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Extemp > Legislation list > Flashcards

Legislation list Flashcards

1
Q

What legislation applies to specials?

A

Extemporaneous preparation comes under section 10 exemption of the Med Act 1968.
Also Part 10 of HMR 2012 wrt the need to have a MA.

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2
Q

What organisations are involved with hazardous substances and/or health and safety? [2]

A

NIOSH: National Institute For Occupational Safety and Health.
IARC: International Agency for Research on Cancer.

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3
Q

EU Directive 2010/32/EU was responsible for:

A

Banning the resheathing of needles in a healthcare setting.

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4
Q

Why is the hospital pharmacy involved with the administration of CIVAS products?

A

Breckenridge report 1976.

Pharmacy should make all additions to infusion bags.

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5
Q

When would a special be exempt from Part 10 of the HMR 2012?

A

When it is in response to a bona fide unsolicited order, formulated in accordance with the specification of a doctor, dentist etc. for use by a prescribers individual patients under his direct responsibility.

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6
Q

What pieces of legislation are in place to deal with hazardous substances? [3]

A

Health and Safety at Work Act 1974.
Personal Protective Equipment at Work Regulations 2002.
COSHH: Control of Substances Hazardous to Health 2002.

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7
Q

The Health and Safety at Work Act of…..

A

1974

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8
Q

Extemporaneous preparation comes under what?

A

Section 10 exemption of the Med Act 1968.

Exemption from need to have MA = HMR 2012 part 10.

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9
Q

COSHH: Control of Substances Hazardous to Health of….

A

2002

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10
Q

What gives pharmacists and pharmacies the ability to manufacture medicines without the need for a MA?

A

Section 10 of the Medicines Act of 1968

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11
Q

IARC

A

IARC: International Agency for Research on Cancer

Involved with hazardous substances/and or health and safety.

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12
Q

What legislation was amended to allow the publication of price lists of specials?

A

Medicines for Human Use (advanced therapy medicinal products and miscellaneous amendments) regs 2010.

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13
Q

NIOSH

A

National Institute for Occupational Safety and Health

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14
Q

What is TSE?

A

Transmissible Spongiform Encephalopathies.
Legislation in 2003 and again 2010.
All manufacturers, importers and exporters of unlicensed medicinal products must comply.

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15
Q

What are the conditions under section 10 of the Med Act 1968 regarding the manufacture of specials?

A

Must be a bonafide unsolicited order.
Product must be formulated for a specified patient in accordance with the requirement of a practitioner registered in the UK.
Product is for use by their individual patients on their direct responsibility.

ALSO:
If a special is manufactured in the UK, manufacturer must hold a specials license from the MHRA or an Investigative Medicinal Products (clinical trial) License.

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16
Q

What did the EU directive 2003/94 dictate?

A

That the RP or Accountable pharmacist is responsible for GMP and that their is a duty of care.
Must comply.

17
Q

What does Chapter 8 of the MHRA’s Orange Guide state in regard to storage temperatures and their monitoring?

A
  • temps should be monitored and recorded daily.
  • records must be reviewed regularly
  • temperature records should be present
  • Small fridges should be measured continually
  • the calibrated electronic thermometer must be able to be read without opening fridge/cold room door and this door must be lockable and alarmed.
18
Q

The Personal Protective Equipment at Work Regulations of……

A

2002

19
Q

What waste disposal guidelines exist?

A

HTM 07-01 The Safe Management Of Healthcare Waste Memorandum.

20
Q

What directive banned resheathing of needles in a healthcare setting?

A

EU Directive 2010/32/EU

21
Q

What regulations govern the handling of gene therapy in viral vectors?

A
  1. GMO (Contained Use) Regs 2014, HSE.

2. GMO (Deliberate Release) Regs 2002, DEFRA.

22
Q

What do the GMO (Contained Use) Regs 2014, HSE stipulate?

A

All possible barriers (physical, biological or chemical) are in place to limit contact of the GMOs with humans and the environment,

23
Q

What do the GMO (Deliberate Release) Regs 2002, DEFRA stipulate?

A

All appropriate measures are taken to avoid damage to the environment from the escape or release from human control of GMOs.

24
Q

What was the purpose of the Medicines For Human Use (Clinical Trials) and Blood Safety and Quality?

A

It dealt with consent for minors and emergency treatment situations.

25
Q

What is the GTAC?

A

Gene Therapy Advisory Committee (GTAC). Est. 1993, Department of Health. National research ethics committee (REC) for gene therapy.

26
Q

What was the purpose of the Medicines For Human Use (Clinical Trials) Regulations 2004?

A

Identified what a clinical trial was.
Formalised when ethics approval was needed and how it was approved.
Good Clinical Practice (GCP) was outlined.
Regulated where trial material, including the placebos can be made (GMP - IMP licence).
Identified that a sponsor was needed who is responsible for compliance with the above^^.

27
Q

Cold Chain transport issues were covered in:

A

GDP Guidelines 2012

28
Q

What legislation impacts the small scale manufacture and supply of individualised investigative medicinal products?

A

2004 - Medicines For Human Use (Clinical Trials) Regulations.

2008 - Medicines For Human Use (Clinical Trials) and Blood Safety and Quality.

2014 - EU Regulations 536/2014 repealing 2001/EC.

29
Q

What do the GMO (Deliberate Release) Regs of…….

A
  1. All appropriate measures are taken to avoid damage to the environment from the escape or release from human control of GMOs.
30
Q

What legislation identified the formal definition for what a clinical trial is and entails?

A

Medicines For Human Use (Clinical Trials) Regulations 2004:
Identified what a clinical trial was.
Formalised when ethics approval was needed and how it was approved.
Good Clinical Practice (GCP) was outlined.
Regulated where trial material, including the placebos can be made (GMP - IMP licence).
Identified that a sponsor was needed who is responsible for compliance with the above^^.

31
Q

HTM 07-01

A

The Safe Management Of Healthcare Waste Memorandum.

32
Q

What was the point of the EU Regulations 536/2014 repealing 2001/EC?

A

Improved harmonisation across Europe.
Dealt with transparency of trial information
Imported products
Labelling requirements
Hospital exemptions WRT re-labelling or re-packaging and the preparation of radiopharmaceuticals used as diagnostic IMP
.

33
Q

In what legislation was GCP outlined?

A

Medicines For Human Use (Clinical Trials) Regulations 2004:
Identified what a clinical trial was.
Formalised when ethics approval was needed and how it was approved.
Good Clinical Practice (GCP) was outlined.
Regulated where trial material, including the placebos can be made (GMP - IMP licence).
Identified that a sponsor was needed who is responsible for compliance with the above^^.

34
Q

What legislation dealt with consent for minors and emergency situations?

A

2008 - Medicines For Human Use (Clinical Trials) and Blood Safety + Quality.

Extemp (12 decks)

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