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CD register
This is probably the most important legal record in the
pharmacy in relation to supply records. Not only
the supply but also the receipt of all CD schedules
one and two are recorded here as a legal requirement
of the Misuse of Drugs Act 1971. Again, they are
found in both the hospital and community pharmacy
and must be kept on the premises for 2 years from the
date of last entry. Discrepancies in the CD register can
lead to serious consequences. If unresolved, there
may be an investigation by the primary care organization (PCO) and the police. As a result of this, all
written entries must be in indelible ink with no cancellations, alterations or obliterations. Any corrections must be made by a dated footnote to prevent
unlawful supplies and create an audit trail. The legal
requirements for the format of the register and information to be recorded can be found in the MEP.
Extemporaneously prepared
medicines
Medicines are sometimes prepared and compounded
by pharmacists in response to a prescription in the
community or hospital pharmacy. This does not include the reconstitution of powders. The RPSGB has
set out guidance in relation to this service which can
be found in the MEP. This service is a type of manufacture which, in the case of pharmaceutical companies, is regulated by the Medicines and Healthcare
products Regulatory Authority (MHRA). Pharmacists
are not subject to these regulations as the manufacture is only small scale; however, the product must be
prepared accurately and meet quality standards.
A product should only be prepared extemporaneously if there are no appropriate licensed products
available. Records of the manufacture must be made,
usually in a bound book used solely for that purpose.
The record is made as an audit trail to be kept for a
minimum of 2 years, but if possible 5 years, and
should include the following:
*
Formula
*
Ingredients
T Quantities
T Source
T Batch number
T Expiry date
*
The personnel involved in the manufacture
*
The pharmacist taking overall responsibility
Record keeping CHAPTER 15
*
Date of dispensing and patient’s and prescription
details if in response to a prescription
Supply of unlicensed medicinal
products (‘specials’)
Some products may need to be compounded by a
specials manufacturer, as there is a safety risk associated with the manufacture or if it is not possible to
prepare the product accurately in the pharmacy.
These products are referred to as ‘specials’. The request for a special can only be made on the order of an
appropriate prescriber, and they should be made
aware that the product is unlicensed. The Medicines
Control Agency (MCA) issued guidance in 2000
about the records the pharmacist should make with
respect to the supply of specials. This is as follows:
*
The source of the special
*
The person to whom the product is supplied
*
The date of the supply
*
The quantity supplied
*
The batch number
*
Details of any adverse drug reactions.
These details should be kept for a period of 5 years
and be available for inspection; however, the format or
place of the record is not specified.
Poisons book
Pharmacists are able to supply non-medicinal poisons
within the pharmacy. In law a poison is defined as a
substance listed in the Poisons Act. It is not very
common to supply poisons, but would be more likely
in a rural pharmacy. The different poisons can only be
supplied for specified purposes and the purchaser
may need a certificate or form of authority and a
signed order for the purchase of the poison. The pharmacist must keep a record of the supply in the poisons
book and the signature of the purchaser is needed
either in the register or on a signed order. The register
must be kept for 2 years from the date of last entry, as
must any certificates. The particulars to be recorded
can be found in the MEP.
Clinical governance records
Clinical governance is the process by which professionals are acco untable for continually improving
the quality of their services and maintaining high
149
SECTION TWO Governance and good professional pharmaceutical practice
standards. It relies on learning from experiences
and therefore being open and honest is essential.
It is a combination of a number of processes including accountability, audit, clinical effectiveness, patient and public involvement, remedying
underperformance, risk management, staff management and continuing professional development (CPD). This process binds all professionals
within the heathcare environment. Clinical governance is covered in more detail in Chapter 8;the
focus here is on record keeping associated with
clinical governance. Some examples are described
below.
Audit
Audit is the process of systematic evaluation of work
against set standards. In the pharmacy many processes
will need to be audited and the results may be used
internally or externally, e.g. by the PCO. The results
of the audit need to be documented and may result in
change in policies or standard operating procedures
(SOPs).
