ASHP Virtual House of Delegates Approves New Supply and Safety Policies
ASHP's virtual House of Delegates recently approved professional policies on the integrity of the drug supply chain and the safety of intranasal route administration.
ASHP’s virtual House of Delegates recently approved professional policies on the integrity of the drug supply chain and the safety of intranasal route administration.
Following discussion in the House of Delegates community on ASHP Connect, delegates voted online during the week of March 25 to April 1. This is the second virtual House of Delegates — the first took place in November 2015 — and the first year in which the ASHP House of Delegates will meet four times in its annual cycle. Delegates will also convene twice in June for in-person meetings during the ASHP Summer Meetings in Baltimore as well as for a second virtual session in November.
“The virtual House of Delegates allows ASHP to be more responsive in addressing the issues that are important to our members,” said ASHP CEO Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP. “These policies reflect the views and expertise of ASHP members and are the foundation of our advocacy efforts to improve patient care and advance pharmacy practice.”
At the virtual House of Delegates, policy recommendations must be approved by at least 85 percent of delegates to become ASHP policy. Recommendations that do not reach that level of consensus will be considered by the House of Delegates when it convenes at the Summer Meetings. More than 92 percent of state delegates participated in voting in the virtual House of Delegates to approve the following two policies:
Safety of Intranasal Route as an Alternative Route of Administration
To encourage the development of institutional guidance and advocate for further research on the pharmacokinetic and pharmacodynamic characteristics of drugs not approved for intranasal administration; further, to foster the development of educational resources on the safety of intranasal administration of drugs not approved for that route.
Drug Product Supply Chain Integrity
To encourage the Food and Drug Administration (FDA) and relevant state authorities to take the steps necessary to ensure that (1) all drug products entering the supply chain are thoroughly inspected and tested to establish that they have not been adulterated or misbranded and (2) patients will not receive improperly labeled and packaged, deteriorated, outdated, counterfeit, adulterated, or unapproved drug products; further, to encourage FDA and relevant state authorities to develop and implement regulations to (1) restrict or prohibit licensed drug distributors (drug wholesalers, repackagers, and manufacturers) from purchasing legend drugs from unlicensed entities and (2) ensure accurate documentation at any point in the distribution chain of the original source of drug products and chain of custody from the manufacturer to the pharmacy; further, to advocate for the establishment of meaningful penalties for companies that violate current good manufacturing practices (cGMPs) intended to ensure the quality, identity, strength, and purity of their marketed drug product(s) and raw materials; further, to advocate for improved transparency so that drug product labeling include a readily available means to retrieve the name and location of the facility that manufactured the specific lot of the product; further, to advocate that this readily retrievable manufacturing information be available prospectively to aid purchasers in determining the quality of a drug product and its raw materials; further, to foster increased pharmacist and public awareness of drug product supply chain integrity; further, to urge Congress and state legislatures to provide adequate funding, or authority to impose user fees, to accomplish these objectives. (Replaces ASHP policy 1503.)
Additional policies on cultural competency and cultural diversity and direct-to-consumer advertising for prescription drugs and implantable devices did not meet the required 85-percent level of consensus. These policies will be discussed during the in-person meeting of delegates in June.
The House of Delegates, ASHP’s chief policymaking body, consists of 163 voting state delegates (a minimum of two from each state, the District of Columbia, and Puerto Rico), members of the Board of Directors, past presidents of ASHP, chairs of the Society’s sections and forums, and five delegates representing the federal services. Delegates were credentialed by late January and acted in late March, the quickest the House has ever convened. For more information about the virtual House of Delegates, refer to these frequently asked questions.