Faculty of Sexual and Reproductive Healthcare
of the Royal College of Obstetricians and Gynaecologists
SERVICE STANDARDS FOR MEDICINES MANAGEMENT
IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES
Reviewed & updated: February 2014
Review Date: February 2017
27 Sussex Place, London, NW1 4RG
www.fsrh.org
Published by Clinical Standards Committee
Faculty of Sexual & Reproductive Healthcare (FSRH)
of the Royal College of Obstetricians and Gynaecologists
Committee members:
Dr Elizabeth Jane Dickson, Chair
Dr Asha Kasliwal, Officer
Dr Lynne Gilbert, vice chair
Dr Jagruti Doshi
Dr Wendy Higson
Dr Paula Briggs
Dr Rachel Westwick
Mrs Michelle Jenkins, Nurse Representative
Dr Louise Melvin, CEU Representative
Dr Immy Ahmed, British Association Sexual Health & HIV (BASHH) Representative
First Published July 2005
Updated February 2014
Next review date: February 2017
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
2
SERVICE STANDARDS FOR MEDICINES MANAGEMENT
IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES
1.
Standard statement on the process of medicines management
Page 6
A medicines management policy and related standard operating procedures (SOPs)
should be in place in employing organisations and updated regularly.
2.
Standard statement on access to treatment
Page 7
All clinicians should be able to directly provide medication or a prescription to
patients to meet their sexual and reproductive health needs.
3.
Standard statement on the process for safe and secure handling of medicines
Page 8/9
The process of ordering, logging receipt, labelling, storage, transport, stock rotation
and disposal of medicines should be in accordance with NHSLA standards
4.
Standard statement on the process for security of prescription pads
Page 10
Prescription pads and other controlled stationery must be kept securely.
5.
Standard statement on the process for prescribing
Page 11
All prescribers must have training and regular updates in order to follow legal and
professional frameworks as stated by the registered professional body.
6.
Standard statement on the process for supply or administration using
a Patient Group Direction (PGD)
Page 12
Health care professionals other than doctors who have completed additional training
and competency based assessments may be authorised to supply or administer
medicines using a locally agreed PGD.
7.
Standard statement on the authorisation and recording of medicines supplied
or administered to patients
Page 13
Medicines are supplied or administered to patients by clinicians accurately and
safely.
8.
Standard statement on the process for supplying or administering medicines
to patients
Page 14
Only a qualified healthcare professional can supply or administer medicines that
have been prescribed or supplied using a locally agreed PGD for an individual
patient.
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
3
9.
Standard statement on remote prescribing
Page 15
In circumstances where a prescriber may need to prescribe remotely, the prescriber
must satisfy themselves that they can make an adequate assessment. The use of
information technology must confirm the prescription before it is administered.
10.
Standard statement on the process for prescribing unlicensed medicines,
and for the use of medicines outside the manufacturer’s licence
(off-label prescribing)
Page 16
The use of unlicensed medicines, and licensed medicines outside the
manufacturer’s licence, should be explicit and follow national and professional
guidance.
11.
Standard statement on reducing errors in prescribing or supplying medication
and on the process for reporting adverse effects of drugs
Page 17
Systems should be in place to minimise risk associated with the use of medicines,
for identification of incidents, errors and adverse events, and to share learning from them.
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
4
SERVICE STANDARDS FOR MEDICINES MANAGEMENT
IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES
Introduction
Medicines Management is the clinical, cost effective and safe use of medicines to ensure patients get the
maximum benefit from the medicines they need, while at the same time minimising potential harm. The Safe
1
and Secure Handling of Medicines, A Team Approach published in March 2005, gives definitive and
detailed guidance on medicines management within all NHS organisations in the UK. Reference to this
resource is made throughout this document. Although its scope does not include general practice or
community pharmacy, we would commend the basic principles in these settings.
These standards relate to medicines and devices used within sexual and reproductive health care settings.
Wherever the term ‘medicine’ is stated in this document, this should be interpreted to cover all the areas
listed here. This standard applies equally to medicines and devices used in research trials.
The term ‘medicines management’ has been interpreted to cover the processes and systems for providing
medicines to patients within these areas. In this context it does not include reference to evidence-based
prescribing, for which readers should refer to the relevant Clinical Effectiveness Unit and NICE guidance.
These standards should be read in conjunction with Service Standards for Risk Management² and Service
3
Standards for Record Keeping
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
5
1.