PMRs
PMRs can be considered as records of supply as well
as clinical governance records. Within clinical governance, PMRs enable pharmacists to be clinically
effective. In order for PMRs to be useful to pharmacists they need to be up to date, accurate and contain as much detail as possible about the patient’s
medication history. The system used must have access control mechanisms, be able to identify drug
interactions and highlight those that are more serious. There are minimum specifications for the contents of PMRs set out in the MEP with respect to
identification of the patient, patient’sGPandprescription details. However, the pharmacy contract
requires more information about patients to be
recorded with regards to advice and counselling
given by pharmacists.
Risk management
Risk management can encompass many aspects of the
service delivery and will apply to both hospital and
community pharmacy. Examples of risk management
procedures include:
Standard operating procedures (SOPs)
These documents should relate to all the work processes within the pharmacy and how they should be
carried out to ensure the least risk and greatest
effectiveness. The process should be portrayed in
a stepwise manner and written so that even people
with no experience can carry it out by following the
SOP.AllSOPsneedtobesignedbytheaccountable pharmacist and all staff working in the dispensary need to be trained regularly on the SOPs and a
record of the training should be made in a training
matrix.
Complaints procedure
There is an NHS complaints procedure and this
applies to both hospital and community pharmacy.
Complaints can be made orally or in writing. In the
case of an oral complaint, a record of the complaint
must be made including the name of the person making the complaint, subject of the complaint and the
date on which it was made. If written, a record of the
date on which the complaint was received must
be made. A written response must be made within
2 days of the date of the complaint. The complaint
should then be investigated and resolved appropriately. A record of all correspondence or phone calls to the
complainant should be kept.
Error reporting and near misses
A near miss is defined as an error in the dispensing
process which is identified before the medicine
reaches the patient. All near misses should be logged
and audited in line with company and RPSGB policy.
The outcome of the audit should be implemented and
a record should be made, and if it results in a change in
procedure the SOPs must be updated. Any incident
that results in patient involvement needs to be logged,
and as of April 2005, reported to the National Reporting and Learning System (NRLS). The information should be logged on a reporting form that has
the minimum information required by the NRLS.
Serious incidents will be reported anonymously to
the National Patient Safety Agency (NPSA) via the
NRLS. Pharmacists need to demonstrate evidence of
recording, reporting, monitoring, analysing and learning from patient safety incidents. The incident may be
reported to the NRLS via the organization’s risk management office (pharmacy superintendent office in
large multiples), via the NPSA website or via the
PCO.
150
Record keeping CHAPTER 15
Control of Substances Hazardous to
Health (COSHH) Regulations 2002
All work places must conduct risk assessments and
produce safety precautions with relation to dangerous substances. A ha zardous substance includes anything that can cause risks to health and safety. There
is no one list of substances. Common substances can
be found in Health and Safety Executive (HSE)
guidance documents and Chemicals Hazard Information and Packaging (CHIP) for Supply Regulations. Even dust can be classed as a dangerous
substance if the concentration in the air exceeds
certain limits.
In the pharmacy there will be a number of d rugs
or chemicals that are classed as dangerous substances, such as hydrogen peroxide and potassium
permanganate. They can usually be identified by
the warning labels on the packaging as directed by
CHIP regulations. Some dangerous substances have
their own regulations such as asbestos, lead and
flammable chemicals and therefore COSHH does
not apply. There are eight steps to carry out to
comply with COSHH regu lations which are listed
in Box 15.2.
COSHH assessments can be recorded on paper or
electronically. They should include why the risks
identified are significant or not, the control measures
and plans that apply to the substance. The COSHH
assessment is a working document and should be
updated every time there is a significant change, although most pharmacies will update the COSHH
assessment once a year. External bodies such as health
and safety officers may request records of COSHH
assessment.
Box 15.2
Steps to carry out to comply with COSHH
regulations
1. Assess the risks
2. Decide what precautions are needed
3. Prevent or adequately control exposure
4. Ensure control measures are used and maintained
5. Monitor exposure
6. Carry out appropriate health surveillance
7. Prepare plans and procedures to deal with
accidents, incidents and emergencies
8. Ensure employees are properly informed, trained
and supervised
CPD
This is a large part of clinical governance for which the
pharmacist must take his or her own responsibility.
