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1.
Title: Plan B for 17-year olds.
Source: Medical Letter On Drugs and Therapeutics. 2009 May 18;51(1312):40.
Abstract: The FDA has announced that it will lower the age for over-the-counter access to the emergency contraceptive Plan B from 18 to 17 years old. In a randomized, controlled trial, the two 0.75-mg levonorgestrel tablets in Plan B, taken 12 hours apart beginning within 72 hours after unprotected intercourse, decreased the overall pregnancy rate to 1.1% (11/976) of women who requested emergency contraception. The sooner the drug is taken after coitus, the more effective it is. Nausea and vomiting can occur with Plan B. Fetal malformations have not been associated with pregnancies that occurred despite use of levonorgestrel-only emergency contraception. (full-text)
Language: English
Keywords:
UNITED STATES OF AMERICA | USFDA | ADOLESCENTS | EMERGENCY CONTRACEPTION | ADMINISTRATION AND DOSAGE | PROGRAM ACCESSIBILITY | Developed Countries | North America | Americas | USPHS | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Program Evaluation | Programs | Organization and Administration
Document Number: 341625

2.
Title: Contraceptive use among postpartum women - 12 states and New York City, 2004-2006.
Author: Centers for Disease Control and Prevention (CDC)
Source: MMWR. Morbidity and Mortality Weekly Report. 2009 Aug 7;58(30):821-6.
Abstract: Postpartum use of highly effective contraceptive methods can prevent unintended pregnancies and ensure adequate birth spacing. Unintended pregnancies and short interpregnancy intervals are associated with adverse maternal and infant outcomes. In 2001, the year for which the most recent data are available, 49% of all pregnancies were unintended, and 21% of women gave birth within 24 months of a previous birth. Two Healthy People 2010 goals are to increase the percentage of intended pregnancies to 70% (objective 9-1) and to reduce the percentage of births occurring within 24 months of a previous birth to 6% (objective 9-2). To estimate the prevalence and types of contraception being used by women 2-9 months postpartum, CDC analyzed data from the 2004-2006 Pregnancy Risk Assessment Monitoring System (PRAMS) from 12 states and New York City. This report summarizes those results, which indicated that 88.0% of postpartum women reported current use of at least one contraceptive method; 61.7% reported using a method defined as highly effective, 20.0% used a method defined as moderately effective, and 6.4% used less effective methods. Rates of using highly effective contraceptive methods postpartum were lowest among Asian/Pacific Islanders (35.3%), women who had wanted to get pregnant sooner (49.9%), women aged >or=35 years (53.0%), and women who had no prenatal care (54.5%). State policy makers and health-care providers can use these results to promote use of highly effective contraception among postpartum women and target interventions for those with particularly low rates of usage, including women with no prenatal care.
Language: English
Keywords:
UNITED STATES OF AMERICA | RESEARCH REPORT | DATA ANALYSIS | POSTPARTUM WOMEN | ETHNIC GROUPS | CDC | CONTRACEPTIVE USAGE | CONTRACEPTIVE METHODS CHOSEN | CONTRACEPTIVE EFFECTIVENESS | PREGNANCY, UNPLANNED | AGE FACTORS | TITLE 19 MEDICAL ASSISTANCE | Developed Countries | North America | Americas | Research Methodology | Puerperium | Reproduction | Cultural Background | Population Characteristics | Demographic Factors | Population | USPHS | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Contraception | Family Planning | Reproductive Behavior | Fertility | Population Dynamics | Public Assistance | Grants | Financial Activities | Economic Factors
Document Number: 342395

Title: Family Health International's Site Identification and Development Initiative (SIDI).
Author: Family Health International [FHI]
Source: [Research Triangle Park, North Carolina], FHI, [2009]. [3] p. (Research Briefs on HIV Prevention)
Abstract: Successful HIV prevention research requires the participation of tens of thousands of women and men at risk for HIV infection. Ultimately, success hinges on the development of multiple international research sites. To increase the number and readiness of such sites, Family Health International (FHI) began the Site Identification and Development Initiative (SIDI) in July 2006.
Language: English
Keywords:
AFRICA | ASIA | PROGRESS REPORT | CLINICAL RESEARCH | HIV PREVENTION | INCIDENCE | NEEDS | USAID | GOALS | STANDARDS | Developing Countries | Research Methodology | HIV Infections | Viral Diseases | Diseases | Measurement | Economic Factors | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Planning | Organization and Administration
Document Number: 331712

