MEP CHAPTER 3 Flashcards

1
Q

What license is needed to administered or prescribe a sch 1 CD?

A

Home office licence

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2
Q

Schedule 2, 3 or 4 CDs can be administered to a patient by who?

A

doctor, dentist, pharmacist IP or nurse independent prescriber.

Supplementary prescriber

Person acting in accordance with the directions of a prescriber entitled to prescribe CDs.

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3
Q

Who can prescribe cocaine, diamorphine or dipipanone for treating addiction?

A

Medical prescribers who hold a special licence from the Home Secretary or Scottish Government’s Chief Medical Officer.

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4
Q

What indication can cocaine, diamorphine or dipipanone be given for using special license?

A

Addiction

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5
Q

Who CANNOT prescribe ocaine, diamorphine or dipipanone for addiction but only for treating organic disease/injury?

A

Pharmacist IP, nurse IP + supplementary prescribers

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6
Q

When is a license NOT needed for import/exporting Schedule 4 (Part II) CDs?

A

If for self-administration

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7
Q

What sch drugs is a licence needed to import or export it?

A

Schedule 1, 2, 3 and 4 (Part I) CDs

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8
Q

Are there any restrictions on the import or export of Schedule 5 CDs ?

A

NO

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9
Q

Who is regulatory body for import/exporting CDs?

A

Home office

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10
Q

What is recommended to carry if patient travelling with CD?

A

Covering letter signed by the prescriber is obtained that confirms the name of the patient, travel plans, name of the prescribed CDs, total quantities and dose.

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11
Q

When is a personal licence is not required by the Home Office when travelling with CDs?

A

IF a person travelling is carrying LESS than 3 months’ supply.

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12
Q

What 5 things should be included in covering letter for patient to carry when travelling with CDs?

A

Name of patient

Travel plans

Name of CDs

Qty + dose

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13
Q

Who should patients check with before travelling with CDs?

A

Embassies or high commissions for the countries they will be travelling through to ensure that the import export regulations in those countries are complied with.

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14
Q

The CD requisition forms apply to both — + —-?

A

Humans + animals

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15
Q

What act made CD requisition forms mandatory?

A

Misuse of Drugs Regulations 2001

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16
Q

What 2 schedule drugs are CD requisition forms needed for in community?

A

Schedule 2 and 3

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17
Q

What 2 places are exempt from using CD requisition forms?

A

Hospices + prisons are exempt.

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18
Q

What are the 6 requirements for a CD REQUISITION?

A

1 Signature of the recipient
2 Name of the recipient
3 Address of the recipient
4 Profession or occupation
5 Total quantity of drug
6 Purpose of the requisition

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19
Q

Why is CD requisition form manadatory?

A

Shipman Inquiry recommendation aimed at ensuring the purchase of all stocks of Sch 2 + 3 CDs are monitored in community.

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20
Q

If CD received by hospital pharmacy, and request is on behalf of ward/dept NOT in same entity is a CD req form needed?

A

Yes

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21
Q

what is CD requisition form used in prisons in england?

A

hospital-style requisition forms usually used

Are printed in a bound, book format

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22
Q

What type of CD requisition is used in Scotland prisons?

A

approved internal ordering form from the supplying pharmacy is used.

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23
Q

Are supplied made using faxed or photocopied requisition acceptable?

A

NO

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24
Q

What 3 CDs can midwife order using supply order?

A

Diamorphine

morphine

pethidine

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25
Q

What should midwife supply order contain?

A

Name of the midwife

Occupation of the midwife

Name of the person to whom the CD is to be administered or supplied

Purpose for which the CD is required

Total quantity of the drug to be
obtained

Signature of an appropriate medical officer

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26
Q

How long should requisitions be held onto for good practice?

A

2 years

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27
Q

When a requisition for a Schedule 1, 2 or 3 CD is received, it is a legal requirement to:? (2 things)

A
  1. Mark the requisition indelibly with the supplier’s name and address, where stamp is clear

2.Send the original requisition to the relevant NHS agency.

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28
Q

When does CD requsiition processing NOT apply?

A

By a person responsible for the dispensing + supply of medicines at a hospital, care home, hospice, prison or organisation providing ambulance services who must mark + retain the original requisition for two years

By pharmaceutical manufacturers or wholesalers

Against Vet requisitions

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29
Q

How long should vet requisition be retained for?

A

5 years

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30
Q

What CD schedule can a pharmist NEVER requisition?

A

CD 1

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31
Q

In an emergency, can a doctor/ dentist can be supplied with Sch 2/3 pending CD requisition form within 24 hrs?