Standard statement on the process of medicines management
A medicines management policy and related standard operating procedures (SOPs)
should be in place in employing organisations and updated regularly.
1.1
Good medicines management should ensure a process for giving appropriate and safe and effective
therapies to patients.
1.2
There should be a Medicines Policy for each employing organisation, which is accessible to staff and
used in conjunction with these standards.
1.3
There should be an agreed process for deciding on medicines to be held in stock in clinical settings,
and processes in place for the provision of other relevant medicines which are not held as stock.
1.4
Every service should have a system of standard operating procedures (SOPs) covering each of the
activities concerned with medicines use. This is to ensure safety and security. Appropriate
pharmaceutical advice must be taken in the development of systems for the safe and secure
handling of medicines. Guidelines for developing and implementing standard operating procedures
4
can be found on the MHRA website .
1.5
Staff should understand the principles of safe and secure handling of medicines, including storage,
handling, issuing and prescribing of drugs.
1.6
There must be an audit trail for each patient’s medicines.in line with the employing organisation’s
medicines policy.
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
6
2.
Standard statement on access to treatment
All clinicians should be able to directly provide medication or a prescription to
patients to meet their sexual and reproductive health needs.
2.1
Services should ensure that patients are able to directly access medication or a prescription which is
appropriate to their sexual and reproductive health needs. This represents efficient treatment,
endorses patient choice of provider and underpins and enhances access to appropriate and timely
services.
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
7
3.
Standard statement on the process for safe and secure handling of medicines
The process of ordering, logging receipt, labelling, storage, transport, stock rotation
and disposal of medicines should be in accordance with national and local
guidance.
3.1
The SOPs for the management of medicines within the service must include reference to medicines
that are heat and light sensitive, medicines for clinical emergencies, any medicines liable to misuse,
and disposal of medicines no longer required.
3.2
All staff, whether clinical or non-clinical, should be trained in the parts of these procedures relevant
to their duties.
3.3
A designated person should be responsible for ordering medicines from the pharmacy to maintain
agreed stocks levels.
3.4
Medicines arriving in the clinic should be checked against the requisition by a designated person
who should record that the delivery is correct and follow up any discrepancies immediately. The
registered healthcare professional in charge of a clinical area has the overall responsibility for the
security and safekeeping of medicines in that area.
3.5
Where premises are shared, each service must be responsible for its own stock of medicines, which
should be stored separately.
3.6
If an outreach worker takes medicines out of the clinic, that outreach worker is responsible for the
5
safe and secure transport and storage of medicines .
3.7
All medicinal products issued by the practitioner must be overlabelled correctly. Standard labelling
6
requirements for all dispensed items include :
 the name of the person to whom the medicine is to be supplied
 the date of issue
 the name and address of the service
 the name of the medicine
 directions for use
 precautions relative to the use of the medicine
 the words ‘keep out of reach of children’
3.8
All medicinal products must be stored in accordance with their summary of product characteristics
(SPC) and any instruction on the label. Lockable cupboards that comply with the relevant regulations
1
should be used for the storage of medicines in the clinic or practice setting . The current British
7
Standard is BS2881 (1989) .
3.9
If heat-sensitive products are kept (e.g. vaccines), a suitable dedicated fridge must be available fitted
with a maximum and minimum thermometer. There should be monitoring of the temperature of the
refrigerator on each working day which is recorded and signed in a log book / record sheet by the
person monitoring the temperature. There should be a policy in place with clear actions to be taken if
the temperature is outside the recommended range.
3.10
Medicines for clinical emergencies should be held in packs clearly marked ‘for emergency use’ .
They should not be locked away, but must be stored in tamper-evident packs and replaced
immediately if used or signs of tampering are evident.
3.11
It should be the duty of a pharmacist to ensure that safe systems are in place to ensure that
medicines are only supplied on the instruction of an authorised clinician. The pharmacist should
carry out inspections of the stock in the clinic, with reconciliation where necessary.
1
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
8
3.12
There should be a local process of stock rotation of medicines to ensure that medicines closer to
their expiry date are used in preference to those with a longer shelf life.
3.13
There must be a policy agreed with the local pharmacy team for the safe disposal of expired
medicines.
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
9
4.
Standard statement on process for security of prescription pads
Prescription pads and other controlled stationery must be kept securely8.
