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Documenting containment for global certification

De acuerdo a la ley Nº 25.649/02 se establece que toda receta y/o prescripción médica u odontológica debe realizarse utilizando el nombre genérico del medicamento, seguida de la forma farmacéutica, cantidad de unidades por envase y concentración, se debe evitar el uso nombres químicos o de investigación, abreviaturas o siglas. Por otra parte de acuerdo a la ley 17.132 (Régimen Legal del Ejercicio de la Medicina, Odontología y Actividades Auxiliares de las mismas, 1967) está prohibido el uso en las prescripciones de signos, abreviaturas o claves que no sean los señalados en las Facultades de Ciencias Médicas reconocidas del país.

Apéndice 2

Muestrario de algunos errores detectados en los formularios de medicamentos con el software de parsing automático

Nro. Certif Descripción del error

22503 Dice “nozinam minor” debería decir “nozinan minor”. 39911 Dice “mg mg” debería decir “mg”.

43157 Dice “alfa 1 antritipsina” debería decir “alfa 1 antitripsina”. 47254 El número “O,25” escrito con la letra O en lugar de con el número 0. 15023 Entre el nombre del componente y la cantidad hay doble especiado. 16813 Dice “casta*a” debería decir “castaña”.

36274 Se abre paréntesis pero nunca se cierra. 4972 No se especifica la cantidad contiene los sobres. 4972 Dice “%” debería decir “ .%”

93 Apéndice 3 <PRESENTACION> --> <PRESENTACION_CANTIDAD_X_N_UNIDADES> <PRESENTACION> --> <PRESENTACION_SOLO_UNIDAD> <PRESENTACION> --> <PRESENTACION_CANTIDAD_X_UNIDAD> <PRESENTACION> --> <PRESENTACION_SOLO_CANTIDAD> <PRESENTACION> --> <PRESENTACION_CANTIDAD_X_CANTIDAD_EN_UNIDADES> <PRESENTACION> --> <PRESENTACION_UNIDADES_X_CANTIDAD>

<PRESENTACION_CANTIDAD_X_N_UNIDADES> --> <NOMBRE> <CANTIDAD_SIMPLE> / <NUMERO> <PRESENTACION_CANTIDAD_X_N_UNIDADES> --> <NOMBRE> <CANTIDAD_SIMPLE> X <NUMERO> <PRESENTACION_SOLO_UNIDAD> --> <NOMBRE> <NUMERO> <UNIDAD>

<PRESENTACION_CANTIDAD_X_UNIDAD> --> <NOMBRE> <CANTIDAD_SIMPLE> / <NUMERO> <PRESENTACION_CANTIDAD_X_UNIDAD> --> <NOMBRE> <CANTIDAD_SIMPLE> X <NUMERO> <PRESENTACION_SOLO_CANTIDAD> --> <NOMBRE> <CANTIDAD_SIMPLE>

<PRESENTACION_CANTIDAD_X_CANTIDAD_EN_UNIDADES> --> <NOMBRE> <NUMERO> <UNIDAD> / <CANTIDAD_SIMPLE> <PRESENTACION_CANTIDAD_X_CANTIDAD_EN_UNIDADES> --> <NOMBRE> <NUMERO> <UNIDAD> X <CANTIDAD_SIMPLE> <PRESENTACION_UNIDADES_X_CANTIDAD> --> <NOMBRE> <NUMERO> X <CANTIDAD_SIMPLE>

<PRESENTACION_UNIDADES_X_CANTIDAD> --> <NOMBRE> <NUMERO> X <CANTIDAD_SIMPLE> <DOSIS> --> <NOMBRE> <DOSIS>

<CANTIDAD> --> <CANTIDAD_POR_CANTIDAD_NORMALIZADA> <CANTIDAD> --> <CANTIDAD_POR_UNIDAD_DE_MAGNITUD> <CANTIDAD> --> <CANTIDAD_SIMPLE>

