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1.
Contraception ; 132: 110361, 2024 04.
Article in English | MEDLINE | ID: mdl-38160962

ABSTRACT

BACKGROUND: Alabama's Human Life Protection Act (the Act) signed in 2019 became law in 2022, making provision of abortion a felony offense. OBJECTIVE: In 2020, we assessed the accessibility of emergency contraception (EC) pills in Birmingham, Alabama prior to the Act's enactment given the probable increased need for EC access due to abortion criminalization. STUDY DESIGN: Pharmacy staff were asked about availability, price, location, and identification requirements to obtain EC. RESULTS: Of 69 pharmacies, 59% had levonorgestrel EC and none had ulipristal acetate EC available. CONCLUSION: There are persistent barriers to EC accessibility that should be addressed as abortion is increasingly restricted.


Subject(s)
Abortion, Induced , Contraception, Postcoital , Female , Pregnancy , Humans , Alabama , Contraceptives, Oral , Levonorgestrel
2.
Am J Pharm Educ ; 87(1): ajpe8973, 2023 01.
Article in English | MEDLINE | ID: mdl-35354559

ABSTRACT

Faculty members in academic roles are often called upon to serve as chair of a search committee. This can be both an important and challenging role. Many faculty members may not have previous experience with search comittees or have undergone formal search committee training. Given the critical nature of conducting an effective search, the goal of this commentary is to provide practical guidance and insight on how to effectively fulfill the role as chair of a search committee. Literature and institutional polices regarding best practices in serving as a search committee chair were reviewed, and recommendations on navigating the various aspects of service as a committee chair and how to approach this role are provided.


Subject(s)
Education, Pharmacy , Faculty, Pharmacy , Humans , Faculty
3.
Sci Rep ; 12(1): 20260, 2022 11 24.
Article in English | MEDLINE | ID: mdl-36424495

ABSTRACT

Cannabis use in pregnancy is associated with adverse perinatal outcomes, which are likely mediated by the placenta. However, the underlying mechanisms and specific vasoactive effects of cannabis on the placenta are unknown. Our objective was to determine the impact of chronic prenatal delta-tetrahydrocannabinol (THC, main psychoactive component of cannabis) exposure on placental function and development in a rhesus macaque model using advanced imaging. Animals were divided into two groups, control (CON, n = 5) and THC-exposed (THC, n = 5). THC-exposed animals received a THC edible daily pre-conception and throughout pregnancy. Animals underwent serial ultrasound and MRI at gestational days 85 (G85), G110, G135 and G155 (full term is ~ G168). Animals underwent cesarean delivery and placental collection at G155 for histologic and RNA-Seq analysis. THC-exposed pregnancies had significantly decreased amniotic fluid volume (p < 0.001), placental perfusion (p < 0.05), and fetal oxygen availability (p < 0.05), all indicators of placental insufficiency. Placental histological analysis demonstrated evidence of ischemic injury with microinfarctions present in THC-exposed animals only. Bulk RNA-seq demonstrated that THC alters the placental transcriptome and pathway analysis suggests dysregulated vasculature development and angiogenesis pathways. The longer-term consequences of these adverse placental findings are unknown, but they suggest that use of THC during pregnancy may deleteriously impact offspring development.


Subject(s)
Dronabinol , Hallucinogens , Animals , Female , Pregnancy , Macaca mulatta , Dronabinol/pharmacology , Placenta , Fetus/metabolism , Hallucinogens/metabolism , Cannabinoid Receptor Agonists/metabolism
4.
Pharmacotherapy ; 42(2): 154-164, 2022 02.
Article in English | MEDLINE | ID: mdl-34967466

ABSTRACT

Hormonal contraceptives have been used in perimenopausal women to manage a variety of symptoms and prevent unintended pregnancy. However, it is unclear what contraceptive regimen is best for these women. To evaluate hormonal contraceptive methods in women experiencing perimenopause using two prespecified outcomes: perimenopausal symptom management and long-term effects. A literature search of PubMed and EMBASE databases was performed (January 1990 to October 2021) using search terms "perimenopause" and "contraception." Relevant full-text articles in English were included. Fifteen clinical articles were reviewed: Fourteen were internationally based, and one study was conducted in the United States. Nine articles evaluated symptom resolution, and six of these nine reported statistically significant changes in favor of treating perimenopausal women with hormonal contraceptives compared with no treatment. Seven studies evaluated long-term outcomes including bone loss and metabolic parameters, and six of these seven showed statistically significant improvements with hormonal contraceptives. Based on limited data and a lack of comparative studies, the use of a levonorgestrel intrauterine device with supplemental low-dose menopausal estrogen has positive results for the management of disruptive perimenopausal symptoms and long-term outcomes. Hormonal contraception in perimenopausal women improves symptom management and long-term outcomes if patients do not have contraindications. When selecting a contraceptive for women in perimenopause, clinicians and pharmacists need to address specific patient risk factors, symptom profiles, long-term risks and benefits, and patient preferences.


