IV and Infusion Pharmacy Startups and Expansions:
IV and infusion pharmacy startups are always at the top of the list when considering opening up a new pharmacy business or expanding an existing pharmacy practice. The IV and infusion pharmacies were the catalyst to the emergence of both the compounding and specialty pharmacy booms that have dominated the pharmacy start up marketplace for the past decade. 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. 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. Ever since the 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 sterile medications.
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.
Along with all the usual considerations involved in the planning and execution of a pharmacy startup operation to become a successful business, 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 pharmacy must be in compliance with all local, state and federal laws, rules and regulations and the task of starting up a new pharmacy exponentially becomes more 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.
Additionally, there are various 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)
– 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)
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.
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 business. The planning and execution are really the keys to a smooth pharmacy operation being opened and becoming a successful business. 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 HCC if you have questions regarding establishing or running an IV and infusion pharmacy. With over 27 years in the Pharmacy Consulting business, HCC 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. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all areas of your business. Contact us online or call us at 800-642-1652.