posted
Morning-after pill sales jump as U.S. access eases By Lisa Richwine
Fri Aug 24, 2:24 PM ET
WASHINGTON (Reuters) - Sales of the Plan B "morning-after pill" nearly doubled in the past year, exceeding expectations after the U.S. government allowed adults to buy the emergency contraceptive without a prescription.
A three-year battle ended last August when the Food and Drug Administration decided that women and men 18 and older could buy the Barr Pharmaceuticals Inc product without a doctor's order if they showed proof of age at a pharmacy .
"More women know about it, and it's just becoming much more part of their mainstream reproductive health care," Planned Parenthood President Cecile Richards said.
Plan B pills contain higher doses of progestin, a hormone used in prescription birth-control pills for 35 years. Two Plan B pills reduce odds of pregnancy by 89 percent if taken within 72 hours of sexual intercourse, studies show.
Plan B sales hit about $40 million a year when the product required a prescription for all women. Industry analysts and Barr projected nonprescription access for adults, approved in August 2006, could boost sales to about $60 million in 2007.
The popularity of Plan B has exceeded those estimates.
Barr launched the nonprescription version last November, and the company predicts 2007 sales will reach about $80 million.
"We believe (sales) will continue to grow," Barr spokeswoman Carol Cox said.
Opponents of wider access say that is exactly what they had feared. Conservative and religious groups argued that easy availability would promote promiscuity and sexually transmitted diseases among teens and others.
Wendy Wright, president of Concerned Women for America, a group that opposed Plan B sales without a doctor's order, said minors may be obtaining it without a prescription or some women may be using it more than once.
"The high sales may indicate that our concerns are occurring," Wright said.
Some organizations want states to effectively limit Plan B access, but those efforts largely have failed to advance.
Family-planning groups say some women have reported trouble getting Plan B, with some pharmacists declining to dispense it or stores refusing to carry it.
Genevieve DeLucchi, 26, of North Carolina, said the first two pharmacies she visited last year did not have it in stock. She was able to buy it at a third.
After that, DeLucchi became a volunteer shopper for Planned Parenthood to gauge availability at stores. At some pharmacies she found "a lot of them had it, but they didn't know what to tell" customers about how to use it, or seemed reluctant to discuss it.
Barr and other backers want the age limit for non-prescription sales removed. Legal challenges on both sides are pending.
The Center for Reproductive Rights said a judge in New York may rule anytime on its argument that the FDA's decision-making was flawed and Plan B should be available without a prescription to women of all ages.
Concerned Women for America and other groups challenged the FDA decision last April in federal court in the District of Columbia. They want a doctor's order for all sales.
I couldn't believe my eyes when reading this article. This is a very poor decision made in the US. Abortion should be 100 % controlled and the last option when becoming pregnant IMO. Posts: 30135 | From: The owner of this website killed ES....... | Registered: Feb 2004
| IP: Logged |
posted
It's not abortion. It prevents pregnancy; it doesn't end it.
Posts: 8794 | From: 01-20-09 The End of an Error | Registered: Dec 2004
| IP: Logged |
posted
It depends how you describe pregnancy. Islamically, this is considered to be an abortion as it stops a fertilized egg - which is the beginning of human life - from implanting in the womb. That is also why certain types of IUDs are not permitted, because they have the same action. If they stop the egg from being fertilized that is different.
Posts: 4576 | From: Cairo | Registered: Jun 2002
| IP: Logged |
posted
A woman is fertile couple of days each month. If she knows that she is not fertile during the period she's having sexual intercourse why then taking this kind of pill? Just to make sure not to have to deal with a possible pregnancy?!
Use a condom to prevent a pregnancy which also protects you from a possible STD!
Posts: 30135 | From: The owner of this website killed ES....... | Registered: Feb 2004
| IP: Logged |
posted
The pill supposedly works to either prevent ovulation, and if not, then prevent fertilization. And some believe it might prevent implantation. It's not like the abortion pill that rips an embryo from the uterine wall.
Why would they use it? What if the condom breaks? What if they were raped? What if (more likely what's happening) they had a casual hook up the night before (perhaps after drinking?) that they seriously regretted the next morning?
