ADAC – Module 3: Pre-2017 Textbook

A number of changes have occurred since the publication of your Module 3 textbook. In order to ensure that your knowledge is current, please read and implement the additional text.

Module 3: Pharmacy law and ethics

A number of changes have occurred since the publication of your Module 3 textbook. In order to ensure that your knowledge is current, please read and implement the additional text below.


 

Section 1: Ethics

Your Module 3 textbook will state:

“Ethics are a written set of standards which must be followed by members of a profession.”

 

Please change this to:

“Ethics are principles or rules of behaviour based on morality, rather than law.  Most professions have their own code of ethics which members are expected to follow.”

 


 

Section 7: Advanced Services

Depending on the version of your Module 3 textbook, it will state either:

“In England, there are five advanced services”; or,

“There are currently four advanced services in England and Wales”

 

Please change this to:

“In England, there are six Advanced Services:

  1. Medicines Use Review and Prescription Intervention Service
  2. New Medicine Service
  3. Stoma Appliance Customisation
  4. Appliance Use Review
  5. Community Pharmacy Seasonal Influenza Vaccination Advanced Service
  6. NHS Urgent Medicine Supply Advanced Service

 

In Wales, there are four Advanced Services:

  1. Medicines Use Review and Prescription Intervention Service
  2. The Discharge Medicines Review Service
  3. Appliance Use Review
  4. Stoma Appliance Customisation”

 

Section 7: Advanced Services

Regarding the national target groups for MURs conducted in Wales, your Module 3 textbook may state that there are four groups. If so, please change this to five groups, and add the following group:

 

“• Patients aged 85 or over who take six or more medicines”

 

Section 7: Advanced Services

New Medicines Service (NMS)

Please add the following text:

“Only medicines used to treat four conditions/therapy areas are included in the NMS ‒ these are: asthma and COPD; type 2 diabetes; antiplatelet/anticoagulant therapy; and hypertension.”

 

Section 7: Advanced Services

Please add the following sub-heading and text:

 

NHS Urgent Medicine Supply Advanced Service

The NHS Urgent Medicine Supply Advanced Service (NUMSAS) is the sixth Advance Service in England.  It has been commissioned as a pilot scheme to run from 1 December 2016 until 31 March 2018. The aims of the service are to manage requests received by NHS 111 for urgent medicine supply, reduce demand on other parts of the urgent care system (such as A & E departments), resolve issues that lead to patients running out of medicines, and increase patient awareness of electronic repeat dispensing. It allows participating pharmacies to make emergency supplies of medicines on the NHS, rather than as private transactions.”

 

Section 7: Pharmacy Contract in Scotland

Please add the following text:

“Other national core services which pharmacies in Scotland can choose to provide include the Gluten-Free Food (GFF) service and the Stoma Service.”

 

 


 

Section 8: The Human Medicines Regulations 2012

Introduction and first activity

Your Module 3 textbook will state:

“In the Regulations the following terms are used:

  • Medicinal Product
  • Medicinal Purpose”

 

Please replace  this with:

“In the HMR 2012, ‘medicinal product’ is defined as:

“(a) any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or

(b) any substance or combination of substances that may be used by or administered to human beings with a view to ‒

(i) restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or

(ii) making a medical diagnosis”

 

Also, please ignore the activity in this section, and all instances of “Medicinal Purpose”.

 

Section 8: Part 3 of The Human Medicines Regulation 2012

Please change this heading to:

“Section 8: Parts 3 and 4 of The Human Medicines Regulation 2012 – licensing

 

In the first sentence underneath this heading, please change “Part 3 of the Regulations is concerned” to “Parts 3 and 4 of the Regulations are concerned”

 

 

Section 8: Part 5 of The Human Medicines Regulations 2012

Please change this heading to:

“Part 12 of The Human Medicines Regulations 2012 – sale and supply of medicines”

 

Section 8: Part 5 of The Human Medicines Regulations 2012

General Sales List medicines

Your Module 3 textbook will state:

Note: Certain strengths of ibuprofen can be sold as GSL if the pack size is not more than 16 tablets, capsules or sachets.”

 

Please change this to:

Note: Certain strengths of ibuprofen can be sold as GSL if the pack size is not more than 16 tablets, 16 capsules or 12 sachets.”

