EDUCATING PHARMACY TECHNICIANS FOR SUCCESS: UNDERSTANDING CURRENT ISSUES IN PEDIATRIC MEDICATION ADHERENCE

Objectives  Understand the common barriers to medication adherence  Discuss implications of poor medication adherence  Review the anatomy and physiology of taste  Identify how taste can impact medication adherence  List common medications associated with poor palatability  List considerations for flavoring medications in clinical practice  Explain the importance of choice and patient preferences with regards to medication adherence  Explain how flavoring can improve the patient medication experience and ultimately improve medication adherence

Adherence

“Patient adherence ~ the extent to which a person's behavior- taking medication, following a diet, and/or executing lifestyle changes- corresponds with agreed recommendations from a health-care provider.” Source: Sabate E, ed. Adherence to long-term therapies: evidence for action. Geneva, World Health Organization, 2003.

Adherence Pediatric non-adherence is a major concern for many reasons  Continued disease processes  Spread of illness  Slower recovery  Health complications  ER visits /Hospitalizations  School/Work absenteeism  Antibiotic resistance  Costs incurred by additional doctor visits and therapeutic drug changes “rugs don’t work in patients who don’t take them.” ~ C. Everett Koop Drugs don’t work in patients who don’t take them. C. Everett Koop

Adherence Several factors that contribute to poor adherence  Duration  Schedule  Formulation  Taste and Palatability  Cost  Adverse effects of medication  Cultural beliefs about illness and medication  Illiteracy or language barriers  Lack of family or social support network Studies suggest that adherence rates for pediatric medications are typically between 50-60%. !

Adherence The heart of the problem 79% of children complain about bad tasting medication or taste that is too “yucky.” 7 in 10 parents report a moderate to severe struggle giving a child medicine because of how it tastes. Until a child is around 8 years old, swallowing pills can be challenging. This is often due to the smaller structure of a child's esophagus. Therefore, children under the age of 8 are typically prescribed liquid medications. While liquids are easier to administer, getting the child to swallow is whole different story. For the pediatric population, taste and poor palatability are identified among the most significant barriers to adherence. Focus group and nationwide studies show:

Adherence Special considerations  While it may seem the child is being difficult, this rejection is rarely the result of a child’s desire to be picky or fussy. Rather, it is an actual physical inability to swallow an unpalatable substance.  Children have a greater number of taste buds than adults. These taste buds regenerate every two weeks. As with many of the senses, taste becomes altered as a function of the aging process. That explains why most children find certain flavors to be too 'strong' when adults do not.  Children, and infants in particular, are most sensitive to bitter and sweet tastes, making them less likely to swallow bitter-tasting medications and also more prone to liking sweeter, fruity flavors.  Unfortunately the active ingredients in many medications often taste bitter and/or have a pungent smell. Masking the taste of these medications can often be difficult simply because the innate flavor is so overpowering.

Anatomy & Physiology of Taste

Studies suggest that adherence rates for pediatric medications are typically between 50-60%. ! At this point its probably helpful to review the physiology of taste, to better understand the biological basis for these underlying problems.

 Taste is a chemical sense. Provides information on chemical composition of food. Acts as final safety checkpoint prior to consumption. The body’s mechanism developed to recognize foods needed for nutritional value, as well as a natural defense mechanisms helping to identify harmful substances. For example, bitter flavors are more commonly associated with natural toxins, where sweet tastes are associated with energy rich foods needed for survival.  Flavor is the culmination of sight, taste, touch and smell. Anatomy & Physiology of Taste

Studies suggest that adherence rates for pediatric medications are typically between 50-60%. ! Sweet provides a recognition of energy rich nutrients Salty allows modulating the diet for electrolyte balance Sour typically indicates the presence of acids and allows for the detection of when foods may be spoiled Bitter allows sensing of diverse natural toxins Umami (savory) it is the taste of amino acids (e.g. meat broth or aged cheese).