Posts: 8794 | From: 01-20-09 The End of an Error | Registered: Dec 2004
| IP: Logged |
quote:Originally posted by Om Bubblemouth: they had a casual hook up the night before (perhaps after drinking?) that they seriously regretted the next morning?
Well there must be a lot of casual hook-ups going on inside the US because sales are expected for 2007 to double increase!
So, Snoozin, hope you have an answer for the following. If a woman is already pregnant and doesn't know it and she takes this pill once or more - what do you think what will happen?
Seriously it's ridiculous that anyone over 18 can buy that pill over the counter. It encourages premarital sponteneous sex and don't think that only people over the age of 18 taking that stuff!
How can FDA approve that? To reduce teen pregnancies which are widely apparent in the US?
Posts: 30135 | From: The owner of this website killed ES....... | Registered: Feb 2004
| IP: Logged |
So, Snoozin, hope you have an answer for the following. If a woman is already pregnant and doesn't know it and she takes this pill once or more - what do you think what will happen?
I have no clue. According to the medical sites, it doesn't do anything to an implanted embryo. I would suppose it's about the same as continuing to take birth control pills while pregnant, which happens quite often.
Posts: 8794 | From: 01-20-09 The End of an Error | Registered: Dec 2004
| IP: Logged |
Many women were regulars despite having been educated.
To me, that sounds like the women are leading desperate lives. Emotional turmoil, substance abuse, relationship dysfunction, financial troubles, what-have-you.
Posts: 8794 | From: 01-20-09 The End of an Error | Registered: Dec 2004
| IP: Logged |
posted
ah well "Drug therapies are replacing a lot of medicines as we used to know it". GW
Posts: 1499 | From: Dark Side of the Moon | Registered: Aug 2007
| IP: Logged |
posted
The decision by the US Food and Drug Administration (FDA) in August 2006 to approve the emergency contraceptive Plan B (levonorgestrel 0.75 mg oral tablets) for over-the-counter (OTC) sale to consumers 18 years of age or older, while continuing to limit its use for women 17 years of age and younger by prescription, makes Plan B the first product to be marketed in the United States with a dual status.1,2 Oral emergency contraceptives, sometimes referred to as the "morning after pill," use the same hormones found in regular birth control pills to prevent pregnancy after intercourse. Plan B is a safe and effective product for preventing pregnancy when a contraceptive method has failed or was not used during intercourse. In the US, approximately one-half of all pregnancies occurring each year are unintended and more than 50% of these unintended pregnancies are terminated by elective abortion.3 When taken within 72 hours of unprotected intercourse, Plan B reduces the risk of pregnancy by 89%.4 It has been estimated that the use of emergency contraception (EC) could reduce the rate of unintended pregnancy in the US by as much as 50%.3
The dual status of Plan B places this product behind pharmacy counters where pharmacists, as the "most accessible" health care providers, have an opportunity to play a crucial role in providing advice and information when consumers have questions about EC. OTC sale to consumers 18 years of age and older will improve access to EC by removing the delay associated with obtaining a prescription for this time-sensitive medication, thereby increasing the utilization of this safe and reliable method for preventing an unplanned pregnancy.
PHARMACOLOGY
History of the Clinical Development of EC
The use of levonorgestrel for EC has been extensively studied worldwide since the 1970s. With more than three decades of use, the high degree of safety and the effectiveness of the method in preventing pregnancy (up to 89% reduction in pregnancy) are well documented.4-7 In 1997, the FDA published an announcement in the Federal Register describing EC or "postcoital contraception" as an important strategy to address the public health crisis of unintended pregnancy in the US. The FDA announcement invited the pharmaceutical industry to apply for approval of EC products.8
As a result, two prescription products were approved for EC: Preven (ethinyl estradiol 0.05 mg/levonorgestrel 0.25 mg tablets) in 1998 and Plan B in 1999. Both were approved for use within 72 hours of unprotected intercourse. The use of commercially available oral contraceptives containing ethinyl estradiol with either norgestrel or levonorgestrel (often referred to as the Yuzpe Regimen) has also been studied. The manufacturer stopped producing Preven in 2004, leaving Plan B as the only FDA-approved product for EC in the US. Unfortunately, lack of public awareness, misconceptions about how EC works, and barriers to timely access limited its use.
