MEDICATION COVERAGE POLICY, Summaries of Infectious disease

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Coverage Policy Infectious Disease Cough & Cold
Page 1
MEDICATION COVERAGE POLICY
PHARMA CY AND THERAP EUTICS AD VISORY COMMITTEE
POLICY
Cough & Cold
P&T DATE
02/09/2021
THERAP EUTIC CLASS
Infectious Disease
REVIEW HISTORY
(MONTH /YEAR )
02/20, 2/19, 12/17, 9/16,
2/12
LOB AFFECTED
Medi-Cal
This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted
medical practice standards, and approved by the HPSJ Pharmacy and Therapeutic Advisory Committee.
OVERVIEW
Common colds are the number one cause of children missing school and adults missing work.1 Most otherwise
healthy people recover within 7-10 days without need for intervention. However, people with respiratory
conditions or weak immune systems can develop serious complications. Peak cough & cold season is typically
during winter and spring.
There is no cure for a cold. This is why it is important for patients to practice good hand hygiene to reduce risk of
catching a cold. Non-pharmacologic therapies (e.g., rest, oral hydration, humidifiers, lozenges/hard candies) can
help expedite the recovery process. Prescription and OTC cough & cold medications only help relieve symptoms.
Patients and providers should also be aware of three potential risks of taking cough and cold medications:
1. Many of these products have age restrictions based on the ingredients. In general, the Centers for Disease
Control and Prevention (CDC) and Food and Drug Administration (FDA) recommend that parents and
caregivers should not administer cough and cold medications to children < 2 years of age without first
consulting a health care provider due to risks for toxicity, lack of dosing recommendations for this age
group, and limited evidence of effectiveness.2,3
2. Many of the active ingredients used for cough & cold symptoms are available in combination products.
The CDC recommends that clinicians always ask caregivers about the use of OTC combination
medications to avoid overdose from therapeutic duplications.2
3. Some of the active ingredients have properties that can lead to abuse potential. Namely,
dextromethorphan-, codeine-, hydrocodone- and pseudoephedrine-containing products have been
associated with abuse.4
The purpose of this coverage policy is to review the coverage criteria of HPSJ’s formulary cough & cold agents
(Table 1).
Table 1: Available Cough & Cold Medications
Brand
Strength & Dosage form
Formulary
Limits
Cost
per Rx
Notes
Phenergan
6.25 mg/5mL solution
-
$2.82
Antitussives Non-Narcotic
Tessalon Perle
100 mg capsule
-
$3.97
200 mg capsule
-
$5.38
Triaminic Cough,
Robitussin Pediatric
Cough
7.5 mg/5 ml syrup
QL; FL
$4.94
Limited to 240 ml per
fill and 7 fills per
year.
Adult Robitussin
15 mg/5 ml syrup
QL; FL
$4.93
Delsym, Robitussin
12 Hour
30 mg/5 ml ER
suspension
NF
--
Afrin
0.05 % nasal spray,
aerosol
-
$1.79
Pediacare
7.5 mg/0.8 ml oral drops
-
--
Children’s Sudafed
15 mg/5 ml oral liquid
-
$5.65
Nasal Decongestant
30 mg/5 ml oral liquid
-
$1.58
Sudafed
30mg tablet
-
$1.53
60 mg tablet
-
$0.96
Sudafed 12 Hour
120 mg XR tablet
-
$5.62
Sudafed 24 Hour
240 mg XR tablet
NF
$10.30
12 Hour Cold Relief
120 mg XR tablet
-
--
PA = Prior Authorization; QL = Quantity Limit; FL = Fill Limit; AL = Age Limit; NF = Non-formulary
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MEDICATION COVERAGE POLICY

PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE

POLICY Cough & Cold P&T DATE 02/09/

THERAPEUTIC CLASS Infectious Disease REVIEW HISTORY

(MONTH/YEAR)

LOB AFFECTED Medi-Cal 2/

This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the HPSJ Pharmacy and Therapeutic Advisory Committee.

 OVERVIEW

Common colds are the number one cause of children missing school and adults missing work.^1 Most otherwise

healthy people recover within 7-10 days without need for intervention. However, people with respiratory

conditions or weak immune systems can develop serious complications. Peak cough & cold season is typically

during winter and spring.

