Facilitator s Guide. Prescription Writing/Patient Safety Author: Benjamin Estrada, MD, University of South Alabama. Active Learning Module

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1 Facilitator s Guide Prescription Writing/Patient Safety Author: Benjamin Estrada, MD, University of South Alabama Active Learning Module Core Concepts In order to master this topic area, students must understand: Pathophysiology: Therapeutic interventions: Pharmacotherapy: Writing prescriptions: Dose calculations: Antibiotic stewardship: The management of wheezing in children should be linked to its pathogenic mechanism. The therapeutic interventions in children with respiratory distress should include those aimed to optimize gas exchange and fluid/electrolyte balance. Pharmacologic interventions are guided by etiologic agents causing lower respiratory tract infection. A prescription is a detailed set of instructions written by a practitioner for a specific patient. Most dose calculations in pediatric prescriptions are based on weight or BSA. Antibiotic stewardship includes interventions and attitudes aimed to provide the optimal drug, dose, and duration with consideration to de-escalation practices (the 4 Ds of antibiotic stewardship) Learning Objectives Students will demonstrate their conceptual mastery by: Clinical Scenario 1 Describing the pathogenesis of bronchiolitis. Describing the management of a patient with bronchiolitis. Describing the indication for the use of B2-agonists in children with wheezing. Describing the contraindications for the use of antihistamines in children. Clinical Scenario 2 Listing the etiologic agents of otitis media. Describing the factors associated with appropriate antibiotic treatment selection. Discussing the rationale behind choice of antibiotic dose and drug pharmacokinetics. Writing an antibiotic prescription for a child with acute otitis media. Describing the principles behind the 4 Ds of antibiotic stewardship. Using a prescription as a communication tool between the provider and the dispensing pharmacist. Formulating a prescription in order to provide specific details of therapy for a pediatric condition.

2 Advance Preparation Assignments Completing CLIPP Case 13 will provide students with the requisite background knowledge to understand and be prepared to apply concepts 1, 2, 3, 4 Competing CLIPP Case 14 will provide students with the requisite background knowledge to understand and be prepared to apply concepts 5, 6, 7, 8, 9, 10 Antibiotic stewardship slide set (included with this module) will provide students with the basic principles of antibiotic stewardship.

3 Readiness Assurance Questions 1. A 2-year-old boy is being seen in the clinic for evaluation of fever. He was treated two weeks ago for otitis media with amoxicillin. On exam his temperature is F. On exam his tympanic membranes are erythematous and bulging with decreased motility. Which of the following would be the best therapeutic approach at this time? A. Oral amoxicillin B. Oral amoxicillin-clavulanate C. Oral steroids D. Parenteral ceftriaxone E. Oral cefuroxime Answer: E 2. A 30-month-old child is brought to clinic for evaluation of speech delay. His past medical history is significant for recurrent otitis media for the past 6 months. Which of the following otic evaluations would provide the best information about his hearing? A. Tympanogram B. Conventional audiometry C. Visual reinforcement audiometry D. Pneumatic otoscopy E. Otoacoustic emissions Answer: C 3. On New Year s Day a 3-week-old infant presents to the emergency department with rhinorrhea and cough for three days. His temperature is 99.8 F, heart rate 126 beats/minute, respiratory rate 36 breaths/minute. On respiratory exam he has bilateral wheezing and subcostal retractions. Which of the following is the most likely etiology of his clinical presentation? A. Asthma B. Viral infection C. Laryngotracheomalacia D. Atypical bacterial pneumonia E. Cystic fibrosis Answer: B 4. A 15-year-old male presents to the clinic for evaluation of exercise intolerance. For the past 2 years he develops shortness of breath and cough during soccer practice. His coach has removed him from the field several times during this season due to this problem. His symptoms resolve slowly after practice is over. He denies any wheezing or cough at other times and does not have any night time symptoms. On exam his vital signs are normal and his exam is unremarkable. His chest is clear to auscultation. Which of the following would be the best initial therapeutic intervention for this patient? A. Inhaled steroids B. Leukotriene receptor antagonists C. Oral antihistamine D. Inhaled beta2-agonist E. Inhaled saline solution Answer: D 5. A 6-month-old female is brought to the Urgent Care Clinic for evaluation of cough. Her mother describes congestion and nonproductive cough for the past 2 days. She is tolerating her feeds well and has not had any vomiting. Past medical history is unremarkable. Her vital signs are normal. Her physical exam is normal except for copious clear rhinorrhea. The child s mother requests guidance on selecting an over-the-counter decongestant and cough suppressant. What would be the best reason for not using these products in this patient? A. They are indicated only for children older than 1 year B. They should be utilized only if the rhinorrhea lasts longer than 5 days C. Increased risk of adverse effects and fatal overdosing D. Lack of efficacy reducing rhinorrhea and congestion E. Cough suppression would lead into a more prolonged illness Answer: C

4 6. You are discussing antibiotic stewardship with a colleague and mention your practical approach utilizing the 4Ds of stewardship. Which of the following is not one of the 4Ds? A. Dose B. De-escalation C. Duration D. Dispense E. Drug Answer: D