4.1
There should be an agreed process for ordering and signed receipt of FP10 prescription pads and
any internal employer prescription pads or other controlled stationery, e.g. internal order forms.
4.2
FP10 prescription pads must only be held by qualified practitioners who are registered as such with
their professional body and who have been issued with them. The practitioner must take
responsibility for their security, which includes security of any prescription pads used outside of the
clinic or practice setting, e.g. home visits.
4.3
Prescription pads and other controlled stationery must be kept in secure locked cupboards at all
times when not in use.
4.4
Records of serial numbers of prescription pads received and issued should be retained for at least
8
three years .
4.5
There should be an audit trail for numbered prescriptions. All individual prescriptions must be signed
out of the record log that accompanies each pad so that each prescription can be accounted for.
Appropriate procedures should be in place for the immediate reporting of any loss or theft
of prescription stationery and staff are aware of what action they need to take if this occurs”
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
10
5.
Standard statement on process for prescribing
All prescribers must have training and regular updates in order to follow legal and
professional frameworks as stated by the registered professional body.
5.1
Medicines should only be prescribed in the following ways:
5.1.1
patient-specific direction, i.e. entry on clinic record
5.1.2
FP10 prescription
5.1.3
Outpatient prescription form for dispensing in a hospital pharmacy
For ease of reference, the term ‘prescription’ is used in this document for all three situations.
5.2
All prescribers must follow the guidance on writing prescriptions given in the British National
Formulary and local/organisational policies and guidelines”
5.3
Non-medical prescribers must undertake a programme of training approved by their professional
body, and this must be recorded in the relevant professional register. For nurses, the Nursing and
9
Midwifery Council (NMC) fulfils this function and for pharmacists it is the General Pharmaceutical
10
Council .
5.4
Non medical prescribers working within sexual and reproductive health must ensure that they
prescribe only within their competence and in accordance with current NHS guidance on
11,12,13,14
independent and supplementary prescribing
.
5.5
Non-medical prescribers are permitted to prescribe black triangle* drugs as long as it is accepted
practice to do so, for instance where such products are included in local formularies.
*A black triangle () will be assigned to a product if the drug is a new active substance. However, a
product containing previously licensed active substances may also be monitored if it meets one or
more of the following criteria:
 a new combination of active substances;
 administration via a novel route or drug delivery system;
 a significant new indication which may alter the established risk/benefit profile of that drug.
The black triangle drugs are monitored closely for a minimum of two years and the black triangle
15
symbol is not removed until the safety of the drug is well established .( Ref 11.7)
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
11
6.
Standard statement on process for supply or administration using a Patient Group Direction
(PGD)
Health care professionals other than doctors who have completed additional
training and competency based assessments may be authorised to supply or
administer medicines using a locally agreed PGD16.
6.1
The legal definition of a PGD is:”a written instruction for the supply and / or administration of a
licensed medicine (or medicines) in an identified clinical situation, signed by a doctor or dentist and a
pharmacist. It applies to groups of patients who may not be individually identified before presenting
20
for treatment” .
6.2
Any Patient Group Directions in use must have been agreed through the authorising process within
21,27
the relevant NHS organisations
.
6.3
PGDs should only be used by registered healthcare professionals who have been assessed as
competent and whose name is identified within each document. Anyone involved in the delivery of
5,16,17-20,27
care within a PGD must be aware of the legal requirement
.
6.4
If a PGD cannot be used (for example where one has not yet been approved, or an individual falls
outside the inclusion criteria), medication can only be provided through a valid prescription.
6.5
Training, updating and audit of those working to PGDs must be provided .
6.6
PGDs should be reviewed and re-authorised according to local guidelines, particularly in the event of
any changes in clinical practice.
6.7
Black triangle drugs (see under 5.5), and medicines used outside the terms of the summary of
product characteristics (off-label) may be included in PGDs provided such use is exceptional,
justified by current best clinical practice and that a direction clearly describes the status of the
20
product .
6.8
When supplying under PGD, this must be from the manufacturers’ original packs or over labelled
pre-packs. The patient’s details, date of supply and any necessary additional instructions must be
5
added to the label at the time of supply. Practitioners must not split prepared pre-packs .
22
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
12
7.
Standard statement on the authorisation and recording of medicines supplied or
administered to patients
Medicines are supplied or administered to patients by clinicians accurately and
safely.
