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IV Infusion Pharmacies

IV Infusion Pharmacies

IV PharmacyIV and infusion pharmacy startups are always at the top of the list when you may be considering opening up a new pharmacy business or an expansion of your existing pharmacy operation. The IV and infusion pharmacies were the primary catalyst to the emergence of both the compounding and specialty pharmacy booms that have been dominating the pharmacy start up marketplace for the past several decades. IV and infusion pharmacies compound medications that are typically administered intravenously, but also provide for drugs to be administered as intramuscular injections and for epidural use.

What Needs Consideration for an Infusion Specialty Pharmacy Startup

The major consideration in opening up an IV and infusion pharmacy is that sterile compounding is a highly regulated area of the specialty pharmacy business and industry. Ever since the terrible meningitis outbreak in 2012 that was linked to the New England Compounding Center (NECC) and resulted in the deaths of 64 patients, IV and infusion pharmacies are under strict guidelines and the scrutiny of numerous federal and state agencies. Formalized IV and infusion preparation training (based on USP 797) is required now for all pharmacists and pharmacy technicians who are involved in the preparation and compounding of all sterile medications such as those produced in an IV infusion specialty pharmacy practice.

The IV and infusion pharmacy primarily compounds sterile medications for patient use in their homes or in a long-term care facility (LCF). Most frequently the patient has a fenestrated catheter inserted and the infusion via the catheter is delivered by one of three methods:
1. Electronic Pumps – typically the medications are pre-mixed from vials and delivered via IV infusion bags using an electronic pump.
2. Elastomeric Pump – these devices deliver the medications stored in a “balloon like reservoir” that is unclamped for delivery of the patient’s IV dosage.
3. Pre-Filled Infusion Therapy – one of latest technologies that delivers a preset (metered) unit dose from a pre-filled IV container.

Additional Statutes and Guidelines Required for Preparing Infusion Meds

Along with all the usual considerations involved in the planning and execution of a pharmacy startup operation to become a successful business venture, an IV and infusion pharmacy must also adhere to numerous additional statutes and guidelines. These include:
503B FDA facility requirements established in the Quality Compounding Act of 2013
USP 797 compliance guidelines
ASHP Guidelines on Home Infusion Pharmacy Services
– The Medicare Home Infusion Therapy Coverage Act (S. 1203 and H.R. 2195)
Additional equipment, supplies, logs and records are necessary. Sterile compounding equipment is a must (such as Laminar Flow Hoods), plus storage and handling requirements pertaining to both the ingredients and the IV drugs prepared must be strictly adhered to. IV and infusion pharmacies additionally must be in compliance with all of these federal and state agencies:
– United States Pharmacopeia (USP)
– HIPAA (The Health Insurance Portability and Accountability Act)
– Federal Food and Drug Administration (FDA)
– Occupational Safety and Health Administration (OSHA)
– Drug Enforcement Administration (DEA)
– The Centers for Medicare and Medicaid Services (CMS)
– National Institute for Occupational Safety and Health (NIOSH)
– Environmental Protection Agency (EPA)

Add into the mix the fact that an IV and infusion specialty pharmacy must also be in compliance with all local, state and federal laws, rules and regulations and the task of starting up a new pharmacy becomes exponentially more complicated, regulated and difficult. It is important to note that there are frequent changes, modifications and additions to both the laws and regulations by these various agencies, yet strict compliance and adherence is a must.

A customized Policy & Procedures manual is a necessity for every IV and infusion compounding pharmacy! As everyone is aware, each pharmacy business is required to have a policy and procedure manual. Every state and most PBMs have specific policy requirements that the pharmacy is expected to incorporate into their manuals. More importantly, the infusion pharmacy is expected to adhere to their own policies and procedures. These must be kept up-to-date and must clearly document that the operation is strictly adhering to all requirements. Merely possessing a generic P & P manual is not enough. This manual must contain the required policies and reflect the actual procedures established to properly and safely operate the specialty pharmacy.

Additional Professional and Accreditation Organizations for Infusion Compounding

Additionally, there are various ancillary professional organizations and accreditation bodies that set the guidelines and best practice standards to ensure the delivery of high quality patient care in regards to IV medication preparation and delivery.
These include:
– JCAHO (the Joint Commission)
– ASPEN (American Society for Parenteral and Enteral Nutrition)
– Medicare
– ACHC (Accreditation Commission for Healthcare)
– PCAB (Pharmacy Compounding Accreditation Board)
– HQAA (Healthcare Quality Association on Accreditation)
– IDSA (Infectious Diseases Society of America)
– CHAP (Community Health Accreditation Program)

Is Additional Training Required?

An additional point that must be taken into consideration is that IV training is now a requirement for all pharmacists and pharmacy technicians who are involved in preparing sterile IV and infusion medications. In fact, according to the directives based on USP 797, formalized training is required for all pharmacists and pharmacy technicians involved in any type of sterile compounding. Many states also now require special licensure for a pharmacist for preparing sterile preparations (and many see this special licensure requirement being the next change on a national level).
Lastly, special permits are also required for the operation of this type of specialty pharmacy practice. One specific application for a permit requires a detailed written response to a list of 21 clinical and operational questions which are based on your Policies and Procedures manual.

How and Where Do You Start?