There is no cure for a cold. This is why it is important for patients to practice good hand hygiene to reduce risk of

catching a cold. Non-pharmacologic therapies (e.g., rest, oral hydration, humidifiers, lozenges/hard candies) can

help expedite the recovery process. Prescription and OTC cough & cold medications only help relieve symptoms.

Patients and providers should also be aware of three potential risks of taking cough and cold medications:

1. Many of these products have age restrictions based on the ingredients. In general, the Centers for Disease

Control and Prevention (CDC) and Food and Drug Administration (FDA) recommend that parents and

caregivers should not administer cough and cold medications to children < 2 years of age without first

consulting a health care provider due to risks for toxicity, lack of dosing recommendations for this age

group, and limited evidence of effectiveness.^2 ,

2. Many of the active ingredients used for cough & cold symptoms are available in combination products.

The CDC recommends that clinicians always ask caregivers about the use of OTC combination

medications to avoid overdose from therapeutic duplications.^2

3. Some of the active ingredients have properties that can lead to abuse potential. Namely,

dextromethorphan-, codeine-, hydrocodone- and pseudoephedrine-containing products have been

associated with abuse.^4

The purpose of this coverage policy is to review the coverage criteria of HPSJ’s formulary cough & cold agents

(Table 1).

Table 1 : Available Cough & Cold Medications

Generic Brand Strength & Dosage form Formulary Limits Cost per Rx Notes Promethazine HCl Phenergan 6.25 mg/5mL solution - $2. Antitussives – Non-Narcotic Benzonatate Tessalon Perle 100 mg capsule - $3. 200 mg capsule - $5. Dextromethorphan HBr Triaminic Cough, Robitussin Pediatric Cough 7.5 mg/5 ml syrup QL; FL $4.94 Limited to^ 240 ml per fill and 7 fills per year. Adult Robitussin 15 mg/5 ml syrup QL; FL $4. Dextromethorphan Polistirex Delsym, Robitussin 12 Hour 30 mg/5 ml ER suspension NF^ -- Decongestants Oxymetazoline Afrin 0.05 % nasal spray, aerosol -^ $1. Pseudoephedrine HCl Pediacare 7.5 mg/0.8 ml oral drops - -- Children’s Sudafed 15 mg/5 ml oral liquid - $5. 65 Nasal Decongestant 30 mg/5 ml oral liquid - $1. Sudafed 30mg tablet - $1. 60 mg tablet - $0. 96 Sudafed 12 Hour 120 mg XR tablet - $5. Sudafed 24 Hour 240 mg XR tablet NF $10. Pseudoephedrine Sulfate 12 Hour Cold Relief 120 mg XR tablet - -- PA = Prior Authorization; QL = Quantity Limit; FL = Fill Limit; AL = Age Limit; NF = Non-formulary

Generic Brand Strength & Dosage form Form. Limits Cost per Rx Notes Phenylephrine HCl Little Noses 0.125% nasal drops - $3. 03 Ephrine, Nose Drops 1% nasal drops - $3. 64 Neo-Synephrine 0.25% nasal spray - $3. Neo-Synephrine 0.5% nasal spray - $3. 23 4 - Way, Nasal Four, Neo-Synephrine 1% nasal spray^ -^ $2. Sudafed PE 5 mg tablet^ -^ -- 10 mg tablet - $1. Expectorants Guaifenesin Robitussin, Iophen- NR, Medifin Expectorant Mucus Relief, Robafen, Tussin Chest Congestion 100 mg/5 ml oral liquid - $1. Liquituss GG, Diabetic Tussin, Mucus Relief 200 mg/5 ml oral liquid^ -^ -- Coughtab, Organidin NR 200 mg tablet^ -^ $1. Allfen, Mucosa, Refenesen 400 mg tablet^ NF^ -- Mucus Relief 600 mg ER tablet - $8. Mucinex ER 1200 mg ER tablet NF -- 1 st^ Generation Antihistamine, Decongestant Promethazine/ Phenylephrine Phenergan VC 6.25 mg-5 mg/5 ml syrup AL; FL $ 2 6. Must be greater than or equal to 2 years of age. Children 2-5. years: limit 1 fill per 365 days. Brompheniramine/ Phenylephrine Brohist D, Ru-hist 4 mg-10 mg tablet NF -- Brovex Peb 4 mg-10 mg/5 ml liquid NF -- Child Triaminic Cold & Allergy, Dimetapp 1 mg-2.5 mg/5 ml solution -^ $2.^24 Brompheniramine/ Pseudoephedrine Lodrane D 4 mg-60 mg capsule NF -- Brotapp, Rynex Pse, V- R Valu-Tapp 1 mg-15 mg/5 ml liquid^ -^ $2. Triprolidine/ Pseudoephedrine Aprodine, Ed A-Hist PSE 2.5 mg-60 mg tablet^ -^ $2. Ritifed 1.25 mg syrup - 30 mg/5 ml - -- Antitussive – Non-Narcotic, 1st^ Generation Antihistamine Dextromethorphan/ Promethazine Phenergan DM^ 6.25 mg-15 mg/5 ml syrup