In 2003, the manufacturer of Plan B applied for OTC approval. To convert a product from prescription status to OTC, the FDA usually requires five years of prescription use of the product that demonstrate a high degree of safety and studies that establish consumers can interpret labeled instructions correctly and use the product correctly under OTC-like conditions. The FDA Advisory Committees on Reproductive Health Drugs and Nonprescription Drugs voted overwhelmingly on December 16, 2003, to support the manufacturer's request for nonprescription status.9
Mechanism of Action
Levonorgestrel, the only active ingredient in Plan B, is a common progestin found in a variety of hormonal contraceptives. The mechanisms by which Plan B prevents pregnancy are thought to be similar to those of other hormonal contraceptives. All currently available hormonal methods of contraception have been shown to act by the following mechanisms: altering the endometrial lining, altering the cervical mucous, interfering with fertilization or transport of an egg, or preventing implantation. There is good evidence that Plan B prevents or delays ovulation as a primary mechanism of action; however, the product works when taken throughout the menstrual cycle, which means that additional mechanisms may be involved.10-13 The contraceptive activity of Plan B can be fully explained by mechanisms of action that do not involve postfertilization effects.14
A number of recent publications have shed light on the mechanisms of action for Plan B.10-13 One such mechanism may be changing the pH of the uterine cavity, which significantly decreases the number of viable sperm. While this process takes several hours, so does the process by which a sperm is made capable of fertilizing ova--a process known as sperm capacitation. Plan B has also been shown to thicken cervical mucous, thus inhibiting sperm transport.
Luteinizing hormone (LH) is also critical to the fertilization process. A properly timed and sufficient surge of LH allows the release of a fertilizable ovum in the process we know as ovulation and the surge supports a number of other processes that must take place for fertilization to be possible. When Plan B is taken prior to a woman's mid-menstrual cycle LH surge, the surge may be suppressed completely. When Plan B is taken closer to the time of the LH surge, it may partially suppress the surge and the resulting ova may be resistant to fertilization. If taken later in the cycle, there may be no more of an effect on the LH surge than with a placebo and fertilization may then occur, leading to a pregnancy. Knowledge of these time-sensitive events helps to explain why taking Plan B as soon as possible after unprotected sex is important.
Studies of Plan B's effects on endometrial function have not shown changes that would prevent the implantation of a fertilized ovum.12 Women who have used Plan B to prevent a pregnancy early in their menstrual cycle are at risk for pregnancy later in the same cycle if contraception is not used or fails again. This indicates that the endometrium is still intact and capable of implanting a fertilized ovum.
Since fertilization occurs in the fallopian tubes, it has been speculated that Plan B could slow the movement of a fertilized egg, which may result in an increased risk for ectopic pregnancy. Studies have not shown this effect, and in fact have shown the risk of an ectopic pregnancy after the use of Plan B is actually slightly lower than national ectopic pregnancy rates.15
The International Consortium for Emergency Contraception, in a 2003 Policy Statement on the mechanism of action, reported EC pills inhibit, delay, or interfere with ovulation and may interfere with fertilization or implantation, although there are no direct clinical data to support mechanisms other than the inhibition, delay, or alteration of ovulation.16 Plan B does not cause abortion or interfere with an established pregnancy. If Plan B is inadvertently taken by women who are pregnant, the pregnancies will not be affected.16
Clinical Study Overview
The FDA-approved dosing regimen for Plan B specifies that the first dose should be taken within 72 hours of unprotected intercourse followed by a second dose taken 12 hours later.4 Available evidence indicates that Plan B may be more effective the sooner it is taken and women should be encouraged to begin taking EC as soon as possible after unprotected intercourse.17 Although there is evidence of efficacy as late as 120 hours after intercourse, women should be encouraged to seek treatment as soon as possible, preferably within the 72-hour timeframe.18-23 Since the time required from intercourse or ovulation to implantation is approximately six to seven days, the use of EC beyond 120 hours is not likely to be effective.16
Studies have also examined the potential to administer the regimen as a single dose of levonorgestrel 1.5 mg (two tablets).21,22 The single-dose regimen may improve compliance by simplifying the EC regimen. Preliminary evidence suggests a single dose of two tablets of levonorgestrel is as effective as and possibly more effective than the standard two-dose regimen. The use of Plan B after 72 hours and the use of a single 1.5 mg dose of levonorgestrel for EC have not been approved by the FDA.
