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Extemp > Tim Sizer > Flashcards

Tim Sizer Flashcards

1
Q

What is a bespoke medicine?

A

Individualised treatments, made-to-order medicines, specials.

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2
Q

What is the definition of personalized medicines?

A

Medical decisions, practices, interventions and/or products tailored to the individual patient based on their predicted response or risk of disease.

Intention is to ensure treatments meet needs of specific patients.

Applications of genomics/molecular data to better target the delivery of healthcare.

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3
Q

Who are specials typically for?

A
  1. Premature babies that cannot tolerate standard doses.
  2. Intensive care patients with specific IV needs (PN)
  3. Stroke patients.
  4. Older patients who cannot swallow.
  5. Children or patients with learning difficulties who won’t take tablets.
  6. Cancer patients
  7. People with excipient allergies, acute eye infections needing eye drops.
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4
Q

What is a special defined as?

A
  1. Non - licensed medicine manufactured to fulfill a prescribers requirements.

Doctors have the clinical freedom to prescribe an unlicensed medicine if it is in the best interests of the patient.

Pharmacist can either make the product themselves or more commonly purchase it from a “specials” manufacturer.

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5
Q

What is one example of a personalised medicine in practice?

A

Trastuzumab/Herceptin.
Humanised mAb that binds human epidermal growth factor receptor 2 protein: HER2 which is overexpressed in 24% breast cancer patients.

Trastuzumab binds to HER2 proteins and mediates anti-cancer effects through a combination of mechanisms promoting lysis, destruction of diseased cells by the immune system and enhancement of cytotoxic drugs.

Initial testing of cancer patients to see if they fall into the HER2 overproduction category can ensure the drug is targeted at those who benefit most.

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6
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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7
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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8
Q

Who has accountability/responsibility for ‘unlicensed medicines’?

A

Pharmacist + Prescriber share this.
The pharmacist has a professional responsibility to liaise with the prescriber and the patient or carer to ensure that a special is (and remains) the most appropriate choice.

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9
Q

Who has the responsibility for the unlicensed medicine formulation?

A

The pharmacist NOT the manufacturer.

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10
Q

Why might a pharmacist choose to outsource the provision of specials?

A
  1. Decrease risk of products prepared under own supervision.
  2. Increase re-numeration.
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11
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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12
Q

What risks are associated with extemporaneous dispensing with regards to the patients

A
  1. Unproven formulations
  2. Lack of standards/deviations
  3. Calculation errors
  4. Formulations errors
  5. OD/UD due to stability issues, binding of drug to excipient etc.
  6. Contamination by microbials.
  7. BA issues.
  8. Measurement, labeling errors.
  9. Use of concentrated chloroform water instead of diluted.
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13
Q

What risks are associated with extemporaneous dispensing with regards to staff?

A

Exposure to harmful substances can occur.
Coal tar use etc.
Crushing tablets, weighing/mixing/reconstituting powders, decanting/pouring, handling volatile liquids.

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14
Q

What is the legal difference between licensed and specials?

A

Medicine that is used within the terms of the license and cause side effects are under the responsibility of the manufacturer.

The pharmacist has the full responsibility for any harmful effects of a pharmaceutical special, unless it can be proved that the medicine itself was at fault.

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15
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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16
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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17
Q

Can specials be advertised?

A

No product license = cannot be offered for sale, must be procured or commissioned by a purchaser.

Specials manufacturers can advertise their services but not specific products.

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18
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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19
Q

How do scale and risk in the manufacture of specials relate?

A

As the scale of manufacture increases the risk decreases.
In order of decreasing risk and increasing scale:
Made on ward.
Made in pharmacy.
Made in pharmacy specials unit.
Made in hospital.
Made in industry.

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20
Q

What should be considered before preparation of a special extemporaneously in a pharmacy is begun?

A
  1. Is there a licensed product available instead?
  2. Can we buy the an unlicensed product from a reputable source?
  3. Are we trained to prepare the product?
  4. Are our premises fit to prepare the product?
  5. Are documented and validated SOPs in place?
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21
Q

Why cannot specials be advertised?

A

No product license = cannot be offered for sale, must be procured or commissioned by a purchaser.
Specials manufacturers can advertise their services but not specific products.

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22
Q

What should a risk assessment relating to the safe preparation of specials extemporaneously contain? [10]

A
  1. State what the risks are and whether an equivalent relevant licensed product exists or is available.
  2. Formula from a recognised source e.g. BP
  3. Method validation
  4. Calculation validation
  5. Need/use of specialist equipment.
  6. Contamination/hygiene methods
  7. GMP assurances
  8. Assessment of the suitability of premises.
  9. Staff competencies
  10. Circumstances that would trigger a new risk assessment.
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23
Q

What essential records must be kept of specials order from a specials manufacturer?