QL; FL;

AL $3.

Limit 240 ml per fill and 7 fills per year. Must be greater than or equal to 2 years of age. Children 2-5. years: limit 1 fill per 365 days. Antitussive – Non-Narcotic, Decongestant Dextromethorphan/ Pseudoephedrine Pedia Relief Infant 7.5 mg drops - 2.5 mg/0.8 ml oral QL; FL -- (^) Limit 240 ml per fill Expectorant Max and 7 fills per year Strength 30 mg-15 mg/5 ml oral liquid

QL; FL --

PA = Prior Authorization; QL = Quantity Limit; FL = Fill Limit; AL = Age Limit; NF = Non-formulary

Generic Brand Strength & Dosage form Formulary Limits Cost per Rx Notes Expectorant, Decongestant Guaifenesin/ Pseudoephedrine Triaminic, Triacting Expectorant 15 mg-50 mg/5 ml syrup^ -^ -- Tussin PE 30 mg-100 mg/5 ml syrup - -- Suphedrin Non- Drying Sinus 30 mg-200 mg capsule^ -^ -- Congestac 60 mg-400 mg tablet - -- Mucinex D 60 mg-600 mg XR tablet - $11. Mucinex D Maximum Strength 120 mg-1,200 mg XR tablet

1 st^ Generation Antihistamine, Decongestant, Analgesic Pseudoephedrine/ Acetaminophen/ Chlorpheniramine Non-Aspirin Child's Cold 0.5 mg-7.5 mg-80 mg chewable tablet

1 st^ Generation Antihistamine, Decongestant, NSAID (COX-nonspecific) Chlorpheniramine/ Pseudoephedrine/ Ibuprofen Advil Allergy Sinus 2 mg-30 mg-200 mg tablet

Antitussive – Non-Narcotic, 1st^ Generation Antihistamine, Decongestant Brompheniramine/ Phenylephrine/ Dextromethorphan Dimetapp DM 1 mg-2.5 mg-5 mg/5 ml Oral Solution QL; FL^ $2.^ Limit 240 ml per fill and 7 fills per year Dextromethorphan/ Phenylephrine/ Chlorpheniramine Cardec DM, Virdec DM 1 mg-3.5 mg-3 mg/ml oral drops QL; FL^ --^ Limit 240 ml per fill and 7 fills per year Dextromethorphan/ Pseudoephedrine/ Brompheniramine Bio-Dtuss Dmx 1 mg-30 mg-20 mg/5 ml oral liquid QL; FL^ -- Limit 240 ml per fill and 7 fills per year Bromfed DM, Dimetane-diagnosis 2 mg-30 mg-10 mg/5 ml syrup

QL; FL $10.

Bromphenex DM 4 mg syrup-60 mg - 30 mg/5 ml QL; FL -- Bromaline DM, Brotapp DM, Medi- Brom, Q-Tapp DM 1 mg-15 mg- 5 mg/5 ml oral elixir QL; FL^ $4.^90 Dextromethorphan/ Pseudoephedrine/ Chlorpheniramine Pediacare Cough- Cold, Triacting Multi- Symptom Cough-Cold 1 mg-15 mg-5 mg/5 ml oral liquid QL; FL^ $2. Limit 240 ml per fill Mesehist DM DM, M-End 2 mg syrup-15 mg - 15 mg/5 ml QL; FL -- and 7 fills per year Rescon-DM 2 mg-30 mg-10 mg/5 ml oral liquid