Records tend to be kept at home and not in the pharmacy. The records may be kept on paper or electronically. Not only will a CPD cycle need to be
completed, a portfolio of evidence supporting the
cycle will also be required. More information about
CPD can be found in Chapter 10.
Consultation records
Consultation records are a new concept for pharmacists and have come about as a result of the expanding
role of pharmacists. The more services pharmacists
provide, the more records they will need to keep.
What to record may be specified and there may be a
form to fill in but some of the time the pharmacist will
need to decide what is relevant to record and where to
record it. This section addresses the records kept for
patient group directions (PGDs), services and the
requirements of the pharmacy contract.
PGDs and services
Most PGDs and services that pharmacists can provide
require some kind of training and accreditation by the
PCO and involve the supply of a drug, usually a POM,
to the patient under NHS payment agreements. All
the terms of the service will need to be kept on the
premises and this will specify the types of records
required to provide the service. Each service will have
its own requirements but they will encompass
requirements of current legislation, namely the Medicines Act 1968. They may also require notes on the
consultation in question, which may look more like a
case history, much like doctors’ notes.
The Pharmacy Contract 2005 in
England
There are three tiers of services provided within this
contract which are essential, advanced and enhanced
services. The essential services include day-to-day dispensing, counselling and the provision of advice.
These are services that pharmacists have already been
providing. Now pharmacists need to provide evidence
of this advice and counselling. MURs are currently the
151
SECTION TWO Governance and good professional pharmaceutical practice
only advanced service to be introduced. An example
of enhanced services is the provision of free emergency hormonal contraception via a PGD, and records of
this need to be kept, as discussed above.
Any interventions made or advice and counselling
given to patients known to the pharmacist that can be
classed as clinically significant need to be recorded by
the pharmacist in the PMR. Clinically significant
could be described as when the action taken has a
direct impact on patient care, which encompasses
most counselling, advising and interventions made
by pharmacists. The information recorded needs to
be sufficient for another person to understand why,
when, who and how this consultation took place. The
following need to be recorded in PMRs for essential
services:
*
Supplies of medicines and appliances dispensed
to patients
*
Advice given and interventions made on prescribed
medication
*
Owed prescription medicines
*
Advice given and interventions made on repeat
dispensed medicines with clear audit trails
*
Opportunistic advice on healthy living and public
health, especially in patients with diabetes,
coronary heart disease or high blood pressure and
patients who smoke or are overweight
*
Referrals to other health, social or support
organizations using the signposting document given
by the PCO
*
Self-care purchases and referrals.
Some of these will also need recording on a specific
form and be filed accordingly, such as the referral
and intervention form, repeat dispensing cardex and
owing dockets.
MURs and prescription
interventions
More information about how to carry out a MUR
or a prescription intervention can be found in Chap-
ter 47.Herewewilldiscusstherecordkeepingissues
around MURs and prescription interventions. There
isastandardformtobefilledinwhencarryingouta
MUR. Care must be taken so that all information is
neat, leg ible and understandable, not only for the
healthcare professional but for the patient as well,
since they should also be given a copy for their own
reference. Abbreviations and jargon should be
avoided where possible and statements that may
alarm patients or damage relationships with doctors
ought to be worded sensitively. Patient, doctor and
pharmacist details should be written in capitals to
avoid misinterpretation.
One copy of the form will need to be kept in the
pharmacy for a minimum of 2 years and filled in an
appropriate manner, and a summary should be entered in the patient’s PMR. One copy will need to
be sent to the GP, usually the top copy, so that they
may be scanned onto the GP’ s patient records. The
third copy should be given to the patient as a reminder of the issues discussed or to be taken to the
GP as a discussion aid. Anonymized MURs and
interventions may be requested by the PCO in order
to check their quality and that they met the service
specifications.
