FDA approval of fentanyl lollipops for pediatric preoperative sedation

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.

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.

The next stage is to refine the evidence by looking at the evidence collected and relating it to the issue and the problem as it was defined. The evidence that is relevant to the problem needs to sorted, understood and prioritized.

Hypotheses then need to be generated based on the evidence that has been collected. These hypotheses need to be listed in the if/then format.

The hypotheses that have been generated then need to be assessed based on the information collected. This is the process of reapplying the data to the hypotheses to see if the hypotheses can either be proved or disproved. This allows for weak arguments to be seen and may also require further research to verify the hypotheses.

Finally, the solution can be arrived at. This involved stating what the conclusion or solution is and then restating the evidence for that solution.

b. What relevant moral or social concerns ought to be considered here?

Consideration needs to be given to why the U.S. wants to store the nuclear waste in New Mexico. This raises concerns of whether New Mexico's financial problems allows the U.S. government to take advantage of them. Social concerns include the effect the storage will have on the tribe, including whether there is a safety or environmental risk. Another consideration is whether the $50 million deal will result in the tribe needing the agreement to continue, for the money they may come to rely on. If this is the case, the U.S. government then becomes in a position of power where it can ask for other concessions for the deal to continue. The political and social significance of the deal therefore becomes relevant.

ASSIGNMENT C

1.

a. From Stan's perspective, what's the problem?

The first problem for Stan is that he does not want to eat meat. His problem when he visits his parents is whether to eat meat to keep his parents happy, even though it is against his beliefs, or to remain with his diet and make his parents unhappy.

Another issue for Stan is with his parents not accepting his beliefs. Stan, being a vegetarian for five years, must have a firm belief in his choice. His parents not respecting his decision but seeing it as 'yet another trend' is another problem for Stan.

b. How does Claudia likely see the issue? How do her parents?

Claudia sees the issue as one of wanting to get out of the trip, but not wanting to lose the money her parents lent her. Claudia clearly does not want to go on the trip and is not interested in finding a way to make the trip workable. Claudia is also likely to be concerned about what she will tell her parents, how they will react and whether they will be hurt and disappointed that the good money they spent will be wasted. There is also the issue of whether they will be able to trust her in the future.

Claudia's parents are likely to see that it is a minor problem not important enough to cancel the trip. They are likely to view Claudia's change of mind as flighty and irresponsible and be concerned that she will change her mind again within the two weeks. There is also an issue for the parent's about having their good money wasted, an issue that is likely to make them feel disappointed in Claudia.

c. How could we set out a way to solve the problem(s) you consider most pressing? Set out a plan and discuss your recommendations.

Claudia clearly is focused on getting out of the trip, not on making the trip work. The first problem is that this initial reaction is preventing Claudia from thinking clearly. This trip was something Claudia wanted, so the switch to being against it indicates that Claudia is thinking emotionally, not logically. Since Claudia cannot get the money refunded the best solution is for her to go on the trip. This solution eliminates the problem of how to tell her parents she is not going and how they will react, avoids her wasting the $450 and avoids the problem of how to get out of the trip. The only problem remaining is how to make the trip workable, this one problem being one Claudia can more easily deal with.

The first step in dealing with the problem is for Claudia to define the specific reasons why going on the trip is a problem. This could be that she does not want to associate with her old boyfriend, that she does not want to associate with her old friends, both, or that she does not have a boyfriend on the trip. Once the problem is specifically defined, Claudia can take action.

If it is only avoiding her boyfriend that is the problem, this can be managed simply by staying away from him. If it is avoiding her boyfriend and her friends that is the problem, Claudia might be able to upgrade her accommodation package so she does not stay with her friends. This would allow her to have a good holiday, while not wasting the $450 dollars, only adding to it with some of her own money. If not having a boyfriend with her is the problem, she could take her new boyfriend, using her money to purchase him a ticket as well. If the old boyfriend also does not want to go, she could purchase his ticket from him and give it to her new boyfriend. The option selected depends on the specific problem that Claudia has defined.

