Emergency contraception in a historic southern city: Mystery caller study in Birmingham, Alabama.

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.

Comparison of reported versus measured content of over-the-counter and prescription prenatal multivitamins and minerals.

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.

Assessment of speech and fine motor coordination in children with autism spectrum disorder.

Autism Spectrum Disorder (ASD) is a developmental disorder characterized by difficulty in communication, which includes a high incidence of speech production errors. We hypothesize that these errors are partly due to underlying deficits in motor coordination and control, which are also manifested in degraded fine motor control of facial expressions and purposeful hand movements. In this pilot study, we computed correlations of acoustic, video, and handwriting time-series derived from five children with ASD and five children with neurotypical development during speech and handwriting tasks. These correlations and eigenvalues derived from the correlations act as a proxy for motor coordination across articulatory, laryngeal, and respiratory speech production systems and for fine motor skills. We utilized features derived from these correlations to discriminate between children with and without ASD. Eigenvalues derived from these correlations highlighted differences in complexity of coordination across speech subsystems and during handwriting, and helped discriminate between the two subject groups. These results suggest differences in coupling within speech production and fine motor skill systems in children with ASD. Our long-term goal is to create a platform assessing motor coordination in children with ASD in order to track progress from speech and motor interventions administered by clinicians.

Seeking emergency contraception in the United States: A review of access and barriers.

Federal regulations governing access to levonorgestrel (LNG) emergency contraception (EC) have evolved since its introduction in the 1990s. LNG EC was initially available by prescription only, but is now available over-the-counter to consumers of all ages. Nonetheless, consumers seeking EC in their communities may face ongoing barriers to access, including low stock and inaccurate information provided by pharmacy staff. We conducted a review of LNG EC secret shopper studies to describe changes in EC access and barriers over time. EC access was compared across all applicable studies, which were published during 2003-2016. When possible, reasons for EC unavailability, helpfulness of pharmacy staff when EC was not in stock, and accuracy of EC information provided by pharmacy staff were described. Overall, access to EC appeared to be improving. However, EC was unavailable during 31 percent of encounters. Pharmacy staff attributed this to "low demand" (30 percent) or EC being "out of stock" (21 percent). Personal objections (9 percent) and store policy (10 percent) were also cited in studies from earlier years. Inaccurate information provided by pharmacy staff persists regarding federal EC regulations, mechanism of action, and drug administration. Pharmacy staff should remain informed about EC and its regulations in order to reduce remaining access barriers.

Evaluation of reported contents in prescription and over-the-counter prenatal multivitamins.

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.

Barriers to Single-Dose Levonorgestrel-Only Emergency Contraception Access in Retail Pharmacies.

OBJECTIVES: In February 2014, the Food and Drug Administration updated its regulations to make all single-dose levonorgestrel-only emergency contraception (LNG-EC) available over the counter. This study examines the availability and access to LNG-EC shortly after this policy change, and any additional barriers to obtaining LNG-EC in Colorado retail pharmacies. STUDY DESIGN: From June to July 2014, three female interviewers posing as women seeking LNG-EC conducted a telephone survey of all 633 Colorado retail pharmacies listed in The Little Blue Book (2014) phone directory. Completely accessible was defined as LNG-EC available on store shelves for purchase without presentation of an ID or prescription on the day of the call. RESULTS: Of 633 pharmacies analyzed, 85.0% (538/633) were in urban settings and 85.3% (540/633) were chain stores. Eighteen of 64 (28.1%) counties in Colorado did not have a pharmacy listed in the phone directory. Overall, 86.9% of pharmacies (550/633) had EC in stock on the day of contact but only 23.2% (147/633) of these had EC completely accessible. Of pharmacies with EC in stock, 41.6% (229/550) kept it behind the counter and 56.0% (308/550) required additional documentation to purchase. In stock and completely accessible rates were not different across rural, urban, and frontier geographic regions within the state (p = .066 and p = .905, respectively), but were significantly different across independent, chain, and 24-hour type stores (p < .001 and p = .008, respectively). In stock rates were 57.5% (42/73), 90.4% (488/540), and 100% (20/20) for independent, chain, and 24-hour stores respectively. CONCLUSIONS: Rates of completely accessible LNG-EC are low in Colorado despite high rates of availability. Behind-the-counter status and proof-of-age requirements are identified as the main sources of access restriction in Colorado.

