HEALTH

Researchers from Johns Hopkins Medicine recommend OTC availability for contraceptives

BY Michael Johnsen

BALTIMORE — Researchers from Johns Hopkins Medicine on Tuesday made the case for the Rx-to-OTC switch of oral contraceptives.

Moreover, the experts reported, the evidence also supports OTC access for teens and adult women, citing studies showing that teens are capable of safely and properly using "the pill" to prevent unwanted pregnancies.

"Decades of research show that a majority of adolescents initiate sex before the age of 18 and that earlier use of contraception reduces the risk of teen pregnancy," stated Krishna Upadhya, assistant professor of pediatrics at the Johns Hopkins University School of Medicine and the paper's lead author. "Our review strongly suggests that giving teens easier access to various contraceptives will not lead to more sex but would result in fewer unwanted pregnancies."

The review by Upadhya and her colleagues comes as reproductive health service providers and federal policymakers continue to debate moving oral contraceptives to OTC status, particularly for teenagers. Additionally, a partnership between HRA Pharma and Ibis Reproductive Health to begin an application for an OTC oral contraceptive to the Food and Drug Administration was recently announced.

For the review, the Johns Hopkins-led team looked for teen-specific data related to the safety and effectiveness of oral contraceptives, pregnancy risk associated with typical use of various forms of contraception, teen ability to use oral contraceptives correctly and consistently, the impact of OTC access on sexual behaviors and concerns that OTC access might reduce clinician counseling opportunities with young people.

The pill is already the most commonly used hormonal method of birth control by teens and other women of reproductive age in the U.S., according to the 2011-2013 National Survey of Family Growth. That survey estimates that 54% of female ages 15 to 19 have used it. Proponents of OTC status say easier, wider access to the pill will further increase contraceptive use, further lowering teen pregnancy rates and abortion.

The Centers for Disease Control and Prevention recently reported that births to teens in the U.S. reached a historic low of 22.3 live births per 1,000 women ages 15 to 19 in 2015. A recent analysis by one of the paper's authors found that the decline in pregnancy risk among U.S. teens between 2007 and 2012 was entirely attributable to increased use of contraception. Critics of OTC status say they fear wider access would lead to more teen sex, sexually transmitted disease and the safety concerns of long-term use, the Johns Hopkins researchers noted.

The research team also reviewed existing research regarding teens' ability to use oral contraceptives consistently and correctly. Upadhya says studies of adolescent development suggest that most teens have the reasoning skills to make informed decisions about oral contraceptives. Because the use of oral contraceptives is a daily behavior not tied to specific or imminent sexual or emotional pressures, teens may actually be more likely to use them consistently, she argued. According to Upadhya, the research suggests that factors like having routines and feeling in control of the decision are more important to consistent use of pills than age.

In addition, Upadhya said, studies comparing the contraceptive failure rate in teens versus young women showed no significant differences, and one study that gauged teens' ability to answer questions about correct use of oral contraceptives found that 90% answered them correctly.

The team reviewed the impact of FDA action in 2012 making the hormonal emergency contraceptive marketed as "Plan B" available OTC for teens. Upadhya and colleagues found that teen use of Plan B increased from 8% in 2002 to 22% in 2011 to 2013. Sales of all female contracteptives like Plan B totaled $338.9 million for the 52 weeks ended Dec. 25 across total U.S. multi-outlets, according to IRI, representing growth of 8.4%.

Finally, the researchers considered the potential of OTC status to negatively impact clinicians' opportunities to counsel teens and provide additional sexual and reproductive health care. The team found that the percentage of teens who get recommended annual preventive visits is already low. According to one study of 14- to 17-year-olds from 2000 to 2004, only 38% received the recommended annual visit, and of those who did receive a visit, only 40% reported having private discussions with their clinician. Upadhya said  the results suggest that providing alternative access points outside of clinics, when possible, is critical to ensuring that all teens in need can use effective contraceptives. Because not all methods can be self-administered, however, Upadhya stresses the importance of continued efforts to ensure that teens have contraceptive visits with clinicians.

"Oral contraceptives are popular, safe and effective methods of pregnancy prevention for women and teens," she said. "Our review emphasizes that any future over-the-counter pill has the potential to benefit teens, and there is no scientific rationale to restrict access based on age."

A report on the literature review was published on March 14 in the Journal of Adolescent Health.

 

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Not enough hip-fracture patients are supplementing with vitamin D, AAOS finds

BY Michael Johnsen

ROSEMONT, Ill. — Despite national recommendations for daily vitamin D intake, a new study presented Tuesday at the 2017 Annual Meeting of the American Academy of Orthopaedic Surgeons found that just 45.7% of patients reported consistently taking vitamin D supplements following a hip fracture, a known treatment and preventative strategy for osteoporosis.

"Vitamin D supplementation following hip fracture surgery is grossly under-prescribed," stated co-study author Mohit Bhandari, an orthopaedic surgeon and research chair in musculoskeletal trauma and surgical outcomes, at McMaster University in Ontario, Canada. "Given its potential to improve patient function independent of other therapies, it seems improved advocacy and education — aimed at doctors and patients — about vitamin D supplementation is both worthwhile and evidence-based."

In the U.S., an estimated 44 million people have osteoporosis and another 10 million are at risk for the disease which causes progressive bone loss and increased fracture risk. One in two women and one in four men older than age 50 years will sustain a bone fracture caused by osteoporosis. These potentially debilitating injuries include fractures of the hip, spine, wrist, arm or leg, often occurring from a fall. A bone fracture is often the first sign of the disease which develops slowly with no other symptoms.

Treatments, which include medication, weight-bearing exercise and/or vitamin D, calcium or estrogen supplements, can prevent subsequent fractures.

The U.S. Food and Nutrition Board at the Institute of Medicine of The National Academies recommends 600 International Units (IUs) of vitamin D each day for adults, and 800 IUs for Americans age 71 and older.

In this study, Canadian researchers interviewed 573 hip fracture patients about their vitamin D intake during doctor visits for two years following hip fracture surgery. The mean patient age was 74.1, and the majority of patients (66.3%) were women.

Less than half of the patients consistently took vitamin D supplements as recommended, while 35.6% took supplements inconsistently and less than 19% took no supplements. Despite well-developed guidelines and close follow-up in a clinical trial, a low proportion of elderly hip fracture patients are consistently taking vitamin D. This suggests a need to develop and evaluate additional strategies to promote compliance.

The AAOS position statement, "Orthopaedic Care of Patients with Fragility Fractures," recommends that U.S. physicians proactively screen, monitor and, if necessary, assist in getting treatment for elderly and other at-risk patients for osteoporosis following an initial bone fracture to prevent subsequent fractures.

 

 

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Sundown Naturals is now 100% non-GMO

BY Michael Johnsen

RONKONKOMA, N.Y. — The Nature's Bounty Company on Thursday announced that its Sundown Naturals brand  is now 100% non-GMO.

"We are thrilled to be deemed 100% Non-GMO as this further showcases our unwavering commitment to the health and wellbeing of our consumers," said John Frame, VP marketing for Sundown Naturals. "At Sundown Naturals, we believe that life is about balance and we strive to help make things just a little bit easier for our health-conscious consumers by offering wholesome, free-of vitamins and supplements to support them through every step of their daily routines."

This new distinction highlights Sundown Natural's continued commitment to being a leader in the 100% "free of" category and dedication to provide its consumers with high-quality vitamins and supplements, the company added.

 

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