MEP: Professional and legal issues: prescription-only medicines Flashcards
1
Q
Name the 7 prescription requirements
A
- Signature of prescriber
- Address of the appropriate practitioner
- Date (must be within 6 months). For private prescriptions, the appropriate date will always be the date on which it was signed
- Particulars
- Name of the patient
- Address of the patient
- Age of the patient if under 12
2
Q
What is an advanced electronic signature?
A
An advanced electronic signature is a signature that is linked uniquely to the signatory, capable of identifying the signatory and created using means over which the signatory can maintain sole control (Regulation 219(5) Human Medicines Regulations 2012).
3
Q
What is the law around prescriptions written in welsh?
A
Medicines legislation describes the requirements which need to be on a legally valid prescription. Language is not specified. There is currently no law or act that specifies that prescriptions in Wales have to be bilingual.
If the pharmacist is not a Welsh speaker and can’t understand the prescription, the RPS advice is to put patient safety first.
4
Q
What do you do if you receive PRESCRIPTIONS FROM THE CROWN DEPENDENCIES (JERSEY,GUERNSEY
AND ISLE OF MAN)?
A
You should be satisfied that all prescription requirements (Diagram 13, section 3.3.1) are present for the prescription to be legally valid. Please note: Prescriptions for Schedule 2 and
3 CDs, the prescriber’s address must be within the UK
A report published by the GMC regulation in Crown Dependencies and other overseas territories www.gmc-uk.org advises the following: “Crown Dependencies such as the Channel Islands and Isle of Man are not part of the UK. We have nevertheless established agreements with those territories to facilitate the revalidation of doctors within their jurisdiction using local system.” Therefore, doctors from Crown Dependencies are expected to be registered with GMC.
5
Q
What are the different colour scripts and who are they for? (green)
A
Green: FP10SS GP Community Practitioner Nurse Prescriber Nurse Independent/Supplementary Prescriber Independent Prescribers Supplementary Prescribers Hospital Unit
6
Q
What are the different colour scripts and who are they for? (BLUE)
A
Instalment: GP Nurse Independent/Supplementary Prescriber Independent Prescribers Supplementary Prescribers Hospital Unit
7
Q
What are the different colour scripts and who are they for? (YELLOW)
A
Dentist
8
Q
What are the different colour scripts and who are they for? (Lilac)
A
Community Practitioner Nurse Prescriber
Nurse Independent/Supplementary Prescriber
Out of Hours (OOH) Centre prescribers
9
Q
What are the different colour scripts and who are they for? (White)
A
CD requisition form
10
Q
What are the different colour scripts and who are they for? (Pink)
A
Prescribers of Schedule 2 and 3 controlled drugs prescribed in the private sector where prescriptions are dispensed by community pharmacy
11
Q
What are ‘repeatable prescriptions’?
A
Repeatable prescriptions are private prescriptions which contain a direction that they can be dispensed more than once e.g. “repeat x 5”.
12
Q
What to do if no number stated on a repeatable prescription?
A
If a number is not stated, they can only be repeated once (dispensed twice) unless the prescription is for an oral contraceptive in which case it can be repeated five times (dispensed six times in total)
13
Q
Are prescriptions for CD SCH 2 + 3 repeatable?
A
Prescriptions for Schedule 2 and 3 CDs are not repeatable; however, those for Schedule 4 and 5 are repeatable
14
Q
How long do you have to make first dispensing of repeatable script?
A
The first dispensing must be made within six months of the appropriate date, following which there is no legal time limit for the remaining repeats
While there is no time limit for remaining repeats, pharmacists should use professional judgement, taking into consideration clinical factors,
to determine whether further repeat dispensing is appropriate
15
Q
If the prescription is for a Schedule 4 CD, the first dispensing must be made within ___ days
A
28 (of the appropriate date, following which there is no time limit for remaining repeats)
16
Q
Can repeatable prescriptions be dispensed from different pharmacies?