KEY POINTS
*
There are three main types of records to be kept by
pharmacists:
Records of supply
T
Clinical governance records
T
Consultation records
T
*
Some of the records may fit into more than one
of these categories as the boundaries are not
clear cut
*
All record keeping must comply with the Data
Protection Act
*
Most records are legal requirements but the
expanding role of the pharmacist means that, as a
profession, we need to record more and more
information for audit trail and to ensure clinical
effectiveness
*
It can be seen that record keeping is an important
skill pharmacists must acquire
*
This skill will need to be developed further in order
to meet the demands of the expanding roles and
clinical governance
152
Section Three Section Three Section Three Section Thre
e
Section Three
Pharmacy Prescribing and
Selection of Medicines
This page intentionally left blank
Chapter Sixteen
Access to medicines and
prescribing – introduction
Jason Hall
16
STUDY POINTS
*
Independent and supplementary prescribing
*
Patient group directions
*
Minor ailment schemes
*
What influences prescribing
Introduction
The legal constraints introduced in the United Kingdom to limit prescribing of certain medicines for
humans to doctors and dentists remained largely unaltered until 1994 when suitably trained community
nurses were added to the list of professions able to
prescribe a limited range of medicines and appliances
listed in the Nurse Prescribers’ Formulary (NPF). Pri-
or to the introduction of community nurse prescribing
it was recognized that many district nurses were prescribing in all but name as they were instructing GPs
what to prescribe and that much time was wasted
waiting for GPs to write the prescription. The review
of prescribing, supply and administration of medicines
chaired by June Crown in 1999 recommended that
there should be two types of prescriber: the independent prescriber and the dependent prescriber, although the term dependent prescriber has now been
replaced by the term supplementary prescriber (De-
partment of Health 1999). The independent prescrib-
er is responsible for diagnosis and the supplementary
prescriber is responsible for the ongoing care of the
patient in line with an agreed clinical management
plan (CMP). At the start of the 21st century there
were significant changes to non-medical prescribing
with the introduction of different classifications of
nurse prescriber and the extension of prescribing to
suitably trained pharmacists and other healthcare professionals (Department of Health 2006).
Over the years there have been many reports from
the Department of Health outlining the benefits of
non-medical prescribing for patients, doctors and
non-medical prescribers themselves (Department of
Health 1999, 2006). Many of these benefits stem
from having the healthcare professional responsible
for the care of a patient’s condition also writing the
prescription (Box 16.1).
Independent prescribing
Independent prescribers (IP) are responsible for the
diagnosis of the patient and can initiate prescriptions
for patients without referring to other healthcare professionals. They have responsibility for monitoring
and reviewing the patient’s progress. The first group
of independent non-medical prescribers were the
community practitioner nurse prescribers. This was
first introduced in 1994 in eight pilot sites. The
scheme was extended nationwide in 1999. It is open
to nurses holding a district nurse (DN) or health visitor (HV) qualification working in the community,
and this includes a small number of practice nurses
with a DN or HV qualification. Training consisted of 2
days of taught sessions in addition to an open learning
package (approximately 15 hours of study material)
followed by a written examination. This has now been
incorporated into the DN and HV course. These prescribers prescribe from the NPF that can be found in
the British National Formulary (see Box 16.2 for
examples of items in the NPF).
SECTION THREE Pharmacy prescribing and selection of medicines
Box 16.1
Anticipated benefits of non-medical
prescribing
Patients
*
Improved patient access to prescribers
*
More accurate assessment of patient needs
*
Better and quicker access to medicines
Doctors
*
Saves time for doctors
*
Clarifies professional boundaries
Healthcare professionals
*
Improved use of healthcare professional’s time
*
Increased job satisfaction
Box 16.2
Examples of products in the Nurse
Prescribers’ Formulary (NPF) that can be
prescribed by community practitioner nurse
prescribers
Types of product that can
be prescribed
Wound management products Granuflex
Catheter care products Bard, Simpla, etc.
