ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00065871HD42427NCT00065871The Direct Access Study: Access to Hormonal Birth Control Through Community PharmaciesImproving Contraceptive Practice and Delivery Through Community Pharmacists: The Direct Access StudyEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
Hormonal birth control methods include birth control pills, patches, and vaginal rings; they
are normally available only with a doctor's prescription. This study will evaluate a program
designed to increase the availability of birth control by allowing pharmacists to give women
hormonal birth control without a doctor's prescription. Under this program, pharmacists will
evaluate women who want to use birth control according to specific guidelines created by
doctors. If a woman meets the criteria in the guidelines, a pharmacist could then give her
the appropriate form of hormonal birth control.
The Institute of Medicine's Committee on Unintended Pregnancy urges increasing access to
contraception through broadening the range of health professionals that provide birth
control. Evidence-based family planning practice no longer requires a physical examination
before prescribing hormonal contraceptives to women. Community pharmacists efficiently
provide emergency contraceptive pills (ECP) and women report satisfaction with the direct
access. These women, as well as many women purchasing less effective over-the-counter (OTC)
contraceptive methods, could benefit from more pharmacist-dispensed birth control choices,
such as hormonal methods. The Direct Access Study will assess the feasibility of pharmacists,
under Collaborative Drug Therapy Agreements with independent prescribers, providing hormonal
contraceptives in community pharmacies. Specifically, the study will evaluate the impact upon
hormonal contraception initiation and continuation rates when women's care is managed by
pharmacists.
Using Collaborative Drug Therapy Agreements jointly developed with licensed prescribers
(physicians and nurse practitioners), pharmacists in four Fred Meyer pharmacies will identify
women who are at risk of unintended pregnancy and will offer to evaluate them for their
suitability to safely use oral contraceptives, contraceptive patches, or the contraceptive
vaginal ring. Through self-administered medical and contraceptive history questionnaires,
interested women will select the most suitable contraceptive methods. Pharmacists will then
complete the screening process and prescribe hormonal contraceptives according to the
protocol guidelines.
Pharmacists will encourage women to follow up with a primary care practitioner or family
planning clinic for cervical exams and reproductive tract infection screening as indicated.
Pharmacists will have authority to provide an initial 3-month prescription and an additional
9-month prescription if blood pressure is normal at a three-month revisit. Effectiveness of
pharmacists' interventions will be measured by initiation and continuation of hormonal
methods by women to whom pharmacists have offered them. Feasibility will be determined by
measurement of both acceptability and sustainability. Acceptability will be measured by
surveys of women, pharmacists, and prescribers. Sustainability will be measured by economic
and work-flow outcomes for the pharmacies, including evidence that women, private third-party
payers, and public payers are willing to pay for the services. If safety is documented after
preliminary analysis, injectable contraceptive methods will be added to the study.
Unknown statusActive, not recruitingJune 2003February 2006N/AInterventionalNoNon-RandomizedPreventionNone (Open Label)The number and characteristics of women who seek hormonal contraceptives from pharmacists as evidenced by study consent or enrollment.The number and characteristics of women not able to obtain hormonal contraceptives due to contraindications, costs, etc.The proportion and characteristics of those women who continue to use the initial method after 3, 6, and 12-months compared with national literature and with women who do not obtain the method by direct pharmacist access.Safety evaluation to include prescribing protocol adherence (no women with absolute contraindication given estrogen; blood pressure monitoring done prior to more than three cycles of estrogen methods; no woman given a hormonal method while pregnant.The number and characteristics of women who choose hormonal contraceptives for the first time compared to national literature.The amount of time required for pharmacists to be trained and to conduct the defined interventions in the course of their ongoing pharmach practice.The number and characteristics of eligible Medicaid waiver applicants enrolled by pharmacists compared with state figures for other providers.The proportion of billed insurance claims that are paid.The number and types of referrals to clinicians made by pharmacists and the proportion of counseled clients who follow through on the referrals that were made.250ContraceptionBehavioralContraceptive Screening by PharmacistBehavioralContraceptive Prescribing by Pharmacist
Inclusion Criteria
- At risk for unintended pregnancy
- Access to participating Fred Meyer Pharmacy
- English-speaking
- Health insurance or ability to pay for contraceptive care
Exclusion Criteria
- Age less than 18 years
- Age greater than 45 years
- Unable to become pregnant
- Not English speaking
- Not planning to remain in area
- Not planning to use the same pharmacy
- Unable to pay for services
Female18 Years45 YearsAccepts Healthy VolunteersJacqueline Gardner, PhDPrincipal InvestigatorUniversity of WashingtonFred Meyer PharmacyKentWashingtonUnited StatesFred Meyer PharmacyKirklandWashingtonUnited StatesFred Meyer PharmacyPuyallup-South HillWashingtonUnited StatesFred Meyer PharmacySeattle-BroadwayWashingtonUnited StatesBartell Drugs, University VillageSeattleWashingtonUnited StatesUnited StatesStewart FH, Harper CC, Ellertson CE, Grimes DA, Sawaya GF, Trussell J. Clinical breast and pelvic examination requirements for hormonal contraception: Current practice vs evidence. JAMA. 2001 May 2;285(17):2232-9. doi: 10.1001/jama.285.17.2232.11325325Gardner JS, Hutchings J, Fuller TS, Downing D. Increasing access to emergency contraception through community pharmacies: lessons from Washington State. Fam Plann Perspect. 2001 Jul-Aug;33(4):172-5. No abstract available.11496935Faculty of Family Planning and Reproductive Health Care. Royal College of Obstetricians and Gynaecologists. First prescription of combined oral contraception: recommendations for clinical practice. Br J Fam Plann. 2000 Jan;26(1):27-38. No abstract available.10819591November 2004August 1, 2003August 4, 2003August 5, 2003April 5, 2007April 5, 2007April 6, 2007Pharmacist prescribersIncreased accessHormonal contraceptionBirth control pillsBirth control patchVaginal contraceptive ringContraceptive Agents