A
The patient can choose to have repeats dispensed from different pharmacies and can retain the prescription. To maintain an audit trail mark on the prescription the name and address of the pharmacy from where supply has been made and the date of supply.
17
Q
Are FP10 forms used for Prisons and other residential custodial secure environments?
A
No - a customised prescription form, generated by the clinical IT system, is used instead, however these are still considered a NHS prescription.
FP10s are available in these settings but are only used to access urgent medicines (e.g. out of hours) or are supplied to a released person to access medicines that couldn’t be supplied to them
on release. Therefore the NHS repeat dispensing scheme using FP10s or EPS cannot be used.
18
Q
The word ‘repeat’ is also used in various contexts in relation to prescribing and dispensing: Aside from repeatable, what else is there?
A
Repeat slips
- These are not prescriptions, themselves, but a list of medications which patients can use to reorder their regular medication.
Instalment prescriptions
- These provide for a single prescription for
a CD to be dispensed in several instalments
NHS repeat dispensing service
- Where the prescriber authorises a prescription with a specified number of ‘batch’ issues that may be dispensed at specified intervals from a pharmacy (England and Wales only).
19
Q
Does the NHS repeat dispensing service apply to Scotland?
A
(England and Wales only).
20
Q
What is the validity of an owing for POMs and CDs Schedule 5?
A
Six months from the appropriate date
21
Q
What is the validity of an owing for P and General Sale Medicines?
A
Six months from the appropriate date
22
Q
What is the validity of an owing for schedule 2, 3 and 4 CD’s
A
28 days after the appropriate date
23
Q
How long should a private prescription for a POM be retained for and what register would they go in?
A
Private prescriptions for a POM must be retained for two years from the date of the sale or supply (or for repeatable prescriptions from the date of the last sale or supply)
Records must be made in the POM register (written or electronically), which should be retained for two years from the date of the last entry in the register.
24
Q
What must the POM record include?
A
• Supply date
The date on which the medicine was sold or supplied
• Prescription date
The date on the prescription
• Medicine details
The name, quantity, formulation and strength of medicine supplied (where not apparent from the name)
• Prescriber details
The name and address of the practitioner
• Patient details
The name and address of the patient.
25
When must the record for a POM be made?
The record should be made on the day the sale or supply takes place or if that is not practical, on the next day following.
26
Are records for oral contraceptives necessary?
Prescriptions for oral contraceptives are exempt from record keeping
27
If a CD entry for a schedule 2 CD has been made, does it need to go in the POM register?
No
28
Are strength, form, quantity and dose legal requirements for POM prescriptions?
NO
29
PRESCRIPTIONS FOR DISCHARGED PRISONERS: What details would go on an FP10? (note, FP10's are only used in special circumstances)
These FP10 forms have the name and address of the prison printed on them and the patient is exempt from payment by virtue of having HMP in the address.
30
When prescribing on an NHS dental prescription, dentists are restricted to the medicines listed in the Dental Prescribers’ Formulary. True or false?
True
31
Is a faxed prescription legally valid?
A fax of a prescription does not fall within the definition of a legally valid prescription within human medicines legislation because it is not written in indelible ink and has not been signed in ink by an appropriate practitioner.
32
Supplying medicines against a fax is associated with considerable risks:
1) Uncertainty that the supply has been made in accordance with a legally valid prescription
2) Risks of poor reproduction
3) Risks of non-receipt of the original prescription and therefore inability to demonstrate that a supply had been made in accordance with a prescription
4) Risks that the original prescription is subsequently amended by the prescriber in which case the supply would not have been made in accordance with the prescription
5) Risks the fax is sent to multiple pharmacies and duplicate supplies are made.
6) Risks that the prescription is not genuine
7) Risks that the system of sending and receiving of the fax is not secure
33
What must you do if you decide to dispense a faxed prescription?