7.1
The authorisation of a suitably qualified practitioner (i.e. doctor or non medical prescriber) should be
obtained before medicines can be supplied or administered to patients. This authority is given in one
of three ways:
7.1.1
a prescription completed by a doctor or a Non Medical Prescriber on an official medicine
record chart or electronic prescribing system (i.e. a patient-specific direction).
7.1.2
in accordance with locally agreed clinical procedures, e.g. for off-prescription medicines
7.1.3
in accordance with Patient Group Directions (PGD).
7.2
Sufficient information about the medicine must be available to the staff and/or patient to enable
identification and correct use of the product.
7.3
A record of administration must be made, and the administering nurse / doctor / practitioner identified
23
(e.g. an entry in the medicines record or electronic health record) .
Medication that is not given due to refusal, wastage or lack of availability must be recorded.
7.4
If a second clinician checks the administration of a medicine, the identity of the checking clinician
should also be recorded; however, the ultimate responsibility remains with the administering nurse /
doctor.
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
13
8.
Standard statement on process for supplying or administering medicines to patients
Only a qualified healthcare professional can supply or administer medicines that
have been prescribed or supplied using a locally agreed PGD for an individual
patient.
8.1
Prescription only medicines may only be supplied or administered by a qualified health care
professional (i.e. doctor, nurse, midwife or pharmacist)
8.2
Dispensing is classed as ‘to label stock and supply a clinically appropriate medicine, for self
administration or administration by another professional and to advise on safe and effective use.
This can only be undertaken by a qualified professional e.g. registered nurse, doctor, or pharmacist,
5
and should be outlined in a local SOP . It is good practice to ensure separation of prescribing and
dispensing whenever possible but if involved in both prescribing and dispensing/ administration a
patient’s medication, a second suitably qualified person should be involved in checking the accuracy
of the medication provided. However, where a stock supply of medication has been labelled and
dispensed by a pharmacist and is then supplied by a nurse/midwife in an ‘out-of–hours’ or family
9
planning situation, this is not dispensing, but supplying . Nurse prescribers who are both prescribing
and supplying in community clinics should be competent and familiar with all the medication they
9
prescribe .
8.3
When supplying or administering a medicine, the healthcare professional has a duty to check the
patient’s identity, that the patient is not allergic to the product, there are no contraindications, that
they consent to take the medication and that the product is appropriately labelled. Only one clinician
5
needs to perform this task. This process should be outlined in a local SOP
8.4
When supplying or administering medicine, the expiry date must be checked, and a clear and
5
immediate record of the medicine should be made
8.5
Wherever "take-home", pre-packed medication is issued from the health care setting, the senior
pharmacist is responsible for ensuring that there is a legal system to ensure that all medicines
issued to service users are recorded and correctly over- labelled.
8.6
Records should be regularly checked by the pharmacy with prescription reconciliation, where
necessary.
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
14
9
Standard statement on remote prescribing
In circumstances where a prescriber may need to prescribe remotely, the prescriber
must satisfy themselves that they can make an adequate assessment. The use of
information technology must confirm the prescription before it is administered.
9.1
Before prescribing for a patient via telephone, video-link or online, the prescriber must satisfy
themselves that they can make an adequate assessment, establish a dialogue and obtain the
patient’s consent.
They may prescribe only when they have adequate knowledge of the patient’s health, and are
satisfied that the medicines serve the patient’s needs. They must consider:
9.1.1
the limitations of the medium through which they are communicating with the patient
9.1.2
the need for physical examination or other assessments
9.1.3
whether they have access to the patient’s medical records .
24
9.5
Contraceptive services often run without direct access to a doctor and it may be necessary for a
doctor to ‘remotely’ prescribe a previously prescribed or unprescribed medicine. It is not acceptable
for a nurse to accept a ‘verbal order’ to supply medication to a patient unless this is in accordance
with the medicines policy of the Trust or organisation. The Nurse is accountable for ensuring all
relevant information has been communicated to the prescriber and he/she may refuse to accept a
remote prescription if it compromises care to the patient. The nurse must document accurately that
5
this communication has taken place . Information technology e.g. fax, text message or email may be
used to confirm a prescription before it is administered. This should be followed up by a written
prescription within one working day.
