Category Archives: Patient Care

“Off Label” Drug Marketing: Are Your Family’s Medications a Safe Fit?

Have you ever wondered whether the prescription your doctor has given you is really intended for you? It’s a very good question. Drug companies market their products to physicians, sometimes for conditions not mentioned on the drug’s Food and Drug Administration (FDA)-approved label. Physicians may not always know when the drug’s abilities have been overstated, and prescribe you a drug not originally made for your condition.

This is called “off-label prescribing”. Widely used drugs like Miralax and Zofran have come under fire recently for being linked to health issues when not used in accordance with FDA-approved labeling. For this reason, it’s important to do your research on a drug is important before you begin a new medicine regimen.

What does “Off-Label” Mean?

The FDA must approve any drug that goes on the market. This includes naming what the drug is intended to do.

According to the FDA, off-label prescribing “mean[s] that the drug is:

  • Used for a different disease or medical condition.
  • Given in a different way (such as by a different route).
  • Given in a different dose.”

Drugs Like Zofran and Miralax Have Given Warning Signs

Many people can take a drug off label with no problem. But when problems pop up, patients should pay attention.

One example is the drug Zofran (ondansetron). Originally prescribed for cancer and post-surgical patients, it is also being used to treat morning sickness in pregnant women. Studies done in 2012 and 2013 showed increased risk for cleft palate and congenital heart defects in newborns whose mother took Zofran in their first trimester. The FDA also issued a warning about ondansetron causing potential heart defects in babies. Yet, the drug is still prescribed by many doctors for pregnancy-related nausea.

The laxative drug Miralax is also getting some heat, namely for its main ingredient polyethylene glycol, or PEG. Miralax’s label originally stated that it was not intended for children, but the label has since changed. Many physicians now prescribe PEG laxatives for children, even though these drugs have been connected to neuropsychiatric events such as tremors, tics and obsessive-compulsive behaviors. The FDA is funding research to better understand the long-term effects of the drug, and whether its absorption in the colon differs in children and adults.

Off-Label Safety is in Your Hands

What can you do to learn more about a drug before taking it? Searching for a drug online will tell you its intended use. You should also talk to your pharmacist about the drug. Find out if your prescription is approved to use with your condition, and if the dosage you are given is appropriate. If the medicine is for your child, ask if the medicine has been approved for non-adult use. Most importantly, ask about all known side effects caused by the drug.

The Cerebral Palsy Family network Facebook page is often filled with parents’ questions about different drugs. Why? Because parents know that medications can have different reactions for each child. It’s important to understand whether a new medication’s benefits outweigh its risks, especially when going “off label”.

Adaptive Seating Devices for Children with CP

By Casey Daniel

Technically speaking, adaptive seating is defined as “modifications to seating devices to improve sitting posture and/or postural control in mobility-impaired individuals.” In layman’s terms, this means your child may use a special desk or wheelchair that has been personalized to meet their needs. This chair may involve features like external supports, “saddle seating,” adjustable seat depth, and so forth. There are several different types of adaptive seating devices.

Common Types of Adaptive Seating Devices

Saddle Seats (Bolster Chairs)

These narrow seats allow your child to sit in “saddle position.” Recommended for children with spastic or athetoid CP who experience stiffness in their legs, saddle seats help maintain hip flexion. Bolster chairs are considered a safer seating alternative for kids who sit on the floor with their legs beneath them (“W-sitting”), which can cause muscle contractures and skeletal deformities.

In bolster chairs, pelvic and foot supports maintain bodily alignment, freeing the hands for activities – and preventing loss of posture when the child moves. The adjustable foot supports keep the hips and knees at right angles, so the child is always centered over the base of support.

Seat Inserts

Seat inserts range from elaborate biofeedback devices to simple contoured foam pieces. Contoured foam seating (CFS) is a popular option because it is affordable, easy to transport, and simple to modify.

Built with an eye for skeletal alignment, CFS inserts hold the pelvis in a neutral position. These inserts are thought to increase postural stability and sharpen somatosensory feedback – meaning the child’s perception of bodily sensations (like pressure and warmth) becomes clearer.

External Supports

There are a variety of external support features on special needs chairs for children, but the most common is the corner chair. Corner chairs assist with visual scanning, breathing, eating, and development of arm mobility; they are ideal for children who lack postural control of the head, neck, or trunk.

The back of the chair is V-shaped rather than straight, and the seat can be lifted or lowered. A raised seat promotes thigh alignment, reducing both tightness in the hamstrings and spasticity in spinal and pelvic alignment. A lowered seat allows the child to relax with legs extended.

Corner chairs often come with abductors, or rectangular cushions that are placed between the distal femurs to ensure hip alignment. The abductor, in conjunction with the seatbelt, helps prevent the child from sliding or pushing out of their chair.

Some adaptive chairs are similar to corner chairs, but with one key difference: they have a straight back, rather than a V-shaped back. These seats are ideal for children who struggle less with head and neck control, but more with hip adduction. Straight-backed adaptive chairs are often recommended for kids who experience undue rotation stress on their femoral heads.

Some adaptive chairs offer a pelvic femoral stabilizer – a vertical, padded board that extends across the front of the knees, keeping the child positioned firmly on the seat.

Benefits of Adaptive Seating Devices

Adaptive seating devices are believed to provide skeletal stability, thus improving postural control. Postural control allows children to develop heightened functional ability – particularly mobility of the arms, grasping, visual scanning and tracking, and especially self-feeding. These devices are particularly useful in the development of self-feeding skills because they hold the pelvis in a neutral position, providing a secure foundation for the rest of the spine. Altogether, this promotes trunk alignment, which both frees the child’s hands and allows for proper digestion.