Pharmacists considering supplying medicines against a fax should make an informed decision and take steps to safeguard patient safety, and where possible mitigate the risks identified above.
Where appropriate, you should consider making a record of the decision-making process and your reasons leading to a particular course of action. The supply of Schedule 2 and 3 CDs without possession of a lawful prescription could be prosecuted as a criminal offence.
34
The following checklist may be useful to help detect fraudulent prescriptions and prompt further investigation:
* Is a large or excessive quantity prescribed and is this appropriate for the medicine and condition being treated?
* Is the prescriber known?
* Is the patient known?
* Has the title ‘Dr’ been inserted before the signature?
* Is the behaviour of the patient indicative? (e.g. nervous, agitated, aggressive, etc.)
* Is the medicine known to be commonly misused?
35
Who would you report concerns to about a forged prescription?
use your professional judgement
to assess whether or not it is a matter that requires referral to the police, NHS Counter Fraud Services (for NHS prescriptions only) or whether the matter can be resolved by discussions with the patient and prescriber.
36
PRESCRIPTIONS FROM THE EEA OR SWITZERLAND: Are they legally recognised?
Prescriptions and repeatable prescriptions issued by an approved health professional in an approved country are legally recognised in the UK. Emergency supplies for patients of these healthcare professionals are also permitted.
Approved health professionals include doctors
and dentists as well as other professions with prescribing rights i.e. chiropodists or podiatrists, nurses (including community nurses), optometrists, paramedics, pharmacists, physiotherapists and therapeutic radiographers.
37
Approved countries comprise EEA countries and Switzerland:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Republic
of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland.
38
If the prescription originates from a country
| or prescriber not on the approved list, what should you do?
If the prescription originates from a country or prescriber not on the approved list the prescription is not valid and you should use your professional judgement (e.g. refer to local GP), in finding the best way to help the patient.
39
PRESCRIPTION REQUIREMENTS
| What details are required on a prescription from an approved health professional from an approved country:
Patient details
Patient’s full first name(s), surname and date of birth
Prescriber details
Prescriber’s full first name(s), surname, professional qualifications, direct contact details including email address and telephone or fax number (with international prefix), work address (including the country they work in)
Prescribed medicine details
Name of the medicine (brand name where appropriate), pharmaceutical form, quantity, strength and dosage details
Prescriber signature
Date of issue
Prescriptions are valid for up to six months from the appropriate date (prescriptions for Schedule 4 CDs 28 days). For prescriptions from these countries the appropriate date is the date on which the prescription was signed.
Even if the prescription requirements have been written in a foreign language the prescription is still legally acceptable.
40
How do you go about confirming registration status of the approved EEA and Switzerland HCP's?
An international database of prescribers does not exist and, indeed, not all of the approved countries have a register of practitioners or online registers in English. Therefore, it may not always be possible to check the registration of approved health professionals.
Up-to-date contact details for EEA competent authorities to check registration details of doctors and dentists can be obtained from:
• Doctors --> General Medical Council (GMC) www.gmc-uk.org
• Dentists --> General Dental Council (GDC) www.gdc-uk.org
(search for ‘List of EEA competent authorities’)
You can search regulated professions and competent authorities in the approved countries on the European Commission website
41
IF YOU ARE UNABLE TO CONFIRM REGISTRATION STATUS, what do you do?
If it is not possible to confirm the registration status of the approved health professional after taking
all reasonable steps to do so, then it may still be possible to make a safe and legal supply in the interests of patient care. It would be beneficial to keep a record of the details of any interventions and steps taken. This would require checking (and being satisfied) that prescription requirements are fulfilled, questioning the patient and careful use of professional judgement.
42
What medicines aren't available to be dispensed if reed by EEA rxers?
Schedule 1, 2 and 3 CDs and medicinal products without a marketing authorisation valid in the UK are not permitted.
Consider referral to an appropriate UK-registered prescriber if such items are required.