9.6
Use of text messaging. In community contraceptive services an order to supply and administer a
medicine by text message or e-mail is becoming increasingly common. Under these circumstances a
second signature recorded in the patient record ideally by another registered nurse (if this is not
possible another employee) should sign to confirm the documentation is in agreement with the text
message. The text message must be regarded as a patient contact. All received text messages
should be deleted once documentation has been completed to maintain patient confidentiality.
9.7
Any community service where it is likely that remote prescribing may be required should have local
policies in place to ensure that any web based products used for texting / emailing are secure,
provide a robust audit trail and comply with clinical governance standards.
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
15
10.
Standard statement on the process for prescribing unlicensed medicines and for the use of
medicines outside the manufacturer’s licence (off-label prescribing)
The use of unlicensed medicines, and licensed medicines outside the
manufacturer’s licence, should be explicit and follow national and professional
guidance.
10.1
The purpose of using a medication outside its licence should be justifiable and in line with a
recognised body of opinion.
10.2
Health care professionals should be satisfied that they have sufficient information to administer an
unlicensed or ‘off label’ drug safely.
10.3
Patients must be given sufficient information about the medicines proposed to be prescribed to allow
them to make an informed decision. The General Medical Council produced the guidance document
24
‘Good Practice in prescribing Medicines’ in February 2013 . This document states that; “where
prescribing unlicensed medicines is supported by authoritative clinical guidance, it may be sufficient
to describe in general terms why the medicine is not licensed for the proposed use or patient
population. Questions from patients about medicines should be answered fully and honestly. If it is
intended to prescribe an unlicensed medicine that is not routine or if there are suitably licensed
alternatives available, this should be explained to the patient, and the reasons for doing so. Health
care professionals should be careful about using medical devices for purposes for which they were
not intended”.
9
The situation for non-medical prescribers is different . Non medical prescribers cannot prescribe an
unlicensed medicine but may prescribe a medicine outside the manufacturers licence if done under
9
current recognised guidance for use by a professional body , i.e. when a contraceptive preparation is
used within current guidance from the Faculty’s Clinical Effectiveness Committee,
10.4
Any medication provided in this way as a ‘named patient prescription’ should have an audit trail.
10.5
Adverse reactions occurring during use of a medicine outside its licence should be reported on a
25
Yellow Card to the Medicines and Healthcare Products Regulatory Agency (MHRA)
http://yellowcard.mhra.gov.uk/
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
16
11.
Standard statement on the process for reporting adverse effects of drugs and for reducing
errors in prescribing or supplying medication.
Systems should be in place to identify and learn from incidents and adverse events
related to medication.
11.1
Details of the patient using the medicine should be checked before supply or administration.
11.2
The name of the medicine should be checked with the patient prior to administration or supply. The
patient should be made aware of the patient information leaflet and if there are any differences
26
between this and the Family Planning Association (FPA) leaflet provided .
11.3
Clinical history, including anaphylaxis and past side effects, and concurrent medication should be
checked and updated at each visit.
11.4
Dose, administration instructions, expiry date and batch numbers should be checked on the label
3
and contents and recorded in the notes as recommended by local policy.
11.5
Warnings to identify contraindications to medicines should be clearly identifiable in the records.
11.6
Where packaging is similar for different medicines, these supplies should not be kept adjacent to
6
each other. Systems should be employed to minimise this source of risk .
11.7
Adverse effects to a medicine, medical device or medicated device should be reported to the MHRA,
25
according to their guidelines , to the manufacturer and to local pharmacy governance lead.
11.8
Any incident (including medicines errors, adverse effects, and theft of supplies or prescriptions),
should be reported on local clinical incident forms. The pharmacist and clinical lead or site manager
for the area must be informed to commence appropriate investigation, improve practice and reduce
future risk. This also ensures that incidents / adverse effects are collated nationally by NRLS
and used to inform national policy with regard to patient safe
11.9
Risk assessments should be carried out (in accordance with the local risk management policy) in
connection with the drug products and procedures (including the use of delivery devices) to
determine potential risks to service users and staff.
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
17
References
1.
Royal Pharmaceutical Society of Great Britain (RPSGB)(2005). The Safe and Secure Handling of
Medicines: A Team Approach. A revision of the Duthie Report (1998). Accessed 30 July 2013 at
http://www.rpharms.com/support-pdfs/safsechandmeds.pdf
2.
Faculty of Sexual and Reproductive Healthcare (2010). Service Standards for Risk Management.
Accessed 1 August 2013 at http://www.fsrh.org/pdfs/ServiceStandardsRiskManagement.pdf
3.