Title: Starting with the classroom: updating family planning knowledge in East Africa.
Author: IntraHealth International. Capacity Project
Source: Chapel Hill, North Carolina, IntraHealth International, Capacity Project, 2009 Feb. [2] p. (Voices No. 28)
Abstract: In Kenya, a dedicated midwifery tutor is working hard to train students at Aga Khan University but worries that he isn't teaching them the latest information and techniques. Many of his fellow instructors are in the same situation. "We had our last refresher training ten years ago," he laments. In Tanzania, a midwifery tutor from Tumaini University Faculty of Nursing observes, "Many nurses who are providing service have never been updated on new issues [in family planning]. It will be our responsibility to see how we can help as a training institution because we will send our students to some of these clinics." To build instructors' capacity and address the knowledge gaps, the Capacity Project partnered with East, Central and Southern Africa (ECSA) Health Community and Africa's Health in 2010 to deliver a week-long workshop on Contemporary Issues in Family Planning for midwifery tutors in Kenya, Tanzania and Uganda. Held in Dar es Salaam in April 2008, the workshop updated the knowledge of 22 tutors and enabled them to teach their students more effectively. A quantitative and qualitative evaluation showed the workshop to be highly successful. Average scores climbed from 58% on the pre-test to 81% on the post-test. Additionally, 94% reported that they have used the workshop information and resources to update their colleagues. (excerpt)
Language: English
Keywords:
AFRICA, SUB SAHARAN | PROGRESS REPORT | EVALUATION | MIDWIVES AND MIDWIFERY | NURSE-MIDWIVES | FAMILY PLANNING EDUCATION | SEX EDUCATION | USAID | CAPACITY BUILDING | WORKSHOPS | CONTRACEPTION | MATERNAL-CHILD HEALTH SERVICES | PERFORMANCE IMPROVEMENT | AUDIOVISUAL AIDS | Africa | Developing Countries | Health Personnel | Delivery of Health Care | Health | Education | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Program Sustainability | Programs | Organization and Administration | Family Planning | Primary Health Care | Health Services | Management | Educational Methods | Educational Activities
Document Number: 325236

Title: After receiving USAID | DELIVER Project logistics training, access to health products improves in Nepal.
Author: John Snow [JSI]. DELIVER
Source: Arlington, Virginia, JSI, DELIVER, 2009 Jul. [2] p. (Success Story)
Abstract: Just three years ago, under the previous health commodity distribution system in Nepal, the average stockout rate for family planning was 8.2 percent; for maternal and child health commodities it was 22.9 percent. Many women and children did not have the health commodities they needed. To prevent stockouts and to increase the availability of health commodities nationwide, the USAID | DELIVER PROJECT partnered with the Government of Nepal / Ministry of Health and Population (Logistics Management Division / Department of Health Services [LMD / DOHS]) and others to develop a series of logistics training programs. The goal was to create an efficient pull system that the country could use to manage stock levels at all health facilities. The project and the LMD collaborated to successfully implement two training programs -- one for community logistics and one for web-based logistics management information systems (LMISs). Conducted by the Nepali government, the USAID | DELIVER PROJECT, and their partners, these trainings taught community and district health workers how to improve the national health commodity logistics system and how to ease the transition to the new district-level pull system, which allows each health facility to determine the amount of stock that it needs to order. As a result, after 25 of the poorly performing districts participated in the training programs, stockouts of key commodities in their health facilities -- condoms, vitamin A capsules, iron tablets, cotrimoxazole, oral rehydration salt, and oxytocin decreased, while product availability for the end user increased. (Excerpt)
Language: English
Keywords:
NEPAL | SUMMARY REPORT | COMMUNITY-BASED DISTRIBUTION WORKERS | USAID | LOGISTICS | DISTRIBUTIONAL ACTIVITIES | TRAINING PROGRAMS | INFORMATION RETRIEVAL SYSTEMS | INTERNET | HEALTH FACILITIES | PERFORMANCE IMPROVEMENT | Developing Countries | Asia, Southern | Asia | Community Workers | Health Personnel | Delivery of Health Care | Health | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Management | Organization and Administration | Program Activities | Programs | Education | Data Storage and Retrieval | Information Processing | Information | Information Networks | Communication
Document Number: 331664

Title: The logistics handbook: A practical guide for supply chain managers in family planning and health programs.
Author: John Snow [JSI]. DELIVER
Source: Arlington, Virginia, JSI, DELIVER, 2009 Jul. 182 p. (USAID Contract No. GPO-I-01-06-00007-00) Oringinally published in 2004.
Abstract: The Logistics Handbook includes the major aspects of logistics management with an emphasis on contraceptive supplies. The text should be helpful to managers who work with supplies every day as well as managers who assess and design logistics systems for entire programs. Policymakers may find the text useful in exploring the inputs needed to create an effective logistics system. Key terms and concepts are clearly defined and explained, and the design and implementation of management information systems and inventory control are discussed in detail. Storage and quality control practices are also discussed, and overviews of forecasting and procurement processes are included.
Language: English
Keywords:
DEVELOPING COUNTRIES | MANUAL | USAID | FAMILY PLANNING PROGRAMS | LOGISTICS | CONTRACEPTIVE METHODS | DRUGS | INFORMATION RETRIEVAL SYSTEMS | RECORDS | QUALITY CONTROL | MONITORING | STORAGE AND WAREHOUSES | IMPLEMENTATION | PLANNING | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Family Planning | Management | Organization and Administration | Contraception | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Data Storage and Retrieval | Information Processing | Information | Evaluation | Programs
Document Number: 331681