43
Can an emergency supply be given to them? (EEA and Swiss)
Emergency supplies at the request of a patient, or at the request of an approved health professional, are legally possible. Following the usual emergency supply process
where the request originates from an approved health professional then a prescription needs to be received within 72 hours.
Schedule 1, 2 and 3 CDs (including phenobarbital) or unlicensed products cannot be supplied in
an emergency to a patient of an approved health professional.
44
Where the request originates from an approved health professional, how long must the prescription be received within
72 hours
45
What products cannot be supplied on an emergency supply?
Schedule 1, 2 and 3 CDs (including phenobarbital) or unlicensed products cannot be supplied in an emergency to a patient of an approved health professional.
46
What forms are military prescriptions dispensed on?
Military prescriptions are written on a military form FMed 296,
47
How are military prescriptions processed?
The remaining, smaller medical centres have outsourced the dispensing process to designated community pharmacies under a Ministry of Defence (MOD) contract. Community pharmacies not covered by the contract will not routinely handle military prescriptions.
Pharmacies with a dispensing contract with the MOD will usually invoice the MOD directly.
48
What to do if an FMed 296 is presented to a non-contracted pharmacy?
The prescription should be treated as
a private prescription. In these circumstances, non-contracted pharmacies are not to invoice the MOD directly but are to charge the patient
the appropriate fee. It is then up to the individual patient to recover any costs incurred from their military unit (please note: this practice should only be used in exceptional circumstances)
49
What forms are CD Sch2 + 3 written on for the military?
Prescriptions for Schedule 2 and 3 CDs should be written on pink FP10PCD forms (or equivalent in Devolved Administrations) which prescribers obtain from their regional Defence Primary Health Care headquarters supplied by NHS England and
NHS Scotland.
A Schedule 2 or 3 CD written on an MOD FMed296 form cannot be legally dispensed by community pharmacies.
50
Legal requirements for a label on a medicinal product?
- Name of the patient
• Name and address of the supplying pharmacy
- Date of dispensing
• Name of the medicine
• Directions for use
• Precautions relating to the use of the medicine.
The RPS recommends the following also appears on the dispensing label:
‘Keep out of the reach and sight of children’
‘Use this medicine only on your skin’ where applicable.
51
True or false - it is illegal to label the actual product, i.e. an inhaler?
False -Whilst it is lawful to label the outer container,
we advise that the labelling recommendations
of the National Patient Safety Agency are followed. These guidelines raise the issue that the outer container may be discarded and, therefore, the labelling information could be lost
52
Are pharmacists are able to break down bulk containers into smaller quantities more appropriate for dispensing against prescriptions which have already been received and are being dispensed
or in anticipation of these prescriptions?
YES:
53
If medicines have been BROKEN DOWN FROM BULK CONTAINERS FOR DISPENSING, what must the label contain?
For the latter case medicines must be labelled with the:
- Name of the medicine
- Quantity of the medicine in the container
- Quantitative particulars of the medicine (i.e. the ingredients)
- Handling and storage requirements where appropriate
- Expiry date
- Batch reference number (e.g. LOT number or BN).
54
Can a HCP prescribe and administer?
Where clinical circumstances make it necessary and in the interests of the patient, the same healthcare professional can be responsible for the prescribing and supply/administration
of medicines. Where this occurs, an audit trail, documents and processes are in place to limit errors.
55
Can parenteral be given in an emergency situation?
There is an exemption allowing administration for saving life in an emergency and a list of parenteral medicines authorised for this purpose can be found in Schedule 19 of The Human Medicines Regulations 2012 i.e. naloxone for overdose or adrenaline for anaphylaxis
56
What is cover administration?
‘Covert administration’ is the term used when medicines are administered in a disguised format without the knowledge or consent of the person receiving them, for example, in food or in a drink.
57
When is covert administration appropriate:
Medicines are administered covertly only to people who actively refuse their medication and who are considered to lack mental capacity in accordance with an agreed management plan.
