Pharmaceuticals

 


Cough and Cold medications
– a UAE survey

By Dr Yasser Sharif and Dr Sherif El Ghandour

Introduction

Until recently, most cough and cold medications in the United Arab Emirates (UAE) were sold as over the counter (OTC). Dispensing OTC medications allowed pharmacists to sell cough and cold medications for any age group without physician’s consultation. This practice was common, despite the fact that many of these products, especially those indicated for children, are registered by the UAE - Ministry of Health (MOH) as prescription only medicines (POM).

Usually, the pharmacists rely on the information which is listed on the label of the product in regard to indications, doses, and the age of the patient who can use the medication.

This common practice raises a lot of safety concerns, especially with the availability of many cough and cold products, which are manufactured by different pharmaceutical companies inside and outside of the UAE.

For instance, one might find two different brands with exactly the same active ingredients at the same strength; however, the dosing instructions on their respective labels are different. In one of them, you may find in the dosage administration section certain dose for a specific age group, while the other similar product explicitly contraindicates the product use in the same age group.

These discrepancies arose due to products approval by different regulatory organizations from different countries. As a result, these labels have created a great deal of confusion for the physician, the pharmacist, and consequently the patient.

In addition, due to the fact that most of cough and cold products share common active ingredients, there is a potential for an overdose to occur. This can happen, especially if a patient self administers more than one cough and cold medication at the same time for the same condition without consultation. To demonstrate the severity of this problem, in the United States (from 2004 to 2005) an estimated 1,519 children aged less than 2 years were treated in the emergency department for adverse events, including overdoses, that were associated with cough and cold medications[1]. Data for the UAE is currently lacking regarding accidental overdose in children from cough and cold medications.

In response to the situation, the Health Authority Abu Dhabi Poison and Drug Information Center (HAAD-PDIC) took the initiative to conduct a comprehensive survey on all cough and cold products which are available in community pharmacies in the UAE to determine the appropriateness of the packaging, accuracy of labels, and safety of the ingredients. The primary objective of the survey was to identify those products with potential risk on the public’s health and, subsequently, take the appropriate regulatory actions.

Methodology

1. All cough and cold medications that are available at community pharmacies within the UAE were purchased for analysis. Products that contained codeine and dextromethorphan were excluded from the survey as they are not accessible without a controlleddrug prescription as per the UAE pharmacy law.

2. The following information were collected and analyzed using a spread sheet; name of the product; dosage form; ingredients’ class; decongestants, antihistamines, expectorants, cough suppressants, and miscellaneous ingredients such as menthol, camphor, etc.; and strength of each ingredient.

3. Another spread sheet was created to include only cough and cold syrups in order to describe other criteria such as:

- Alcohol content
- Presence of child resistant cap
- Presence of measuring device which is clearly marked and easy to use
- Active ingredients in regard to the concentration and appropriateness of indication
- Label instructions in regard to complete information on age group that can use the product and the recommended daily doses for different age groups

Findings

The total number of cough and cold medicines that were screened for analysis were 105 products, covering all dosage forms; tablets, syrup, nasal drops, and rubs.

Syrups represent 53% (56 products) of the available products (Figure 1). Alcohol content There were inconsistencies and lack of clarity in about 2/3 of the screened syrup products with regard to the alcohol content, as follows: (Figure 2)

Alcohol content in cough and cold products is a challenge, where the majority of consumers in UAE may not prefer to take alcohol containing medications, for personal or religious reasons. Therefore, consumers have the right to be notified about the alcohol content in cough and cold products. It was found that only 20% of the screened products are alcohol free, in addition to another 12% of the products, where the alcohol content was specified. On the rest of the products (67%), either the alcohol is present, however, without specifying the exact amount or there is no mention at all whether it contains alcohol or not. The US FDA established – from safety perspective - the maximum concentration limits for alcohol as an inactive ingredient in OTC products as follows[2]; (table 1)

Therefore, it is highly recommended that the alcohol presence should be clearly stated as well as its concentration.

   

Child-resistant cap

A major safety concern in the survey was lacking of child–resistant cap in 77% of the syrup products(Figure 3), which leads to a high risk of accidental ingestion by children, the FDA advises that caregivers choose OTC cough and cold medicines with child-resistant caps when available[3].

Measuring devices

Another equally important safety issue is the dose measuring device, which was missing in 41% of the screened products. Furthermore, when the measuring device is present, it is inconvenient to measure the correct dose - this was the case in another 30% of the screened products (Figure 4). Measuring devices enables the consumer to get the accurate dose and, therefore, prevents errors in dosing. According to the Australian regulatory guidelines for OTC medicines 2003, “if the recommended doses cannot be measured using a readily available metric measuring device, a suitable measuring device should be provided in the pack”[4].

Inappropriate indication

One product has promethazine (2.5 mg/5 ml) as an active ingredient, was found to have dosing instructions for children who are 1 year and older. It is well documented that promethazine has been reported to cause respiratory arrest in children less than 2 years of age. The reports involved children who received a wide range of weight adjusted doses[5].