Title: Spatial analysis of logistics indicator data for health commodities.
Author: John Snow [JSI]. DELIVER
Source: Arlington, Virginia, JSI, DELIVER, 2009 Jul. 6 p.
Abstract: The USAID | DELIVER PROJECT has developed robust monitoring and evaluation tools to quantitatively and qualitatively assess the performance of logistics systems for essential health commodities. The purpose of this paper is to explore how analysis of stock indicators by location provides added value to these data sets, through a relatively minor investment in GPS devices and GIS software. Beginning with visual examination of logistics indicator data within a geographic context and progressing to network analysis, each of the spatial analysis methods presented in this paper presents its own set of strengths and weaknesses, yet they all excel in providing insights into the logistics system that might not otherwise be understood or even observed by simply looking at tabular data of stock levels for different facilities in the health system. Since a logistics system is inherently a geographically heterogeneous entity, using cartographic and spatial analysis tools may prove to be a crucial asset in assisting managers to identify key questions related to the performance of the logistics system and focus on potential causes and solutions. Moving forward, it will be useful to build off of the descriptive strengths of the spatial analysis methods described herein and begin building more robust statistical models that measure correlation between different components of the logistics system and commodity availability, while still accounting for the geographical variability of the data. (Excerpts)
Language: English
Keywords:
ZAMBIA | PARAGUAY | SUMMARY REPORT | PILOT PROJECTS | DATA COLLECTION | DATA ANALYSIS | USAID | LOGISTICS | GEOGRAPHY | INFORMATION RETRIEVAL SYSTEMS | DISTANCE | STREETS AND ROADS | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | South America, Central | South America | Latin America | Americas | Studies | Research Methodology | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Management | Organization and Administration | Social Sciences | Science | Data Storage and Retrieval | Information Processing | Information | Geographic Factors | Population | Transportation | Economic Factors
Document Number: 331660

10.

11.

Title: Voluntary population planning activities -- supplemental requirements (January 2009) [letter]
Author: United States. Agency for International Development [USAID]. Bureau for Management. Office of Acquisition and Assistance
Source: Washington, D.C., USAID, Bureau for Management, Office of Acquisition and Assistance, 2009 Jan 26. [5] p.
Abstract: The purpose of this letter is to amend the Standard provisions of all grants and cooperative agreements involving any aspect of voluntary population planning activities and which contain the provision VOLUNTARY POPULATION PLANNING ACTIVITIES - SUPPLEMENTAL REQUIREMENTS (May 2006). This provision is deleted and replaced by the new provision VOLUNTARY POPULATION PLANNING ACTIVITIES - SUPPLEMENTAL REQUIREMENTS (January 2009) which removes the conditions relating to the Mexico City Policy that were set forth in the May 2006 version of the provision. (Excerpt)
Language: English
Keywords:
DEVELOPING COUNTRIES | GOVERNMENT PUBLICATION | RECOMMENDATIONS | EVALUATION | POLICYMAKERS | USAID | STANDARDIZATION | GRANTS | POPULATION POLICY | FAMILY PLANNING PROGRAM EVALUATION | INCENTIVES | FAMILY PLANNING POLICY | CONTRACEPTIVE AGENTS | ABORTION LAW | STERILIZATION, SEXUAL | Administrative Personnel | Organization and Administration | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Data Adjustment | Research Methodology | Financial Activities | Economic Factors | Social Policy | Policy | Family Planning Programs | Family Planning | Contraception | Fertility Control, Postconception
Document Number: 331346 Notification

12.

Title: WHO / USAID / FHI Technical Consultation: Expanding Access to Injectable Contraception, 15-17 June 2009, Room M405, WHO, Geneva.
Author: World Health Organization [WHO]; United States. Agency for International Development [USAID]; Family Health International [FHI]
Source: [Unpublished] 2009. 5 p.
Abstract: The agenda for the consultation is presented. The objectives of the consultation were: To review systematically the evidence and programmatic experience on interventions designed to expand access to / provision of contraceptive injectables, focusing on non clinic-based services and programs; To reach conclusions on issues: (a) for which evidence is consistent and strong; (b) for which evidence is mixed; and (c) for which evidence is marginal or entirely lacking and, thus requires additional research; To document discussions and conclusions of the Consultation, including policy and program implications, and to disseminate these widely.
Language: English
Keywords:
GLOBAL | TABLES AND CHARTS | CONFERENCES AND CONGRESSES | WHO | USAID | INJECTABLES | CONTRACEPTIVE AVAILABILITY | INTERVENTIONS | NEEDS | COMMUNITY-BASED DISTRIBUTION | CONTRACEPTION CONTINUATION | UN | International Agencies | Organizations | Political Factors | Sociocultural Factors | Government Agencies | Contraceptive Methods | Contraception | Family Planning | Programs | Organization and Administration | Economic Factors | Nonclinical Distribution | Distributional Activities | Program Activities | Contraceptive Usage
Document Number: 331853

13.

