Dr. Geoff welcomes the learner to the unit on understanding the legislative framework for medication use in social care. The learner will learn about three assessment criteria: 1) identifying relevant legislation, 2) outlining the legal classification system for medication, and 3) explaining how policies must reflect legislative requirements. Dr. Steve then discusses the various acts governing medication use, including the Medicines Act of 1968 which established the classification of medications as general sales list, pharmacy, or prescription-only.

1. Hello I’m Dr. Geoff and I’m really happy to welcome
you to Outcome 1 of your new unit.
Me and a few of my friends are going to give you
the vital information to achieve your assessment
criteria.
Click next to find out more……

2. Learning outcome 1 is to understand the legislative
framework of the use of medication in social care
settings
In order to achieve learning outcome 1 you need to
learn about 3 pieces of assessment criteria within it.
Click next to find more………

3. Your 3 pieces of assessment criteria include;
1.1 Identify legislation that governs the use of
medication in social care settings
1.2 Outline the legal classification system for
medication
1.3 explain how and why policies and procedures or
agreed ways of working must reflect and incorporate
legislative requirements
Click next to let my friends explain
your assessment criteria

4. Hello I’m Dr. Steve an expert in medication legislation in
social care.
It is extremely important that health and social care workers
understand the legislation surrounding the use of
medication (1.1).
The purpose of this legislation framework is to protect the
people being cared for and the workers caring for them.
Click next to learn about the legislation covering medication

5. o Medicines Act 1968
o Human Medicines regulations 2012
o Misuse of Drugs Act 1971
o Misuse of Drugs Regulations 2001
o Misuse of Drugs (Safe Custody) Regulations 1973
o Health Act 2006
o Controlled Drugs (Supervision of Management and Use)
Regulations 2006
o Control of Substances Hazardous to Health (COSHH)
Regulations 1999
o Hazardous Waste Regulations 2005
Click next to learn about each act……….

6. Medicines Act 1968
The Medicines Act 1968 defines three legal categories of
medicines; general sales list medicines (GSL), pharmacy
medicines (P) , prescription-only medicines (POM)
Under this act, most medicines can only be sold or supplied
against a prescription at a pharmacy under the supervision
of a pharmacist. However, some medicines (GSL) can be
sold at other premises, such as convenience stores, as long
as they’re pre-packed and the premises can be closed to
exclude the public. It’s illegal to sell medicines from market
stalls or from vehicles, such as at car boot sales.
http://www.nhs.uk/chq/Pages/1325.aspx?CategoryID=73&Sub
CategoryID=101

7. Human Medicines regulations 2012
On 14 August, the human medicines regulations 2012 came into effect,
replacing most of the Medicines Act 1968 and about 200 statutory
instruments with a simplified set of rules.
They are the result of the Medicines and Healthcare Products Regulatory
Agency’s consolidation and review of the UK’s medicines legislation.
The new regulations implement European directive 2001 relating to
medicinal products for human use (the medicines directive). The new
regulations set out a comprehensive regime for the authorisation of
medicinal products for human use; for the manufacture, import,
distribution, sale and supply of those products; for their labelling and
advertising; and for pharmacovigilance.
http://www.hsj.co.uk/topics/efficiency/new-regulations-simplify-40-years-of-medicines-law/5051815.fullarticle

8. Misuse of Drugs Act 1971
Whilst much of this Act consolidated earlier legislation, it introduced some
important changes.
It set up the Advisory Council on the Misuse of Drugs, it introduced the concept
of irresponsible prescribing, the Tribunal procedure (which is no longer used)
and gave the Home Secretary the power to introduce strict standards of
security rather than the 'lock and key' requirements of the earlier legislation.
It also introduced the terms 'controlled drugs' and 'CD' to replace the
previously used expressions 'dangerous drugs' or 'DDA' respectively.
The main purpose of the Act is to prevent the misuse of controlled drugs and
achieves this by imposing a complete ban on the possession, supply,
manufacture, import and export of controlled drugs except as allowed by
regulations or by licence from the Secretary of State.
https://www.dhsspsni.gov.uk/articles/misuse-drugs-legislations

9. Hazardous Waste Regulations 2005
Some wastes are considered to present a particularly high risk to
health or the environment and require special handling and
treatment.
The Hazardous Waste Regulations, which came into force in July
2005, set out the regime for the control and tracking of
hazardous waste in England and Wales . Under these
Regulations, a process of registration of hazardous waste
producers and a new system for recording the movement of
waste was introduced.

