The Safest Painkillers For Children Essay

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Use of those and other opioids has skyrocketed in recent years. Prescriptions have climbed 300 percent in the past decade, and Vicodin and other drugs containing the narcotic hydrocodone are now the most commonly prescribed medications in the U.S. With that increased use have come increased deaths: 46 people per day, or almost 17,000 people per year, die from overdoses of the drugs. That’s up more than 400 percent from 1999. And for every death, more than 30 people are admitted to the emergency room because of opioid complications.The Safest Painkillers For Children Essay

Find out the 5 things to know about prescription painkillers.

With numbers like that, you would think that the Food and Drug Administration would do all it could to reverse the trend. But against the recommendation of its own panel of expert advisers, last December the agency approved Zohydro ER, a long-acting version of hydrocodone. “We think the benefits of the drug outweigh its risks,” says Douglas Throckmorton, M.D., who oversees regulation of drugs for the FDA. He says that Zohydro ER offers an option to some people in pain, and that the FDA has taken steps to make all opioids safer by, for example, requiring stronger warnings on drug labels. The FDA says it will also keep a close eye on how Zohydro ER is used in the marketplace.The Safest Painkillers For Children Essay

But attorneys general from 28 states have asked the FDA to reconsider its decision because the drug offers no clear advantages over others already on the market and its potency makes it a target for misuse and abuse. And more than a dozen Republican and Democratic members of Congress have signed a bill that would ban Zohydro ER.

Opioids aren’t the only painkillers that pose serious risks. Almost as dangerous is a medication renowned for its safety: acetaminophen (Tylenol and generic). Almost 80,000 people per year are treated in emergency rooms because they have taken too much of it, and the drug is now the most common cause of liver failure in this country.The Safest Painkillers For Children Essay

Though some of those tragedies stem from abuse, many are accidental. It’s not just that people are careless. Advice to “take only as directed” doesn’t cut it when the advice is confusing and conflicting. And with acetaminophen, the advice is exactly that. For example, the FDA has lowered the maximum per-pill dose of prescription acetaminophen, but it hasn’t taken the same step for over-the-counter products. And OTC drugmakers have wildly different notions of what people can take: Some labels advise taking no more than 1,000 milligrams of acetaminophen daily; others set the limit almost four times as high.The Safest Painkillers For Children Essay

And with acetaminophen, accidentally taking too much is all too easy. That’s because it’s the most common drug in the U.S., found as an ingredient in more than 600 OTC and prescription medications, including allergy aids, cough and cold remedies, fever reducers, pain relievers, and sleep aids.

“All of this doesn’t mean that everyone should avoid opioids and acetaminophen altogether,” says Marvin M. Lipman, M.D., chief medical adviser for Consumer Reports. “But it does mean that the FDA should fulfill its role to protect consumers by taking strong steps to reduce the dangers, starting by reconsidering its approval of Zohydro ER and finally establishing consistent standards for acetaminophen.”

It also means you need to know the risks, not only of opioids and acetaminophen but also of drugs such as ibuprofen (Advil and generic), naproxen (Aleve and generic), and Celebrex. That last drug, now prescribed only under its brand name, should be available in the next year or so as a lower-cost generic called celecoxib. But like its nonprescription cousins, it poses serious risks to your heart and stomach when taken regularly, as millions of Americans do.The Safest Painkillers For Children Essay

Children experience pain in much the same way as adults do, but may manifest or display that pain in a different way. Pain for children is often emotionally complex, and the involvement of parents and caregivers can add to the difficulty of management. These factors, along with a cautious approach to giving analgesia to children, can lead to pain being under-treated in some situations.