Title: Zambia: National long term forecasting and quantification for family planning commodities, 2009-2015.
Author: Bwembya M; Mbewe RK
Source: Arlington, Virginia, John Snow [JSI], DELIVER, 2009. 23 p. (USAID Contract No. GPO-I-01-06-00007-00)
Abstract: In December 2008, the Ministry of Health (MOH) and the Society for Family Health (SFH), with technical assistance from the USAID | DELIVER PROJECT, conducted a national long term quantification of contraceptive needs from 2009 -2015. The quantification's overall objective was to calculate the contraceptive requirements for each year of the forecast period and to use those requirements to mobilize resources for the country to support contraceptive commodity security. This report presents the findings of the quantification as well as the methodology used and assumptions made to arrive at these findings.
Language: English
Keywords:
ZAMBIA | SUMMARY REPORT | RESEARCH METHODOLOGY | TECHNICAL ASSISTANCE | USAID | NEEDS ASSESSMENT | CONTRACEPTIVE PREVALENCE | CONTRACEPTIVE SECURITY | COLD CHAIN | LOGISTICS | FUNDS | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Programs | Organization and Administration | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Evaluation | Contraceptive Usage | Contraception | Family Planning | Contraceptive Availability | Management | Financial Activities | Economic Factors
Document Number: 331474

14.

Title: Guinea. Village health committees drive family planning uptake: communities play lead role in increased acceptability, availability.
Author: Diakite O; Keita DR; Mwebesa W
Source: Washington, D.C., Core Group, [2009]. 8 p.
Abstract: This document highlights the Village Health Committee (VHC), a vital player in the child survival project and the integration of family planning work within Save the Children's portfolio in Guinea. The document briefly describes the committee's purpose, membership, and tasks. It focuses on a handful of the people and activities that exemplified the VHCs' unique role in ensuring that family planning was not only accessible but acceptable to the villagers they served. The document concludes with some outcomes of Save the Children's family planning component in Mandiana and Kouroussa. In effect, the VHCs' stellar success in building demand for contraception (when coupled with modest investments in existing health workers' ability to supply modern methods) resulted in a sustained increase in the use of contraception in the project zone.
Language: English
Keywords:
GUINEA | PROGRESS REPORT | EVALUATION | COMMUNITY | RURAL POPULATION | USAID | COMMUNITY HEALTH SERVICES | DELIVERY OF HEALTH CARE | PROGRAM ACCESSIBILITY | QUALITY OF HEALTH CARE | PERFORMANCE IMPROVEMENT | RURAL HEALTH SERVICES | FAMILY PLANNING | HEALTH SERVICES EVALUATION | PROGRAM ACCEPTABILITY | Developing Countries | Africa, Western | Africa, Sub Saharan | Africa | Residence Characteristics | Population Distribution | Geographic Factors | Population | Population Characteristics | Demographic Factors | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Primary Health Care | Health Services | Health | Program Evaluation | Programs | Organization and Administration | Management
Document Number: 325193

15.

Subscription may be needed for full text

Peer Reviewed

Title: International family-planning budgets in the "new US" era.
Author: Gillespie D; Maguire ES; Neuse M; Sinding SW; Speidel JJ
Source: Lancet. 2009 May 2;373(9674):1505-7.
Abstract: Anticipating major shifts in the political complexion of Washington as a result of the 2008 Presidential election, we, as five former directors of the US Agency for International Development's (USAID) population and reproductive health programme, recently issued a report as part of an effort to increase USAID's stagnant family-planning budget. Our evidence-based report, Making the case for international family planning, recommends an increase from the present level of US$457 million to $1.2 billion in 2010, with modest further annual increases thereafter. With dramatic political shift in Washington, we are optimistic that our message will resonate well in the new policy environment. We have no illusions about the treacherous political terrain of reproductive health in the USA. However, we are much encouraged by President Obama's commitment to bring science back into the service of public policy, his efforts to find common ground in the national debate about abortion, and his and Secretary of State Hillary Clinton's determination to make international development cooperation and women's rights far more prominent features of US foreign policy. (excerpt)
Language: English
Keywords:
UNITED STATES OF AMERICA | CRITIQUE | USAID | FAMILY PLANNING | FINANCIAL ACTIVITIES | POLITICAL FACTORS | HEALTH POLICY | REPRODUCTIVE HEALTH | SOCIAL SCIENCES | FAMILY PLANNING PROGRAMS | PROGRAM EFFECTIVENESS | Developed Countries | North America | Americas | Government Agencies | Organizations | Sociocultural Factors | Economic Factors | Policy | Health | Science | Program Evaluation | Programs | Organization and Administration
Document Number: 341020

16.

