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.

 

 


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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.

 

 

 


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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.

 

 


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Recent FDA 503 Actions

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

The Events Leading To The Conviction

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

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

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

A Closer Look At the FDA’s 503 Processes

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

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

About HealthCare Consultants

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

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

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

 

 

 


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FDA Form 483

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

What Is an FDA Warning Letter?

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

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

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

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

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

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

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

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

About HealthCare Consultants

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

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

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

 


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GHRP

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

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

What is the Background and History of these GHRPs?

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

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

What are the Current Clinical Uses of GHRPs?

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

What Is the FDA’s Current View on GHRPs?

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

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

Who Can Help With GHRP Related Issues?

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

About HealthCare Consultants

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

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


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503A Pharmacies

503a pharmaciesCompounding pharmacies and 503A specialty pharmacies have been the center of  FDA (U.S. Food & Drug Administration) focus ever since the tragic 64 deaths associated with the NECC (New England Compounding Center) occurred back in 2012. The 64 patients that died and the 750+ others that were injured due to the contaminated drugs compounded by the NECC were eventually directly linked to what was called “a lack of proper oversight” that the State Board of Pharmacy failed to provide to protect patients in the United States.

The FDA  subsequently divided what were traditionally termed compounding pharmacies into two separate entities: 503A Compounding Pharmacies and 503B Outsourcing Facilities.

What Exactly is the Definition of a 503A Compounding Pharmacy?

The FDA defined a 503A pharmacy as what had always traditionally simply been labeled as a “compounding pharmacy”. In other words, those operations that compounded and prepared medications for individual patient use and dispensed for a specific prescription to be used ONLY by the patient that the medication was prescribed for. The 503A pharmacy is prohibited from dispensing medications for office use and is therefore limited to only drugs that a patient can use in their own home.

As always, they are required by each State Board of Pharmacy to comply with all the existing USP requirements and state rules, statutes and guidelines.

Are These 503A Pharmacies Subject to FDA Oversight?

Traditional compounding pharmacies, those state licensed pharmacies meeting the requirements of FDCA section 503A, may believe that, since they are compliant with state pharmacy rules and statutes and USP requirements (including chapters 795, 797, 71, 85, 1116), they are not subject to FDA oversight. They would be wrong. Recent aggressive FDA inspections of 503A pharmacies, often conducted in concert with the home State Board of Pharmacy inspectors, have lead to many compounding pharmacies being issued FDA Form 483s based on “Insanitary Conditions”. Under FDCA section 501(a)(2)(A) the FDA has the right to inspect anywhere medications are prepared, packed, or stored and that drugs are deemed adulterated if they are prepared, packed, or held under insanitary conditions whereby they may be contaminated with filth or rendered injurious to health. However, there are statutory restrictions on what the FDA inspectors can review within a 503A pharmacy. But if the compounding pharmacist or business owner doesn’t understand these limitations, they are at great risk of unwittingly waiving their rights to an aggressive FDA inspector.

How Do I Make Sure That My Pharmacy is 503A Compliant?

All compounding pharmacies should have a customized 503A policies and procedures manual, as well as a defined plan of what to do when the FDA shows up at their pharmacy’s door. HCC has expert in-house consultants (all are pharmacists with extensive compounding experience) that can assess your pharmacy and operations to identify areas of risk and assist with risk mitigation. HCC also works closely with knowledgeable and experienced FDA legal attorneys who are experts in the 503A pharmacy area of law and who can protect your rights, plus potentially interact with the FDA inspectors when they arrive at your pharmacy operation. In other words – be proactive and prepare your pharmacy for the inevitable FDA inspection.

Who Can Help With 503A 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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503B Outsourcing Facilities – Are You in Compliance?

Pharmacy Inspections 503BA lot of discussion about how FDA 503B inspections are having a huge impact on 503B outsourcing facilities and their operations. It’s easy to see that being prepared with your 503B P&P manual up to date is the key to a successful inspection results and compliance audit outcomes. The 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 30+ 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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