MEDICINES PURCHASING FOR SAFETY POLICY
Version
2
Name of responsible (ratifying) committee
Formulary and Medicines Committee
Date ratified
16 January 2015
Document Manager (job title)
Director of Medicines Management and Pharmacy
Date issued
06 February 2015
Review date
31 January 2018
Electronic location
Clinical Policies
Related Procedural Documents
Medicines Management Policy; Unlicensed Medicines
Policy; Adverse Drug Reaction Reporting Guidelines;
Policy for the Management of Adverse Events and
Near Misses (including Serious Untoward Incidents)
Key Words (to aid with searching)
Medicines, Purchasing, Safety, Procurement, Drugs
Version Tracking
Version
Date Ratified
Brief Summary of Changes
Author
1
20.11.2009
Initial Document
Bhulesh Vadher
2
16.01.2015
Review and rewrite
Richard Eyles
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
Page 1 of 12
CONTENTS
QUICK REFERENCE GUIDE ............................................................................................................. 3
INTRODUCTION ................................................................................................................................ 4
PURPOSE .......................................................................................................................................... 4
SCOPE ............................................................................................................................................... 4
DEFINITIONS ..................................................................................................................................... 4
DUTIES AND RESPONSIBILITIES ..................................................................................................... 6
PROCESS .......................................................................................................................................... 7
MEDICATION ERROR / RISK REPORTING SYSTEM ....................................................................... 8
TRAINING REQUIREMENTS ............................................................................................................. 8
REFERENCES AND ASSOCIATED DOCUMENTATION ................................................................... 8
EQUALITY IMPACT STATEMENT ..................................................................................................... 9
MONITORING .................................................................................................................................. 10
APPENDIX 1 - MEDICINE ERROR, INCIDENT AND DEFECT REPORTING SYSTEMS ................. 11
APPENDIX 2 - PURCHASING OPIOID MEDICINES FOR SAFETY ................................................. 12
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
Page 2 of 12
QUICK REFERENCE GUIDE
For quick reference the guide below is a summary of actions required. This does not negate the need
for the document author and others involved in the process to be aware of and follow the detail of this
policy.
1. PHT will endeavor to purchase licenced products rather than unlicenced alternatives as
the first choice to treat patients
2. If possible medicines will be purchased using a CMU or Regional contract.
3. Where possible all contracted medicines will be assigned a MEPA score by QA
specialists
4. All purchases of medicines must be from an approved pharmaceutical supplier
5. Products purchased will be reviewed in light of any incidents reported where the product
itself was a contributory factor.
6. Use of unlicensed products will be reviewed annually to assess the appropriateness of
their use and the existence of satisfactory licenced alternatives.
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
Page 3 of 12
1. INTRODUCTION
The use of all medicines may not only incur a risk of an adverse drug reaction (ADR) but also of
a clinical incident such as an inappropriate reconstitution or administration error. These types of
medication error risks can and should be minimised by “Purchasing for Safety” in the first
instance.
All NHS pharmacy staff assume a duty of care when supplying a medicine. In order to reduce
the number/frequency of incidents caused by medication errors it is essential that all risks are
identified and assessed. Following risk identification and assessment action must be taken to
minimise the possibility of a patient safety incident
Effective procurement of the right medicine is an important tool in the risk reduction process.
This includes Clinical Pharmacists not only assessing a product's clinical effectiveness and
ADR potential but also it's safety in use when responding to a request for a new medicine.
Medicines should only be purchased if they are of a suitable quality, safe to use and fit for
purpose. Moreover it is essential that the procurement process assesses the capabilities of the
supply chain to the hospital to ensure that products are genuine, have been correctly stored
and are available when required.
2. PURPOSE
The purpose of this policy is to provide a consistent trust-wide approach to the safe and timely
procurement of medicines including opioids (as a result of NPSA 2008 RRR05 Reducing
Dosing Errors with Opioids – see Appendix 2) and any subsequent alerts which include specific
Purchasing for Safety guidance which ensures the timely provision of medication and that
relevant legislation and government guidance is adhered to.
3. SCOPE
This policy applies to all medicines purchased for Portsmouth Hospitals NHS Trust and all staff
involved in medicines management from the decision to purchase to the point of administration.
‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises
that it may not be possible to adhere to all aspects of this document. In such circumstances,
staff should take advice from their manager and all possible action must be taken to
maintain ongoing patient and staff safety’
4. DEFINITIONS
Adverse Drug Reaction (ADR)
Any noxious, undesired, or unintended response to a drug, which occurs at dosages used for
prophylaxis, diagnosis, therapy, or modification of physiologic functions
CE Mark
a symbol applied to products to indicate that they conform with relevant EU directives regarding
health and safety or environmental protection
Commercial Medicines Unit (CMU)
Part of the Department of Health responsible for National and Regional contracting for
Medicines.
Duopoly
A situation in which two companies owns all or nearly all of the market for a given type of
product or service.
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
Page 4 of 12
Generic Medication
A term to identify non-brand name medications. Typically, a generic medication is a
pharmaceutical equivalent to a branded medication product and has identical strength, dosage
form, and concentration.
JAC
The PHT Pharmacy Medicines Management and Electronic Prescribing Solution
Licensed Medicine
Medicinal product for human use, which has been determined by the MHRA to be industrially
produced for marketing purposes, have required efficacy, reliability and quality for human use.
Medicines legislation (specifically The Medicines for Human Use Regulations 1994/SI 3144)
requires that medicinal products are licensed before they are marketed in the UK.
Medecator
A web-based pharmaceutical e-procurement solution provided by AAH
Medication Error Potential Assessment (MEPA)
A risk score that reflects a product's suitability for use, based upon a wide number of factors
e.g. clarity of labelling, packing, availability of patient information
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK government agency responsible for ensuring that medicines and medical devices work,
and are acceptably safe.
Monopoly
A situation in which a single company owns all or nearly all of the market for a given type of
product or service.
National Reporting and Learning System (NRLS)
The world’s most comprehensive database of patient safety information, the successor to the
National Patient Safety Agency
Pharmaceutical Market Support Group (PMSG)
An operational sub-committee of the National Pharmaceutical Supply Group
Pharmacy Manufacturing Unit (PMU)
PHT's MHRA licenced pharmaceutical manufacturing unit based at Farlington
Powergate
Independent commercial e-procurement software
Quality Assurance (QA)
A system under which it is ensured that all products and services are of high quality and will
satisfy the expectations of patients, carers and health care professionals.
Reconstitution
The preparation of a drug using a diluent for administration to a patient.
Regional Drug Purchasing Centre (RDPC)
The PHT Pharmacy Procurement and Distribution Hub
The Trust (PHT)
Portsmouth Hospitals NHS Trust
Unlicensed
Medicine
A medicinal product not licensed for use with the UK by the MHRA; but may be used by
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
Page 5 of 12
individual patients on the direct personal responsibility of a doctor or dentist registered in the
UK.
5. DUTIES AND RESPONSIBILITIES
5.1 Regional and National Quality Control
5.1.1 Assesses contracted products according to an assessment tool developed by the
National NHS QA Committee and attributes a MEPA score to each product. All medicines
included onto a NHS CMU contract have a product licence or are CE marked.
5.1.2 Will upload product assessments onto the PharmaQC database which is accessible by
the Pharmacy Department.
5.2 Pharmaceutical Market Support Group
5.2.1. Ensures that all awards made for CMU contracted lines do not introduce any additional
risk into the supply chain.
5.2.2. Utilises supplier performance measurement as undertaken by NHS CMU when
adjudicating awards. Where possible, those suppliers who provide not only the highest quality
product but also the best price and service are awarded contracts.
5.2.3. Ensures that National guidance such as that from the NRLS and MHRA is taken into
consideration at the adjudication stage.
5.2.4. Ensures that market management is delivered by ensuring monopoly or duopoly markets
are not created as part of the adjudication process for critical pharmaceutical products.
5.3. Regional Procurement Lead
5.3.1. Is responsible for representing the views of the Wessex & Thames Valley Region at
PMSG in relation to preferred suppliers for generic awards.
5.3.2. Leads tenders for the region for products not covered by CMU contracts.
5.3.3. Feeds back concerns and general procurement issues from the region's members to
relevant National committees.
5.4. Formulary and Medicines Committee
5.4.1. Is the ratification forum for this policy and is responsible for ensuring that the safety
considerations are taken into account for any new product requests.
