Legal and Ethical Issues Flashcards
Specials & Unlicensed medicines include…
- Medicines licensed in europe or elsewhere but not on sale in this country
- Medicines for a specified persn in accord with a prescriber’s instructions
- Medicines obtained from holder’s of a manufacturer’s ‘specials’ license
- Re-packed medicines (prepacks)
- Section 10: Medicines prepared for a specified patient in accord with prescribers instructions (i.e extemporaneous dispensing, crushing of tablets, TPN etc)
- Products that arn’t medicines but used to treat rare conditions
How does Medicines, Ethics and Practice relate to specials & extemps?
- Make patients your first concern
- Exercise your professional judgement in the interests of patients and the public
- Develop your professional knowledge and competence (& recognise your limits)
- Take responsibility for your working practices
Principle 3:
- The environment & conditions of the premises safeguard health, safety and well-being of patients and public
Principle 4:
- The Management of medicines includes:
-> Arrangements for obtaining, keeping, using and supplying medicinal products
-> Security and waste management
Which legislation governs the manufacture, sale and supply and medicines?
The Medicines Act 1968
- Updated into Human Medicines Regulations 2012 (which requires all medicines to be licensed before sold or supplied, there are exemptions! (e.g. Section 10)
What are the conditions required for supply under the section 10 exemptions of the Medicines Act 1968?
- Bona fide unsolicited order
- Product is formulated for a specified patient in accordance to the requirement of a practitioner prescriber registered in the UK (UK only!)
- > The drug is for use by their individual patient on their direct personal responsibility
- Pharmacies must have the appropriate equipment and facilities available to produce a high quality, safe product
- Essential records must be kept! (Detailed preparation records)
Can ‘specials’ be advertised?
No!
- They have no product licence and cannot be offered for sale by a manufacturer
- Manufacturers can advertise their specials services but NOT their specials products
- > Price lists allowed to be published
What is a risk assessment?
A careful & thorough look at what, in your work, could cause harm to patients.
- & what needs to be done to prevent this!
Is a risk assessment a professional requirement?
Yes!
Risk assessments should be specific to…
- Individual pharmacy
- The staff working in it
- Each medicine to be made
When should risk assessments be reviewed?
Regularly! & When circumstances change
A Risk assessment should include…
What the risks are
Whether a suitable licensed product exists
Also: Formula (from a recognised source) Method validation Calculation validation Need/use of specialist equipment Product-specific risks Assurances around ingredients and starting materials Suitability of premises Staff competence Circumstances that would trigger a new risk assessment
What are the minimum requirements of records kept for specials?
- Name of product
- Specification
- Name of prescriber
- Manufacturer (& supplier if different)
- Date ordered
- Quantity ordered
- Batch number recieved
- Kept for 5 years
How long should records be kept for specials/unlicensed medicines?
5 years
What do the TSE (Transmissible Spongiform Enchephalopathies) guidelines mean?
If an unlicensed medicines (special or extemp) is suppled and is proved to carry a risk from TSE and any harm to the patient is caused, those MAKING, IMPORTING or MARKETING that product would be held liable
Do the TSE guidelines apply to pharmacists preparing unlicensed medicines in pharmacies?
No
With reference to principle 3, what should be done to mimimise contamination in pharmacies?
- Enough space
- Environment suitable for medicine preparation
- Specific steps taken to ensure that risk of chemical cross-contamination and microbial contamination is eliminated/minimised.
Users (i.e. prescribers and pharmacists) need a process for assessing the risk, quality and suitability of unlicensed specials and extemps. What form does this usually come in?
A policy or SOP
What should be included in the Policy/SOP regarding specials/unlicensed products
It should detail the responsibilities of all staff involved in:
- Commissioning
- Purchase
- Supply
Records should be kept! (e.g. product, specification, prescriber, supplier, batch number etc.)
Local ‘QC’ procedures can control risks relating to…
- Ordering or supplying the wrong product
- Damage in transit
- Product not manufactured or distributed in accordance with a Framework or Agreed Specification
Good practice in relation to the control of risks includes…
- Verification (of clinical need, lack of suitable alternative etc.)
- Quarantine (to prevent supply prior to approval)
- Inspection (check for identity, appearance, labelling etc)
- Certificate of analysis or certificate of conformity
- Formal recorded approval (records made and kept)
What should you do if there is a problem with an unlicensed medicine that you have prepare or obtained?
- Contact members of the public and recall any unlicensed medicines issues
