Sarah McBane

Collaborative Drug Therapy Management and Comprehensive Medication Management―2015

The American College of Clinical Pharmacy (ACCP) previously published position statements on collaborative drug therapy management (CDTM) in 1997 and 2003. Since 2003, significant federal and state legislation addressing CDTM has evolved and expanded throughout the United States. CDTM is well suited to facilitate the delivery of comprehensive medication management (CMM) by clinical pharmacists. CMM, defined by ACCP as a core component of the standards of practice for clinical pharmacists, is designed to optimize medication‐related outcomes in collaborative practice environments. New models of care delivery emphasize patient‐centered, team‐based care and increasingly link payment to the achievement of positive economic, clinical, and humanistic outcomes. Hence clinical pharmacists practicing under CDTM agreements or through other privileging processes are well positioned to provide CMM. The economic value of clinical pharmacists in team‐based settings is well documented. However, patient access to CMM remains limited due to lack of payer recognition of the value of clinical pharmacists in collaborative care settings and current health care payment policy. Therefore, the clinical pharmacy discipline must continue to establish and expand its use of CDTM agreements and other collaborative privileging mechanisms to provide CMM. Continued growth in the provision of CMM by appropriately qualified clinical pharmacists in collaborative practice settings will enhance recognition of their positive impact on medication‐related outcomes.

Changing oral contraceptives from prescription to over-the-counter status: an opinion statement of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy.

Addressing the issue of unintended pregnancy is a national priority. One proposed strategy to reduce unintended pregnancy is to improve access to oral contraceptives by changing them to over‐the‐counter (OTC) status. Existing data indicate that oral contraceptives meet safety criteria required of OTC products. Available literature demonstrates that women can self‐screen for contraindications to oral contraceptives and can do this as well as clinicians, and experience with OTC emergency contraception suggests that OTC oral contraceptives would not increase sexual risk‐taking behavior. Women support OTC access to oral contraceptives, but express an interest in accessing pharmacist counseling. On the basis of these data, the Womens Health Practice and Research Network of the American College of Clinical Pharmacy supports changing oral contraceptives to OTC status under two conditions: that they are sold where a pharmacist is on duty and that there are mechanisms in place to cover OTC contraceptives through Medicaid. Future research should address the issues of out‐of‐pocket costs to individuals, label‐comprehension studies, and models for pharmacist reimbursement for time spent counseling on contraception.

An Evidence-Based and Practical Approach to Using Bydureon™ in Patients With Type 2 Diabetes

Glucagon-like peptide (GLP)-1 agonists are one of the newer classes of medications for use in type 2 diabetes. There are currently three GLP-1 agonists on the market: exenatide twice daily, liraglutide, and exenatide extended release (ER). Exenatide ER is a new weekly formulation of exenatide. Exenatide ER reduces glycosylated hemoglobin by 1.6%, with fewer gastrointestinal side effects compared with twice-daily exenatide. Like other GLP-1 agonists, exenatide ER can be used in combination with metformin, sulfonylureas, or thiazolidinediones. Patients should be assessed for risk of pancreatitis and renal impairment. Education about proper administration technique is vital with the novel delivery system. Prescribers may also consider the use of exenatide ER to improve medication adherence in patients who have successfully tolerated exenatide twice daily or use in patients who have gastrointestinal side effects with exenatide twice daily. Exenatide is a reasonable option that can be added to the regimen of a patient with type 2 diabetes.