Subject(s)
Contraceptive Agents , Perimenopause , Contraception/methods , Female , Humans , Menopause , Pregnancy , Risk Factors
5.
F S Sci ; 2(3): 287-294, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34901892

ABSTRACT

OBJECTIVE: To determine the dose-dependent effect of contemporary marijuana exposure on female menstrual cyclicity and reproductive endocrine physiology in a nonhuman primate model. DESIGN: Research animal study. SETTING: Research institute environment. ANIMALS: Adult female rhesus macaques (6-12 years of age; n = 8). INTERVENTIONS: Daily delta-9-tetrahydrocannabinol (THC) edible at medically and recreationally relevant contemporary doses. MAIN OUTCOME MEASURES: Menstrual cycle length (MCL), anti-Müllerian hormone, prolactin, basal follicle-stimulating hormone (FSH), estradiol (E2) and progesterone, luteinizing hormone (LH), and thyroid-stimulating hormone. RESULTS: The average before THC weight was 6.9 kg (standard deviation, 0.8), and at the highest THC dosing, the average weight was 7.2 kg (standard deviation, 0.8). With increasing THC dosing, MCL and FSH concentrations increased, while basal E2 concentration was stable. The average MCL concentration increased 4.0 days for each mg/7 kg/day of THC (95% CI, 1.4-6.6 days). Follicle-stimulating hormone concentration increased significantly with increasing THC dose, 0.34 ng/mL for each mg/7 kg/day of THC (95% CI, 0.14-0.57 ng/mL). No significant trends were observed between THC dosing and average basal progesterone, anti-Müllerian hormone, prolactin, LH, or thyroid-stimulating hormone concentrations. CONCLUSIONS: In rhesus macaques, a dose response toward increased MCL and basal FSH concentrations but plateau of basal E2 and LH concentrations was observed with increasing THC dosing, suggesting ovulatory dysfunction. Further studies are needed to determine the effects of a longer duration of exposure and whether the significant increase in MCL and FSH concentrations results in reduced fecundity.


Subject(s)
Dronabinol , Progesterone , Animals , Anti-Mullerian Hormone , Dronabinol/pharmacology , Female , Follicle Stimulating Hormone , Luteinizing Hormone , Macaca mulatta , Menstrual Cycle , Periodicity , Prolactin , Reproductive Health , Thyrotropin
6.
Curr Pharm Teach Learn ; 13(9): 1244-1251, 2021 09.
Article in English | MEDLINE | ID: mdl-34330405

ABSTRACT

PROBLEM DESCRIPTION: To meet the evolving role of today's pharmacist, student pharmacists need to be given independent responsibilities that increase in rigor as they advance through the curriculum and be able to practice both autonomously and as part of an interprofessional team. Quality improvement methods: The University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS) experiential programs office undertook a 20-year process of developing independence for students. Students faced increasing challenges and responsibilities as they moved through experiential practice settings, with constant, cyclic adjustments made in response to feedback. RESULTS OF CQI INQUIRY: The continuous focus on developing independence in students has established a culture of trust in the Colorado pharmacy practice community. Students are allowed autonomy, and are challenged with increasing rigor as they advance. Graduates are well-prepared to perform both independently and as part of a team. INTERPRETATION AND DISCUSSION: The curricular framework based on trust and independent learning has helped the SSPPS train student pharmacists to meet the demands of current pharmacy practice, as well as expected roles in the future. Requiring increasing responsibilities from students as they move through the curriculum allows them to move along the spectrum set up through the entrustable professional activity (EPA) assessments to achieve high ratings for an individual skill. Continuous feedback and adjustments are necessary to identify what can be accomplished in pharmacy practice settings. CONCLUSIONS: This 20-year approach to curricular design and modifications within experiential education has produced independent pharmacy practitioners upon graduation.


