Consumer medicine information (CMI) gives you information about your medicines. The CMI gives you facts you need to know before, during and after taking your medicine.

A CMI leaflet gives you information on how to use your medicine safely. For example, it tells you about:

• who should take the medicine
• who should not take it
• how to take the medicine
• any known side effects
• other medicines it may interact with

Your pharmacist will give you a CMI when you start a new medicine. You can also ask them for the CMI.

Pharmaceutical companies write the CMIs. They must follow government guidelines on what to include. The information must be correct, unbiased, and easy to understand.

All prescription medicines and some non-prescription medicines have a CMI leaflet.

What other information is in a CMI?

The CMI will also include:

• the brand name of the medicine
• the active ingredients
• other ingredients
• information on the safe storage of medicine
• instructions on what to do if you miss a dose
• instructions on what to do if you have left over medicine
• information on possible interactions with other medicines
• contact details for the pharmaceutical company

Where to find your CMI

You can get your medicine’s CMI by:

• checking the medicine packaging (it is sometimes inside)
• asking your pharmacist or doctor to print it for you
• contacting the maker of your medicine 

Using your CMI

Always make sure you have the right CMI. Check that the brand name on the CMI matches the brand name of your medicine.

Read the CMI before taking any new medicine.

Keep all your CMIs in the one place so you can easily find them. You may need to check some details while using the medicine. For example, you may want to check what to do if you miss a dose.

Is this medicine right for me?

If you have read the CMI and you aren’t sure whether the medicine is right for you, talk to your doctor or pharmacist.

Understanding interactions

Sometimes one medicine can affect how another medicine works. One medicine can change the side effects of another. This is called an ‘interaction’.

Interactions can also happen between medicines and certain foods or drink, including alcohol.

Known interactions are listed in your medicine’s CMI.

Before you start any new medicine, ask your doctor or pharmacist if there are any interactions you should know about.

Tell them about any other medicines (including any over-the-counter and complementary medicines) you are taking.

Looking for more medicine information?

Medicine21’s medicines section section allows you to search for medicines by brand name or active ingredient. It provides useful information about medicines such as:

• their use
• whether they are available on the Pharmaceutical Benefits Scheme
• product recalls

• When the chemicals in medicines breakdown, they can become dangerous.
• All medicines (including tablets, creams, liquids and others) display their expiry date on their packaging.
• Don’t keep unused medicines past their expiry dates.
• Take expired medicines to a pharmacy for safe disposal.
• Throwing away unwanted medicines in the bin or by flushing down the toilet is dangerous to others, and harmful to the environment.

What is an out-of-date medicine?

All medications have an expiry date. The expiry date is the point in time when the medication will no longer be as effective as it should be. Medicines should not be used past their expiry date. This includes prescribed as well as over-the-counter (OTC) medicines.

Expiry dates can vary widely between different medicines and different forms of medicine. For example, dry tablets are likely to have a later expiry date than liquids. It doesn’t matter what form your medicine is in, all medicines expire, including patches, creams, lotions, ointments, liquids, injections and tablets.

The law states that each medicine’s expiry date must be written on the packaging. You might find it underneath a label, on the lid of a bottle or at the end of a tube of cream. If you can’t find it, ask your pharmacist for help.

Why do medicines expire?

Medicines lose their effectiveness over time because they are made up of chemicals that break down as time passes. They may also become dangerous due to a change in their chemical make-up. Taking old medicines can cause harm, or even be fatal, especially if you are taking them for a serious health condition.

Which medicines do I need watch out for?

All medicines expire, but you need to be particularly careful with certain medicines for serious medical conditions such as:

• EpiPen for the treatment of severe allergic reaction
• glyceryl trinitrate or GTN for angina and chest pain
• insulin for diabetes

Compounded medicines usually expire quicker than other medicines, usually 28 days or less and never longer than 6 months. Be extra careful to store compounded medicines according to your pharmacist’s instructions, as they can be particularly sensitive to conditions such as high temperatures.

Eye drops also have strict expiry dates. Like all medicines, eye drops become less effective when they are out-of-date, but eye drops have the extra complication of becoming more easily contaminated with bacteria. A general rule is to never use eye drops after their expiry date, and to throw them out 30 days after you’ve opened them, even if it is before the expiry date.

What is the safest way to store my medicines?

For your medications to stay effective until the expiry date, you need to store them properly. Different medicines need different storage conditions. Always follow the instructions on the packaging, which might include storage below 25°C, in a dark place or in the refrigerator at about 4°C. Ask your pharmacist how to store each medicine when you purchase it from the pharmacy. This is true for prescribed and over-the-counter medicines.

All medicines (including patches, creams, lotions, ointments, liquids, injections and tablets) should be locked away and kept out of children’s reach.

If you take several medicines or have a complex health condition, it is a good idea to have your medicines reviewed every 6 to 12 months. Talk to your GP or pharmacist about a Home Medicines Review.

What do I do if I have been taking expired medicines?

If you discover that you have been taking expired medication, talk to your pharmacist or your doctor. You might need to get a fresh, fully active batch.

How can I safely dispose of my expired or unused medicines?

It’s a good idea to check all of your medicines regularly and safely dispose of any that are out of date or that you no longer need. Your local pharmacy provides a free and convenient way to dispose of your unwanted or expired medicines responsibly. Flushing them down the toilet or putting them in a rubbish bin can be dangerous, and can harm the environment.

Over-the-counter and prescription medicines, gels, creams, liquids, herbal or complementary supplements and pet medicines can all be returned for free, safe disposal at the pharmacy.

• Taking the wrong medicine or too much medicine can be dangerous and even life-threatening.
• The more medicines you take, the higher your risk of an overdose is.
• When taking a medicine, always follow the instructions of your doctor or pharmacist.
• It can be dangerous to mix medicines with alcohol. Before you drink alcohol, find out if it’s safe with the medicines you’re taking.

What is an accidental overdose of medicine?

Taking too much of a medicine is known as an overdose. More Australians are dying from accidentally overdosing on medicines than ever before. Taking too much of a medicine can be very dangerous, and even life-threatening, but accidental overdoses can be prevented.

Most medicines have risks as well as benefits. Medicines are toxic (harmful) if you take too much. Some medicines can also be toxic if you take them at the same time as alcohol or some other medicines.

An accidental overdose can happen if:

• you take a medicine by mistake
• you use the wrong medicine by mistake
• you take too much of a medicine by mistake
• you take a medicine together with another medicine or alcohol which cause a harmful reaction if they are combined

Accidental overdoses can also happen during medical or surgical procedures.

How can accidental overdose happen?

The more medicines you take, the more you’re at risk of harm from them. In recent years, more than 1 in every 2 deaths from accidental overdose have involved a person taking 3 or more substances.

You are more at risk of accidental overdose if:

• you are taking a combination of different medicines
• you don’t follow the instructions of your doctor or pharmacist properly
• you mix medicine with alcohol.

There are mistakes that can mean overdose is more likely:

• Taking more than one medicine with the same active ingredient (for example, 2 cold and flu medicines might have different brand names but both contain paracetamol, which means you will take double the dose if you take both).
• Taking medicine that is stronger than you thought (for example, medicines with the same brand name may come in different strengths, meaning that a tablet in one package contains a higher dose of medicine than a tablet in a different package).
• Using the wrong measuring device for the medicine (for example, using a tablespoon rather than a teaspoon means you take more than you need).
• Forgetting how much medicine you’ve already taken.

Your child is more at risk of accidental overdose if:

• you incorrectly calculate your child’s dosage of medicine based on their weight
• you don’t store a medicine safely, meaning that your child can reach the medicine and accidentally swallow it

It’s always important to read the label, even if you have taken the medicine before.

What are the symptoms of an overdose of medicine?

The symptoms of a medicine overdose depend on the type of medicine. If someone has overdosed, 

Call or ask for an ambulance if someone:

• is not breathing, or their breathing is shallow
• appears to be unconscious, can’t be woken up, is snoring or gurgling
• appears to be confused
• has blue lips or fingertips
• has a seizure
• has floppy arms and legs, or cool, clammy skin
• has pinpoint-sized pupils

Which medicines are the most dangerous?

It’s important to be careful with all medicines, but some are more dangerous or involved in more overdoses than others.

Opioids

Opioids, such as the strong pain medicines oxycodone and fentanyl, are the most common cause of fatal accidental overdoses in Australia. The risk is higher if you are also drinking alcohol or taking other medicines at the same time, in particular benzodiazepines (such as diazepam and alprazolam), antidepressants or antipsychotics.

Paracetamol

Paracetamol is the most common cause of people being admitted to hospital for accidental overdose. Paracetamol is also one of the most common causes of accidental overdose in children. Taking too much paracetamol can lead to yellow eyes and skin (jaundice), loss of coordination, liver damage and even death. It’s important to get medical help as quickly as possible if you think you or your child have taken too much paracetamol, as the damage can happen even before you notice any symptoms.

Benzodiazepines

Benzodiazepines, such as diazepam and temazepam, are the second most common cause of accidental overdoses resulting in death, mostly when they are combined with other substances. The risk is higher if they are taken with alcohol, or if they are taken with many other medicines, including opioids and some over-the-counter medicines.

Diabetes medication

If you have diabetes, taking too much insulin or other diabetes medicines can cause your blood sugar level to drop too low. This can develop into a serious situation — ask your doctor or diabetes educator what to do if this happens to you. It’s also dangerous for people who don’t have diabetes to take these medicines.

What should I do if someone has overdosed?

If someone has taken a medicine and is unresponsive, don’t assume they are just asleep — an overdose is a medical emergency.

While waiting for the ambulance, follow these steps:

1. Stay with the person who has overdosed.
2. Lie them on their side.
3. Talk to them, if they’re conscious.
4. Loosen any tight clothes.
5. Open a window or take them outside for air.
6. Be aware that they may need CPR.
7. Call the Poisons Information 

If you are worried that someone has taken the wrong type or amount of medicine, 

How is an overdose treated?

Treatment of an overdose depends on the type of medicine taken.

There are antidotes available for some medicines. An antidote is a substance that may be able to reverse the effects of the overdose.

Naloxone is a medicine that can temporarily reverse the effects of an opioid overdose. The Take Home Naloxone Program, funded by the Australian Government, makes this medicine available for free and without a prescription to anyone who might experience or witness an opioid overdose.

Learn more about the Take Home Naloxone program.

How can I reduce my risk of an accidental overdose?

Make sure you understand which medicines you’re taking and how to take them. Always follow any instructions from your doctor or pharmacist.

It’s very important to store medicines correctly and always keep medicines out of the reach of children.

There are some things you can do to reduce your risk of an overdose:

• Always read the medicine label and consumer medicine information (CMI) leaflet.
• Find out which medicines can be taken together, and which need to be taken at different times.
• Make sure you understand what you can and can’t do while you are taking the medicine, for example, if you should avoid driving. Find out if it’s safe to drink alcohol.
• Always measure the medicine accurately. Take special care when measuring medicine for children.
• Only take medicine that has been prescribed for you — never take someone else’s medicine.
• Talk to your pharmacist about managing your medicines safely, or to organise a Home Medicines Review.
• Talk to your doctor about whether you can gradually reducine the amount and number of medicines you are taking.

• Sunscreen is a cream or lotion used to help protect your skin from the damaging effects of the sun.
• Sunscreen should be applied 20 minutes before going out into the sun and should be reapplied every 2 hours.
• Use sunscreen that is SPF 30 or above, broad spectrum and waterproof whenever the UV radiation level is at 3 or above.
• Apply generous amounts of sunscreen to any part of your body that is exposed to the sun.
• See your doctor if you notice any skin changes that may suggest a skin cancer.

What is sunscreen?

Sunscreen is a cream or lotion used on your skin to help protect your skin from the damaging effects of the sun. Sunscreen is also called sunblock or sun cream.

What is sunscreen used for?

