Paper prepared following the approval of the supply without prescription in pharmacies.
Professional intervention in relation to the so-called "morning after pill" (PDD) raises serious problems from the standpoint of professional ethics for many health professionals. Especially now, for the pharmaceutical, health care worker involved only in relation to the DDA, a correct interpretation of their professional duties may lead you to not dispense this product. EFFECT
Reproductive effects of DBM
The official sheet recognizes at least two main effects of DBM on reproductive function: the birth and antiimplantatorio. The contraceptive mechanism occurs by inhibiting ovulation. When this does not occur, and fertilization takes place, you may receive antiimplantatorio effect: by altering the ability of the lining of the uterus to receive the embryo at the right time, it can not implant in it and ends up being deleted.
In one study, women who received the DDA had a pregnancy rate of 1%. Accordingly, it is estimated that the use of the PDD could be reduced by 85% the chance of pregnancy. This figure could be overestimated, since the probability of pregnancy in the PDD applicants may already be impaired by stress, partial use of contraceptives, etc.
Effect of DBM in the rate of unplanned pregnancy
Numerous epidemiological studies of different nature and origin, show that the use of the PDD does not reduce the rate of unintended pregnancies, or the rate of abortions in the population (Raymond, Obstetrics & Gynecology 2007). How
can explain this paradox? First, the ability of DDA to reduce the likelihood of pregnancy may be overestimated. Moreover, it is known that a greater sense of protection induces greater acceptance of risk. There is difficulty in detecting changes in intimate behavior, some studies show that the availability of the PDD causes an increase in risky sexual behavior in adolescents (Belzer, Los Angeles, 2005), while other studies show no difference.
In Spain, the total number of units sold PDD has increased since its adoption in 2001, from 160,000 to over 600,000 in 2007. At that time, the rate of induced abortions not has decreased (69 858 abortions in 2001, 112,138 abortions in 2007, the latest official data available). Among adolescents, abortions have followed the same increase. In Andalusia, the PDD has been provided free at health centers. However, between 2000 and 2006, developments in Andalusia was 5 more abortions per thousand women, compared with 4 in the rest of Spain, failed to confirm it projected on the basis of epidemiological studies. SAFETY
Security
PDD for women
The PDD is a megadose hormone, equivalent to 20 times the daily dose of levonorgestrel used as anticonteptivo. Consequently, reactions occur frequently effects such as nausea (in 15% of cases), vomiting (15%), diarrhea (3%), fatigue (13%), vertigo or dizziness (20%), headache (10%), breast (8%), abdominal pain (15%), vaginal bleeding (31%) and delayed menstruation (5%).
These reactions may be more severe and frequent in people with a hormonal disorder, underlying disease, or ages at which sexual hormone balance is still in development.
is not known with certainty the safety of the PDD in adolescents, which were excluded from major clinical trials. Neither is known in government security repeated. This can be facilitated by a dispensing without prescription, even several administrations per year, which can have harmful effects on the female cycle.
uterine relaxing properties of levonorgestrel may delay the spontaneous abortion of viable embryos and implanted, increasing the risk of complications for women. For that reason, avoid progestogens in women who are at the beginning of pregnancy (Levonorgestrel, Micromedex 2009).
Finally, if the availability of the PDD induced an increase in risky sexual behaviors, such as observed by some authors, would increase the spread of disease transmission sexual such as AIDS, gonorrhea, yeast infections, human papillomavirus and cervical cancer, etc.. Security
PDD for the embryo
The PDD is not safe for the embryo, on the contrary, as by interfering with implantation in the uterus, prevent their physiological development, leading inevitably to death.
on an embryo or fetus resulting from a previous relationship which motivates the use of the DDA, and already in place, the safety of massive doses of postcoital levonorgestrel is poorly understood. Studies in a few cases seem to indicate that no significant adverse effects, but would require more extensive studies to verify their security. ADDITIONAL ISSUES
ethical and professional considerations
"It's not ethics admit the existence of a period in which human life is worthless. Consequently, the doctor is obliged to respect it from the beginning "(Article 25.1 of the Code of Ethics and Medical Ethics). For its part, "the pharmacist shall refrain from participating in any type of action, whether or not related to their profession, their knowledge and skills are put to the service of acts against life, human dignity or the rights of man "(Art. 10 of the Code of Professional Ethics Pharmaceuticals).