5 Application Exercises EXERCISE 1 Clinical Scenario A 9-month-old male who has been consistently evaluated in your office since birth for well-child checkups presents to your office today with history of rhinorrhea and cough for four days. His mother states that his oral intake has decreased and he has been coughing since yesterday. His mother had rhinorrhea for two days one week prior to this visit. On exam his temperature is F, his heart rate is 146 beats/minute, his respiratory rate is 52 breaths/minute, and his O2 saturation is 89% on room air. He has visible rhinorrhea, mild subcostal retractions, and bilateral expiratory wheezing. His RSV rapid antigen detection test is negative. The child s immunizations are up to date. Question 1.1 Which of the following is the most appropriate therapeutic intervention? A. Prescribe azithromycin for five days B. Administer nebulized albuterol every 6 hours until wheezing resolves C. Admit this infant for observation and IVF maintenance and replacement D. Discharge the patient home with instructions for oral rehydration solution and nasal suctioning E. Administer a dose of chlorpheniramine in the office and continue its administration every 6 hours at home until the rhinorrhea and cough resolve Applied core concepts: Pathophysiology Therapeutic interventions Pharmacotherapy ¾ Allow 30 minutes for this question. Team discussion: 15 minutes Large group discussion: 15 minutes

6 Question 1.1 Discussion Guide APPLIED CORE CONCEPTS AND CASE-SPECIFIC TEACHING POINTS ANSWER CHOICES PATHOPHYSIOLOGY THERAPEUTIC INTERVENTIONS PHARMACOTHERAPY A. Prescribe azithromycin for five days Mycoplasma pneumoniae can cause pneumonia associated with wheezing, but it is more typically observed among school-aged children, not infants. Treatment with azithromycin should be considered if atypical pneumonia is suspected. The epidemiologic and clinical factors of this case are not consistent with atypical pneumonia. A negative rapid RSV does not rule out other viral etiologies of bronchiolitis. B. Administer nebulized albuterol every 6 hours until wheezing resolves Given the pathogenesis of wheezing in bronchiolitis, treatment with albuterol around the clock is no longer standard of care. The difference between bronchiolitis and reactive airway disease can be emphasized at this time. (This is a good opportunity to discuss evidence-based benefit vs risk when implementing a therapeutic approach.) Data do not show that beta2-agonists increase gas exchange in bronchiolitis. C. Admit this infant for observation and IVF maintenance and replacement. (correct answer) Although bronchiolitis is a selflimiting illness, it sometimes requires intensive support. Even with acceptable O2 saturation, it is important to remember that infants with moderate to severe tachypnea are unable to tolerate PO well. They could become dehydrated or aspirate if IV fluids are not initiated. (Ask the students what would happen if they attempted to drink while breathing 50 breaths a minute.) D. Discharge the patient home with instructions for oral rehydration solution and nasal suctioning. This approach could be valid if the infant was not tachypneic or hypoxemic. Appropriate parental education and follow-up can be delivered. (Also a good opportunity to discuss communication strategies to assure that caretakers understand instructions regarding the outpatient management of bronchiolitis.)

7 E. Administer a dose of chlorpheniramine in the office and continue its administration every 6 hours at home until the rhinorrhea and cough resolve. The main etiology of wheezing in bronchiolitis is accumulation of debris in the LRT airway, not bronchospasm. Rhinorrhea in this case is not histamine-mediated. (This is a good opportunity to discuss indications and adverse side effects of chlorpheniramine and the importance of age-appropriate prescription practices.) This approach will not help to optimize gas exchange and could potentially cause respiratory depression. Notes: During the debriefing of this case it is helpful to discuss different communication techniques to ensure caregivers understanding of the technique and importance of nasal suctioning in infants with URIs. It is also important to discuss the need to avoid antibiotic therapy when the clinical presentation is consistent with a viral process. This case facilitates the discussion of viral pathogenesis related to lower respiratory tract infection, albuterol, and chlorpheniramine mechanism of action as basic science links.

8 EXERCISE 2 Clinical Scenario JR is a 3-year-old male who presents to your office with fever (102.5 F) for three days. He has been irritable and has had associated right ear pulling for five days. His past medical history is negative, and he has never received any prescription medication. His immunizations are up to date. His weight is 31 lb., his right tympanic membrane is bulging, and erythematous purulent retrotympanic exudate is visualized. Question 2.1 Which of the following prescriptions (see next page) would you provide for this patient? (Be prepared to defend the rationale for your choice.) A. Example A B. Example B C. Example C D. Example D E. Example E Applied core concepts: Writing prescriptions Dose calculations Antibiotic stewardship ¾ Allow 35 minutes for this question. Team discussion: 15 minutes Large group discussion: 20 minutes It takes the students a significant amount of time to come up with a decision especially if the exercise is held at the beginning of the year.