Subject(s)
Community Pharmacy Services , Education, Pharmacy , Students, Pharmacy , Humans , Pharmacists , Quality Improvement , Trust
7.
J Am Pharm Assoc (2003) ; 61(3): 233-239, 2021.
Article in English | MEDLINE | ID: mdl-33414014

ABSTRACT

OBJECTIVE: To examine the measured contents of over-the-counter (OTC) and prescription (Rx) prenatal multivitamins and minerals (PMVMs) and compare the findings with the amounts reported on the nutrition labels. The findings were subsequently examined on the basis of cost and ability to adequately supplement dietary intake during pregnancy on the basis of The National Academies' dietary reference intakes (DRIs) and tolerable upper intake levels. METHODS: This was an observational convenience sample of OTC and Rx PMVMs available through online retailers and retail pharmacies. The amounts of folic acid, vitamin B6, vitamin C, and choline were measured in triplicate using mass spectrometry. RESULTS: Twenty OTC and 16 Rx PMVMs were evaluated. The average measured quantities of the vitamins were not statistically different from the mean reported quantities for OTC and Rx PMVMs. When a standard diet was combined with the labeled nutrition information, 95% of the OTC PMVMs and 88% of the Rx PMVMs met the DRIs for folic acid and vitamins B6 and C. When a standard diet was combined with the actual measured PMVM quantities, 79% of the OTC PMVMs and 82% of the Rx PMVMs met the DRIs for folic acid and vitamins B6 and C. The measured choline content, with and without diet considerations, did not meet the DRIs. No statistically significant difference was found for the adequacy of supplementation between the OTC and Rx PMVMs on the basis of cost. CONCLUSION: On the basis of a comparison of the measured and reported values for folic acid, vitamin C, vitamin B6, and choline, it seems that either OTC or Rx PMVMs at low or high cost can be recommended to supplement diets and meet the DRIs during pregnancy for these vitamins.


Subject(s)
Dietary Supplements , Vitamins , Diet , Female , Humans , Minerals , Pregnancy , Prescriptions
8.
J Clin Rheumatol ; 27(3): 97-101, 2021 Apr 01.
Article in English | MEDLINE | ID: mdl-31789996

ABSTRACT

BACKGROUND/OBJECTIVE: Rheumatoid arthritis (RA) is a complex disease that may require treatment with one or several disease-modifying antirheumatic drugs (DMARDs). Many DMARDs have potential teratogenic effects or are newer agents with limited safety data in pregnancy. This study evaluated 20 common RA medications and the rate of contraceptive prescribing and counseling patterns in women with RA of childbearing ability. METHODS: This was an observational study of women with RA and childbearing ability aged 18 to 44 years who were seen at an academic rheumatology clinic from April 1, 2014, to March 31, 2016. Descriptive statistics and univariate logistic regression were used for analysis. RESULTS: One hundred fifty women were included in the analysis. The majority of patients were taking methotrexate (55.3%), followed by chronic prednisone (31.3%) and hydroxychloroquine (28.7%). A documented method of contraception was noted in 64/150 (42.7%). For women on contraception, most used combined oral contraceptives (31/64, 48.4%) or levonorgestrel intrauterine device (10/64, 15.6%). Of the 86 patients not on contraception, 19 (22.1%) received counseling regarding a pregnancy plan. CONCLUSIONS: Most women with RA of childbearing age and ability were not using contraception. Among these patients, only a minority prescribed DMARD therapy had documented pregnancy or contraceptive counseling. Women with RA who were prescribed with a DMARD should discuss the use of effective contraception with their provider if sexually active and not desiring pregnancy or wanting to avoid potential teratogenic effects. Potential strategies are discussed to improve healthcare delivery to this population in hopes of avoiding unintended pregnancy and potential teratogenic effects of RA medications.


Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Adolescent , Adult , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/diagnosis , Arthritis, Rheumatoid/drug therapy , Contraception , Contraceptive Agents/therapeutic use , Female , Humans , Methotrexate/adverse effects , Pregnancy , Young Adult
9.
Pediatr Emerg Care ; 37(12): e850-e854, 2021 Dec 01.
Article in English | MEDLINE | ID: mdl-30998654

ABSTRACT

OBJECTIVES: This study aimed to evaluate the process of identifying marijuana exposure in a children's hospital emergency department and compare the cost of diagnostic testing and procedures. METHODS: A retrospective chart review was performed on patients 31 days to 20 years old with a positive marijuana toxicology screen result between November 2009 and December 2014. Primary outcomes included time to provider recognition of marijuana exposure, number of diagnostic tests and procedures performed, and length of hospital stay. Patients were analyzed based on time of exposure recognition (forthcoming compared with not forthcoming of marijuana exposure) and age (children <12 years compared with adolescents >12 years). RESULTS: There were 37 children and 38 adolescents included. Mean time to exposure recognition was 2.3 ± 4.3 hours in children compared with 0.4 ± 0.9 hours in adolescents (P = 0.02). Patients who were not forthcoming of marijuana exposure experienced more than twice as many diagnostic tests or procedures compared with children who were forthcoming of marijuana exposure (mean, 8.91 vs 4 tests, P < 0.0001) and more than a 4-fold higher cost of potentially avoidable diagnostic tests/procedures. Length of hospital stay was significantly longer in children (18.34 ± 2.39 hours) compared with adolescents (4.22 ± 0.52 hours; P ≤ 0.0001). Few parents or guardians were able to disclose characteristics of the marijuana product. CONCLUSION: Delay in recognition of marijuana exposure is associated with high resource utilization, unnecessary medical costs, and prolonged length of stay.


Subject(s)
Cannabis , Adolescent , Child , Health Care Costs , Humans , Length of Stay , Parents , Retrospective Studies
10.
J Pediatr Pharmacol Ther ; 25(8): 697-704, 2020.
Article in English | MEDLINE | ID: mdl-33214780

ABSTRACT

OBJECTIVE: To assess high school students' knowledge and perceptions of human papillomavirus (HPV) and HPV vaccines and evaluate high school students' self-reported uptake of the HPV vaccine. METHODS: This was an observational, descriptive study using a 44-question survey. Participants were ninth grade students in a Colorado public school district. The survey was administered as part of a health education course. RESULTS: Ninety-two surveys were included in the analysis. Demographic characteristics included 64/92 (69.6%) male and 55/92 (59.8%) Hispanic/Latino students. There was no difference between males and females regarding self-reported vaccination status. Non-Hispanic students were 71.6% less likely to have received the HPV vaccine than Hispanic students (OR 0.284; 95% CI, 0.088-0.920; p = 0.036). The average score on the knowledge section was 42.7% with a standard deviation of 22.6%. When assessing students' perceptions, 71/92 (77.2%) disagreed or strongly disagreed that they felt at risk for getting an HPV infection. There was no significant difference between males and females regarding awareness of the HPV vaccine (p = 0.14). More than half of students (58.7%) did not know if they had received the HPV vaccine. CONCLUSION: HPV vaccine awareness was low and many students did not know if they had received the HPV vaccine. Ninth grade students did not have accurate knowledge of HPV and HPV vaccines and this study presents opportunities for increased education.

11.
Curr Pharm Teach Learn ; 12(4): 395-399, 2020 04.
Article in English | MEDLINE | ID: mdl-32334754

ABSTRACT

INTRODUCTION: Pharmacists prescribe contraception in some states following expansions in scope of practice. Adequate education on contraception in pharmacy curricula is crucial to effectively deliver these services. METHODS: A 26-item survey assessing contraception curricula regarding was administered by email to instructors and administrators at 139 pharmacy schools in the United States. The survey assessed teaching methods, hours taught, topic content, and opinion of adequacy of contraceptive education provided by the program. RESULTS: The survey achieved a response rate of 40% (n = 56). All programs that responded offer emergency contraception and hormonal contraception content, 96% offer non-hormonal over-the-counter contraception content, and 91% offer long-acting reversible hormonal contraception content. Average number of hours taught were as follows: non-hormonal over-the-counter contraception 2.0 hours, emergency contraception 0.9 hours, hormonal contraception 3.0 hours, long-acting reversible hormonal contraception 0.8 hours, and non-reversible hormonal contraception 0.5 hours. Patient cases were most used to supplement didactic content in all topics. Standardized patient interviews were used less frequently for both hormonal contraception (25%) and emergency contraception (7%). About 68% of programs agreed or strongly agreed that the contraceptive education provided by the program was adequate. A majority (70%) indicated interest in a standardized contraceptive curriculum. CONCLUSIONS: Contraceptive education is broadly covered in didactic curricula within pharmacy education. Further assessment and development of curricula standards may be warranted to assess quality and adequacy of contraceptive education in pharmacy.


