Experimental Design Details
Here we describe in detail the steps taken at each point in the intervention including an overview of the notification, return, and data matching process.
Identification of Treatment Day: Pharmacists will check the posted schedule for the week to see which days are treatment days. Notification cards will be made available in plain sight for pharmacists on treatment days as an additional visual reminder. A pop-up will be placed in the pharmacy calendar to alert pharmacists when they first log in to their computer that it is a treatment day.
Identification of Treatment Group: Patients receiving an opioid prescription for 14 or fewer days will be assigned to the treatment group based on the day that their prescription is filled by the pharmacist. Such patients will be identified when the medication is placed in the queue for pick-up, and a notification postcard will be stapled to the bag along with a “See Pharmacist” stamp.
Initial Notification: Notification of the incentive buy-back program will take place during pick-up as a pharmacist consultation. The pharmacist will verbally explain the program using a pre-developed script and provide the patient with the notification postcard as a reminder. Both the script and the written notification postcard will be developed in collaboration with pharmacy staff to ensure the appropriate literacy level, language (e.g. English and Spanish), and cultural considerations. We will also consult a behavioralist specializing in patient interventions to ensure that the script and the notification card appropriately educate the patient about the potential for addiction and the need to return any unused medication. The notification card will include the patient name and Rx number and will instruct the patient to return any unused medication in the original bottle.
Text Reminder: At one of the larger information-only locations, the pharmacy staff will send one text reminder at the end of the month to remind individuals in the treatment group to return any unused medication.
Receipt and Verification: When medication is returned to the pharmacy, a pharmacist will visually verify that the medication is an opioid and visually estimate the number of pills. Under no circumstances will the pharmacist ever touch the medication. An image chart will be posted in the pharmacy verification area (“the bench”) to help the pharmacist visually verify which medication is being returned. The pharmacist will record the patient’s name, the date, the Rx number (if possible), the type of medication returned, the estimated amount, and how the patient heard about the program (e.g., notified by pharmacist or word-of-mouth).
Opioid medications from other pharmacies will also be accepted to determine spillovers to other patients in the community who are not served by the community health center. Other medications brought to the pharmacy that are not opioids will be directed to a collection site in the community. If a patient insists a medication is an opioid that the pharmacist cannot verify, then the medication will be treated as if it were an opioid but the pharmacist will note that it cannot be verified as such.
Disposal of medication into the kiosk by the patient: Once the medication has been visually verified by the pharmacist, the patient will dispose of the medication in a kiosk in compliance with DEA and Massachusetts Board of Pharmacy regulations. In accordance with DEA regulations, the disposal kiosk will be placed in the pharmacy waiting area under video surveillance.
Disposal of medication from the kiosk: A DEA-approved vendor who will install the kiosks in accordance with DEA regulations and handle the disposal of the medication. The units will be shipped to each location with the bolts to have a maintenance team install them to the floor. When disposing of the medication from the kiosk, the unit will be opened with two members of the pharmacy per DEA regulations and a security guard at all times. The two pharmacy members would open the unit together, immediately pull the self-adhesive tape and seal the liner.. The box will remain in the kiosk and will be locked until the common carrier picks it up. After locking the kiosk, the common carrier will be contacted immediately to schedule a pick up within 24 hours. Once the carrier drops off the filled liner to the vendor, they take possession of the liner. The vendor will weigh the box containing the liner with at minimum two employees present and scan the tracking label to upload the weights into the reporting site. The box is then moved into the secure cage area waiting for the DEA representatives’ arrival for transport with minimum of two vender employees. From there the box is transported to the DEA approved controlled clean energy burn site. At the site, the tracking number is scanned, and the liner is weighed again. The liner is then burned in the presence of both the DEA officials and vendor representatives. A destruction manifest is then signed and uploaded to the web portal.
Financial Incentive (main location only): The pharmacist will dispense the gift card and the individual returning the medication will print and sign their name to acknowledge that they have received the gift card. We propose a $10 gift card for any amount of medication returned as sufficient to compensate individuals for their time but not so large as to encourage adverse behavior.
Notification Tracking: For internal purposes only, pharmacy staff will run a report of all opioid prescriptions for 14 days or less that will be placed in an excel spreadsheet each month. The spreadsheet will contain one row for each prescription that provides information on patient first and last name, date or birth, Rx number and date, type of medication and amount prescribed, and other patient characteristics (e.g., gender, English proficiency). At a later date, a pharmacy researcher will merge in data on diagnosis associated with the prescription (e.g. surgery, injury). All data will be de-identified by removing personally identifying information (e.g., name, date of birth, Rx number and date) before sending to the Northeastern University research team.
Return Tracking: Pharmacy staff will use a paper system to track which patients have returned medication. This information will include the patient’s first and last name, date of birth, and Rx number (if available from the notification card or prescription bottle). The pharmacist will also record the type and estimated quantity of opioids collected for disposal when visually verifying the medication as well as the date the medication was returned. Pharmacy staff will also record how the patient heard about the program to determine whether the patient was given the information directly or if they heard it through another source (e.g., word of mouth). This data will then be merged into the notification data using Rx number or first and last name. All data will be de-identified by removing personally identifying information (e.g., name, date of birth, Rx number and date) before sending to the Northeastern University research team.
Data Matching: The notification and return data will be matched to determine if the patient who returned medication was in the treatment group, the control group, or outside GLFHC. Data will be matched by Rx number or the combination of patient name and/or date of birth. This will allow us to measure any spillovers to those who were not initially informed as well as the amount returned relative to the amount prescribed.
Transmission of Data to Northeastern University: Pharmacy staff will remove any personally identifiable information (PII) from the excel spreadsheet that is shared with the researchers including first and last name, date of birth, Rx number, and date filled. To assess the impact of the program on different types of patients, patient characteristics will be provided at the group level (e.g., males age 25-34 years old) as long as there are at least five individuals in that group to prevent identification. To assess any seasonal variation as well as the spread of the program, the month that the prescription was filled and the month that it was returned will be provided. The spreadsheet will then be password protected and sent via email with the password sent separately. Data will be shared on a monthly basis with the researchers to monitor data robustness and identify emerging trends.
Pharmacy Staff Training: Training materials will be developed and used to educate and monitor pharmacy staff regarding the notification of patients, no handling of returned opioid medication, proper disposal or medication, and secure tracking of information. The training module will be delivered online, including a short quiz on the material, and an online verification when the pharmacists completes the training by the pharmacist that they have completed the training. Pharmacists will be required to take the training twice during the intervention period at six-month intervals to ensure compliance with the research protocol and DEA regulations. A one-page description of the return protocol will be posted in the pharmacy bench area to remind pharmacists of the steps for returning medication. Similarly, a one-page description of the notification protocol will be posted in the pharmacy bench area to remind pharmacists of script for notifying patients about the program.
Follow-up: At the six-month mark, the research team will conduct three focus groups with patients to uncover any unforeseen barriers or unintended consequences that could inform future programming.The three groups be comprised of individuals who were informed and returned medication, individuals who were informed and did not return medication, and individuals who were not informed but returned medication anyway.