Faculty of Sexual and Reproductive Health Care (2010). Service Standards for Record Keeping.
Accessed 30 July 2013 at http://www.fsrh.org/pdfs/ServiceStandardsRecordKeeping.pdf
4.
Medicines and Healthcare Products Regulatory Agency (MHRA)(2012). Understanding the value of
standard operating procedures (SOPs) and basic guidance on writing them. Accessed 1 August
2013 at http://www.mhra.gov.uk/home/groups/is-insp/documents/websiteresources/con195916.pdf
5.
Nursing & Midwifery Council (NMC)(2007). Standards for Medicines Management. Accessed 30 July
2013
at
http://www.nmc-uk.org/Documents/NMCPublications/238747_NMC_Standards_for_medicines_management.pdf
6.
Royal Pharmaceutical Society (2013). Medicines, Ethics and Practice: the professional guide for
pharmacists. Edition 37. RPS London.
7.
Department of Health (2013). Pharmacy and radiopharmacy facilities (Health Building Note 14-01).
DH: London.
8.
NHS Security Management Service (2011). Security of prescription forms guidance. Accessed 1
August
2013
at
http://www.nhsbsa.nhs.uk/SecurityManagement/Documents/SecurityManagement/Security_of_presc
ription_forms_GUIDANCE_March_2011_FINAL.pdf
9.
Nursing & Midwifery Council (NMC)(2006). Standards of proficiency for nurse & midwife prescribers.
Accessed 30 July 2013 at http://www.nmc-uk.org/Documents/NMC-Publications/NMC-Standardsproficiency-nurse-and-midwife-prescribers.pdf
10.
General Pharmaceutical Council (GPhC) www.pharmacyregulation.org
11.
Department of Health (2006). Improving patients’ access to medicines: A Guide to Implementing
Nurse & Pharmacist Independent prescribing in England. Accessed 1 August 2013 at
http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/
groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4133747.pdf
12.
NHS Scotland (2006). Non-Medical Prescribing in Scotland. Accessed 1 August 2013 at
http://www.scotland.gov.uk/Resource/Doc/145797/0038160.pdf
13.
Welsh Assembly Government (2011). Non-Medical Prescribing in Wales: A guide for
implementation.
Accessed
1
August
2013
at
http://www.wales.nhs.uk/sites3/Documents/371/Non%20medical%20prescribing%20guidance%2020
10.pdf
14.
Department of Health, Social Services and Public Safety (Northern Ireland). Non-Medical
Prescribing. Accessed 1 August 2013 at http://www.dhsspsni.gov.uk/non-medical-prescribing
15.
Medicines and Healthcare Products Regulatory Agency (MHRA). Black Triangle Scheme. Accessed
1
August
2013
at
http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthesafetyofproducts/Medicines/BlackTriang
leproducts/index.htm
16.
The Human Medicines Regulations 2012, SI 1916.
http://www.legislation.gov.uk/uksi/2012/1916/contents/made
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
Accessed
2
August
2013
at
February 2014
18
17.
NHS
England.
Patient
Group
Directions.
Accessed
1
August
http://www.medicinesresources.nhs.uk/en/Communities/NHS/PGDs/About-us/
18.
NHS
Scotland.
Patient
Group
Directions.
Accessed
1
August
2013
at
http://www.nes.scot.nhs.uk/education-and-training/by-theme-initiative/prescribing-and-patient-groupdirection/patient-group-directions.aspx
19.
Health in Wales. Accessed 1 August 2013 at http://www.wales.nhs.uk/
20.
Medicines and Healthcare Products Regulatory Agency (MHRA). Patient Group Directions in the
NHS.
Accessed
1
august
2013
at
http://www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingandsupplyingofmedic
ines/ExemptionsfromMedicinesActrestrictions/PatientGroupDirectionsintheNHS/index.htm
21.
The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential,
Transitional and Saving Provisions) Order 2013, SI 235. Accessed 2 August 2013 at
http://www.legislation.gov.uk/uksi/2013/235/contents/made
22.
National Prescribing Centre (NPC)(2009). Patient Group Directions: A practical guide and framework
of competencies for all professionals using patient group directions. Accessed 1 August 2013 at
http://www.npc.nhs.uk/non_medical/resources/patient_group_directions.pdf
23.