Subject(s)
Contraceptive Agents/therapeutic use , Curriculum/standards , Schools, Pharmacy/standards , Contraceptive Agents/administration & dosage , Curriculum/statistics & numerical data , Humans , Schools, Pharmacy/organization & administration , Schools, Pharmacy/statistics & numerical data , Surveys and Questionnaires , United States
13.
Clin Pharmacokinet ; 59(8): 1005-1012, 2020 08.
Article in English | MEDLINE | ID: mdl-32048179

ABSTRACT

BACKGROUND AND OBJECTIVES: Despite limited evidence, cannabidiol-rich cannabis extracts have been popularly used in pediatrics. With increased use, it is critical to determine basic pharmacokinetic parameters of cannabidiol in these extracts in the pediatric population. The objective of this study was to determine the disposition of oral cannabidiol cannabis extracts and drug interactions in children with pediatric epilepsy. METHODS: We conducted a prospective observational study evaluating the disposition of oral cannabidiol in children (< 18 years of age) receiving cannabidiol extracts for epilepsy. Subjects underwent serial blood draws after oral cannabidiol administration. Cannabidiol and metabolites, along with anticonvulsant concentrations were determined. RESULTS: Twenty-nine patients had sufficient pharmacokinetic data and were included in the analysis. Mean age was 9.7 years (standard deviation 4.3) and 17 patients (59%) were male. Median peak plasma cannabidiol concentrations was 13.1 ng/mL (interquartile range 6.8-39.3 ng mL); median time to peak of 2.0 h (interquartile range 2.0-4.0 h). Mean acute elimination half-life of oral cannabidiol was 6.2 h (standard deviation 1.8 h). There was an observed half-life of degradation of 533 days noted for cannabidiol concentrations when stored for 0.6-3.1 years. There was some impact on cannabidiol pharmacokinetic parameters when cannabidiol was co-administered with zonisamide (elimination rate constant and V1) and levetiracetam (elimination rate constant). CONCLUSIONS: In pediatric patients using oral cannabidiol-rich cannabis extract for epilepsy, the time to peak concentration of plasma cannabidiol and average acute elimination half-life were shorter than those reported for adults. Co-administration of zonisamide and levetiracetam had some impact on cannabidiol pharmacokinetic parameters. There was an observed degradation of plasma cannabidiol in long-term storage. CLINICAL REGISTRATION: ClinicalTrials.gov Identifer no. NCT02447198.


Subject(s)
Anticonvulsants , Cannabidiol , Epilepsy , Plant Extracts , Anticonvulsants/pharmacokinetics , Anticonvulsants/therapeutic use , Cannabidiol/pharmacokinetics , Cannabidiol/therapeutic use , Cannabis , Child , Epilepsy/drug therapy , Female , Humans , Male , Plant Extracts/pharmacokinetics , Plant Extracts/therapeutic use
14.
Clin Toxicol (Phila) ; 58(2): 124-128, 2020 02.
Article in English | MEDLINE | ID: mdl-31111749

ABSTRACT

Introduction: Although over half of US states have legalized marijuana for medical indications, there is limited research in use in the pediatric population. The objective was to evaluate the disposition of oral tetrahydrocannabinol (THC) in children receiving cannabis extracts for pediatric epilepsy.Methods: Prospective, observational study, evaluating the disposition of oral THC in children receiving cannabis extracts. Subjects were less than 18 years of age, receiving oral cannabis for pediatric epilepsy. Subjects included in the study had at least 2 detectable THC and related metabolite plasma concentrations during serial blood draw over a 10-12 h study period.Results: Nine subjects with a median age of 11 years (IQR 4.75) were included in the study, with oral doses ranging from 0.02 mg/kg to 1.59 mg/kg. Peak plasma concentrations (0.8 to 3.6 ng/ml) in most patients were achieved within 2 hours, while acute phase elimination half-life ranged from 1 to 5 hours. THC-COOH and glucuronide remained elevated through the study period. There was significant variation between the dose ingested and peak concentrations (R2 = 0.05).Conclusion: In pediatric patients receiving oral THC cannabis extracts, mean time to peak plasma concentrations was 2-7 hours, while mean acute phase elimination half-life was 4.0 hours. THC-COOH and THC-COOH glucuronide metabolites persisted throughout the 10-12 hour study period. Large variation and no correlation was noted between dose of THC by weight and peak concentrations, suggesting variation of bioavailability amongst pediatric population or inaccurate reporting of THC contents.


