As a pharmacy, it is part of the job to stock and dispense controlled substances. But with all of the headlines about misuse of opioids and DEA raids, pharmacists are concerned about the risks of having controlled substances on hand and confused about when to refuse to fill a prescription.
But there are a few simple steps pharmacies and pharmacists can take to control their risks. Doing so should help pharmacists feel more at ease in handling CS inventory and evaluating CS prescriptions.
Effective Controls on CS Inventory
Ordering and accounting for controlled substances can be a challenge. But many risks can be controlled by having well-written policies and procedures that are strictly followed, as well as assuring adequate security and periodic inventory/audits.
Inventory Policies and Procedures
Policies and procedures should limit who can order and receive controlled substances as well as the process for receiving those controlled substances into inventory (consider use of security cameras- see Security Systems below). Periodically, those orders should be reviewed for any patterns of concern. Policies should also address losses of controlled substances and the reporting of any such losses to the DEA and state authorities. Many pharmacies/pharmacists are not aware that a single unaccounted dose of a CS is a “loss” for reporting purposes. As a result, it is also important to have policies around wasting or reverse distribution of any controlled substances.
Access to the pharmacy should be restricted to when a pharmacist is in the secured pharmacy area. If a pharmacist must leave the secured area for a break, the pharmacy must be locked until the pharmacist returns and no prescriptions can be dispensed during that time.
In addition, security cameras are one of the most effective deterrents to theft of controlled substances, particularly when strategically placed to identify the removal of controlled drugs from the shelves or locked cabinets.
Although most pharmacies use a perpetual inventory system and conduct CS counts, additional audits should be considered periodically to confirm inventory, assure CS dispensing logs are accurate and complete, and evaluate the overall security around CS inventory and compliance with policies and procedures.
Effective Controls on Filling Controlled Substance Prescriptions
In addition to strict inventory controls, having effective controls on when and how CS prescriptions are filled can mitigate many of a pharmacist’s concerns. As every pharmacist should know, although the physician writing a prescription is primarily responsible for prescribing controlled substances, the pharmacist filling a prescription has a corresponding responsibility to assure the prescription is written for a legitimate medical purpose pursuant to a valid patient-prescriber relationship.
So, how does a pharmacist fulfill this “corresponding responsibility”? By following well-established dispensing policies, assuring use of available data and information, making appropriate inquiries, and using his/her professional judgment.
First and foremost, the pharmacy should establish unambiguous policies and procedures that, while allowing the pharmacist to exercise his/her professional judgment, set minimum expectations for evaluating whether to fill each controlled substance prescription. Those policies and procedures should incorporate, at a minimum, expectations for validation of patient identification, reviewing the state’s prescription drug monitoring platform (in Florida, eForce), and telephoning the prescriber. Completing each of these steps can provide meaningful information to assist the pharmacist in exercising his/her professional judgment as to whether to fill a prescription.
When a pharmacist refuses to fill a prescription, the policy should specify the type of documentation to be maintained and any refusal to fill documentation should be available for evaluation in conjunction with any subsequent prescription presented for that patient or from that prescriber. The policy should also require reporting to local law enforcement of any prescription believed to be fraudulent.
Use of Available Data and Information
With the data available today through each state’s prescription drug monitoring program, pharmacists can access a significant amount of information to evaluate each prescription. In many smaller pharmacies, this may require a separate step outside of the pharmacist’s dispensing workflow, but it is essential to mitigate the risk of filling a fraudulent prescription. By checking the database, a pharmacist can obtain information such as how many physicians a patient sees (“doctor shopping”) and how many other controlled substances a patient is taking. These pieces of information coupled with other more subjective inquiries and judgment assist the pharmacist in determining whether to fill a prescription.
Inquiries and Judgment
Certainly, knowing the patient and prescriber and reviewing the patient’s profile on the state’s prescription drug monitoring program platform are great initial steps. But they may not sufficient. Pharmacists should be prepared (and empowered) to exercise their professional judgment as well. Examples include the need for pharmacists to be alert to any geographic patterns of concern (e.g., patient address, physician location, pharmacy location). Also, knowing what controlled substance prescriptions other members of the same household are receiving from the pharmacy could be critical to a pharmacist identifying concerns. A pharmacist should be expected to ask patients to explain any unusual circumstances.
Without strong policies and procedures for CS inventory and the filling of CS prescriptions, pharmacists may be confused as to expectations and how to exercise their “corresponding responsibility.” Tight controls on CS inventory coupled with expectations for evaluating each controlled substance prescription that is presented should alleviate that confusion and reduce the risks to the pharmacy.