Identifying pain involves observing the child’s verbal and non-verbal cues and listening to the parent’s judgement of the child’s pain. The signs and symptoms that indicate pain in children may be different from those seen in adults, and can be counterintuitive, e.g. quietness and withdrawal.The Safest Painkillers For Children Essay

Children presenting with pain in general practice fall into three broad categories:

Mild, acute presentations of conditions that are associated with pain and can be managed in the community, e.g. otitis media, sore throat and minor trauma
Acute presentations that require assessment or management in secondary care, e.g. burns, fractures, severe abdominal pain
Ongoing management of pain associated with long-term conditions, e.g. rheumatological disorders, cancer pain and pain without an identifiable cause, e.g. recurrent abdominal pain
For General Practitioners, the key decision point in an acute setting is: “is this child’s pain severe enough to warrant referral”? Depending on the cause, mild pain can usually be managed in the community, whereas moderate to severe pain is best managed in secondary care. If the source of the child’s pain cannot be identified, consider referral. In most situations, infants aged under six weeks should be discussed with or referred to a Paediatrician if pain relief is required and there is not an identifiable cause.The Safest Painkillers For Children Essay

Assessing and managing mild pain associated with general illness and injury in childhood
Assess the cause and severity of the child’s pain
The aim of assessment of children with mild pain is to identify the location, quality, duration and intensity of their pain.1 Consider aggravating and relieving factors, and if the child has already taken analgesia, consider the medicine, preparation, dose and effect in relation to current pain intensity.1

Self-reporting of pain by the child is the preferred method of assessing the level of pain.2 From approximately age 18 months, children will have acquired words to express pain, and from age three to four years, children may be able to provide information on the location of pain and describe the characteristics of their pain.1 However, consider whether the child is competent to provide such information.The Safest Painkillers For Children Essay

If pain has been present for some time, usual behavioural indicators of pain, such as grimacing and crying, may be replaced with abnormal posturing or movement, lack of facial expression or interest in surroundings, quietness, low mood and changes in sleep patterns, appetite or sociability.1

The signs and symptoms present will also depend on the physical and emotional state of the child, their coping style and their familial and cultural expectations of pain and illness, e.g. stoicism, hiding pain to avoid parental distress, expressing pain to receive attention.2

Pain assessment tools can be considered, but these tools are subjective and may under or over estimate pain. Examples include the Faces scales where the child is shown a series of faces in increasing distress and asked to identify the one they most relate to and the Poker chip tool where the child is given a set of chips that represent “hurt” and asked how many pieces their pain equals. Many of these tools are available online Managing mild pain: Paracetamol and ibuprofen The Safest Painkillers For Children Essay
In most acute childhood presentations associated with pain, analgesia should be used to provide short-term symptomatic relief while the cause of the pain is being investigated and managed, e.g. in a child with stomach pain due to constipation analgesia may be used until laxatives and dietary changes have had time to be effective.

Paracetamol (usually first-line) or ibuprofen are the most appropriate medicines for children with mild pain. These medicines are also commonly used for their antipyretic effect. Aspirin is contraindicated in children aged under 16 years.The Safest Painkillers For Children Essay

When prescribing analgesia to a child:

Calculate dose based on an up-to-date measurement of weight and then double-check the calculation
Check that the prescribed strength of liquid is as intended
Check that the total volume of medicine does not exceed what is required
Ensure the child is not being given any over-the-counter medicines that also contain the prescribed medicine
If pain is constantly present, analgesics should be administered on a regular schedule, i.e. “by the clock”.1 This results in more predictable and consistent levels of analgesia. The exception to this is children with intermittent or unpredictable pain, e.g. due to otitis media, where analgesia given on an as required basis is more appropriate.1 Estimating the peak effect time of analgesics in children is difficult due to the variability in absorption rate. For example, paracetamol absorption rate following oral administration depends on gastric emptying time, which is variable in infants and children, ranging from five minutes to several hours (average approximately one hour).The Safest Painkillers For Children Essay

NOW

The most fatally abused drugs are legal and sitting in the medicine cabinet: opioid pain relievers.

Sixty people die every day as a result of overdoses from opioids. In a year, that’s 22,630 deaths, a total roughly equal to the population of a small town.

