Every sector of the health care industry is evolving rapidly. Here are a few current examples. Drug distributors are currently working to implement serialization of products as mandated by the DSCSA to further secure the integrity of the supply chain. Health care companies who handle, distribute, fulfill, dispense, or administer hazardous pharmaceutical products; and entities who compound non-sterile, sterile, non-sterile hazardous, and sterile hazardous products for administration to patients are feverishly assessing operations, weighing process changes, and finalizing educational components for employees about revised USP 795, USP 797, and USP 800 standards scheduled to take effect December 1, 2019. The passage of the Farm Bill in late 2018 has caused an explosion of cannabidiol (CBD) product offerings. What CBD products are safe to carry? What are my State’s laws regarding CBD products, and where should I source CBD products? Retail pharmacy accreditation is receiving renewed interest. Is retail accreditation something I should be pursuing? How should I prepare for this accreditation?
Admittedly, it’s difficult, if not extremely challenging to balance everyday responsibilities and tasks while still trying to keep abreast of the changes occurring in your business ecosystem. So how DO you keep up with the changes? Importantly, where do you start?
That’s where PMC can assist you. We provide specialized services in the areas of management, administration, regulatory compliance, and identifying best practices. We assist clients by conducting an internal review of operations to identify potential opportunity areas. Then we collaboratively work with you to implement action plans to bring your operation forward. We help our clients better manage the challenge of staying abreast with market changes and we assist them in matching resources to business needs.
Take that first step to “keep up” and advance your future success. Use the Contact Us page to reach us and request a time to discuss your needs and how we can help.
Have you ever encountered a situation where you thought and said to yourself, “this could not happen at a more inopportune time”? It perfectly describes Board of Pharmacy and other regulatory agency inspections. They come like the proverbial thief in the night, completely unexpected and unannounced.
With rules and regulations constantly changing, it is difficult, even for the most vigilant and attentive operators, to stay abreast of ever-changing state and federal laws and associated regulations. Combine the difficulty of staying aligned with the dynamic nature of regulatory changes with human nature’s characteristic inclination and tendency toward complacency and you are positioned to be unprepared for an inspection. As we all know, whether it’s a Board of Pharmacy, FDA, or DEA inspection, these inspections rarely result in total compliance no matter how diligently pharmacies are operated.
Knowing what inspectors focus on during an inspection can mitigate penalties and consequences that may ensue after an inspection. Board of Pharmacy inspections can result in substantial financial penalties. DEA and FDA inspectors often conduct their inspections accompanied by Board of Pharmacy officials. The penalty costs of inspections are aggravating and distasteful. They can exceed thousands of hard earned dollars.
A poor inspection can have other more deleterious financial consequences that may not, at first glance, be as obvious. Dismissal or expulsion from contracts and networks, outright impediment to inclusion in certain networks, contracts, and programs are unforeseen, devastating, and long-lasting outcomes of a bad inspection. Pharmacy is so very regulated and controlled by various organizations and groups. Because of this, it is imperative that inspection results be more than just substantially compliant.
An introspective analysis for compliance with all regulatory matters can result in sizable savings of capital. By being proactive and investing time and capital to assure compliance, before the unexpected presents itself, you will avoid the pitfalls that complacency presents.
Can you honestly say that you are ready for an inspection at any point in time? We can assist you in being better prepared. Give us a call.
USP General Chapter <800> applies to all healthcare personnel who handle hazardous drug (HD) preparations and all entities that store, prepare, transport, or administer HDs (e.g., pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians’ practice facilities, or veterinarians’ offices). Personnel who may potentially be exposed to HDs include pharmacists, pharmacy technicians, and other personnel who work in a pharmacy.
Community pharmacies handle HDs in their normal course of business. Some examples of common HDs include:
• Estradiol tablets
• Methotrexate tablets
• Azathioprine tablets
• Cyclophosphamide tablets
• Cyclosporine capsules
• Risperidone tablets
• Paroxetine tablets
The risks involved in handling these drugs depend on many factors including the actual toxicity of the drug, how the drugs may enter the body (dermal, inhalation, ingestion, etc.), how they may be manipulated, how often they are handled, and availability and use of primary and secondary engineering controls and personal protective equipment. Non-compounding pharmacies often don’t think about primary and secondary engineering controls or personal protective equipment. The emergence of USP <800> forcibly changes that unawareness.