A

yes

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32
Q

What are the 3 classes of medicinal products under human meds regulations 2012?

A

GSL

Pharmacy P meds

POM

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33
Q

Within a pharmacy when can GSLs be sold?

A

Only when pharmacist assumes role of RP - but can be gone for limited amount of time.

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34
Q

What is GSL?

A

Meds available self selection in registered pharmacies

Also sold in retail outlets

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35
Q

What is a P med? (OTC)

A

Pharmacy med- sold from registered pharmacy by pharmacist/ person acting under supervision of pharmacist

Not access via self-selection

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36
Q

What is POM?

A

Prescription meds written by docs, dentist, IP, EEA/swiss HCP, IP opto, paramedic, radiographer IP

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37
Q

What 2 types of drugs can optometrist IPs not give?

A

CDs

Parenteral medicines

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38
Q

What can pseudoephedrine be used to make?

A

Crystal Meth

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39
Q

What is max supply of Pseudoephedrine or Ephedrine without RX?

A

720mg Pseudoephedrine OR 180mg Ephedrine at any 1 time

Cannot sell BOTH at one time

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40
Q

Can you sell Pseudoephedrine and Ephedrine?

A

NO only 1

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41
Q

List signs of possible Pseudoephedrine or Ephedrine missues?

A

Lack of symtpoms of cold/flu

Rehersed answers

aggressive

opportunistic

specific products

quantities

frequent

Buys other - lithium + acetone

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42
Q

Where to report suspicion if someone buying Pseudoephedrine or Ephedrine for bad reasons?

A

GPHC inspector

Local CD police

Accountable officer

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43
Q

What are 3 methods of emergency contraception?

A

Copper IUD

Oral ulipristal

Oral levonorgestrel

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44
Q

Age levonorgestrel licensed?

A

16 or over

within 72 hrs of sex

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45
Q

Can Pharmacists provide an advance supply of oral emergency contraception?

A

YES- if patient needs

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46
Q

What to do if child under 13 requests emergency contraceptive?

A

Too young to consent- need to treat this seriously, report to social services

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47
Q

What are fraser guidelines?

A

apply specifically to advice and treatment around contraception + sexual health when speaking to a young person under 16 years old.

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48
Q

Can pharmacists provide contraceptive to person under 16?

A

Yes- if they meet fraser criteria + consent sought.

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49
Q

What is Paracetamol and aspirin OTC legal restriction?

A

No more than 100 non effervescent tabs/caps sold at ONCE.

So 96 is max

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50
Q

What is most OTC paracetamol and aspirin pack sizes?

A

16 or 32 - so max is 96 tabs sold

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51
Q

Is there legal limits of OTC effervescent paracetamol and aspirin tabs/granules or liquids?

A

NO- but use professional judgement

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52
Q

Is soluble or dispersible formulations same as effervescent?

A

No - should be regarded as non-effervescent

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53
Q

What indication is OTC codeine and dihydrocodeine used for noe?

A

Short term acute, mod pain not relieved by paracetamol, ibu or aspirin

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54
Q

Can codeine be used to treat cold, flu, cough and sore throat?

A

Not anymore- removed

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55
Q

What pack size of codeine makes it a POM?

A

More than 32

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56
Q

What are labels for codeine?

A

Can cause addiction, Only 3 days use.

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57
Q

How many packs of OTC codeine recommended to be sold?

A

1 pack

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58
Q

What are 7 legal prescription requirements?

A
  1. Prescriber sign
  2. Prescriber address
  3. date
  4. prescriber details
  5. patient name
  6. patient address
  7. age
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59
Q

When is age of patient needed?

A

If under 12

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60
Q

What is rx validity in normal prescriptions?

A

6 months

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61
Q

For NHS prescription what is validity?

A

6 months - date when rx was signed or

date indicated by prescriber as date before which it should not be dispensed

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62
Q

What is validity for private rx?

A

6 months - from date it was signed.

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63
Q

Can carbon copies be used for RX?

A

Yes as long as signed in ink

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64
Q

Do copies of RX on email or patients phone on online account count as signature?

A

No

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65
Q

Can you accept a welsh RX?

A

Put patient safety first - find best way to help patient.

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66
Q

Can prescriptions be accepted from crown dependencies?

A

Satisfied that all requirements met to be legal

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67
Q

Can CD 2 + 3 be on RX from crown dependencies?

A

prescriber address has to be within UK

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68
Q

Which type of prescription can be repeated?

