On August 22nd, 2014, the FDA announced the up-scheduling of hydrocodone combination products (HCP). Effective October 6th 2014, all HCP will be classified as Schedule II controlled substances which require additional safeguards with regards to prescribing, procurement, recordkeeping, inventory and storage.
Regardless of your opinion on this issue, pharmacists must be prepared to be compliant on October 6th. This article provides a quick reference tool to help pharmacists prepare for the process by outlining steps that needs to be taken prior to October 6th.
Pharmacies must have valid state and federal (DEA) registrations to purchase and dispense Schedule II products.
Storage: take stock of the maximum quantity of HCP you normally carry in your pharmacy. Can your current stock of HCP be relocated to your schedule II vault or safe? If the answer is no then you might need to purchase or source additional vault space.
Recordkeeping: one way to prepare for this change is to close out all HCP records from your Schedule 3-5 register on September 30th, 2014. The closed records should be transferred to your Schedule 2 register on that same day meaning that you would be keeping the right records on HCP by October 6th.
Inventory: be sure to take a physical inventory count of all your HCP by September 30th, 2014. The DEA requires an exact physical count of Schedule II controlled substances and an estimated count or measure of the contents of a schedule III, IV, or V controlled substance (unless the container holds more than 1,000 tablets or capsules in which case an exact count of the contents must be made). The Controlled Substances Act also requires that all inventory records be maintained at the registered location in a readily retrievable manner for at least two years for copying and inspection. In addition, the inventory records of schedule II controlled substances must be kept separate from all other controlled substances.
Procurement: Pharmacists and agents authorized to order Schedule II controlled substances will have to use paper DEA 222 or its electronic equivalent, Controlled Substance Ordering System (CSOS), to place their orders for HCP from October 6th, 2014.
Prescribing: This aspect of controlled substances management will be impacted the most as the changes will be significant. As pharmacists, we can be proactive and take certain actions in advance to minimize the impact of this change on our patients particularly those with chronic pain.
Write to all your patients who have had HCP filled at your pharmacy in the last 90 days informing them of the change and advising those without prescription refills to make arrangements with their physicians’ offices as soon as possible. The DEA will allow patients’ with existing legitimate prescription refills issued before October 6th, 2014 to be refilled until April 8th, 2015. Click here for a sample patient letter
Write to physicians in your local area informing them of this change and how it will affect their usual course of practice. Click here for a sample physician letter
Further information about entire rescheduling process can be found at this link Hydrocodone Combination Products – Fact Sheet