Your Questions Answered

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Which medicines can cause drowsiness?

Some over-the-counter (OTC) medicines have the potential to make people feel sleepy. These include medicines that might be taken for allergy relief e.g. hayfever; cough; to prevent nausea e.g. travel sickness; and sleep remedies. It is important to always read the label as this will help you identify medicines liable to cause drowsiness.
Antihistamines are the most common cause of drowsiness. There are two main types:

• first generation (sedating) – can only be bought under the supervision of a pharmacist and are kept behind the counter.
• second generation (non-sedating) – have less potential to cause drowsiness.

Although this drowsiness can have a beneficial effect, such as helping someone sleep if they are suffering from a cough, it can also present a risk, particularly for people’s ability to drive safely.

Is everyone affected in the same way?

No. Some people are more sensitive than others to the particular ingredients known to cause drowsiness. There is increasing understanding that there is a genetic link and that some people metabolise the ingredients differently. However, it isn’t possible to predict how an individual will be affected at the point of taking the medicine: external factors such as taking more than one OTC medicine at the same time and drinking alcohol can also increase the risk of drowsiness. It is also important to note that illness itself can be a distraction for drivers if symptoms are not treated. People should ask their pharmacist for advice on choosing a suitable product.

Labelling and regulation
Medicines labelling is regulated and approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Products that have the potential to cause drowsiness have to display a warning statement on the back of the pack. This reads:

“This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel. See the leaflet inside for more information.”

The warning on packs and information in patient information leaflets (PILs) was reviewed and updated to reflect changes to the drug driving law (2015):

Drug Driving Law
It is illegal to drive if you’re unfit to do so because you have taken legal or illegal drugs. Legal drugs are prescription or over-the-counter medicines. If you’re taking them and not sure if you should drive, talk to your doctor, pharmacist or healthcare professional.

Further details can be found on the gov.uk website

 

Do cough medicines work?

Cough medicines will not ‘cure’ a cough but they can help relieve the symptoms. The key to effective management of cough is to identify the most troublesome symptom and to choose an appropriate product.

All cough medicines have been assessed for safety, quality and efficacy by the Medicines and Healthcare products Regulatory Agency (MHRA) before they could be put on the market.4 When the product is licensed, MHRA also reviews the claims that can be made about the product, such as what the product can be used to treat, how fast the product works and how long it works for. Only claims that are consistent with the product’s licence can be used on the packaging and in advertising.

For traditional herbal medicines only, products can be marketed without formal clinical trials provided that their efficacy is plausible on the basis of long-standing use and experience. It is made clear on the pack that the medicinal claims are based solely on a long history of use as a traditional remedy.

Cough medicines have been used for decades by millions of people to relieve their cough symptoms. While it can be very difficult to measure the effectiveness of cough medicines scientifically, customer satisfaction with cough medicines is high. Consumer research has found that 86% of people used OTC cough mixtures to treat their coughs, while 8% sought advice from a doctor or pharmacist.1 In an earlier research study, cough medicines were described as effective by 90% of users.2

The British National Formulary, which is the doctor’s prescribing reference, says that ‘When there is no identifiable cause, cough suppressants may be useful, for example if sleep is disturbed.’3

Safe use of cough medicines

When used as directed, over-the-counter cough medicines are safe and effective medicines. The most important things to remember are:

• Always follow the instructions on the pack and in the patient information leaflet that comes with the product.
• Don’t take more than the recommended dose.
• Some cough medicines are only recommended for night time use and include ingredients (such as diphenhydramine) that can help people to sleep. Do not take these products during the day as drowsiness can affect people’s ability to drive or carry out other activities safely.
• Speak to a pharmacist if you need advice, particularly if you have another medical condition or are taking other medicines, either prescribed or OTC.

1 PAGB/Reader’s Digest ‘A Picture of Health’ research 2005
2 British Market Research Bureau Everyday Healthcare Study 1997
3 BNF 66, September 2013-March 2014, page 214

How is advertising for OTC medicines regulated?

The advertising and promotion of medicines is strictly regulated to ensure that it encourages a responsible approach to self-medication and is not misleading.
Advertising has to comply with medicines-specific regulations and codes, as well as the general advertising controls that apply to all consumer products. Further information about how advertising is regulated can be found on the Advertising Standards Authority (ASA) website.

PAGB – promoting best practice in medicines advertising
PAGB member companies must comply with the PAGB Medicines Advertising Codes when advertising over-the-counter medicines. These self-regulatory codes are designed to reflect the law and to ensure that any claims made can be fully substantiated.
All member companies must have their consumer advertising checked against the Advertising Codes and approved by PAGB before it can be published or broadcast. This includes newspaper and magazines, television and radio commercials, direct mail materials, point-of-sale materials, sales promotions, brand–related sponsorship materials, website and social media materials.