<CANTIDAD> --> <CANTIDAD_RANGO> <CANTIDAD> --> <CANTIDAD_PORCENTAJE>

< CANTIDAD_POR_UNIDAD_DE_MAGNITUD > --> <NUMERO> <MAGNITUD> / <NUMERO> <UNIDAD>

< CANTIDAD_POR_UNIDAD_DE_MAGNITUD > --> <NUMERO> <MAGNITUD> / <NUMERO> <UNIDAD> <MAGNITUD> <CANTIDAD_PORCENTUAL> --> <NUMERO> <MAGNITUD> .%

<CANTIDAD_PORCENTUAL> --> <NUMERO> <MAGNITUD> %. <CANTIDAD_PORCENTUAL> --> <NUMERO> <MAGNITUD> . <CANTIDAD_PORCENTUAL> --> <NUMERO> <MAGNITUD> %

<CANTIDAD_RANGO> --> <NOMBRE> <NUMERO> A <NUMERO> <MAGNITUD> <CANTIDAD_SIMPLE> --> <NUMERO> <MAGNITUD>

< CANTIDAD_POR_CANTIDAD_NORMALIZADA > --> <NUMERO> <MAGNITUD> / <NUMERO> <MAGNITUD> <NOMBRE> --> <LETRA> <NOMBRE>

<NOMBRE> --> <LETRA>

<NUMERO> --> <DIGITO> <NUMERO> <NUMERO> --> <DIGITO>

<LETRA> --> a | b | c | d | e | f | g | h | i | j | k | l | m | n | o | p | q | r | s | t | u | v | w | x | y | z <DIGITO> --> 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 0

94

Apéndice 4

Apéndice 5 Caso 1:

The plaintiff's ward, then age forty-nine, entered a major teaching hospital to have an infection on his left little finger surgically debrided. The surgery went well. but upon awakening from anesthesia, the patient became combative and agitated, probably because he was an alcoholic. The defendant, a resident psychiatrist, began administering intravenous haloperidol to control the agitation. During the next sixteen hours. 1.270 milligrams of intravenous Ilaldol were administered, which is a far greater amount than any ever reported in medical literature. The patient was not hooked to a heart monitor during the administration of the drug. and the next morning, he suffered a dangerous and irregular heart rhythm, resulting in cardiac and respiratory arrest and leaving him in a semivegetative state. The plaintiff has since died, leaving an adult son as his only heir. The plaintiff claimed the resident psychiatrist was negligent in ordering an excessive dose of intravenous Haldol and failing to monitor for signs of irregular heart rhythm. The plaintiff also claimed the chief and director of psychiatric service at the hospital was negligent for failing to properly supervise and train his resident. The defendants claimed the amount of Haldol given was appropriate and that cardiac monitoring was not necessary. According to published accounts. a S1,050.000 settlement was reached.[…] [23]

Caso 2:

On September 26. 1994, Dorothy Majchzrak, a patient at St. Margaret's Hospital in Spring Valley, Illinois, was diagnosed as hypomagnesemic (low magnesium). Her physician ordered three doses of 40 milli-equiva-lents (mEq) of magnesium sulfate per liter (MgSO/1), to treat the elderly woman's condition. Three hours later. Majchzrak suffered a cardiac and respiratory ar-rest. brain anoxia, and subsequent seizures as a result of an overdose of magnesium sulfate. She never recovered from the event and was eventually transferred to another facility, where she died on December 10. 1994. A cash settlement of $650,000 was made by St. Margaret's Hospital (unpublished case). [23]

95

The tragedy of Majchzrak's overdose, say outside cx-pens, was that it was completely avoidable and involved the mistakes of not one but four members of the hospital's phar-macy and nursing staff. The first link in the chain of errors occurred before the physician ordered the prescription. The pharmacy at Si Margaret's used a 40-gram bottle of magnesium sulfate when compounding MgSO4 orders. They should have selected a smaller vial of magnesium. This particular 40-gram bottle of magnesium sulfate is designed to be hung in obstetrics and to be used at a certain amount per hour. The particular concentration and volume are a very dangerous product to start with, and if it's going to be used, it has to be used with very strict precautions and not used outside obstetrics at all. This author (JOD) is aware of a number of other eases of magnesium overdose resulting from use of that particular bottle, including the 1990 death of an obstetrics patient who was also a pharmacist. The pharmacy's practice of using the 40-gram bottle to compound prescriptions set the stage for the events that led to Majchzzak's overdose. The pharmacist who wrote down the prescription left for lunch before filling it and instead passed the 40-gram bottle and the order to another pharmacist to fill. That second pharmacist mistook the order for 40 mEq, as one for 40 gm, the amount in the bottle that had been left on the counter with the order. The first pharmacist returned from lunch to -double-check" the order by reading the chart copy but did not look at either the computer entry by the second pharmacist or the product sent to the floor. The chart copy did not include any compounding records or a copy of the computer-generated label. It was supposed to be a compounded prescription, but there were no computation or compounding records of any son. Had the record existed, the pharmacist who checked the order would have noted that no compounding had occurred.[…] [23]