Since it is a scientifically proven fact that human life begins at conception, these requirements have a direct application to the conduct of health professionals.
should clarify that, where information dissemination and / or promotional DDA stated that the PDD is not abortion, it can be confusing the beginning of human life, with the time of clinical diagnosis of pregnancy (which is done after implantation). Moreover, although not always produce the effect antiimplantatorio, an elementary principle of precaution against an action that could endanger human life leads us to avoid actions that could end this life.
Moreover, the Code of Ethics and Pharmaceuticals, which meets minimum ethical principles require the pharmacist (Art. 1), provides in its general principles, that this, in practice, exceed the strict compliance adopt existing legislation and ethical behavior in all its activities (Art. 2), but not be requested or required (Art. 9).
A pharmacy is not just a trade, but a health facility. Activity and health, professional, pharmacist covers all functions in relation to the drug, since its acquisition, until dispensed and pharmaceutical care, including their duties in promoting community health. All of them can and should be your best professional and ethical criteria, for the sake of everyone's health. These criteria affect both their knowledge about the effect of PDD on the embryo, as the difficulty of ensuring maximum safety for women in the specific conditions under which the dispensing occurs.
The Medical Association has specified that "a medical act is not because it makes use of a technique, to a chemical or an instrument of those used in medicine." (Medical Journal, 15/09/1998). Similarly, the entire dosage form is worthy be considered medicine or any procedure that involves a dosage form is an act pharmacist. In this sense, the possibilities for cooperation in actions that threaten the health and even human life (abortion, death penalty, assisted suicide or not, euthanasia, etc.) Products using dosage forms, are expanding in some countries, and are a drift in the health professions clearly lost the ethical foundation that has sustained its historical development and its contribution to a better society.
Other considerations (psycho-social, economic, legal, etc.).
Consider, authoritatively, that the harmful effect of PDD the embryo is not relevant to the user, denying them access to that information in a clear and understandable, it is unfair to them and inconsistent with the scientific literature. Many women may face psychological feelings of guilt and frustration if, after using the DDA, come to the knowledge that their use may have killed a human life. Unfortunately, some brochures on the DDA, including the recently published by the Ministry of Health, fall into this defect.
The measure to allow the use of DBM without prescription counter as indicated in two judgments of the High Court (February 4 and October 8, 2003), justifying its distribution provided that is authorized by a physician prescription. In addition, the 1 st sentence assumes that the DDA can not be given to minors.
The total cost of the PDD in Spain, even if consumption remained stable, would be around 13 million euros annually. Recently (04/08/2009), the English Agency of Medicines in Spain has approved a new product for postcoital contragestation (ulipristal acetate, RH Pharma). The availability of the PDD without prescription in pharmacies allow their dealers (Bayer, Chiesi and Medimpex) make a market repositioning, the imminent advent of a new competitor. Using
PDD under 16 years:
- No representative studies in which it is shown that the use of PDD in children under 16 years (30-40% of consumers) is secure. Consequently, the supply charge and without prescription may conflict with Article 10.1.b) of LGURM which states that among the applicable requirements for approval of drugs is safety. We can not assure that the frequent intake during adolescence is without negative effects on sexual and reproductive health in adulthood.
