Comply with state and federal regulations on dispensing and handling controls to avoid possible disciplinary or DEA actions and penalties.
Controlled substances can be a minefield. Despite articles, seminars, and opinions written on compliance and the legal implications of dispensing, ordering, and storing controlled substances, it remains the number one reason for disciplinary actions. Here are the most cited violations of state or federal laws pertaining to controlled substances.
Up Next: Improperly Performed Inventories
Improperly Performed Inventories
Pharmacy inventory commonly omits time of day the inventory was taken or the finished form of the substance . Many states have modified their requirements on proper inventory. California, for example, now requires a manual count of all Schedule II drugs at least every three months.
Up Next: Power of Attorney
Power of Attorney
All ordering personnel must properly execute a power of attorney with the registrant. Often, the power of attorney is not dated, does not come from the registrant, or is missing.
Up Next: Physical Controls
It is recommended that all Schedule II drugs be locked, and Schedules III-V be separated from the rest of the inventory and be in a high-visibility place (not at the back of storage or by the bathroom). The keys to the controls should be in the possession of a pharmacist at all times.
Up Next: Employee Screening
Federal regulations say a pharmacy shall not employ anyone with access to controls who has been convicted of a felony relating to controls or whose application with the DEA had been denied, revoked, or surrendered for cause. Pharmacies should run state, county, and federal background checks on all employees with access to controls.
Up Next: Reporting Theft/Loss
Pharmacy must report any theft or substantial loss of controls within one day of discovery by filing Form-106. If not timely filed, the DEA may investigate the delay. It is common to delay filing 106 while the investigation is pending. However, the DEA requires that the registrant file the report first and then investigate. If the pharmacy determines there was no loss or no significant loss, the report may be withdrawn or amended. States vary on reporting requirements.
Up Next: Security Features on Prescriptions
Security Features on Prescriptions
Many states have updated their requirements on what information should be stated on a prescription. California now requires a new security feature, a serial number uniquely attributable to a prescriber.
If a prescription for Schedule III-V medications is missing any security features, a pharmacist may treat a noncompliant form as an oral prescription. The pharmacist must verify the order with the prescriber and include notations on the prescription form.
Up Next: Corresponding Responsibility
Pharmacists can run into this problem when they do not run PDMP reports on new and existing patients or are filling scripts coming from problematic prescribers who are already on the DEA’s or medical board’s radar.
Up Next: Records of Receipt and Dispensing
Records of Receipt and Dispensing
Dispensing records must state number of units dispensed, name and address of the person to whom it was dispensed, date of dispensing, and name or initials of the person who dispensed. Pharmacy records often omit patient addresses or/and the DEA number of the prescriber, or get the number wrong. Invoices and ordering records must be properly prepared and have information on the supplier, date of receipt, and number of containers.