Variability of bacterial vaginosis over 6- to 12-month intervals.

OBJECTIVES: To examine variability in bacterial vaginosis (BV) over 6- to 12-month intervals. STUDY DESIGN: One thousand one hundred ninety-three women were followed for a median of 3 years with serial vaginal swab Gram stains for BV. Discrete time hazard models were fit to identify independent risk factors for BV. RESULTS: Women with BV at study entry were categorized as having normal flora at the next visit 20% of the time, and women with normal flora at study entry were categorized as having BV at the next visit 20% of the time. Among women with initially normal flora, factors associated with BV were black race, lower education, a history of BV, a history of chlamydial/gonococcal cervicitis, and lack of monogamy. CONCLUSION: About one fifth of women with normal flora develop BV over a given 6- to 12-month interval, and the modifiable risk factors of cervicitis and lack of monogamy contribute to the development of BV.

A cluster analysis of bacterial vaginosis-associated microflora and pelvic inflammatory disease.

Controversy surrounds the association between bacterial vaginosis (BV) and pelvic inflammatory disease (PID). Women (N = 1,140) were ascertained at five US centers, enrolled (1999-2001), and followed up for a median of 3 years. Serial vaginal swabs were obtained for Gram's stain and cultures. PID was defined as 1) histologic endometritis or 2) pelvic pain and tenderness plus oral temperature >38.8 degrees C, leukorrhea or mucopus, erythrocyte sedimentation rate >15 mm/hour, white blood cell count >10,000, or gonococcal/chlamydial lower genital infection. Exploratory factor analysis identified two discrete clusters of genital microorganisms. The first correlated with BV by Gram's stain and consisted of the absence of hydrogen peroxide-producing lactobacillus, Gardnerella vaginalis, Mycoplasma hominis, anaerobic gram-negative rods, and, to a lesser degree, Ureaplasma urealyticum. The second, unrelated to BV by Gram's stain, consisted of Enterococcus species and Escherichia coli. Being in the highest tertile in terms of growth of BV-associated microorganisms increased PID risk (adjusted rate ratio = 2.03, 95% confidence interval: 1.16, 3.53). Carriage of non-BV-associated microorganisms did not increase PID risk. Women with heavy growth of BV-associated microorganisms and a new sexual partner appeared to be at particularly high risk (adjusted rate ratio = 8.77, 95% confidence interval: 1.11, 69.2). When identified by microbial culture, a combination of BV-related microorganisms significantly elevated the risk of acquiring PID.

Bacterial vaginosis (BV) and the risk of incident gonococcal or chlamydial genital infection in a predominantly black population.

OBJECTIVE: The objective of this study was to assess in prospective data whether bacterial vaginosis (BV) is associated with gonococcal/chlamydial cervicitis. STUDY: A total of 1179 women at high risk for sexually transmitted infections was followed for a median of 3 years. Every 6 to 12 months, vaginal swabs were obtained for Gram stain, culture of microflora, and Neisseria gonorrhoeae and Chlamydia trachomatis. A Gram stain score of 7 to 10 based on the Nugent criteria categorized BV. RESULTS: Baseline BV was associated with concurrent gonococcal/chlamydial infection (adjusted odds ratio, 2.83; 95% confidence interval [CI], 1.81-4.42). However, the association between BV and subsequent, incident gonococcal/chlamydial genital infection was not significant (adjusted relative risk [RR], 1.52; 95% CI, 0.74-3.13). Dense growth of pigmented, anaerobic Gram-negative rods (adjusted RR, 1.93; 95% CI, 0.97-3.83) appeared to elevate the risk for newly acquired gonococcal/chlamydial genital infection. CONCLUSIONS: BV was common among a predominantly black group of women with concurrent gonococcal/chlamydial infection but did not elevate the risk for incident infection.

Douching, pelvic inflammatory disease, and incident gonococcal and chlamydial genital infection in a cohort of high-risk women.