ACCP Clinical Pharmacist Competencies

The purpose of the American College of Clinical Pharmacy (ACCP) is to advance human health by extending the frontiers of clinical pharmacy. Consistent with this mission and its core values, ACCP is committed to ensuring that clinical pharmacists possess the knowledge, skills, attitudes, and behaviors necessary to deliver comprehensive medication management (CMM) in team‐based, direct patient care environments. These components form the basis for the core competencies of a clinical pharmacist and reflect the competencies of other direct patient care providers. This paper is an update to a previous ACCP document and includes the expectation that clinical pharmacists be competent in six essential domains: direct patient care, pharmacotherapy knowledge, systems‐based care and population health, communication, professionalism, and continuing professional development. Although these domains align with the competencies of physician providers, they are specifically designed to better reflect the clinical pharmacy expertise required to provide CMM in patient‐centered, team‐based settings. Clinical pharmacists must be prepared to complete the education and training needed to achieve these competencies and must commit to ongoing efforts to maintain competence through ongoing professional development. Collaboration among stakeholders will be needed to ensure that these competencies guide clinical pharmacists’ professional development and evaluation by educational institutions, postgraduate training programs, professional societies, and employers.

Use of Compounded Bioidentical Hormone Therapy in Menopausal Women: An Opinion Statement of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy

Menopausal symptoms affect a significant portion of women. Traditional treatment with manufactured hormone therapy can alleviate these symptoms, but many women and their health care providers are concerned about the risks, such as venous thromboembolism and certain types of cancer, demonstrated with manufactured hormone therapy. Compounded bioidentical hormone therapy has been proposed and is often used as a solution for these concerns. Despite this use, no data are currently available to support the claims that compounded bioidentical hormone therapy is a safer or more efficacious option compared with manufactured hormone therapy. A common misperception is that all manufactured products consist of synthetic hormones and all compounded medications consist of natural hormones; however, in fact, significant overlap exists. Several key stakeholder organizations have issued statements expressing concern about the lack of evidence regarding the efficacy and safety of compounded bioidentical hormone therapy, in addition to concerns regarding prescribing patterns. The Womens Health Practice and Research Network of the American College of Clinical Pharmacy recommends against the consistent use of compounded bioidentical hormones as a safer option compared with manufactured therapy and supports the statements of other key organizations, acknowledging the need for more robust clinical studies to evaluate the potential advantages and disadvantages of compounded bioidentical products compared with manufactured products.

Over-the-counter access to emergency contraception without age restriction: an opinion of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy.

Family planning remains a high priority area for the United States, with goals to increase the proportion of pregnancies that are intended, reduce pregnancy rates among adolescents, and increase contraceptive use prioritized in the Healthy People 2020 objectives. Contraception intended for use after unprotected intercourse, known as emergency contraception, remains underutilized. Levonorgestrel is one method of oral emergency contraception, which prevents fertilization and does not disrupt an already established pregnancy; thus, timing of administration is critical. Despite data demonstrating safety and efficacy, evidence‐based decision making has been overshadowed by politically charged actions involving levonorgestrel emergency contraception for over a decade. The Womens Health Practice and Research Network of the American College of Clinical Pharmacy supports expanded access to levonorgestrel emergency contraception and removal of barriers such as age restrictions on the nonprescription drug product. Pharmacists remain a key provider of emergency contraceptive services and can help ensure timely access. In states where direct pharmacy access to emergency contraception is available, pharmacists are encouraged to participate. Education, research, and advocacy are other important responsibilities for pharmacists in this arena.

Over-the-Counter Access to Emergency Contraception without Age Restriction

Family planning remains a high priority area for the United States, with goals to increase the proportion of pregnancies that are intended, reduce pregnancy rates among adolescents, and increase contraceptive use prioritized in the Healthy People 2020 objectives. Contraception intended for use after unprotected intercourse, known as emergency contraception, remains underutilized. Levonorgestrel is one method of oral emergency contraception, which prevents fertilization and does not disrupt an already established pregnancy; thus, timing of administration is critical. Despite data demonstrating safety and efficacy, evidence‐based decision making has been overshadowed by politically charged actions involving levonorgestrel emergency contraception for over a decade. The Womens Health Practice and Research Network of the American College of Clinical Pharmacy supports expanded access to levonorgestrel emergency contraception and removal of barriers such as age restrictions on the nonprescription drug product. Pharmacists remain a key provider of emergency contraceptive services and can help ensure timely access. In states where direct pharmacy access to emergency contraception is available, pharmacists are encouraged to participate. Education, research, and advocacy are other important responsibilities for pharmacists in this arena.