Subject(s)
Dronabinol/blood , Epilepsy/drug therapy , Medical Marijuana/blood , Administration, Oral , Biological Availability , Child , Dronabinol/therapeutic use , Epilepsy/blood , Half-Life , Humans , Medical Marijuana/therapeutic use , Metabolic Clearance Rate , Prospective Studies , Tissue Distribution
15.
Am J Pharm Educ ; 83(7): 7060, 2019 09.
Article in English | MEDLINE | ID: mdl-31619826

ABSTRACT

Objective. To reach a consensus on a working definition for leadership and identify expectations for leadership among all pharmacy faculty members. Methods. A modified Delphi process was employed to establish consensus among experienced department and division chairs regarding the definition and expectations of faculty leadership to guide faculty evaluation and development. From the AACP faculty roster, 280 department and division chairs were surveyed to identify participants with at least five years of experience in their roles and willingness to participate. Twenty-three chairs were identified from a variety of colleges and schools to comprise the expert panel and asked to participate in three rounds of questions over a two-month period. One Likert-type question and six open-ended questions were included in round 1. A thematic analysis of round 1 responses provided items for participants to rate their agreement with and provide comments on in rounds 2 and 3. Consensus for items was set prospectively at 80% of participants selecting agree or strongly agree for each item. Items could be modified by the panel in subsequent rounds of surveys if participants suggested edits to items. Results. Consensus was achieved among 23 chairs regarding a definition, 10 guiding principles, four learning competencies, six skills, six expected leadership activities (ELAs), and 20 personal characteristics related to faculty leadership. Conclusion. The results of this study provide guidance to pharmacy faculty members and administrators regarding leadership characteristics including knowledge, skills, and activities expected for faculty members to develop into effective leaders for the academy and the pharmacy profession.


Subject(s)
Education, Pharmacy/standards , Faculty, Pharmacy/organization & administration , Leadership , Professional Competence , Delphi Technique , Humans , Staff Development/methods , Surveys and Questionnaires
16.
Ann Pharmacother ; 53(6): 603-611, 2019 06.
Article in English | MEDLINE | ID: mdl-30616356

ABSTRACT

OBJECTIVE: To review the efficacy, safety, pharmacology and pharmacokinetics of pure, plant-derived cannabidiol (CBD; Epidiolex) in the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). DATA SOURCES: Relevant information was identified through EMBASE and Ovid MEDLINE (1946 to October 2018). Product labeling and https://www.clinicaltrials.gov were also reviewed. STUDY SELECTION/DATA EXTRACTION: English language articles evaluating efficacy and safety in humans with treatment-resistant epilepsies were reviewed; additional pharmacology and pharmacokinetic studies in humans, animals, and in vitro were also included. DATA SYNTHESIS: Pure, plant-based CBD is a pharmaceutical grade extract that exhibits clinically significant antiseizure properties, with a hypothesized multimodal mechanism of action. In the GWPCARE trial series, CBD displayed superior efficacy in reducing key seizure frequencies (convulsive seizures in DS; drop seizures in LGS) by 17% to 23% compared with placebo as adjunctive therapy to standard antiepileptic drugs in patients 2 years of age and older. Common adverse effects were somnolence, diarrhea, and elevated hepatic transaminases. Noteworthy drug-drug interactions included clobazam, valproates, and significant inducers/inhibitors of CYP2C19 and 3A4 enzymes. Relevance to Patient Care and Clinical Practice: A discussion regarding CBD dosing, administration, adverse effects, monitoring parameters, and interactions is provided to guide clinicians. CBD offers patients with DS and LGS a new treatment option for refractory seizures. CONCLUSION: This is the first cannabis-derived medication with approval from the US Food and Drug Administration. This CBD formulation significantly reduces seizures as an adjunct to standard antiepileptic therapies in patients ≥2 years old with DS and LGS and is well tolerated.


