Question Title

* 1. Policy Recommendation 1: Research on Drug Use in Obese Patients
Source: Council on Therapeutics

To encourage drug product manufacturers to conduct and publish pharmacokinetic and pharmacodynamics research in obese patients to facilitate safe and effective dosing of medications in this patient population, especially for medications most likely to be affected by obesity; further,

To encourage manufacturers to include in the Food and Drug Administration (FDA)-approved labeling detailed information on characteristics of individuals enrolled in drug dosing studies; further,

To advocate that the FDA develop guidance for the design and reporting of studies that support dosing recommendations in obese patients; further,

To advocate for increased enrollment and outcomes reporting of obese patients in clinical trials of medications; further,

To encourage independent research on the clinical significance of obesity on drug use, as well as the reporting and dissemination of this information via published literature, patient registries, and other mechanisms; further,

To recognize that pharmacists are medication therapy experts who should provide guidance on appropriate drug dosing for obese patients.

(Note: This policy would supersede ASHP policy 1515).

Question Title

* 2. Policy Recommendation 2: Testing and Documentation of Penicillin Allergy as a Component of Antimicrobial Stewardship
Source: Council on Therapeutics

To advocate involvement of pharmacists in the clarification and assessment of penicillin allergy, intolerance and adverse drug events; further,

To advocate for documentation and de-labeling of penicillin allergies, intolerances, reactions and severities in the medical record when appropriate to facilitate optimal antimicrobial selection; further,

To recommend the use of penicillin skin testing, graded antibiotic challenges, and oral direct challenges in appropriate candidates when clinically indicated to optimize antimicrobial selection; further,

To support the education and training of pharmacists in the assessment, management, and documentation of penicillin allergies, intolerance, and adverse events; further;

To advocate that state board of pharmacy regulations include penicillin allergy skin testing under pharmacists' scope of practice.

(Note: This policy would supersede ASHP policy 1517).

Question Title

* 3. Policy Recommendation 3: Antimicrobial Use in Agriculture
Source: Council on Therapeutics

To advocate that the Food and Drug Administration (FDA) eliminate future approval of antimicrobials for nontherapeutic uses in agricultural animals that represent a safety risk by contributing to antimicrobial resistance; further,

To encourage efforts to phase out and eliminate the nontherapeutic uses of antimicrobials previously approved by the FDA; further,

To support the therapeutic use of antimicrobials in animals only under the supervision of a veterinarian; further,

To encourage the agricultural industry to report to the appropriate regulatory bodies the specific antimicrobials used, the purpose or indication for their use, and the settings in which they are used; further,

To encourage the FDA, Centers for Disease Control and Prevention, and other stakeholders to monitor and limit, when effective alternatives are available, the therapeutic use of antimicrobials that are essential to the treatment of critically ill human patients; further,

To advocate for the inclusion of pharmacists in antimicrobial surveillance and related public health efforts based on pharmacists' knowledge of antimicrobial drug products and antimicrobial resistance.

(Note: This policy would supersede ASHP policy 1009).

Question Title

* 4. Policy Recommendation 4: Appropriate Use of Testosterone
Source: Council on Therapeutics

To discontinue ASHP policy 1536, Appropriate Use of Testosterone, which reads:

To educate pharmacists, patients and the public about the risks and benefits of testosterone use and about best practices for safe handling of testosterone, specifically regarding harmful effects of contact with another person; further,

To educate healthcare providers about the importance of including accurate testosterone levels and confirmed evidence of clinical symptoms in the evaluation of candidates for testosterone therapy; further,

To encourage additional research on the long-term effects of testosterone therapy.