5.4.2. Provides feedback to the author of the document. If amendments are required these
must be completed and the document re-submitted to the Committee.
5.5. Director of Medicines Management and Pharmacy
5.5.1. Has responsibility for ensuring processes are in place to support this policy
5.5.2. Will ensure that all the medicines management systems in the Trust are efficient and
robust.
5.5.3. Will ensure that systems to reduce the risk of medication errors are built into medicine
management processes and so safety will occur as a matter of course.
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
Page 6 of 12
5.5.4. Will ensure that National best practice will be utilised to develop systems to limit the risk
of medication errors.
5.6. Clinical Pharmacists
5.6.1. Will ensure that the appropriate level of clinical/pharmaceutical scrutiny is carried out
when presented with a request to provide a new drug for a patient.
5.7. The Pharmacy Department Procurement Lead
5.7.1. Will endeavour to purchase licenced products rather than unlicenced alternatives as the
first choice to treat patients.
5.7.2. Will ensure that where feasible that all orders for pharmaceuticals are placed for lines
contracted by NHS CMU or Regional Contracts where available.
5.7.3. Will ensure that where feasible ‘ready to use’ products are purchased.
5.7.4. Will report products which are deemed not suitable for use within the Trust to CMU.
5.7.5. When purchasing generic products off-contract, will obtain as first line, products
assessed by QA and listed on the PharmaQC database as suitable alternatives. Where
overlabelled or pack-down products are required this work will be placed with PHT PMU.
Where PMU is unable to undertake this work e.g. due to capacity or capability issues, the
requesting pharmacist will undertake a risk assessment exercise in conjunction with the
Pharmacy Risk Team to consider alternatives e.g. other drugs, dispensary pack-down etc.
6. PROCESS
6.1. All purchases for medicinal products will be made from trusted sources of supply to ensure
the suitability of products purchased and minimise the possibility of counterfeit medicines.
6.2. Suppliers and wholesalers are required to hold an appropriate licence from the MHRA and
this will be checked for authenticity by the pharmacy procurement staff.
6.3. The government holds a list of inspected suppliers who hold or have successfully held a
public sector contract; this data base (SID) is held on their website at
https://sid4gov.cabinetoffice.gov.uk/. This may be utilised by the pharmacy procurement staff to
check the status of any new suppliers prior to including the supplier onto the pharmacy system.
6.4. Any concerns with a supplier will be raised with CMU and if deemed necessary audit
reports undertaken to access the supplier performance.
6.5. Safe and secure methods of procurement (e.g. e-procurement via Powergate/Medecator)
should be utilised to minimise the potential for error during the process. Telephone orders
should be used as a last resort or in an emergency. The trading status of suppliers not set up
on JAC to trade electronically should be reviewed annually. Suppliers should only be moved to
e-procurement if they can show that the chosen method feeds directly into their stock control
system and therefore eliminates re-keying errors.
6.6. New products, including unlicenced manufactured products and unlicenced imports, should
be entered on JAC by the Pharmacy IT Team upon receipt of an appropriately completed form
to ensure that all products are described to the same standards.
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
Page 7 of 12
7. MEDICATION ERROR / RISK REPORTING SYSTEM
7.1. Systems for reporting patient safety incidents and defects in medicine and medical devices
will integrate with the Trust clinical governance reporting streams.
7.2. External reporting schemes as outlined in Appendix 1 will be actioned where relevant by
pharmacy staff.
8. TRAINING REQUIREMENTS
Training of staff will occur at induction, and during appropriate update training. On-call
pharmacists will be trained prior to commencing their on-call duties. A copy of this policy should
also be available to consult if guidance is needed
9. REFERENCES AND ASSOCIATED DOCUMENTATION
Alert 20. Safer Practice with injectable medicines. 2007. National Patient Safety Agency
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59812
Reducing Dosing Errors with Opioids 2008 National Patient Safety Agency
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59888
Ensuring safer practice with high dose ampoules of diamorphine and morphine - Safer Pratice
Notice 2006 National Patient Safety Agency
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59803
Pharmaceutical Market Support Group (PMSG)
http://nww.cmu.nhs.uk/Medicines/Strategicgroups/pages/PharmaceuticalMarketSupportGroup.