At a minimum, community pharmacies should be doing the following:
• Review USP <800> (download for free after registering at the USP website).
• Download and review a copy of the NIOSH 2016 List of Hazardous Drugs
• Create a list of NIOSH listed HDs in your inventory.
• Conduct assessments of risk for handling those HDs in you inventory.
An assessment of risk may be used only for counting and packaging HD finished dosage forms in preparation for dispensing. An assessment of risk may NOT be used to avoid the requirements of USP 800 if any manipulation (crushing, breaking, or compounding) of the finished dosage form occurs.
Pharmacies must incorporate the standards in Chapter <800> into their occupational safety plan. Components of your pharmacy’s health and safety management system must, at a minimum, include:
• A list of HDs
• Facility and engineering controls
• Competent personnel
• Safe work practices
• Proper use of appropriate personal protective equipment (PPE)
• Policies for HD waste segregation and disposal
The good news is that on September 29, 2017 USP announced its intention to postpone the effective date of these new standards that were to take effect July 1, 2018. The purpose of this postponement is to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797> Pharmaceutical Compounding — Sterile Preparations, to provide a unified approach to quality compounding. The new effective date is December 2019.
If you want further information, and assistance in developing your strategies to meet these new standards please give us a call.
The clock is now running for entities to implement the new USP Chapter <800> Hazardous Drug Handling in Health Care Facilities. General Chapter <800> was published February 1, 2016 and becomes official July 1, 2018. All USP Chapters below <1000> are enforceable by regulatory oversight agencies such as boards of pharmacy, so pharmacies will need to integrate USP <800> requirements into their existing operating practices, and provide mandatory training for employees based on their job functions by July 1, 2018. The chapter applies to all healthcare personnel who handle hazardous drug preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians). ‘Handling’ includes the receiving, storing, compounding, dispensing, administering, and disposal of hazardous drugs. A hazardous drug is any drug identified as hazardous or potentially hazardous by the National Institute for Occupational Safety and Health (NIOSH) on the basis of at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity. NIOSH maintains a list of antineoplastic and other hazardous drugs used in healthcare settings.
Non-compliance with USP <800> will not only leave workers unprotected, but could also potentially harm your pharmacy’s fiscal performance. Penalties, fines, potential legal actions and, ultimately, suspension or termination of license are all potential outcomes of non-compliance.
Your plan of action to fall within compliance should include a thorough study of the chapter, a gap analysis of your current facility’s operations, including equipment, workflow processes, personnel awareness and training; and development of an implementation budget and timeline. For starters, USP is offering a home study course on their education website. With the implementation of <800>, combined with the pending revisions to <797> Pharmaceutical Compounding – Sterile Preparations weighing in the balance, engaging the assistance of experts should be seriously considered. The proposed changes to <797> reflect new science and evidence based on updated guidance documents, best practices, and new learnings from investigations. USP received over 8,750 comments from over 2,500 individuals when the comment period for the <797> revisions closed January 31, 2016.
PMC can assist you with both <797> and <800> from preemptively examining your operation to developing corrective action plans should you get an inspection. We encourage you to address these changes proactively, and engage the assistance of informed experts early rather than having to reactively address cited deficiencies.
One constant about pharmacy is change. Both the profession of pharmacy and the business of pharmacy are constantly changing. Educational requirements, scope of responsibilities, and sophistication of skill sets required to be a pharmacist continue to grow. The competitiveness in the healthcare marketplace has intensified with the emergence of limited product distribution, preferred networks, and outcomes-based payments. Both chains and independents face these business challenges. For both groups, the strong will only get stronger. The pressure to expand service offerings and service quality will not diminish. Investments in these improvements must be equally balanced with savings realized through labor efficiencies, expense control, and strong asset management. Because of this constant, yet ever-evolving change in professional and business practices business plans must be constantly monitored and adjusted to ensure the business continues to properly anticipate and meet customer/patient needs. PMC can provide you the needed guidance to select the best means to harvest success. With PMC assistance and you exercising the PIE principle (Plan, Implement, and Evaluate) you can successfully keep pace with today’s ever changing environment.