 

Section 8: Part 5 of The Human Medicines Regulations 2012

Prescription Only medicines

Your Module 3 textbook will state:

“are only available to the public on a prescription issued by a UK registered:

  • Doctor
  • Dentist
  • Nurse or Pharmacist Prescribers”

 

Please change this to:

“are only available to the public on a prescription issued by an ‘appropriate practitioner’, which means a UK registered:

  • Doctor
  • Dentist
  • Independent prescriber (within their area of competence) – this may include a suitably qualified pharmacist, nurse, optometrist or chiropodist (but restrictions apply)
  • Supplementary prescriber (in accordance with a clinical management plan)
  • District/community practitioner nurse, or Health visitor prescriber (restricted to the Nurse Prescriber’s Formulary)”

 

Your Module 3 textbook will then state:

“Additionally, a prescription issued by an European Economic Area (EEA) or Swiss doctor or dentist is also legally valid in the UK.”

 

Please change this to:

“Additionally, ‘appropriate practitioner’ can include health professionals registered in another European Economic Area (EEA) country. Prescriptions issued by EEA and Swiss prescribers are legally valid in the UK, provided that the prescription is issued in the country in which they are registered.”

 

 

 

Section 8: Part 5 of The Human Medicines Regulations 2012

Prescription Only medicines

Your Module 3 textbook will state:

“The above prescription requirements are also necessary for prescriptions issued by an EEA or Swiss doctor or dentist. The only difference is there is no requirement for the address and age of the patient, if under 12, to be included on a prescription.”

 

Please change this to:

“In addition to the above prescription requirements, prescriptions issued by an EEA or Swiss prescriber must also include the:

  • Patient’s date of birth
  • Prescriber’s email address
  • Prescriber’s telephone or fax number (with the relevant international prefix)
  • Name of the relevant member State (i.e. country)”

 

Section 8: Part 5 of The Human Medicines Regulations 2012

Prescription Only medicines

With regard to repeats on prescription, your Module 3 textbook will state:

“• The first time it is dispensed is within 6 months of the date on the prescription.”

 

Please change this to:

“• The first time it is dispensed is within six months (28 days for Schedule 4 CDs) of the date on the prescription. Note that the remaining repeats are valid indefinitely thereafter, unless the prescriber has specified otherwise. However, the pharmacist should use their clinical judgment to check if the medicine/dose is still appropriate. Repeats on a veterinary prescription, however, are only valid for six months from the prescription date.”

 

Then, the third bullet point in the same list will state:

“The exception to this rule is a prescription for oral contraceptives which can be dispensed a total of six times”

Please add the following text to this sentence:

“before the end of six months from the prescription date.”

 

Then, please remove the following text from the next paragraph, which will state:

“As with any prescription the items must be dispensed within 6 months of the date of the prescription (28 days for a CD).”

 

Section 8: Part 5 of The Human Medicines Regulations 2012

Prescription Only medicines

Following the activity in this section, your Module 3 textbook will state:

“Script C – No name of the patient and qualification of doctor – No quantity of Cefuroxime”

 

Please add the following text:

“(although the quantity of cefuroxime is missing, this is not a legal requirement)”.


 

Section 9: Responsible Pharmacist (RP)

Supervision

Your Module 3 textbook will state:

“Supervision requires the physical presence of the pharmacist, where the pharmacist is able to advise and intervene.”

 

Please change this to:

“Among the activities that require supervision by a pharmacist, some require the pharmacist’s physical presence, and others do not.”

 

Your Module 3 textbook will also state:

“There is also a table detailing activities that may take place without supervision.”

 

Please change this to:

“Table A2 details activities that require supervision and which may take place without the pharmacist’s physical presence.”

 


 

Section 12: Schedules

Schedule 2

Please add the following text to the list of Schedule 2 Controlled Drugs:

“Pethidine

Secobarbital (quinalbarbitone)”

 

Note: This may help students to correctly answer some of the questions in the Module 3 assessments

 

Also, please remove the following text if it is in the list of Schedule 2 Controlled Drugs:

“Dexedrine”

 

Section 12: Schedules

Schedule 3

Please remove the following text if it is in your Module 3 textbook:

“• Prescriptions for temazepam do not have to be written in a special way.”

 

Section 12: Schedules

Schedule 4

Please replace this section in your Module 3 textbook with the following text:

“Schedule 4 is divided into two parts. Part 1 includes benzodiazepines (such as chlordiazepoxide, clobazam, diazepam, lorazepam and nitrazepam), Sativex oromucosal spray, zolpidem and zopiclone.  Part 2 includes danazol and testosterone.