As previously mentioned, the Yuzpe Regimen (the combination of ethinyl estradiol and levonorgestrel given up to 120 hours after unprotected intercourse) is effective for EC, although slightly less effective than levonorgestrel alone and with more side effects.18-20 The Yuzpe Regimen may provide an option for some women in the event that Plan B is not available or when formulary issues arise.
Concerns have been raised that providing EC to women in advance of need to keep on hand "just in case" of a contraceptive failure might lead to an increase in unprotected intercourse or encourage women to discontinue the use of their usual method of contraception. Studies that have evaluated the outcomes of providing EC in advance of need have not found that women engage in more unprotected intercourse or abandon their usual method. The studies have reported that women are more likely to use EC after unprotected intercourse when it is provided in advance of need.24,25
Regulatory Status
The terms of the FDA approval of OTC Plan B included requirements for the manufacturer to provide support and education about the use of the product to health care providers and consumers. The dual status of this product necessitates the product be kept within the pharmacy or behind the counter. The FDA wanted consumers to have access to a knowledgeable health care provider who would be able to answer questions they might have when purchasing Plan B. Therefore, the product may be shipped and stocked only by pharmacies or clinics and will not be available at general retail locations.
CARE: CONVENIENT ACCESS, RESPONSIBLE EDUCATION
Plan B will be distributed to pharmacies and sold to consumers under the terms of the Convenient Access, Responsible Education (CARE) program approved by the FDA and developed by Duramed Pharmaceuticals, Inc. for marketing Plan B for OTC sale.2 The CARE program details the requirements for the distribution, labeling, and packaging of Plan B and includes both pharmacist and consumer education components, as well as monitoring plans to ensure compliance.
The dual-labeled, behind-the-counter distribution of Plan B marks the first time the FDA has approved the same product for OTC use for adults and prescription-only use for those under the age of 18. The packaging has room for a prescription label (to be used when the product is dispensed by prescription), as well as the required Drug Facts box for OTC sales to eligible adults ( Figure 1). The dual-label packaging contains a new NDC number and is the only product that may be provided to consumers as an OTC product.
The CARE program specifies that Plan B is to be sold only from behind the counter in the pharmacy and not be available through non-pharmacy retail outlets. Pharmacies must have a pharmacist on duty and available for consumer consultation in order to sell Plan B. Although the pharmacist must be available, it is not required for the pharmacist to consult with the consumer for OTC purchases. Medical clinics may also sell Plan B, but they must have a licensed health care provider on the premises available for consumer consultation at the time of all sales.
The approval by the FDA permits Plan B to be sold without a prescription to women and men as long as they are at least 18 years of age. To purchase Plan B without a prescription, a consumer must only show proof that she or he is at least 18 years of age. 2 Any member of the pharmacy staff working behind the pharmacy counter may sell Plan B to eligible consumers as long as a pharmacist is on duty and available for consultation if requested by the consumer. Retail outlets with pharmacies where the retail store has longer hours of business than the pharmacy are not able to sell Plan B when the pharmacy is closed. Once proof of age is established, Plan B can be sold without consultation from the pharmacist or requiring the consumer's signature on the record of the sale.
Figure 1. The Plan B Package is the Same for Both Rx and OTC
The FDA-approved packaging has room for an Rx label (to be used when the product is dispensed by prescription) and the required Drug Facts box for OTC sales to eligible adults.
There is no limit to the number of Plan B packages that may be sold to an eligible individual; multiple packages can be purchased in a single transaction. There is also no requirement that Plan B must be used by the purchaser. Men may purchase it as long as they are at least 18 years of age.