58
Name three brands of adrenaline:
Epipen®, Emerade® and Jext®.
59
Can a pharmacist treat an anaphylactic reaction?
Yes -
If emergency situation, also, pharmacists who administer vaccines should have anaphylaxis training (and should have an anaphylaxis pack)
60
What are patient specific directions?
The Human Medicines Regulations 2012 provides a range of exemptions to the restrictions on the sale, supply and administration of medicines.
A number of these exemptions are collectively described as patient specific directions (PSDs).
it is generally accepted to mean
a written instruction from a doctor, dentist or non-medical prescriber for a medicine
to be supplied or administered to a named patient after the prescriber has assessed that patient on an individual basis.
61
There are several exemptions that allow POMs to be sold or supplied without a prescription.
Pharmacists are likely to be involved in many of these mechanisms and need to be aware of:
* Patient group directions (PGDs)
* Patient specific directions (PSDs)
* Emergency supplies
* Optometrist or podiatrist signed patient orders
* Supply of salbutamol inhalers to schools
* Supply of adrenaline autoinjectors to schools
* Supply of naloxone by individuals providing recognised drug treatment services
62
What is a PGD?
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. I.e. a vaccine?
63
Pharmacists can't supply, offer to supply and administer diamorphine or morphine under a PGD for the immediate, necessary treatment of sick or injured persons. True or false
False, they can
64
How do you label a PGD?
Prescription only medicines supplied under a PGD should be labelled in the same way as if supplied against a prescription.
65
What is an emergency supply?
In an emergency a pharmacist working in a registered pharmacy can supply POMs to a patient (humans not animals) without a prescription on the request of a 'relevant prescriber' or a patient
Each request should be considered on a case- by-case basis, using professional judgement in the best interests of the patient.
66
What prescribers can request an emergency supply?
- A doctor
• A dentist
• A supplementary prescriber
• A nurse independent prescriber
• A pharmacist independent prescriber
• A community practitioner nurse prescriber
• A physiotherapist independent prescriber
• A podiatrist independent prescriber
• A therapeutic radiographer independent prescriber
• An optometrist independent prescriber
• An EEA or Swiss health professional
(see section 3.3.5)
• A paramedic independent prescriber
Healthcare professionals from countries outside
of the EEA or Switzerland are not recognised as “relevant prescribers” in the United Kingdom.
67
EMERGENCY SUPPLY AT THE REQUEST OF A PRESCRIBER: What are the conditions
Relevant prescriber
The pharmacist is satisfied that the request is from one of the prescribers stated above
Emergency
The pharmacist is satisfied that a prescription cannot be provided immediately due to an emergency (e.g. patient cannot collect the prescription from the prescriber, the prescriber
is unable to drop off prescription at the pharmacy and patient urgently needs the medicine
Prescription within 72 hours
The prescriber agrees to provide a written prescription within 72 hours
Directions
The medicine is supplied in accordance with the direction given by the prescriber
Not for CDs, except phenobarbital
Schedule 1, 2 or 3 CDs cannot be supplied
in an emergency whether requested by UK, EEA or Swiss health professionals. Phenobarbital (also known as phenobarbitone or phenobarbitone sodium) is the exception and can be authorised by UK doctor, dentist, nurse or pharmacist independent prescriber or supplementary prescriber in an emergency for the treatment
of epilepsy.
Record kept
Labelling requirements needed
68
What needs to be recorded for an emergency supply and where?
POM register (remember three dates)
An entry must be made into the POM register on the day of the supply (or, if impractical, on the following day). The entry needs to include:
• The date the POM was supplied
• The name (including strength and form where appropriate) and quantity of medicine supplied
• The name and address of the prescriber requesting the emergency supply
• The name and address of the patient for whom the POM was required
• The date on the prescription (this can be added to the entry when the prescription is received by the pharmacy)
• The date on which the prescription is received (this should be added to the entry when the prescription is received in the pharmacy)
69
The conditions for an emergency supply at the request of a patient are:
1) Interview
2) Immediate need
3) Previous treatment - The POM requested must previously have been used as a treatment and prescribed by a UK, EEA or Swiss health professional listed above.