Anatomy & Physiology of Taste Studies suggest that adherence rates for pediatric medications are typically between 50-60%. !  Many diagrams present “taste-zones,” however it is now believed that while there are differences to taste sensitivity around the tongue, the different tastes are perceived in any area taste buds exist.  Presence and density of taste buds may be different individual to individual Super-tasters, normal tasters, non-tasters Age variation  Additional patient-specific factors influencing taste: Concurrent disease states Concurrent medications Cultural factors Environmental factors Variation in taste perception

Anatomy & Physiology of Taste Studies suggest that adherence rates for pediatric medications are typically between 50-60%. !  It is estimated that 25% of the population are super-tasters, indicating a higher density of taste-buds and increased sensitivity to certain tastes.  Women, as compared to men, are more likely to be super-tasters.  Normal-tasters make up 50% of the population, and non-tasters the remaining 25%.  Non-tasters are less effected by strong flavors.  Research indicates a decline in the number and change in the shape of taste buds with age.  Age related decline in taste is more often correlated to co-morbidities affecting smell, which in turn can impact an individuals sensitivity to taste.  Additionally, certain disease states, medications, dental work, as well as cultural or environmental factors may influence taste sensitivity and preference. Variation in taste perception

Medications, Taste, & the Role of Flavor

Studies suggest that adherence rates for pediatric medications are typically between 50-60%. !  Research supports taste as being a significant factor in adherence and recognizes that this issue should be considered when selecting medications, especially among pediatric patients.  The chemical structure of a medication determines not only the pharmacological efficacy of a drug but the bitter taste as well. In a recent article “Helping the Medicine Go Down,”Dr. Julie Menella, a researcher from the Monell Chemical Senses Center stated “The number one reason for non-compliance among children when taking medicine or eating vegetables is that they don't like the taste.”  Earlier we addressed the fact that rejection of bitter flavors is part of basic biology. Bitter flavors are most commonly associated with natural toxins and poisons. Rejection of such tastes is thought to have evolved to protect the consumer from harm.

Medications, Taste, & the Role of Flavor Studies suggest that adherence rates for pediatric medications are typically between 50-60%. !  A substantial number of liquid medications are dispensed each year, many of which are associated with poor palatability.  While companies recognize palatability issues with medication administration, often only one flavor per formulation is manufactured. This is primarily due to Research and Development costs as well as production costs.  Having the ability to change the flavor of medications to improve palatability as well as meet patient preference can increase adherence and improve the overall patient experience.

Medications, Taste, & the Role of Flavor The unpleasant experience “Many parents are faced with the daily challenge of getting their children to take a medication. The unpleasant flavor of the medicine can thwart the benefits of even the most powerful drug, and failure to consume medication may do the child harm, and in some cases may be life-threatening.” Julie Mennella of Monell Chemical Senses Center Like most of us, children will resist unpleasant experiences.

Medications, Taste, & the Role of Flavor The unpleasant experience  It is a vicious cycle that all begins with an unpleasant tasting medication and a hesitant child.  Consequently, medicine-time becomes a stressful and unpleasant experience for parents and children.  Struggling with or forcing a child to take an unpleasant tasting medication adds additional strain to the already unpleasant state of feeling sick.  It can also predispose children to believe that all medications, regardless of taste or smell, are unpleasant, giving them a negative impression of all medicinal treatments.  Oftentimes a parent's frustration with administering a bad tasting medication will cause them to stop treatment as soon as their child’s symptoms go away, thus not completing the full course of medication as prescribed by their physician.

Medications, Taste, & the Role of Flavor Coping with the stress of taking medication  Arguments about taking medication, kicking, screaming, and spitting become part of a daily struggle for parents trying to get their children to take their medication.  To lessen the stress and anxiety of taking medications, parents have resorted to improving palatability through refrigeration, or by mixing medications with milk, juice, soda, or syrup.  Unfortunately, these “home remedies” can compromise the stability, efficacy, and potency of many liquid medications.  A more feasible option is to have a liquid prescription flavored at a local pharmacy.  Flavoring is a safe and effective solution that not only helps mask the unpleasant taste of a medication, but also customizes the medication to satisfy an individual child’s taste preferences.

Medications, Taste, & the Role of Flavor The role of flavoring medications  Flavoring circumvents limitations in single-flavoring options available.  Provides choice to children in the flavor of their medication.  Provides a method to ensure the 1st line therapy is used, even when taste is a potential barrier.  Offers an opportunity to improve adherence issues related to taste.  Provides individualization of care.

