Friday, November 23, 2007

Chex Mix Recipe With Sesame Seeds

Risk Disclosure: An Analysis of a pharmaceutical case

risk disclosure is usually done through two communication channels. On one side is the formal education through which one can not only release but to educate against risks such as that involves the presence of a tsunami and on the other hand, the media, which ultimately are the most publicly convened . This second channel can be converted, as u turn at risk. Luhmann expresses about:

"Faced with the inability to decide on a perfectly rational (optimal) and against the impossibility of predicting what will have been a decision, all communication becomes at risk: of not having served something that later turns out to be important or have decided in a way that later prove to be wrong or somehow reprehensible. But the lack of communication also protects us from this risk, since it can be converted, as default, in a decision. "

(Luhmann, 1998, pg. 242)

The disclosure must be so objective, responsible and effective (best), enabling the successful prevention and risk management.

course the case that management is closely related to the disclosure, dissemination, and perception of risk, if only because it can produce an expansion of the real risks the same way communication of potential risks

(Alvarez Alvarez, 2005)

Extension, attenuation, distortion, stigma, fear mongering, panic may be present in the pharmaceutical case analysis of this corner.

In 2004 an email circulated from a source from Argentina, which had led CIRCULAR DO! URGENT - RISK OF DEATH, with the following contents:

The Ministry of Health through the National Agency Health Surveillance suspended by Resolution 96 manufacturing , distribution, handling, marketing and storage of medicines with the active ingredient called FENILPROPALAMINA. The move came after the Food and Drug Administration (FDA), U.S., found that the substance caused adverse effects on users FATAL Americans (cerebral hemorrhage). In Brazil, the suspension is preventive once that there are no reported cases. THE FENILPROPALAMINA drug is present in 21 ...

Then there is a list of 21 drugs, including some flu there for public sale in shops and Colombian supermarkets [1] . Why this disclosure is in Argentina and not in Colombia? What happens to the mass of the population without access to this means of communication? Were my first questions when reading this post.

E was massively circulated Internet. I know that not everything on the net is to be believed, so I consulted the FDA (Food and Drug Administration) cited by the mail, it announced:

Scientists at Yale University School of Medicine recently issued a report
Entitled "Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final Report of the Hemorrhagic Stroke Project." This study reports PPA That Increase the Risk Taking of hemorrhagic stroke (bleeding Into Into the brain or tissue surrounding the brain) in Women. Men May Also Be at Risk. Although the Risk of hemorrhagic stroke is very low, FDA Recommends That Consumers Not Any use PPA products That Contain

Federal Register (Volume 66, Number 157)

In 2007 the FDA page presents the following warning:

Not satisfied with this, I managed to find the scientific study of Yale University. In a document dated 25 May 2000 pages (the problem was detected four years earlier), we present the results of a study performed on a sample of nearly 800 patients. Without more details of this investigation, I find the following conclusion:

In conclusion, the results of the Hemorrhagic Stroke Project (HSP) Suggest That phenylpropanolamine (PPA) Increase the Risk for hemorrhagic stroke. For Both Individuals considering use of PPA and for policy makers, the HSP Provides important data for a contemporary Assessment of Risks associated with the use of PPA.

why the Argentine government takes such a decision and not Colombian? Argentina amplifier station gave more prominence to the event, it would be a plausible answer.

In October 2007, a notice is generated globally from the U.S. lab Wyeth. In Colombia, well reported,

Wyeth The U.S. lab just recall the Dimetapp cold medicine pediatric drops as a preventive measure. In Colombia are sold between 20 thousand and 30 thousand bottles of Dimetapp pediatric drops that are for consumption by children aged 0 to 2 years old. "We have adopted such measures and responsible for suspending the sale of pediatric drops Dimetapp in Colombia," said Wyeth's medical director in the Andean region, Andres Zapata [...] claims that the pediatric drops Dimetapp is not harmful to health children and 20 years sold in Colombia. What happens according to lab spokesman, is that abuse can cause side effects in infants such as drowsiness.

http://www.caracol.com.co/ (October 10, 2007)

According to information, risk generators are the irresponsible parents who do not know how to use the-counter medication or prescription.