Claims made in medicines advertising
Medicines advertising often makes claims about the product; for example, what the product can be used to treat, how quickly it works and how long for.
One of the most important principles of the law (and the PAGB Consumer Code) is that all claims must be in line with the product’s Summary of Product Characteristics (SmPC). The SmPC is part of the Marketing Authorisation that is granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) when the product is licensed and approved for sale and requires the company to provide evidence that the product meets strict criteria in terms of safety, efficacy and quality.
Some types of claims will not be covered by the SmPC such as ‘the fastest acting pain relief tablet’, ‘unique one daily dose’, ‘nothing acts faster’ etc. and these are individually considered by PAGB. In these cases, the company must submit all known available evidence in order to provide substantiation for the claim, such as published data in a peer-reviewed journal, standard textbooks, such as ‘Martindale: The Complete Drug Reference’ and ‘British National Formulary’ and unpublished company data that has been approved by the company’s medical or regulatory departments.

How is advertising for self care medical devices regulated?

Medical devices advertising is controlled through general advertising law and the industry Codes of Practice (CAP/BCAP, PAGB, ABHI, BIVDA). PAGB is currently consulting with its members on advertising guidelines for substance based self care medical devices. The guideline will apply to advertising materials relating to substance based self care medical devices intended for the public and marketed by PAGB member companies. All eligible medical devices owned by PAGB members should comply with the guideline.

How are food supplements regulated?

Food supplements are regulated under food legislation. Much of the UK’s food law comes from the EU, and within the UK all food law falls under the Food Safety Act 1990. Legislation specifically prohibits any food from making any claim, or implying, that it can treat, prevent or cure any human disease. It begins from the principle that products must be safe for consumption and not be misleadingly labelled.

Food supplements are defined in legislation as “Concentrated sources of vitamins, minerals or other substances with a nutritional or physiological effect, whose purpose is to supplement the normal diet.” There is a clear difference between food supplements and medicine. For example, a vitamin D product sold to treat or prevent deficiency would be a medicine, whereas a vitamin D product sold to support healthy bones would be a supplement. The dosage may be the same but the legal framework they fall under differs.

Food and food supplements have been subject to increasing levels of legislation in recent years, with the aim of increasing consumer protection and helping people make informed choices. This has led to improvements in labelling requirements. Since 2006 all foods, including food supplements sold in the EU must comply with the Nutrition and Health Claims Regulation (EC/1924/2006).

 

What is a health or nutrition claim?

A health claim is a direct, indirect or implied claim in words, pictures or any other representation that suggests that consumption of any product making the claim carries a specific health benefit (e.g. calcium helps in the development of strong teeth and bones). A nutrition claim is a claim which states, suggests or implies that a food has particular beneficial nutritional properties due to the presence, absence, increased or reduced levels of energy or of a nutrient or other substance (e.g. high in vitamin C, low in fat). The regulation applies to all commercial communications about food – this includes packaging, labelling and all forms of advertising including web advertising and company web pages.

Any health or nutrition claim on foods is assessed by the European Food Safety Authority (EFSA) and, if approved, may be authorised for use by the European Union through a complex legislative process. Once authorised, the claim is added to a central list of permitted claims that can be used in the advertising, promotion and labelling of food products, for example:

• Iron contributes to the reduction of tiredness and fatigue
• Vitamin D contributes to the maintenance of normal bones
• Zinc contributes to normal fertility and reproduction

Government recommended food supplements
Some specific groups of people are at particular risk of deficiency or need a higher intake of vitamins and minerals. As part of its wider prevention strategy, the Department of Health recommends some food supplements, including:

• Folic acid for pregnant women (up to 12 weeks) and women who are planning a pregnancy. This is to help prevent neural tube defects such as spina bifida.
• Vitamin D supplements for pregnant and breastfeeding women, children aged six months to five years, people aged 65 and older, people with darker skin, and people who may not get enough sun.
• Vitamin A, C and D for children aged six months to five years. A precaution to prevent deficiency, especially in growing children and those without a varied diet.
Getting the right advice about food supplements
People can be unsure about whether a food supplement will benefit them and may seek advice about which to choose. Pharmacists are well-placed to have conversations with people in a community setting. PAGB encourages pharmacists to undertake additional training in nutrition and food supplementation. A range of useful information about supplements is available from:

www.hsis.org, Health Supplements Information Service, funded by PAGB
www.bda.uk.com, The Association of UK Dieticians
www.bant.org.uk, The British Association for Applied Nutrition and Nutritional Therapy

The above is part of a longer overview of this topic by Helen Darracott, Deputy CEO at PAGB, which appeared in Today’s Pharmacist, April 2016.

How is advertising for food supplements regulated?

Some nutritional supplements are licensed as medicines and are subject to the same advertising rules. However, most vitamin and mineral products are legally classified as food supplements and are regulated under food law. Food supplements advertising cannot make medicinal claims i.e. claims that the product can prevent, treat or cure disease.

As with medicines, PAGB members must have their food supplement advertising pre-approved by PAGB for compliance with relevant guidelines, including advertising and food law. Any claims made about the product must be substantiated with appropriate evidence.