Prescribing Traditional and Complementary Therapies in Pediatrics
National Patient Safety Goals Regarding Prescribing Medications
Organization and Purpose: The Joint Commission publishes National Patient Safety Goals (NPSGs) to address medication practices in ambulatory healthcare clinics and hospitals.
Medication Reconciliation (2014 & 2022 Updates): Since 2014, these goals have emphasized reconciling medication information. Effective January 2022, NPSGs for ambulatory clinics define medication reconciliation as a process to address duplications, omissions, interactions, and the necessity of continuing current medications.
Critical Information Points: PCPs must obtain the following from patients/caregivers: * Medication name. * Dose. * Route. * Frequency. * Purpose.
Post-Care Episode Requirements: Healthcare providers are directed to provide written information at the conclusion of every care episode, detailing the name, dose, route, frequency, and purpose of all medications the patient should be taking.
Management Strategies: PCPs should encourage families to maintain an updated medication list and share it at every visit to support management during each episode of care.
Regulation and Safety of Pharmaceuticals
Pharmaceutical Labeling and "Highlights": Labels must provide accessible, comprehensive information. The "Highlights" section at the beginning of prescribing information and package inserts includes: * Benefits and risks of the drug. * Date of initial product approval. * Contact information (phone and website) for reporting adverse effects. * Electronic prescribing tools must follow similar formatting.
The FDA Pediatric Advisory Committee (PAC): * Responsible for identifying pediatric therapeutics and setting research priorities. * Advises on ethical considerations and the design/analysis of pediatric clinical trials. * Recommends FDA actions regarding pediatric adverse event reports, such as caveats for suicide risks, neonatal withdrawal, toxicity, and off-label drug use. * Reports indicate that many pediatric adverse effects go unreported, meaning the true safety profile of some drugs may be incomplete.
European Medicines Agency (EMA): Responsible for medication availability and evidence in the EU. Their 2020 action plan focuses on five areas: 1. Identifying pediatric medical needs. 2. Strengthening cooperation between decision-makers. 3. Timely completion of pediatric investigation plans. 4. Improved handling of pediatric investigation plan applications. 5. Increased transparency regarding pediatric medicines.
Global Pharmaceutical Supply and Chain Risks
Supply Chain Threats: Natural disasters, pandemics, and manufacturing quality issues threaten global supply.
Reliance on Foreign Sources: There is an overreliance on China and India for active pharmaceutical ingredients. An estimated of the world’s supply originates from China, India, and other foreign countries.
Drug Shortages: Monitored by the FDA.
Counterfeit and Internet Risks: PCPs must counsel families against buying reduced-price medications online direct-to-consumer due to safety and quality risks, emphasizing the use of reputable pharmacy outlets.
General Prescribing Guidelines for Pediatrics
Indication and Pressure: PCPs must resist pressure from parents to prescribe without a clear clinical indication.
Required Clinical Knowledge: Effective management requires understanding indications, contraindications, dosages, adverse reactions, and drug interactions, alongside pharmacodynamics and pharmacokinetics in developing patients.
Core Prescribing Points: * Assess renal and hepatic system maturation and function. * Follow clinical practice guidelines when available. * Recognize the influence of pharmaceutical advertising. * Utilize decision-support systems (EMR tools or online apps) for interactions and side effects. * Check for interactions between drugs and herbs, botanicals, or dietary supplements.
Pediatric Pharmacokinetics and Physiology
Limitations of Adult Extrapolation: Dosing shouldn't just be reduced adult doses based on weight. This fails to account for metabolism, pharmacokinetics, and age-specific adverse effects (e.g., SSRIs and suicide risk in adolescents).
Pharmacogenomics: A field studying unique responses to drugs based on genetic factors. Phase 1 enzymes are involved in the biotransformation of more than of prescription drugs; variations in these enzymes can significantly affect blood levels.
Key Fundamental Principles: * Drug Absorption: * Subcutaneous/Intramuscular: Affected by blood flow; poor flow delays absorption. * Gastrointestinal (GI): Neonates have decreased acid secretion, prolonged emptying, lower enzyme activities, and irregular peristalsis. * Topical/Skin: Infants have a thin stratum corneum, variable hydration, and higher permeability, increasing the risk of systemic absorption. Large body surface area in infants relative to weight is also a factor. * Drug Distribution: * Body Composition: Neonates/infants have the highest percentage of body weight as water. * Plasma Proteins: Albumin is the primary binding protein; concentration is lower in infants/children than adults. * Membrane Permeability: Increases in blood-brain barrier tight junction capacity and efflux transporter expression occur as the child matures. * Drug Metabolism: * Primarily occurs in the liver via Phase I and Phase II reactions. * Neonates and young infants have decreased metabolism rates, slower clearance, and prolonged elimination half-life. * Metabolism increases with age until adult levels are reached during puberty. * Drug Elimination: * Glomerular Filtration Rate (GFR): In neonates, GFR is approximately to of adult levels. Adult levels are reached by to months. * Over-performance in Children: Children may exceed adult GFR levels, requiring higher doses per kilogram for drugs like penicillin, gentamicin, and digoxin.
Off-Label Prescribing in Pediatrics
Definition: Using a drug without specific FDA pediatric labeling. This is not illegal or experimental; it often occurs because data has not been submitted to the FDA or small populations make trials difficult.
Common Off-Label Classes: Antibiotics, asthma medications, dermatologics, ophthalmologic drops, and psychotropics.