A

Only private mainly

not NHS

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69
Q

If number not stated on Rx how many times can it be repeated?

A

1 TIME-

dispensed twice

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70
Q

what is max times to repeat Rx for contraceptives

A

5 times

dispense 6 times in total

71
Q

Can CD 2 and 3 be repeated?

A

No

72
Q

When can 1st dispensing for Schedule 5 CD/POM be made?

A

Within 6 months

73
Q

When should RX for CD 4 drug be dispensed first?

A

first dispensing within 28 days

74
Q

Can repeat dispensing be done with FP10 or EPS?

A

No- FP10 only for urgent medicines

75
Q

What is an instalment prescriptions?

A

Single RX for CD to be dispensed in several installments.

76
Q

What is a repeat slip ?

A

Not an RX - list of meds which patients can use to reorder their reg meds

77
Q

When is validity of owings for Schedule 2, 3 + 4 CD?

A

28 days of date

78
Q

When is validity of owings fo P and GSL?

A

6 months

79
Q

When is validity of owings fo POM + sch 5 CD?

A

6 months

80
Q

When is validity of owings for POM if on PPP?

A

owing can exceed 7 days from when RX was written only if PPP checklist followed to ensure no risk of pregnancy

81
Q

How long to keep private rx for POM?

A

2 years from supply

82
Q

Where should Private RX for schedule 2 + 3 be sent?

A

Relavent NHS agency

Make POM register + keep it.

83
Q

What should POM record include?

A

Supply date

Rx date

Med details

Rx details

Pt details

84
Q

What 2 meds exempt from record keeping?

A

Oral contraceptives

sch2 CD- different register

85
Q

What RX details not legal requirments for POM but important?

A

Name, strength, form, quantity, dose

86
Q

Are faxed RX or online copies legal?

A

No- not written in indelible ink or signed

87
Q

What are some risks of faxed/digital copies of RX?

A

Uncertainty that supply made with legal RX

risk of duplicates, fake rx, not secure source

88
Q

Where are forged rx reported for NHS prescriptios only?

A

NHS counter fraud services

Police

89
Q

Can repeat rx issued by approved HCP in approved country allowed?

A

Yes

90
Q

List some approved HCP?

A

Chiropodists, podiatrists, nurses, optom paramedics, pharmacists, physios, radio

91
Q

List some approved countries?

A

EEA countries + switzerland

92
Q

What details are needed on RX from approved HCP?

A

Patient details

Prescriber details

Prescribed medicine details

signature

Date of issue

93
Q

When is validity of schedule 4 CDs?

A

28 days after the appropriate date

e.g. if 1st Nov date then 28 day will run till 29th
so 30th Nov = NO compliant to supply.

94
Q

What should you do to confirm status of approved HCP?

A

Check their status on the register

95
Q

Are Schedule 1, 2, 3 without MA valid in Uk?

A

NO

96
Q

Can schedule 1, 2 + 3 CD including phenobarbital be supplied emergency to patient of approved health professional?

A

No, only in UK

97
Q

When should prescription be sent if emergency supply at request of prescriber?

A

72 hrs.

98
Q

What is a military RX?

A

doctor gives out dispensing function to trained person.

Smaller medical centres have community pharmacies under a MOD contract

99
Q

What form is millitary rx written?

A

FMED 296

100
Q

How is military rx treated if sent to non-contracted pharmacy?

A

As private rx - not to invoice directly but charge patient.

101
Q

What form are rx for schedule 2 + 3 CDs written on?

A

FP10PCD pink form

102
Q

Can schedule 2 + 4 drug written on MOD FMED 296 be dispensed?

A

NO

103
Q

What are legal RX of labels?

A

Patient name

Name/ address of pharmacy

date dispense

Directions

Name of med

Precautions - for external use

104
Q

What 2 extra things does RPS recommend appear on label?

A

Keep out of the reach + sight of children

Use med only on skin - if applicable

105
Q

Does the inner container need to be labelled?

A

Good practice as outside usually thrown away.

106
Q

How to label meds broken down from bulk containers for dispensing? (6)

A

Name of med

Quantity of meds in container

Ingredients of med

Handling/storage req

Expiry

Batch ref number/ lot

107
Q

How are parenteral POMS given to another person?

A

Directions of appropriate practiser except life saving

e.g. naloxone or adrenaline

108
Q

What is covert administration of meds used for?

A

people who actively refuse their medication and who are considered to lack mental capacity in accordance.

109
Q

What regulation allows adrenaline to be given to anyone to save a life?

