IV 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.
– JCAHO (the Joint Commission)
– ASPEN (American Society for Parenteral and Enteral Nutrition)
– 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.