How a Pharmacy Compliance Consultant Can Help Lighten the Load for Pharmacy Owners

I think most pharmacy owners would agree they are wearing too many hats!  Is it because they feel a need to do the task themselves or is it because they don’t have enough staff to complete the task?  Either way, many jobs and responsibilities end up on the shoulders, or in this analogy, on the head of the pharmacy owner. Payroll, orders, HR actions, paperwork, billing issues, IT support, etc., each one of these items is a “hat” that need to be continually worn.  Now think about compliance, I would say that's probably a Texas-sized 10-gallon hat.  It’s awkward, balky, slightly unattractive, and for some reason, no one else wants to wear that hat!

What is Pharmacy Compliance?

That term encompasses many aspects within pharmacy. Is it medication adherence, where your patient is taking the right dose at the right time, refills are never late, and they are consistently taking it as directed? Is it following the prescribed rules for any number of regulatory agencies that pharmacy owners work with:  DEA, FDA, CMS, HHS, OSHA, USP, and the State Board of Pharmacy? Is it keeping a written set of policies and procedures to document processes in the facility? Is it training? The answer is YES to all those questions.  So how does a pharmacy owner keep up with everything that is changing and make sure they are doing everything correct when they have so many other "hats" or items to address everyday all while taking care of their patients?  They look for help in the form of a compliance consultant. 

How a Pharmacy Consultant Helps

Working with a compliance consultant can bring several benefits to an independent pharmacy, ensuring regulatory compliance and overall operational success.  If you are wearing too many hats in your pharmacy and want a second set of eyes on your compliance needs, here are a few things that a compliance consultant can bring to the table.

1. Expertise and Knowledge:

The regulatory environment in pharmacy, especially compounding, can be complex and subject to frequent changes (did someone say USP <800> or maybe <795>?).  A compliance consultant brings specialized knowledge and expertise to navigate these complexities, ensuring the pharmacy stays up to date with the latest regulations.

A compliance consultant also understands customizations are needed for unique needs.   Independent pharmacies often have unique practices and have many regulatory agencies they need to comply with.  A compliance consultant can tailor guidance, policies and procedures, and support documents to meet the specific needs of the pharmacy, ensuring a personalized and compliant approach.

2. Risk Mitigation and Avoidance

Pharmacy owners have legal and financial risks. Non-compliance with regulatory requirements can lead to legal and financial consequences for pharmacies.  A compliance consultant helps identify potential risks, implement preventive measures, and establish proactive compliance strategies to mitigate the risk of regulatory violations.

Your pharmacy compliance consultant can help lighten the load with audit preparedness. They'll be well-versed in the different types of audits, and in the event of an audit or inspection, having a compliance consultant on board ensures that the pharmacy is well-prepared.  They can assist in organizing documentation, implementing checklists and measures for encompassing best practices into daily routines, demonstrating a commitment to compliance, and, if need be, helping to address corrective actions, thereby minimizing the impact of audit or inspection.  

3. Efficiency and Process Improvement:

Streamlined processes are a lifesaver.  Compliance consultants can streamline compounding processes by introducing efficient workflows and best practices.  This not only enhances regulatory compliance but also improves overall operational efficiency, allowing the pharmacy to focus on patient care.

Streamlining process often requires technology integration.  A compliance consultant can recommend and help integrate technology solutions that facilitate compliance monitoring, documentation, billing, and reporting.  This ensures that the pharmacy stays technologically advanced and aligned with regulatory expectations.

Are All Pharmacy Compliance Consultants and Services the Same?

No, they are not.  In fact, there are several places pharmacy owners can get compliance help.  They may get free items from their state pharmacist association, software company, maybe even their wholesaler, PSAO, or Buying Group.  They can hire an employee to handle all requirements, or they can hire a compliance consultant or company to handle their needs.

Free Services from Affiliations:

Let's talk about free options; I love FREE, and in today’s economy, FREE is always a nice solution.  But what happens when the free compliance program doesn’t include the item an auditor or inspector is looking for, or when the free HIPAA policies don’t have instructions or support for handling a breach, or when a regulation changes and things need to be updated?  Beware of free because it may not solve all your compliance needs.  Also keep in mind, FREE may mean you are actually paying for the service through membership fees or possible deducted through rebates that aren't identified.

DIY or In-house Compliance Employee:

You can certainly DIY (Do-It-Yourself) or hire someone in-house, specifically for compliance, this can be is a huge allocation of payroll.  The subject matter is very complex and takes a considerable amount of time to research, this person needs to be very focused and diligent.  Designating one person to be in charge of all compliance can be  overwhelming, and puts owners in a precarious situation if the individual choose to leave.  Additionally that one person is responsible for the success and failures of audits, inspections and surveys (which is difficult to navigate even with tips from the experts).  This is a lot of pressure and requires an immense about of faith in one person; have you hear the saying "don't put all your eggs in one basket"?