9 Example A Example B Example C Name: Child Patient Name: Child Patient Name: Child Patient Date of birth: 2/2/15 Date of birth: 2/2/15 Date of birth: 2/2/15 Medical record #: Rx Amoxicillin-clavulanate 500/125 tablets Sig: 1 PO BID for 10 days Disp: 20 Medical record #: Rx Amoxicillin Suspension: 250 mg/5 ml Sig: 5 cc PO BID for 10 days Disp: 100 cc Medical record #: Rx Amoxicillin-clavulanate Suspension: 250/5 ml Sig: 80 mg/kg/dose every 12 hours for 10 days Product selection permitted: Yes No Product selection permitted: Yes No Product selection permitted: Yes No Dispense as written: Patient Doctor, MD Dispense as written: Patient Doctor, MD Dispense as written: Patient Doctor, MD Date: 3/1/15 Date: 3/1/15 Date: 3/1/15 LABEL LABEL LABEL Refill 0 times DEA No. Refill 0 times DEA No. Refill 0 times DEA No. State License No. State License No. State License No. Example D Example E Name: Child Patient Name: Child Patient Date of birth: 2/2/15 Date of birth: 2/2/15 Medical record #: Rx Amoxicillin Suspension: 400 mg/5 ml Sig: 7.5 cc PO every 12 hours for 10 days Disp: 150 cc Medical record #: Rx Amoxicillin Suspension: 400 mg/5 ml Sig: 1 đ tsp PO BID Product selection permitted: Yes No Dispense as written: Patient Doctor, MD Date: 3/1/15 LABEL Refill 0 times DEA No. State License No. Product selection permitted: Yes No Dispense as written: Patient Doctor, MD Date: 3/1/15 LABEL Refill 0 times DEA No. State License No.

10 Question 2.1 Discussion Guide APPLIED CORE CONCEPTS AND CASE-SPECIFIC TEACHING POINTS ANSWER CHOICES WRITING PRESCRIPTIONS DOSE CALCULATIONS ANTIBIOTIC STEWARDSHIP Example A A prescription should include the appropriate form. Given the child s age, tablet form is not appropriate. The child would not be able to swallow it, and it may also represent a choking hazard Non weight-based standard dose prescription utilized in adults is not appropriate for young children. (This is a good opportunity to discuss not to calculate dose based on weight once the child reaches adult weight.) Amoxicillin-clavulanate could be considered in a younger child or one with high fever and severe symptoms. Example B A prescription for a pediatric patient should include the appropriate dose. This dose of amoxicillin is too low. The dose would be appropriate for GAS pharyngitis but not appropriate to cover for the possibility of intermediate resistant strains of S. pneumoniae in the middle ear. A dose of mg/kg/day would result in higher serum and middle ear fluid concentrations effective against strains that are intermediately resistant. The appropriate dose is one of the 4 Ds of antibiotic stewardship. (This is an appropriate time to talk about de-escalation, the fourth D of antibiotic stewardship. If the pathogen is identified and susceptible to an antibiotic with more restricted spectrum this antibiotic should be considered. De-escalation also means to change the route of administration from IV to PO.) Example C The amount of drug to be administered instead of the dose per kg should be entered in the prescription. For an antibiotic, unless the prescription is for chronic prophylaxis, no refills should be selected. No refills should be selected for an antibiotic, unless the prescription is for chronic prophylaxis. Example D Prescribing a suspension as concentrated as possible facilitates oral administration to a young child (unless the amount becomes so small that it is difficult to measure accurately). The best initial antibiotic choice in this fully immunized 4-year-old is amoxicillin. This would be the effective drug choice with the most restricted spectrum. Example E Emphasize to the students that when writing a prescription they are making all decisions and are providing guidance to the dispensing pharmacist. Guidance has to be as specific as possible in order to maximize treatment efficacy, minimize the risk for medical errors, and improve drug utilization. A prescription for an antibiotic should include duration of therapy.

11 Notes: This case may be utilized to discuss different aspects related to prescription writing, including need for additional documentation (DEA numbers or State license if a controlled substance is being prescribed) and prescriptions for generics vs. non-generics. The case also offers a good opportunity for discussion of the decision-making process regarding selection of antibiotics for a given clinical syndrome. Factors to consider into this decision include possible etiologies, site of infection and pharmacodynamics and pharmacokinetics. This case may be utilized to open a discussion regarding antibiotic stewardship and the rationale for antibiotic selection. The case scenario and question choices facilitate a discussion related to the 4Ds of antibiotic stewardship (drug, dose, duration, and de-escalation). PRESCRIPTION TEMPLATE Name: Date of birth: Medical record #: Rx Product selection permitted: Yes No Dispense as written: Date: LABEL Refill times DEA No. State License No.

12 References Ralston L, et al. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics 2014;134:e1474 e1502 Lister PD et al. Rationale behind high-dose amoxicillin therapy for acute otitis media due to penicillin no susceptible pneumococci: support from in vitro pharmacodynamic studies. Antimicrob Agents Chemother. 1997;41(9): Hersh A, et-al. Antibiotic prescribing in ambulatory pediatrics in the United States. Pediatrics 2011; 128: CDC. Pediatric antibiotic treatment guidelines: