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How to Start a Specialty Pharmacy

Today, in the pharmaceutical market, specialty pharmacies are growing faster than anything else. Differing from your average pharmacies, specialty pharmacies are state-licensed pharmacies that provide special medications for people with serious health conditions that require complex treatments.

In other words, a specialty pharmacy is the place that you go when your needs can’t quite be met by a run-of-the-mill pharmacy - and business is doing extremely well.

Specialty pharmacies cover both mail-order and on-site facilities and treat conditions that err towards the rare side of the spectrum - conditions like HIV/AIDS, cancer, hormone deficiencies, STIs, and multiple sclerosis. These conditions call for complex treatments that many average pharmacies don’t carry. Specialty pharmacies do.

From 2015 to 2019, the percentage of pharmacies that receive specialty accreditation jumped 280%. This might have something to do with the fact that the need for specialty drugs has also increased - by almost double - since 2009, while traditional medication needs are on a downward slope.

This article will explore what it takes to start a specialty pharmacy, describing five factors to consider before opening your own location. These factors include:

1. Licensing Requirements

In order to open your own specialty pharmacy, you must have a wide and complex knowledge of specialty medications, an understanding of patients with rare/difficult to treat/untreatable conditions, care plans, and interventions.

Here’s what it takes to become qualified as a specialty pharmacist:

● BSPharm or PharmD degree from an accredited college/university

● No felony convictions

● A current and active license that’s in good standing

● 3,000 hours of specialty pharmacy experience within the span of 4 years

● 30 hours spent continuing education in specialty pharmacy within the last 2 years

● Completion of the CSP exam

As a specialty pharmacist, you’ll need to get your pharmacy set with the required accreditation. In order to qualify for such accreditation, your pharmacy must be licensed and operated in the United States, employ a licensed pharmacist-in-charge, and remain compliant with your state’s business rules and regulations.

The five major accrediting bodies are:

● Accreditation Commision for Health Care (ACHC)

● Utilization Review Accreditation Commission (URAC)

● Center for Pharmacy Practice Accreditation (CPPA)

● The Joint Commission

● National Association of Boards of Pharmacy (NABP)

Depending on which organization you choose to move through, the process can take anywhere from 6 months to 3 years because of the differing standards and eligibility requirements.

2. The Cost to Open a Specialty Pharmacy

There will always be costs to deal with when opening a new business, no matter what kind of business it happens to be. When creating the plan to open a specialty pharmacy, here are some working costs that you should keep in mind:

● Build-out costs (things like your mortgage payment to interior design)

● Initial inventory stock

● Operating expenses (these will cover daily expenses until you start to make a profit)

It’s also important to create a financial plan. This could mean approaching investors or applying for loans - whichever you choose, you will need to show proof of upfront investment, good credit, and a long-term plan for your specialty pharmacy.

It’s common knowledge that all businesses require money to get off the ground, and the same can be said for all beginner pharmacies. What might not be obvious, though, is the fact that specialty pharmacies’ complex needs typically require higher costs than your average pharmacy because of the complex needs of the patients.

These costs can cut into your profit, so you should always keep them at the forefront of your mind. A few examples of these costs are:

● Cost of purchasing specialty drugs

● Ongoing accreditation, certifications, and training for staff

● Increased DIR fees for specialty drugs

● Specialized software

● Storage, handling, and delivery costs

In order to keep these costs from becoming overwhelming, place a priority on the relationships between your pharmacy and wholesalers, and also third-party coverage. This makes for patient care that's affordable and reimbursements that help keep costs down.

3. The Time it Takes to Open

If you want to start your own specialty pharmacy, there are three ways that you can go about doing it: establishing a partnership, buying, or building your own. Here’s what those three options look like:

Partnership - This offers the most time to market because you have instant resources at your fingertips, along with a ready-made staff.

Buying - If you purchase an existing business, you have everything already established, with more investment on your part. You’ll be up and running relatively quickly.

Building - Though this method is rewarding, it takes the most time out of the three. A grand opening doesn’t happen overnight, and you have to take into account the lengthy process of accreditation.

4. Location

If you’re looking at creating a brick-and-mortar pharmacy, you have to look at where your customers are located. You want to prioritize proximity to your patients, and also your pharmacy’s accessibility.

It’s always a good idea to be near a main road, or on the main road itself - it keeps your business visible and at the forefront of people’s minds. But when researching where to place your pharmacy, look at the potential competition that may surround you. If the town's too small, you might not be able to afford competition. Your location must be strategic.

Accessibility is just as important as location. While you may be highly visible on a busy street, there may not be adequate parking for customers - and that negates the convenience of the location. A trip to your pharmacy should be easy and stress-free.

Opening up your pharmacy near neighboring medical facilities encourages future collaborations in the future, and almost always guarantees the presence of a parking lot. That’s always a good idea.

5. Technology Requirements

Specialty pharmacies require different technology than average pharmacies because of the audiences that they cater to. This technology includes advanced management software and comprehensive data reporting platforms - things you must incorporate into your financial plan.

A list of further things to incorporate into your business’s financial plan:

● A management system that meets regulatory needs, and also handles prescription records, lifestyle, and adherence

● Patient management software - including a feature for secure messaging

● Medical benefit verification, billing, and systems for submitting claims

● A reporting solution that tracks patient interactions, touchpoints, and clinical documentation

Though the process of getting a specialty pharmacy off the ground isn’t always easy, it’s worth it for a successful business in a prosperous market.


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