4) Dose --> The pharmacist must be satisfied of knowing the dose that the patient needs to take
5) Not for CDs 2 + 3, except phenobarbital - for purpose of epilepsy
6) Length of treatment
7) Record kept
8) Labelling - n addition to standard labelling requirements, the words ‘Emergency supply’ need to be added to the dispensing label.
70
What needs to go on the record for an emergency supply at request of patient and where is it to be recorded?
An entry must be made in the POM register on the day of the supply (or, if impractical, on the following day). The entry needs to include:
- The date the POM was supplied
- The name (including strength and form where appropriate) and quantity of medicine supplied
- The name and 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 and why a prescription cannot be obtained, etc.
71
How much supply do you give to a patient who has requested an emergency supply?
- If the emergency supply is for a CD (i.e. phenobarbital or Schedule 4 or 5 CD), the maximum quantity that can be supplied is for five days’ treatment.
- For any other POM, no more than 30 days can be supplied except in the following circumstances:
--> if the POM is insulin, an ointment, a cream, or an inhaler for asthma (i.e. the packs cannot be broken), the smallest pack available in the pharmacy should be supplied
--> If the POM is an oral contraceptive,
a full treatment cycle should be supplied
If the POM is an antibiotic in liquid form for oral administration, the smallest quantity that will provide a full course of treatment should be supplied.
72
Can pharmacists working in a registered pharmacy supply certain POMs directly to patients in accordance with a signed order from ANY registererd optometrist or podiatrist?
Yes
The medicine requested must be one which
can be legally sold or supplied by the optometrist or podiatrist rather than one which they can
only administer.
73
Does the signed order have the same legal requirements as a POM?
The signed patient order is not a prescription; therefore the usual prescription requirements would not be needed.
However, you should be satisfied the optometrist or the podiatrist has provided sufficient advice to enable the patient to use the medicine safely and effectively.
74
Do labelling requirements apply to signed orders?
Yes: If the supply is made, the pharmacist should ensure that the medicine is labelled accordingly as a dispensed medicinal product (see section 3.3.7), a patient information leaflet is supplied to the patient and an appropriate record is made in the POM register.
75
How are medicines given to schools?
Schools can obtain supplies of adrenaline auto- injectors (AAIs) and/or salbutamol inhalers from a pharmacy on a signed order. These can then be administered in an emergency, by persons trained to administer them, to pupils previously prescribed such medication and where parental consent has been received.
76
What should be included on the signed order for a school?
The signed order should contain:
• Name of the school
• Product details (including spacer if relevant)
• Strength (if relevant)
• Purpose for which the product is required
• Total quantity required
• Signature of the principal or head teacher
Ideally, appropriately headed paper should be used; however, this is
77
How much adrenaline/salbutamol be order for a school?
The number that can be obtained by individual schools is not specified in legislation.
Schools can purchase salbutamol inhalers and/or AAIs from pharmacies provided it is for small quantities, on an occasional basis and not for profit.
78
What records need to be kept in the pharmacy for signed orders?
The signed order needs to be retained for two years from the date of supply or an entry made into the POM register.
Even when the signed order is retained, it is good practice to make a record in POM register for audit purposes.
79
In line with normal record keeping requirement an entry in the POM register for a signed order would include:
- 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 to whom the medicine was supplied
• Purpose for which it was sold or supplied.
80
Can naloxone be obtained by a wholesaler?