A
  1. Name of the product
  2. Contact details of patient supplied.
  3. Specification of product.
  4. Prescribers name:
  5. Manufacturer and (if different) the supplier
  6. Date ordered
  7. Quantity ordered
  8. Cost
  9. Batch number received.

HMR2012 dictates that any person selling or supplying an unlicensed medicine must keep a record for 5 years.

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24
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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25
Q

In what ways can we minimise the risk of contamination during extemporaneous dispensing?

A
  1. Buy a special from a certified specials manufacturer.
  2. Have enough workspace
  3. Have a suitable environment for medicine preparation
  4. Specific steps should be taken to ensure that risk of chemical cross-contamination and microbial contamination is eliminated or minimised.
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26
Q

What examples of incidents that have occurred due to contaminated specials are there?

A
  1. Manchester Incident 1994
  2. Fungal Meningitis 2013
  3. French Alps Baby deaths 2013-14
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27
Q

How long do records of unlicensed medicine supply need to be kept? why?

A

HMR2012 dictates that any person selling or supplying an unlicensed medicine must keep a record for 5 years.

28
Q

What does good practice in regards to controlling the risks associated with extemp/unlicensed medicines include? [5]

A
  1. Verification of a clinical need.
  2. Quarantine on receipt, to prevent supply prior to approval.
  3. Inspection
  4. Certificate of analysis or certificate of conformity
  5. Formal recorded approval.
29
Q

What are ‘Local Quality Control’ procedures?

A

They are local guidelines to help control the risks relating to:

  • ordering or supplying the wrong product.
  • damage in transit
  • product not manufactured or distributed in accordance with a written framework or agreed specification.
30
Q

How must complaints and recall be dealt with? [5]

A

Under GMP standards.

  1. Systems for handling complaints must be in place.
  2. Concerns must be made when you suspect medicines are not fit for purpose.
  3. Systems must be in place so that you can demonstrate you respond to situations in an effective and controlled manner,
  4. Systems must be in place to contact members of the public and recall any unlicensed medicines issued.
31
Q

What are the 4 principles of a quality management system?

A
  1. Manufacturers must produce medicines that are fit for their intended purpose and not put patients at risk due to inadequate safety, quality or efficacy.
  2. Quality Assurance
  3. GMP
  4. QC.
32
Q

What is ISO 9000? [5]

A 
It is a management system to direct and control an organisation with regard to quality. 
It involves:
1. Senior management commitment
2. Management review and governance 
3. Process approach 
4. Measurement, Analysis and Assurance
5. Continuous improvement.
33
Q

Why should quarantine of ordered specials occur?

A

To prevent supply prior to approval.

34
Q

What do GMP standards dictate in regards to complaints and recall procedures? [5]

A
  1. Systems for handling complaints must be in place.
  2. Concerns must be made when you suspect medicines are not fit for purpose.
  3. Systems must be in place so that you can demonstrate you respond to situations in an effective and controlled manner,
  4. Systems must be in place to contact members of the public and recall any unlicensed medicines issued.
35
Q

What is ICH Q10?

A

Uses ISO 9000 as a base: complementary system to GMP.

“Establish and maintain a state of control and facilitate continual improvement”

36
Q

What definitions of quality exist?

A

“The totality of characteristic satisfying the stated and implied needs”

“The degree of fit for purpose”

37
Q

What does ISO 9000 involve? [5]

A
  1. Senior management commitment
  2. Management review and governance
  3. Process approach
  4. Measurement, Analysis and Assurance
  5. Continuous improvement.
38
Q

Who was responsible for developing ICH Q10?

A

International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.
Oh, and the FDA.

39
Q

What part of PQS is GMP?

A

The part which ensures products are consistently produced and controlled to the quality standards appropriate for their intended use and the product specifications.
Production and Quality Control.

40
Q

What complementary systems to GMP are there?

A

ISO 9000

ICH Q10

41
Q

What is ‘Quality Control’ in relation to GMP?

A

It is the part of GMP that is concerned with:
Sampling
Specifications
Testing
Oganisation, documentation and release procedures.

42
Q

What does Quality Control ensure?

A

That the necessary and relevant tests are actually carried out and that materials are not released for sale or supply until their quality has been judged to be satisfactory.

43
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.

44
Q

How is it possible to measure PQS?