Sunscreen is used to help protect your skin from the damaging effects of the sun. Sunlight is made up of different types of rays. One of these is called ultraviolet (UV) rays. There are different types of ultraviolet rays including ultraviolet A (UVA) and ultraviolet B (UVB). UVB rays cause sunburn while UVA rays damage skin cells causing premature aging and some types of skin cancer. Broad spectrum sunscreen helps to protect your skin from the harmful effects of UVA and UVB rays.

Apply sunscreen to clean, dry skin, and use enough to spread evenly on your skin surface. Use around 5mL (approximately 1 teaspoon) of sunscreen to each part of your body that is exposed to the sun.

You can buy sunscreen without a prescription in your local pharmacy or supermarket.

What are the different types of sunscreens?

Different types of sunscreens give you different levels of protection against UV rays. Some features to look for in a sunscreen include the SPF value, the type of UV rays they protect against, and how they respond to water (for example, at the beach or pool).

When you buy sunscreen, you will see a SPF number on the bottle. SPF stands for ‘sun protection factor’. The SPF number represents the amount of time it takes for redness to appear on the skin compared to when no sunscreen is used. This test is done in a lab. For example, if you normally burn after 10 minutes of unprotected exposure to the sun, properly applying SPF 30 sunscreen to your skin means it will take 30 times longer (around 300 minutes) to burn.

Broad spectrum means that the sunscreen protects against the harmful rays of both UVA and UVB rays.

It is best to use sunscreen that is SPF 30 and above, broad spectrum and waterproof.

Be aware that cosmetic products such as makeup should not be used instead of sunscreen. These products do not undergo the same rigorous testing that therapeutic products do and are not regulated in Australia the way sunscreens are. Cosmetic products have different amounts of SPF protection — many have very low levels of protection.

How does sunscreen work?

Sunscreen can work in either one of two ways. Sunscreens with absorbing ingredients protect your skin by absorbing nearly all the UV radiation. Sunscreens that use scattering ingredients work by scattering or reflecting the UV rays away from your skin.

Sunscreens that are absorbent contain a variety of different chemicals and are usually invisible when applied to the skin.

Reflectant or scattering sunscreens contain minerals such as zinc oxide or titanium oxide. They may leave a milky-white appearance on the skin.

Sunscreens come in different forms including creams, lotions and sprays. The Australian Cancer Council warns against the use of aerosol (spray) sunscreens since it is very hard to get good levels of UV protection when using them.

Sunscreen should be applied 20 minutes before going out into the sun and should be reapplied every 2 hours. If you are swimming or exercising, remember to reapply your sunscreen more often.

When should I use sunscreen?

You should use sunscreen whenever the UV radiation level is at or above 3 and you plan to go outdoors. You can use a weather app that shows you the UV radiation level for the day. Check the UV rating for any of Australia’s capital cities at the Bureau of Meteorology website, or download the bureau’s app.

Some parts of Australia have a UV radiation level of 3 or above most days of the year. UV radiation is not affected by temperature, so there may be a high level of UV radiation on cool or cloudy days.

When should I see my doctor?

Some people develop skin rashes or reactions to sunscreen. This is rare and is usually a result of a sensitivity or allergy to one of the ingredients in the sunscreen. If you have a reaction to sunscreen, you should see your doctor and ask your pharmacist to recommend a sunscreen that works differently to the one you are sensitive to, or one that is designed for sensitive skin.

It’s important to see your doctor if you have noticed any skin changes that may suggest a skin cancer. Skin changes that may be worrying include:

• any crusty non-healing sores
• any lumps that are small, pale or pearly in colour
• freckles, moles or spots that have changed in size, colour, shape or thickness

• All medicines and poisons in Australia are classified by how freely they are made available to the public.
• Medicines with a low safety risk are usually less tightly controlled than medicines that have a higher safety risk.
• This system of categorising medicines is called ‘scheduling’.
• Medicines with a lower safety risk may be available at a supermarket or at a pharmacy without a prescription.
• Medicines considered higher risk may be available only with a prescription from your doctor.

Why is the schedule important?

The schedule is designed to protect public health and safety. Some medicines have a higher risk of causing harm than others. Also, some medicines are more likely to be misused, such as medicines that can cause dependence or addiction.

Scheduling is a way of sorting out which medicines or poisons need to be more tightly controlled, and which don’t. Some poisons are so dangerous that they are not to be used at all.

What information is in the schedule?

Each category has different rules for how a medicine or poison should be labelled, sold, bought, stored and thrown away. These categories also tell you if you need a prescription to buy a certain medicine.

How is the schedule classified?

There are 10 categories (‘schedules’) arranged from least tightly controlled to most tightly controlled. Medicines are usually in Schedules 2, 3, 4 or 8.

Not all medicines are scheduled. Some medicines such as vitamins and herbal remedies can be sold in supermarkets and pharmacies. These are classified as ‘unscheduled’. It is not considered necessary to control access to these medicines. However, this does not mean that these medicines are harmless. If you buy an unscheduled medicine, make sure you read and follow the directions on the packet. You can also ask your doctor or pharmacist if you have any questions about an unscheduled medicine.

The Poisons Standard lists all the medicines or poisons available in Australia and their classification schedule. The Australian Department of Health lists which schedule a medicine or poison should be in. However, it is up to each state and territory to legislate the scheduling of medicines in their own area. This means that there may be slight differences in the regulation of certain medicines in different states.

If you are thinking about taking a medicine while you’re pregnant, there are a few things to consider.

This is because your baby’s growth and development can be affected by what you take.

Each medicine is different. To make the best decision for you and your baby, learn what you need to be aware of.

What should I be aware of when taking medicines during pregnancy?

While many medicines are safe to take during pregnancy, a small number of medicines can harm your baby. The effect of the medicine on your baby can depend on the stage of your pregnancy.

Tell your doctor or pharmacist about any medicines you are planning to take when pregnant.

Should I stop taking my prescription medicines if I’m pregnant?

Some medicines must not be taken when you are pregnant. Others should be used carefully.

Don’t stop taking your prescription medicines until you have spoken with your doctor.

With some conditions, you will need to keep taking medicine. Stopping treatment can cause problems that can affect you and your baby. Such conditions include:

• diabetes
• high blood pressure
• depression
• epilepsy
• asthma

If your doctor thinks a medicine will cause more harm than the condition itself, then they may:

• change your medicine
• change the dose
• stop your medicine altogether

You might find that your doctor doesn’t change your medicine. If you take regular medicines, it’s a good idea to talk to your doctor when you are planning a pregnancy.

Are over-the-counter medicines safe to take when pregnant?

Over-the-counter medicines are medicines you can buy in a pharmacy, supermarket, or shop without a prescription.

During your pregnancy, you may have colds, sore throats, indigestion and headaches. Always talk to your doctor or pharmacist before taking any:

• cold and flu medicines
• pain relievers
• other non-prescription medicines

Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and aspirin should be avoided during pregnancy.

You can use paracetamol to help mild to moderate pain during pregnancy.

Will complementary medicines affect my pregnancy?

Complementary medicines are also called ‘traditional’ or ‘alternative’ medicines. They include:

• vitamins
• minerals
• herbal medicines
• aromatherapy
• homeopathy products

While these medicines are often described as natural, they are not necessarily safe. This is especially true during pregnancy. We often don’t know much about their safety.

If you want to use complementary medicines during your pregnancy talk to your doctor or local pharmacist. They can give you advice about which medicines are safe to use.

All pregnant women in Australia are advised to take folic acid, iodine, and vitamin D supplements. Visit the vitamins and supplements during pregnancy page to find out more about what to take and what to avoid.

Where to get more information

Sometimes it’s not clear if a medicine is safe to use when you are pregnant. Before taking any medicine get advice from your pharmacist or doctor.

You can also look at the packaging or read the Consumer Medicine Information leaflet (CMI).

You can search for medicines by brand name or active ingredient in healthdirect’s medicine section. You can also find their CMIs here.

• The Pharmaceutical Benefits Scheme (PBS) offers safe, affordable medicines to all Australians.
• It also covers visitors from countries with reciprocal health care agreements.
• If you spend a lot of money on medicines, you may be able to apply for the PBS Safety Net.
• Some medicines are available on 60-day prescriptions.

Pharmaceutical Benefits Scheme (PBS)

What is the PBS?

The Pharmaceutical Benefits Scheme (PBS) lets Australians use lots of prescribed medicines without paying full price.

The PBS is part of the Australian Government’s National Medicines Policy. The National Medicines Policy aims to balance the need for medicines with good health results and economic limits.

The government subsidises the cost of medicine for most medical conditions, through the PBS. The PBS has existed since 1948.

You can browse the PBS online:

• to look at all drugs listed on the PBS
• to learn more about the prescribing of PBS medicines
• for detailed patient information on medicines prescribed by your doctor or dentist
• to find out what you can expect to pay for medicines

Some PBS medicines are available on a 60-day prescription. If you’re eligible, this means you may be able to get twice the amount of medicine for the price of one prescription. To find out if it will apply to your medicines, speak with your doctor or the person who prescribes your medicines.

Who can use the PBS?

The PBS can be used by all Australians who hold a current Medicare card.

Overseas visitors from countries that have a Reciprocal Health Care Agreement with Australia can also get medicines through the PBS.

This covers visitors from:

• Belgium
• Finland
• Italy
• Malta
• The Netherlands
• New Zealand
• Norway
• The Republic of Ireland
• Slovenia
• Sweden
• United Kingdom

How much do medicines cost on the PBS?

Co-payments

Everybody has to pay something towards the cost of medicines. This is called the co-payment. Many PBS medicines cost much more than the co-payment.

The amount of the co-payment changes on 1 January each year, in line with the Consumer Price Index (CPI). You can check the current fees.

To be able to use the concession benefit, you must hold one of the following cards:

• Commonwealth Seniors Health Card
• Department of Veterans Affairs White, Gold, or Orange Card
• Health Care Card
• Pensioner Concession Card

Brand premiums

Some medicines might have a price premium or brand premium. This is an extra payment that you pay to the supplier of the specified brand of a PBS medicine. The extra charge does not mean there is any difference in quality between brands.

This happens when there are 2 or more brands of the same medicine available. The Government subsidises each brand to the same amount. They are subsidised up to the cost of the lowest priced brand, minus your co-payment.

If you are prescribed a more expensive brand, you pay the difference in price. This cost goes to the supplier NOT to the Government.

This brand premium is in addition to your co-payment.

You can ask your pharmacist to give you a less expensive brand. This is often called “generic medication”. Your doctor must agree that you can have a different brand of medicine to the one they prescribed.

If you have any concerns, you should talk to your doctor or pharmacist.

PBS safety net

The Australian Government gives more support for people who spend a lot of money on health care. This is called the safety net.

The safety net uses the idea of a ‘family unit’. This could be:

• a person
• a couple
• a family

After your family unit spends a certain amount of money on healthcare, new PBS prescriptions become cheaper or free.

General patient Safety Net threshold: When your family unit’s total co-payments reach the threshold amount, you can sign up for a Safety Net concession card. After this point, you pay the concessional co-payment amount for the rest of the calendar year.

Concessional Safety Net threshold: When your family unit’s total co-payments reach the threshold amount, you can sign up for a Safety Net entitlement card. This lets you receive pharmaceutical benefits free of charge for the rest of the calendar year.

• You can buy OTC medicines without a prescription.
• There are OTC medicines you can only buy in pharmacies, but you can buy other medicines in general shops, such as supermarkets and health food stores.
• Speak to a pharmacist for healthcare advice before buying OTC medicines.
• You might experience side effects from OTC medicines and they can interact with your prescription or other medicines.

What are over-the-counter (OTC) medicines?

You don’t need a prescription for some medicines. These are called over-the-counter medicines, or OTC medicines.

You can buy pain medicines, for example, paracetamol and ibuprofen, as well as cough and cold remedies, over the counter. You can also buy complementary or alternative medicines over the counter.