Analgesics Paracetamol
Laxatives Lactulose, phosphate enema
Skin preparations Aqueous cream
In 2002 a new class of nurse prescriber was created; these were originally called extended formulary
nurse prescribers. This opened prescribing to any registered nurse and it originally covered four main areas:
*
Minor ailments
*
Minor injuries
*
Health promotion
*
Palliative care.
Nurses that chose this route to becoming a prescriber
were required to complete a training course which
consisted of 26 taught days and 12 days learning in
practice, which included prescribing under the supervision of a medical prescriber (Department of Health
2006). It should be noted that the taught element of
Examples
Ò
the training programme did not include therapeutics,
i.e. it did not cover what to prescribe for a particular
condition; it did cover how to prescribe in a way that
complied with legal requirements. In 2006 many of
the previous restrictions on extended formulary nurse
prescribers were removed and their name was changed to independent nurse prescribers. The independent nurse prescribers are able to prescribe any
licensed medicine and some controlled drugs. Therefore there is no need for the extended nurse prescriber’s formulary, which is no longer in existence. The
changes in 2006 also paved the way for independent
pharmacist prescribers. Independent pharmacist prescribers can prescribe any licensed medicine except
controlled drugs.
Supplementary prescribing
Supplementary prescribing is viewed by the Department of Health as a voluntary partnership between the independent and the supplementary
prescriber that has the agreement of the patient
(Department of Health 2005). Therefore the patientmustbeinformedregardingtheunderlying
principles of the prescribing partnership by the independent prescriber and give their consent to the
transfer of care to a supplementary prescriber (SP).
The patient does not have to give written consent,
but once consent has been given it should be noted
in the patient’s medical notes.
Providing the patient agrees, there is very little
restriction as to what can be prescribed. The drugs
that can be prescribed by supplementary prescribers
include all ‘prescription only medicines’, ‘pharmacy’
medicines and ‘general sales list’ medicines, although
the NHS prescribers cannot prescribe items listed in
the Black List (Part XVIIIA of the Drug Tariff) at
NHS expense. Controlled drugs and unlicensed medicines were added to the list of drugs that can be
prescribed by supplementary prescribers in May
2005.
An independent prescriber, who must be a doctor
or a dentist, makes the diagnosis. If the independent
prescriber thinks that the patient can be safely managed by a supplementary prescriber then both the
independent prescriber and supplementary prescriber agree a clinical management plan for the patient.
However, the independent prescriber does not discard all their responsibility and must still review the
patient at suitable intervals, which should rarely exceed a year (Department of Health 2005).
156
Access to medicines and prescribing – introduction CHAPTER 16
Figure 16.1*Clinical management plan used in supplementary prescribing.
The clinical management plan is central to supplementary prescribing in that it forms the agreement
between the independent and supplementary prescribers that sets out what the supplementary prescriber
is able to prescribe (Fig. 16.1). Each clinical management plan must be drawn up for a specific named
patient. The nature of the clinical management plan
can vary in terms of its detail and scope. At one end of
the spectrum it could be very specific, allowing only
relatively minor modifications to be made to the original prescription under specified criteria such as increasing the dosage of an antihypertensive drug in
order to reduce blood pressure to a specified level.
At the other end of the spectrum it could be very
open, allowing the supplementary prescriber to prescribe a wide range of drugs in accordance with a
clinical guideline such as the British Thoracic Society’s
guidelines for the management of asthma. The nature
of the clinical management plan will depend upon the
confidence and competence of the supplementary
prescriber in each therapeutic area and also the will-
ingness of the independent prescriber to delegate
the responsibility. The plan also sets out the circumstances that would require referral back to the independent prescriber.
The patients most likely to benefit from supplementary prescribing are those with chronic conditions requiring ongoing care, such as diabetes
mellitus, asthma or hypertension. In addition,
those with uncomplicated conditions rather than
those patients with multiple problems are likely to
be the most suitable candid ates for supplementary
prescribing. In practice the supplementary prescriber is likely to continue prescribing the items initiated
by the independent prescriber until there is a change
in the patient’s condition, provided such items have
been included in the clinical management plan. A
change in the patient’s condition could involve a
deterioration of a chronic progressive condition.