- With PDD dispensing without prescription, the pharmacist must be the one to judge in some cases on the maturity of the child to decide on making a product affecting their health, entering into competition with the right and duty of parents to an educational intervention, a role that seems foreign to the work of a pharmacist. Experience shows that many children are not yet known sexual cycle, so taking a medicine that depends on these factors can lead to complicated situations.
or Article 9, 3.c) of Patient Autonomy Act states that where the minor patient is not intellectually or emotionally capable of understanding the scope of the intervention, consent shall be given by the legal representative . In the case of children unable or not disabled, but emancipated or sixteen years old, no it should give consent by proxy. However, in case of serious risk of action, at the discretion of the physician, parents will be informed and their views be taken into account when making the decision.
- Nothing prevents it from being a man who acquires the DDA unintentionally can facilitate unscrupulous and even criminal behavior of abuse of female minors, such as those that occur within the family. SUMMARY
the evaluation of the PDD:
The PDD is a product that does not reduce the population incidence of unplanned pregnancy or induced abortion, antiimplantatorio its effect can be fatal to the life of the embryo, which has troublesome side effects are very common for users, which could be harmful in adolescents, or repeated misuse or as a contraceptive, etc., representing unnecessary cost to society and that is a conflict of ethics and ethical principles recognized by many health professionals.
The dispensation of the PDD without medical supervision can encourage their use, difficult information for users and aggravate its security problems.
Legal considerations and performance to the dispensation of the PDD
The law requires pharmacists to dispense medications that are properly required except for just cause (Art. 101.15 of the Act guarantees and rational use of medicines, LGURM), including non-prescription for dispensing. We understand that a petition for dispensation of the DDA, may be valid reasons to oppose his best professional approach to the dispensation of the PDD:
- Knowledge about the harmful impact of PDD on the embryo
- Knowledge its overall negative effect on public health, for their ineffectiveness population, insecurity and cost.
- Failure to ensure safety for women, due to:
or the uncertainty of possible diseases, pregnancy or other baseline of the user,
or lack of a record of usage to detect repeated use would be harmful to your health,
or inability to properly judge the maturity of a child in the concrete conditions of the supply of the DDA, or uncertainty
who will actually be the recipient of the product being dispensed,
or inability to take responsibility, as the only health worker involved in the process, for any errors or adverse consequences that may arise from the administration of the product dispensed and would be potentially avoidable.
These would, in our view, sufficient conditions to express explicitly the PDD and applicants who may require, the unsuitability of the supply. Constitute what has been called "object of science." This is a pharmacist's performance, exercising their professional autonomy in the interest of the health of those who are covered by their professional liability (including potential embryo), refuses to dispense a harmful product, or in conditions that are far from ensuring an appropriate risk-benefit balance. Other health professionals (doctors, nurses) could exercise their professional autonomy as scientific and ethical criteria analogous paraprofessionals.
addition, the professional involved in the use of the PDD (doctor, pharmacist, nurse) qualifies for conscientious objection, refusing to dispense a product harmful to the life of the embryo. This is a fundamental right, which is part of freedom of ideology and conscience, and that enables in exceptional and duly justified situations, not to comply with a legal obligation because it conflicted with personal conscience.
As much as you say, the legal measure to enable the dispensing of DBM without prescription in pharmacies did not change, nor can it change the validity and legitimacy of the right to conscientious objection, as a fundamental right linked to the constitutional freedom of conscience (Art. 16 of the Constitution), recognized by several statements, enshrined in the Code of Ethics and collected, in addition, several regional laws (Galicia, La Rioja, Castilla-La Mancha). This right, as noted, among others, the TC can be exercised regardless of whether there is a specific law to regulate it. Professional who recognizes the need to invoke this right as a citizen should not give it, since the objection is a right for all, and if the rights are not exercised, will end up losing.
The refusal of a health professional to dispense a product harmful to human life, fit both the simple exercise of best professional criteria, such as invoking a conscientious objection as relevant scientific, ethical and professional are inseparable. A truly professional performance worthy of the name only when it is both ethically impeccable and based on the best scientific evidence available.
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