Like all medicines, you should think about the risks and benefits of OTC medicines before using them.

Types of over-the-counter medicines

In Australia, over-the-counter medicines can be supplied in three ways.

Pharmacist-only medicines

There are some over-the-counter medicines you can only buy after you have spoken to the pharmacist. Examples include inhalers (puffers) for asthma and mild steroid-containing creams for skin irritations. Your pharmacist is a qualified expert in medicines and can help you and your family with advice on health and medicines.

Pharmacy medicines

There are other over-the-counter medicines that you can only buy in pharmacies, but you do not need to speak to a pharmacist to buy them. Examples include medicines to treat diarrhoea and symptoms of allergy.

Medicines for general sale

You can buy some over-the-counter medicines in supermarkets and health food stores. Examples include cough and cold remedies, some pain medicines such as paracetamol, and vitamins.

What are the risks of taking over-the-counter medicines?

Over-the-counter medicines have side effects as well as benefits, just like any other medicine. For example, there are some over-the-counter pain medicines you shouldn’t use if you have stomach, kidney, liver or heart problems, or are pregnant.

Some over-the-counter medicines and alternative medicines can interact with other prescribed medicines, making them less effective for you. Combining medicines, including OTC medicines, may increase your chance of experiencing side effects.

Always let your doctor or pharmacist know what prescription, over-the-counter and alternative or complementary medicines you are taking.

• Older people have more chance of having medicine-related problems.
• Polypharmacy is when you take 5 or more medicines.
• It is helpful to keep a current list of your medicines to share with your healthcare provider.
• Talk to your doctor or pharmacist if you have questions about your medicines.

Why am I more likely to have problems with my medicines as I get older?

Your chance of problems with medicines increases as you age for 2 main reasons:

1. how your body works changes with age
2. you are more likely to be taking multiple medicines (polypharmacy) as you get older

Changes in your body

Your body changes in many ways as you age. For example, the amount of water, fat and muscle you have changes.

Because of these changes, your body may:

• become more sensitive to your medicines
• not be able to process your medicines properly
• have difficulty getting rid of medicines from your body

You may also become more likely to get side effects and have interactions between your medicines.

Some health conditions can make it more difficult to take medicines. These can include:

• poor eyesight, which may make it hard to read the instructions on your medicine
• arthritis, which may make it hard for you to open your medicine
• memory loss, which may make it hard for you to remember to take your medicine

Polypharmacy (multiple medicines)

If you have a few chronic (ongoing) conditions you might be prescribed multiple medicines. When you take 5 or more medicines this is called polypharmacy.

If you take 5 or more medicines daily, you are:

• more likely to be taking medicines that can interact with each other
• more likely to make a mistake with your medicines

How can I improve my medicine safety?

There are some things you can do to make sure that you use your medicines safely. These are:

• keep a current medicines list including vitamins and other complementary medicines
• ask your doctor questions about your medicines
• ask for a medicine review

Keep a medicines list

You can use a medicines list to keep track of:

• what each medicine (prescription and non-prescription) is for
• the dose (how much) of each medicine you take
• when to take each medicine
• how to take each medicine, for example some medicines you need to take with food.

You can keep a medicine list by:

• writing down the names and amounts of each medicine you take on a piece of paper
• downloading and using a medicines list app on your smart phone
• asking your doctor or pharmacist for a medicine list at your next visit

Medicine lists help to make sure that everyone involved in your healthcare knows what you are taking.

Ask your doctor questions about your medicines

When getting a new medicine, you should ask your doctor or pharmacist these questions.

• Why do I need to take this medicine?
• Are there side effects?
• What should I do if I notice any side effects?
• What should I do if I don’t feel like my medicine is working?
• Are there any things I need to do when taking this medicine, such as not driving?
• Does this medicine affect my other medicines? This includes both prescription and non-prescription medicines.
• Do I need to have blood tests to check how the medicine is affecting me?
• Is there a way to lower the number of medicines I’m taking?

Your doctor will consider your age when deciding if a medicine is right for you.

You can also talk to your doctor about other concerns you may have with your medicines. They may:

• change your dose
• change your medicine

Ask for a medicine review

If you take multiple medicines, ask your doctor or pharmacist for a regular medicine review.

Ideally, your medicines should be checked every 6 to 12 months. But you can ask for a medicine review at any time. You may want to ask for a review when you:

• start a new medicine
• stop a medicine

Having an up-to-date medicine list helps to make sure all your medicines are reviewed.

You may be able to have a Home Medicines Review (HMR). This is where a pharmacist visits you in your home. The review gives you the opportunity to ask the pharmacist about your medicines and how to manage them well.

Your doctor will use the results of your review to create a medication management plan with you. You will need a referral from a doctor to have a Home Medicines Review. This service is free of charge.

How do I organise my medicines?

You can try using a weekly dosing aid. This is a container that you can fill with your tablets each week.

If you’re having trouble remembering which medicines to take when, talk to your pharmacist. They might be able to make you a pharmacy pack (also called a blister pack or a Webster pack). These help you take the right medicines at the right time.

Your pharmacist can also help answer any questions that you may have about your medicines.

• Some medicines for children can only be prescribed by a doctor, and others can be bought over-the-counter in a pharmacy or shop.
•  
• In Australia, the most-used medicines for pain and fever in children are paracetamol and ibuprofen.
• Antibiotics are prescription medicines used to treat infections caused by bacteria.
• Antihistamines are medicines used to treat symptoms of allergies.
• In Australia, giving the wrong medicine dose is the most common cause of accidental poisonings in infants (children under one year of age).

What medicines are commonly given to babies and children?

Medicines for children can be either:

• prescribed by a doctor
• bought over-the-counter in a pharmacy or shop

If your doctor prescribes a medicine for your child, the doctor should tell you:

• the full name of the medicine
• what the medicine is for
• how often it should be taken
• if it is best taken before or after meals, or if it doesn’t matter
• for how long your child should take it
• if there are any common side effects

Make sure you tell your doctor about any other medicine your child is taking, including over-the-counter medicines, complementary medicines, vitamins or supplements. Some medicines interact with each other, so it’s important your doctor knows about all the medicines your child is taking. Also be sure to let the doctor know if your child has any allergies.

Prescription medicines should only be taken by the person they are prescribed for — they should never be shared between people.

If you buy over-the-counter medicines, remember to always follow the written instructions carefully and give the dosage recommended for your child’s weight. Ask your pharmacist for advice.

Here are some of the most common types of medicine given to babies and children.

Medicines for pain and fever

In Australia, the most commonly used medicines for pain and fever in children are:

• paracetamol
• ibuprofen

You can use paracetamol for mild to moderate pain and fever in babies over 1 month of age.

You can use ibuprofen for mild to moderate pain and fever in babies over 3 months of age. Ibuprofen can upset an empty stomach. It’s best to give it with, or soon after, milk or food. Ibuprofen should NOT be given to babies with asthma or a bleeding disorder. Ask your pharmacist if you’re not sure if ibuprofen is a good choice of medicine for your child.

Both paracetamol and ibuprofen come as liquid drops for babies. They are both available over-the-counter in pharmacy without a script.

Discuss using pain medicines with your doctor if your child has pain that keeps returning or lasts for a long time.

Antibiotics

Antibiotics are medicines used to treat infections caused by bacteria.

Your doctor will prescribe the dose of antibiotics your baby or child needs, based on the type of infection. This is called a course. If your baby or child is prescribed antibiotics, it’s important that they finish the whole course, even if the symptoms go away.

Antibiotics don’t work with viruses, including those that cause colds and flu. Read more on the differences between bacterial and viral infections.

Antibiotic resistance is when antibiotics stop working for certain infections. It can develop if you:

• use antibiotics when they’re not needed
• don’t take them properly

Antihistamines

Antihistamines are medicines used to treat symptoms of allergies, such as:

• itching
• sneezing
• swelling
• rash

There are 2 types of antihistamines available:

• those that make you feel drowsy (sedating)
• those that don’t make you drowsy (non-sedating)

Sedating antihistamines such as promethazine are not suitable for children under 2 years of age.

If your child needs an antihistamine, speak to your doctor or pharmacist.

Vitamins and mineral supplements

Your child should be getting all the vitamins and minerals they need without any supplements if:

• they are breastfeeding (and you eat well and regularly)
• they are on infant formula
• your baby has started eating solid food and they are eating a balanced, varied diet.

However, some babies or children may need vitamin and mineral supplements. These include:

• low birthweight babies
• babies or children with some medical conditions
• babies or children on a vegan diet

Check with your doctor if you have any concerns about your child’s nutrition.

Remember, most children do not need vitamin supplements to grow and develop normally.

Are there health conditions that might not need medicines?

Constipation

The best way to help your child pass bowel motions regularly is by ensuring they eat enough fibre (which means plenty of fruit and vegetables, wholegrain bread and cereals). Drinking plenty of water, and staying physically active are also important.

A child who does not have a bowel motion every day is not necessarily constipated. If your child feels pain or discomfort when passing a bowel motion, it is best not to give them over-the-counter laxatives. Instead, see your doctor to find the cause of the problem and get the right treatment.

Sleeping problems

If your child is having sleeping problems, talk to your doctor or child health nurse.

Unless medically advised to, it is best not to give sedating antihistamines (such as promethazine) to children, especially babies, as they may be unsafe. They can also cause side effects including hyperactivity and nightmares.

Do not give your child alcohol as it is likely to harm your child’s health.

It’s always best to check with your doctor or pharmacist before giving your baby any medicine.

What happens if my child has a reaction to a medicine?

Children do not always react to medicines in the expected way. If you think a medicine is not working or if side effects occur, such as rashes, abdominal pain, diarrhoea or drowsiness, let your doctor know.

How do I ensure my child receives the correct dose of medicine?

It’s very important to give your child the right dose of medicine.

If your child has difficulty swallowing pills, ask your doctor or pharmacist if the prescribed medicine comes in another form.

Small children sometimes spit medicines out or refuse to swallow them. If this happens and you think your child is not taking the recommended dose of medicine, ask your doctor for advice.

In Australia, giving the wrong medicine dose is the most common cause of accidental poisonings in children under one year.

There are 3 actions you can take to help protect your child:

1. Know how much your child weighs. Medicine doses are calculated based on your child’s weight, so knowing your child’s weight will ensure the dose is accurate.
2. Learn how to give commonly used medicines (such as paracetamol) to your child before they get sick. Ask your doctor, pharmacist or child health nurse for advice.

Useful tips for giving your child medicine:

• Know the strength of the medicine. Children’s medicines often come in different strengths for different age groups. Check the strength on the packet before you measure the dose. If you have children of different ages in your household, know which dose to give each child.
• Check the use-by date of the medicine. Take old medicines to your local pharmacy for safe disposal.
• Check the active ingredient/s. It’s important that you don’t give your baby more than one medicine with the same active ingredient. For example, some medicines contain paracetamol on its own, while others include combinations of paracetamol plus another medicine
• Check how the medicine needs to be stored. Some medicines must be kept in the fridge.

How do I give the right dose to my child?

• Always read the dose and measurements carefully. The dose will depend on your baby’s age and weight. Never give more than the recommended dose.
• Shake liquid medicines before measuring out the dose.
• Always use the measuring device provided in the package (such as an oral syringe). If there isn’t a device in the package, ask your pharmacist which device would be best.
• Before using the measuring device, check that it can accurately measure the dose you need. Pay attention to decimal points (for example 0.5 ml).
• If possible, ask another adult to double-check that you are giving the medicine correctly.

When you give your baby or child medicine, write down:

• the name of the medicine
• the time given
• the dose given
• the active ingredient

This will help you avoid over-dosing, especially if another adult gives your child some of their medicine doses.

Don’t add medicines to infant formula, as your baby may not take the full dose if they don’t finish the bottle.