 

Schedule 4 CDs do not have the same prescription writing requirements as Schedule 2 and 3 CDs; nor do they have to recorded in the CD register, or be kept in the CD cabinet. Sativex has specific record-keeping requirements.”

Note: This may help students to correctly answer some of the questions in the Module 3 assessments

 

Section 12: Prescriptions for Schedule 2 and 3 Controlled Drugs

Please remove the following text if it is in your Module 3 textbook:

“(not including temazepam)”

 

Section 12: Prescriptions for Schedule 2 and 3 Controlled Drugs

Amending prescriptions for Controlled Drugs

Please remove the following highlighted text if it is in your Module 3 textbook:

“Pharmacists can amend Controlled Drugs schedule 2 or 3 prescriptions (excluding temazepam) where there are:”

 

Section 12: Prescriptions for Schedule 2 and 3 Controlled Drugs

Pharmacist checks required

Your Module 3 textbook will state:

“It is the duty of the pharmacist to check that all prescriptions (NHS and Private) comply with the following:”

 

Please add the following text to the start of this sentence:

“For Schedule 2 or 3 CDs,”

 

Then add the following text to point 4:

“(this also applies to Schedule 4 CDs, but not Schedule 5).”

 

Then add the following text to point 5:

“(this also applies to Schedule 4 CDs, but not Schedule 5).”

 

Section 12: Requisitions or Signed Orders for CDs

Your Module 3 textbook will state:

“7. Other pharmacists working in a community pharmacy setting.

  1. A senior registered nurse in charge of a ward in a hospital or care home.”

 

Please change this to:

“7. A pharmacist or nurse independent prescriber.

  1. A person in charge of an organisation providing ambulance services, or a paramedic.”

 

Section 12: Requisitions or Signed Orders for CDs

Your Module 3 textbook may state:

“It is not a legal requirement to use these standardised requisition forms but it is good practice.”

 

If so, please change this to:

“In England, Scotland and Wales, it is a mandatory requirement to use standardised CD requisition forms.”

 

 

Section 12: Requisitions or Signed Orders for CDs

Your Module 3 textbook may state:

“The requisition must:

  • be signed by the purchaser
  • state the purchaser’s name, address and profession or occupation
  • state the total quantity of drug to be supplied (this does not have to be in words and figures)”

 

If so, please change this to:

“The requisition must state details of the:

  • Supplier
  • ‘Customer’ receiving the CD
  • CD being requisitioned”

 

Also, in the same section, there may be an example (illustration) of a CD requisition form – please ignore this.

 


 

Section 13: Legal Classification

A prescription for a POM-V or POM-VPS medicine must:

Please add the following text:

“If the prescription is for a Schedule 2 or 3 CD, the prescription must also contain:

  • The Royal College of Veterinary Surgeons (RCVS) registration number of the veterinary surgeon
  • The quantity written in words and figures
  • The strength of the drug, if more than one exists

 

NB: Veterinary prescriptions are always private prescriptions, as animals cannot be treated on the NHS.”

 

Note: This may help students to correctly answer some of the questions in the Module 3 assessments

 

Section 13: Veterinary Medicines Directorate (VMD)

Your Module 3 textbook will state:

http://www.vmd.gov.uk/

 

Please change this to:

“these resources can all be found on the VMD section of the GOV.UK website: https://www.gov.uk/government/organisations/veterinary-medicines-directorate


 

Section 14: Poisons and Legal Controls Over Retail Sale and Supply

Please replace this entire section (except for the section titled “Storage of Schedule 1 poisons”)with the following text:

[Note: The section titled “Storage of Schedule 1 poisons” in your Module 3 textbook should not be removed, except for the words “Schedule 1”.]

 

“Section 14: Supplying explosives precursors and poisons

There are legal restrictions on the supply of certain substances deemed to be poisons or explosives precursors.  England, Scotland and Wales are subject to the same regulations, while Northern Ireland has its own legislation.

