Revised: 28 June 2013

Safety Information

Minutes of the Second Cough and Cold Review Group Meeting

18 August 2009

The second meeting of the Cough and Cold Review Group was held on 18 August 2009 in the Board Room, Medsafe, Wellington, New Zealand. The meeting commenced at 9.30 am and closed at 3.20pm.

Cough and Cold Working Group Members present

A Shirtcliffe (Chair)
L Bryant
S Cole
M Dalton
E Galloway
A Jamieson
H Kingston
D Reith
T Roper
R Savage
L Toop

Invited Guests and Experts present

P Abernethy
F Brounéus
P Tuohy

Medsafe staff present as observers

A Cutfield
K Daly
J Hart
C James
S Kenyon
J McNee
E Yousuf

1 Matters of Administration

1.1 Welcome and Apologies

The Chair welcomed the attendees to the meeting and briefed the Group on the reasons for the meeting.

Members were reminded that the role of the Working Group was to advise Medsafe on the use of cough and cold medicines in children.

The purpose of the current meeting was to assess the risk-benefit profile of bromhexine and topical nasal decongestants for use in children in the treatment of the common cold, and to make a final recommendation on the risk-benefit balance of all cough and cold medicines in children.

The Group was also asked to discuss and recommend possible risk management options and appropriate implementation, communication and education strategies to improve the safety profile of cough and cold medicines in children.

The Chair introduced the new members of the Group, the invited experts and the Medsafe staff observing. Apologies were received from B Buckham.

1.2 Minutes of the 1^st meeting of the Cough and Cold Review Group

The minutes of the 1^st meeting of the Cough and Cold Review Group were accepted as a true and accurate record of the first meeting.

1.3 Summary of discussions from the first meeting

The Chair summarised the conclusions of the 1^st meeting of the Cough and Cold Review Group.

The Group noted that cough and cold medicines are already contraindicated for use in children <2 years of age. The majority of members considered that it would be appropriate to extend the contraindication to children <6 years of age, with the exception of bromhexine and topical nasal decongestants which required further review by the Group.

The Group noted that the majority of members considered the reclassification of cough and cold medicines to a pharmacy-based classification (Pharmacy-only medicine or Restricted medicine) to be appropriate, with the exception of bromhexine and topical nasal decongestants which required further review by the Group. The Group noted that such a reclassification would need to be assessed by the Medicines Classification Committee, and that this process involves a public consultation.

1.4 Potential Conflicts of Interest

The Chair reported on the conflicts of interest and confirmed there were none declared that would adversely influence the discussions or decisions of the Working Group.

2 References

2.1 Bromhexine

The Group considered the following data supplied by pharmaceutical companies and/or literature searches by members in their review of the safety and efficacy of bromhexine.

• Data regarding bromhexine supplied by Boehringer Ingelheim.
• Tarantino V., et al. (1988). Advantages of treatment with bromhexine in acute infant sinus inflammation: Randomised double blind study vs placebo. Minerva Pediatrica. 40 (11) : 649-652.
• Van Bever H., et al. (1987). Nebulization treatment with saline compared to bromhexine in treating chronic sinusitis in asthmatic children. Allergy . 42 (1) : 33-36.
• Stewart A., et al. (1985). Bromhexine in the treatment of otitis media with effusion. Clinical Otolaryngology and Allied Sciences . 10 (3) : 145-149.
• Schulz M., et al. (2006). Safety and usage pattern of an over-the-counter ambroxol cough syrup: a community pharmacy-based cohort study. International Journal of Clinical Pharmacology and Therapeutics . 44 (9) : 409-421.
• Rimsza M. and Newberry S. (2008). Unexpected infant deaths associated with use of cough and cold medications. Pediatrics . 122 (2) : e318-322.

2.2 Topical Nasal Decongestants

The Group considered the following data supplied by pharmaceutical companies and/or literature searches by members, in their review of the safety and efficacy of topical nasal decongestants.

• Data regarding xylometazoline supplied by Novartis.
• Data regarding oxymetazoline supplied by Novartis
• Data regarding oxymetazoline supplied by Schering-Plough.
• Fradis M., et al. (1987). Treatment of perennial allergic rhinitis by sodium cromoglycate plus 0.025 per cent xylometazoline (a double blind study). The Journal of Laryngology and Otology . 101: 666-672.
• Jensen J., et al. (1990). Topical application of decongestant in dysfunction of the Eustachian tube: a randomised, double-blind, placebo-controlled trial. Clinical Otolaryngology and Allied Sciences . 15 (3) : 197-201.
• Michel O., et al. (2005). The value of Ems Mineral Salts in the treatment of rhinosinusitis in children: Prospective study on the efficacy of mineral salts versus xylometazoline in the topical nasal treatment of children. Internaltional Journal of Pediatric Otorhinolaryngology . 69 (10) : 1359-1365.
• Van Heerbeek N., et al. (2002). No effect of a nasal decongestant on Eustachian tube function in children with ventilation tubes. The Laryngoscope . 112 (6) : 1115-1118.
• Turner R. and Darden P. (1996). Effect of topical adrenergic decongestants on middle ear pressure in infants with common colds. The Pediatric Infectious Disease Journal . 15 (7) : 621-624.
• Dunn C., et al. (1993). Coma in a neonate following single intranasal dose of xylometazoline. European Journal of Pediatrics . 152 (6) : 541-541.
• Söderman P., et al. (1984). CNS reactions to nose drops in small children. Lancet . 323 (8376) : 573-573.
• Thompson R. (1970). Nose-drop intoxication in an infant. The Journal of the American Medical Association . 211 (1) : 123-124.
• Musshoff F., et al. (2003). Naphazoline intoxication in a child - a clinical and forensic toxicological case. Forensic Science International . 134 (2) : 234-237.

3 Introduction To Communication Strategies

3.1 Consideration of Communication Methods

P Tuohy (Chief Advisor - Child and Youth, Population Health Directorate, Ministry of Health) was available to contribute to discussions of the Group during the first hour of the meeting. Please refer to section 10 for an overall summary of the Group's discussion on communication.

4 Bromhexine and Topical Nasal Decongestants

4.1 Summary of efficacy data

L Bryant provided a presentation on the evidence of efficacy of bromhexine and topical nasal decongestants in children in the treatment of the common cold.

The Group considered data available in the literature and data supplied by the pharmaceutical companies. A broad literature search using Medline was undertaken to obtain any studies with relevant substances (mucolytics and topical nasal decongestants).

4.1.1 Bromhexine

The Group noted that bromhexine is a mucolytic (breaks up phlegm) used for conditions with abnormal mucus secretion and impaired mucus transport.