If you’re not sure how much medicine to give, check with your doctor or pharmacist.

How should I store medicines?

• Keep all medicines out of your child’s reach, preferably in a locked child-proof cabinet.
• Keep medicines in the labelled containers they came in.
• Don’t use medicines beyond their use-by-date. Ask your pharmacist how to dispose of out-of-date medicines.

What medicines should I avoid giving my child?

There are some medicines that you should never give to your baby or young child.

• Aspirin should not be given to children under 12 years unless it is specifically prescribed by your doctor.
• Cough and cold medicines (including nasal sprays) are not suitable for children under 6 years.
• Chewable tablets (including vitamins) could cause your young child to choke. Follow the age directions on the package.
• Anti-nausea medicines should not be used, unless instructed by your doctor.

You should also never give your child any medicine that has:

• been prescribed for another person
• been prescribed for another condition
• expired

• Some medicines can affect your ability to drive safely.
• These can be medicines that you need a prescription to buy or ones that you buy over the counter at a pharmacy or supermarket.
• When starting a new medicine, ask your doctor or pharmacist whether it is safe to drive.

Which medicines can affect my driving?

Some medicines have side effects that can affect your ability to drive safely. It’s illegal to drive under the influence of drugs. This means all drugs, whether they are:

• over-the-counter medicines
• complementary medicines
• prescribed medicines from your doctor
• illicit drugs

How will medicines affect my driving?

To drive safely, you need to be able to see, think and react properly.

Some medicines, can affect these skills. If you are taking these medicines, it may not be safe to drive.

The risks of being affected by your medicines are greater if you are:

• taking more than one medicine
• drink alcohol while you are taking medicines

How can my medicines affect me?

Some common side effects of medicines that can affect your driving include:

• feeling drowsy or tired
• feeling dizzy, faint or nauseous
• blurred or double vision
• shakiness or unsteadiness
• confusion and being less alert
• not being able to concentrate properly
• not being able to judge distance or speed properly
• reacting more slowly
• muscle weakness or being less coordinated
• anxiety or other changes to your mood

Some medicines can affect your driving to a great extent. The effect can be the same as driving when you are over the legal limit for alcohol.

If you think your medicine is affecting your driving, do not stop taking the medicine. You should stop driving and talk to your doctor. There might be other medications you can take.

Which medicines could affect my driving?

Some examples of medicines that might impair your driving are:

• sleeping pills and medicines for anxiety (including complementary medicines)
• epilepsy medicine
• some antidepressants — used for nerve pain, migraines, bladder problems and depression
• antipsychotics — used for conditions like schizophrenia and bipolar disorder
• some antihistamines — used for allergies, colds and flu
• opioids — used for pain relief
• some cold and flu preparations
• some medicines for blood pressure, nausea, inflammation or fungal infections
• diet pills
• medicinal cannabis that contains delta-9-tetrahydrocannabinol (THC)

Cannabidiol does not contain THC but it can also cause you to feel sleepy or tired. It could cause low blood pressure. Talk to your doctor about whether it is safe to drive.

Not everyone’s driving will be affected by these medicines. It depends on:

• how your body adapts to the medicine
• how long you take it before you drive
• what other medicines you are taking

Your sickness or your medical condition can also be a factor in any effect on driving.

Safe medicines

Some medicines can make you a safer driver. These medicines are used to treat conditions that would affect your driving, such as:

• diabetes
• epilepsy
• heart disease

What should I do when I start a new medicine?

Ask your doctor or pharmacist whether it is safe to drive. You should also:

• Always read and follow the instructions on the medicine’s warning label.
• Do not take more than the prescribed dose of the medicine.
• Do not drink alcohol or take other drugs while you are taking medicines.
• Remember that the medicine might affect your driving more when you first start taking it. Over time, you may get used to it and experience fewer side effects.

Do not drive if you have missed a dose of medicine that you need to control symptoms that could affect your driving. Arrange another form of transport, such as public transport or a taxi.

Do not stop taking your medicine or change the dose without talking to your doctor first.

Tips for starting a new medicine

When you are taking a new medicine, it’s a good idea to see what effect the medicine has. You should not drive until you are sure that the medicine will not affect your ability to drive.

Some medicines can last in your system for a long time. You might still be affected by a medicine the next day.

If you’ve taken a sleeping tablet you might still be drowsy the next morning. This is similar to having a ‘hangover’ from too much alcohol the night before.

You need to be sure that you can drive safely after taking your medicines.

Prescription medicines and driving laws

Driving under the influence of drugs can carry heavy fines.

If you have a medical condition that could affect your driving, you will need to tell your state or territory licensing authority. You may need to give them a medical report from a doctor stating that you are fit to drive.

• Many medicines are safe to use while breastfeeding.
• Avoid using medicines and complementary medicines that aren’t necessary.
• If you are prescribed medication, try feeding your baby just before you take the next dose.
• Always check with your doctor or pharmacist before taking a new medicine while breastfeeding.

Can I take medicines while breastfeeding?

Many medicines are safe to take while breastfeeding — only a very small amount of these medicines passes into your breast milk, and will not affect your baby.

Before your doctor prescribes a medicine, make sure they know that you are breastfeeding.

If you forget, check that the medicine is ok to take while breastfeeding with your pharmacist.

Can medicines affect my breastfed baby?

Some medicines can cause your baby to have diarrhoea or make them sleepy or irritable. Other medicines can change your breast milk supply.

The amount of medicine that enters your breast milk and the effect on your baby depends on:

• the type of medicine
• the dose — how much you take
• when you take it

What medicines can I take while breastfeeding?

Allergy and hay fever medicines: antihistamines that do not make you sleepy are considered safe while breastfeeding. Nasal sprays and eye drops are safe. Antihistamines that make you sleepy are not recommended because they may make your baby sleepy.

Antibiotics: most antibiotics used to fight bacterial infections are safe but always take your doctor’s advice. Tetracyclines may be used short term. Metronidazole can make your breast milk taste bitter.

Antidepressants: some antidepressants are safe. Talk with your doctor.

Asthma medicines: most preventers and relievers are safe. It’s very important that you do not stop your asthma medicines while you are breastfeeding.

Cold and flu medicine: it’s best to use saline nasal sprays and decongestant nasal sprays. Avoid medicines containing pseudoephedrine.

Cough medicines: ask your pharmacist to suggest a suitable cough linctus.

Oral contraceptives (the pill): the progesterone-only mini pill is best while breastfeeding. The pill (combined oral contraceptive pill) should not be taken.

Painkillers: paracetamol is safe to take at the recommended dose while breast feeding. Ibuprofen should only be taking in low doses for a short time. Low doses of aspirin, less than 150mg daily, are considered safe to take.

Worm treatments: most worm treatments are safe to take when breastfeeding.

Sore throat medicines: lozenges are safe to use in moderation — too many can cause diarrhoea. A salt water gargle or drinking lemon and honey may also ease your sore throat. Avoid gargles containing povidone-iodine.

What if I need a vaccination?

Most vaccinations are safe and effective while you are breastfeeding.

You can continue to breastfeed after you get the flu (influenza) vaccine.

However, yellow fever vaccination should only be given if needed.

How can I minimise the risk to my baby?

Ask your doctor about ways to reduce the amount of medicine that goes into your breast milk. It may be possible to:

• take a lower dose of your medicine
• take it for a shorter period
• take a quicker acting form of medicine

The amount of medicine in your body is lowest just before you take your next dose. This is a good time to feed your baby.

When taking any medicine, watch for signs of possible side effects in your baby. These may be:

• increased sleepiness
• rash
• bad diarrhoea

What medicines are dangerous to take when breastfeeding?

You may be advised to stop breastfeeding while you are taking some medicines, in case they harm your baby.

Examples of medicines that are not suitable while you are breastfeeding are:

• some anti-cancer drugs
• lithium for some mental health conditions
• injectable medicines used during some scans

For some medicines, you may be advised to stop breastfeeding for a short period of time — hours or days. In these cases, it’s best to express and discard your milk. This will keep up your milk supply.

Can I use complementary medicines while breastfeeding?

Complementary medicines, including vitamin and mineral supplements, herbal preparations and natural medicines, may also have risks for your baby.

You should always talk to your doctor or midwife before taking a herbal medicine or tea.

Like other medicines, complementary medicines can:

• have side effects
• cause allergic reactions
• interact with your prescription medicines

With most herbal and traditional medicines, there is not enough research to check their safety when breastfeeding. It’s always best to ask your health professional for advice.

Alcohol can interact with many medicines. This can change how both the alcohol and medicine affect you. This can happen even if you only drink one or 2 standard drinks a day.

How can alcohol affect my medicines?

There are 2 ways that alcohol can affect your medicines:

1. The alcohol interferes with how your body deals with the medicine. Your body might speed up or slow down the breakdown of the medicine.
2. The alcohol increases the effects of your medicine, particularly to your central nervous system (e.g., sedation).

Both problems can have serious consequences and can seriously affect your ability to:

• drive
• operate heavy machinery
• work safely

Your body takes many hours to process and remove the alcohol that you drink. Reactions between the alcohol and your medicines can happen at any time when you have alcohol in your body.

Which medicines cause problems with alcohol?

Many over-the-counter medicines and herbal medicines should not be taken with alcohol.

The most common medicines that react with alcohol are:

• opioids
• antidepressants
• antipsychotic medicines
• benzodiazepines
• sleeping tablets
• antihistamines
• cold and flu medicines
• some antibiotics (metronidazole, azithromycin and nitrofurantoin)

You should also be careful with pain relief medicines sleeping tablets and some travel medicines.

If you take any of these medicines with alcohol, you may get:

• nausea and vomiting
• headaches
• drowsiness or sleepiness
• dizziness and fainting
• blood pressure changes
• uncharacteristic behaviour
• poor or loss of coordination
• accidents

The effects of drinking alcohol and taking medicine depend on:

• the type and amount of medicine you are taking
• the amount of alcohol you drink
• your genetics, sex and health

Generally, females, older people and people with liver problems are more likely to have an alcohol-medicine interaction.

The sedative effects of alcohol and some medicines are additive. Medicines that can cause sedative effects include:

• all opioids
• some antidepressants
• all antipsychotics
• all sleeping tablets
• all anti-anxiety medicines
• antihistamines
• cold and flu medicines
• erectile dysfunction medicines
• antibiotics (metronidazole, azithromycin and nitrofurantoin)

These medicines depress your central nervous system. Drinking alcohol and taking these medicines puts you at risk of: weakened breathing, heavy sedation, coma and death. Alcohol can be very dangerous — even fatal — if you are taking these medicines.

It’s important to know how your medicine interacts with alcohol.

Sleeping tablets, some anti-anxiety and antidepressant medicines

Alcohol can increase the effects of medicines that relax or sedate your body. These can include: sleeping tablets and some anti-anxiety and antidepressant medicines.

Increased drowsiness and dizziness may make it harder for you to: think clearly, make you more likely to fall and affect your ability to do complicated things like drive a car.

Cough, cold, allergy and travel sickness medicines

Some medicines contain ingredients that can relax or sedate you. These can include:

• cough
• cold
• allergy
• travel sickness medicines

The ingredients may interact with alcohol to cause increased drowsiness and dizziness.

Pain relief medicines

Some pain relievers (including aspirin, celecoxib, ibuprofen and naproxen) can react with alcohol to cause:

• stomach upsets
• stomach bleeding
• ulcers

Regularly having more than 3 alcoholic drinks a day may increase your chance of problems with these medicines.

It’s always best to talk about the side effects of any new medicines with your doctor or pharmacist.

What are the complications of drinking alcohol and taking medicines?

Drinking alcohol and taking some medicines can cause serious complications such as:

• liver damage
• heart problems
• internal bleeding
• weakened breathing
• depression

Mixing alcohol and medicine can also make it dangerous to:

• drive
• operate machinery
• do physical activity

The risk of interactions between your medicines and alcohol increases as you get older. This is because older people:

• often take more medicines
• can’t metabolise medicines as well as younger people

Age also changes how your body works. It increases the chance of you having an interaction between alcohol and your medicine at a lower dose.