aspx
Quality Assurance And Risk Assessment Of Licensed Medicines For The NHS NHS
Pharmaceutical Quality Assurance Committee
http://www.qcnw.nhs.uk/docs/QA%20&%20Risk%20Assessment%20of%20licensed%20Medici
nes%20for%20the%20NHS.pdf
PharmaQC Database http://nww.cmu.nhs.uk/Medicines/pharmaQCdatabase/LandingPage.htm
Purchasing for Safety Project: Injectable Medicines CMU
http://nww.cmu.nhs.uk/Purchasingforsafetyinjectablemedicines/Pages/LandingPage.aspx
Duthie Report Royal Pharmaceutical Society http://www.rpharms.com/supportpdfs/safsechandmeds.pdf
Medicines Management Policy PHT http://www.porthosp.nhs.uk/Downloads/Policies-AndGuidelines/Clinical-Policies/Medicines_Management.doc
Adverse Drug Reaction – Drug Therapy Guideline PHT
http://pht/Departments/Pharmacy/Drug%20Therapy%20guidelines/Adverse%20Drug%20Reacti
on%20Reporting.doc
Policy for the Management of Adverse Events and Near Misses PHT
http://www.porthosp.nhs.uk/Downloads/Policies-And-Guidelines/ManagementPolicies/Adverse_Incidents_and_Near_Misses_Management_Policy.doc
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
Page 8 of 12
10. EQUALITY IMPACT STATEMENT
Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably
practicable, the way we provide services to the public and the way we treat our staff reflects
their individual needs and does not discriminate against individuals or groups on any grounds.
This policy has been assessed accordingly
Our values are the core of what Portsmouth Hospitals NHS Trust is and what we cherish. They
are beliefs that manifest in the behaviours our employees display in the workplace.
Our Values were developed after listening to our staff. They bring the Trust closer to its vision
to be the best hospital, providing the best care by the best people and ensure that our patients
are at the centre of all we do.
We are committed to promoting a culture founded on these values which form the ‘heart’ of our
Trust:
Respect and dignity
Quality of care
Working together
No waste
This policy should be read and implemented with the Trust Values in mind at all times.
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
Page 9 of 12
11. MONITORING COMPLIANCE
This document will be monitored to ensure it is effective and to assurance compliance.
Minimum requirement
to be monitored
Lead
Tool
Frequency of
Report of
Compliance
Suppliers have the
appropriate MHRA licence
to supply medicines
Specialist
Pharmacist IT
&
Procurement
Website
Annual
Supplier electronic trading
status reviewed for
appropriateness
Specialist
Pharmacist IT
&
Procurement
Medecator &
Powergate
Annual
Medication Errors related
to issues identified in this
policy
Risk
Pharmacist
Datix
Annual
Unlicenced Products
Review
Risk
Pharmacist
JAC
Reporting arrangements
Lead(s) for acting on
Recommendations
Policy audit report to:
Specialist Pharmacist IT &
Procurement
Pharmacy Procurement
Operations Manager
 Director of Medicines
Management and Pharmacy
Policy audit report to:
 Director of Medicines
Management and Pharmacy
Policy audit report to:
 Director of Medicines
Management and Pharmacy
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
Annual
Policy audit report to:
 Director of Medicines
Management and Pharmacy
Page 10 of 12
Pharmacy Procurement
Operations Manager
Specialist Pharmacist IT &
Procurement
Pharmacy Procurement
Operations Manager
Clinical Pharmacy Leads
APPENDIX 1 - MEDICINE ERROR, INCIDENT AND DEFECT REPORTING SYSTEMS
What systems are there and when to use them
When to Use
Reporting
System
MHRA
Defective
Medicines
Reporting
Centre
Suspected or actual product defect
where patient safety clearly at risk.
Guidance from the MHRA here
http://www.mhra.gov.uk/home/group
s/islic/documents/publication/con00757
2.pdf
Examples
(not
exhaustive
list)
Serious
unexpected
reaction.
Severe, visible
microbial or
particulate
contamination.
