Narcotics Lollipop A. Should the FDA Ban Term Paper

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Narcotics Lollipop a. Should the FDA ban the narcotics lollipop? Go through the steps of the linear model to decide how this issue could be resolved.

Define Problem

The problem to be addressed is whether or not the narcotic lollipop should be barred. Answering this question requires consideration of various factors. Questions raised include:

Is the narcotic fentanyl too dangerous for children?

Is the narcotic fentanyl more dangerous than the tranquilizers used?

Is the lollipop as a means of distributing the drug also a problem?

Do doctors make up their own unregulated sedatives to calm children before surgery?

Is the lollipop preferable if the alternative is the unregulated sedatives doctors use?

Is there a problem with controlling the dosage of the drug?

Gather Evidence

Fentanyl is a drug used to treat chronic pain, pain associated with operative procedures and used to enhance general anaesthetics. It is commonly used as a preoperative medication to sedate patients prior to surgery, including being used for children. It is a narcotic in that it is addictive. Fentanyl is also a drug that is used illicitly, with actions similar to heroin, though the drug is around 100 times more potent than heroin. Fentanyl has been approved by the Food and Drug Administration (FDA) and is administered via injection and in lozenge form.

Tranquilizers used in preoperative conditions are mild sedatives, with diazepam the most common. Diazepam is used for preoperative sedation and for light anaesthesia. Diazepam can also be addictive with long-term use and is not recommended to be used for young infants.

Research has reported that the stress a child experiences on the day of surgery is a significant problem, with children experiencing nightmares, sleep and eating disturbances two weeks after the surgery and twenty percent of children experiencing problems six months after the surgery. One study also reports that preoperative sedation significantly reduces the occurrence of these postoperative problems. The same study reports that other non-drug methods such as preparing the child for the experience and having the parent present can be useful (Kain).

Sedation is also commonly used preoperatively, with it most important that the medication be easy to administer and have a rapid onset and offset. The most common preoperative medication for children is midazolam, with around 80% of cases using this drug. Midazolam is taken in oral form, has rapid onset, few side effects and is FDA approved (Kain).

3. Refine Evidence

The evidence collected has shown that reducing stress in the preoperative child is important enough to warrant using medication. The evidence needs to be assessed based on whether it indicates a problem with using fentanyl.

Firstly, fentanyl is approved by the FDA for use in preoperative conditions. This approval suggests that there is not a safety problem associated with fentanyl. Fentanyl also compares with the most commonly used drug, midazolam, in terms of working quickly, being easy for the child to take and having few side effects. Based on this information, there is no indication that fentanyl poses a safety concern. Fentanyl is addictive but with its use as a one-time medication, this fact is not relevant to the safety concerns.

The method of delivering the drug via a lollipop may be an issue of concern, with it worth considering what message this sends to children. However, considering the child does not need to be aware that the lollipop contains a drug, this point does not seem to be of concern.

One issue the research raises is whether fentanyl is a concern because of its narcotic effect. This concern is not associated with the children who use it, but with the question of whether it will lead to illicit drug users using the product for its heroin-like properties.

The other possible problem indicated is the concern over managing the dosage. However, the lozenge or lollipop form is no different from an oral dosage such as a tablet, with the content of the lollipop being known. The dosage is also not critical since it is the sedative effect that is required, an effect that an anaesthetist can observe.

4. Generate Hypotheses

If the preoperative stress children experience is significant, the use of a drug to reduce stress is warranted.

If the drug fentanyl is medically safe for children, its use to reduce stress is warranted.

If the drug fentanyl is for one-off preoperative use, its addictive or narcotic nature is not a concern.

The dosage method does not cause a concern since the lollipop sedative is only used once and the child does not need to be aware it contains a sedative.

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The dosage rate is not a concern since the lollipops have known drug content and the content consumed can be observed based on the effect seen in the child.

If the drug is a narcotic that illicit drug users are seeking, its misuse may be an issue.

5. Evaluate Hypothesis / Compare Old and New Data

The research has shown that fentanyl is medically safe for small children, leading to a conclusion that there is no reason to warrant its barring. At the same time, the use of a sedative has been seen to be important to reduce the stress children experience. Fentanyl then, is medically beneficial, something that the FDA approval confirms.

The narcotic effect of the drug is insignificant for the child, assuming the child is administered the drug correctly, that is, as a one-off preoperative dose. Problems would occur though, if the child was administered the drug more often, such as after surgery or for extended periods of time. This leads to the question of whether the lollipop format may reduce the product being seen as a drug and result in medical staff over-using it as a tool to calm children. Proper training and staff awareness then become issues worth considering. Medical staff need to be aware that the lollipop is a drug. Problems may also occur if the child is given too many lollipops prior to surgery. The consideration then, is how the product may be perceived by medical staff because of its form as a harmless-looking lollipop.

Finally, there is an issue with the drug being an illicit narcotic. This causes concern over how the drug is controlled.

6. Arrive at a Solution

The FDA should not ban the narcotic lollipops. They are an effective and safe drug that help reduce the stress of preoperative stress, a stress that can lead to major problems for the child. The drug being in the form of a lollipop makes administration to children easier. It does, however, need to be ensured that medical staff are aware of the nature of the product and that it is administered correctly. The issuing of the drug also needs to be controlled to prevent misuse by illicit drug users.

b. What further information is needed to make a decision?

The question of whether doctors do make up their own sedatives before surgery needs to be addressed. If this is the case, it needs to be known why available and approved drugs are not used. It would also be useful to know how medical staff perceive the product and whether they underestimate its nature as a narcotic because of the lollipop form. Finally, it needs to be known whether the lollipops are only used for preoperative sedation, or whether they are also used more regularly to calm children.

c. If you had to vote on this issue, would you allow the narcotic lollipop to be distributed?

If I had to vote on the issue, I would allow the lollipop to be distributed. A child having an operation is a significant stress and the process needs to be managed effectively. If the product was dangerous for children, I would not vote for its distribution. However, since the product is not dangerous to children but helpful to them, I see no good reason to bar it.

ASSIGNMENT B. a. Going through the linear model, spell out what needs to be done to reach a decision as to whether the Mescalero Apaches ought to store nuclear waste.

Firstly, the problem needs to be defined. The problem is whether or not the tribes should allow the U.S. government to store nuclear waste on their reservation. The problem can also be broken down into several areas, such as asking questions like, 'what impact the $50 million a year will have on the tribe' and 'what the cost is to the tribe.'

The next step is to gather evidence. Areas that need to be investigated include what difference the $50 million will make to the tribe, whether the nuclear waste storage is a long or short-term commitment, what will happen if the U.S. government later removes the waste and the $50 million income associated with it, whether there will be a social or safety cost to the tribe, why the U.S. government wants to store the waste in New Mexico and what relationship there is between the storage of the waste and the U.S. military.

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