Medicines and Healthcare Products Regulatory Agency (MHRA), a division of the Her Majesty’s Government that dictates which drugs can be sold in the United Kingdom. Their website is http://www.mhra.gov.uk/.
Patient Information LeafletsEdit
Their website houses Patient Information Leaflets (PILs) which are similar to the Consumer Medicine Information leaflets issued in Australia. These are designed and written for lay persons prescribed the drug. They are produced by the drug company that markets the drug and they summarize:
- What the drug is and what it is used for
- Contraindications, that is, pre-existing conditions that should prevent the patient from using this drug, or at least spark a conversation with their pharmacist or physician.
- Drug interactions, including with over-the-counter remedies such as herbs.
- How to take the drug, might seem condescending but some drugs are less than obvious in how they are taken. For example, bupropion is only available as a sustained release formulation in the U.K. and if these tablets are crushed they are no longer sustained release tablets and rather serves as immediate release tablets.
- Possible side effects, including ones that merit immediate medical attention
- Storage conditions, that is the temperature and other conditions in which the drug should be stored.
- Further information
Summary of Product CharacteristicsEdit
The MHRA website also houses the Summary of Product Characteristics (SPCs) which are similar to the Product Information sheets issued in Australia. They are written for healthcare professionals including nurses, pharmacists and physicians. They are written by the drug company marketing the drug and they summarize the available scientific information regarding the drug that is relevant to efficient clinical use of the drug. They are divided up into the following sections:
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Therapeutic indications
- 4.2 Posology and Method of Administration
- 4.3 Contraindications
- 4.4 Special Warnings and Special Precautions for Use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable Effects
- 4.9 Overdoses
- 5. PHARMACOLOGICAL PROPERTIES
- 5.1 Pharmacodynamic Properties
- 5.2 Pharmacokinetic Properties
- 5.3 Pre-clinical Safety Data
- 6. PHARMACEUTICAL PARTICULARS
- 6.1 List of Excipients
- 6.2 Incompatibilities
- 6.3 Shelf-Life
- 6.4 Special Precautions for Storage
- 6.5 Nature and Contents of Container
- 6.6 Instruction for Use, Handling and Disposal
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
- 10. DATE OF REVISION OF THE TEXT