QL; FL --

Antitussive – Non-Narcotic, Decongestant, Analgesic Dextromethorphan/ Pseudoephedrine/ Acetaminophen Infants' Non-Aspirin Cold 15 mg- 5 mg-160 mg/1. ml oral drops QL; FL -- Limit 240 ml per fill and 7 fills per year Antitussive – Non-Narcotic, Decongestant, Expectorant Guaifenesin/ Dextromethorphan/ Phenylephrine Robitussin Cough & Cold CF, Adult Tussin Multi-Symptom Cold 5 mg-10 mg-100 mg/5 ml oral liquid QL; FL^ $2.39 Limit 240 ml per fill Guaifenesin/ and 7 fills per year Dextromethorphan/ Pseudoephedrine Tussin CF 30 mg-10 mg-100 mg/ ml syrup QL; FL^ -- Antitussive – Non-Narcotic, 1st^ Generation Antihistamine, Decongestant, Analgesic Dextromethorphan/ Pseudoephedrine/ Acetaminophen/ Chlorpheniramine Alka-Seltzer Plus-D Sinus-Cold 2 mg-30 mg-10 mg- 325 mg capsule QL; FL^ -- Limit 240 ml per fill and 7 fills per year Tylenol Cold 30 mg-15 mg-325 mg tablet

QL; FL --

Dextromethorphan/ Pseudoephedrine/ Acetaminophen/ Doxylamine Tylenol Cold & Flu Severe 12.5 mg-60 mg-30 mg- 1000 mg/30 ml oral liquid

QL; FL --

PA = Prior Authorization; QL = Quantity Limit; FL = Fill Limit; AL = Age Limit; NF = Non-formulary

Generic Brand Strength & Dosage form Formulary Limits Cost per Rx Notes Antitussive – Narcotic, 1st^ Generation Antihistamine, Decongestant Promethazine/ Phenylephrine/ Codeine Phenergan VC With Codeine 6.25 mg-5 mg-10 mg/5 ml syrup QL; FL; AL $24.53 Limit 240 ml per fill and 4 fills per year. Must be greater than or equal to 18 years of age. Pseudoephedrine/ Codeine/ Chlorpheniramine Phenylhistine DH 2 mg-30 mg-10 mg/5 ml oral liquid

QL; FL; AL --

Antitussive – Narcotic, Decongestant, Expectorant Pseudoephedrine/ Codeine/ Guaifenesin Cheratussin DAC 30 mg syrup - 10 mg-100 g/5 ml QL; FL; AL $35. Limit 240 ml per fill and 4 fills per year. Must be greater than or equal to 18 years of age. PA = Prior Authorization; QL = Quantity Limit; FL = Fill Limit; AL = Age Limit; NF = Non-formulary  CLINICAL JUSTIFICATION

HPSJ’s cough & cold policy is based on recommendations by the British Thoracic Society (BTS), American College of

Chest Physicians (ACCP), American Academy of Pediatrics (AAP), National Institute for Health and Clinical Excellence

(NICE). The BTS Guidelines define acute cough as recent onset lasting < 3 weeks, while chronic cough lasts > 8

weeks.5,6^ These guidelines stress the importance of identifying the source of the cough and treating underlying

conditions if possible. Some examples of underlying conditions are 1. upper respiratory tract infections (e.g.,

bacterial bronchitis), which can be treated with antibiotics, or 2. cough variant asthma, which can be identified

with appropriate testing and a trial of anti-asthma therapy for 8-12 weeks. The BTS Guidelines also found that

OTC medications are as effective as placebo for acute cough with head colds in children; however, antihistamines

and intranasal steroids are beneficial for children with allergic cough in the pollen season.^5 Both BTS and AAP

Guidelines for pediatric patients recommend fluids, rest and humidity over cough suppressants because coughing

can be a protective mechanism for clearing the airway and there is limited evidence of efficacy in these patients.5,

The age restriction for codeine-containing products was in place due to the FDA’s Black Box Warning and

contraindication in children < 6 years of age, based on reports of respiratory depression and death occurring in

children ages 2 to 5.8,

The ACCP 2006 Guidelines recommend that suppressant therapy be used for short-term reduction of coughing.

