Specialty Pharmacy Medication

Unable to fill Specialty Medication?

Unable to fill Specialty Medication?

How many times has a patient presented to you with a prescription for a “specialty medication" that you were unable to fill? It could be that you are not able to order the medication from your wholesaler. Or worse, the patient’s insurance is mandating a specific pharmacy different than yours. It can be frustrating when a current or prospective customer is coming to you, the pharmacist for a solution to their chronic and sometimes rare, condition.

There is no finite definition for what qualifies as a “specialty medication". In general, specialty medications are used to treat chronic or complex conditions and usually require special handling or administration and close monitoring of the patient. Sometimes, these prescription medications are indicated for rare diseases, which means that the disease affects less than 10,000 people. And they are therefore given “orphan drug status” under the Orphan Drug Act of 1983. This Act allows for fast-track FDA approval for drugs intended to treat these rare diseases due to limited drugs available on the market.

Some "specialty medication" manufacturers may limit the number of pharmacies who have access to order their medication. These are deemed “Limited Distribution Drugs,” or LDDs for short. When attempting to order one of these medications from your wholesaler, you may notice that the drug’s name is not listed in the system. Or it may take you straight to a screen that reads, “due to manufacturer limitations, this product is only available through a limited distribution network” and to contact the manufacturer directly.

Upon calling the manufacturer, you may find out that in order to gain access to this drug, there are many rigorous requirements to meet first. It is also worth mentioning that all manufacturers are different and have different specifications that must be met. A common theme among these manufacturers is some sort of specialty accreditation. This is often the first step to becoming a Specialty Pharmacy.

Achieving accreditation proves a commitment to quality and standards that are becoming the norm in the specialty space. Accrediting bodies such as the Accreditation Commission for Health Care (ACHC) and the Utilization Review Accreditation Commission (URAC) are arguably the most reputable in the field. Both sets of standards set the stage for core activities such as:

  • Patient Care
  • Coordination of Care and/or Delegation
  • Information Management
  • Compliance Program
  • Quality Management and Continuous Quality Improvement

Accreditation is strongly recommended but could become mandatory by payers in the near future in order to ascertain preferred contracts for reimbursement purposes. The entire process can take up to six months to a year for full accreditation and can be very arduous and labor intensive.

The key is to connect with a professional who has been through the process. Ideally, they should have been able to achieve and has maintained accreditation for some time. Embarking on a project like this size could be overwhelming and a competent expert can guide you through the process.

There are many resources available though, if you choose to take on a project independently. However, there is a lot of competition out there in specialty pharmacy but accreditation can set you apart from others.

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