Suspected
counterfeit
product
Report Sent
To
Contact Information
MHRA
Defective
Medicines
Reporting
Centre
Telephone:
020 3080 6574
(08:45 - 16:45
weekdays)
07795 641532 for
urgent calls outside of
normal working hours,
at weekends or on
public holidays.
Email:
dmrc@mhra.gsi.gov.uk
Quality
Assurance
Defect
Reporting
Scheme
Product defects which are quality
assurance in nature, with no
immediate severe risk to patient
safety. Defects reported to the
MHRA should also be copied to
CMU for contract lines
ProMS
(Potential
Risk of
Medication
Selection)
Incidents where products have been
selected or supplied incorrectly,
where issues relating to packaging
design and presentation are felt to
be contributory factors.
CMU
Issues relating to supply of
medications purchased through
CMU contracts.
Empty blister
in strip.
Missing batch
number or
expiry date,
particulate
contamination.
Defective
unlicenced
medicines
should also be
reported.
Selection of
lookalike and
sound-alike
drugs.
Manufacturer's
packaging has
poor
differentiation
between
different
products or
strengths.
Change in
manufacturer
of product
supplied.
Financial and
contractual
issues.
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
Inform
manufacturer.
If necessary
send sample
to an NHS
Regional QA
service
Send to an
NHS
Regional QA
Service
As for minor defects
above.
Relevant
CMU buyer
for Trust
concerned.
See contact details for
individual buyers.
https://www.gov.uk/gov
ernment/collections/co
mmercial-medicinesunit-cmu
In addition these must
be reported via the
Trust Incident Reporting
process via Datix
Page 11 of 12
APPENDIX 2 - PURCHASING OPIOID MEDICINES FOR SAFETY
Introduction
This procedure for purchasing opioids safely is based on the NPSA Safer Practice Notice 12
“Ensuring safer practice with high dose ampoules of diamorphine and morphine” and
NPSA/2008/RRR05 “Reducing dosing Errors with Opioid Medicines”
This procedure covers the procurement of:
Buprenorphine,diamorphine, dipipanone, fentanyl,
morphine, oxycodone, papaveretum and pethidine
hydromorphone,
meptazinol,
methadone,
Procedure
There are significant and potentially fatal risks associated with the procurement, prescribing, supply
and administration of opioid medicines, particularly when there are:
a)
b)
c)
d)
e)
different concentrations of an opioid e.g. injections, oral solutions e.g. Oramorph oral
solution 10mg/5ml and 100mg/5ml
different brands of the same opioid e.g. MST and Zomorph
different formulations of an opioid e.g. once a day or twice a day controlled release
morphine preparations e.g. MST and MXL
similar packaging of different strengths or concentrations of the same opioid
similar names of the same opioid e.g. Oxynorm and Oxycontin
For these reasons the following steps are taken to ensure safe procurement of opioid medicines:
1.
The procurement of the majority of opioids for the Trust is driven by NHS CMU via
Regional or National contracts. Contracts for opioids are awarded following advice from Quality
Control and senior pharmacy representatives from all Trusts at adjudication meetings. Locally the
representative for PHT is the RDPC Operations Manager.
2.
a)
b)
Contracts for opioids are awarded taking into account the following criteria:
the quality and clarity of labelling and packaging
presentation and appropriateness to clinical practice e.g. ampoules, vials or pre-filled
syringes
c)
d)
e)
bio-equivalence between different brands
supplier performance
cost
3.
The impact of the awarding of these contacts on PHT is assessed by the Specialist
Pharmacist for IT & Procurement.
4.
Responsibility for the procurement of opioids outside of CMU contracts rests with the
Specialist Pharmacist for IT & Procurement or the Chief Pharmacist.
5.
If there are communication or clinical safety issues to consider due to a change in
contract or the requirement to purchase off-contract then these are either referred to the Area
Prescribing Committee or Medicines Safety Committee, as appropriate
6.
The range of epidural opioid/local anaesthetic infusion products procured by pharmacy is
agreed by the Clinical Director of Anaesthetics and ratified by Medicines Safety Committee.
7.
All requests for new opioids or new presentations of existing opioids must be made via
the Area Prescribing Committee following the New Drugs Application procedure
Medicines Purchasing for Safety Policy
Version: 2
Issue Date: 06 February 2015
Review Date: 31 January 2018 (unless requirements change)
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