New and emerging technologies in the field of automated dispensing devices and systems are proving to be a most innovative advancement for the provision of medications for facilities and institutions. The benefits of utilizing these devices and systems extend to providers of pharmacy services, nursing staffs, patients, and insurers.
Bar coding and chip technologies allow for pharmacists to more efficiently manage human resources and improve on the accuracy of fulfillment and dispensing. Dispensing devices and systems that utilize bar coding and chip technologies reduce waste, eliminate packaging storage and distribution considerations, and are a deterrent to diversion. The costs and associated problems with blister packaging and bingo cards are substantially reduced as well as the expenses associated with discontinued medications and returns to stock.
These devices and systems are user friendly and have been embraced by nursing staffs due to convenience, ease of operation, and coordination of dispensing and medication administration record keeping. Patients are less at risk of receiving wrong medications; and the probability of medication shortages is greatly reduced by tighter inventory control.
In the event medications are discontinued, diversion and waste is reduced, resulting in cost savings to taxpayers and insurers. For the pharmacy community these new technologies also present new challenges and responsibilities. Provider pharmacies and their Pharmacists-In-Charge will be responsible for the overall operation of these devices and systems. Policies and procedures addressing all aspects of operation to include: security, access, location, accuracy, inventories, maintenance, licensing, filling, and dispensing must be developed, maintained and reviewed. Policies and procedures must also address quality assurance and adverse events associated with the use of these devices and systems. Most importantly, these devices and systems must conform to the rules and regulations of regulatory boards. In many cases the devices and systems must be inspected and approved by the regulatory board before initiating their use.
These new technologies also present challenges to regulatory boards, particularly, when regulatory boards do not have rules and regulations that adequately apply to and address these devices and systems. The time it takes to draft new rules and the process associated with approval and adoption of proposed new rules often lag behind new innovations, processes, and technologies. These regulatory challenges must not be an impediment to the benefits and progression of new and improved technology.
Resolution of these challenges requires collaboration between licensees and regulatory bodies to work cooperatively to safely introduce and utilize these new technologies. There is no question that new technological advances offer a better way of improving outcomes for all involved and interested stakeholders. In the absence of specific rules and regulations, licensees and regulatory boards should develop a framework and action plan which will allow for the safe utilization and implementation of these innovative improvements. Pilot programs, dialogue, and continuous quality oversight which address all areas of concern and challenges are excellent ways for licensees and regulatory bodies to work together. Boards of Pharmacy, licensees, and developers of new technologies must mutually embrace the challenges facing each affected party. A middle ground can be reached and the ultimate benefactor will be the patient.
Need any assistance with the challenges discussed? Give us a call.
How do you take a great idea and grow it into a successful business? How you differentiate yourself from the competition in the eyes of your customers? How do you transform good customer service into great customer service? How do you improve sales and margin? How do you convince a bank to loan you money to acquire a new store location? All of these business-related challenges can be successfully addressed and positive results achieved with a plan.
There is a simple acronym in business known as PIE. It stands for Plan, Implement, and Evaluate. It’s important to organize all of the ideas floating around in your mind into a cohesive plan. Developing the plan includes setting the goal or goals you want to achieve, and listing the action steps that you believe need to be taken to accomplish your goal. Once you’ve outlined your plan the next important step in the process, and often the more difficult step, is to implement your plan. Poor implementation of the plan or lack of consistent execution of the plan will impact results. It’s important that the plan also include on-going, periodic evaluation of results. Without this component, your plan is incomplete.
There are nuances to plan development that can improve the quality of your plan, and dramatically enhance results. As with almost every business venture, results achieved will be largely dependent on the quality of the people you enlist to assist you. If you are unfamiliar with business plan processes, then seeking the advice of people who have consistently demonstrated positive results is an important first step in developing your plan.
Ensure you have the right people in place to execute the plan. Realize that you may have to recruit new team members to achieve desired results. If you want to attract quality people, your employment opportunity has to be attractive to the person you are trying to recruit. Here again, a business plan will help you market yourself.
If you need money from a bank to carry out your plan, the loan officer will absolutely want to see your business plan. The presentation of a well-developed plan provides confidence to both borrower and lender.
Do you want to improve your business? Do you have an idea, but think you need help with your plan? Are you struggling to achieve desired results? Write to us, or give us a call.