hundred and fifty thousand errors (156,503) would be prevented or eliminated each year.

The Monetary Impact Considerations In The United States

Now let’s extrapolate these estimates to the USA. It’s important to note that the UK assessment pointed out that there are numerous factors why a pharmacist would fail to report a medication dispensing mistake, but they estimated that over twenty percent (20%) of the non-reporting is due to the fear of prosecution.

As reported in 2016 by the Healthcare Financial Management Association (HFMA), an estimated economic cost of over $20 billion in the United States is due to medical errors. This number obviously includes all errors, of which only a portion can be attributed to errors in Rx dispensing by pharmacists. However, as reported by the Institute of Healthcare Improvement’s National Patient Safety Foundation almost ten years ago (in 2007), an estimated 3 billion dispensing errors occur annually in retail pharmacies alone in the US.

Although there may be no way to actually extrapolate the monetary savings that could be realized, the possible reduction in deaths caused by dispensing errors is quite considerable. According to a report released by the US Food and Drug Administration (FDA), there are greater then seven-thousand (7,000) deaths annually in US hospitals alone that are directly attributed to medication dispensing errors. This number does not include any deaths that are related to dispensing errors made by retail pharmacies. The real question may be: If the UK assessment is correct and the proposed legislative change could result in a thirty percent (30%) reduction in medication errors in four years, would the saving of nearly 2,100 patient lives a year in our nation’s hospitals alone not justify the  change?

Contact HCC For Answers To Your Questions

With over 29 years of experience, Healthcare Consultants has been known as a national leader in regards to pharmacy consulting since 1989. Should you have any questions on how proposed legislation may affect your pharmacy or business, we encourage you to us contact us online now or call today at 800-642-1652. Let us help you ensure that your pharmacy operation has no issues by performing a comprehensive Compliance and Audit Review, or by simply having our experienced team of in-house pharmacy consultants address any questions or issues that you may have.

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