These guidelines recommend codeine and dextromethorphan specifically for short-term relief in patients with

chronic bronchitis, while antihistamine/decongestant combination therapy may be used for acute cough due to

the common cold.^10 The quantity and fill limits for codeine- and hydrocodone-containing cough syrups allow

patients sufficient quantity for short-term relief of acute cough and are in alignment with these ACCP

recommendations. These limits are in place to reduce potential for overuse.

The British Thoracic Society (BTS) 2008 and American College of Chest Physicians (ACCP) 20 16 guidelines

recommend that chronic cough (lasting >8 weeks) should be managed by first identifying the underlying cause

and addressing treatment for that condition.5,11^ The Drug Enforcement Administration (DEA) lists

dextromethorphan as a potential drug of abuse.12,

The European Medicines Agency published a recommendation in July 2013 stating that codeine should only be

used to relieve acute moderate pain in children older than 12 years of age if treatment failure to other painkillers

such as acetaminophen or ibuprofen.^14 ,15^ Health Canada announced a safety recommendation against the use of

pain and cough medications containing codeine in children younger than 12 years.^16 The American Academy of

Pediatrics published a clinical report in September 2016 calling for more formal restrictions regarding its use in

children and suggesting the use of genetic variability in drug metabolism to guide physicians in safe and effective

treatment.^17 In January 2018 the Food and Drug Administration announced a safety update to limit the use of

prescription opioid cough and cold medications to adults 18 years and older due to the risks of misuse, abuse,

addiction, overdose, respiratory depression, and death from codeine and hydrocodone in the pediatric

population.^18

The Food and Drug Administration 2004 Safety Labeling Change for promethazine-containing products added a

contraindication in children under age 2.19,20^ This safety labeling change also added a Black Boxed Warning

stating that caution should be used in children over 2 years old (use lowest possible dose and avoid other

respiratory depressant drugs). Because of the FDA contraindication for children < 2 years of age, promethazine

 Other Notes: None

Brompheniramine/Phenylephrine 1 mg-2.5 mg/5 ml solution, Brompheniramine/Pseudoephedrine 1

mg-15 mg/5 ml liquid (Brotapp), Triprolidine/Pseudoephedrine (Aprodine, Ed A-Hist PSE, Ritifed)

 Coverage Criteria: None

 Limits: None

 Required Information for Approval: N/A

 Other Notes: None

 Non-Formulary: Brompheniramine/Phenylephrine 4 mg-10 mg tablet (Brohist D, Ru-hist);

Brompheniramine/Phenylephrine 4 mg-10 mg/5 ml liquid (Brovex Peb);

Brompheniramine/Pseudoephedrine 4 mg-60 mg capsule (Lodrane D)

Antitussive – Non-Narcotic, 1st^ Generation Antihistamine

Dextromethorphan/Promethazine (Phenergan DM)

 Coverage Criteria: None

 Limits: 240 ml per fill; 7 fills per year; Must be greater than or equal to 2 years of age. Children 2-5.

years: limit 1 fill per 365 days.

 Required Information for Approval: N/A

 Other Notes: None

Antitussive – Non-Narcotic, Decongestant

Dextromethorphan/Pseudoephedrine (Expectorant Max Strength, Pedia Relief Infant)

 Coverage Criteria: None

 Limits: 240 ml per fill; 7 fills per year

 Required Information for Approval: N/A

 Other Notes: None

Antitussive – Non-Narcotic, Expectorant

Guaifenesin/Dextromethorphan (Adult Robitussin Peak Cold, Iophen DM-NR, Alka-Seltzer Plus Mucus-Congestion,

Coricidin HBP, Mucinex DM)

 Coverage Criteria: None

 Limits: 240 ml per fill; 7 fills per year

 Required Information for Approval: N/A

 Other Notes: None

Antitussive – Narcotic, 1st^ Generation Antihistamine

Promethazine/Codeine (Phenergan with Codeine)

 Coverage Criteria:

 Limits: 240 ml per fill; 4 fills per year; patient must be greater than or equal to 18 years of age

 Required Information for Approval: N/A

 Other Notes: Oxycodone- and hydrocodone-containing products can also help relieve cough.