Americans know opioids are addictive, but they do not understand how addictive, according to a public opinion poll conducted by the National Safety Council. Nine out of 10 opioid painkiller users said they were unconcerned about addiction. Yet, nearly 60% reported at least one addiction risk factor in looking at personal or family history.The Safest Painkillers For Children Essay

In part, these findings help explain the steady increase in prescription drug overdoses, which has raised death rates for white adults between the ages of 25 and 34, and helps explain why drug overdose deaths have spiked in nearly every corner of America.

NSC examined a physician study of Medicare claims in Pennsylvania and New Jersey and found those taking opioids experienced:

A greater risk of having a cardiovascular event
Equal rates of GI bleeding
Four times as many fractures
68% greater risk for being hospitalized for an adverse drug event
87% greater risk of dying during the study period
Centers for Disease Control and Prevention guidelines call for everyone on chronic opioid treatment to undergo periodic evaluation to assess the risk of opioid-related side effects.

Opioids to Heroin: All Too Common Transition
When Louis Miceli suffered an injury playing high school football in suburban-Addison, IL, his doctor prescribed opioid painkillers. He grew addicted to the drugs. He later switched to heroin and eventually died of an overdose. Studies show 4% to 6% of opioid misusers will transition to heroin.The Safest Painkillers For Children Essay

Today, Miceli’s mother, Felicia, works with NSC to address the risks of opioids that can lead to addiction. Research indicates 80% of new heroin users started with opioid pain relievers.

Opioid Side Effects: On the Road, in the Workplace
Opioids are known to increase patient sensitivity to pain and produce harmful side effects. Emotional and physical withdrawal symptoms range from anxiety and restlessness to muscle tension and tightness in the chest.

On the road and in the workplace, opioids pose risks, too, particularly for those involved in safety-sensitive positions such as forklift drivers and crane operators. In larger doses, opioids can cause marked impairment, leading to drowsiness, lethargy and even death.The Safest Painkillers For Children Essay

Factors affecting drug disposition in children
Oral absorption
Variable gastric and intestinal transit time: in young infants, gastric emptying time is prolonged and only approaches adult values at around 6 months of age. In older infants, intestinal hurry may occur.
Increased gastric pH: gastric acid output does not reach adult values until the second year of life.
Other factors: gastrointestinal contents, posture, disease states and therapeutic interventions, such as drug therapy, can also affect the absorption process.

Distribution
Increased total body water: as a percentage of total body weight, the total body water and extracellular fluid volume decrease with increasing age. Neonates require higher doses of water-soluble drugs, on an mg/kg basis, than adults.
Decreased plasma protein binding: plasma protein binding in neonates is reduced as a result of low levels of albumin and globulins and an altered binding capacity. High circulating bilirubin levels in neonates may displace drugs from albumin.The Safest Painkillers For Children Essay
Metabolism
Enzyme systems mature at different times and may be absent at birth, or present in considerably reduced amounts.
Altered metabolic pathways may exist for some drugs.
Metabolic rate increases dramatically in children and is often greater than in adults. Compared with adults, children may require more frequent dosing or higher doses on an mg/kg basis.
Excretion
Complete maturation of renal function is not reached until 6-8 months of age.

Route of administration and drug regimes
Compliance in children is influenced by the formulation, taste, appearance and ease of administration of a preparation.
Prescribed regimens should be tailored to the child’s daily routine. Where possible, treatment goals should be set in collaboration with the child.
Whenever possible, the use of products which avoid the need for administration during school hours should be considered (eg, modified-release preparations or drugs with long half-lives). When administration at school is unavoidable, consideration should be given to prescribing and supplying the school time dose in a separate labelled container.The Safest Painkillers For Children Essay
Most schools will request written permission from parents to administer the medicine, or may ask parents to return to school to give the medicine themselves.[1]
Whenever possible, painful intramuscular (IM) injections should be avoided in children.
Product licence
Where possible, medicines for children should be prescribed within the terms of the marketing authorisation (product licence). However, many children may require medicines not specifically licensed for paediatric use.
The Medicines Act 1968 and European legislation make provision for doctors to use medicines in an off-label capacity or to use unlicensed medicines. However, individual prescribers are always responsible for ensuring that there is adequate information to support the quality, efficacy, safety and intended use of a drug before prescribing it.
Although medicines cannot be promoted outside the limits of the licence, the Medicines Act does not prohibit the use of unlicensed medicines. It is recognised that the informed use of unlicensed medicines or of licensed medicines for unlicensed applications (‘off-label’ use) is often necessary in paediatric practice.The Safest Painkillers For Children Essay