The primary source of data for efficacy was provided by Boehringer Ingelheim. The data provided included 28 studies involving a total of 1441 exposures. Conditions resulting in treatment were mixed, including asthma and pneumonia. The studies included various formulations of bromhexine, including formulations no longer available. The majority of the studies (25) were small, involving less than 55 participants, while 23 studies were non-randomised, longitudinal studies. The treatment period for all studies ranged between 5 and 30 days, with a mean of 10 days, which is longer than expected for the treatment of symptoms of the common cold.

A search of published literature regarding the efficacy of bromhexine revealed three notable studies.

One randomised controlled trial (Tarantino, 1988) investigated the use of bromhexine (n=15) vs placebo (n=15) in children aged three to twelve years with acute sinus inflammation (whooping cough, measles complications, etc). The children received eight days treatment with bromhexine or placebo. All children received concomitant amoxicillin. The outcomes were assessed using a 5-point Likert scale for nasal secretions and rhinitis score. The outcome statistically favoured bromhexine, however baseline characteristics did not appear balanced as a higher number of participants in the placebo group (5/15) experienced pain than the bromhexine group (2/15) and the measurements were not validated. The Group noted the apparent slow onset of effect demonstrated in this study with the effect of bromhexine most evident between days four and six.

A second study (Van Bever, 1987) investigated the effect of nebulised bromhexine compared to saline on asthma symptoms in children aged three to fourteen years old. The treatment duration was two weeks. The Group noted this study demonstrated no significant difference compared to saline.

A third study (Stewart, 1985) investigated the effect of bromhexine compared to placebo in 95 children aged three to eight years with Otitis Media Effusion. Each child received two 4-week courses of either bromhexine or placebo. The Group noted this study demonstrated no significant difference to placebo.

The Group was informed of further studies investigating the effects of ambroxol (a metabolite of bromhexine) and letostein. The Group noted that these studies did not add any significant efficacy data regarding the use of mucolytics for the common cold.

4.1.2 Topical Nasal Decongestants

The Group noted that topical nasal decongestants used in the treatment of the common cold include xylometazoline, oxymetazoline and phenylephrine.

The Group noted four randomised controlled trials involving xylometazoline, provided by Novartis. One of the trials (Fradis, 1987) investigated the use of xylometazoline for allergic rhinitis in participants aged between ten and 75 years. This trial included sodium cromoglycate and demonstrated a positive beneficial effect over placebo. The second study (Jensen, 1990) investigated the use of xylometazoline for tympanic membrane perforation in participants aged between twelve and 75 years and also demonstrated a positive beneficial effect over placebo. However, these studies did not investigate the use of xylometazoline in children less than ten years of age. The remaining two trials investigated the use of xylometazoline and adjunctive amoxicillin for chronic maxillary sinusitis, but demonstrated no significant difference to placebo.

The sponsor provided an additional eight studies for review by the Group, however these studies did not contain a placebo comparator.

A search of published literature regarding the efficacy of xylometazoline revealed two notable studies.

One study (Michel, 2005) investigated the use of xylometazoline (n=66) compared to mineral salts (n=66) in children aged two to six years with rhinosinusitis. The children received two weeks treatment with xylometazoline or mineral salts. The results demonstrated no significant difference between the xylometazoline or mineral salts groups, with both groups improving by two weeks.

A second study (Van Heerbeek, 2002) investigated the effect of xylometazoline on eustachian tube function in 80 children with ventilation tubes due to persistent otitis media effusion compared to placebo. Each child was treated with intranasal administration of five drops of 0.05% xylometazoline hydrochloride or placebo. The Group noted this study demonstrated no significant difference on eustachian tube function compared to placebo.

The Group noted a further study investigating the effect of phenylephrine (Turner, 1996) on middle ear pressure in children aged six to eighteen months with the common cold compared to placebo. No significant difference was demonstrated. The Group noted that this study demonstrated that treatment of nasal obstruction with topical adrenergic decongestants does not improve abnormal middle ear pressure during the common cold.

4.1.3 Additional discussion

The Group noted that a search for Cochrane reviews involving acute respiratory infections in children revealed no studies demonstrating or supporting efficacy of bromhexine and topical nasal decongestants.

The Group considered that many of the studies investigating efficacy of topical nasal decongestants were undertaken in adults and questioned whether the NNT (number needed to treat) would be the same in children as it is in adults. The Group noted that children have narrower airways which are more prone to obstruction which affects the flow of mucus. Additionally, the Group noted that children have relatively larger tonsils and adenoids than adults, therefore if these become inflamed obstruction is more likely to result. The Group questioned whether absorption through the nasal mucosa is the same in children as it is in adults. If not, there may be a potential for altered systemic absorption resulting in an altered safety profile.

The Group considered the clinical benefit of the mechanism of action of bromhexine. The Group noted that by moving phlegm away from the lungs, bromhexine may reduce the risk of secondary infection.

The Group noted that further studies investigating the efficacy of cough and cold medicines are underway in the United States with completion expected in 2011. The Group recommended that the results of these studies be forwarded to the Medicines Adverse Reactions Committee for consideration when they become available.

4.1.4 Conclusions

The Group noted there was a paucity of good clinical trials demonstrating efficacy of bromhexine and topical nasal decongestants in children.

4.2 Summary of safety data

R Savage provided a presentation on the safety of bromhexine and topical nasal decongestants in children in the treatment of the common cold, with a focus on New Zealand poisons and adverse reaction data.

The Group noted that adverse effects with cough and cold medicines can occur as a result of adverse reactions and interactions at therapeutic doses, accidental ingestion by a child resulting in overdose, medication/dosing errors by parents and prescribers resulting in unintentional overdose or deliberate overdose.

4.2.1 Bromhexine

The Group noted that MIMS New Zealand indicates various brands of bromhexine for relief of heavy chest cough, productive and persistent cough, congested chest and cough due to common cold, bronchitis, emphysema, asthma and other conditions with tenacious or excessive mucoid secretions.

The Group also noted that the common adverse reactions associated with bromhexine include hypersensitivity reactions, rash, anaphylaxis, headache, dizziness, sweating, GI effects and hepatic effects including transient increases in serum transaminases.

4.2.1.1 Published literature

The Group noted that no randomised controlled trials or observational studies involving bromhexine with safety endpoints were identified. However the Group noted one observational uncontrolled study (Schulz, 2006) involving the mucolytic ambroxol (a metabolite of bromhexine). This study included 266 pharmacies covering 2664 evaluable questionnaires where participants self assessed and reported adverse events. There were 81 adverse reactions identified in 67 participants. The reports detailed gastrointestinal events (53) and skin and subcutaneous events (9). No serious or previously unknown adverse events were reported.

