Pharmacy Law 4

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  • Created by: LBCW0502
  • Created on: 18-10-17 20:48
Describe the Harold Shipman case
GP used diamorphine to kill over at least 200 patients, sentenced to prison, committed suicide in prison in January 2004
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What happened to the pharmacist?
Charmed by GP, lost all professional objectivity, gave GP drugs without checking strength/frequency/dose
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What did the regulator say? (3)
Credited for record keeping retained long after law required, much of what the police uncovered about GP would have been lost forever and the case was dimissed
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What did the pharmacist do wrong? (2)
Failed to notice unusual prescription patterns, failed to check whether an unnecessary/excessive dose was being prescribed while repeatedly dispensing the dose
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What was the response to the Shipman Inquiry? (3)
Government sponsored, 6 reports July 2002-January 2005, 4th report published in July 2004 recommended changes (procurement, storage, supply of CDs)
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What was were the changes made after the Shipman Inquiry? (3)
Changes to Misuse of Drugs Regulations enacted in Health Act 2006 (changes in March 2006, came into effect in March 2007), not everything 'legally enforceable' but recommended as 'best practice'. Root of changes of professional regulation
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What were the outcomes? (5)
Drugs inspectorate to monitor/audit how GPs/pharmacists prescribe/store CDs, special prescriptions, require identity for collection, rules for disposal, criminal offence to prescribe for own use
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What is the audit trail? (6)
Manufacturer, wholesaler, pharmacy, other practitioners authorised to possess, patient (and potentially carer), 'destruction' (tighter record keeping)
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What are the requirements who record keeping (collection)? (5)
Identity of person collecting, record of who collected (patient/representative/health professional), details of healthcare professional (name/address), proof of identity (requested/provided), register of balance (good practice/not legal requirement)
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What does the Misuse of Drugs Act 1971 control?
Sale/supply/possession of CDs, these substances are liable to misuse (dangerous/harmful)
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What does the Misuse of Drugs Act 1971 prohibit? (4)
Possession, supply, manufacture, import/export (except as allowed by Licence/Regulations from Secretary of State - Home Office). Act also intended to deal with treatment and control of those with a substance misuse problem
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When is the act not unlawful? (Misuse of Drugs Act 1971)
The Act specifies that can action can be taken by an individual in regards of a CD
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Do many of the classes of the Act have no practical importance to pharmacists and other practitioners?
Yes (lots of amendments over the year as evidence gathered over potential for misuse)
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What are the classes of drugs (A, B, C) based on?
Based on decreasing order of harmfulness (solely for determining penalties for offences under the Act)
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Give examples of Class A drugs (4)
Heroin, cocaine, ecstasy and LSD
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What are the consequences of possessing Class A drugs?
Found guilty in the court of law, go to prison for up to 7 years and fined
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What is the consequence of selling Class A drugs?
Life imprisonment
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Give examples of Class B drugs (4)
Amphetamines, speed, barbiturates and cannabis
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What are the consequences of possessing Class B drugs?
Found guilty, go to prison up to five years and fined
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What is the consequence of trafficking a Class B drug?
Sent to prison for up to 14 years
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Give examples of Class C drugs (3)
Tranquilisers, diazepam and anabolic steroids
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Is it illegal to have, give away or deal in Class C drugs?
Yes
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What are the consequences of being in possession of Class C drugs?
Maximum penalties are two years in prison and an unlimited fine
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What are the consequences of dealing or suppling Class C drugs?
14 years in prison and an unlimited fine
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What does Schedule 1 state?
CD Licence, drugs with virtually no current therapeutic use, licensed solely for research purposes. Home Office Licence required for: supply, prescribing and possession
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What does Schedule 2 state?
CD POM, includes opiates (e.g. diamorphine), major stimulants (e.g. amphetamines) and other POMs with special requirements for: prescription, recording and storage
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Are there prescription requirements for drugs under Schedule 2?
Yes
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What is a validity of a prescription for a drug under Schedule 2?
28 days
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Is the UK prescriber address required on a prescription for a drug under Schedule 2?
Yes
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Are there repeats for a prescription for a drug under Schedule 2?
No
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Is there an emergency supply for a prescription for a drug under Schedule 2?
No
