Pharmacy rules
Each rule adds to the articles for a robot that works in a pharmacy. Massachusetts rules are cited because they are specific; other states have their own.
| Topic | Rule for the robot | Basis |
|---|---|---|
| Final check | The final dispensing check stays with a licensed pharmacist; the robot never releases a prescription without that sign-off | 247 CMR 9.04 |
| Counting, filling and labeling | Automation counts, fills and labels only with technological checks such as bar codes or weight, and keeps lot numbers traceable for recalls | 247 CMR 9.11 |
| Pharmacist on duty | The robot runs only while a pharmacist is on duty, matching the rule that a pharmacist be present whenever the pharmacy is open | 247 CMR 9.19 |
| Secure areas | The pharmacist Manager of Record and the pharmacist on duty control access to the prescription area, including the robot's | 247 CMR 9.21 |
| Hazardous drugs | Antineoplastic tablets and capsules must not go into automated counting or packaging machines, and other hazardous drugs should not. The robot moves only sealed stock bottles of hazardous drugs and never opens, counts or packs them; staff who handle them are trained and checked yearly | Board advisory on USP <800> |
| Controlled substances | Schedule II to V drugs stay in a locked cabinet or dispersed through other stock. The Schedule II perpetual inventory is reconciled at least every 10 days and unlicensed people may not edit it, so the robot never does; Schedule II and III drugs never go in multi-drug single-dose packages | 21 CFR 1301.75; 247 CMR 9.21 and 9.08 |
| Patient information | Label images are protected health information, so the robot's maker signs a business associate agreement with the pharmacy before go-live | HHS |
| Retention | Controlled-substance surveillance video is kept at least 14 days, or 2 years when theft or diversion is suspected; prescription records at least 2 years | 247 CMR 9.16 and 9.21 |
The step record
Every step of the pharmacy workflow is checked and recorded, for robot and human work alike, with one audit trail per prescription.
| Step | What happens | What proves it |
|---|---|---|
| 1. Receive | Stock is scanned in | Photo, video clip and AI check of the scan |
| 2. Pick | The right drug is picked | Bar code and label match, photo, video clip, AI check |
| 3. Count and pack | The right dose is counted and packed | A second technological count check, photo, video clip, AI check |
| 4. Label | The right patient's label is applied | Label read back against the prescription, photo, AI check |
| 5. Final check | The pharmacist signs off | The pharmacist reviews the product and its audit trail |
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