Can I drink and take my medicines safely?

Always read your medicine label. This is important for:

• prescription medicines
• over-the-counter medicines
• complementary (herbal) medicines

If it carries a warning, do not drink alcohol.

It’s best to get your doctor’s or pharmacist’s advice before you take any new medicine.

You can find out more about how alcohol will react with your medicine by reading the Consumer Medicine Information (CMI). You can get your medicine’s CMI by:

• asking your pharmacist or doctor to print it for you
• searching in healthdirect’s medicines section
• searching NPS MedicineWise Medicines finder
• getting in touch with the maker of your medicine — the company details are on their Australian website

• Generic medicines have the same active ingredient as brand-name medicines and work in the same way, but may look different and contain different non-active ingredients.
• Generic alternatives are often cheaper than brand-name medicines. This is because the company that produces the medicine did not need to invest money in developing and marketing it.
• In Australia, you can only sell generic medicines if they work the same way as the brand-name medicine.
• Prescribers in Australia must include the name of the active ingredient on prescriptions. This can help you know exactly what you are taking and avoid mistakes.

Are generic medicines the same as brand-name medicines?

Generic medicines work the same way as brand-name medicines, but there are some differences.

Every medicine has 2 names:

• a brand name, from the pharmaceutical company that markets the medicine
• a generic name, which is the medicine’s active ingredient that makes it work

When a medicine with a new active ingredient is first developed, a patent (a legal right given to a new or innovative product or process) protects it for several years. The patent allows the company to make profits to recover the money it spent developing the medicine, or on buying the rights to market it.

Under a patent, other companies cannot sell a similar medicine that contains the same active ingredient.

After the patent expires, other companies are allowed to develop medicines based on the active ingredient. These are known as ‘generic’ medicines. Several different brand-names may all have the same active ingredient as the original medicine.

Generic medicines may be different from the brand-name version in:

• shape, size and colour
• packaging
• ‘inactive ingredients’ that do not contribute to the treatment effect of the medicine

Are generic medicines as effective and safe as brand-name medicines?

Yes. Generic medicines contain the same active ingredient. This is why they work the same way as brand-name medicines.

Generic medicines can only be sold in Australia if they meet the same strict standards of quality, safety and effectiveness as the original brand.

Why are generic medicines often less expensive?

Generic medicines may cost less than brand-name medicines. This is because the manufacturers have not spent money on research and development of the medicine or buying the rights to sell it.

Should I buy a generic medicine?

Your pharmacist might ask if you prefer the generic version of your medicine. Here are some things to consider:

• A generic medicine will usually cost less and will have the same effect as the original.
• You may choose not to switch from a brand-medicine to it’s generic, in order to avoid confusion, especially if you take several different medicines.
• Many medicines contain fillers, binding agents, flavours or other ingredients that may trigger an allergic reaction in some people. If you have a known allergy, you should check whether a generic medicine contains ingredients that you are allergic to.

It’s usually your choice whether to buy a brand-name medicine or a generic option if one is available, but sometimes your doctor will prescribe a specific brand.

If you have any questions about generic medicines, ask your doctor or pharmacist.

What is active ingredient prescribing?

All Australian health professionals who prescribe medicines must write a medicine’s active ingredient on the prescription. If your prescriber would like to include a brand-name on your prescription, they can add it after the active ingredient.

Active ingredient prescribing makes it easier for you to identify different medicines that may contain the same ingredient. This will help you to:

• avoid accidental double-dosing
• avoid taking a medicine that you’re allergic to
• check that it is safe to combine the medicine with another medicine
• identify suitable alternatives if you need to buy your medicines when you are overseas

For specific medicines, such as the blood thinner warfarin, you will need to continue taking the same brand. Your doctor will specify this on the prescription (by writing or ticking the box ‘brand substitution not permitted’ on your prescription), so the pharmacist knows which medicine they should give you.

• A general anaesthetic makes you unconscious during surgery, so you won’t be aware, move or feel pain.
• Medicines are given through a drip in your vein and through a breathing mask.
• Tell your anaesthetist about your health, allergies, medicines and any past problems with anaesthetics.
• You will need to fast before a general anaesthetic.
• You might feel tired, nauseous or cold or have a sore throat for a short time after the anaesthetic.

What is a general anaesthetic?

A general anaesthetic uses medicines to make you unconscious so you will not feel pain, move or be aware during surgery.

Why might I need a general anaesthetic?

General anaesthetics are used for major and some minor operations. Some operations can only be done under general anaesthetic.

Alternatives to a general anaesthetic are:

• local anaesthetic, which numbs a small part of your body
• regional anaesthetic, which numbs a whole area of your body
• sedation, which makes you sleepy

The best anaesthetic for you depends on the procedure, your health and your and your doctors’ preferences. You can discuss this with your doctor or anaesthetist before surgery.

Sometimes children have a general anaesthetic to help them keep still for a procedure, such as an MRI.

How do I prepare for a general anaesthetic?

Meeting your anaesthetist

You will usually meet with your anaesthetist before the surgery. This might be in the few days before your surgery, especially if you are having major surgery or have any health concerns. Usually, it will be in the hours before surgery.

Your anaesthetist will ask you about your health and if you or your family have had any problems with anaesthetics in the past. They may also ask about the medicines you take, whether you have allergies and whether or not you smoke. You should provide any medical information you may have from a previous anaesthetist.

They might examine your mouth, teeth and veins and may listen to your heart and lungs.

Your anaesthetist will explain the type of anaesthetic you will have and what could possibly go wrong. They may ask you to sign a consent form. The form says you agree to the anaesthetic and understand why you are having it and the risks involved.

Your anaesthetist may arrange tests to prepare you for surgery.

You should discuss any questions or concerns with your anaesthetist.

Before surgery

You will need to fast before you have a general anaesthetic. This is so you do not vomit up food in your stomach and inhale it into your lungs (known as aspiration). This can cause serious complications. Your anaesthetist will tell you when you need to start fasting.

They may advise you:

• what medicines you should not take before and on the day of surgery
• not to drink alcohol from the day before surgery
• to quit smoking before surgery
• not to use drugs for at least a week before surgery

How will I get my general anaesthetic?

In most cases, you will receive the general anaesthetic as an injection into a vein on the back of your hand, through a thin plastic tube called a cannula. Sometimes, you will inhale (breathe in) an anaesthetic gas through a mask.

During surgery, your anaesthetist will monitor your level of consciousness, breathing, oxygen level, heart rate and blood pressure. They will usually put a breathing tube into your mouth and give you oxygen.

What happens once I wake up from my anaesthetic?

When you wake from the general anaesthetic, you might feel sleepy, nauseous or cold. You will probably be in the recovery room when you wake up. A nurse will monitor you. You may need medicines to reduce nausea or pain.

If you are staying in hospital, you will be transferred to a ward once you are fully awake.

You can go home after day surgery when you are:

• fully conscious, alert and mobile
• able to manage any side effects
• drinking fluids
• able to urinate (wee)

You can’t drive home after a general anaesthetic. You should arrange for someone to pick you up or help you get home. It’s best to be with someone for the next 24 hours so they can check on you.

What are the risks and side effects of a general anaesthetic?

Common side effects include:

• nausea and vomiting
• dizziness
• tiredness
• itching
• shivering
• blurred vision
• sore throat or dry lips

Older people may have confusion and memory loss.

Other possible risks include:

• damage to your teeth
• allergic reactions to anaesthetic medicines
• temporary numbness or paralysis
• aspiration
• chest infection

In rare cases, patients may lose their sight, have a stroke or brain damage, or die.

Some people are frightened that they might be aware during the operation or feel pain. This is rare. Your anaesthetist will monitor you throughout the operation to make sure this is very unlikely to happen.

If you are worried about risks and side effects, talk to your anaesthetist before surgery.

Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for Pharmacogenetics-guided Warfarin Dosing: 2016 Update(December 2016) 

Updates since publication:

No updates on dosing recommendations since this publication.

Figures provided in the main manuscript of the guideline:

Supplement to: Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for Pharmacogenetics-guided Warfarin Dosing: 2016 Update

Tables provided in the guideline publication supplement or referenced in the guideline^a:

^aSome of the tables included in the guideline may have been updated on-line, particularly to reflect newly described or newly characterized alleles. These include the gene-specific information tables (https://www.pharmgkb.org/page/pgxGeneRef) that support CPIC guidelines by providing information regarding star (*) allele definitions, allele function, allele frequency by major ethnic groups, translations of diplotype to phenotype, and gene resource mappings.

^bBecause this guideline’s recommendations are based on genotype and not phenotype, the diplotype-phenotype tables were not created for these genes.

Original publication (October 2011):

November 2013 update to 2011 guideline:
CPIC guideline authors are aware of several recently published studies on warfarin pharmacogenetics [Articles:24251361, 24251363, 24251360]. These papers have prompted several opinion pieces [Articles:24328463, 24251364]. The authors are evaluating the information, which will be incorporated into the next update of the CPIC guideline on warfarin.

• Clinical Pharmacogenetics Implementation Consortium Guidelines for CYP2C9 and VKORC1 Genotypes and Warfarin Dosing
• 2011 supplement
• IWPC Pharmacogenetic Dosing Algorithm

This guideline has been endorsed by the American Society of Health-System Pharmacists (ASHP).

The EU drug approval system includes several routes that pharmaceutical companies can utilize to get their products approved across the 27 member states. These pathways are designed to accommodate the diverse nature of medicinal products and their intended uses:

1. Centralised Procedure (CP)
2. Mutual Recognition Procedure (MRP)
3. Decentralised Procedure (DCP)

1. Centralised Procedure (CP):

The Centralised Procedure is the process used by the European Medicines Agency (EMA) for the evaluation and approval of medicines for human and veterinary use, intended to be marketed within the European Union. Here’s a breakdown of the three main steps:

Step I: Pre-submission to Application

Pre-submission: Before an application is formally submitted, applicants can engage with the EMA to gain an understanding of regulatory requirements, submission processes, and timelines. Early dialogue is encouraged to ensure a clear and streamlined submission process.

Early Advice: Applicants may seek scientific advice or protocol assistance (especially for orphan medicines) from the EMA. This can cover clinical trial design, quality issues, and non-clinical aspects to optimize drug development.

Rapporteur/Co-rapporteur Appointment: The EMA appoints a rapporteur and a co-rapporteur from among its members to lead the evaluation. These individuals are responsible for coordinating the assessment of the application and preparing the assessment reports.

Assessment Team: An assessment team is formed, often including members from the rapporteur and co-rapporteur’s national competent authorities, to evaluate the submission in depth.

Application: The company submits the application, including all required documentation such as results from clinical trials, manufacturing details, and proposed labeling.

Validation: The EMA verifies the application to ensure it is complete and meets the necessary criteria to enter the evaluation process.

Step II: Scientific Evaluation

Scientific Evaluation: The rapporteurs and assessment team conduct a detailed scientific review of the submitted data to evaluate the medicine’s quality, safety, and efficacy.

Assessment Reports: The rapporteurs produce initial assessment reports which are circulated to the CHMP members and the applicant.

List of Questions (+ clock stop): The CHMP may have questions for the applicant, leading to a “clock stop” in the evaluation timeline, giving the applicant time to respond to the queries.

CHMP Opinion: The CHMP, after deliberation and considering the rapporteurs’ assessments and the applicant’s responses, adopts an opinion on whether the medicine should be authorized.

Possibility to Appeal: If the opinion is negative, the applicant has the right to request a re-examination of the decision.

Transfer to EU Commission: A positive CHMP opinion is then forwarded to the European Commission, which has the authority to grant marketing authorization.