The Group noted that no published case reports involving bromhexine were identified. However, two case reports were published in a paper (Rimsza, 2008) detailing death associated with ambroxol, one in a two month old male and one in a five month old female. However, the paper advises that administration of ambroxol was not identified as the cause of death.

4.2.1.2 CARM data

The Group noted that the New Zealand Centre for Adverse Reactions Monitoring (CARM) have not received any reports for bromhexine which indicate that the individual involved was a child.

4.2.1.3 Poisons Centre data

The Group noted the New Zealand Poisons Centre has received one enquiry involving bromhexine, leading to medical attention, involving a child.

The Group noted that out of 18575 enquires to the Maryland Poisons Centre (USA) involving exposure of children <6 years of age to any substance, none involved mucolytics.

4.2.1.4 Sponsor data

The Group noted that Boehringer-Ingelheim estimates that their bromhexine-containing formulation has been used by approximately 164 million individuals aged <12 years, based on sales of age appropriate products and two week courses. The Group noted that the common cold is not the main indication for the bromhexine-containing formulation.

The Group noted that the Boehringer-Ingelheim Adverse Reaction Information System global (ARISg), which includes all ICSR reports received, literature, clinical studies and disease registries, contains 82 reports involving bromhexine in children aged between two and six years. There were no fatal reports, three serious reports, 70 non-serious reports and nine reports of unknown seriousness.

The Group noted that most of the reports detail gastrointestinal reactions and allergy, including anaphylaxis and skin reactions; however most were listed as having 'insufficient data'. The Group noted that there are a similar number of reports in the zero to two year age group (81) and the two to six year age group (82), including three serious reports in each age group. There were fewer reports in the six to twelve year age group. The Group noted that the three serious cases in the two to six year age group reported the following adverse events: accidental overdose, diarrhoea, Stevens Johnson Syndrome (SJS) and skin reaction/weight loss/tonsilitis. The report of SJS in the two to six year age group and an additional report of Toxic Epidermal Necrolysis (TEN) in the six to twelve year age group contained sufficient information to suggest that there were alternative explanations for these events. This was also the case with most of the similar reports in the WHO International Drug Monitoring database.

The Group noted that overdose of bromhexine, in general, has been associated with skin and gastrointestinal reactions, but not with significant toxicity or death.

4.2.1.5 International regulatory actions

The Group noted that neither the United Kingdom medicines regulator (MHRA) nor the Canadian medicines regulator (Health Canada) have contraindicated the use of bromhexine in children <6 years of age, because bromhexine-containing medicines are not marketed in the United Kingdom or Canada.

4.2.2 Topical Nasal Decongestants

The Group noted that MIMS New Zealand indicate that imidazoline derivatives can be used to relieve the symptoms of the common cold in children.

The Group also noted that MIMS New Zealand indicates that ipratropium can be used for rhinitis (with dosage advice for children) and the common cold (with no dosage advice for children).

4.2.2.1 Published literature

The Group noted that there were no safety endpoints in published randomised controlled trials or observational studies investigating topical nasal decongestants. Additionally the Group noted that no randomised controlled trials or observational studies large enough to provide adequate safety data were identified. Therefore the consideration by the Group of safety data for topical nasal decongestants was based on case reports and spontaneous reports.

The Group noted four published case histories detailing CNS depression associated with topical nasal decongestants. One published case (Dunn, 1992) detailed coma in a neonate following a single intranasal dose of xylometazoline. A second published case (Söderman, 1984) detailed CNS reactions to nose drops in small children following repeat doses of a topical nasal decongestant. A third published case (Thompson, 1970) detailed nose drop intoxication in an infant, following repeat doses of a topical nasal decongestant. A fourth, and more recent, published case (Musshoff, 2003), detailed CNS depression and bradycardia following administration of intranasal naphazoline in an seven year old, due to medication error (eight times the adequate childhood dose).

4.2.2.2 CARM data

Xylometazoline

The Group noted that the New Zealand Centre for Adverse Reactions Monitoring (CARM) has received 33 reports involving xylometazoline. Although age is not stated in all reports, five reports detailed individuals <19 years of age. The Group considered the five reports.

One report detailed rhinitis medicamentosa, nasal obstruction, stertorous breathing and chest retraction, resulting in hospitalisation in a one month old female. The second report detailed accidental administration of an adult spray in a seven year old female, with no adverse effect. The third report detailed rebound congestion in an eight year old male. The fourth report detailed aplastic anaemia in a 14 year old female three to four weeks following administration of a multi-ingredient preparation including xylometazoline. The fifth report detailed angioedema in an 18 year old male.

Oxymetazoline

The Group noted that the New Zealand Centre for Adverse Reactions Monitoring (CARM) has received one report involving oxymetazoline in an adult, with no reports involving individuals <18 years of age.

4.2.2.3 Poisons Centre data

The Group noted the New Zealand Poisons Centre has not received any enquiries involving topical nasal decongestants leading to medical attention.

The Group noted that nine of the 567 enquiries for cough and cold medicines received by the Victorian Poisons Centre in Australia involve imidazoline-based nose drops or sprays.

The Group noted that out of 18575 enquires to the Maryland Poisons Centre (USA) involving exposure of children <6 years of age to any substance, none involved topical nasal decongestants.

4.2.2.4 Sponsor data

Xylometazoline

The Group noted that Novartis estimates that their xylometazoline-containing nasal formulation has been used by more that 2.5 million individuals in the United Kingdom.

Up to July 2007, the company adverse reaction database holds 28 adverse event reports involving 20 children aged <12 years (including a duplicate). Of the 19 reports, ten involved children <2 years of age, seven involved children ≥2 to <6 years of age and two involved children ≥6 to <12 years of age. Adverse events reported in children ≥2 to <6 years of age include epistaxis, anxiety, hyperreflexia, rash, erythema, blisters, hallucinations and drug abuse. The report of epistaxis was considered to be probably related to the use of xylometazoline. The remaining reports contained insufficient data to establish causality.

According to the reports in the Novartis adverse reaction database, the most frequent organ classes affected are psychiatric, skin and subcutaneous, and general and administration site disorders. Serious reports include apnoea (2), epilepsy (1), cyanosis (1) and death (1); however these were reported in children <2 years of age.

Collation of information from the United States medicines regulator adverse reactions database, the United States national poisons service database and the literature identified a total of 77 reports involving xylometazoline. One of these reports (1.3%) detailed fatality, 17 (15.3%) detailed a serious, non-fatal reaction and 19 (24.7%) detailed reactions of unknown seriousness. The Group noted that this data needed to be interpreted with caution, as if all 19 reports of unknown severity were subsequently considered serious the safety profile of xylometazoline would be affected.