Medications, Taste, & the Role of Flavor The role of flavoring medications  Manufactured medications come pre-flavored, however flavoring systems offer the opportunity to modify the medications taste to not only improve palatability but also to tailor the medication to the patients’ taste preference.  Flavoring medication offers parents and prescribers the opportunity to incorporate the child and his or her taste preference in taking medication, “offering children a choice in a no choice situation.”  The ability to flavor medications offers the pharmacist the opportunity to individualize the medication to the patient, recognizing that taste is not one-size fits all in medicine.  Studies have demonstrated that improving the taste of medications leads to improved adherence among pediatric patients, which has significant implications for clinical outcomes.  Finally, it may reduce the parent/caregiver stress of administering medication when the child’s choice for flavor is incorporated.

Medications, Taste, & the Role of Flavor Less stress, more delight  Offering mom and dad a solution to what is normally a high stress situation elevates their pharmacy experience to a higher level. Most parents will be surprised to learn that custom flavoring their child’s medication is even an option.  Flavoring leaves a lasting impression because it makes medicine-time so much easier.  With less stress comes more delight. More delight translates to happy patients and loyal pharmacy customers. Studies suggest that adherence rates for pediatric medications are typically between 50-60%. 60% of parents say medicine-time with their kids is highly stressful ! 7/10 Americans now report “stress” as their #1 health concern.

Medications, Taste, & the Role of Flavor Children taking charge  Not surprisingly, children embrace pleasant experiences, including pleasant tastes.  Flavoring not only helps mask the unpleasant taste of a medication but also customizes the medication to satisfy the individual child’s taste preferences.  Studies have shown that allowing a child to play an active role in choosing the flavor of their medication makes him/her more compliant to drug regimens. Showing a child that they have the capability to modify the flavor of a medication to a flavor of their liking grants them some authority in their treatment.  Allowing them to choose how their medication will taste encourages a child to take charge of their own health and is yet another way to promote adherence.

Medications, Taste, & the Role of Flavor Flavoring can help!  The addition of a safe pharmaceutical flavoring to medicine can greatly improve a child's sensations of taste and smell, leading to acceptance and therefore adherence. In fact, studies show that proper flavoring can increase adherence in children from 53% to over 90%.  As a pharmacist or technician, simply recommend a product like FLAVORx when dispensing a child's medication. The process is scientifically-proven, safe and effective. Unlike the addition of food or drink, FLAVORx flavoring available at the pharmacy will not adversely affect a medicine's stability, efficacy, or potency.

Medications, Taste, & the Role of Flavor Medication “tastes” may fit best with certain flavorings Consider patient age and taste preference Flavoring agents commonly used  Simple syrup  Ora-sweet, Ora-blend  Fruit flavored syrups (cherry, orange, etc)  Commercially available flavoring agents (FLAVORx) When flavoring medications…

Medications, Taste, & the Role of Flavor When flavoring medications…  Patient age and taste preferences should be considered when choosing what flavor to add to medications. Younger patients are more likely to prefer sweeter flavors, as compared to older patients.  Important to consider the type of medication to be flavored as certain flavors may be better at masking bitter medications versus sour medications.  Traditional approaches to flavoring medications have included the use of simple syrups, ora-sweet syrups or even masking in fruit and chocolate flavored syrups.  FLAVORx is a commercially available flavoring system that is commonly used by retail pharmacies in flavoring both compounded and manufactured medications.

Medications, Taste, & the Role of Flavor Examples of medications with poor palatability  Acetaminophen with codeine elixir  Albuterol liquid  Amoxicillin/ clavulanic acid suspension  Azithromycin suspension  Clarithromycin suspension  Cefuroxime suspension  Cephalexin suspension  Dexomethorphan syrup  Erythromycin liquid  Erythromycin and sulfisoxazole suspension  Iron Liquid  Loratadine suspension  Nitrofurantoin suspension  Phenobarbital elixir  Prednisolone syrup  Ranitidine syrup  Sulfamethoxazole/ trimethoprim suspension  Vitamin liquids