Step III: Decision Making Process

Review by the European Commission: The European Commission reviews the CHMP’s opinion and draft decision, considering any scientific or legal issues.

Consultation: The draft decision is usually subject to a consultation process with the member states.

Final Decision: The European Commission issues a final decision, which is legally binding in all EU member states.

Implementation: Following the decision, the company can begin marketing the medicine across the EU, and the decision is also communicated to the public.

The centralized procedure is designed to ensure that medicines are evaluated to the highest scientific and regulatory standards and that once approved, they can be made available to patients across the entire European Union efficiently.

2. Mutual Recognition Procedure (MRP):

The Mutual Recognition Procedure (MRP) is a regulatory pathway in the European Union for obtaining marketing authorization for a medicinal product in multiple EU Member States when the product is already authorized in one EU Member State (the Reference Member State, or RMS). Here’s a step-by-step explanation:

 Application to Reference Member State (RMS)

Initial Authorization: The pharmaceutical company first obtains a national marketing authorization from the RMS, which involves a full assessment of the product’s quality, safety, and efficacy.

RMS Approval (Day 210)

Assessment Period: The RMS completes its evaluation within 210 days, providing a national marketing authorization for the product.

Submit Mutual Recognition (MR) Application to Member States

Application for Recognition: The company then applies for mutual recognition in other Member States, known as Concerned Member States (CMS), providing the assessment report from the RMS to support the application.

Closure of Procedure

Assessment Reports (AR): CMS review the assessment report and raise any concerns or agree to the mutual recognition.

Product Information Harmonization: The Summary of Product Characteristics (SPC), labelling, and Patient Information Leaflet (PIL) are harmonized across all involved Member States.

National Authorizations: If no objections are raised, the procedure is closed, and national authorizations are granted based on the RMS’s assessment.

Serious Objections Referral to CMDh

Objections and Referral: If any CMS has serious objections that could lead to a refusal of mutual recognition, the issues are referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh).

Arbitration by CMDh (60 Days): The CMDh, comprising representatives from all EU Member States, has 60 days to reach a consensus or agreement, which is binding unless an appeal is made.

Serious Objections Referral to CHMP

Continued Dispute: If the serious objections are not resolved, the dispute can be referred to the Committee for Medicinal Products for Human Use (CHMP).

Arbitration by CHMP (Art 32, 33, 34): The CHMP, part of the EMA, then conducts its arbitration under Articles 32, 33, or 34 of Directive 2001/83/EC, depending on the type of issue at hand.

60 Days CHMP Opinion + 30 Days Commission Decision: The CHMP has 60 days to formulate an opinion, which is then sent to the European Commission. The Commission has an additional 30 days to make a final decision.

 The MRP allows companies to efficiently extend their product’s market reach within the EU based on an existing national marketing authorization, leveraging mutual recognition among Member States while ensuring that all have agreed upon the product’s safety and efficacy. This process supports the EU’s aim to facilitate access to medicines and protect public health while respecting the national sovereignty of each Member State’s regulatory system.

 3. Decentralised Procedure (DCP)

The Decentralised Procedure (DCP) is designed for the approval of non-centralized medicines in the European Union. It allows a pharmaceutical company to apply for the simultaneous authorization of a medicinal product in several EU Member States if the medicine has not yet been authorized in any EU country. Here’s an explanation of the process:

Step 1: Submission and Evaluation (Day 1 to Day 120)

Submission of Dossier: The applicant submits a registration dossier to the selected Reference Member State (RMS) and Concerned Member States (CMSs).

RMS Evaluation: The RMS begins the evaluation process and drafts a preliminary Assessment Report (AR).

CMS Comments: The CMSs review the AR and provide comments.

Questions to Applicant: The RMS compiles a list of questions based on the comments from CMSs and sends them to the applicant.

Clock Stop: The procedure is paused (usually for a recommended three months) to give the applicant time to respond to the questions.

Step 2: Finalization and Approval (Day 121 to Day 210)

Draft Assessment Report: Once the applicant’s responses are received, the RMS prepares the draft final AR, draft Summary of Product Characteristics (SPC), and draft labelling/packaging leaflet.

Closure of Procedure: If all CMSs agree with the RMS’s assessment and the applicant’s responses to the list of questions, the procedure can be closed, leading to national approvals.

Serious Objections Referral to CMDh: In case any CMS has a serious objection that cannot be resolved, the issue is referred to the CMDh.

Arbitration by CMDh (60 Days): The CMDh, consisting of representatives from all EU Member States, has 60 days to resolve the dispute.

Further Serious Objections Referral to CHMP: If the CMDh cannot reach a consensus, the issue is referred to the CHMP for arbitration.

Arbitration by CHMP (Art 32, 33, 34): Under the relevant articles of Directive 2001/83/EC, the CHMP has 60 days to formulate an opinion.

CHMP Opinion and Commission Decision: The CHMP’s opinion is then forwarded to the European Commission, which typically has 30 days to issue a final decision.

 The DCP allows for simultaneous national approvals in multiple EU countries while ensuring that the medicinal product meets the necessary standards. The use of a single RMS for the initial assessment provides a unified approach, and the collaboration with CMSs ensures that the interests and regulations of individual Member States are taken into account. This procedure benefits both the applicant and the Member States by reducing duplication of effort and enabling a coordinated decision-making process.

Abstract

Background

Many factors determine empirical antibiotic treatment of community-acquired pneumonia (CAP). We aimed to describe the empirical antibiotic treatment CAP patients with an acute hospital visit and to determine if the current treatment algorithm provided specific and sufficient coverage against Legionella pneumophila, Mycoplasma pneumoniae, and Clamydophila pneumoniae (LMC).

Methods

A descriptive cross-sectional, multicenter study of all adults with an acute hospital visit in the Region of Southern Denmark between January 2016 and March 2018 was performed. Using medical records, we retrospectively identified the empirical antibiotic treatment and the microbiological etiology for CAP patients. CAP patients who were prescribed antibiotics within 24 h of admission and with an identified bacterial pathogen were included. The prescribed empirical antibiotic treatment and its ability to provide specific and sufficient coverage against LMC pneumonia were determined.

Results

Of the 19,133 patients diagnosed with CAP, 1590 (8.3%) patients were included in this study. Piperacillin-tazobactam and Beta-lactamase sensitive penicillins were the most commonly prescribed empirical treatments, 515 (32%) and 388 (24%), respectively. Our analysis showed that 42 (37%, 95% CI: 28–47%) of 113 patients with LMC pneumonia were prescribed antibiotics with LMC coverage, and 42 (12%, 95% CI: 8–15%) of 364 patients prescribed antibiotics with LMC coverage had LMC pneumonia.

Conclusion

Piperacillin-tazobactam, a broad-spectrum antibiotic recommended for uncertain infectious focus, was the most frequent CAP treatment and prescribed to every third patient. In addition, the current empirical antibiotic treatment accuracy was low for LMC pneumonia. Therefore, future research should focus on faster diagnostic tools for identifying the infection focus and precise microbiological testing.

Background

Community-acquired pneumonia (CAP) is one of the most common infections among patients in the emergency department and carries high mortality worldwide [1, 2]. Globally, the yearly incidence of CAP in adults is estimated to be between 1.5 and 14.0 per 1000 people, with short-term mortality for hospitalized patients between 4 and 18% [3].

The most frequent CAP pathogens, Streptococcus pneumoniae and Haemophilus influenzae,typically respond to narrow-spectrum beta-lactam antibiotics like benzylpenicillin in countries with low penicillin resistance [4, 5]. Other CAP pathogens like Legionella pneumophila, Mycoplasma pneumoniae, and Clamydophila pneumoniae (LMC) are uncommon, seldom cause severe pneumonia and can be treated with macrolides or quinolones [5, 6].

Indiscriminate use of antibiotics like macrolides and quinolones is problematic. Firstly, they are drivers of the increasing worldwide problem of antimicrobial resistance (AMR) [7, 8]. WHO has classified AMR as a major global threat, and antibiotics like third generation cephalosporins, macrolides, fluoroquinolones, piperacillin/tazobactam, and amoxicillin/clavulanic acid as critical antibiotics for humans, so unnecessary use should be limited to avoid resistance. Secondly, these antibiotics are associated with serious side effects, e.g. Clostridium difficile infection, cardiotoxicity and teratogenicity [9,10,11,12].

The microbiological etiology is rarely known when a patient is treated for suspected CAP, and empirical antibiotic treatment should be adjusted to local epidemiology and AMR patterns [2]. Guideline recommendations can be based on various severity scores such as the Pneumonia severity index (PSI), CRB-65, and CURB-65 [13]. Great Britain, Germany, and Denmark use the CRB-65/CURB-65 severity score approach to guide empirical antibiotic treatment for CAP [13,14,15,16]. These guidelines recommend penicillin, such as benzylpenicillin and amoxicillin, for patients with low CURB-65 scores. For patients with high CURB-65 scores, guidelines recommend coverage against LMC pathogens as a precaution. However, LMC pathogens are less common in patients with high CURB-65 scores [17, 18].

In addition to the guidelines, factors such as comorbidities, previous antibiotic treatment, community outbreaks of specific pathogens, treatment sites, antibiotic supplies, and the treating physicians’ knowledge and compliance with guidelines all impact the choice of empirical antibiotic treatment [19,20,21]. Despite the many factors determining the empirical antibiotic treatment of CAP and the increasing antibiotic resistance worldwide, we found little knowledge about which antibiotics are prescribed for patients with CAP and if the current guidelines based on scoring systems for pneumonia are successful in recommending antibiotic treatments that target the actual bacterial etiology.

Therefore, our aim was 1) to describe the type of empirical antibiotic treatment prescribed to CAP patients on arrival and 2) to determine if the current treatment algorithm provided specific and sufficient coverage against LMC pneumonia.

Method

Study design

This study was conducted in the Region of Southern Denmark, the third largest region in Denmark, with a population of 1.2 million. The region has four hospital units: Odense University Hospital, Lillebaelt Hospital, Hospital South West Jutland, and Hospital Sønderjylland.

We conducted a descriptive cross-sectional study based on the Southern Denmark Antibiotic Stewardship (SODAS) database. The database was established to evaluate the impact of the implementation of the Region of Southern Denmark’s antibiotic stewardship (RSDAS) in 2017 on individual antibiotic treatment [22]. SODAS consists of retrospective data collection from eight departments distributed across 4 hospitals receiving acute patients over 18 years. All data were extracted from the patient’s electronic medical record and supplemented with data from the Danish National Patient Registry [23].

RSDAS was implemented through campaigns and mandatory educational training [24, 25]. In addition, a comprehensive and rigorous material sampling for microbiological analysis was recommended.

Our study adheres to the STROBE guidelines for reporting observational studies in epidemiology [26].

Participants

All patients from SODAS with a discharge diagnosis of pneumonia between January 2016 to March 2018 (International classification of diseases 10^thedition (ICD-10): DJ100, DJ111, DJ158, DJ159, DJ180, DJ189) were eligible (appendix 1). Patients with previous admissions within the last 14 days were excluded as they were deemed readmissions or hospital-acquired pneumonia. In addition, patients not receiving antibiotic treatment within the first 24 h of admission were excluded to ensure that only community-acquired infection was included. Only patients with identified bacterial infections were included in this study.

Variables

Charlson Comorbidity Index (CCI) was calculated from the last ten years’ discharge diagnoses prior to admission and grouped into three groups; 0, 1, ≥ 2 points [27]. CURB-65 score was not possible to calculate because the data contained no urea data, but CRB-65 was calculated when possible.

Antibiotic treatment

The last prescribed antibiotic treatment within 24 h of admission was regarded as the empirical treatment. Antibiotic guidelines for CAP are listed in Table 1. Before 2017 guidelines for antibiotic treatments for pneumonia were described in leading national textbooks [28]. In 2017 national and regional guidelines (RSDAS) were instituted.