In an effort to demonstrate to the FDA the successful implementation of the CARE program, Duramed Pharmaceuticals, Inc. will use secret/undercover shoppers in order to monitor the 18-years-of-age minimum age requirement for OTC Plan B. The company has agreed to monitor pharmacies and report the results to the FDA every six months or as requested by the FDA. Pharmacists and pharmacy staff not adhering to the age limit requirements will be provided education and additional information about the CARE program. If a pharmacy is found to be violating the program a second time, it may be reported to the board of pharmacy.
OTHER REGULATORY ISSUES
The availability of OTC Plan B comes at the same time that pharmacies are required to limit access to pseudoephedrine and other potential methamphetamine precursors from behind the counter. Consumers seeking EC are not subject to the same requirements as consumers seeking methamphetamine precursors; there is no requirement for purchasers of Plan B to sign a registry in the pharmacy or to provide photo identification (ID). Similar to the sale of OTC nicotine products, the sale of Plan B is limited only by the age of the purchaser, with no requirement for record keeping of purchases.
PHARMACIST CONSULTATION
Although consultation with the pharmacist is not required for the OTC purchase of Plan B, consumers may have questions. When consumers ask the pharmacist about what to expect from Plan B, the pharmacist should include information about side effects, when to expect the next menstrual period, and when follow-up care is indicated ( see FAQ).
Most women who take Plan B will not experience side effects. The most commonly experienced side effects (nausea, dizziness, fatigue, headache, and breast tenderness) are mild and do not occur in most women taking Plan B (Table 1). 4 These side effects do not require treatment and resolve quickly after treatment is completed. The vast majority (87%) of women will have their next menses within one week of the originally expected date.4 Other menstrual effects may include spotting and either lighter or heavy than expected menses during the next cycle. The pharmacist should reassure women that changes in menses, while common, are self-limiting. Follow-up care is recommended if menses does not occur within seven days of the expected onset date, or for women with irregular or unpredictable menses, within three weeks of taking Plan B.
Table 1. Most Common Adverse Events Experienced by Women Receiving Plan B2
Adverse Events (> 5%) Plan B (levonorgestrel 0.75 mg oral tablets) N=977 (%)
The pharmacist should reinforce with purchasers that taking Plan B does not provide protection from sexually transmitted infections (STIs) such as syphilis, gonorrhea, or HIV. When requested, the pharmacist should be prepared to make referral to clinics or physicians who provide testing and treatment for STIs. The use of condoms for protection from STIs should be encouraged, when applicable.
Plan B is not as effective as ongoing methods of contraception and should not be relied upon as a routine method. Condoms or another method of ongoing method of contraception should be used for future acts of intercourse.
Because Plan B may be more effective the sooner it is used after unprotected sex, the pharmacist may advise consumers to keep the product at home for use in case of a contraceptive failure. Pharmacists should encourage consumers to purchase the product to "back up" their current contraceptive method even if they have never had a contraceptive failure. There is no requirement that consumers wait to purchase Plan B until after they have experienced a contraceptive failure.
Although not a CARE program requirement, pharmacists who routinely make themselves available to consumers requesting Plan B will have an opportunity to provide them with answers to their questions, make referrals to community resources, and for those without proper ID or for women under 18 years of age, either generate pharmacist-initiated prescriptions if pharmacy access is available in their state (to be discussed in the next section) or make a referral to a local provider. Pharmacists are in an excellent position to serve as a resource regarding methods of contraception, which may be more effective than EC in preventing unintended pregnancies. Because hormonal contraceptives do not prevent STIs, pharmacists should also encourage the continued use of condoms.
Pharmacists should have the contact information of local medical services available to give to consumers whose contraceptive needs cannot be met in the pharmacy. These people include those who do not have proper ID to purchase OTC Plan B, who are under the age of 18, who do not have the finances to pay for Plan B, or who need to be examined for STIs or care related to sexual violence. In the event that the pharmacy does not have EC in stock, the pharmacy staff should be prepared to refer consumers to a nearby pharmacy where Plan B is in stock to avoid delays in starting therapy.