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Are the requisitions for supply of a prescription for a drug under Schedule 2?
No
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Is there an invoice retention for 2 years for a prescription for a drug under Schedule 2?
No
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Is there safe custody for a drug under Schedule 2?
Yes
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Is there a licence required for import/export of a drug under Schedule 2?
Yes
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What does Schedule 3 state?
CD no register POM, minor stimulants, buprenorphine, some benzodiazepines (midazolam, tempazepam), phenobarbitone (some subject to safe custody, others are not)
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What are the summary requirements for Schedule 3? (9)
Prescription required (except temazepam), valid for 28 days, UK prescriber address, no repeats, no emergency supply (except phenobarbitone for epilepsy), requisitions for supply, invoice retention for 2 years, safe custody, licence to import/export
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What does Schedule 4 part 1 state?
CD Benz POM, all the benzodiazepines (except for those in higher schedules)
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What does Schedule 4 part 2 state?
CD Anab POM, anabolic steroids, androgenic steroids, clenbuterol (adrenoceptor stimulant), growth hormones
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What are the summary requirements for Schedule 4? (9)
No prescription required , valid for 28 days, UK prescriber address, repeats, emergency supply, no requisitions for supply, no invoice retention for 2 years, no safe custody, licence to import/export
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It is unlawful for any person to be in possession of Schedule 2, 3 and 4 unless what? (4)
Holds appropriate Home Office licence. Person is member of class specified in regulation (provided person is acting in capacity of a member of class). Regulations specify possession is not lawful. Lawfully prescribed for that person (or their animal)
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Who has general authority to procure, possess and supply CDs (except those in Schedule 1)?
Practitioners and pharmacists
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Who must obtain a licence from Home Office to have general authority to procure, possess and supply CDs?
Wholesalers, importers and exporters
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Secretary of State can make a direction against a practitioner in relation to what? (6)
Possession, prescribing, administering, manufacturing, compounding and supplying
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What does safe custody apply to?
Applies to all in Schedules 1 and 2 (except quinalbarbitone) and most of 3. Locked safe, cabinet/room (Safe Custody Regulations 1973)
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What happens where specifications are not met but conditions still meet security requirements?
Able to seek certification from police (includes patient-returned and expired CDs where patient-returned CDs must be separate and clearly marked)
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The requisition for Schedules 1, 2 and 3 include which details (5)
Signed by recipient, state recipient's name/address, state recipient's profession/occupation, specify total quantity, specify purpose for which it is required
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Requisition must be obtained prior to supply to who? (9)
Practitioners, hospitals, care homes, ship/offshore installation personnel, supplementary prescribers, senior registered nurses in charge of wards, theatres, other hospital departments
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In an emergency, there can be a supply without requisition to who?
Practitioners - requisition must be provided within 24 hours
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Which recipients are not included in this legal requirement?
Registered pharmacies - but as a matter a good practice a standardised requisition form should always be used
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What are the details for standardised forms involving supply? (3)
No legal requirement to use but seen as good practice, lawful for community pharmacies to supply against non-standardised requisitions, community pharmacy to community pharmacy should obtain standardised form
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What must a pharmacist do with the standardised form? (3)
Mark with supplier's name and address, retain a copy for 2 years and send original to relevant NHS agency
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What happens during collection? (3)
Messenger sent by purchaser must produce written statement that authorises this, supplied must be reasonably satisfied that it is genuine and statement has to be kept for 2 years (not applicable to carrier engaged by supplier)
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What happens during collection in hospitals? (5)
Very different, ward requisitions exist, written directions rather than prescriptions, where supply to patient then prescription requirements apply, don't have to send to any NHS agency
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Which organisations are in charge of regulation? (3)
Home Office, GPhC/PSNI for registered pharmacies and Care Quality Commission (CQC) through 'accountable officer'
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Other cards in this set

Card 2

Front

What happened to the pharmacist?

Back

Charmed by GP, lost all professional objectivity, gave GP drugs without checking strength/frequency/dose

Card 3

Front

What did the regulator say? (3)

Back

Preview of the front of card 3

Card 4

Front

What did the pharmacist do wrong? (2)

Back

Preview of the front of card 4

Card 5

Front

What was the response to the Shipman Inquiry? (3)

Back

Preview of the front of card 5
View more cards

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