You Get What You Pay For:

Compliance Consultants are the third option.  My personal motto is "Do what you do best and contract the rest!"  There are individuals and companies for hire that provide a wide range of services from creating custom Standard Operating Procedures (SOPs) for your facility to providing Policies & Procedures to meet guidelines and regulations.  Some provide one time services, while others provide on going support. These experts have a pulse on regulations and know exactly what you need and have helped people prepare for and survive compliance nightmares.  They've seen the good, the bad, and the ugly, and if they are worth their fee- they've helped many people along the way. 

When looking for a consultant, you need to first determine what level of help you need, consider if you need support or will you be sufficient?  Be sure to ask if  they provide supporting documentation and forms.  Finding a consultant that provides Policies & Procedures for a low cost may seem like a bargain, but what happens when items need updated?   Next, look at what material they are providing you; are they providing one-time deliverables such as manuals, or do they have a web-based platform to host files?  Last and probably most important are they available for your staff when they have questions and need support ?  Will they assist with Medicare Applications & Revalidations?  Are they able to help you if you have a problem with DEA or your State Board of Pharmacy?  If you are going through an ownership change or a location change, are they able to help update documents and provide you with the sequences to complete tasks so your licenses aren’t interrupted?

Are You Ready for a Pharmacy Compliance Consultant?

A compliance consultant provides essential expertise, helps mitigate risks, and enhances operational efficiency, making them valuable partners for independent pharmacies striving to maintain regulatory compliance in the dynamic and demanding landscape of pharmacy.

Now, wouldn’t it be nice to give that compliance hat to someone else?  That’s where R.J. Hedges & Associates can help.  We know you have many things that need done, but the most important is taking care of your patients.  We’ve developed our compliance programs to be as detailed as you need to cover as many areas of compliance as you may need.  To save you time, everything has been customized for you and you’ll even have a dedicated Project Manager that can help train and answer questions while you are implementing and maintaining these programs within your facility.

I get asked a lot about what separates us from our competitors, and I always say our concierge level support and staff.  Our Project Managers are essentially like an assistant Compliance Officer and will partner with your staff to support them.  I’m sure if we were to separate our services and simply offer a Policy & Procedure Manual, we would be very similarly priced to our competitors, maybe even a tad less expensive.  However, our fees are higher because we have dedicated staff available to support our clients because we choose to offer and provide a full-service solution. 

So, if you are looking for concierge-level service, where you can get help and support implementing and maintaining your compliance programs, R.J. Hedges & Associates might be your solution.  Feel free to schedule a one-on-one compliance chat for more details or to see what compliance solutions may be helpful for your pharmacy.

I can't let you go without some type of checklist or guide.  Here are 10 topics and questions you should ask when vetting and interviewing consultants and consultant companies to help secure the best match for your pharmacy.

1. Experience and Expertise:
   1. What is your experience in providing compliance consulting services specifically for pharmacies?
   2. Can you provide examples of pharmacies you have worked with in the past and the outcomes of your consulting services?
      
2. Regulatory Knowledge:
   1. How do you stay up to date with the latest regulatory changes from DEA, OSHA, FDA, USP, and state board of pharmacy?
   2. Can you give examples of recent regulatory changes that have impacted pharmacies and how you helped clients adapt to them?
3. Customization and Tailoring:
   1. How do you tailor your compliance solutions to meet the unique needs and challenges of each pharmacy?
   2. Can you provide examples of how you've customized policies and procedures for pharmacies similar to ours?
4. Training and Education:
   1. What types of training and education do you provide for pharmacy staff regarding compliance requirements
   2. How do you ensure that staff members understand and implement compliance measures effectively?
5. Support and Accessibility:
   1. What level of ongoing support do you provide after implementing compliance policies and procedures?
   2. How quickly can we expect a response from you if we have questions or concerns about compliance issues?
6. Risk Assessment:
   1. How do you conduct risk assessments for pharmacies to identify potential compliance vulnerabilities?
   2. Can you outline the process you would use to assess our pharmacy's compliance risks?
7. Documentation and Record Keeping:
   1. What methods do you recommend for maintaining accurate documentation and records to demonstrate compliance?
   2. How do you ensure that our pharmacy's documentation meets regulatory standards?
8. Conflict Resolution:
   1. How do you handle disagreements or conflicts with regulatory agencies regarding compliance issues?
   2. Can you provide examples of how you've successfully resolved compliance related disputes for your clients?
9. References and Testimonials:
   1. Can you provide references from other pharmacy clients who have used your compliance consulting services?
   2. Do you have any testimonials or case studies that demonstrate the effectiveness of your compliance solutions?
10. Cost and Contract Terms:
    1. What is your fee structure for compliance consulting services?
    2. Are there any additional costs or fees we should be aware of?
    3. What are the terms of your consulting contract, including duration and termination clauses?