Subject(s)
Cannabidiol/therapeutic use , Lennox Gastaut Syndrome/drug therapy , Adolescent , Adult , Cannabidiol/pharmacology , Child , Child, Preschool , Female , Humans , Male , Young Adult
17.
Obstet Gynecol ; 132(5): 1198-1210, 2018 11.
Article in English | MEDLINE | ID: mdl-30234728

ABSTRACT

The prevalence and perceived safety of marijuana use in pregnancy are increasing with expanding legalization. Marijuana crosses the placenta and passes into breast milk, resulting in fetal and neonatal exposure. Many women cite medical reasons for prenatal marijuana use such as nausea and vomiting of pregnancy, anxiety, and chronic pain. The scientific literature regarding marijuana in pregnancy is mixed, resulting in confusion among practitioners as to how to counsel women about risks of use. In addition, there is a paucity of literature related to marijuana use and breastfeeding. Existing pregnancy studies are predominantly retrospective cohorts with a reliance on self-report for ascertainment of exposure, which underestimates use. Many studies fail to adjust for important confounding factors such as tobacco use and sociodemographic differences. Despite the limitations of the existing evidence, there are animal and human data suggesting potential harm of cannabis use. The harms are biologically plausible given the role of the endocannabinoid system in pregnancy implantation, placentation, and fetal neurologic development. Two recent systematic reviews and meta-analyses found an association between marijuana use and adverse perinatal outcomes, especially with heavy marijuana use. In addition, three longitudinal cohort studies demonstrate a possible effect of prenatal marijuana exposure on long-term neurobehavioral outcomes. Marijuana use may be associated with growth restriction, stillbirth, spontaneous preterm birth, and neonatal intensive care unit admission. Therefore, women should be advised to refrain from using marijuana during pregnancy and lactation.


Subject(s)
Breast Feeding , Endocannabinoids/metabolism , Marijuana Use/adverse effects , Animals , Cannabinoids/pharmacology , Congenital Abnormalities/etiology , Directive Counseling , Female , Fetal Development , Humans , Infant, Low Birth Weight , Infant, Newborn , Intensive Care Units, Neonatal , Medical Marijuana/therapeutic use , Pregnancy , Premature Birth/etiology , Stillbirth
18.
Obstet Gynecol ; 131(6): 1031-1038, 2018 06.
Article in English | MEDLINE | ID: mdl-29742676

ABSTRACT

OBJECTIVE: To characterize recommendations given to pregnant women by Colorado cannabis dispensaries regarding use of cannabis products for nausea during the first trimester of pregnancy. METHODS: This was a statewide cross-sectional study in which advice about cannabis product use was requested using a mystery caller approach. The caller stated she was 8 weeks pregnant and experiencing morning sickness. Dispensaries were randomly selected from the Colorado Department of Revenue Enforcement Division website. The primary outcome was the proportion of marijuana dispensaries that recommended a cannabis product for use during pregnancy. We hypothesized that 50% of dispensaries would recommend use. A sample size of 400 was targeted to yield a two-sided 95% CI width of 10%. Secondary outcomes included the proportion endorsing cannabis use as safe during pregnancy, specific product recommendations, and encouraging discussion with a health care provider. Recommendations were compared by licensure type (medical, retail, or both) and location (rural vs urban). RESULTS: Of the 400 dispensaries contacted, 37% were licensed for medical sale (n=148), 28% for retail (n=111), and 35% for both (n=141). The majority, 69% (277/400), recommended treatment of morning sickness with cannabis products (95% CI 64-74%). Frequency of recommendations differed by license type (medical 83.1%, retail 60.4%, both 61.7%, P<.001). Recommendations for use were similar for dispensary location (urban 71% vs nonurban 63%, P=.18). The majority (65%) based their recommendation for use in pregnancy on personal opinion and 36% stated cannabis use is safe in pregnancy. Ultimately, 81.5% of dispensaries recommended discussion with a health care provider; however, only 31.8% made this recommendation without prompting. CONCLUSION: Nearly 70% of Colorado cannabis dispensaries contacted recommended cannabis products to treat nausea in the first trimester. Few dispensaries encouraged discussion with a health care provider without prompting. As cannabis legalization expands, policy and education efforts should involve dispensaries.