 

England, Scotland and Wales

The sale of poisons and explosives precursors through pharmacies is governed by the Poisons Act 1972 (as amended) and the Control of Poisons and Explosives Precursors Regulations 2015. This legislation lists four classes of substances (each regulated in different ways):

  • Part 1 ‒ regulated explosives precursors
  • Part 2 ‒ regulated poisons
  • Part 3 ‒ reportable explosives precursors
  • Part 4 ‒ reportable poisons

 

Supply of Part 1 and Part 2 substances

Part 1 lists explosives precursors which are regulated if the substance exceeds a certain strength ‒ for example, hydrogen peroxide at strengths higher than 12% w/w is a Part 1 substance, whereas lower strengths of hydrogen peroxide are not.  Part 2 lists poisons such as arsenic, mercury and strychnine.  Part 2 substances can only be supplied by a pharmacist, whereas Part 1 substances can be supplied by any retailer.

 

Members of the public need to obtain a licence from the Home Office before they can purchase a Part 1 or Part 2 substance. If a pharmacist wishes to supply a Part 1 or Part 2 substance, they need to check the purchaser holds a valid licence, and check their photographic identification referred to on their licence.

 

Pharmacists cannot supply Part 1 or Part 2 substances to a member of the public unless they have a valid licence and photo ID. However, businesses do not need to hold a Home Office licence to purchase regulated substances from pharmacies.

 

When supplying Part 1 or Part 2 substances, the pharmacy must label the substance to indicate that ‘acquisition, possession or use by the general public is restricted’ or similar wording.  The details of the transaction should be recorded on the back of the purchaser’s licence.

 

Record-keeping

Before a Part 2 substance is sold, a record of the sale must be made in the pharmacy’s poisons register, and the purchaser must sign the entry. The following details need to be recorded – the:

  • Date of the sale
  • Name and quantity of the regulated poison supplied
  • Name and address of the purchaser
  • Purpose for which the regulated poison is supplied

 

Suspicious transactions and theft

Suppliers must report any suspicious requests to purchase Part 1, 2, 3 or 4 substances. Note that a licence is not required for members of the public to purchase Part 3 or 4 substances. Significant losses or theft of any regulated or reportable substance should also be reported.  Reports should be made using the anti-terrorism hotline (0800 789321).

 

Part 3 substances include acetone, and Part 4 substances include formaldehyde.

A full list of regulated and reportable substances, together with guidance for pharmacists, can be found at: https://www.gov.uk/government/publications/supplying-explosives-precursors

 

Northern Ireland

Northern Ireland’s legislation regarding poisons is contained in the Poisons (Northern Ireland) Order 1976 (as amended) and the Poisons Regulations (Northern Ireland) 1983 (as amended).

 

The legislation lists poisons and divides them into two categories ‒ Part I and Part II. Part I substances can only be sold by a pharmacist from a registered pharmacy.  Part II substances can be sold by a pharmacist or by a registered seller who has been authorised by the district council to sell such substances.

 

Poisons are further divided into eight Schedules. Schedule 1 poisons have special restrictions relating to their sale, record-keeping and storage. Any request for a Schedule 1 poison must be dealt with by your pharmacist. The purchaser must either be known to the pharmacist, or supply a certificate certifying that the person may be properly sold the poison. Before a Schedule 1 poison is sold, a record needs to be made in the pharmacy’s poisons register and signed by the purchaser. The record needs to include the:

  • Date of the sale
  • Name and address of the purchaser
  • Name and address of the person who gave the certificate (if applicable) and the date of the certificate
  • Name and quantity of the poison
  • Purpose for which it is required
  • Business, trade or occupation of the purchaser

 

The same storage requirements apply to Schedule 1 poisons in Northern Ireland, as apply to poisons in England, Scotland and Wales.

 

Northern Ireland also has it own Control of Explosives Precursors etc. Regulations (Northern Ireland) 2014.  These divide explosives precursors into two tiers.  Tier 1 substances require a licence to supply, acquire, possess, use or import them.  Tier 2 substances require members of the public to have a licence to possess, acquire, use or import them, if the strength exceeds a specified concentration ‒ for example, hydrogen peroxide at a strength of greater than 12% is a Tier 2 substance.  There is a requirement to report any suspicious transactions, disappearances or thefts of Tier 1 or Tier 2 substances, along with some additional substances, including acetone. Further information can be found at https://www.gov.uk/guidance/marketing-and-use-of-explosives-precursors-in-northern-ireland.

 

 

Revision exercise

Activity 1: Are there any restrictions on selling hydrogen peroxide 35% solution? Write down how you would handle a request from a member of the public for this product and discuss your answer with your pharmacist.

 

Activity 2: What details need to be recorded in the poisons register, when supplying a poison?”