Nursing & Midwifery Council (2009) Record keeping guidance for nurses and midwives. Accessed 1
August 2013 at http://www.nmc-uk.org/Documents/NMC-Publications/NMC-Record-KeepingGuidance.pdf
24.
General Medical Council (2013). Good Practice in Prescribing and Managing Medicines and
Devices. Accessed 1 August 2013 at http://www.gmc-uk.org/guidance/ethical_guidance/14317.asp
25.
Medicines and Healthcare Products Regulatory Agency (MHRA). Yellow Card Scheme. Accessed 1
August 2013 at https://yellowcard.mhra.gov.uk/
26.
FPA (Family Planning Association www.fpa.org.uk
27.
National Institute for Clinical Excellence (2013). Good Practice Guidance 2. Patient Group Directions.
th
Accessed 11 February 2014 http://publications.nice.org.uk/patient-group-directions-gpg2
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
2013
at
February 2014
19
Other sources of information:
BMJ Group / Pharmaceutical Press (2013). British National Formulary (BNF) Edn 65. BMJ/Pharmaceutical
Press: London. Accessed March 2013 at www.bnf.org
Care Quality Commission (2010). Essential standards of quality and safety. Accessed 1 August 2013 at
http://www.cqc.org.uk/sites/default/files/media/documents/gac_-_dec_2011_update.pdf
Department of Health (2000). An Organisation with a Memory: Report of an Expert Group on Learning from
Adverse Events in the NHS. Accessed 2 August 2013 at
http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/d
h_digitalassets/@dh/@en/documents/digitalasset/dh_4088948.pdf
Department of Health (2005). Medical Foundation for Aids and Sexual Health (MedFASH) Recommended
Standards for Sexual Health Services. Accessed 2 August 2013 at
http://www.medfash.org.uk/uploads/files/p17abl5efr149kqsu10811h21i3tt.pdf
Department of Health (2006). Medicines Matters - A guide to current mechanisms for the prescribing, supply
and administration of medicines. Accessed 2 August 2013 at
http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/d
h_digitalassets/@dh/@en/documents/digitalasset/dh_064326.pdf
Department of Health, Social Security and Public Safety (2003). Medicines Management Standard (Safe and
Secure Handling of Medicines). Accessed 2 August 2013 at http://www.dhsspsni.gov.uk/medicines_03.pdf
Faculty of Sexual And Reproductive Health (2012). Service Standards on Confidentiality. Accessed 2 August
2013 at http://www.fsrh.org/pdfs/ServiceStandardsConfidentiality.pdf
Medicines Act 1968 (as amended). Accessed 2 August 2013 at
http://www.legislation.gov.uk/ukpga/1968/67/contents
National Patient Safety Agency (2010). Vaccine Cold Storage Rapid Response Report 008. Accessed 1
August 2013 at http://www.nrls.npsa.nhs.uk/alerts/?entryid45=66111
National Patient Safety Agency website. Accessed 1 August 2013 at http://www.nrls.npsa.nhs.uk
National Prescribing Centre (2002). Modernising Medicines Management: A guide to achieving benefits for
patients, professionals and the NHS. Executive summary and parts one and two accessed 1 August 2013 at
http://www.npc.nhs.uk/developing_systems/intro/resources/library_good_practice_guide_mmmexecutive_su
mmary_2002.pdf,
http://www.npc.nhs.uk/developing_systems/intro/resources/library_good_practice_guide_mmmbook1_2002.
pdf and
http://www.npc.nhs.uk/developing_systems/intro/resources/library_good_practice_guide_mmmbook2_2002.
pdf
NHS Litigation Authority (2013). NHSLA Risk Management Standards 2013-14 for NHS Trusts providing
Acute, Community, or Mental Health & Learning Disability Services and Non-NHS Providers of NHS Care.
Accessed 1 August 2013 at
http://www.nhsla.com/safety/Documents/NHS%20LA%20Risk%20Management%20Standards%20201314.doc
The Medicines for Human Use (Miscellaneous Amendments) (No.2) Regulations 2009, SI 3063. Accessed 1
August 2013 at http://www.legislation.gov.uk/uksi/2009/3063/contents/made
The Prescription Only Medicines (Human Use) Amendment Order 2003, SI 696. Accessed 2 August 2013 at
http://www.hmso.gov.uk/si/si2003/20030696.htm
Service Standards for Medicines Management in
Sexual and Reproductive Health Services
February 2014
20