Another safety concern with this product was that, the product container was not child resistant. Therefore, HAAD took immediate action and withdrew the product from all community pharmacies in the emirate of Abu Dhabi and subsequently, from the whole UAE market with the full cooperation of the manufacturer.

Strength of active ingredients

Another product was found to have pseudoephedrine in extremely high concentration (60 mg/5ml), which is the highest among all of the MOH registered products.

This high concentration could be extremely problematic as even a small excess of the dose may lead to an overdose. In addition, although the label of the product clearly states, “Not recommended for children less than 6 years old”, there is an infant image on the outer box.

The presence of infant image on a product that is not meant to treat pediatric patients less than 6 years of age may cause consumers to believe that the product can be given to any pediatric age group, particularly if the precautionary statement is not read or understood. HAAD contacted the manufacturer who agreed to withdraw the product from Abu Dhabi community pharmacies. In addition to the above findings, there are some other significant observations with regard to labeling and packaging included the following:

– Out of 56 products, only three products (5.4%) were found to follow the standards by the FDA for OTC products including clarity of label instructions, accurate and clearly stated doses, clearly categorized age groups, the presence of convenient measuring devices, and contained child resistant caps[3, 6].

– 32 products (57%) are recommended for use for children less than 2 years old. Two products (3.5%) recommend the use in children without specifying any age group.

– Three products (5.4%) have misleading images, which may attract children to drink them, especially in absence of the parents’ supervision.

– One product (~2%) has the following dosing instructions: (one teaspoonful every 3 hours), if this instruction is followed literally, will definitely lead to overdose in children. This product contains diphenhydramine 7 mg/5 ml, in addition to ammonium chloride 67.5 mg/5 ml.

– Eight products (14.3%) use inaccurate measuring term such as one quarter teaspoon, (1.25 mL) for children dosing, which is practically impossible to be measured accurately by the average consumer.

Note: some of the products have more than one safety concern; therefore the total percentage does not add up to 100%

The main focus of this project has been on the safety of cough and cold syrup dosage forms since there is a lot of controversy in regards to both the safety and efficacy of these products in children less than 12 years of age. For those products which have major risks for public health, HAAD took immediate action and withdrew them from pharmacies in Abu Dhabi.

During the survey, there were a lot of changes worldwide in regard to safety concerns for using cough & cold products in children as shown in the table. (Table 2)

     

Conclusion

Cough & cold products are not suitable for children younger than 6 years old. Due to lack of efficacy and high risk of overdose, we endorse the decision that was taken by the UAE MOH to recommend against the use of cough and cold products for children younger than 6 years old. We believe that this survey will be very helpful in the process of standardisation of label information, active ingredients, and safety measures of cough and cold products nationwide. Our next step at HAAD is to take the initiative along with the MOH to consider changes in labeled information for cough & cold medications.

About the Authors

• Dr Yasser Sharif is Head of Medication & Medical Product Safety at the Health Authority - Abu Dhabi. Email: ysharif@haad.ae
• Dr Sherif El Ghandour is a Poison and Drug Information Officer at the Health Authority - Abu Dhabi

Website
For more information visit: www.haad.ae/haaddeps/pdic

References

1. Infant deaths associated with cough and cold medications – two states, 2005. MMWR Morb Mortal Wkly Rep 2007. 56: p. 1-4.

2. 21CFR328.10, Over-the-counter drug products intended for oral ingestion that contain alcohol, FDA, Editor. Revised as of April 1, 2002, U.S. Government Printing Office.

3. FDA. Statement Following CHPA's Announcement on Nonprescription Overthe- Counter Cough and Cold Medicines in Children. 2008 [cited 2009 April 25]; Available from: http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ 2008/ucm116964.htm

4. TGA, Australian regulatory guidelines for OTC medicines "ARGOM". 2003.

5. Starke, P.R., J. Weaver, and B.A. Chowdhury, Boxed Warning Added to Promethazine Labeling for Pediatric Use. N Engl J Med, 2005. 352(25): p. 2653.

6. 21CFR 341 – cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. [Revised as of April 1, 2008].

7. MHRA, Children’s over-the-counter cough and cold medicines in Press release. 2009: London.

8. Canada, H. Decision on the Labelling of Cough and Cold Products for Children. Advisory 2008 [cited; Available from: http://www.hc-sc.gc.ca/ahc-asc/media/ advisories-avis/_2008/2008_184-eng.php

9. Medical Practice and License. Safety of medications that are used for cough and cold. 2009, Ministry of Health: Abu Dhabi- UAE.

10. Children’s Use of Cough and Cold Medicines Reviewed. Media Release 2009 [cited; Available from: http://www.moh.govt.nz/moh.nsf/ UnidPrint/MH8872?OpenDocument

11. TGA announcement regarding the use of cough and cold medicines in children. April 2008 [cited May 10, http://www.tga.gov.au/media/2008/ 080409cold.htm


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ate of upload: 15th Aug 2010

                                  
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