Title: Extended cycling or continuous use of hormonal contraceptives for female adolescents.
Author: Gold MA; Duffy K
Source: Current Opinion In Obstetrics and Gynecology. 2009 Jun 12;
Abstract: PURPOSE OF REVIEW: The purpose of this review is to present the most recent data on extended cycling and continuous use of hormonal contraception for female adolescents. RECENT FINDINGS: Since 2003, several new products have been US Food and Drug Administration approved to provide extended cycling or continuous use of hormonal contraception. Clinical trials have been conducted with adult women of 18 years and older and not with adolescents under age of 18 years. Studies find successful menstrual suppression using extended cycling and continuous-use regimens that are safe and effective without negative effects on the endometrium or hemostasis. Extended cycling and continuous use improves menstrual symptoms attributed to the hormone-free interval in traditional cyclic regimens. Adolescent health providers report prescribing extended cycles of contraception with increasing frequency to adolescents. It is unknown how well female adolescents tolerate breakthrough bleeding, but data suggest that bleeding is the main reason for discontinuing. Supplementation with intermittent estrogen or instituting a 4-day hormone-free interval in response to persistent bleeding may decrease this side effect; adolescents should be counseled about these options. SUMMARY: Extended cycling or continuous use of hormonal contraception offers adolescents an opportunity to decrease, delay or suppress monthly menstruation for health or personal reasons.
Language: English
Keywords:
UNITED STATES OF AMERICA | CRITIQUE | ADOLESCENTS, FEMALE | CONTRACEPTIVE METHODS | HORMONES | ADMINISTRATION AND DOSAGE | MENSTRUATION | PRODUCT APPROVAL | USFDA | COUNSELING | CONTRACEPTIVE SAFETY | CONTRACEPTIVE AGENTS, SIDE EFFECTS | Developed Countries | North America | Americas | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Contraception | Family Planning | Endocrine System | Physiology | Biology | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Reproduction | Legislation | Political Factors | Sociocultural Factors | USPHS | Government Agencies | Organizations | Clinic Activities | Program Activities | Programs | Organization and Administration | Safety | Public Health | Contraceptive Agents
Document Number: 341708

17.

19.

Title: Confronting the legal risks of prescribing the contraceptive patch with ongoing litigation [letter]
Author: Patsner B
Source: Obstetrics and Gynecology. 2009 Jun;113(6):1367.
Abstract: The valuable commentary by Drs. Phelps and Kelver on potential liability issues for physicians prescribing the Ortho-Evra (norelgestromin/ethinyl estradiol [E2]), Ortho Women's Health & Urology, Raritan, NJ) contraceptive patch1 provides a much-needed start, but only one perspective, on this important and ongoing clinical practice issue. As a food and drug law attorney as well as a former Senior Medical Officer in the Division at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), which handled the original approval of the contraceptive patch as well the ensuing controversy, I would like to provide additional information and a different perspective. None of the major verdicts on the contraceptive patch litigation are in yet. There is likely to be more information, some potentially negative, forthcoming on both FDA and sponsor conduct. There was a great deal of controversy within the FDA itself over whether the controversy was handled correctly, whether the original new drug application should have been approved, how the original data and the data corrections on pharmacokinetics and adverse events were reviewed and rereviewed, whether there was an attempt at "information control" of either FDA errors or unfavorable information about the product, and significant internal disagreements over the general lack of timely cooperation by the FDA with organizations such as the American College of Obstetricians and Gynecologists when the latter urgently requested guidance for its member physicians. The two studies quoted by the authors clearly do not provide a sufficient basis for their claim that "the transdermal patch may be the best choice for many patients who prefer the convenience of a weekly patch." Citing the higher incidence of venous thromboembolism in pregnancy as a possible defense to claims concerning the incidence for the contraceptive patch is largely irrelevant because the comparison in any malpractice action will be with oral contraceptives, not pregnancy.Physicians should be aware that even the best informed consent likely will provide little or no shield if they are sued in a medical malpractice action for prescribing the patch and that significant safety concerns remain for this product, particularly because it has been difficult to predict which women are at greatest risk for early embolic events. Absent an overwhelming reason for prescribing the contraceptive patch, I personally think ob-gyns should steer clear of the product. More importantly, it would have been more instructive for the authors to go to the original new drug application itself (readily accessed although the Center for Drug Evaluation and Research Web site at www.cder.fda.gov) to discuss the original safety data as well as why the approval decision was made, rather than just citing the labeling update or an FDA "Talk Paper." Even a cursory perusal of the original new drug application2 reveals many pages discussing concerns about the potentially higher risk of venous thromboembolism for this product. Because there are no firm FDA "rules" for determining the outcome of the risk-benefit calculus for any new prescription drug product, and because the patch not only did not work "better" than existing oral contraceptives but also had a potentially greater risk, the justification for approving the product was largely because it was a novel delivery system. The fact is that the FDA can and does approve new drug products that are less effective or more dangerous than existing drug products already on the market. All practicing physicians should be aware of this. When drug safety is less of an FDA priority than getting new products to market (as was the case under the Bush administration), the risks to patients will be greater. When the FDA does its job poorly, regulation of big pharma depressingly comes down to the plaintiffs' bar. (full-text)
Language: English
Keywords:
UNITED STATES OF AMERICA | TEXAS | CRITIQUE | USFDA | PRESCRIPTIONS | ETHINYL ESTRADIOL | DRUGS | CONTRACEPTION | PRODUCT APPROVAL | Developed Countries | North America | Americas | USPHS | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Distributional Activities | Program Activities | Programs | Organization and Administration | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Family Planning | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Legislation
Document Number: 341194

20.

Peer Reviewed

Title: Confronting the legal risks of prescribing the contraceptive patch with ongoing litigation.
Author: Phelps JY; Kelver ME
Source: Obstetrics and Gynecology. 2009 Mar;113(3):712-6.
Abstract: Recent changes in U.S. Food and Drug Administration (FDA) labeling and news reports of lawsuits resulting in million-dollar settlements understandably may deter gynecologists from prescribing the transdermal contraceptive patch Ortho Evra (Ortho-McNeil Pharmaceutical, Inc., Titusville, NJ). Gynecologists who, with all good intentions, prescribe an FDA-approved drug such as the contraceptive patch potentially could find themselves liable for an adverse drug reaction. Although much of the current focus by plaintiff attorneys and the news media is on the contraceptive patch, no prescription contraceptive method is without medical risks to the patient or legal risks to the prescribing gynecologist. The purpose of this commentary is to provide an overview of the medical-legal controversies and pitfalls in prescribing the contraceptive patch as well as to outline how gynecologists can avert legal liability by providing proper informed consent. Despite FDA labeling changes and ongoing litigation, with proper informed consent, the contraceptive patch still may be the best choice for many patients who prefer the convenience of a weekly patch over a daily oral contraceptive. Also, regardless of the contraceptive option chosen, the principles of providing and documenting proper informed consent in medical records are applicable not only to providing quality care to patients, but also to protecting the legal interests of the prescribing gynecologist. By documenting proper informed consent in medical records, gynecologists should feel more at ease in prescribing the contraceptive method that best fits their individual patients' needs, even in the presence of ongoing litigation.
Language: English
Keywords:
UNITED STATES OF AMERICA | CRITIQUE | RECOMMENDATIONS | EVALUATION | PHYSICIANS | LITIGATION | RISK ASSESSMENT | PRESCRIPTIONS | CONTRACEPTIVE AGENTS, FEMALE | ADMINISTRATION AND DOSAGE | USFDA | SIDE EFFECTS | INFORMED CONSENT | RECORDS | Developed Countries | North America | Americas | Health Personnel | Delivery of Health Care | Health | Political Factors | Sociocultural Factors | Distributional Activities | Program Activities | Programs | Organization and Administration | Contraceptive Agents | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | USPHS | Government Agencies | Organizations | Information Processing | Information
Document Number: 330700

21.

Peer Reviewed

Title: Confronting the legal risks of prescribing the contraceptive patch with ongoing litigation.
Author: Phelps JY; Kelver ME
Source: Obstetrics and Gynecology. 2009 Jun;113(6):1367-8.
Abstract: As former Senior Medical Officer in the Division at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), which handled the original approval for Ortho Evra (norelgestromin/ethinyl estradiol [E2], Ortho Women's Health & Urology, Raritan, NJ), Dr. Patsner's insider perspective is informative and a worthwhile contribution. However, we respectfully disagree with his comments that "physicians should be aware that even the best informed consent likely will provide little or no shield if they are sued in a medical malpractice action for prescribing the patch . . ." and that ". . . ob-gyns should steer clear of the product." We stand firm that providing proper informed consent is critical not only to providing quality patient care but also to deterring potential lawsuits against physicians prescribing the contraceptive patch. Additionally, despite litigation, we believe that the contraceptive patch should remain an option for many patients. The two primary causes of action that plaintiff attorneys may pursue against physicians prescribing the contraceptive patch are 1) medical negligence for breaching the standard of care by prescribing the contraceptive patch and 2) failure to provide informed consent by not warning patients of the risks of the contraceptive patch. As long as the contraceptive patch remains U.S. Food and Drug Administration-approved, it will be difficult for plaintiff attorneys to prevail in arguing that a physician breached the standard of care by prescribing the contraceptive patch, unless it was prescribed to a patient with a known contraindication to the contraceptive patch. The vast majority of patients seeking birth control do not have known medical contraindications to the contraceptive patch. The best way to negate the other potential cause of action-failure to provide informed consent-is to provide and document informed consent in the medical records. Once informed consent is documented in the medical records, there is the legal presumption in favor of the physician that the medical records are accurate and that the patient was provided proper informed consent. However, this is a rebuttable presumption, and an injured patient will be given the opportunity to dispute that she was not properly informed of the risks and that she would not have chosen the contraceptive patch as a means of contraception if she had been properly informed of the risks. Nevertheless, the legal presumption remains that the information documented in the medical records is accurate. By documenting proper informed consent in the medical records, physicians should be more comfortable in prescribing the contraceptive method they believe best fits the needs of their patients, regardless of ongoing litigation and controversies surrounding a contraceptive product. (full-text)
Language: English
Keywords:
UNITED STATES OF AMERICA | TEXAS | CRITIQUE | USFDA | PHYSICIANS | PRESCRIPTIONS | CONTRACEPTION | PRODUCT APPROVAL | INFORMED CONSENT | Developed Countries | North America | Americas | USPHS | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Health Personnel | Delivery of Health Care | Health | Distributional Activities | Program Activities | Programs | Organization and Administration | Family Planning | Legislation | Health Services
Document Number: 341195

22.