Educational Outcomes Necessary to Enter Pharmacy Residency Training

It is the position of the American College of Clinical Pharmacy (ACCP) that formal postgraduate residency training, or equivalent experience, is required to enter direct patient care practice. Therefore, it is important to align professional degree educational outcomes with the knowledge, skills, and attitudes needed to enter residency training. This position statement addresses the outcomes necessary in the professional degree program curriculum to ensure the ability of pharmacy graduates to transition effectively into postgraduate year one residency training. Five key outcome areas are identified: communication, direct patient care, professionalism, research, and practice management. The position statement examines how performance in each of the five outcome areas should be addressed by professional degree programs. The ACCP believes that for the student to achieve the clinical proficiency necessary to enter residency training, the professional degree program should emphasize, assess, and provide adequate opportunities for students to practice: communication with patients, caregivers, and members of the health care team in direct patient care environments; provision of direct patient care in a wide variety of practice settings, especially those involving patient‐centered, team‐based care; professionalism under the supervision and guidance of faculty and preceptors who model and teach the traits of a health care professional; application of principles of research that engender an appreciation for the role of research and scholarship in ones professional development; and application of practice management, including documentation of direct patient care activities that affect drug‐related outcomes.

Azathioprine-Induced Fever in Sarcoidosis

Objective: To report a case of drug-induced fever associated with azathioprine treatment in a patient with sarcoidosis. Case Summary: A 52-year-old man with pulmonary sarcoidosis presented to the emergency department with a 1 -day history of fever (temperature 39.9 °C), chills, nausea, and vomiting. One week earlier, azathioprine 50 mg/day had been started for worsening dyspnea. The patient was admitted and evaluated for acute infectious processes. All of his home medications (hydroxychloroquine, prednisone, fluticasone/salmeterol, lovastatin, pantoprazole, Zolpidem, ibandronate, albuterol), except prednisone, were held. Results of chest X-ray, viral cultures, and urine and blood cultures revealed no source of infection. The patients temperature returned to normal within 30 hours after discontinuation of azathioprine; rechallenge was not performed. Discussion: Fever as an adverse drug reaction is often unrecognized, particularly in medically complex patients. Azathioprine has been reported to cause drug fever in patients with inflammatory bowel disease and in those with rheumatoid arthritis; to our knowledge, there have been no previous reports documenting azathioprine-induced fever in patients with sarcoidosis. The chronological course of febrile response and defervescence is highly suggestive of drug-induced fever. Conclusions: The rapid resolution of fever after discontinuation of azathioprine suggests that it was the likely source of fever in this patient. If azathioprine is increasingly prescribed in patients with sarcoidosis, fever as an adverse reaction may become more common.

Guide for Drug Selection During Pregnancy and Lactation: What Pharmacists Need to Know for Current Practice:

Objective: To provide guidance for clinicians on risk assessment of medication use during pregnancy and lactation. Data Sources: Authors completed PubMed searches to identify articles focused on the use of medications in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Study Selection and Data Extraction: Articles were reviewed to provide overall guidance to medication selection during pregnancy. The following information was reviewed: medication use in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Data Synthesis: This article will provide an overview of medication safety considerations during pregnancy and lactation. Information was interpreted to help clinicians predict the potential risk and benefit in each patient to make an evidence-based decision. The article concludes with guidance on risk assessment and how pharmacists may support fellow health care providers and their patients when considering medication use. Conclusions: Information about the effects of medication use during reproductive periods is limited. With the removal of the Food and Drug Administration pregnancy categories, clinicians will be relying on pharmacists to aid in the appropriate selection of therapies for patients. It is critical that pharmacists keep abreast of resources available and be able to assess data to help prescribers and their patients.