A

regulation 238 of human meds regulations 2012

110
Q

What is a PSD?

A

written instruction from a doctor, dentist or non-medical prescriber for a Med to be given to a named patient.

111
Q

How are PSDs given?

A

Enough info needed for person to give meds safely but NOT LAW/

Directions on pt chart copied onto discharge.

112
Q

What are some exemptions that allow POMS to be sold without rx?

A

PGD

PSD

Emergency supply

Opto/podiatrist signed orders

Salbutamol+ Epipens to schools

Naloxone

113
Q

What is a PGD?

A

A PGD is a written direction that allows the supply and/or administration of a specified medicine or medicines, by named authorised health professionals, to a well-defined group of patients requiring treatment for a specific condition.

114
Q

Can morphine/ diamorphine be supplied in PGD?

A

can supply, offer to supply and administer diamorphine or morphine under a PGD for the immediate, necessary treatment of sick people

115
Q

Do PGDs need labels?

A

Only POMS supplied do.

116
Q

What 4 criteria to meet to do emergency supply at request of prescriber?

A

Relevant prescriber

emergency

RX given within 72 hrs

Directions

NO CDS EXCEPT PHENOBARBITAL IN uk

117
Q

When can phenobarbital be given as emergency supply?

A

Only by UK doc, dentist, nurse, pharm for epilepsy treatment.

118
Q

Can CD 1, 2 3 be supplied as emergency?

A

No - except phenobarbital by UK HCP

119
Q

When is POM register made for emergency supply?

A

On day of supply or following day

120
Q

What does POM reg need to include? (6)

A

The date POM supplied

The name (including strength and form where appropriate) and quantity of medicine supplied

The name + address of the prescriber requesting the emergency supply

The name + address of the patient for whom the POM was required.

The date on RX (this can be added to the entry when the prescription is received by the pharmacy).

The date on which the prescription is received (added to the entry when RX is received in the pharmacy)

121
Q

What 5 conditions for emergency supply at request of Patient?

A

Interview

previous treatment

immediate need

Dose

Not CDS, except phenobarbital

122
Q

Can an EEA/swiss patient make requisitions?

A

Cannot be given if NO MA valid in UK

123
Q

What is maximum quantity of CD in emergency supply?

A

Max 5 days

124
Q

What is max supply for emergency supply POM?

A

no more than 30 days supplied unless if insulin/oiment/cream or inhaler.

125
Q

What to do if emergency supply product is insulin, ointment, cream or inhaler, contraceptive, antibiotic

A

Give smallest pack size available and a full treatment cycle should be given.

Smallest amount for full course.

126
Q

What is included in POM reg for emergency supply at request of patient?

A

The date the POM was supplied.

The name (including strength and form where appropriate) and quantity of medicine supplied.

The name + address of the patient for whom the POM was supplied.

Information on the nature of the emergency, such as why the patient needs the POM + why a prescription cannot be obtained, etc.

127
Q

What should be on label for emergency supply?

A

Words ‘emergency supply’ need to be added.

128
Q

What is the community pharmacy consultation service?

A

Enables 111, 999 to refer patients to pharmacy for emergency meds

129
Q

Can pharmacists supply certain meds with signed patient order from registered optom/podiatrist?

A

Yes- but should be one legally sold/supplied by them rather then one they can only administer.

130
Q

Are usual RX requirements needed for signed patient order?

A

No because not a prescription

131
Q

What 2 medications can schools obtain on signed order?

A

Adrenaline auto-injectors

Salbutamol inhalers

132
Q

What 6 pieces of info included in signed order?

A

Name of school

Product details

Strength

purpose

total qty

signature of head teacher

133
Q

What should be used to write signed order ideally?

A

Headed paper

134
Q

Schools can buy salbutamol inhalers + adrenaline provided it meets 3 criteria :

A

Small amounts

occasional basis

not for profit

135
Q

How long signed order kept?

A

2 years from supply date/POM entry

136
Q

What 4 things does POM reg
need for signed order?

A

Date the POM was supplied

Name, quantity and where it is not apparent formulation and strength of POM supplied

Name and address, trade, business or profession of the person.

Purpose for which it was sold or supplied.

137
Q

Who are oral retinoids initiated by?

A

Dermatologist, prescribing GP with derm role, specialist nurse.

138
Q

What is max supply for oral retinoinds?

A

30 day supply

Only more if confirm as not being under PPP.

139
Q

Repeat prescriptions allowed for oral retinoids?

A

NO

140
Q

When is telephone request should only be accepted for oral retinoids?

