PMCY01 Prescription Medication Shortages
|Effective Date||June 7, 2019|
|Subject Matter Expert||Pharmacy Branch Manager|
|Approval Authority||TB/HIV/STD Section Director|
To establish uniform procedures used by the TB/HIV/STD Section (THSS) for distributing medications when there are prescription drug shortages and communicating information about the shortages to internal and external stakeholders.
It is the policy of the THSS to apply and adhere to the procedures outlined in this policy when unforeseen prescription medication shortages occur that affect Section programs. The Prescription Medication Shortages Policy and Procedures do not supersede or otherwise circumvent standing delegation orders issued under Texas Administrative Code Title 22, Part 9, Chapter 193.
CDC – U.S. Centers for Disease Control and Prevention
FDA – U.S. Food and Drug Administration
ITEAMS – Inventory Tracking Electronic Asset Management System
LHDs – Local Health Departments
LIDS – Laboratory and Infectious Disease Services Division
PHR – Public Health Region
RLHO – Regional and Local Health Operations
THSS – TB/HIV/STD Section, which includes the Health Communications and Community Engagement Group, the HIV/STD Prevention and Care Branch, the TB/HIV/STD Epidemiology and Surveillance Branch, the TB and Hansen’s Disease Branch, and the Pharmacy Branch.
4.0 Persons Affected
- Staff in the THSS who are responsible for communicating with local and regional health departments
- Branch/Group Managers in the THSS and Regional and Local Health Operations (RLHO)
- THSS Director
- LIDS Medical Officer
- LIDS Associate Commissioner
- Regional Medical Directors, Deputy Regional Directors, Communicable Disease Managers, and TB/HIV/STD Program Managers.
5.1 THSS Pharmacy Branch Manager and Staff will:
- Identify or receive notification about drug shortage and assess situation to determine magnitude and potential impact of the shortage on program operations;
- If deemed necessary, notify affected program managers and staff, THSS Director and LIDS Medical Officer about the drug shortage and relay existing recommendations and directives regarding the shortage;
- Assess the inventory of the drug in short supply at time of notification of medication shortage and continue to monitor the inventory of the drug until the shortage is over;
- Notify Group and Branch Managers, THSS Director, and other appropriate leaders when medication supply becomes severely limited;
- Work with pharmacists to adjust order fulfillments based on drug shortage; and
- Ensure agencies who order the medication(s) through ITEAMS are aware of the plan to address the drug shortage.
5.2 THSS Non-Pharmacy Branch Managers and Staff will:
- Provide guidance, expertise, and communication about the drug shortage to internal and external stakeholders;
- Create and disseminate stakeholder communications and supporting documents relating to the drug shortage in consultation with THSS Central Office Staff.
5.3 THSS Central Office Staff will:
- Respond in a timely manner to all inquiries from providers, contractors, and others who have questions related to the drug shortage;
- Edit stakeholder communications and supporting documents relating to the drug shortage for consistency of messaging, readability, grammar, spelling, punctuation, and formatting prior to routing for approval;
- Communicate with regional and local health department Communicable Disease Managers and the RLHO Public Health Nurse about the drug shortage and how to respond to inquiries; and
- Develop tools to help PHR staff track the distribution of the affected drug(s) to providers for the treatment of the affected condition/disease.
5.4 THSS Director will:
- Provide guidance and expertise as requested;
- Obtain information about the status of the shortage from the Food and Drug Administration and any other appropriate federal agency;
- Work with the DSHS Pharmacy Branch, appropriate Branch(es) within the THSS, LIDS Medical Officer, and RLHO leadership to ensure communication about the drug shortage is shared with contracting agencies, DSHS staff who may be impacted by the shortage, and Texas medical associations, as appropriate.
5.5 The LIDS Medical Officer will:
- Provide guidance and expertise as requested; and
- Review and approve all finalized plans to address any drug shortage.
6.1 Pharmacy Branch personnel will identify or receive notification about a drug shortage and assess situation to determine magnitude and potential impact of the shortage on program operations. If shortage is determined to affect the program, the Pharmacy Branch manager will notify appropriate THSS Branch and/or Group Manager(s) and staff, THSS Director, and the LIDS Medical Officer.
6.2 If the drug shortage may severely impact program operations, Pharmacy Branch personnel will convene a meeting with relevant program staff and managers, THSS Director, the LIDS Medical Officer, and one RLHO representative to outline a plan to address the shortage.
6.3 The Pharmacy Branch Manager or designee will assess current inventory of the drug(s) that are in short supply at the Pharmacy and at the PHRs.
6.4 THSS Program staff will prioritize populations who will receive the identified available supply of the medication in accordance with federal treatment guidelines and recommendations.
6.5 The Pharmacy Branch Manager will consult with the Branch pharmacist(s), the LIDS Medical Officer and one RLHO staff to identify potential substitute drug(s), in the event a drug substitution has not already been identified and announced by the FDA or other federal agency. The Pharmacy Branch Manager will also identify funds for purchasing the substitute drug in consultation with appropriate THSS Branch Managers. Regional Medical Directors have the authority to decide which substitute drug(s) will be used in their PHR for both general and priority populations identified in 6.4 while the shortage persists. If a substitute drug is identified and available, it will be offered through the ITEAMS portal.
6.6 The drug shortage plan, including populations identified as priority for receiving available supply of the drug in shortage will be reviewed by appropriate THSS Branch Managers and the THSS Director. Once reviewed, LIDS Medical Officer will approve the finalized drug shortage plan.
6.7 The appropriate THSS Branch and/or Group Manager(s) will work with the designated RLHO representative to inform PHRs about the drug shortage and subsequently maintain communication about the status of inventory until the shortage is resolved.
6.8 THSS Central Office Staff will disseminate information about the finalized drug shortage plan to internal and external stakeholders.
6.9 The Pharmacy Branch will monitor the distribution of drug(s) in short supply based on the quantity available. If the supply becomes severely limited, the Pharmacy Branch will limit the amount of drug(s) sent in orders and notify all affected stakeholders. Fulfillment of orders for drugs in short supply will be based on the populations prioritized as determined by THSS Program staff in consultation with the LIDS Medical Officer.
6.10 The Pharmacy Branch Manager or designee will review orders submitted through the ITEAMS portal that request the medication in short supply. Quantities supplied for that drug may be limited based on availability and the need of the consumers. Pharmacy personnel will notify requestor if changes are made to their request made in ITEAMS.
6.11 PHR Communicable Disease program staff will track distribution of the drug in short supply using the log provided by THSS.
6.12 PHR Communicable Disease Program staff should contact designated THSS staff or RLHO if a private provider or entity was unable to obtain the drug in short supply through ITEAMS and subsequently contacts the PHR for assistance in obtaining the medication.
6.13 The appropriate THSS Branch and/or Group Manager(s) will inform LIDS Associate Commissioner, RLHO Deputy Associate Commissioner, and RLHO Public Health Nurse of the shortage status on a biweekly basis or more frequently if requested by executive management.
6.14 The THSS Director will utilize existing communication channels to inform stakeholders of the shortage status and any updates to DSHS’ plan for addressing the shortage.
6.15 The Pharmacy Branch Manager and the Branch pharmacist(s) will continuously monitor the status of the shortage through manufacturers and/or distributors and communicate manufacturing and/or distribution status updates to pharmacy stakeholders and affected DSHS programs as needed.
7.0 Revision History