An example of managing the deterioration is stepping up therapy by prescribing an additional item
such as a steroid inh aler (preventer) to an asthmatic
157
SECTION THREE Pharmacy prescribing and selection of medicines
patient who is poorly controlled on a salbutamol
inhaler (reliever) alone (see Ch. 37).
As supplementary prescribers do not diagnose conditions, one might assume that they would be unable
to prescribe for patients presenting with acute conditions. However, they can prescribe items in response to changes in the patient’s condition,
provided such items have been included in the clinical
management plan. A change in the patient’s condition
could involve an acute exacerbation of a chronic condition. An example is prescribing an antibiotic for a
chest infection for a patient with chronic obstructive
pulmonary disease (COPD).
Patient group directions
An alternative way of getting medicines to patients
without writing a prescription involves the use of
patient group directions (PGD). These allow pharmacists, or other healthcare professionals, to supply
named products to patients that meet the inclusion
criteria specified i n the PGD (Department of
Health 1998). The legal definition of a PGD is: ‘A
written instruction for the sale, supply and/or administration of named medicines in an identified
clinical situation. It applies to groups of patients
who may not be individually identified before presenting for treatment.’
Under a PGD, pre-packed licensed medicines can
be supplied to patients who meet the appropriate
inclusion criteria and do not meet any of the specified
exclusion criteria. The PGD must state the qualifications and training required of the staff administering
the PGD, and it must name the medicine(s) that can
be supplied. It must also list any advice that should be
given to the patient, describe the referral procedure
and state the action that should be taken in the case of
a patient suffering an adverse drug reaction (ADR).
The PGD must be reviewed and approved by a team
containing a doctor and a pharmacist.
The Department of Health has made it clear that
the preferred route of getting medicines to patients is
via the issuing of a prescription to a named patient by a
trained and qualified prescriber and that PGDs
should only ever be used where they offer clear advantages to patient care without compromising patient
safety (Department of Health 1998). Situations that
could be suitable for PGDs are those that involve one
off or relatively short courses of standard treatment
(i.e. the PGD operator does not have to select the
drug, dose or formulation). An example of a PGD is
the supply of emergency hormonal contraception
through community pharmacies.
Over the counter medicines
Pharmacists have a long tradition of selling medicines
over the counter to treat minor ailments. In some
situations pharmacists might have a choice regarding
the method of supply of a medicine to treat a patient.
This could be via an over the counter sale, prescribing
a medicine as part of a minor ailment scheme (see
next section) or supply through a PGD. In some of
these situations the exact same product could be supplied and the only differences between the different
methods might be who pays for the treatment and
whether records have to be made. The pharmacist’s
duty of care to the patient does not vary between the
different methods of supply and pharmacists should
not treat an over the counter purchase of medicine
any differently than prescribing a medicine.
When recommending products to patients for over
the counter purchase, the pharmacist is acting as an
independent prescriber, although they can only recommend general sales list (GSL) medicines or pharmacy only (P) medicines. As an independent
prescriber, the pharmacist must go through all the
steps of the prescribing process (see Ch. 17). The
steps include questioning the patient or their carer
to ascertain signs, symptoms and relevant medical
history including prescribed and purchased medicines
that the patient is currently taking, to arrive at a working diagnosis. The patient should be involved in the
decision-making process to achieve concordance, and
appropriate advice given to allow the patient or their
carer to monitor the progress of their treatment and to
know when to seek further help or advice.
Minor ailment schemes
Minor ailments have been described as ‘conditions that require little or no medical intervention’
(see Box 16.3 for a list of minor ailments; Royal
Pharmaceutical Society 2006). It has been recognized
that treatments for minor ailments are responsible for
considerable amounts of GP time and considerable
amounts of NHS expenditure. Minor ailment
schemes have been developed to allow patients to
be seen by community pharmacists to ease the burden
on GPs. There are many schemes in operation and
each scheme is locally agreed by patients, practices,
158