Following legislative changes in October 2015, naloxone falls into a unique category. Naloxone remains a POM but the Human Medicines (Amendment) (No.3) Regulations 2015 allow staff engaged or employed in “lawful drug treatment services” to obtain naloxone from a wholesaler and make direct supplies to patients without a prescription, patient group direction (PGD) or patient specific direction (PSD)
81
Who can administer naloxone?
Anyone can administer naloxone for the purpose of saving a life (Schedule 19 of the Human Medicines Regulations 2012) and there is evidence for the effectiveness of training family members or peers in how to administer the drug. The 2015 amendments widen the groups of people who are eligible to receive supplies of naloxone. This has been extended to cover people likely to witness an overdose and includes family members, peers and staff in regular contact with drug users where naloxone may be required for example.
82
Name some drugs that can cause faecal malformations:
Certain medicines, e.g. oral retinoids, valproate, thalidomide, lenalidomide and pomalidomide,
83
What is the pregnancy prevention programme:
Pregnancy Prevention Programmes (PPP) protect females of childbearing potential by minimising the risk of becoming pregnant while taking these medicines.
84
SPECIAL DISTRIBUTION CONTROLS FOR FEMALES AT RISK OF PREGNANCY
1) Prescription Validity --> Under the PPP, prescriptions are valid only
for seven days and ideally should be
dispensed on the date the prescription is written.
2) Quantity
Check that the quantity is for a maximum
of 30 days’ supply. A quantity for more than 30 days can only be dispensed if the patient is confirmed by the prescriber as not being under the PPP.
85
What is a biologic?
A biologic is a medicine made from a variety
of natural sources that may be human, animal
or microorganism in origin. Examples of a biologic include vaccines, blood and blood products, somatic cells, DNA, human cells and tissues
and therapeutic proteins. In general, the first
or original biologic on the market is termed the originator or reference product.
86
WHAT IS A BIOSIMILAR?
A biosimilar is a biologic medicine that is similar
to an already licensed biologic medicine in terms of quality, safety and efficacy. A biosimilar is specifically developed and licensed to treat the same disease(s) as the original innovator product.
A biosimilar can only be marketed after the patent protecting the originator product and any
period of marketing exclusivity have expired.
87
WHY IS A BIOSIMILAR MEDICINE NOT A GENERIC MEDICINE?
Due to the complexity of structure and greater molecule size of biologics as well as their inherent heterogeneity resulting from their production methods, it is not possible to make an identical copy of the originator biologic. Biosimilars are licensed for use based on extensive data on quality, safety and efficacy compared to the originator product. It is not possible to characterise a biologic to the same extent as a small molecule drug, where an identical copy can be produced, known as a generic medicine.
88
IS IT POSSIBLE TO SWITCH
| BETWEEN AN ORIGINATOR BIOLOGIC AND A BIOSIMILAR?
Any decision to change the brand of a biologic used to treat a patient must only be made by
a prescriber following discussions with the patient. It is recommended that, at the point of dispensing, the pharmacist confirms the patient has received the biologic they expect and that they are aware of how to store and use the medicine.
89
HOW WILL A BIOSIMILAR
| BE PRESCRIBED?
In contrast to generic products, all biosimilars will have their own unique brand name.
The MHRA has recommended that all biologics should be prescribed by brand to avoid automatic substitution.
90
HOW ARE ADVERSE DRUG REACTIONS TO BIOSIMILARS REPORTED?
It is important that both the brand name and batch number of a biologic medicine are provided when reporting suspected adverse drug reactions to biologics to facilitate effective safety monitoring.
To support patient safety, pharmacists should consider it good practice to record the brand name and batch number of any biologic medicine (including biosimilars) supplied to a patient.
91
What are ATMP's?
An advanced therapy medicinal product (ATMP)
is a biological medicinal product based on genes, tissues or cells which is either:
- a gene therapy medicinal product
- a somatic cell therapy medicinal product, or
- a tissue engineered product
92
Can vets authorise emergency supply:
No - human only
93
Can nurses/midwife independent prescribers prescribe unlicensed/ or off label medicines?