Pharmacists should be aware that some women seeking EC may be the victim of nonconsensual sex or rape. Pharmacists should routinely provide all patients with information about local and national domestic violence and sexual assault programs when coming in for Plan B, such as the National Sexual Assault Hotline (800-656-HOPE). It is highly recommended that all pharmacies have written store polices and procedures for assisting victims of violence and what to do if victims identify themselves in the pharmacy.
Frequently Asked Questions (FAQ): A Reference for Pharmacists
What is Plan B? Plan B is an emergency contraceptive. It can be used after intercourse to prevent pregnancy in the event that a contraceptive method has failed or was not used. It contains levonorgestrel, a hormone found in many currently available oral contraceptives.
How effective is Plan B? Plan B has been shown to reduce the risk of pregnancy by 89% when taken within three days (72 hours) of a contraceptive failure or unprotected intercourse. If taken within the first 24 hours after unprotected sex, it can be up to 95% effective. One way to explain the effectiveness of Plan B is: if 100 women had unprotected intercourse during week two or three of their menstrual cycle and no contraception was used, eight women would be expected to become pregnant. If all 100 women used Plan B, only one woman would be pregnant, thus there is an 89% reduction in the pregnancy rate (one instead of 8 women).
Is Plan B the same as the abortion pill? No, RU-486 (the abortion pill, Mifiprex) is completely different. Plan B does not cause an abortion. Plan B prevents pregnancy and will not work if a woman is already pregnant. Similar to other oral contraceptives, Plan B works by preventing ovulation or fertilization; it may also inhibit implantation. Once implantation begins, Plan B is not effective.
When should I take Plan B? For best results, the first tablet should be taken as soon as possible, ideally within three days (72 hours) of unprotected intercourse or contraceptive failure. The second tablet must be taken 12 hours later. Taking Plan B as soon as possible is highly recommended.
How will I know if Plan B worked? Women can expect to begin menstruation within three weeks of taking Plan B. Most women should expect their period within one week of when it would be normally due. If they do not experience menstruation within three weeks, they should consult their health care provider and/or take a home pregnancy test.
Can I take Plan B if I have taken it before? Yes. Plan B is safe and may be used when needed. Plan B is not as effective as regular ongoing methods of contraception and routine use of Plan B is not recommended for this reason.
When can I resume intercourse after taking Plan B? A woman may have intercourse immediately following use of Plan B, but must use another method of contraception. It is important to note that a woman is not protected against pregnancy from intercourse that occurs after she has taken Plan B.
Does Plan B prevent sexually transmitted diseases? No. Plan B, like oral contraceptives, does not protect women from sexually transmitted diseases such as HIV.
What if I am already pregnant? Plan B is not effective if a woman is already pregnant. If taken by a woman who is already pregnant, Plan B will not harm the fetus or disrupt the pregnancy. Women who are pregnant should be referred to their health care provider.
PHARMACY Washington. 26 These states have specific requirements for pharmacist participation that include training and collaborative protocol arrangements. In states with pharmacist access, not only can Plan B be prescribed, but there are also a number of other prescription oral contraceptive products that the FDA has indicated are safe and effective for use as EC (Table 2 ).