Furthermore, both oxycodone and hydrocodone are more potent cough suppressants than codeine.

Therefore, use of codeine-containing cough syrup plus oxycodone- or hydrocodone-containing products

is a therapeutic duplication. Potential for codeine syrup abuse is well-documented and should be strongly

considered for those concurrently on regular hydrocodone/oxycodone therapy.

 Non-Formulary: Hydrocodone/Phenyltoloxamine (Tussionex)

Antitussive – Narcotic, Anticholinergic

Hydrocodone/Homatropine (Hydromet)

 Coverage Criteria: None

 Limits: 240 ml per fill; 4 fills per year; patient must be greater than or equal to 18 years of age

 Required Information for Approval: N/A

 Other Notes: None

Antitussive – Narcotic, Expectorant

Guaifenesin/Codeine Phosphate (Cheratussin AC, Iophen C-NR, Virtussin AC)

 Coverage Criteria: None

 Limits: 240 ml per fill; 4 fills per year; patient must be greater than or equal to 18 years of age

 Required Information for Approval: N/A

 Other Notes: Oxycodone- and hydrocodone-containing products can also help relieve cough.

Furthermore, both oxycodone and hydrocodone are more potent cough suppressants than codeine.

Therefore, use of codeine-containing cough syrup plus oxycodone- or hydrocodone-containing products

is a therapeutic duplication. Potential for codeine syrup abuse is well-documented and should be strongly

considered for those concurrently on regular hydrocodone/oxycodone therapy.

Decongestant, Analgesic

Pseudoephedrine/ Acetaminophen (Daytime Sinus Relief, Tavist)

 Coverage Criteria: None

 Limits: None

 Required Information for Approval: N/A

 Other Notes: None

 Non-Formulary: Pseudoephedrine/Acetaminophen (Nexafed Sinus Pressure + Pain)

Decongestant, NSAID (COX-nonspecific)

Pseudoephedrine/ Ibuprofen (Ibuprofen Cold)

 Coverage Criteria: None

 Limits: None

 Required Information for Approval: N/A

 Other Notes: None

Expectorant, Decongestant

Guaifenesin/Pseudoephedrine (Triaminic, Tussin PE, Suphedrin Non-Drying Sinus, Congestac, Mucinex D)

 Coverage Criteria: None

 Limits: None

 Required Information for Approval: N/A

 Other Notes: None

1 st^ Generation Antihistamine, Decongestant, Analgesic

Pseudoephedrine/Acetaminophen/Chlorpheniramine (Non-Aspirin Child's Cold)

 Coverage Criteria: None

 Limits: None

 Required Information for Approval: N/A

 Other Notes: None

1 st^ Generation Antihistamine, Decongestant, NSAID (COX-nonspecific)

Chlorpheniramine/Pseudoephedrine/Ibuprofen (Advil Allergy Sinus)

 Coverage Criteria: None

 Limits: None

 Required Information for Approval: N/A

 Other Notes: None

Antitussive – Non-Narcotic, 1st^ Generation Antihistamine, Decongestant

Brompheniramine/Phenylephrine/Dextromethorphan (Dimetapp DM), Dextromethorphan/Phenylephrine/

Chlorpheniramine (Cardec DM, Virdec DM), Dextromethorphan/Pseudoephedrine/Brompheniramine (Bio-Dtuss

DMX, Bromfed DM, Bromphenex DM, Bromaline DM) Dextromethorphan/Pseudoephedrine/Chlorpheniramine

(Pediacare Cough-Cold, Mesehist DM, Rescon-DM)

 Coverage Criteria: None

 Limits: 240 ml per fill; 7 fills per year

 Required Information for Approval: N/A

 Other Notes: None

Antitussive – Non-Narcotic, Decongestant, Analgesic

Dextromethorphan/Pseudoephedrine/Acetaminophen (Infants’ Non-Aspirin Cold)