Key Legislation: * Best Pharmaceuticals for Children Act (BPCA): Provides incentives for manufacturers to conduct pediatric studies. * Pediatric Research Equity Act (PREA): Authorizes the FDA to require pediatric studies for certain drugs/biologics. * These acts resulted in over labeling changes.
Prescribing Guidelines for Off-Label Drugs: * Consult reputable apps (Epocrates, Lexicomp, Physician’s Desk Reference). * Review published scientific literature and expert judgment. * Check the FDA website for warnings. * Discuss recommendations with the family and document consent/decision-making in the health record.
Medication Adherence in Pediatrics
Prevalence: CDC data (2015) shows of pediatric visits result in a prescription. Approximately of children and to of adolescents are nonadherent to regimens.
Consequences of Nonadherence: Increased costs, drug escalation, drug resistance, and treatment failure.
Factors Influencing Adherence (Table 23.1): * Length of Treatment: Longer duration leads to poorer adherence. * Condition: Chronic illness and lack of immediate benefit lower adherence. * Dosing Schedule: Increased doses per day drop adherence (especially for working parents/school-aged kids). * Palatability: Unpalatable flavors or difficulty swallowing pills lead to resistance. * Expense: High out-of-pocket costs and lack of insurance coverage. * Belief Systems: Religious views on animal-origin ingredients or fear of medications being a "crutch." * Social Determinants: Health literacy, transportation, and economic stability.
Developmental Considerations: * Infants: Focus on teaching the parent administration and simplifying daycare schedules. * Early Childhood: Address independence; mix meds with the smallest possible amount of food (one spoon of applesauce/pudding). * Middle Childhood: Children are "industrious" and often willing; allow them to choose formulations (liquid vs. chewable). * Adolescence: Transition to self-administration with provider collaboration and parental supervision.
Strategies for Assessment and Improvement: * Use open-ended questions at every visit. * Objective measures: Pickup/refill rates, pill counts, and therapeutic drug monitoring. * Technology: Mobile gaming, mindfulness training, praise text messages, and pictogram-based instruction. * "Teach Back": Have parents/patients repeat instructions back in plain language.
Disposal of Pharmaceuticals
Drug Take-Back Programs: The most preferred method.
Home Disposal (Trash): Mix medicine with coffee grounds or cat litter in a sealed container. Identify and remove personal information from packaging.
The FDA "Flush List": Only specific medications should be flushed down the toilet; the FDA decided the risk of accidental exposure to these drugs outweighs the environmental risk of flushing.
Overprescribing Antibiotics and Stewardship
Statistics: Approximately million illnesses and deaths annually in the U.S. are due to antimicrobial-resistant infections.
Misuse: An estimated of prescribed antibiotics are unnecessary. Primary misuse areas include acute upper respiratory infections (otitis media, pharyngitis).
Effect of Misuse: Patients given antibiotics for a first episode of bronchitis are more likely to have a second episode and receive further antibiotics.
Antimicrobial Stewardship Goals: * Correct drug, dose, and duration. * Limiting spectrum to the specific infection. * Use of diagnostic stewardship (characteristic findings before Rx) and antibiograms (local effectiveness data).
Guidelines for Accurate Prescription Writing
Step-by-Step Logic: Diagnosis $\rightarrow$ Pathophysiology $\rightarrow$ Objective $\rightarrow$ Drug selection $\rightarrow$ Dosing $\rightarrow$ Monitoring plan $\rightarrow$ Endpoint.
Metric System: Use milligrams () or milliliters (). Avoid teaspoons or tablespoons.
Decimal Safety: * Leading Zero: Use (not ). * No Trailing Zero: Use (not ).
Abbreviations and Logic (Box 23.1): * Avoid "U" (units), "IU" (international units), and "qd/qid/qod." * Do not use abbreviations for body parts (e.g., o.d.). * Specify the exact number of pills rather than a time duration. * State the indication/purpose on the prescription to aid the pharmacist. * Handwritten Prescriptions: Use block letters rather than cursive.
Complementary and Integrative Therapies
Definitions: * Complementary Health: Nonmainstream approach used together with conventional medicine. * Integrative Health: Coordinated combination of health approaches with a whole-person focus. * Alternative Healthcare: Nonmainstream approach used in place of evidence-based conventional medicine.
Subgroups of Complementary Health: * Nutritional (vitamins, herbs, probiotics). * Psychological (mindfulness, meditation). * Physical (massage, spinal manipulation). * Combinations (yoga, acupuncture).
Patient-Provider Communication: Broach the topic nonjudgmentally to ensure disclosure. Common reasons for nondisclosure include fear of disapproval or failure of the PCP to ask.
Safety and Regulation: * The FDA does not approve dietary supplements before marketing; manufacturers only submit safety notifications. * "G" Herbs: Ginger, garlic, ginkgo, ginseng, and green tea can interact with warfarin or the hepatic cytochrome system. * Surgical Warning: Stop herbal supplements at least week before surgery to prevent coagulation or anesthesia issues.
Verification Seals for Quality: * USP (US Pharmacopeia): Verified standards for contamination and manufacturing. * NSF International: Good Manufacturing Processes (GMP). * NPA (Natural Products Association): Ingredient quality/purity. * CL (Consumer Lab): Tests for potency, purity, and bioavailability. * Commission E: European equivalent of FDA standards for safety. * MA/THR: Marketing Authorization/Traditional Herbal Registration numbers in England.