In states with pharmacy access programs, women seeking Plan B who are unable to show proof of age or who need a prescription for insurance purposes can immediately have their pharmacist initiate a prescription for Plan B, thus improving the woman's chance of preventing an unintended pregnancy. This service is not available, however, to men seeking Plan B, as they are not the ones taking the medication. If formulary restrictions limit the use of Plan B or the product is out of stock, the alternate regimens can also be provided by the pharmacist under these access programs. Although the alternative products may have more side effects and may be less effective, they should be kept in mind as a backup.6,17
Table 2. Select Brands and Doses of Products Used for Emergency Contraception Brand Manufacturer Dose Ethinyl Estradiol per Dose (mcg) Levonorgestrel per Dose (mg)* Two-Dose Regimens (administered immediately and 12 hours later) Dedicated Emergency Contraception Plan B Duramed 1 tablet per dose 0 0.75 Oral Contraceptive Pills † Alesse Wyeth 5 pink tablets per dose 100 0.50 Aviane Duramed 5 orange tablets per dose 100 0.50 Levlen Berlex 4 light-orange tablets per dose 120 0.60 Levlite Berlex 5 pink tablets per dose 100 0.50 Levora Watson 4 white tablets per dose 120 0.60 Lo/Ovral Wyeth 4 white tablets per dose 120 0.60‡ Low-Ogestrel Watson 4 white tablets per dose 120 0.60‡ Nordette Wyeth 4 light-orange tablets per dose 120 0.60 Ogestrel Watson 2 white tablets per dose 100 0.50‡ Ovral Wyeth 2 white tablets per dose 100 0.50‡ Tri-Levlen Berlex 4 yellow tablets per dose 120 0.50 Triphasil Wyeth 4 yellow tablets per dose 120 0.50 Trivora Watson 4 pink tablets per dose 120 0.50
*WHO data ( Lancet. 2002;360:1830-1880) for levonorgestrel showed that a 1.5 mg single dose can substitute two 0.75 mg doses 12 h apart. This simplifies the use of levonorgestrel without an increase in side effects. Pregnancy rates were slightly lower for the single-dose regimen, but not statistically significant. Similar findings on single-dose efficacy were obtained by Arowojulu A, et al ( Contraception. 2002;66:269-273). †Generic equivalents to these products may be available. Tablet colors may vary from brands. Ensure tablets with active hormones are being used. ‡The progestin in Ovral, Lo/Ovral, Low-Ogestrel, and Ogestrel is norgestrel, which contains two isomers, only one of which (levonorgestrel) is bioactive; the amount of norgestrel in each dose is twice the amount of levonorgestrel. Adapted with permission from the Pharmacy Access Partnership.
Pharmacists initiating EC prescriptions have been shown to greatly improve women's access to EC.27 In Washington state, pharmacists using collaborative drug therapy agreements have begun initiating on-going hormonal contraception prescriptions such as oral contraceptive pills, patches, and vaginal rings in order to assist patients using EC to move to a more effective contraceptive method. Pharmacists could also provide urine-based STI screenings for consumers at risk, such as those requesting Plan B due to a condom failure.
SUMMARY AND CONCLUSIONS
Emergency contraception is a safe and effective method of preventing unintended pregnancy. The approval of Plan B for OTC sale to those at least 18 years of age is a major step toward improving access and removing barriers to the use of EC in the US. Pharmacists will play a critical role in expanding access to Plan B in pharmacies and will be relied upon to provide information to consumers regarding the product's safety and efficacy. The time-sensitive effectiveness of Plan B means that ready access is an essential component of successful use. Pharmacists can help to dispel myths and misinformation about EC, and in states where collaborative practice allows them to prescribe EC directly, pharmacists can become certified/qualified providers to further improve access.
CASE STUDY #1: Prescription Presented for a 16-Year-Old Female A 16-year-old female with a prescription for Plan B written by her physician comes to the pharmacy to obtain the product. However, she heard that this is now available OTC and would like to purchase it. Can the pharmacy provide her with Plan B? Although Plan B may be purchased directly by consumers at least 18 years of age, at age 16, the woman is able to purchase Plan B by prescription only. Since she has a prescription, the pharmacy can simply fill it. If she did not, the pharmacist could refer her to a local clinic or health care provider, or if she was in one of the nine states with pharmacist-access to EC, the pharmacist could provide her the product by completing a prescription under established protocols.
CASE STUDY #2: 18-Year-Old Male Purchasing the Product An 18-year-old man comes to the pharmacy counter and asks to purchase Plan B. Can the pharmacy provide Plan B to this man? There is no requirement that this OTC product has to be used by the purchaser, thus men may purchase it as long as they are at least 18 years of age and show proof of age at the pharmacy counter.
