Current topics in Pharmacy Policy Flashcards
What is the role of professional associations
seek to further a particular profession, the interests of individuals engaged in that profession and the public interest
What is the importance of professional organization involvement
-help further your career through advocacy and advancement
-provides a network or resources and mentorships and opportunities
-provides learning opportunities
-provides career resources
What is legislative policy
statutes that give guidance and define authority
What is regulatory policy
give detail and outline enforcement within delegated authority
What is practice policy
similar to that of professional policy, but policies put into place my professional organizations to establish how pharmacy practice should be run
What is the difference between laws and regulations
laws define the authority where regulations give detail and outline the enforcement within the defined authority
What is a medication shortage
FDA def: products used to prevent or treat diseases or medical conditions for which there is no other available source with sufficient supply of product or an alternative
ASHP def: a supply issue that affects how a pharmacy prepares or dispenses a drug product or influences patient care
What are the common causes of medication shortages
-loss of manufacturing
-discontinuation
-increased demand
-raw material shortage
-delays/capacity
-manufacturing issues
What are some proposed ways to address shortages
Federal: FDASIA requires companies to notify FDA when mfg changes could lead to supply disruption
State: price gouging prevention laws
Professional: Mitigating Drug Product Shortages Policy Position
Practice: communication with all healthcare system facilities and staff
What are the main provisions of the Pharmacy and Medically Underserved Areas Enhancement Act
-pharmacist is legally authorized to perform in the state in state in which individual performs such services that would otherwise be done by a physician
-done in the setting where there is a health professional shortage or medically underserved population/area
What are the main provisions of the Equitable Community Access to Pharmacy Services Act
-expands medicare coverage to permanently include services provided by a pharmacist such as incidental services and supplies, related to testing, drug regimens and vaccines for certain illnesses
-provides continued coverage of pharmacist services related to testing and vaccines for COVID-19 and influenza
-provides for coverage of testing for RSV and strep throat and initiation of drug regimens used to treat covid-19, influenza or strep throat
-reimbursement for said services is set for 85% of applicable amount
Describe the recognition of pharmacist services and federal provider status
-list of health care professionals as providers in Medicare Part B of the Social Security Act
-heath plans reference Medicare Part B for beneficiary coverage
Describe the main provisions of WI Act 98
-reimbursement of pharmacist services under the Medical Assistance program
-department shall provide reimbursement for services that are reimbursable under this section and provided by a licensed pharmacist
-must be within the scope of license
What are the ASHP legislative principles regarding medication shortages
- require mfg to provide FDA with more info about cause and expected duration
- require mfg to disclose manufacturing sites and sources of API
- require mfg to establish contingency plans to maintain supply
- establish incentives to produce drugs at risk of shortage
- require HHS and DHS to conduct risk assessment on national security threats
- require FDA to establish quality ratings
