6 Questions
What is the main reason homeopathic remedies cannot make medicinal claims?
They are not proven to have therapeutic indications
What is the main purpose of the Misuse of Drugs Regulations 2001?
To regulate the use of controlled drugs in veterinary medicine
What is the characteristic of a Schedule 1 controlled drug?
Has high potential for misuse and is not used in veterinary medicine
What is the characteristic of a Schedule 5 controlled drug?
Has very low strength preparations with low risk of misuse
How many homeopathic remedies are currently licensed under the scheme?
7
What is the purpose of the cascade in relation to homeopathic remedies?
To allow vets to use extemporaneously prepared homeopathic remedies
Study Notes
Homeopathic Remedies
- Pre-registered with the Veterinary Medicines Directorate (VMD)
- Cannot make any medicinal claims
- Must be of sufficient dilution to guarantee safety
- Categorised as AVM-GSL (Authorized Veterinary Medicine-General Sales List)
- Defined as 'homeopathic veterinary medicinal product without approved therapeutic indications'
- Currently, 7 products are licensed under this scheme
Licensed Homeopathic Remedies
- Aconite Tablets
- Anxt-F Oral solution
- Arnica Montana tablets
- Arsenicum Album tablets
- Belladonna tablets
- Nux Vomica tablets
- Rhus Tox tablets
Controlled Drugs
- Regulated by the Misuse of Drugs Regulations 2001
- Risk of misuse by people
- Divided into 5 schedules
- Subject to increased controls, including access, recording, and storage
Schedules of Controlled Drugs
- Schedule 1: Highest potential for misuse, not used in veterinary medicine (e.g. Ecstasy, Heroin)
- Schedule 2: Therapeutic value but addictive, strict controls on use (e.g. Morphine, Ketamine)
- Schedule 3: Some potential for abuse, less strict control measures (e.g. Barbiturates, Buprenorphine)
- Schedule 4: Divided into two parts, Part 1 contains benzodiazepines, Part 2 contains anabolic and androgenic steroids, no additional controls (e.g. Diazepam, anabolic steroids)
- Schedule 5: Very low strength preparations, low risk of misuse, no additional controls (e.g. Codeine, Paracetamol)
Pharmacovigilance
- Suspect Adverse Reaction Surveillance Scheme (SARSS)
- Legal requirement for all manufacturers
- Applies to all medicines
- Includes monitoring of adverse reactions in animals, people, environment, and food, as well as lack of efficacy
Responsibilities and Requirements
- Manufacturers: Report adverse events to the VMD
- Animal health professionals: Report suspected adverse events to the VMD
- Public: Report suspected adverse events directly to the VMD using the 'yellow form'
- Four pillars of reporting: identifiable person, identifiable patient, suspected substance, and one or more reaction
Test your knowledge on the IATA packing regulations for biological samples. Learn about the requirements for primary receptacles, leak-proof containers, absorbent layers, secondary containers, and itemised lists of contents.
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