Oxymetazoline

The Schering-Plough adverse reaction database contains 62 events in 35 individuals aged between two and twelve years, involving single and multiple ingredient preparations. Reports detail accidental exposure with no adverse reaction (5), epistaxis (4), nasal discomfort (5), cardiac arrest (3) and cardiac failure (1). Three out of the four reports of cardiac arrest and cardiac failure were related to procedures for which oxymetazoline was administered intraoperatively. There are also two reports of overdose; one details personality change and hallucinations and the other details vomiting, sweating and somnolence.

Schering-Plough estimates the incidence of adverse events associated with oxymetazoline in children to be 0.56 per 100,000 patient years (compared to 0.14 in all age groups).

Collation of information from the United States medicines regulator adverse reactions database, the United States national poisons service database and the literature identified a total of 1323 reports involving oxymetazoline. None of these reports detailed fatality, 17 (1.2%) detailed a serious, non-fatal reaction and 543 (41%) detailed reactions of unknown seriousness. The Group noted that this data needed to be interpreted with caution, as if all 543 reports of unknown severity were subsequently considered serious the safety profile of oxymetazoline would be affected.

The Group considered information regarding the safety profile of oxymetazoline contained in Martindale (2008). Specifically:

• Oxymetazoline is a direct-acting sympathomimetic with marked alpha-adrenergic activity.
• Rebound congestion may occur after frequent or prolonged use.
• Systemic effects may occasionally follow the topical use of sympathomimetic decongestants; these include nausea, headache and dizziness.
• Overdosage or accidental dosage by mouth may cause CNS depression with marked reduction of body temperature and bradycardia, sweating, drowsiness, and coma, particularly in children.

It was noted that the information contained in Martindale was consistent with the data from spontaneous sources.

4.2.2.5 International regulatory actions

The Group noted that the United Kingdom medicines regulator (MHRA) has contraindicated the use of topical nasal decongestants in children <6 years of age, while the Italian medicines regulator has prohibited their use in children <12 years of age. The Group also noted that topical nasal decongestants were not included in the decisions of the Canadian medicines regulator (Health Canada).

4.2.3 Additional discussion

The Group noted that denominator data from sales data should be considered with caution due to non-use, product wastage and dose differences.

A member of the Group questioned where else in the world bromhexine is marketed. The Group noted that a list of countries in which bromhexine is marketed could not be easily provided, but that it was known to be marketed in 115 countries; the first marketing authorisation was granted in Germany.

4.2.4 Conclusions

The Group noted that the extent of reporting of bromhexine and topical nasal decongestant toxicity is less than that for other substances discussed at the previous meeting. The Group noted that the safety profile of bromhexine appears to be less harmful than that for other substances discussed at the previous meeting.

4.3 Discussion of risk-benefit balance of bromhexine and topical nasal decongestants

The Group was asked to consider whether there was a basis for a separate recommendation regarding the use of bromhexine and topical nasal decongestants in children from the other substances discussed at the previous meeting.

The Group considered that there are difficulties associated with undertaking safety and efficacy studies involving cough and cold medicines, but was aware that such studies are currently being undertaken in the United States. As the common cold is a self-limiting condition, it would be difficult to distinguish whether symptom relief was achieved by the medicine or by the spontaneous resolution of the common cold. Additionally the Group considered that safety and efficacy studies involving topical nasal decongestants would be difficult as such medicines should only be used short-term (two to three days).

The Group noted that bromhexine and topical nasal decongestants are scheduled as Pharmacy-only medicines and are currently contraindicated in children <2 years of age.

4.3.1 Argument for taking further regulatory action

The Group noted the lack of efficacy data for both bromhexine and topical nasal decongestants in children.

The Group noted that if cough and cold medicines excluding those containing bromhexine and topical nasal decongestants were contraindicated, there may be an increase in use of bromhexine and topical nasal decongestants.

The Group considered whether the lack of good evidence of efficacy data for bromhexine should result in a similar recommendation to other mucolytics and expectorants, such as guaifenesin.

The Group noted that although the safety profiles of bromhexine and topical nasal decongestants appear to be more favourable than those for other substances contained in cough and cold medicines, without accurate denominator data this is not certain.

The Group noted that an exemption of bromhexine and topical nasal decongestants from regulatory actions for other substances contained in cough and cold medicines could be confusing and lead to mixed messages to the public.

4.3.2 Argument against taking further action

The Group noted that the safety profiles of bromhexine and topical nasal decongestants in therapeutic use appear to be more favourable than those of other substances in cough and cold medicines. The Group considered that the pattern of adverse reactions is also different, with a smaller proportion of serious adverse reactions reported involving bromhexine and topical nasal decongestants.

The Group noted that spontaneous reports involving bromhexine suggest that the toxicity profile of bromhexine in overdose is potentially less dangerous than that for other substances contained in cough and cold medicines.

The Group noted that the lack of poisons data for topical nasal decongestants suggest that the frequency of toxicity from overdose is less for these medicines compared to oral decongestants.

The Group considered that medicines improving nasal patency would be beneficial for children. The lack of positive effect in efficacy studies for topical nasal decongestants may be mostly due to the difficulty of performing the studies.

4.3.3 Conclusions

A member of the Group expressed concern that if a medicine has no evidence of efficacy, then any risk is unacceptable.

The majority of the Group considered that the lack of evidence of toxicity of bromhexine in overdose provides a case for making a recommendation separate from that for other cough and cold medicines as discussed at the previous meeting.

The majority of the Group considered that the small number of reported adverse reactions and enquiries to poisons centres involving topical nasal decongestants compared to oral decongestants provides a case for making a recommendation separate from that for other cough and cold medicines as discussed at the previous meeting.

5 Final recommendations on risk-benefit balance of cough and cold medicines

5.1 Mucolytics and Expectorants

5.1.1 Guaifenesin

The Group recommended that guaifenesin-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of guaifenesin-containing medicines indicated for treatment of the symptoms of the common cold.

5.1.2 Ipecacuanha

The Group recommended that ipecacuanha-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of ipecacuanha-containing medicines indicated for treatment of the symptoms of the common cold.

5.1.3 Bromhexine

The Group considered that bromhexine-containing medicines indicated for treatment of the symptoms of the common cold should remain contraindicated in children <2 years of age. Due to less evidence of harm, the Group concluded that these medicines could be considered for use in children ≥2 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of bromhexine-containing medicines indicated for treatment of the symptoms of the common cold.