 Coverage Criteria: None

 Limits: 240 ml per fill; 7 fills per year

 Required Information for Approval: N/A

 Other Notes: None

  1. FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy. Food and Drug Administration Web Site. http://www.fda.gov/Drugs/DrugSafety/ucm339112.htm. Updated January 15, 2016. Accessed May 1, 2016.
  2. American College of Chest Physicians. Cough Suppressant and Pharmacologic Protussive Therapy. Diagnosis and Management of Cough. 2006;129(1):238S-249S.
  3. American College of Chest Physicians. Treatment of Unexplained Chronic Cough: CHEST Guideline and Expert Panel Report. Chest. 2016;149(1):27-44.
  4. Drug Enforcement Administration. Drug Fact Sheet: Dextromethorphan (DXM). DEA Web Site. http://www.dea.gov/druginfo/drug_data_sheets/Detromethorphan.pdf. Accessed May 13, 2016.
  5. Drug Enforcement Administration. Prescription for Disaster: How Teens Abuse Medicine. California Board of Pharmacy Web Site. http://www.pharmacy.ca.gov/consumers/parents_how_teens_abuse_medicine.pdf. Updated August 2012. Accessed May 13, 2016.
  6. Drug Safety Update – Codeine for analgesia: restricted to use in children because of reports of morphine toxicity. European Medicines Agency Web Site. https://www.gov.uk/drug-safety-update/codeine-for-analgesia-restricted- use-in-children-because-of-reports-of-morphine-toxicity. Updated July 10, 2013. Accessed May 17, 2016.
  7. European Medicines Agency. Restrictions on use of codeine for pain relief in children – CMDh endorses PRAC recommendation. 2013. EMA/385716/2013.
  8. Health Canada. Health Canada’s review recommends codeine only be used in patients aged 12 and over. Ottawa, Canada: Health Canada; 2013. http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/33915a- eng.php. Updated July 28, 2016. Accessed September 19, 2016.
  9. Tobias JD, Green TP, Coté CJ, AAP Section on Anesthesiology and Pain Medicine, AAP Committee on Drugs. Codeine: Time to Say “No”. Pediatrics. 2016; 138(4):e20162396.
  10. FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use. U.S. Food and Drug Administration Web Site. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592109.htm. Updated January 11, 2018. Accessed January 18, 2019.
  11. Information for Healthcare Professionals – Promethazine (marketed as Phenergan and generic products). U.S. Food and Drug Administration Web Site. http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm126465.htm. Updated August 14, 2013. Accessed May 18, 2016.
  12. Starke PR, Weaver J, Chowdhury BA. Boxed Warning Added to Promethazine Labeling for Pediatric Use. New England Journal of Medicine. 2005;352:2653.
  13. Promethazine HCl, Phenylephrine HCl, and Codeine Phosphate Oral Solution – Detailed View: Safety Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER) – November 2008. U.S. Food and Drug Administration Web Site. http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety- RelatedDrugLabelingChanges/ucm121084.htm. Updated August 14, 2013. Accessed May 13, 2016.
  14. FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. U.S. Food and Drug Administration Web Site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116839.htm. Updated April 20, 2017. Accessed May 1, 2017.
  15. Statement from FDA Commissioner Scott Gottlieb, MD – FDA is carefully evaluating prescription opioid medications approved to treat cough in children. Food and Drug Administration Web Site. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm572466.htm. Updated August 21, 2017. Accessed November 23, 2017.
  16. Minutes of the Pediatric Advisory Committee. Food and Drug Administration Web Site. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee /UCM581720.pdf. Updated September 11, 2017. Accessed December 5, 2017.  REVIEW & EDIT HISTORY Document Changes Reference Date P&T Chairman Creation of Policy Codeine DUR summary 2- 21 - 2012.docx 02 /20 12 Jonathan Szkotak, PharmD, BCACP Update to Policy HPSJ Coverage Policy – Infectious Disease – Cough & Cold 2016-09.docx 09/2016 Johnathan Yeh, PharmD Update to Policy HPSJ Coverage Policy – Infectious Disease – Cough & Cold 2017-12.docx 12/2017 Johnathan Yeh, PharmD Update to Policy HPSJ Coverage Policy – Infectious Disease – Cough & Cold 2019-2.docx 02/2019 Matthew Garrett, PharmD Update to Policy Cough & Cold 02/2020 Matthew Garrett, PharmD Review of Policy Cough & Cold 02/2021 Matthew Garrett, PharmD Note: All changes are approved by the HPSJ P&T Committee before incorporation into the utilization policy

Please review the Seasonal Allergies Coverage Policy for coverage criteria of allergy products.