CASE STUDY #3: Use Beyond 72 Hours A 25-year-old woman comes to the pharmacy counter asking to speak with the pharmacist about EC. During the discussion, she reveals that she had unprotected intercourse four days ago and is terrified about possibly becoming pregnant. She would like to use emergency contraception but has heard that it is only effective for 72 hours (three days). Can the pharmacist sell Plan B OTC to this woman? Available research indicates that Plan B retains significant activity in reducing the risk of pregnancy for at least 120 hours after unprotected intercourse. Although it is most effective when taken earlier and the use of Plan B as quickly as possible should be encouraged, in this situation there is evidence to support the use of Plan B. (Please note that the use of Plan B after 72 hours for EC has not been approved by the FDA.) The pharmacist should inform her that the product may be less effective when taken later than 72 hours after unprotected intercourse; however, there is strong support to provide the product in this situation and the sale would be appropriate.
CASE STUDY #4: Use in Perimenopausal Women A 46-year-old woman comes to the pharmacy to purchase Plan B. She is a current smoker and suffers from migraine headaches. Can EC be taken safely by this woman? The only contraindications to the use of Plan B are established pregnancy (because it will not work), allergy to levonorgestrel, or undiagnosed vaginal bleeding. Migraine headaches and smoking, like other contraindications to the regular use of hormonal contraceptives, have not been shown to be reasons to limit the use of Plan B. Available evidence indicates Plan B is safe for women of all ages at risk for pregnancy. WHO guidelines for the use of EC include established pregnancy as the only contraindication to its use.28,29
CASE STUDY #5: Use By a Woman Who is Uncertain About Pregnancy A 32-year-old woman inquires about EC at the pharmacy counter. She confides that she may need EC, but she is uncertain whether or not she might be pregnant. What advice can the pharmacist provide to her? When a woman is concerned that she may already be pregnant, the pharmacist can recommend purchase of a urine pregnancy test along with the Plan B product. Urine pregnancy tests are readily available in the pharmacy and the woman can take the test at home before taking Plan B. The woman should be advised that if the test result is negative, she should take the doses of Plan B. If the urine pregnancy test is positive, then Plan B will not be effective and therefore should not be taken. She can be reassured that even if she discovers she is pregnant after having taken Plan B, there will be no harmful effects on the pregnancy.
CASE STUDY #6: Plan B is Currently Out of Stock A 21-year-old woman comes to the pharmacy counter and asks to buy Plan B. After making sure the customer is at least 18 years old, the pharmacy staff members realize they are currently out of Plan B. What is the best way to handle this situation? There are several ways this situation could be handled. Ideally, the pharmacy should have a list of local pharmacies and clinics that stock Plan B. This would allow staff members to verify the product's availability and then refer the patient to another local resource. To simply tell the woman that the pharmacy cannot help her may delay care and increase the risk of an unintended pregnancy. If the woman explains that Plan B is being purchased for future use, then a decision could be made to either wait until new product arrives in the pharmacy or to make an immediate referral. In no case should the pharmacy staff tell someone to wait a day or two to obtain Plan B if unprotected sex has already occurred. If no local sources of Plan B are available, then FDA-recognized, alternative contraceptive products may need to be prescribed by a physician, nurse practitioner, or pharmacist (in pharmacy access states).
quote:Originally posted by Sashyra88: Everything regarding those "morning after"pills is in that pharmacist`s directed article as a source of Continued Education for us.
wouldn't be the good morning kiss and smile better then 1000 bills amr
Posts: 1499 | From: Dark Side of the Moon | Registered: Aug 2007
| IP: Logged |
quote:Originally posted by Y're unique just like everyone else:
quote:Originally posted by Sashyra88: Everything regarding those "morning after"pills is in that pharmacist`s directed article as a source of Continued Education for us.
wouldn't be the good morning kiss and smile better then 1000 bills amr
UBBFriend: Email this page to someone!
![[Confused]](confused.gif)
This is a very poor decision made in the US. Abortion should be 100 % controlled and the last option when becoming pregnant IMO. ![[Frown]](frown.gif)
![[Roll Eyes]](rolleyes.gif)
![[Smile]](smile.gif)
![[Big Grin]](biggrin.gif)
Printer-friendly view of this topic