Adaptive seating is also associated with decreased risk of spinal deformity. In some cases, these devices can promote the correction of existing scoliosis in children with CP.

Researchers commonly observe that individuals who use adaptive seating devices often experience increases in social interaction, occupational satisfaction, and performance of the activities of daily living (ADL). Many of these improvements persist even after the device is removed.

One study suggested that regular use of adaptive seating devices can “prevent deterioration of [an individual’s] measured skill set over a period of five years.” This means that, in addition to increasing function and posture during use, these devices can help “lock in” existing abilities and result in cumulative improvement over time.

Studies About the Benefits of Adaptive Seating Devices

Dozens of studies about the benefits of adaptive seating devices have been conducted since the 1980s, but their findings have varied widely. At the end of 2008, the American Physical Therapy Association (APTA) oversaw a comprehensive review of these studies’ methods and results, which was published in their pediatric journal.

APTA concluded that the devices seem to help manage impairments associated with CP and can improve overall function. They noted that quality research on whether these devices truly improve postural control is limited, and the results of this research have been mixed.

Research into the benefits of saddle seats yielded mixed results – some children experienced improved mobility and posture, while others did not. Seat inserts, external supports, and modular seating systems produced more uniformly positive findings, with the majority of children demonstrating improvements. All devices – especially saddle seats and seat inserts – seemed to bolster social skills and ADL performance to some degree.

Nearly all adaptive seating devices showed positive results moreover, APTA concluded – but the improvements were rarely drastic. Anecdotal evidence for the benefits of these devices, however, is strong; an overwhelming majority of families report substantial improvements in their child’s performance when the child is using an adaptive seating device.

For more information about the implications of various seat inclinations, see Proper Positioning for Children with CP.

Sources

Pediatric Physical Therapy Journal:  Effectiveness of Adaptive Seating on Sitting Posture and Postural Control in Children with Cerebral Palsy

E-Special Needs:  Adaptive Classroom Seating and Proper Positioning

Aubrey Bailey for the Houston Chronicle:  Adaptive Equipment for Kids with Cerebral Palsy for Feeding Themselves

Rifton Adaptive Mobility and Positioning Blog – Adaptive Seating:  Evidence for Practice

 

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The Benefits of Family-Centered Care

Many, if not most, treatment plans for children with CP are centered exclusively on the child. While a child’s interests must always be considered, the narrow focus of such plans can overlook crucial factors, like “living environment” and “family dynamic.”

In contrast, family-centered care is a philosophy – and an approach to healthcare – that fosters close, mutually beneficial relationships between patients, families, and healthcare professionals. Family-centered care integrates the needs and input of relatives into the child’s treatment plan. After all, family life is the prevailing constant in the life of any child.

Key Components of Family-Centered Care

St. Jude’s Children’s Research Hospital outlines the core concepts of family-centered patient care:

  • Dignity and respect – each family’s values, backgrounds, and choices are honored;
  • Information sharing – communication is open and honest between families and doctors; families are updated with timely, thorough, and accurate details about a patient’s treatment;
  • Involvement – patients and families actively participate in the child’s care and the decision-making process; and
  • Collaboration –patients and family members work with healthcare staff to develop and evaluate programs and policies.

Caretakers’ Needs

Family-centered care emphasizes the needs of family members as well as those of the patient. Caretaking is a demanding job that can incur serious stress upon family members – a reality that family-centered care acknowledges.

Caretakers must consistently attend to numerous needs, like feeding a child, helping them use the bathroom, or taking them to medical appointments. Additionally, caretakers must appropriately manage a child’s “challenging behaviors.” For example, when a toddler with CP cries persistently, is the child simply having a temper tantrum – or are they expressing that they’re in pain due to muscle spasticity? Caretakers must routinely make difficult, stressful judgment calls about important issues. Researchers believe that this contributes to the heightened levels of chronic physical ailments, like stomach ulcers, among the caregiving population.

Relatives must maintain a healthy balance within their personal lives in order to effectively support a child with CP. In fact, studies show that family function is the strongest predictor of mental health in caregivers. In other words, a solid, functional support system works wonders for everyone involved! Prevention and reduction of family stress is a must.

Family Knows Best

Family-centered care also recognizes that parents or other caretakers know the patient best, and thus have the greatest insights into what a patient needs. Unlike the “take it or leave it” approach exercised by many healthcare providers, a family-centered approach actively involves family members in decisions about the child’s care.

In family-centered care scenarios, healthcare professionals solicit insights from relatives about how to better plan and deliver care. Information is exchanged openly, and a family’s preferences are respected. It’s difficult to understand why family-centered care is not a universal norm! After all, what is right for one family is not necessarily right for another. Healthcare isn’t “one size fits all,” and cannot be treated as such.

Learning More About Family-Centered Care

As a family member, caregiver, or individual with CP, it is worthwhile to request a family-centered approach to therapeutic, health, and educational services! Bring the subject up to your child’s service providers and other individuals within your healthcare community.

When seeking preliminary information about family-centered care, Dr. James Blackman of the CP International Research Foundation recommends this section of The CanChild Centre for Childhood Disability Research’s website. From there, we hope you will continue to educate yourself and pursue the option of family-centered care for your child and family. Family-centered care will improve the outcomes of your child’s treatment plan – and hopefully will inspire other families to follow suit!

Sources

Cerebral Palsy International Research Foundation: Medical Director’s Desk – Family Centered Care

St. Jude Children’s Research Hospital: Family-Centered Care

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