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Adherence to a flexible extended regimen for oral hormonal contraception provided in blister packaging compared with an adherence-supporting digital tablet dispenser: historical comparison of data from two clinical studies.
International Journal of Women's Health. 2016; 8:351-6.BACKGROUND: The Clyk digital pill dispenser helps ensure correct and consistent administration of a flexible extended regimen of the combined oral contraceptive, ethinylestradiol (EE) 20 mug/drospirenone 3 mg (EE/drospirenone ; YAZ((R)) Flex Flex), guiding users through the intake cycle and 4-day pill break and providing visible and acoustic daily reminders when pill intake is due. A study showed that the audible alarm function of the dispenser could help reduce the number of missed pills, but it lacked an appropriate "non-dispenser" group for a meaningful assessment of the impact of the dispenser on adherence. This study indirectly assessed the overall effect of the digital dispenser on adherence by comparing data from a treatment with standard blister packaging. MATERIALS AND METHODS: One-year adherence data were compared from two similarly designed, Phase III, open-label, randomized trials of EE/drospirenoneFlex. In study 1, women used diary cards to record adherence with EE/drospirenoneFlex dispensed in blister packs (n=640), and in study 2 the dispenser was used with the alarm activated (n=250) or deactivated (n=248) in addition to using diary cards. RESULTS: A mean (+/-SD) of 4.3 (+/-4.24) missed pills over 1 year were recorded in diary cards among women who dispensed their pills from the blister packages (study 1) compared with 1.0 (+/-2.4) recorded by the alarm-activated dispenser (study 2). In study 2, a mean of 1.9 (+/-4.2) missed pills were reported in the diaries over 1 year compared with 4.4 (+/-9.1) from automatic recording by the dispenser (both arms of study 2), indicating underreporting of missed pills in diary cards vs the digital dispenser. Adjusting for this rate of underreporting, an estimated mean of ten pills were missed over 1 year by women using EE/drospirenoneFlex in blister packs, or ten times more than with the digital dispenser with activated acoustic alarm. CONCLUSION: The digital dispenser helps reduce the number of missed pills and increases adherence.
AMERICAN JOURNAL OF PUBLIC HEALTH. 1993 Aug; 83(8):1094-9.More is known about the safety of oral contraceptives (OCs) than any other drug. 30 years of OC use show that they are safe. Some reproductive health specialists propose that OCs be available without a prescription. Obtaining a prescription keeps women from using this effective contraceptive because they need to make a costly initial clinic visit, undergo a pelvic examination, and periodic visits or telephone calls for refills, all of which are barriers to OC use. Women themselves can determine their need for OCs. They consider their risk of pregnancy and sexually transmitted diseases (STDs) and the costs and benefits of pregnancy and other contraceptives. Some people argue that OC users are more likely to receive preventive care services, such as STD screening, than are nonusers. Yet, men do not need an annual prescription for condoms to promote early detection of prostate and testicular cancer. This carrot (i.e., coercion) policy assumes that women cannot make their own decisions. Family planning clinics fear losing revenue if OCs were available without a prescription, but family planning providers need to be reimbursed for the primary prevention services they already provide and not for providing prescriptions to OCs. Improper compliance already exists even though women need a prescription to use OCs, so making OCs available over-the-counter will not effect user compliance. Some options to make OCs more accessible include a 28-day format packaging of OCs with comprehensible and legible labels including guidelines on compliance and key danger signals, an initial examination only, elimination of the pelvic examination, and counseling only for first-time users. Over-the-counter options could be a self-administered knowledge inventory maintained by pharmacists, a toll-free telephone authorization process a fax or mail-in order form, over-the-counter purchases for experienced users, and over-the-counter purchase with no restrictions.