Subject(s)
Commerce , Medical Marijuana/therapeutic use , Off-Label Use/statistics & numerical data , Professional-Patient Relations , Adult , Colorado , Cross-Sectional Studies , Female , Humans , Legislation, Drug , Morning Sickness/drug therapy , Nausea/drug therapy , Pregnancy , Pregnancy Trimester, First
19.
J Pediatr ; 197: 90-96, 2018 06.
Article in English | MEDLINE | ID: mdl-29605394

ABSTRACT

OBJECTIVES: To evaluate state-level prevalence estimates of prenatal and early postnatal cannabis use in a state with legalized medical and recreational marijuana and the association with adverse neonatal outcomes. STUDY DESIGN: We conducted a cross-sectional study on 3,207 respondents from the 2014-2015 Colorado Pregnancy Risk Assessment Monitoring System with state-developed questions on cannabis use. Differences in perinatal cannabis use were evaluated according to maternal characteristics, breastfeeding patterns, and pregnancy intendedness. Multiple logistic regression models evaluated the relationship between prenatal cannabis use and adverse neonatal outcomes including low birth weight, small for gestational age, preterm birth, and admission to the neonatal intensive care unit. RESULTS: The self-reported prevalence of cannabis use at any time during pregnancy was 5.7 ± 0.5% and the prevalence of early postnatal cannabis use among women who breastfed was 5.0% (95% CI, 4.1%-6.2%). Prenatal cannabis use was associated with a 50% increased likelihood of low birth weight, independent of maternal age, race/ethnicity, level of education, and tobacco use during pregnancy (OR, 1.5; 95% CI, 1.1-2.1; P = .02). Small for gestational age, preterm birth, and neonatal intensive care unit admission were not associated with prenatal cannabis use, independent of prenatal tobacco use. CONCLUSIONS: Our findings underscore the importance of screening for cannabis use during prenatal care and the need for provider counselling about the adverse health consequences of continued use during pregnancy and lactation.


Subject(s)
Cannabis/adverse effects , Marijuana Use/epidemiology , Medical Marijuana/adverse effects , Pregnancy Outcome/epidemiology , Prenatal Exposure Delayed Effects/epidemiology , Adolescent , Adult , Breast Feeding/statistics & numerical data , Colorado/epidemiology , Cross-Sectional Studies , Female , Humans , Infant, Newborn , Marijuana Use/adverse effects , Pregnancy , Prevalence , Risk Factors , Young Adult
20.
J Am Pharm Assoc (2003) ; 58(3): 258-267.e3, 2018.
Article in English | MEDLINE | ID: mdl-29605475

ABSTRACT

OBJECTIVES: To evaluate the reported amount of 14 vitamins and 10 minerals in over-the-counter (OTC) and prescription (Rx) prenatal multivitamins and minerals (PMVMs) and compare them with the Health and Medicine Division (HMD) of the National Academies recommended dietary allowances (RDAs) and tolerable upper intake levels for intake. DESIGN: Observational convenience sample of supplemental facts labels on OTC and Rx PMVMs identified and evaluated from online retailers, grocery stores, and pharmacies. SETTING AND PARTICIPANTS: Not applicable. OUTCOME MEASURES: Reported vitamin and mineral amounts in PMVMs were compared with HMD RDAs to determine whether PMVMs could correct RDA deficiencies in the average pregnant woman's diet. Reported vitamin and mineral amounts were compared in OTC and Rx PMVMs and to HMD upper intake levels. RESULTS: One hundred sixty-three OTC and 88 Rx PMVMs were evaluated. The average pregnant woman in the United States is deficient in many vitamins and minerals from food intake alone. Over 80% of OTC and Rx PMVMs would correct the RDA deficit for vitamin B6, folic acid, vitamin C, vitamin E, and iron. Over 90% of OTC products would correct the deficit for vitamin A and zinc; however, 47% and 74% of Rx products would correct for those deficits, respectively. Approximately 73% of OTC and 60% of Rx PMVMs corrected calcium deficit, and 33% of OTC and 24% of Rx PMVMs corrected vitamin D deficit. A minority of PMVMs corrected deficits for magnesium and choline. OTC products have significantly more of each vitamin compared with Rx, with several exceptions including: iron, folic acid, copper, and vitamin B6. CONCLUSION: Most pregnant women take PMVMs. If pregnant women are not consuming enough essential micronutrients from diet, it is possible that PMVMs will provide adequate amounts; however, this depends on the specific vitamin or mineral. There is notable variation between Rx and OTC PMVM options.


Subject(s)
Nonprescription Drugs/administration & dosage , Prescription Drugs/administration & dosage , Vitamins/administration & dosage , Diet , Dietary Supplements , Female , Humans , Micronutrients/administration & dosage , Minerals/administration & dosage , Pregnancy , Prenatal Care/methods
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