Title: Making the case for U.S. international family planning assistance.
Author: Speidel JJ; Sinding S; Gillespie D; Maguire E; Neuse M
Source: [Chapel Hill, North Carolina, Ipas], 2009 Jan. 15 p. (Report)
Abstract: This report documents the urgent need for greater U.S. assistance to family planning programs in the developing world and recommends targeted investment in such programs, primarily through the U.S. Agency for International Development. Five former directors of the Population and Reproductive Health Program of the United States Agency for International Development (USAID) issue a call for renewed U.S. political and financial commitment to international family planning programs. USAID has been the largest donor to international population and family planning efforts and a transformative source of leadership and innovation in the field. Its professional staff and technical resources are unparalleled among donor agencies. However, its funding peaked in 1995 and has declined in real terms ever since, even as the worldwide demand for family planning and other reproductive health services has grown. As a result, many successful programs in developing countries have stagnated and global fertility decline has slowed. At the beginning of a new administration and a new Congress, it is time to reverse the decline in U.S. political and financial commitment to this field of signature U.S. leadership and accomplishment, to satisfy the unmet need for services, and to improve women's reproductive health worldwide. We estimate that USAID's population budget should be increased to $1.2 billion. (Excerpts)
Language: English
Keywords:
UNITED STATES OF AMERICA | DEVELOPING COUNTRIES | RECOMMENDATIONS | EVALUATION REPORT | EVALUATION | POLICYMAKERS | FAMILY PLANNING | FOREIGN AID | USAID | REPRODUCTIVE HEALTH | FAMILY PLANNING POLICY | POPULATION POLICY | GOVERNMENT PROGRAMS | GOVERNMENT FINANCING | Developed Countries | North America | Americas | Administrative Personnel | Organization and Administration | Financial Activities | Economic Factors | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Health | Social Policy | Policy | Programs
Document Number: 331360

23.

Title: Transporting, storing, and handling malaria rapid diagnostic tests at central and peripheral storage facilities.
Author: World Health Organization [WHO], Regional Office for the Western Pacific; John Snow [JSI]. DELIVER; Foundation for Innovative New Diagnostics [FIND]; Roll Back Malaria Partnership; United States. President's Malaria Initiative
Source: Arlington, Virginia, John Snow [JSI], DELIVER, 2009 Jul. [35] p. (USAID Contract No. GPO-I-03-06-00007-00)
Abstract: The publication is intended for staff at central and peripheral storage facilities that use malaria rapid diagnostic tests (RDTs). It describes the basic principles for management and storage of RDT stock, and it outlines practical solutions for protecting RDTs against high temperatures during storage and transport. It also describes how to manage waste generated from RDT use.
Language: English
Keywords:
DEVELOPING COUNTRIES | SUMMARY REPORT | MANUAL | TECHNICAL ASSISTANCE | USAID | MALARIA PREVENTION | TREATMENT | ANTIMALARIAL DRUGS | IMPLEMENTATION | LOGISTICS | PHARMACY DISTRIBUTION | SAFETY | QUALITY CONTROL | TESTING | EXAMINATIONS AND DIAGNOSES | PROGRAM ACTIVITIES | Programs | Organization and Administration | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Malaria | Parasitic Diseases | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Management | Nonclinical Distribution | Distributional Activities | Public Health | Measurement | Research Methodology
Document Number: 331476

24.

Title: Private Sector Mobilization for Family Health (PRISM). Year 4 annual report, 1 October 2007 to 30 September 2008. Contract No. 492-C-00-04-0036-00.
Author: Chemonics International
Source: [Manila], Philippines, Chemonics International, 2008 Nov 15. 81 p. (USAID Contract No. 492-C-00-04-0036-00)
Abstract: The Private Sector Mobilization for Family Health (PRISM) project successfully completed the fourth of its five years with most targets accomplished and many activities yielding valuable lessons and new capacities for increasing private sector responses to meeting family health needs of Filipinos. PRISM has generated results from engaging the private sector to take advantage of commercial opportunities in providing family health goods and services to the market through the following: Workplace-based family health services at 500 companies and cooperatives, 365 of which have signed letters of commitment; Commercial sales of four low-priced contraceptives by pharmaceutical companies; Community-based health services of 213 private-practice midwives; Synergistic combinations of these three elements (workplace programs, commercial pharmaceutical market, midwives in private practice (PPMs)) in 33 provinces and cities. (Excerpt)
Language: English
Keywords:
PHILIPPINES | ANNUAL REPORT | USAID | SOCIAL MOBILIZATION | PRIVATE SECTOR | PRIMARY HEALTH CARE | HEALTH SERVICES | NEEDS | CONTRACEPTIVE PREVALENCE | CONTRACEPTIVE USAGE | COUNSELING | REPRODUCTIVE HEALTH | FAMILY PLANNING | WORKPLACE | MATERNAL-CHILD HEALTH SERVICES | CHILD HEALTH | FUNDS | PROGRAM DEVELOPMENT | Developing Countries | Asia, Southeastern | Asia | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Social Change | Macroeconomic Factors | Economic Factors | Delivery of Health Care | Health | Contraception | Clinic Activities | Program Activities | Programs | Organization and Administration | Employment | Financial Activities
Document Number: 331438

25.