5.2 Antitussives

5.2.1 Dextromethorphan

The Group recommended that dextromethorphan-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of dextromethorphan-containing medicines indicated for treatment of the symptoms of the common cold.

5.2.2 Pholcodine

The Group recommended that pholcodine-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of pholcodine-containing medicines indicated for treatment of the symptoms of the common cold.

Medsafe note:

Pholcodine-containing compound medicines are Class C6 Controlled Drugs and are scheduled under the Misuse of Drugs Act 1975, but classified by the Medicines Regulations 1984 as Pharmacy-only medicines .

5.3 Nasal Decongestants

5.3.1 Oxymetazoline

The Group considered that oxymetazoline-containing medicines indicated for treatment of the symptoms of the common cold should remain contraindicated in children <2 years of age. Due to less evidence of harm, the Group concluded that these medicines could be considered for use in children ≥2 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of oxymetazoline-containing medicines indicated for treatment of the symptoms of the common cold.

5.3.2 Xylometazoline

The Group considered that xylometazoline-containing medicines indicated for treatment of the symptoms of the common cold should remain contraindicated in children <2 years of age. Due to less evidence of harm, the Group concluded that these medicines could be considered for use in children ≥2 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of xylometazoline-containing medicines indicated for treatment of the symptoms of the common cold.

5.3.3 Phenylephrine

5.3.3.1 Oral phenylephrine

The Group recommended that oral phenylephrine-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of oral phenylephrine-containing medicines indicated for treatment of the symptoms of the common cold.

5.3.3.2 Intra-nasal phenylephrine

The Group considered that intra-nasal phenylephrine-containing medicines indicated for treatment of the symptoms of the common cold should remain contraindicated in children <2 years of age. Due to less evidence of harm, the Group concluded that these medicines could be considered for use in children ≥2 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of intra-nasal phenylephrine-containing medicines indicated for treatment of the symptoms of the common cold.

5.3.4 Pseudoephedrine

The Group recommended that pseudoephedrine-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of pseudoephedrine-containing medicines indicated for treatment of the symptoms of the common cold.

Medsafe note:

Pseudoephedrine-containing medicines are Class C Controlled Drugs and are scheduled under the Misuse of Drugs Act 1975, with the direction that their sale by retail correspond to the circumstances for the sale of Pharmacy-only medicines.

5.4 Antihistamines

5.4.1 Brompheniramine

The Group recommended that brompheniramine-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of brompheniramine-containing medicines indicated for treatment of the symptoms of the common cold.

5.4.2 Chlorphenamine

The Group recommended that chlorphenamine-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of chlorphenamine-containing medicines indicated for treatment of the symptoms of the common cold.

Medsafe note:

Chlorphenamine is the International Non-proprietary Name (rINN) for chlorpheniramine.

5.4.3 Diphenhydramine

The Group recommended that diphenhydramine-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of diphenhydramine-containing medicines indicated for treatment of the symptoms of the common cold.

5.4.4 Doxylamine

The Group recommended that doxylamine-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of doxylamine-containing medicines indicated for treatment of the symptoms of the common cold.

5.4.5 Promethazine

The Group recommended that promethazine-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of promethazine-containing medicines indicated for treatment of the symptoms of the common cold.

5.4.6 Triprolidine

The Group recommended that triprolidine-containing medicines indicated for treatment of the symptoms of the common cold be contraindicated in children <6 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of triprolidine-containing medicines indicated for treatment of the symptoms of the common cold.

6 Risk Management Options

The Group was asked to consider the limits of the existing legislation when discussing possible risk management options.

6.1 Package labelling improvements

6.1.1 Maximum daily dose

The Group considered whether the package labelling for cough and cold medicines should include a maximum daily dose. It was noted that if a maximum daily dose is included, it should be provided in a clear form understandable to the consumer, for example "Do not exceed the recommended dose".

The Group noted an Australian industry initiative is underway to redesign package labels with a usability guide.

The Group recommended that the sponsors be requested to include a maximum daily dose on the package labelling. The Group was advised that this recommendation may be best considered by the Medicines Classification Committee.

6.1.2 Use with other cough and cold medicines and complementary medicines

The Group considered whether the package labelling for cough and cold medicines should include advice not to take with other cough and cold medicines and complementary medicines. The Group considered such advice on the package labelling to be appropriate.

6.1.3 Seek advice

The Group considered whether the package labelling for cough and cold medicines should include a statement to seek advice from a healthcare professional before using in children ≥6 years of age. The Group considered such a statement on the package labelling to be appropriate.

6.1.4 Better dosing instructions

The Group considered whether the package labelling for cough and cold medicines should contain better dosing instructions for children ≥6 years of age.

The Group questioned whether the package labelling for cough and cold products can include weight-based dosing instructions, or both weight- and age-based dosing instructions, rather than age-based dosing instructions alone.

The Group noted that it is the responsibility of the sponsors to provide better dosing instructions for the use of cough and cold medicines in children ≥6 years of age, and depends on whether the sponsors have data to support the dose recommendations.

The Group appreciated that a recommendation to include better dosing instructions for children on the package labelling of cough and cold medicines was desirable but may not be feasible.

6.1.5 Use as sedatives

The Group considered whether the package labelling for cough and cold medicines should contain advice not to use the medicine as a sedative. It was noted that a proposal to include this statement on cough and cold medicines has been made in the United States.

The Group noted that ideally such advice is more appropriate for the Consumer Medicine Information or package insert rather than on the package labelling for cough and cold medicines.

The Group appreciated that the provision of Consumer Medicine Information for cough and cold medicines is made on a voluntary basis by the sponsor.

The Group noted that it may therefore be appropriate to list sedation as an adverse event on the package labelling for cough and cold medicines.

6.2 Additional safety measures

6.2.1 Child resistant packaging

The Group considered whether cough and cold medicines should be supplied to consumers in child resistant packaging. It was noted that a high proportion of reported child deaths involving cough and cold medicines were due to overdose and that most cases of overdose resulted from exploratory behaviour.

The Group noted that many cough and cold medicines are already supplied in child resistant packaging and that re-packed medicines are more of an issue.

The Group recommended that the good practice of most sponsors in providing these medicines in child resistant packaging be endorsed.

6.2.2 Maximum product size

The Group considered whether the pack size of cough and cold medicines should be restricted. It was noted that the most common pack sizes of liquid cough and cold medicines are 100mL and 200mL, but that some are supplied in 500mL volumes.

The Group noted that a pack size of up to and including 200ml is appropriate, but that restrictions on size were not likely to have a significant impact on safety.