Caso 3:

Fatal Error he night before, Goff had received a doctor's order for 330 micrograms of zinc, a nutritional upplement to help the baby's metabolism. But when Goff entered the order into the machine hat mixes the compound, she entered milligrams — the wrong unit of measurement — on the drop-down menu.

I put in the 330 and when I went to pick the units ... [I] grabbed 330 milligrams per decaliter instead of micrograms per decaliter," said Goff.

This meant that 1,000 times more zinc than had been prescribed was transfused into baby Alyssa.

In July 2007, during an emotional hearing before the Nevada Pharmacy Board, Goff apologized personally and publicly to the Shinns for the first time.

Nothing I could ever say would ease your pain. I know that," Goff said in court, turning to face ha hinn "And I want you to know that I'm really sorry."

Shinn hugged Goff and said, "Oh, Pam, I know you're sorry?

The pharmacy board and an investigation by Portfolio magazine have raised troubling questions about the hospital's oversight of its pharmacy. Katherine Eban, the magazine's investigative reporter, says she thought the hospital was run inconsistently (click here to read "ortfolio's report).

I think the Summerlin pharmacy operated like a giant temp agency," Eban said. "Staff came and went. There were six pharmacy directors in six years. One of them was even commuting long distance."

In 2006. Summerlin Hospital had just taken back the operation of its pharmacy from a management company — the third in 10 years — that had hired many of the employees. The night Alyssa received a fatal overdose. the pharmacy was short-staffed. according to Goff. "It can make it very hectic, and make it very stressful, a stressful situation on everyone that's involved." Goff said of the staffing issues. [23]

Caso 4:

Una mujer de 86 años de edad, con antecedentes de enfermedad de la arteria después de la cirugía de derivación coronaria coronaria, enfermedad de la válvula mitral con el reemplazo, insuficiencia cardíaca congestiva, insuficiencia renal crónica fue tratado en un centro de servicio de urgencias terciaria para la insuficiencia cardíaca congestiva.

Proveedores creían que el paciente se beneficiaría de rehabilitación antes de regresar a casa, por lo que fue trasladado a un centro de rehabilitación para la supervisión médica y terapia para mejorar su función. La lista de medicamentos traslado incluido "digoxina 0.625 mg al día." Sin embargo, fue en realidad tomando 0,0625 mg. Su lista de medicamentos en casa había declarado "0.0625" para la digoxina, pero no incluyen la unidad, y no fue comprobada durante la reconciliación del medicamento.

En el centro de rehabilitación, el sistema de entrada de la computadora no permitió mg, y el residente admitir correctamente convirtió la dosis de digoxina incorrecta desde mg a mcg. El orden en el centro de rehabilitación fue para Digoxina 625 mcg, cuando debería haber sido 62. El farmacéutico revisa las órdenes del paciente, entró en la dosis de digoxina en el sistema informático, y recibió una advertencia que indica la cantidad supera la dosis diaria máxima.

El farmacéutico anuló la alerta sistema informático, y no pudo comunicarse con el médico solicitante para verificar la dosis por la política del hospital para cuando se produce una discrepancia.