The Dimetapp is one of 21 drugs reported by the Argentine post. Until the previous news fenilpropalamina the problem was now presented as case reports of withdrawal of pseudoephedrine Dimetapp.

Two days later (12 October) the deputy director of drugs Invima announced that "a week" there will be the evaluation of cold medicines that counter in the country.

A little help for the deputy. The same Invima published a list of over 1200 Wyeth products in Colombia. Over 300 of these have fenilpropalamina or pseudoephedrine, 60 of them with pseudoephedrine hydrochloride (Dimettap, dristancito, hot Dristan, Sinutab, Robitussin, ...) and 125 with pseudoephedrine hydrochloride (do not know what the difference with the previous but including DolEx is the flu, the noxpirín and acetaminophen). As I have removed phenylpropanolamine the following table:

PRODUCT

REGISTER

FORM FARMECUTICA

COMPONENT

Dimetapp JUNIOR

INVIMA M-013 658

SYRUP

HCL PHENYLPROPANOLAMINE

pediatric drops Dimetapp

INVIMA 2001M-0000388

ORAL SOLUTION

HCL USP PHENYLPROPANOLAMINE

CONTAC C-

INVIMA M-010 139

CAPSULE HARD

CLORHIDRATO DE phenylpropanolamine

DESCONGEL L TABLETAS

INVIM M-13518

TABLET

phenylpropanolamine CLORHIDRATO

DESENFRIOLITO DD TABLETAS

M-005 052

TAB

PHENYLPROPANOLAMINE HYDROCHLORIDE


Another little help,

The National Institute Food and Drug Monitoring - INVIMA informs the general population taking into account the results of the program demonstrates the quality of 2006, has applied to the sections of the country's health and pharmaceutical market withdrawal of the drugs listed attached, because not meet the quality standards established within the health record.

Bogotá, August 25, 2007

Of 827 samples tested in 2006, 34 did not meet the quality parameters, 11 of them with the active component pseudoephedrine hydrochloride trade name "Dristan Ultra" Wyeth Lab

The laboratory notes now used more cough and cold medicines children under 2 years

What can we do with this information? "Stigmatize the lab? "To generate panic in the population? Or simply go to one of the early world of uncertainty ... caution.

In a matter of precaution we have much advantage as European countries. During my visit to Spain in the first quarter of 2007 bought a shot, transcribed verbatim side effects posted "conspicuously" in the box: "The most common side effect is sedation and drowsiness, gastrointestinal upset, constipation, confusion, euphoria, visual disturbances, dry mouth and difficulty urinating. Have also been reported rashes, hives and severe allergic reactions and blood disorders. " Therefore recommend consulting your doctor or pharmacist the right shot, in contrast to Colombia, which allows the free sale at any corner store.

'm not a doctor or pharmacist, you may be exaggerating the information received, but in my house will not buy and consume influenza as set forth in this section ... just as a precaution.

Bibliography

Alvarez Alvarez, JF (2005). A great evils small remedies: risk management. In JL Luján, & J. Echeverría (Edits.) Governing risk: science and values \u200b\u200bin risk society (pp. 310-325). Madrid: Biblioteca Nueva.

Luhmann, N. (1998). Sociology of Risk. Mexico: Triana Editores.






[1] The 21 Argentina suspended medications include: Benadryl, day and night, Contac, Naldecon Bristol; Acolde; Rinarin Expectorant; DeltaP; Desfenil; HCl fenilpropalamina; Naldex; Nasaliv; Decongex Plus; Sanagripe, Descon, Descon AP; Descon Expectorant; Dimetapp ; Dimetapp Expectorant; Plus CERACOL; Ornatrol; Rhinex AP; Contilen and Decidex.


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