10. Misuse of Drugs (Safe Custody) Regulations 1973
These regulations outline the storage and safe custody
requirements for controlled drugs and are enforced by
the Home Office via the police.
The degree of control depends on the premises within
which the drugs are being stored. Particularly stringent
requirements apply to retail premises and certain care
homes.

11. Health Act 2006
Under this act the concept of a controlled drug (CD)
accountable officer was introduced. All designated bodies
such as health care organisations and independent
hospitals are required to appoint an accountable office
and any issues regarding controlled drugs and dealt with
by this person and their team.
The Act imposes a duty of collaboration on all bodies to
share intelligence on controlled drug issues and gives the
police and other nominated people power of entry to
inspect stocks and records of them.

12. Controlled Drugs (Supervision of Management and Use) Regulations 2006
The Government fully accepted the need to strengthen arrangements for
the management of controlled drugs, without hindering patients from
accessing necessary treatments.
The result is the Controlled drugs (supervision of management and use)
regulations 2006,3 which contains measures that underpin the safe
management and use of controlled drugs in England and Scotland.
Primary care trusts (PCTs) and a number of other healthcare bodies (e.g.
health boards, NHS trusts) are defined by the regulations as designated
bodies that are required to appoint accountable officers who must be
adequately resourced by the healthcare body appointing them
http://www.guidelinesinpractice.co.uk/jun_09_panting_drugs_jun09

13. Control of Substances Hazardous to Health (COSHH)
Regulations 1999
These regulations require the employer to protect all
employees from any potential hazards posed by substances
and materials they may come into contact with while
performing their job.
Some medicines are more hazardous to a care workers
health than others. Cytotoxic drugs are used to treat
various conditions, including cancer, rheumatoid arthritis
and Cohn's disease , e.g. methotrexate

14. Control of Substances Hazardous to Health (COSHH)
Regulations 1999
These regulations require the employer to protect all
employees from any potential hazards posed by substances
and materials they may come into contact with while
performing their job.
Some medicines are more hazardous to a care workers
health than others. Cytotoxic drugs are used to treat
various conditions, including cancer, rheumatoid arthritis
and Cohn's disease , e.g. methotrexate
http://www.wastecare.co.uk/regulations/hazardous-waste-
england-and-wales-regulations-2005/

15. Welcome Back
You have successfully worked through the legislation
that governs the use of medication in social care
settings with Dr. Steve.
Now it time to move onto assessment criteria 1.2
Outline the legal classification system for medication
Click next to let my next friend explain your 1.2
assessment criteria

16. Hello name is Dr. Kath and I am an expert in the
classification of medication in the health and social
care industry (1.2).
Medical Products for human use fall into three legal
classes, as defined by the Medicines Act 1968:
o GSL (General Sales List)
o P (Pharmacy)
o POM (Prescription Only Medicines)
Click next to work through each classification………..