Prescription writing
Inclusion of age is a legal requirement in the case of prescription-only medicines for children under 12 years of age, but it is preferable to state the age for all prescriptions for children. It is particularly important to state the strengths of capsules or tablets.
Although liquid preparations are particularly suitable for children, they may contain sugar which encourages dental decay. Sugar-free medicines are preferred for long-term treatment. Many children are able to swallow tablets or capsules and may prefer a solid dose form; involving the child and parents in choosing the formulation is helpful.
When a prescription for a liquid oral preparation is written and the dose ordered is smaller than 5 mL, an oral syringe will be supplied.
Parents should be advised not to add any medicines to the infant’s feed, since the drug may interact with the milk or other liquid in it; moreover, the ingested dosage may be reduced if the child does not drink all the contents.
Dosages
Children are not mini-adults. Paediatric doses should be obtained from a paediatric dosage reference text and not extrapolated from the adult dose.
When considering drug use in children, the following age groups should be used: Preterm (born before 37 weeks), neonate (birth to 1 month), infant (1 month to 12 months), child (1 to 12 years) and adolescent (12 to 18 years).
Unless the age is specified, the term ‘child’ in the British National Formulary (BNF) includes persons aged 12 years and younger.

Dose calculation
Children’s doses may be calculated from adult doses by using age, body weight, or body surface area, or by a combination of these factors. The most reliable methods are those based on body surface area.The Safest Painkillers For Children Essay
Body weight may be used to calculate doses expressed in mg/kg. Young children may require a higher dose per kg than adults because of their higher metabolic rates.
Other problems need to be considered. For example, calculation by body weight in the overweight child may result in much higher doses being administered than necessary; in such cases, dose should be calculated from an ideal weight, related to height and age (there is a simple table at the back of the Children’s BNF – see under ‘Further reading & references’, below).
Body-surface area estimates are more accurate for calculation of paediatric doses than body weight since many physiological phenomena correlate better to body surface area.
Body surface area may be calculated from height and weight by means of a nomogram or using the Body Surface Area (BSA) Calculator although other paediatric drug calculators are available.[2]The Children’s BNF uses the Boyd calculation here. The Safest Painkillers For Children Essay
Adverse drug reactions
Adverse drug reaction profiles in children may differ from those seen in adults. Doctors and pharmacists should report suspected adverse drug reactions to the Medicines and Healthcare products Regulatory Agency (MHRA), even if the product is being used in an ‘off-label’ manner or is an unlicensed product. Identification and reporting of adverse reactions to drugs in children are particularly important because:

The action of the drug and its pharmacokinetics in children (especially in the very young) may be different from that in adults.
Drugs are not extensively tested in children.
Many drugs are not specifically licensed for use in children and are used ‘off-label’.
Suitable formulations may not be available to allow precise dosing in children.
The nature and course of illnesses and adverse drug reactions may differ between adults and children.

Safety in the home
Patients must be warned to keep all medicines out of the reach of children. All solid dose and all oral and external liquid preparations must be dispensed in a child-resistant container unless:

The medicine is in an original pack or patient pack such as to make this inadvisable.
The parent will have difficulty in opening a child-resistant container.
A specific request is made that the product shall not be dispensed in a child-resistant container.
No suitable child-resistant container exists for a particular liquid preparation. The Safest Painkillers For Children Essay

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