Proposed policy and standard consent agreement for Pharmacy Substance Use Disorder (PSUD) DISCUSSION: Presented by V. BERG Requirements to be eligible for PSUD were summarized. Permission to PMP analyze must be granted with appropriate release forms. A form was distributed with specific substances for testing and Board members were invited to make changes to the tested substances list. Labs are offered by First Lab which has a medical officer. Suggestion made to list so not to “generalize” be locked into specific substances. DEA website will be consulted for trending drugs of abuse and the list will be reviewed every 6 months. Proposed consent agreement would be triggered by staff action policy: Executive Director can offer PSUD agreement without the Board involvement when: a.) License is in good-standing b.) There is a signed application; signed self-assessment program c.) Appropriate health records, CORI and referral to a designated provider are referred to the PSUD committee d.) There is no recent history of criminal record e.) There are no mental health conditions. ACTION: No action Above Action Level Staff Action Policy Time: 9:24 AM DISCUSSION: Presented by M. CHAN Staff action policy to manage remediation of above action level environmental monitoring results for sterile compounders. Ultimately will reduce cases brought to the Board. Staff will be able to evaluate results, remediation, reporting compliance and close file if remediation and reporting are compliant. If not, then file will be escalated to staff action or complaint to be ultimately heard by the Board. ACTION: Motion by K. CONLEY, seconded by P. GANNON and unanimously to approve Above Action Level Staff Action Policy. VII REGULATIONS Time: 9:26 AM 247 CMR 18: Non-Sterile Compounding DISCUSSION: Presented by H. ENGMAN Executive Office revisions that were made to the changes from the previous Board meeting were discussed. Section 18.10 to state pharmacist/pharmacy intern counsel requirement for shall – new compounding. If compound is being sent by mail, a leaflet or phone call would suffice for counseling. Communication of changes will be made through CEs and stakeholder groups.
Proposed policy and standard consent agreement for Pharmacy Substance Use Disorder (PSUD) DISCUSSION: Presented by V. BERG Requirements to be eligible for PSUD were summarized. Permission to PMP analyze must be granted with appropriate release forms. A form was distributed with specific substances for testing and Board members were invited to make changes to the tested substances list. Labs are offered by First Lab which has a medical officer. Suggestion made to “generalize” list so not to be locked into specific substances. DEA website will be consulted for trending drugs of abuse and the list will be reviewed every 6 months. Proposed consent agreement would be triggered by staff action policy: Executive Director can offer PSUD agreement without the Board involvement when: a.) License is in good-standing b.) There is a signed application; signed self-assessment program c.) Appropriate health records, CORI and referral to a designated provider are referred to the PSUD committee d.) There is no recent history of criminal record e.) There are no mental health conditions. ACTION: No action Above Action Level Staff Action Policy Time: 9:24 AM DISCUSSION: Presented by M. CHAN Staff action policy to manage remediation of above action level environmental monitoring results for sterile compounders. Ultimately will reduce cases brought to the Board. Staff will be able to evaluate results, remediation, reporting compliance and close file if remediation and reporting are compliant. If not, then file will be escalated to staff action or complaint to be ultimately heard by the Board. ACTION: Motion by K. CONLEY, seconded by P. GANNON and unanimously to approve Above Action Level Staff Action Policy. VII REGULATIONS Time: 9:26 AM 247 CMR 18: Non-Sterile Compounding DISCUSSION: Presented by H. ENGMAN Executive Office revisions that were made to the changes from the previous Board meeting were discussed. Section 18.10 to state pharmacist/pharmacy intern shall counsel – requirement for new compounding. If compound is being sent by mail, a leaflet or phone call would suffice for counseling. Communication of changes will be made through CEs and stakeholder groups.