6.2.3 Combination products

The Group considered whether the combinations of active ingredients in cough and cold medicines should be reviewed to ensure they are logical (for example do not combine a cough suppressant with an expectorant) and are not expected to increase the risk of particular adverse events.

The Group appreciated that there is a long history of medicines containing these combinations.

The Group recommended that the sponsors of cough and cold medicines containing illogical combinations of ingredients be asked for justification to support some ingredient combinations.

6.2.4 Formulations

The Group considered whether the formulations of cough and cold medicines should be reviewed to make them less attractive to young children, thereby reducing the risk of accidental ingestion.

The Group considered that this may be difficult and may not make a significant impact on child exploratory overdoses.

6.2.5 Standardised concentration

The Group considered whether a standardised concentration of active ingredients across all cough and cold medicines would be appropriate to help avoid accidental dosing errors.

The Group discussed whether concentration should be expressed per millilitre or per 5ml spoonful. No conclusion was reached.

The Group recommended that the sponsors be asked to provide Medsafe with a review of the best method of expressing concentrations on the package labelling for cough and cold medicines.

6.2.6 Accurate measuring devices

The Group considered whether relevant cough and cold medicines should be supplied to consumers with an accurate measuring device to help avoid accidental dosing errors.

The Group considered the supply of an accurate measuring device with cough and cold medicines to be appropriate.

6.2.7 Limit the number of products

The Group considered whether the number of cough and cold medicines with the same ingredients but different names for each sponsor should be limited. It was noted that the wide range of cough and cold medicines is a source of confusion to consumers which adds to the risk of overdose.

The Group considered that no practical recommendations to limit the number of cough and cold medicines available could be made.

6.2.8 Information in other languages

The Group considered information regarding cough and cold medicines should be made available in other relevant languages. The Group questioned whether this referred to information on the package labelling, the generic messages communicated to the wider population, or both.

The Group noted that the Pharmacy Guild Translation Kit provides translations only for the basic information such as dose and does not extend to all aspects of medicine information.

The Group noted that the Office of Ethnic Affairs could be approached to aid in the dissemination of advice regarding the use of cough and cold medicines in children in other relevant languages.

6.3 Educational needs

6.3.1 Education of healthcare professionals and the public

The Group considered whether healthcare professionals and the public require improved education and communication regarding the natural history of the common cold and the use of cough and cold medicines.

The Group considered further education and communication to be most important and suggested that it include clarification of the term 'contraindication', an understanding of the natural history of the common cold and an understanding of the use and perceived effects of cough and cold medicines.

The Group noted that adult attitudes to the common cold such as using medicines to allow them to return to work are not appropriate for children; specifically, the common perception that giving a cough and cold medicine to a child allows them to attend child care or school, thereby allowing the parent to return to work. The Group considered it appropriate to remind parents that children with the common cold need rest and comfort.

6.3.2 Sharing medicines

The Group considered whether the public understanding that medicines should not be shared needs improvement. It was noted that this message needs to be very specific and should include advice against sharing medicines indicated only for older siblings with younger siblings as well as against using adult medicines in children.

6.4 Information provision

6.4.1 Data sheets and Consumer Medicine Information

The Group considered whether data sheets should be made available for all cough and cold medicines. It was noted that data sheets are only required under New Zealand legislation Prescription medicines and Restricted medicines. The Group considered that data sheets are a very useful source of information for healthcare professionals and would be useful for the safe use of cough and cold medicines.

The Group considered whether Consumer Medicine Information (CMI) should be made available for all cough and cold medicines. It was noted that, although encouraged, there is no mandatory requirement for sponsors to provide Consumer Medicine Information. The Group considered that Consumer Medicine Information is a very useful source of information for consumers and would be useful for the safe use of cough and cold medicines.

The Group recommended that the sponsors be asked to prepare data sheets and/or Consumer Medicine Information for all cough and cold medicines.

6.5 Alternatives

6.5.1 Consideration of alternative treatments

The Group noted that the use of complementary alternative medicines to treat the common cold may increase if the use of cough and cold medicines was restricted. The Group noted that they had no information on the safety of such alternatives.

The Group recommended that providing a comfortable environment and non-medicinal treatments such as the use of honey in children ≥1 year of age to relieve a sore throat or cough should be endorsed.

7 Final Recommendations on Risk Management Options

7.1 Package labelling improvements

The Group recommended that sponsors of cough and cold medicines be requested to consider improved dosing instructions including a maximum daily dose on the package labelling.

The Group recommended that the sponsors of cough and cold medicines be requested to include advice not to take with other cough and cold medicines including complementary medicines on the package labelling.

The Group recommended that the sponsors of cough and cold medicines be requested to include a statement to seek advice from a healthcare professional before using in children ≥6 years of age on the package labelling.

The Group recommended that sponsors of cough and cold medicines be requested to include sedation as an adverse event on the package labelling where appropriate.

The Group suggested that these recommendations be included in the submission to the Medicines Classification Committee.

7.2 Additional safety measures

The Group recommended that the current good practice of providing medicines in child resistant containers be endorsed.

The Group recommended that the sponsors of cough and cold medicines containing illogical combinations of ingredients be asked to provide justification for the combinations.

The Group recommended that the sponsors be asked to provide Medsafe with a review of the best method of expressing concentrations of active ingredients on the package labelling for cough and cold medicines

The Group recommended that the sponsors of cough and cold medicines be requested to supply an accurate measuring device with each product to help avoid dosing errors.

The Group recommended that the Office of Ethnic Affairs be approached to aid in the dissemination of advice regarding the use of cough and cold medicines in children in other relevant languages.

7.3 Educational needs

The Group recommended that healthcare professionals and the public be provided with clarification of the term 'contraindication'.

The Group recommended that healthcare professionals and the public be provided with an understanding of the natural history of the common cold.

The Group recommended that healthcare professionals and the public be provided with an understanding on the use and perceived effects of cough and cold medicines.

The Group recommended that the public be reminded that children with the common cold need to rest and be made comfortable. The Group considered it inappropriate to give children cough and cold medicines in order to send them to school or childcare.

The Group recommended that the public be advised against sharing medicines indicated only for older siblings with younger siblings as well as against using adult medicines in children.

7.4 Information provision

The Group recommended that the sponsors be asked to prepare data sheets and/or Consumer Medicine Information for all cough and cold medicines.

7.5 Alternatives

The Group recommended that the practice of providing a comfortable environment and non-medicinal treatments to settle the symptoms of the common cold should be endorsed.

8 Implementation

8.1 Industry perspective

T Roper provided information on the implementation of the Group's recommendations from a pharmaceutical industry perspective.