 


 

Section 16: Completely Denatured Alcohol

Your Module 3 textbook will state:

“CDA, is purple in colour and contains 90% alcohol, pyridine, wood naphtha, and mineral naphtha (added to make it bitter and distasteful).”

 

Please change this to:

“CDA is alcohol to which isopropyl alcohol, methyl ethyl ketone and denatonium benzoate have been added. It used to be a requirement that a purple dye was added, but this is no longer the case, although producers can add the dye if they wish.”

 

 


 

Section 17: Freedom of Information Act

Activity – Your Module 3 textbook will state:

www.ico.gov.uk

 

Please change this to:

https://ico.org.uk

 

Also, please add the following text to this activity:

“If your pharmacy is in Scotland, use the website of the Scottish Information Commissioner (www.itspublicknowledge.info)”

 

Section 17: Equality and Diversity

Activity – Please replace this activity with the following text:

 

“Use the internet to look up information on the Equality Act 2010 and write down any reasonable adjustments that can be made to overcome any obstacles which may prevent or limit disabled patients receiving services from the pharmacy. Students in England, Scotland and Wales may find the Equality and Human Rights Commission website helpful (https://www.equalityhumanrights.com/en/multipage-guide/three-requirements-duty); students in Northern Ireland are advised to look at the Equality Commission for Northern Ireland’s website (http://www.equalityni.org/Employers-Service-Providers/Service-Providers/Services/Disability)”

 

Section 17: Adult and Child Protection

A vulnerable adult may be a person who:

Please add the following text:

  • A person with visual impairment or profound deafness

• Subject to other types of discrimination such as age, culture or race

 


 

Additional section

Please add the following section to your Module 3 textbook (if it is not already included):

 

Section 18: Drug driving legislation

Section 5A of the Road Traffic Act 1988 came into effect on 2 March 2015 and introduced a new offence of driving while taking specified Controlled Drugs (CDs). It means that it is an offence for anyone to drive, attempt to drive or be in charge of a motor vehicle, on a road or public place, with a specified CD in their body in excess of a specified limit. This legislation applies only to England and Wales.

 

Medical defence

The legislation provides a statutory “medical defence” for drivers who have taken a specified drug, provided their driving is not impaired, the drug was prescribed, supplied or sold to treat a valid medical problem, and it was taken correctly. Raising the medical defence means that drivers might not be required to give a blood sample if they have tested positive on a roadside saliva test.

 

Patient counselling

This legislation does not necessarily mean that patients should stop taking their medicines or cannot drive. They should be informed about the drug driving legislation and should be advised to avoid driving if their medicines are likely to impair their ability to drive, i.e. make them drowsy. Healthcare professionals are able to assess the risk.

 

Patients should also carry evidence to prove that they are receiving a prescribed or purchased medicine and taking it in accordance with instructions set by the prescriber or the patient information leaflet (PIL).

 

Some factors to consider when determining the likelihood of a drug impairing the patient’s ability to drive are age, gender, physiological conditions, metabolism, lifestyle choices, drug interactions and the dose. Discuss these factors with your supervising pharmacist.

 

Some useful checks you could advise patients to make before driving include:

  • Are you taking other prescribed and/or over-the-counter medicines at the same time (which may also impair driving)?
  • Do you have a developing medical condition that may increase the risk of impaired driving ability?
  • Are you starting any additional medication? (in case of interactions unaccounted for)
  • Have you remembered to carry evidence with you of the supply of your medicine and advice received? (for example, a repeat prescription, or a receipt with the PIL)
  • Do you drink alcohol? – evidence shows that the risk of accidents is significantly increased if alcohol is taken in combination with any of the drugs included in the legislation. Also, the effects of alcohol may continue to the morning after drinking (this would be a good opportunity to give healthy lifestyle advice on appropriate alcohol consumption)

 

Patients should be advised not to drive if:

  • The medicine causes drowsiness, dizziness, loss of concentration or visual disturbances
  • Starting a new medicine or if changing doses as this could temporarily increase the risk of impaired driving
  • They are in doubt whether driving may be impaired by the medicine (or due to any other reason)

 

Important note: pharmacy staff should always refer to their pharmacist when considering the risk a drug poses on the ability to drive, as this is often complex and requires the clinical skill of a pharmacist or doctor.

 

A list of the specified drugs and blood limits covered by the drug driving legislation can be found at https://www.gov.uk/government/collections/drug-driving#table-of-drugs-and-limits.”

 


 

Download ADAC Module 3 Addendum for Pre-2017 textbook