Despite many articles, seminars, and educational opinions written on compliance and legal implications of dispensing, ordering, and storing controlled substances, it still remains the number one reason for disciplinary actions across the nation. This article focuses on the most cited violations of state or federal laws pertaining to working with the controlled substances.
- Improperly performed inventories. It’s common for pharmacy inventory to omit
- Time of the date the inventory was taken (beginning or end of the business day);
- Finished form of the substance (e.g., tablet or vial).
Many states have updated or modified their requirements on proper inventory. California, for example, now requires a manual count of all Schedule II drugs at least every three months. For other schedules, the count could be estimated, unless the container holds more than 1,000 tablets or capsules.
- Records of receipt and dispensing. Dispensing records must state number of units dispensed, name and address of the person to whom it was dispensed, the date of dispensing, the name or initials of the individual who dispensed. Very often, pharmacy records omit patient addresses or/and the DEA number of the prescriber (or state an incorrect number).
Invoices and ordering records (such as 222s) must be properly prepared and have the information on the supplier, date of receipt, number of containers.
- Power of attorney. All ordering personnel must properly execute a power of attorney with the registrant. Often, the power of attorney is not dated, not coming from the registrant, or missing altogether.
- Physical controls. It is recommended that all Schedule II drugs be locked and Schedules III-V be separated from the rest of the inventory in some high-visibility place (not at the back of storage or by the bathroom or a locker room). The keys to the controls should be in the possession of a pharmacist at all times.
- Employee screening.Per federal regulations, a pharmacy shall not employ anyone who has access to controls, if such person has been convicted of a felony relating to controls or whose application with the DEA had been denied, revoked, or surrendered for cause. Pharmacy should run state, county, and federal background checks on all employees with access to controls.
- Reporting theft/loss. Pharmacy must report any theft or substantial loss of controls within one day of discovery by filing Form-106. If not filed timely, the DEA may “visit” the pharmacy to 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 perform the investigation. If the pharmacy determines that there was no loss or it was not significant, the report may be withdrawn or amended. States vary on reporting requirements.
7. Security features on prescriptions. Many states have updated their requirements on what information should be stated on a prescription. California – for example – now requires a new security feature, a uniquely serialized number attributable to a prescriber.
If a prescription for Schedule III-V medications is missing any of the security features, a pharmacist may treat a noncompliant form as an oral prescription. The pharmacist, however, must verify the order with the prescriber and include notations on the prescription form.
- Corresponding Responsibility. Pharmacists usually run into this problem when they do not run PDMP reports on new and existing patients or they are filling scripts coming from problematic prescribers who are already on the DEA’s or Medical Board’s radar.
Remember,every record-keeping violation could potentially turn into a monetary penalty. Therefore, training staff on proper record-keeping, following every state requirement and regulation of Title 21 Code of Federal Regulations (starting with § 1300) and incorporating them into your policies and procedures is a part of a solution to comply with state and federal regulations on dispensing and handling controls and avoiding potential disciplinary actions, DEA’s administrative actions, and monetary penalties.