As with any pharmacy operation, there are numerous factors to consider in the planning, execution and long term success of opening and maintaining a new IV and infusion pharmacy pharmacy business. Planning and proper execution are really the keys to a smooth pharmacy operation being opened and then becoming a successful and profitable business venture. Just a few of the considerations and tasks that are required for any successful pharmacy start-up operation include:
– The creation and review of a business plan
– Guidance regarding type of corporation to form – Limited Liability or LLC, C-Corporation, S-Corporation, Sole Proprietorship or a General partnership
– Startup cost estimates
– Obtaining financing
– Work flow design
– Assistance and guidance with the DEA & State Board of Pharmacy application process
– Creating Policy and Procedure manuals and Continuance Quality Improvement (CQI) manual
– Purchasing the equipment and supplies
– Obtaining legal support
– Staffing (not only the pharmacist, but technicians and ancillary support staff personnel)

As always, please contact us here at Healthcare Consultants if you have any questions regarding establishing or running an IV and infusion specialty pharmacy. With over 30+ years in the pharmacy consulting business, HCC can assist with expert advice in any area of your pharmacy operation or practice. We urge you to contact us today to see how our Pharmacy Consulting services can help YOU. With a full-time staff of in-house pharmacy consulting specialists, HCC can answer any questions that you may have in all areas of your business. Contact us online now or call us at 800-642-1652.


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Specialty Pharmacies

Specialty Pharmacy Consultation specialty pharmacy startupSpecialty pharmacies have been designated by numerous industry experts as the fastest growing segment of the pharmacy industry. This is based on the number of new specialty pharmacies opening up nationally, plus the 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 20% per year according to the AMCP (American Society of Managed Care), many entrepreneurs are investing in the continued success of specialty pharmacies as a lucrative business model. Yet the industry is still in its infancy according to several 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 all 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 spending reaching around $400 billion (or slightly less than 10% of the US health spending in total). Add in the fact that of the 27 new drugs approved in 2013 by  alone by the FDA, 14 were specialty pharmaceutical medications, and just such statistics are reminding many of the famous California Gold Rush of 1848. Perhaps we should call it the “Specialty Pharmacy Gold Rush”? It is clear that the prospect of success regarding starting up a specialty pharmacy is there, but remember that it is directly proportional to the number of specialty pharmacies “panning for the gold” that is rapidly expanding.

Which Specialty Model Is a Lucrative Startup Now?

An analysis in 2012 by UnitedHealthcare reveals that about 51 percent of spending on specialty drugs is for 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 rapidly expanded into many other types and models of specialty pharmacies that have proven to be successful business models. A quick look at several lucrative “winners” currently in the specialty pharmacy game are listed below for your review.

Compounding Pharmacies
Dermatologicals were a perfect prescription type for specialty pharmacies to embrace. Any pharmacist can tell you that each dermatologist has their own “secret sauce” that most chain drug stores always turned away. Add in the explosion of compounding opportunities (examples such as penile implant solutions, veterinary medications, the delivery of medications in alternative strengths, dosage forms and flavors for infants are just a few) and the number of compounding pharmacies has increased exponentially in the last decade alone. Compounding pharmacies additionally must meet the 503B FDA facility requirements established in the Quality Compounding Act of 2013, plus meet USP 797 compliance guidelines.

Mail-Order Pharmacies 
This market segment of specialty pharmacies is undergoing rapid growth and equally rapid change. Most of the specialty pharmacies have contracts with Pharmacy Benefit Managers (PBM), but some are independent mail order pharmacies specializing in a specific niche or disease such as cystic fibrosis, hospice, nuclear, COPD and respiratory medications, plus oncology and cancer. The major mail order pharmacies are associated with many insurance providers and large retail chains such as Walgreens, Humana, Aetna and Caremark. The three largest are Express Scripts, OptumRx (UnitedHealthcare) and CVS Health.

IV and Infusion Pharmacies –
Special permits are required for the operation of this type of specialty pharmacy practice. One specific application for a permit requires a detailed written response to a list of 21 clinical and operational questions which are based on your Policies and Procedures. Additional  equipment, supplies, logs and records are necessary. Sterile compounding equipment is a must (such as Laminar Flow Hoods), plus storage and handling requirements pertaining to both the ingredients and the specialty drugs prepared must be strictly adhered to.  As with other types of compounding pharmacies, IV and infusion pharmacies additionally must meet the 503B FDA facility requirements established in the Quality Compounding Act of 2013, plus meet USP 797 compliance guidelines.

Specialty pharmacy startups were again at the forefront of discussions earlier this year after the release of an article by HealthLeaders Magazine (a division of Simplify Compliance). The study stated that the commercial pharmacy spending rate in the USA had risen to a new high that greatly exceeded the previous five year average of a 14% increase. The spending rate increased by over 18%, far exceeding the already optimistic economic projections that analysts were expecting. What’s important to note from the study for our current discussion regarding a specialty pharmacy startup’s viability is the fact that oncology and immunotherapy drugs were cited in the report as the most significant drivers of the higher spending rate seen. One can then extrapolate that data to predict that investments made in the startup of a pharmacy dealing with both oncology and immunotherapy drugs will most likely yield a lucrative return or result. That’s obviously dependent in the end on how well the business startup is planned and executed, plus the proper management of the business and operation afterwards.

How Do I Start Up a Specialty Pharmacy?

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 an investment decision. While more and more pharmacies are entering the specialty pharmacy market, the market is not without its challenges. 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.

Who Can Help Me Start Up a Specialty Pharmacy?

If you’re considering opening or starting a Specialty Pharmacy, or perhaps expanding or turning a portion of your existing pharmacy business into a specialty pharmacy, then Healthcare Consultants can help you! HCC 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 pharmacy recruitment and staffing business for over 30+ years now, as well as 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 so you can win in the Specialty Pharmacy arena. Contact us online now or call us today at 800-642-1652 to discuss how we can help you startup, grow and/or expand your pharmacy business.

 


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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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