17. GSL (General Sales List)
These are medicines which can be purchased over the counter
from any shop.
All General Sale List medicines, except those that have been
designated as foods or cosmetics, must be licensed products.
GSL medicines can be sold by a wide range of shops, such as
newsagents, convenience stores and petrol stations. Often, only
a small pack size or low strength of the medicine may be sold.
For example:
o the largest pack size of paracetamol that shops without a
pharmacist working in them can sell is 16 tablets, but
pharmacies can sell packs of 32 tablets
o the highest strength of ibuprofen tablets that shops can sell is
200mg, but pharmacies can sell tablets at 400mg strength
http://www.nhs.uk/chq/pages/1325.aspx?categoryid=73&subc
ategoryid=101

18. P (Pharmacy)
Only pharmacies may sell these medicines and a pharmacist
must make or supervise the sale.
You’ll be asked if you have any medical conditions or take any
other medicines, to check that it’s safe for you to take the
medicine. For example, some nasal decongestants can raise
your blood pressure, so you’ll be asked if you have high blood
pressure before being sold the medicine.
Some pharmacy medicines may only be sold if the pharmacist
is satisfied that it is suitable and safe for you to take.
For other medicines, the pharmacist may suggest that you see
your GP. For example, if you’ve used clotrimazole pessaries
for vaginal thrush more than twice in six months, you should
see your GP so they can decide whether this is the most
appropriate treatment.
http://www.nhs.uk/chq/pages/1325.aspx?categoryid=73&subc
ategoryid=101

19. Prescription-only medicines
You cannot get these medicines without a prescription,
usually from your GP. However, in some cases, your medicine
may be prescribed by your dentist, a nurse, pharmacist,
midwife or other healthcare professional, such as an
optometrist.
Some prescription-only medicines are classed as controlled
medicines, such as morphine, pethidine and methadone, due
to their potential for abuse. Stricter legal controls apply to
these medicines.
http://www.nhs.uk/chq/pages/1325.aspx?categoryid=73&subc
ategoryid=101

20. Controlled Drugs (CD POM)
Certain POM medicines are further categorised as controlled
drugs (CDs) under the Misuse of Drugs Act 1971 and the
Misuse of Drugs Regulations 2001. Under the regulations
there are five classes of CD, e.g. preparing containing
morphine.
Some medicines are even classified under more than one
category depending on their formulation, strength, quantity
or what they are to be used for.
Paracetamol is a GSL medicine when sold in a packet of 16,
but is classified as a P medicine when sold in a packet of 32
and is a POM when supplied in a pack of 100.
http://www.nhs.uk/chq/pages/1325.aspx?categoryid=73&subc
ategoryid=101
I forgot to mention
the CD POM

21. Welcome Back
You have successfully worked through the legal classification
system for medication in social care settings with Dr. Kath.
Now it time to move onto assessment criteria 1.3 explain
how and why policies and procedures or agreed ways of
working must reflect and incorporate legislative
requirements
Click next to let my next friend explain your 1.3 assessment
criteria

22. Hello name is Dr. Matt and I am the leading
health expert in the field of policies and
procedures of medication.
I am going to explain how and why policies
or agreed ways of working must reflect and
incorporate legislative requirements
Click next to read my personal diary entries
when I was in med school……….

23. When working in social care settings it is important that all health and social
care professionals work in a standardised way ensuring all individuals receiving
care and support receive the same level of service. Working within the
framework of the law safeguards both the care giver and receiver.
All policies and procedures are produced from legislation. The policies and
procedures are put in place to ensure that legislation is being followed and
obeyed by all people in the home including the team and the children requiring
medication. It is essential that all of the needs of the children receiving the
medication and the team member assisting in this, are met and by following the
policies of the home, the team ensure that the law is being obeyed. For example
if a team member in the home did not follow the medication policy set out by
the company, it could cause the home to break the law and could potentially
cause harm to the person who was in receipt of the medical attention.
Within the home’s policy regarding medication covers all aspects of medicated
equipment in the house. The policy stipulates actions to take when dealing with
over-the-counter medication, prescribed medication, the storage of any
medications, the administration of medication, the method and importance of
recording of the administration and refusal of medication and signing medicines
in and out of the house including safe disposal of non-used or expired
medicines. All of the information in the house’s policy is based on the current
legislation surrounding medication and for the house to operate within legal
frameworks, ensure the safety of the children in our care whilst maintaining
their health.