The solution then is for Claudia to eliminate all the problems except one by deciding to go on the trip. The plan involves defining exactly why she does not want to go on the trip. Based on this reason, alternatives can be determined of ways to avoid the problems of the trip. These alternatives can then be assessed. For example, if upgrading to different accommodation is an alternative, the research will determine whether this is possible. If taking her new boyfriend is an alternative, research will determine whether he can go. The end results is that solutions to these problems that prevent Claudia from enjoying the trip are eliminated so that the trip is the enjoyable vacation she wanted in the first place.

3.

a. Given that this event took place over 40 years ago, is there any reason to publicize it now?

Even though this event took place 40 years ago, there is still reason for it to be publicized now. Firstly, it is not known whether this zinc cadmium sulfide is still present and still represents a health risk. This chemical may have also leached through to the groundwater or be having other significant environmental effects. By publicizing the event now, this can be investigated to see if there are any current health or environmental problems.

Secondly, this leads to questions of whether these types of practices are still being carried out. The article does not say whether this activity was carried out openly or secretly. If this was carried out secretly, risking lives while not informing people of the risks, it is of concern that these practices may still be taking place in the current time.

Finally, if this area was a toxic test site in 1953, are there other toxic test sites that people are unaware of? The issue leads to questions of whether other sites that are health risks exist, with people being unaware of the risks.

b. Given that this was done without the knowledge or consent of people living in the area, should those involved in planning and executing such toxic spraying be held accountable?

There are several questions that need to be answered before deciding whether those planning and executing the toxic spraying should be held accountable.

Firstly, were the risks associated with the process known in 1953? The chemical is described as being a toxic one and a suspected carcinogen, but this may not have been known in 1953. The concentration of the toxic material is also not stated. The concentration may have been within safe levels and therefore would not be thought to pose a risk to people.

Secondly, it may be important to determine who made the decision to carry out the toxic testing. Presumably, it was carried out by military personnel. These personnel are in a position of following orders rather than making decisions, so it is difficult to suggest these people should be held accountable.

Finally, it is worth considering why the testing was completed. The testing was for the purpose of testing a screen to protect people from nuclear fallout. At the time of the testing, the threat of a nuclear war may have been a significant threat. The damage the testing is attempting to prevent may justify the potential damage to a town. Whether these decisions can be justified though, depends how much was known about the risk the process posed for the people of Minneapolis. Even though this activity seems unjustified at first, it must be looked at from the perspective of the time the decision was made. With a very real threat of nuclear war existing, the decision to complete the tests may have been a valid one.

c. What ought to be done further, in terms of notifying affected citizens and examining public safety concerns regarding this event?

This event needs to be assessed to determine if it does pose a current health risk. If it does, then affected citizens should be informed of the risks. If there is no current health risk, nothing needs to be done about this particular event.

However, this information can be used to look at current and future military tests. This information can be used to look into how current military testing is carried out and how the health risks associated with testing are identified. This also involves looking at how public safety is assessed, with it unacceptable that people are unknowingly put at risk for the purpose of military testing.

ASSIGNMENT D

D. DeWayne Murphy situation - Linear Method

The first step is to define the problem, which is whether convicted felons should be provided expensive medical care. Other questions the issue raises include what rights felons have and how decisions are made on who receives medical services. The argument would be for providing the prisoner with the medical care.

The second step is to gather evidence. The evidence to be collected includes who is financially responsible for prisoners, what the prison system is meant to achieve, how decisions are normally made on who receives medical services such as organ donations, what the implications would be if the prisoner died because he did not receive the operation, and whether there are any other cases of this type of problem.

The third step is to refine the evidence by selecting the evidence that is relevant to the issue and relating it to the argument that Murphy should be provided with medical care.

The next step is to generate hypotheses based on the evidence collected.

The fifth step then evaluates the hypotheses by relating them back to the information collected. This also includes reassessing the issue from different perspectives. This issue can be seen from several perspectives and poses various complex questions. The prison appears to be more concerned about the outlay of money, leading to the question of whether the operation is acceptable if the prisoner can finance it. This can also lead to other questions such as is the prisoner entitled to medical insurance while in prison. Another question raised is whether the worthiness of a prisoner to medical care can be determined based on the seriousness of a crime. Would the issue change if Murphy was in prison for murder, rather than possession? This step involves looking at these other issues raised and determining if they have any impact on the hypotheses.

The final step is the solution, which describes the conclusions the other steps have led to. This step states whether the hypotheses have been proved or disproved and then provides the reasons for the conclusions made.