Yes as can vets, doctors, dentists and doctors
94
Can optometrist independent prescribers prescribe unlicensed/ or off label medicines?
Only off label and can authorise an emergency supply
95
Can the same person prescribe and dispense:
The initial prescribing, and supply of medicines prescribed, should normally remain separate functions performed by separate healthcare professionals in order to protect patient safety.
Where exceptionally it is in the interests of the patient for the same pharmacist prescriber to
be responsible for prescribing, clinical check and supply of medicines on the same occasion, it would be good practice to: ensure processes are in place to limit errors (i.e. taking a break or implementing additional checks), maintain an audit trail, and to document reasons.
96
DISPENSING SELF-PRESCRIBED PRESCRIPTIONS AND PRESCRIPTIONS FOR
CLOSE FRIENDS AND FAMILY - is it allowed
Pharmacists are occasionally requested to dispense medicines that have been self-prescribed by a prescriber or have been prescribed for close family and friends of the prescriber.
Although a prescription (including one for CDs) in these circumstances may fulfil the usual legal requirements, pharmacists should consider
the following before making a supply:
--> It is generally considered poor practice to self- prescribe or to prescribe for persons for whom there is a close personal relationship
--> In an emergency, after exercising professional judgement, a pharmacist may decide that it is appropriate to dispense a medicine that has been self-prescribed or prescribed for persons with whom the prescriber has a close personal relationship.
97
WHOLESALER LICENCE REQUIREMENTS
| Anyone trading medicines, other than to a patient, is required to:
* Hold a wholesaler licence – also known as a wholesale distribution authorisation (WDA)
* Comply with the Good Distribution Practice (GDP) standards, and pass regular GDP inspections
* Have a suitable experienced ‘Responsible Person’ named on the licence to ensure that medicines are procured, stored and distributed appropriately.
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What are WDA's?
Wholesale distribution authorisations (WDA) are specific to human medicines WDA(H) or veterinary medicines WDA(V) (see section 3.5.5. for further information on veterinary medicines wholesaling).
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WDA exemptions?
Pharmacies supplying stock to another pharmacy within the same legal entity are not required to have a WDA.
Where however, a legal entity does hold a WDA,
the pharmacy supplying the medicines for the purposes of wholesaling must be named on the WDA.
Additionally, registered pharmacies and hospitals supplying small quantities of medicines to healthcare professionals for treatment or onward supply to their patients, or to other community pharmacies or hospitals to meet a patient’s individual needs are not required to hold a wholesale distribution authorisation provided:
- The transaction takes place on an occasional basis
- The quantity of medicines supplied is small
- The supply is made on a not for profit basis
- The supply is not for onward wholesale distribution.
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What advice did the MHRA and Home office advise on wholesaling of controlled drugs.
The Home Office and MHRA have advised that
if a WDA(H) is required, this also means that,
if supplies include CDs in Schedules 2 to 5 to the Misuse of Drugs Regulations 2001, then it is likely that a corresponding Home Office CD licence
is also needed by the pharmacy.
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Does a signed order need a record?
When a POM is supplied from a registered pharmacy to healthcare professionals or organisations, an entry needs to be made in the POM register or the signed order/invoice needs to be retained for two years from the date of supply. Even where the signed order/invoice is retained, it is good practice to make a record in the POM register for audit purposes.
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An entry in the POM register must include:
- Date the POM was supplied
- Name, quantity and, where it is not apparent, formulation and strength of the POM supplied
- Name and address, trade, business or profession of the person to whom the medicine was supplied
- Purpose for which it was sold or supplied.
Legislation does not specify the details that need to be included on a signed order although local standard operating procedures (e.g. local NHS Trust policies or company SOPs) may require templates to be used. It would be advisable
for the details required for a POM register entry (i.e. the list above) to be requested as a minimum for a signed order as this information would
be required to complete the POM register.