8.1.1. Actions previously taken

The Group was advised of the implementation of the contraindication of cough and cold products in children <2 years of age. It was noted that sponsors had nine months (August 2008 to May 2009) to implement the change, ensuring that all stock on shelf had compliant labelling by 1 May 2009. It was expected that any non-compliant stock on shelf by 1 May 2009 would be recalled by the sponsors.

Industry advised that the timing to implement the package labelling changes regarding use in children <2 years of age was inappropriate and that Medsafe was the only regulator in the world to require a recall of non compliant stock.

To avoid a recall the New Zealand Self-Medication Industry negotiated a compromise with Medsafe whereby pharmacies were supplied with stickers stating "Do not use in children under two years of age". Under the direct control or delegated authority of the pharmacist, stickers were placed on the primary container of non-compliant stock at the point of sale and a patient leaflet detailing the reason for the sticker was handed to consumers. Stickers were placed on stock in warehouse and wholesale channels by company personnel prior to distribution. The Group noted that 31 December 2009 is the deadline for compliant package labelling on shelf, without stickers. At this time, non compliant stock is to be recalled however companies expect that all non-compliant stock will have sold through. The Group noted that there were difficulties in the implementation of this approach.

8.1.2 Timing for proposed actions

The Group noted that the package labelling of many cough and cold medicines are unique to New Zealand due to labelling requirements and therefore any changes require long lead times. That is, sponsors have to order products well in advance from the manufacturers. This can result in higher levels of stock to meet minimum order runs.

The Group was advised that around 12 to 18 months is required for current stock to sell through and that it is dependant on the timing of Medsafe's decision relative to the season. It was noted that the common cold season is usually between May and August of each year. It is likely that changes will be implemented for the 2011 cough and cold season.

The Group noted that if pharmacists are aware of a proposed package labelling change, they can adjust their orders to reduce the amount of non-compliant stock that remains until implementation of the labelling changes. The Group therefore recommended early communication with key stakeholders, particularly pharmacists to reduce the amount of non-compliant stock on shelf in the future.

The Group did not consider there to be a need for a recall of non-compliant stock during the implementation of contraindicating cough and cold products in children <6 years of age.

8.1.3 Implementation of recommendations

The Group was advised that a collaborative approach to a package labelling change would be appropriate whereby industry has some input.

The Group noted that industry would prefer to be involved in the decisions around wording on the package labelling, the production of Consumer Medicine Information for cough and cold medicines and the need for non-compliant stock to be recalled.

8.1.4 Training and education

It was suggested that Medsafe and industry work together on a campaign to educate parents and caregivers on the safe use of cough and cold medicines in children. A member of the Group questioned the appropriateness of Medsafe and industry working together on an education strategy. The Group was advised there would be no conflict providing the message is carefully considered and Medsafe has rights of veto over any messages in the campaign in association with the use of the Medsafe name or logo.

The Group noted that in-store pharmacy training will need to be undertaken, as well as further training through professional societies. The Group noted that it would be desirable for pharmacy assistants to be retrained regarding the common cold and cough and cold medicines in time for the roll out of the package labelling changes. It was considered that education through Plunket and parenting centres, schools and television campaigns would also be of benefit.

The Group noted that a media campaign with a clear message would be appropriate. Channels for the campaign could include television, radio, newsprint, magazines and websites. It was noted that there are advantages for different media outlets, however they can be very expensive.

The Group was advised that Medsafe usually deals with the regulatory side of medicine-related issues, and has no budget for wider communication other than through its usual media channels such as media releases and the Medsafe and Ministry of Health websites.

8.1.5 Additional discussion

The Group noted feedback from pharmacists regarding discussions from the first meeting of the Cough and Cold Review Group.

The feedback suggested that pharmacists would prefer cough and cold medicines to be classified as Pharmacy-only medicines. The Group noted that whilst a Restricted medicine classification would ensure that consumers receive appropriate advice before purchasing a medicine to treat the symptoms of the common cold, this would place the pharmacist under great pressure during winter.

The Group noted the importance of continued reporting and monitoring of adverse events involving cough and cold medicines.

The Group's attention was drawn to initiatives by the NZSMI to advance the concept of self-care. This will include educating consumers about the importance of personal responsibility for their own and their family's health. The notion focuses on prevention rather than cure for a range of different conditions.

The Group noted that if efficacy results of studies being carried out in the United States are conclusive, then the risk benefit profile for these medicines will have changed. The use of cough and cold medicines in children should be re-evaluated once the results from these studies are known

A member of the Group questioned whether it would be appropriate to communicate a message to the public about safe use of medicines. This includes the storage of medicines and disposal of unused medicines to prevent accidental, exploratory overdose. The Group agreed that this would be an appropriate message to communicate to the public for all medicines, not just cough and cold medicines, but that this was outside Group's scope.

The Group noted the availability of Pharmacy SelfCare cards in member pharmacies of the SelfCare programme, and recommended that the Pharmaceutical Society of New Zealand be approached to revise the 'Coughs and Colds' card and/or create a specific SelfCare card for the common cold in children.

8.2 Pharmacy perspective

E Galloway provided information on the implementation of the Group's recommendations from a pharmacy perspective.

8.2.1 Communication

The Group noted that it would be beneficial to include articles regarding the safe use of cough and cold medicines in Pharmacy Today, New Zealand Doctor and Prescriber Update to initiate the communication process with pharmacists and other healthcare professionals.

The Group considered whether alternatives should be offered to healthcare professionals and the public. The Group noted that if alternatives are suggested, pharmacists and other healthcare professionals will want to see evidence that the alternatives are safer and more effective than cough and cold medicines.

If cough and cold medicines are removed from general sale, the Group noted that extensive public-orientated media coverage would be required.

The Group appreciated that if cough and cold medicines are reclassified, pharmacists and other healthcare professionals should be informed of the reasons for the change, evidence to support the change and counselling points to give parents and caregivers. It was noted that specific information such as the evidence of risk and the inability to distinguish evidence of efficacy in a self-limiting condition, is required to change the way of thinking by healthcare professionals.

In addition, in the event that cough and cold medicines are reclassified to Restricted medicines, the Group considered it important that data sheets be made available at the time of implementation. The Group noted that it is not appropriate to include evidence of non-efficacy in the data sheets but that they should include the statement "no evidence of efficacy has been demonstrated in children", or words to this effect.

8.2.2 Package labelling changes

It was noted that no matter what the Group recommends, the dosing schedule on the package labelling for cough and cold medicines needs to be visually and grammatically clear. The Group questioned whether the Medicines Classification Committee could request sponsors to test package labelling for usability.