A

if an emergency supply at the request of a PPP specialist prescriber together with confirmation that pregnancy status has been established as negative within the preceding seven days

141
Q

What to do if unplanned pregnancy and taking valproate?

A

Do not stop treatment and see prescriber urgently.

142
Q

What is a biologic medicine

A

Med made from natural sources that may be human, animal or microorganism in origin. E.G.include vaccines, blood + blood products, somatic cells, DNA, human.

143
Q

WHAT IS A BIOSIMILAR?

A

Similar to an already licensed biologic medicine in terms of quality, safety and efficacy.

144
Q

When can biosimilar be marketed?

A

after patent of original expires

145
Q

How are biologics prescribed?

A

By brand

146
Q

How are SEs of biosimilars reported?

A

Brand + batch number given

record it - good practice

147
Q

What is an advanced therapy medicinal product (ATMP)?

A

biological medicinal product based on genes, tissues or cells

tissue engineered, somatic cell therapy, gene therapy medicinal product.

148
Q

Where does the prescribed need to be based if prescribing schedule 2 + 3 CD drugs?

A

adress in UK

149
Q

Can community practitioner nurse prescribe sch 2-5 CD?

A

No

150
Q

What off label med can community nurse prescriber prescribe?

A

Nystatin off label for neonates only

151
Q

Can a dentist prescribe Sch2-5?

A

Yes- home office license needed

152
Q

What is needed to prescribe cocaine, diamorphine or dipapanone for addiction?

A

Home office license

153
Q

Can dentist and doctor authorise emergency supply?

A

Yes- phenobarbital , NOT other CD 1,2 ,3

154
Q

What controlled drugs can EEA, swiss doctor prescribe?

A

Schedule 4 + 5 only

155
Q

Can EEA/swiss HCP prescribe unlicensed or offlabel?

A

Only off label meds

155
Q

What 5 CDs can paramedic IP prescribe?

A

Morphine- oral /inj

Diazepam - oral/ inj
Midazolam - oromucosal / inj

Lorazepam - inj

Codein- oral

155
Q

What 3 CDs can PHYSIO IP prescribe?

A

Oral admin- diazepam, dihydrocodeine, lorazepam, morphine, oxy, temazepam

Morphine inj

transdermal - fentanyl

155
Q

What CD can podiatrist give?

A

Oral - diaz, dihydrocodeine, lorazepam, temazepam

155
Q

Which 5 HCP are covered by exemptions as they can supply certain medicines?

A

Midwives

Opthoptist

optometrist

paramed

Podiatrist/chiropodist

155
Q

Can you prescribe for friends family?

A

Strongly recommended not to - refuse supply unless urgent.

155
Q

Min of how many people involved in dispensing process?

A

2

156
Q

What 3 things needed for trading medicines?

A

Have wholesale license - WDA

Comply with GDP standards

Need suitable RP named on licensed in order to store/distribute

157
Q

What type of meds are wholesale distribution authorisations specific to?

A

Human meds or vet meds

158
Q

In what case do pharmacies not need a WDA?

A

If pharmacy giving stock to another pharmacy in same legal entity.

But legal entity should have WDA and pharmacy supplying meds should be named on it.

159
Q

When do pharmacies/hospitals supplying small qty of meds NOT need a WDA?

A

If transaction occasional

qty is small

Supply not based on profit

Supply is not for future wholesale distribution

160
Q

If wholesaling CD schedule 2 to 5 what else is needed?

A

Home office CD license

161
Q

Who can receive meds via wholesale?

A

Doc, dentist, pharmacies, hosp, midwives, chiropodists, optometrists, paramedics, owner/ master of ship, 1st aiders, Occupational Health schemes

NHS trusts, Drug tx services

162
Q

What is needed to be done when a POM is supplied from pharmacy to a healthcare professional/organisation?

A

Entry in POM reg or Signed order/ invoice

163
Q

How long to keep POM reg/Signed order invoice?

A

2 years

164
Q

What schedule and act states which person needs a
to provide a written signed order?

A

Schedule 17 Human meds regulation 2012

If not needed- good practice to get one for audit trail.

165
Q

What 4 things should POM register have?

A
  1. Date POM given
  2. Name, qty, and formulation/ strength
  3. Name, address, trade, business or profession of person who med was given to
  4. purpose for it.
166
Q

When making supply under Wholesale Dealer’s license what should you follow?

A

Good distribution practice.

167
Q

What is serious shortage protocol (SSP)?

A

Pharmacists in England, wales + NI can make changes to RX + supply alternatives.