Title: Analysis of the operational policy barriers to financing and procuring contraceptives in Malawi.
Author: Constella Futures. Health Policy Initiative; John Snow [JSI]. DELIVER
Source: Washington, D.C., Health Policy Initiative, Constella Futures, 2008 Jun. :viii, 23 p.. viii, 23 p. (USAID Contract No. GPO-I-01-05-00040-00USAID Contract No. GPO-I-01-06-00007-00)
Abstract: Contraceptive security exists when every person can choose, obtain, and use high-quality contraceptives whenever they need them. Two of the most important factors in achieving contraceptive security are adequate financing and efficient contraceptive procurement mechanisms. The USAID | Health Policy Initiative and USAID | DELIVER Project are working together to develop a methodology for identifying operational policy barriers in the financing and procurement of family planning (FP) products. The goal is to help national governments, donors, and other key stakeholders improve the policy environment for contraceptive security. This report presents the findings from a pilot study the two projects conducted in Malawi to test this methodology.
Language: English
Keywords:
MALAWI | METHODOLOGICAL STUDIES | OPERATIONS RESEARCH | PILOT PROJECTS | DEMOGRAPHIC AND HEALTH SURVEYS | PRIVATE SECTOR | USAID | GOVERNMENT FINANCING | FINANCIAL ACTIVITIES | CONTRACEPTIVE AVAILABILITY | EQUIPMENT AND SUPPLIES | LOGISTICS | CONTRACEPTIVE PREVALENCE | DECENTRALIZATION | CAPACITY BUILDING | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Program Evaluation | Programs | Organization and Administration | Research Methodology | Studies | Demographic Surveys | Population Dynamics | Demographic Factors | Population | Macroeconomic Factors | Economic Factors | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Contraception | Family Planning | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Management | Contraceptive Usage | Program Sustainability
Document Number: 308944

26.

Title: Sakhi Saheli -- promoting gender equity and empowering young women: a training manual.
Author: CORO for Literacy; Population Council. Horizons
Source: New Delhi, India, Population Council, 2008. [130] p. (USAID Cooperative Agreement No. HRN-A-000-97-00012-00)
Abstract: The Sakhi Saheli program was adapted from Instituto Promundo's Program M by CORO and Horizons/ Population Council as part of a larger research study aimed at reducing HIV risk among young men and women by addressing gender norms. In earlier phases of the study, the Yaari Dosti program with young men was piloted and evaluated leading to the work with young women in the last phase by piloting the Sakhi Saheli program. At the start of the Sakhi Saheli program, CORO and Horizons undertook qualitative research to explore young women's construction and expression of femininity and masculinity in two urban slum communities in Mumbai. A team of peer leaders from CORO was intensively trained in data collection methods to undertake social mapping, in-depth interviews and group discussions with girls and women aged 16-24 years and key informants such as parents, community elders and teachers. The peer leaders were engaged in interpreting and analysing research findings, under the guidance of the researchers. This training manual was prepared through a two-year-long participatory process undertaken in Mumbai, India. Young women were engaged as leaders in the design and implementation of program activities, which were subsequently validated through community-based research in selected urban slum communities in India. This manual aims to promote critical reflection on the social construction of gender that promotes inequality and women's vulnerabilities, and to create support for challenging these norms so as to enhance women's adoption of risk reduction practices. The manual is aimed at peer educators, community and health educators, teachers and/or other professionals working, with young women aged 16 to 24 years. Each section includes a series of educational activities based on participatory methods including role plays, games and interactive activities aimed at engaging young women in discussion, debate and critical thinking. (excerpt)
Language: English
Keywords:
DEVELOPING COUNTRIES | MANUAL | EVALUATION | WOMEN IN DEVELOPMENT | ADOLESCENTS, FEMALE | GENDER ISSUES | WOMEN'S EMPOWERMENT | MOTHERS | INEQUALITIES | USAID | PERSONHOOD | SEX DISCRIMINATION | SEX EDUCATION | HEALTH EDUCATION | DOMESTIC VIOLENCE | Economic Development | Economic Factors | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Sociocultural Factors | Women's Status | Socioeconomic Factors | Parents | Family Relationships | Family Characteristics | Family and Household | Government Agencies | Organizations | Political Factors | Human Rights | Social Discrimination | Social Problems | Education | Crime
Document Number: 326011

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