Douching has been linked to gonococcal or chlamydial cervicitis and pelvic inflammatory disease (PID) in retrospective studies. The authors conducted a 1999-2004 prospective observational study of 1,199 US women who were at high risk of acquiring chlamydia and were followed for up to 4 years. Cervical Neisseria gonorrhoeae and Chlamydia trachomatis were detected from vaginal swabs by nucleic acid amplification. PID was characterized by histologic endometritis or pelvic pain and tenderness plus one of the following: oral temperature >38.3 degrees C, leukorrhea or mucopus, erythrocyte sedimentation rate >15 mm/hour, white blood cell count >10,000, or gonococcal/chlamydial lower genital tract infection. Associations between douching and PID or gonococcal/chlamydial genital infections were assessed by proportional hazards models. The 4-year incidence rate of PID was 10.9% and of gonococcal and/or chlamydial cervicitis was 21.9%. After adjustment for confounding factors, douching two or more times per month at baseline was associated with neither PID (adjusted hazard ratio = 0.76, 95% confidence interval: 0.42, 1.38) nor gonococcal/chlamydial genital infection (adjusted hazard ratio = 1.16, 95% confidence interval: 0.76, 1.78). Frequency of douching immediately preceding PID or gonococcal/chlamydial genital infection was not different between women who developed versus did not develop outcomes. These data do not support an association between douching and development of PID or gonococcal/chlamydial genital infection among predominantly young, African-American women.

Bacterial vaginosis and risk of pelvic inflammatory disease.

BACKGROUND: Bacterial vaginosis commonly is found in women with pelvic inflammatory disease (PID), but it is unclear whether bacterial vaginosis leads to incident PID. METHODS: Women (n = 1,179) from 5 U.S. centers were evaluated for a median of 3 years. Every 6-12 months, vaginal swabs were obtained for gram stain and culture of microflora. A vaginal microflora gram stain score of 7-10 was categorized as bacterial vaginosis. Pelvic inflammatory disease was diagnosed by presence of either histologic endometritis or pelvic pain and tenderness plus one of the following: oral temperature greater than 38.3 degrees C; sedimentation rate greater than 15 mm/hour; white blood count greater than 10,000; or lower genital tract detection of leukorrhea, mucopus, or Neisseria gonorrhoeae or Chlamydia trachomatis. RESULTS: After adjustment for relevant demographic and lifestyle factors, baseline bacterial vaginosis was not associated with the development of PID (adjusted hazard ratio 0.89, 95% confidence interval 0.55-1.45). Carriage of bacterial vaginosis in the previous 6 months before a diagnosis (adjusted risk ratio 1.31, 95% confidence interval 0.71-2.42) also was not significantly associated with PID. Similarly, neither absence of hydrogen peroxide-producing Lactobacillus nor high levels of Gardnerella vaginalis significantly increased the risk of PID. Dense growth of pigmented, anaerobic gram-negative rods in the 6 months before diagnosis did significantly increase a woman's risk of PID (P =.04). One subgroup of women, women with 2 or more recent sexual partners, demonstrated associations among bacterial vaginosis, Gardnerella vaginalis, anaerobic gram-negative rods, and PID. CONCLUSION: In this cohort of high-risk women, after adjustment for confounding factors, we found no overall increased risk of developing incident PID among women with bacterial vaginosis. LEVEL OF EVIDENCE: II-2

Can known risk factors explain racial differences in the occurrence of bacterial vaginosis?

BACKGROUND: Black women are more likely to have bacterial vaginosis (BV) than are non-Hispanic white women. We examined whether this disparity can be explained by racial differences in known BV risk factors. METHODS: Nine hundred black and 235 white women were enrolled from five US sites. At baseline, structured interviews were conducted and vaginal swabs self-collected for Gram-stain and culture. RESULTS: Black women were more likely than white women to have BV/intermediate vaginal flora. They also were more likely to be older, have lower educational attainment and family incomes, have a history of a sexually transmitted disease, and douche. After adjustment for demographic and lifestyle factors, blacks remained at elevated risk for BV/intermediate flora (OR 2.2, 95% CI 1.5-3.1). Blacks also were more likely to have specific BV-related vaginal microflora, as well as gonococcal or chlamydial cervicitis (OR 2.2, 95% CI 1.2-3.8) after adjustment for known BV risk factors. CONCLUSION: Risk factor differences did not explain the observed racial disparity in the occurrence of BV, BV-related microflora, or gonococcal or chlamydial cervicitis. These findings highlight our limited understanding of the factors accounting for the occurrence of bacterial vaginosis and cervicitis among black and white women.