La enfermera registrada transcribe 625 mcg al día con el registro de administración de medicamentos y documentado que se administraron medicamentos. Así, el paciente fue dado 10 veces la dosis prevista de la digoxina durante cuatro días. Se quejaba de náuseas, y fue tratado con compazine y zofran. Su ritmo cardíaco se redujo en los años 30, y su análisis de sangre reveló un nivel de potasio elevado (7). Pruebas posteriores mostraron un nivel de digoxina de 27,5 (rango terapéutica normal: 0,8 a 2 ng / ml). Ella fue trasladada a un centro terciario para su tratamiento, donde regresó a la línea de base.

96

Después se produjo el incidente, la rehabilitación de la admisión de la enfermera negó que el paciente recibió digoxina, indicando que ella había descuidado un círculo en el formulario para reflejar que no se le dio. La enfermera modificado la historia clínica para indicar que no proporcionan la digoxina, y luego salió con la nota como si hubiera escrito todo él ese día.

Seis semanas más tarde, el paciente murió de insuficiencia renal y la miocardiopatía. [23]

Caso 5:

Woman Given Prescription for 100 Milligram Dosage of Phenergan Which Was Filled By Pharmacy Despite Claims That Prescribing Physician Called to Cancel Prescription Due to Dosage Error - Resulting in Lingering Tinnitus - $1.4 Million Verdict

The plaintiff, age forty-eight, went to her primary care physician, defendant “A” in October 2008. The plaintiff was suffering symptoms associated with food poisoning . Defendant “A” gave the plaintiff a prescription for Promethazine (Phenergan) for 100 milligrams to be taken once a day. The plaintiff’s husband took the prescription to a local pharmacy to have it filled. Prior to the prescription being filled, defendant “A”’s office allegedly notified the pharmacy to cancel the prescription because the dosage was incorrect. The pharmacy, however,filled the prescriptio n in the amount originally written.

The plaintiff took 100 milligrams of the drug that evening and began experiencing dizziness, shakiness, anxiety, agitation, difficulty speaking,and impaired vision. After several hours she also developed a ringing sound in her head. Shortly after the plaintiff took the medication, a pharmacy employee called to notify the plaintiff of the error and advised the plaintiff to not take the medication, and to bring it back for a refund.

The plaintiff’s husband took the plaintiff to the nearest emergency room after being advised to do so by the poison control center. The plaintiff was treated and released. The plaintiff continued to have ringing in her ears (tinnitus) and saw a neurotologist who advised the plaintiff that the tinnitus was due to the overdose of Promethazine.

According to a published account defendant “A” was dismissed from the case prior to trial. A $1,400,000 verdict was returned against the pharmacy. A motion for new trial and/or judgement notwithstanding the verdict was pending.

[23]

Apéndice 6

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xmlns:xsd="http://www.w3.org/2001/XMLSchema" xmlns:xsi="http://www.w3.org/2001/XMLSchema- instance">

<soapenv:Body>

<getInteractionsWithMedicamentsResponse xmlns="http://Web">

<getInteractionsWithMedicamentsReturn>

<ambiguedad xsi:nil="true"/>

<explicacion>MONITOR CLOSELY: Some quinolone antibiotics have been reported

to potentiate the hypoprothrombinemic effect of warfarin and other coumarin anticoagulants. The exact mechanism is unknown but may involve inhibition of coumarin metabolism and/or depletion of certain clotting factors due to

suppression of vitamin K-producing intestinal flora.[...]</explicacion>

<gravedad>3</gravedad> <gravedadPalabra>4</gravedadPalabra> <idDrogaMed1>372756006</idDrogaMed1> <idDrogaMed2>372840008</idDrogaMed2> <idmanfarMed1>11247</idmanfarMed1> <idmanfarMed2>2695</idmanfarMed2>

<nombreDrogaMed1>warfarin</nombreDrogaMed1>

<nombreDrogaMed2>ciprofloxacin</nombreDrogaMed2>

<nombreMed1>COUMADIN 5 MG</nombreMed1>

<nombreMed2>ciriax 500</nombreMed2>

<presentacionMed1/>

<presentacionMed2/>

<tratamiento>MANAGEMENT: Given the potential for clinically significant

interaction and even fatality in the occasional, susceptible patient, close monitoring is recommended if a quinolone antibiotic is prescribed

during coumarin anticoagulant therapy. [...]</tratamiento>

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</getInteractionsWithMedicamentsResponse>

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