Medications, Taste, & the Role of Flavor Pairing medications with flavor BITTERFOUL  Cephalexin  Clindamycin  Ferrous Sulfate  Polysaccharide-iron complex SALTY  Potassium Chloride  Sodium Fluoride  Peridex  Citrate Magnesia  Bi Citra or Poly Citra  Acetaminophen  Amoxicillin/ Clav acid  Cimetidine  Cefuroxime  Erythromycin/ Sulfisoxazole  Fluoxetine  Haloperidol  Loperamide  Metronidazole  Naproxen  Penicillin  Risperidal  SMZ/TMP  Theophylline

Medications, Taste, & the Role of Flavor Pairing medications with flavor For medications which are bitter tasting, grape and bubblegum flavors have been shown to be the most successful at masking these flavors. For foul tasting medications such as clindamycin, the use of oil based flavors such as lemon, orange and raspberry produces the best result. For salty flavors, grape and raspberry appear to work the best. Something to keep in mind- for medications with more potent tastes, increasing the concentration of sweetener is more likely to produce a better product versus increasing the concentration of the flavoring agent.

Medications, Taste, & the Role of Flavor The customer experience and flavoring  One of the most impactful ways to generate a positive customer experience is through customization – giving customers the feeling of personalization and control.  There is no easier way for your pharmacy teams to accomplish this than through taste customization using a product like FLAVORx.  With a wide-assortment of flavors to choose from, your customers can tailor the taste of their liquid prescriptions and OTC medications to their favorite flavor.  Flavoring is a powerful way to create a lasting positive experience with your customers which in turn builds brand loyalty.  By providing a choice of flavors, no matter what medication is being dispensed, you’re providing excellent customer service and increasing the likelihood of higher prescription adherence. What could be better than that?

Medications, Taste, & the Role of Flavor Promoting the flavoring service  Promoting the flavoring service to your customers can be fun and easy. You’re providing a valuable service to parents who, at the very least, appreciate you giving them the option to have the medication custom flavored.  We’ve heard from countless parents who say they love the service and are so thankful their pharmacy recommended it.  On the flip side, we also hear from more parents than we’d like to admit who are so frustrated by the fact that flavoring wasn’t mentioned by anyone when they dropped off or picked up the prescription.  The fact is, there are a whole bunch of moms and dads out there who want to know about custom flavoring for their child’s medicine. So tell them about it!

Medications, Taste, & the Role of Flavor Future issues in flavoring  Research continues to identify factors that may assist in predicting taste preferences. Trying to determine the role genetic factors may play in predicting taste preference.  Continued research in the role of flavoring to improve patient adherence and health outcomes. While initial studies have shown positive results on medication adherence resulting from interventions using flavoring to mask taste, continued research is necessary.

Medications, Taste, & the Role of Flavor Future issues in flavoring  A Pediatric Formulation Initiative was established to improve pediatric formulations. The issue of palatability with respect to pediatric medications has also been recognized as an area for national focus. The Best Pharmaceuticals for Children Act of 2002 led to the Pediatric Formulation Initiative (sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD) which is focused on addressing the lack of appropriate medication formulations for children.  Continued efforts are ongoing in identifying new methods to improve the ease of medication administration.

Concluding thoughts  Medications successfully taken because of flavoring are far less physically, emotionally, and financially exhausting.  For children, taste and choice may be the only motivation to take a medication and complete a full treatment program.  Improving the taste of a medication and allowing patients to choose how their medication will taste can improve therapy adherence, leading to both improved clinical and economic outcomes.  Medication adherence is a major concern in the realm of healthcare. And, now YOU have a solution!

Medication Flavoring Options Apotheca Supply, Inc Highway 31 South Decatur, AL FAGRON 2400 Pilot Knob Road Saint Paul, MN FLAVORx 9475 Gerwig Ln Columbia, MD Galenova Inc 4555 Beaudry St-Hyacinthe CANADA Gallipot, Inc Pilot Knob Road, Saint Paul, MN Medisca 661 Route 3, Unit C, Plattsburgh, NY USA Naturally Vitamins/ Marlyn Nutraceuticals 4404 E Elwood St Phoenix, AZ Professional Compounding Centers of America (PCCA) 9901 S. Wilcrest Dr. Houston, TX Here is an additional list of Compounding/ Medication Flavoring Supply Companies :

Contact Us FLAVORx, Inc Gerwig Lane, Columbia, MD F: P: Contact us