A 
KPIs: Key Performance Indicators. 
Statistical Process Control
Trends
People Surveys
Deviations
Opinions
Audits 
Customer Feedback.

Decision making and event reactions should be based on fact.

45
Q

How can the ‘Cost of Quality’ limit a PQS?

A

If the system is too complex it will not be appropriate for a small organisation.

46
Q

How can documentation limit the effectiveness of a PQS?

A

If there is too much of it.

Do not over-complicate with too many SOPs, records etc.

47
Q

How does a PQS compare with GMP?

A

ISO is voluntary.
GMP is mandatory.

GMP is not a system in it’s own right, it lists mandatory guidelines intended to ensure product quality, safety and efficacy.

PQS is a management tool.
Religiously following GMP does not equate to PQS.

48
Q

What is GDP?

A

Good distribution practice is that part of quality assurance that ensures products are consistently stored, transported and handled under suitable conditions.

49
Q

What are KPIs?

A 
KPIs: Key Performance Indicators. 
Statistical Process Control
Trends
People Surveys
Deviations
Opinions
Audits 
Customer Feedback.

Decision making and event reactions should be based on fact.

A way to measure PQS.

50
Q

What are the risks if GDP is not followed? [2]

A
  1. Inadequately controlled environments can lead to ineffective medicines, spoiled products, damaged materials and critical equipment failures.
  2. May also allow for falsified medicines to penetrate the supply chain.
51
Q

Why is keeping medicines in a bathroom cabinet a bad idea?

A
  1. Considerable temperature cycling.

2. Too much heat and humidity.

52
Q

What are the 6 main threats to quality and patient safety?

A
  1. Manufacture related.
  2. Microbiological related.
  3. Biological related.
  4. Chemical related.
  5. Temperature related.
  6. Malicious intentions`
53
Q

How can microbiological risks to patient safety be introduced during transport and storage of medicinal products?

A

Improper storage of medicines in areas of high microbiological bioburden/ high dust areas.

54
Q

What biological risks to the quality of medicines are involved in their storage and distribution?

A

Insects, rodents, ants, moths etc can damage medicines.

Can be controlled by ensuring appropriate humidity, no food sources, clean and tidy premises, use of traps.

55
Q

What is the continuum of cleanliness?

A

Incoming medicinal product containers should be cleaned prior to storage.

Progressive removal of layers of packaging from lowest classification to highest classification zones.

Discard any non-film coated cardboard.

56
Q

Why should medicinal products be stored separately from each other?

A

They can negatively influence the chemical stability of each other.

Compliance aids result in compromised drug stability and efficacy.

57
Q

How does temperature influence the quality of medicines?

A

Cold chain products need to be stored and shipped at lower than ambient temperatures to ensure their quality and efficacy.

The number of temperature-sensitive products continues to grow: biologics etc.

58
Q

What can happen if drugs are stored at too low temperatures?

A

If they become frozen some drugs can become toxic or lose efficacy.

Insulin, vaccines, PN, biotech meds, blood products.

59
Q

How do we know what storage temperatures should be used?

A

SmPC
PIL
Chapter 8 of Orange Guide.
Aim for 5*C

60
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.
61
Q

Why is the MHRA concerned with temperature control?

A

32% of all critical and major deficiencies seen by GDP inspectors relate to the control and monitoring of storage and distribution temps.

62
Q

What problems can arise when attempting to use temperature mapping?

A
  1. The location of the probe/data logger.
63
Q

What are the problems commonly associated with the use of fridges to store medicines?

A
  1. Condensation leads to mould.
  2. Bottom shelf is not a shelf, is needed for air recirculation.
  3. Leaky seals can occur leading to inability of vacuum formation and entering of moisture into the fridge.
  4. Overwork to compensate can lead to mechanical failure.
64
Q

Cold chain transport issues were covered in what?

A

GDP guidelines 2012.

65
Q

What matters need to be considered regarding cold chain transport?

A
  1. The nature of the product.
  2. Labelled storage requirements/associated warnings.
  3. The sensitivity of the product to temperature extremes.
  4. Likely periods of exposure to temperatures outside the storage requirements
  5. Max + Min temperatures that may be experienced by the product.
  6. Reaction to fluctuating temperatures.
  7. Number and nature of stages in the chain.
  8. Number of drop-off points in the delivery chain.
  9. Carrier competence.

Transport arrangements from one location to another should be regarded as an extension of the storage activities.

66
Q

What is the mean kinetic temperature?

A

ICH QIA - A single derived temperature which, if maintained, over a defined period, would afford the same thermal challenge to a drug as experienced over a range of higher and lower temperatures.

Extemp (12 decks)

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