1. *Suspected Mycoplasma pneumoniae pneumonia, based on patient age or doing Mycoplasma pneumoniae outbreaks
2. **CURB-65 score ≥ 3 and hypoxia (SAT < 92%) or involving ≥ 2 lung lobes radiologically or sepsis
3. ***Need for mechanical ventilation or oral treatment not possible

Information on penicillin allergy was not available.

For our second aim, prescribed macrolide or fluoroquinolone was assumed to reflect the application of treatment guidelines to ensure antibiotic coverage against LMC pneumonia. Tetracyclines are not recommended in Danish guidelines and are rarely used for CAP in Denmark.

Microbiology

The microbiological identified etiology of CAP was determined from standard clinical, microbiological testing. Guidelines for microbiological testing are described in appendix 2. A list of creditable CAP pathogens identified in sputum and blood culture was determined by a microbiologist (FSR) and an infectious disease consultant (CBM) (appendix 3). In cases with more than one identified pathogen, LMC pathogens were used if one was identified.

More extensive microbiological testing, Polymerase chain reaction (PCR) for LMC pathogens and treatment targeting LMC pathogens, were recommended for patients with CURB-65 score > 2, and a source of potential detection bias.

Analysis

Patients’ characteristics were reported with mean or proportion when relevant. Empirical antibiotic treatment and microbiological etiology were reported as quantity and percentage of the total. Empirical antibiotic treatment accuracy for LMC pneumonia was expressed as 1) quantity and proportion of LMC pneumonia prescribed antibiotic covering LMC pneumonia. 2) Quantity and proportion of patients prescribed antibiotics covering LMC with LMC pneumonia. 3) Number of prescribed antibiotics covering LMC pneumonia needed to correctly treat one LMC pneumonia. 95% confidence interval was calculated for proportions when appropriate.

Cases with missing microbiological etiology or empirical antibiotic treatment were excluded from the main analysis.

The sample size was determined by the number of cases in the SODAS cohort. Data analysis was done using STATA 17 (StataCorp, USA).

Ethics

The study was performed in accordance with the Helsinki declaration. According to the Danish Act on scientific ethical treatment of health science research projects, register based studies do not require ethics committee approval [29]. The need for informed patient consent was waived by the Danish Patient Safety Authority (record 3–3013-2272/1/), and the processing of personal data was approved by the Region of Southern Denmark and listed in the internal record (2012–58-0018 no. 17/24904) cf. art 30 of The EU General Data Protection Regulation.

Results

Participants

During the study period, a total of 443,953 contacts were included in the SODAS database, of which 21,624 had a discharge diagnosis of pneumonia (Fig. 1), 2,491 were excluded as readmissions within 14 days, resulting in 19,133 contacts for inclusion. We identified pathogen causes in 2,091 patients, of which 501 did not receive antibiotics within 24 h. In total, 1590 (8.3%) CAP patients were included in our analysis.

Descriptive data

Patient characteristics

Characteristics of the study population are listed in Table 2. An extended list of antibiotics can be found in appendix 4. Identified viral pneumonias, the frequency of microbiological testing and the frequency of positive test can be found in appendix 5 and appendix 6.

Main results

Antibiotic treatment

Monotherapy piperacillin-tazobactam and Beta-lactamase sensitive penicillins accounted for more than half of all empirical antibiotic treatments, with 515 (32%) and 388 (24%), respectively (Table 2).

Prescribed antibiotics coverage against LMC-pneumonia

Antibiotics with LMC coverage were prescribed to 364 (23%) totally, among these to 42 (37%, 95% CI: 28–47) of 113 LMC pneumonia patients and 42 (12%; 95% CI: 8–15) with prescribed LMC antibiotics had LMC pneumonia (Table 3). The number of patients prescribed LMC covering antibiotics needed to treat one LMC pneumonia was 8.7.

Discussion

Our study found that piperacillin-tazobactam and Beta-lactamase sensitive penicillins were the most prescribed empirical treatments, with 515 (32%) and 388 (24%), respectively. Additionally, our analysis showed that only 42 (37%, 95% CI: 28–47%) of patients with LMC pneumonia were covered by the empirical antibiotic treatment, while only 71 (12%, 95% CI: 8–15%) of patients treated with antibiotics with LMC coverage actually had LMC pneumonia.

Prescribed empirical antibiotics

The majority, 515 (32%) of all antibiotics prescribed were monotherapy Piperacillin-tazobactam. This was notwithstanding a shortage of Piperacillin-tazobactam from May to September 2017 [30]. Piperacillin-tazobactam monotherapy is the recommended empirical treatment for patients with an unknown infection focus, sepsis, or Chronic obstructive pulmonary disease (COPD) exacerbation requiring mechanical ventilation or where oral treatment were impossible [22]. Although some of the Piperacillin-tazobactam prescribed may have been for patients with COPD, only 96 (6%) of included patients were prescribed the first-line antibiotic, Amoxicillin/clavulanate. Suggesting that some COPD patients were prescribed piperacillin-tazobactam, instead of the recommended Amoxicillin/clavulanate. Additionally, the frequent use of monotherapy piperacillin-tazobactam and antibiotics targeting urinary tract infections indicate that the focus of infection is often uncertain in CAP patients at admission. Furthermore, it highlights a need for better diagnostic tools to determine the focus and microbiological etiology of the infection. Diagnostic uncertainty has previously been mentioned as a cause for the increased use of broad-spectrum antibiotics [31].

In a Danish study, 45% of CAP patients were treated with Beta-lactamase sensitive penicillins, compared to only 24% in our study [32]. The higher prescription rate of narrow-spectrum antibiotics may result from increased diagnostic certainty as the study used new infiltrates on chest x-ray as a criteria for diagnosing pneumonia which we did not. Although chest x-ray is the current first-line imaging tool for pneumonia, it has low sensitivity for pneumonia [33, 34]. Including only patients with new infiltration on chest x-ray excludes a significant number of CAP patients. In the future, tools like thoracic ultrasound and ultra-low-dose CT might improve focal diagnostics and facilitate focal targeted antibiotic treatment [35,36,37].

Prescribed antibiotic coverage against LMC pneumonia

We found that the empirical treatment guided by severity scores covering LMC pneumonia to be non-specific and insufficient. This result is not surprising, as studies assessing the ability of severity scores to predict the etiology of CAP reported a decreased frequency of LMC pneumonia in patients with high severity scores [18, 38]. In addition, other studies have shown that up to half of patients with low CURB-65 scores, where beta-lactam antibiotics were recommended, were treated with both a beta-lactam and a macrolide antibiotic [19,20,21]. Since empirical antibiotic coverage against LMC is based on a patient’s severity score, LMC pneumonia not treated with empirical antibiotics is likely to be less severe.

All these factors may explain our results: the prescription of antibiotics with LMC pneumonia coverage in 23% of patients despite LMC only being identified in 7% of patients, only 37% of patients with LMC pneumonia were prescribed antibiotics with LMC coverage, and only 12% (95% CI: 8–15) of patients prescribed antibiotic covering LMC had an LMC-pneumonia. This indicates a considerable potential for improvement in use of antibiotics with more accurate and faster microbiological testing in the future.

In our setting, PCR analysis for LMC pathogens was only recommended in patients with a CURB-65 score of 3–5. Therefore, we were less likely to identify LMC-pneumonias in the group prescribed antibiotics without LMC coverage and likely overestimated the proportion of LMC-pneumonias prescribed antibiotics covering LMC pneumonia. To PCR test all CAP patients or all patients prescribed antibiotics with LMC coverage [39] may lead to reduced antibiotic use, cost and length of hospital stay [40].

Generalizability

The relative frequency of each pathogen in our study was consistent with other studies from Denmark and Norway [41, 42]. We had a low frequency of Streptococcus pneumoniaecompared to other European countries but a similar frequency compared to USA and Canada [4]. Concerning LMC pneumonia pathogens, this study has a low frequency compared to many other studies that reported a frequency of approximately 21% [4]. The frequency difference could be attributed to regional differences, the use of serology, and the more consistent use of PCR for LMC in other studies.

Denmark and other Scandinavian countries have a low level of LMC frequency and antibiotic resistance, and guidelines usually recommend narrow-spectrum penicillin, in contrast to non-Scandinavian countries where broad-spectrum antibiotics are often used as first-line empirical treatment [14, 16, 42,43,44]. Therefore these results might not apply to countries with different etiology, antibiotic resistance patterns, or guidelines for CAP. Nevertheless, the underlining observations from this study may be more broadly applicable. Inappropriate use of broad-spectrum antibiotics may be driven by diagnostic uncertainty regarding infection focus and etiology.

Limitations

A limitation of this study was that the population was selective and only included 8% of patients with CAP, as it was only possible to identify microbiological etiology in 13% of patients. Sputum culture and PCR are the primary microbiological tests for CAP. However, studies have shown a tendency for a low sputum culture yield of 14–17% in CAP patients because of an inability to obtain sputum samples and a low positive rate of sputum culture [45, 46]. In addition, patient factors such as age > 75 years, weakness, and ability to cough will impact the ability to produce a sputum sample. Furthermore, antibiotic treatment before sputum sampling reduces sputum culture yield, so some pathogens are particularly challenging to identify via culture [46].

Some, limitations stem from our population-based design, which relies on discharge diagnoses for pneumonia, potentially skewing results due to less robust patient selection. Furthermore, the overrepresentation of patients from Odense University Hospital, with its unique patient demographic and extensive microbiological testing, could have biased our results, specifically in antibiotic prescription patterns. The impact of these factors is challenging to quantify or account for.

Conclusion

In conclusion, piperacillin-tazobactam was the most frequent empirical antibiotic treatment for CAP with later established clear etiology. The accuracy of empirical antibiotic treatment covering LMC pneumonia was low. We found that there was potential for improvement of empirical antibiotic treatment of CAP and that diagnostic uncertainty regarding focus and cause of infection may be major factors for unnecessary use of broad-spectrum antibiotics.

Availability of data and materials

Due to Danish laws on personal data, data cannot be shared publicly. To request data, please contact the corresponding author for more information.

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DRAP has enabled both electronic and manual systems for collection of reports of suspected adverse events:-

LEARNING OBJECTIVES

• Define an adverse drug reaction.
• Discuss the detection of adverse drug reactions.
• Discuss the assessment of adverse drug reactions.

WHAT HAPPENS TO THE REPORT?

Your report matters. Together, letus save lives through vigilant reporting.

Objective

Combination biological therapies are being considered increasingly for patients with multiple co-morbidities requiring biologics. There are limited data available on this approach, and concerns remain about the possible risk of adverse events, particularly infection.

Methods

We present three patients on dual biologics for rheumatic disease and asthma. The biologic combinations used were etanercept and mepolizumab, infliximab and omalizumab, and etanercept and omalizumab. The time on combination biologic therapies ranged from 24 to 36 months. Patients were monitored for any serious adverse events.

Results

All three patients were able to tolerate combined biologic therapies, with no serious adverse events. All three patients gained improvement in their rheumatic and asthma disease control, with reduction in disease activity scores and reduction in steroid usage.

Conclusion

The decision to start dual biologic therapy should be considered carefully, on a case-by-case basis. The number of patients who are on combination biological therapy is small, and data are sparse. Real-world data are needed to examine the long-term benefits and risks of different forms of combination biologic therapies.

Lay Summary

What does this mean for patients?

Biological therapies are specific therapies that target particular parts of the immune system. These medications are used in the treatment of autoimmune conditions, such as rheumatoid arthritis (RA). In RA, they work by stopping particular chemicals in the blood from activating the immune system to attack joints. They are very effective medications to treat inflammatory autoimmune conditions. In some cases, they can be associated with side effects, particularly increased risk of infections. We have written a case series about three people who have inflammatory autoimmune conditions and are receiving two biologics to treat these. All three people have inflammatory arthritis and asthma and are receiving two different biological therapies. They have been receiving these for a period ranging from 24 to 36 months. All three people have been able to tolerate combined biologic therapies, with no serious adverse events thus far. They have gained improvement in their arthritis and asthma control, with reduction in disease activity and the use of steroids. Although the number of people receiving more than one biological treatment is small, this study suggests that dual therapy could be used in certain situations. The decision to start dual biologic therapy should be considered carefully, on a case-by-case basis, by the specialists.