Why women douche and why they may or may not stop.

BACKGROUND: Although douching is common, it is a potentially harmful habit. GOAL: We studied attitudes and knowledge around the behavior of douching. STUDY DESIGN: Of 1,200 women enrolled in this multisite study, 532 douched and answered questions on a structured interview regarding douching behaviors. RESULTS: Over half had douched for 5 or more years. Douching was most often initiated on the recommendation of female relatives and practiced for reasons of hygiene. Half of women considered douching to be healthy. Those who considered douching to be unhealthy reported that douching may disrupt vaginal flora but did not cite more serious risks. Nonetheless, women who had been advised by a health professional to stop douching were less likely to consider douching healthful and were more likely to have tried to stop. CONCLUSION: Women had a limited understanding of potential adverse health consequences associated with douching. Targeted health messages may influence women to initiate douching cessation.

Douching in relation to bacterial vaginosis, lactobacilli, and facultative bacteria in the vagina.

OBJECTIVE: To study how frequency, recentness, and reason for douching impact bacterial vaginosis-related vaginal microflora and the occurrence of cervical pathogens. Douching has been linked to bacterial vaginosis as well as to chlamydial cervicitis in some, but not all, studies. METHODS: A total of 1200 women at high risk for sexually transmitted infections were enrolled from five clinical sites around the United States. Cross-sectional, structured interviews were conducted and vaginal swabs were self-obtained for Gram stain, culture, and DNA amplification tests for Neisseria gonorrhoeae and Chlamydia trachomatis. RESULTS: Douching at least once per month was associated with an increased frequency of bacterial vaginosis. Those who douched recently (within 7 days) were at highest risk [odds ratio (OR) 2.1, 95% confidence interval (CI) 1.3, 3.1]. Douching for symptoms (OR 1.7, 95% CI 1.1, 2.6) and for hygiene (OR 1.3, 95% CI 1.0, 1.9) both related to bacterial vaginosis risk. The associations between douching and Gardnerella vaginalis, Mycoplasma hominis, and lack of hydrogen peroxide-producing lactobacilli were similar to those between douching and bacterial vaginosis. Gonococcal or chlamydial cervicitis was not associated with douching. CONCLUSION: Douching for symptoms or hygiene, particularly frequent or recent douching, was associated with bacterial vaginosis and bacterial vaginosis-associated vaginal microflora, but not with gonococcal or chlamydial cervicitis.

Oral valacyclovir versus intravenous acyclovir in preventing herpes simplex virus infections in autologous stem cell transplant recipients.

Patients who are seropositive for herpes simplex virus (HSV) and are undergoing autologous marrow or peripheral blood stem cell transplantation require prophylaxis for HSV infection. Most prophylaxis regimens have used intravenous acyclovir (ACY). Oral valacyclovir (VAL), the L-valyl ester of ACY, can be used to achieve plasma concentrations equivalent to levels achieved with intravenous ACY. In this study, adults undergoing autologous stem cell transplantation were randomized to receive ACY, 250 mg/m2 intravenously (IV) every 12 hours from day 0 to engraftment, or VAL, 1 g orally every 12 hours from day 0 to engraftment. The primary study objective was to compare cost of HSV prophylaxis between study groups. Thirty patients were randomized to receive either oral VAL (n = 14) or IV ACY (n = 16) prophylaxis. Mean pharmacy cost of HSV prophylaxis in the patient group randomized to IV ACY was $1080 versus $320 for the group randomized initially to VAL. This study demonstrates the feasibility and significant cost savings of using oral VAL for HSV prophylaxis.