The Group noted that if changes are required to the package labelling for cough and cold medicines, Medsafe should allow a phased transition with plenty of time so that old stock can sell through and be replaced by new compliant stock, allowing for seasonal sales. The Group was advised that pharmacists would prefer if a stock recall could be avoided.

8.2.3 Additional discussion

The Group was asked to consider whether the use of cough and cold medicines in children <6 years of age was an urgent issue requiring immediate action, or whether these actions can be implemented over 12 to 18 months.

The Group agreed that it would be appropriate to allow one cough and cold season for manufacturers to implement the changes. However it was noted that the communication and education strategies should start now while the package labelling changes roll in.

The Group noted that a change in advertising should be considered to advise the public not to use cough and cold medicines in children <6 years of age. The advertising should also advise the public that new packaging will be introduced over the next 12 to 18 months and outline the contradiction that may appear between advertising and the current package labelling.

To aid in the campaign to re-educate the public, the Group recommended that the New Zealand Self Medication Industry and the Therapeutic Advertising Pre-vetting System be approached to request that any adverts encouraging the use of cough and cold medicines in children <6 years of age be ceased.

The Group expressed some disappointment that implementation of changes to the package labelling would take 12 to 18 months due to long lead times. However the Group appreciated that a recall of cough and cold medicines could result in the loss of availability of these medicines for adults. As the risk of harm is less in the ≥2 to <6 year age group compared to the <2 year age group, the proposed time frame was considered acceptable.

9 Final Recommendations on Implementation

The Group recommended that manufacturers be provided with a reasonable timeframe to implement the package labelling changes, allowing current stock to sell through the over the next cough and cold season. It was agreed that a recall of non-compliant stock would not be appropriate. The Group recommended that a collaborative approach to the package labelling changes be undertaken by Medsafe and industry.

The Group recommended early communication with key stakeholders to inform them of the changes being implemented and to provide an explanation as to why the process will take time and the resulting contradictions that may result (for example, dosage advice for children <6 years of age on the package labelling). The Group noted that pharmacists should be advised early to reduce the amount of non-compliant stock on shelf in the future.

The Group recommended that the risk-benefit profile of cough and cold medicines in children be re-evaluated by the Medicines Adverse Reactions Committee when the results of the studies currently underway in the United States become available (expected in 2011).

The Group recommended that the Pharmaceutical Society of New Zealand be approached to revise the 'Coughs and Colds' SelfCare card and/or create a specific SelfCare card for the common cold in children.

10 Communication

P Tuohy and P Abernethy (Media Relations Manager, Corporate Services Directorate, Ministry of Health) provided the Group with a background of communication experience through the Ministry of Health.

The Group was advised that there are two models which describe the methods by which parents obtain information - the process driven model based on the pathway of care, and the ecological model.

The Group discussed the possible options for communicating messages regarding the use of cough and cold medicines in children to the New Zealand population.

The Group considered and advised on the key stakeholders involved with this issue, the key messages to be communicated, the sources of information, and the possible mechanisms, difficulties, timing and oversight of the communication in New Zealand.

The Group noted that changing behaviours towards self-limiting conditions is difficult as previous behaviours will appear to have had a positive effect. For example, if a child recovers from the common cold following use of a cough and cold medicine, one might assume that the medicine worked; however the fact that the child was always going to get better due to the self-limiting nature of the condition is forgotten. Therefore there is a strong belief that cough and cold medicines work.

In addition the Group noted that healthcare professionals have a long history of acceptance of cough and cold medicines and therefore there may be active and passive resistance to change.

The Group noted that an understanding of the safety and efficacy of cough and cold medicines in children may not necessarily result in a change of practice.

11 Final Recommendations on Communication

The Group recommended that healthcare professionals should be informed before the public and should have access to a greater depth of information in order to provide adequate advice to consumers.

The Group recommended that communication to healthcare professionals should only occur once it is certain that the changes will be implemented.

The Group recommended that the communication strategy should start small and build up to the start of the next cough and cold season.

The Group recommended that information on the natural history of the common cold and positive actions that parents can take for children with the common cold be communicated to all key stakeholders.

The Group recommended that Medsafe request assistance from, and work with, the Ministry of Health to develop a communication strategy.

12 Closing remarks

12.1 Recommendations to Medsafe

The Group recommended that all medicines indicated for the treatment of the symptoms of the common cold containing: guaifenesin, ipecacuanha, dextromethorphan, pholcodine, oral phenylephrine, pseudoephedrine, brompheniramine, chlorphenamine, diphenhydramine, doxylamine, promethazine or triprolidine; be contraindicated for use in children <6 years of age.

The Group recommended that all medicines indicated for the treatment of the symptoms of the common cold containing only bromhexine or topical nasal decongestants (oxymetazoline, xylometazoline and intra-nasal phenylephrine) remain contraindicated in children <2 years of age.

The Group recommended that a referral be made to the Medicines Classification Committee to review the classification of all medicines indicated for the treatment of the symptoms of the common cold.

The Group recommended that section 36 of the Medicines Act 1981 be utilised to request package labelling improvements and additional safety measures by the sponsors of cough and cold medicines, as outlined in sections 7.1, 7.2 and 7.4 of these minutes. It was also recommended that these measures be referred for consideration as part of the Medicines Classification Committee processes.

The Group recommended that a collaborative approach to the package labelling changes be undertaken by Medsafe and industry, allowing one cough and cold season for non-complaint stock to sell through. It was agreed that a recall of non-compliant stock would not be appropriate.

The Group recommended that Medsafe and the Ministry of Health develop a communication strategy involving early communication with key stakeholders once it is certain that the changes will be implemented. The early communication should inform key stakeholders of the changes being implemented and provide an explanation as to why the process will take time. It was recommended that healthcare professionals should be informed before the public and should have access to a greater depth of information in order to provide adequate advice to consumers.

The Group recommended that information on the term 'contraindication', the natural history of the common cold and positive actions that parents can take for children with the common cold be communicated to all key stakeholders.

The Group recommended that the Pharmaceutical Society of New Zealand be approached to revise the 'Coughs and Colds' SelfCare card and/or create a specific SelfCare card for the common cold in children.

The Group recommended that the risk-benefit profile of cough and cold medicines in children be re-evaluated by the Medicines Adverse Reactions Committee when the results of the studies currently underway in the United States become available (expected in 2011).

12.2 Date of next meeting

No further meetings of the Cough and Cold Review Group are anticipated.

The Chair thanked the members, the invited experts and the Medsafe observers for their attendance and input to the deliberations of the Cough and Cold Working Group and closed the meeting at 3.20pm.