Key message 

• Combination biological therapies are being considered increasingly for patients who present with multiple co-morbidities.
• Data presented here suggest that combination biologics can be used safely, without serious adverse events.
• The decision to start dual biologic therapy should be considered carefully, on a case-by-case basis.

Introduction

Combination biological therapies are being considered increasingly for the treatment of patients who present with multiple co-morbidities requiring biological treatment. There are limited data available regarding this, and concerns remain about the risk of adverse events, particularly infections, in addition to potential drug interactions in patients receiving more than one biological therapy . We present a case series of three patients who have benefited from dual biologic therapy for rheumatic disease and asthma.

Literature on dual biologic therapy is limited, owing to the infrequency of this clinical approach. There are significant clinical reservations in taking this approach owing to the potential risk of serious infection from immunosuppression . In addition, the wide variety of biological therapies and their potential combinations makes consistent comparison of outcomes difficult, and structured clinical trials are infrequent.

Development of newer agents targeting different pathways has made it possible to use combination therapy in selected patients. Simultaneous use of more than one biological agent has been used in two main scenarios: patients with severe inflammatory disease unresponsive to a single biological agent, or patients with co-existing severe medical conditions, such as Inflammatory Bowel Disease , asthma and psoriasis . There is limited real world evidence from case-based literature on combining biological therapies across different clinical specialties.

Methods

We present three cases illustrating the outcome of combination therapy for severe asthma and inflammatory arthritis. Formal ethics approval was not required for this work because only anonymized patient information was included and no change to patients’ standard care was required in order to be included in the case series. All patients gave written informed consent to the use of their data. A summary of the clinical presentations and therapies can be found in Table 1.

Table 1.

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Summary of key points of each case

Etanercept and infliximab are anti-TNF-α agents licensed for the treatment of moderate or severe RA. Omalizumab is an anti-IgE biologic used for the treatment of atopic asthma . Mepolizumab is an anti-IL-5 agent used for the treatment of severe eosinophilic asthma.

We have defined serious adverse events in accordance with the US Food and Drug Administration definition. A serious adverse event is an undesirable experience associated with the use of a medical product, which is life threatening, can result in death, hospitalization, disability, permanent damage or congenital anomaly. This also includes other serious events, such as allergic bronchospasm, serious blood dyscrasias or seizures. We have also included transaminitis and infections requiring antibiotics. Information was gathered by reviewing medical notes at the tertiary centre, the local hospital, from general practitioner records and by contacting patients.

Case one

Case one is a 56-year-old woman with severe eosinophilic asthma diagnosed in the late 1990s and seronegative RA diagnosed in 2019. Her asthma was previously treated with bronchodilator and steroid inhalers, montelukast and daily maintenance prednisolone. Mepolizumab was commenced in 2018, and since then she has reported no exacerbations of her asthma. Mid-2022, she was reviewed by the asthma service and was tolerating mepolizumab well, was no longer on montelukast or the steroid inhaler, and had not had to use her salbutamol inhaler for ∼7 months.

For RA, she was initially treated with sulphasalazine (SSZ), but this was not tolerated and was stopped. She commenced methotrexate (MTX) 20 mg s.c. once weekly along with prednisolone in early 2020, but after 6 months remained symptomatic, with evidence of active synovitis on musculoskeletal ultrasound (US), despite being on prednisolone 25 mg daily. At this time, her disease activity score (DAS28) was 6.25.

Etanercept was then commenced alongside MTX and prednisolone. Twenty-four months after commencing etanercept, she continues etanercept and has reduced her prednisolone to 11 mg daily. Her DAS is 2.27. It has been difficult to reduce her prednisolone further thus far owing to ongoing joint pain, although there is no synovitis on US. She is being encouraged to reduce the corticosteroids (CS) dose gradually. She has been on dual therapy for 24 months and has not had any recorded serious adverse events.

Case two

Case two is a 35-year-old man, known to have asthma since childhood, requiring multiple hospital admissions and an intensive care unit admission in 2002. He has previously been on a combination of inhalers, aminophylline and montelukast, but still required frequent courses of oral CSs. He was diagnosed with Crohn’s disease in 2006 and was subsequently diagnosed with Crohn’s-associated arthritis, for which he has been on azathioprine (AZA) and infliximab since 2008. In April 2019 he was started on omalizumab for severe asthma that was difficult to control. On follow-up, he reported significant improvement in asthma symptoms, with no further need for oral CSs, and he no longer requires nebulized therapy. He continues infliximab at the same dose and omalizumab and has achieved good control of his Crohn’s disease and associated arthritis. He has not experienced any serious adverse effects after 36 months of combination therapy.

Case three

Case three is a 62-year-old woman who was diagnosed with atopic eosinophilic adult-onset asthma in the late 1980s and seropositive RA in 2012. Prior therapy for asthma included a combination of bronchodilator and steroid inhalers. She was referred to the severe asthma service in 2018, and omalizumab was commenced in June 2019. Since starting this, her asthma has been well controlled, supported by clinical examination and ACQ-6 score (asthma control questionnaire). Initially, her RA was treated with MTX and hydroxychloroquine (HCQ). However, despite this combination she had evidence of ongoing joint inflammation, and in 2018 she was started on etanercept. She has continued both biologics for 36 months with good control of asthma and RA, without any serious adverse events, and has not required any steroid therapy. This was confirmed by reviewing the omalizumab record sheet.

Results

In these three cases, dual biologic therapy has been used to good effect, with no infection or other serious adverse events. This has also enabled patients to reduce oral CS dependence significantly, with the added benefit of minimizing CS-related adverse effects.

Discussion

The decision to start a patient on dual biologic therapy should be considered carefully, on a case-by-case basis, only when conventional treatment options have failed and in the context of life-threatening or significantly disabling disease. The main concerns regarding the use of dual biologic therapy centre around safety, especially a theoretical risk of serious infections [1]; no infections were seen in this small case series. This potential risk must be balanced carefully against the potential long-term harm from ongoing severe disease and the well-documented risks associated with other adjuvant therapies, specifically CSs, which would be the most likely alternative treatment option in this group of difficult-to-treat patients. The number of patients requiring combination biological therapies is a small but important group. Data are sparse, because they are generally excluded from clinical trials. Thus, real-world data are important and needed to examine the long-term benefits and risks of different forms of combination biologic therapies across different disease areas.

Data availability

The data underlying this article cannot be shared publicly owing to ethical/privacy reasons.

Funding

No specific funding was received from any bodies in the public, commercial or not-for-profit sectors to carry out the work described in this article.

Disclosure statement: E.W. has received speaker fees/honoraria from AbbVie, Internis, Novartis, Nordic Pharma, Roche, Thornton & Ross and UCB and contributed to advisory boards for Lilly. C.H. has received honoraria or sat on advisory boards for Abbvie, BMS, Celltrion, Chugai, Galapagos/Gilead, Janssen, Lilly, Napp, Novartis, Pfizer and UCB. The remaining authors have declared no conflicts of interest.

Any unwanted or unexpected effects of a medicine, including a vaccine, are called side effects. Side effects can also occur due to interactions with other medicines, food or alcohol.

Not all side effects are serious.

Some side effects may get better over time. For example, a new medicine might cause nausea at first but then this will go away.

Sometimes side effects don’t happen right away. They can develop after you have been taking the medicine for a while.

What is an adverse event?

Adverse events are things that happen due to the use of a medicine, vaccine, or medical device. Adverse events include side effects, but can also be caused by user error.

An adverse event does not necessarily mean that there is something wrong with the medicine, vaccine, or device.

What types of medicines can cause side effects?

All types of medicines can have side effects. This includes:

• prescription medicines
• over-the-counter medicines that you can buy from a pharmacy, supermarket or other shops

Vitamins and minerals and herbal, complementary, alternative or natural medicine can also have side effects.

Even though all medicines can cause side effects, not everyone will get them.

How can I manage the side effects?

Always take your medicine exactly according to the instructions.

Specific instructions can include:

• starting with a low dose and increasing that dose slowly over time
• taking your medicine with meals (for example, as recommended with anti-inflammatory medicines)
• taking your medicine on an empty stomach (before you eat)
• taking your medicine at a specific time of the day
• staying out of the sun (for example, as recommended with isotretinoin)

If you are having trouble with side effects of a medicine, talk to your doctor. There may be things you can do to reduce the side effects or other medicines that suit you better.

Vaccinations and side effects

Vaccines, like other medicines, can also have side effects. However, all vaccines used in Australia offer benefits that greatly outweigh their risks.

After vaccines are given to people, their safety continues to be checked using:

• passive surveillance
• active surveillance

Passive surveillance requires people to report side effects to the Therapeutic Goods Administration (TGA). Find out more about reporting a side effect with a medicine.

Active surveillance is done using a system called AusVaxSafety.

AusVaxSafety sends a short text message to people after they have received a vaccination. This asks if they had a reaction to the vaccine. Experts look at the responses to make sure that any safety issues are found quickly.

COVID-19 vaccination side effects

Vaccination against COVID-19 is the best way to reduce deaths and severe illness. The protective benefits of vaccination far outweigh the potential risks.

Like all medicines, COVID-19 vaccines may cause some side effects. The most frequently reported side effects are:

• injection-site reactions (such as a sore arm)
• headache
• muscle pain
• fever and chills

Myocarditis (inflammation of the heart) is a known but very rare side effect of the Comirnaty (Pfizer) and Spikevax (Moderna) COVID-19 vaccines. Most people get better within a few days. Myocarditis is reported in:

• around 1-2 in every 100,000 people who get Comirnaty (Pfizer)
• around 2 in every 100,000 people who get Spikevax (Moderna)

However, it is more common after the second dose in 12 to 17 year-old boys and in men under 30 years.

Thrombosis with thrombocytopenia syndrome (TTS) is a very rare but serious side effect of the Vaxzevria (AstraZeneca) COVID-19 vaccine. TTS is reported in:

• about 2 in every 100,000 people who get Vaxzevria (AstraZeneca), following their first dose

The risk of TTS is much lower after the second dose of this vaccine.

You can find out more about how Australia is monitoring COVID-19 vaccine safety through the Therapeutic Goods Administration website.

Where to get information on side effects

Your doctor and pharmacist are the best people to speak to about potential side effects.

Here are some questions you might want to ask them:

• What are the possible side effects of this medicine?
• Does this medicine have any serious side effects?
• How often do these side effects happen?
• What can I do to avoid or lower my risk of side effects?
• Do the side effects get better with time?
• What should I do if I think I’m having a side effect?

You can also get information on side effects from the medicine’s Consumer Medicine Information (CMI) leaflet. This is given to you by the pharmacist when you are prescribed a new medicine. You can also ask your pharmacist for a copy.

All prescription medicines and some non-prescription medicines have a CMI. You can also search for CMIs in healthdirect’s medicines section.

Thinking about side effects

If you are thinking about starting a new medicine, it’s worth thinking about the side effects.

• How common are they?
• How serious are they?
• And what do they mean to you?

This is especially important if you have a serious health condition, and the medicines might have serious side effects.

How to get help if you have side effects

If you think you might be having a serious side effect, see your doctor at once. If it’s an emergency, call triple zero (000) for an ambulance.

If you think you have taken too much medicine, call the Poisons Information Centre, 24 hours a day on 13 11 26.

If it’s not an emergency but the side effects are bothering you, talk to your doctor or pharmacist. You can also call healthdirect on 1800 022 222 (known as NURSE-ON-CALL in Victoria) to speak to a registered nurse.