Medicines e-book Flashcards
HMR 2012 (and previously the Medicines Act 1968) allows pharmacists to supply POMs to patients without a prescription at the patient’s request provided the following requirements are met:
- The pharmacist has interviewed the person requesting the POM and is satisfied there is an immediate need, the patient has had the POM previously and the dose is appropriate for them to take
- No greater quantity shall be supplied than will provide 5 days treatment of a Schedule 4 or 5 POM, or phenobarbital or phenobarbital sodium (for the treatment
of epilepsy), or 30 days treatment of other POMs - The pharmacist makes an entry in the POM register
- The container or package is labelled with the required information
- The POM is not specifically excluded from emergency supply provision rules
The pharmacist has interviewed the person requesting the POM
HMR 2012 requires the pharmacist to interview the patient however this isn’t always possible, therefore the RPS recommend that pharmacists use their professional judgement where it is not possible to interview the patient e.g. if it is a child or a house-bound patient.
There must be an immediate need for the medicine and it not be practical for the patient to obtain a prescription – this could be where the GP surgery is closed, and the patient must have previously been prescribed the medicine by an appropriate prescriber.
Pharmacists are required to consider the medical consequences of not supplying a medicine in an emergency and must advise the patient on how to obtain essential medical care where the decision is made not to supply.
Finally, as a pharmacist you must ensure the dose is appropriate for the patient to take and that this is the current dose for the patient. This could be through referral to the patient’s PMR, repeat prescription form, the box from the most recent dispensing or through accessing the patient’s Summary Care Record (SCR). The patient does not have to be a patient at the pharmacy you are working at, but you must be satisfied that the information about the POM is up to date and appropriate.
emergency supply quantity restrictions
Quantity supplied does not exceed 30 days treatment (or 5 days for Phenobarbital or Phenobarbital Sodium for epilepsy, and Schedule 4 and 5 CDs)
When making an emergency supply the quantity should not exceed the quantity that is required to provide 30 days of treatment. There are however exceptions to this:
• For insulin, ointments, creams, or inhalers – give the smallest pack available
• Oral contraceptives – give a full treatment cycle
• Antibiotics in liquid for oral administration – supply the smallest quantity that will provide a full course of treatment
• Schedule 4 and 5 controlled drugs – give a maximum of 5 days
• Phenobarbital or Phenobarbital Sodium – give a maximum of 5 days. Must only be for treatment of epilepsy
It is at the discretion of the pharmacist how much to supply provided the above guidance is not exceeded e.g. the pharmacist could supply enough medication to cover the patient until they are able to obtain a prescription for the POM e.g. 2 days of treatment.
The Pharmacist makes an entry in the POM register
An entry should be made in the POM register no later than the day following the supply detailing:
• The date of supply
• The name, strength, form and quantity of medicine
• The name and address of the patient
• Information on the nature of the emergency, such as why the patient needs the POM and why they cannot obtain a prescription
The container or package is labelled with the required information
The medicine should be labelled as per the standard labelling requirements under HMR 2012, with the addition of the words “Emergency Supply” on the label
The legal requirements for an emergency supply at a prescriber’s request are:
- The pharmacist is satisfied the prescriber is unable to supply a prescription immediately by reason of some emergency
- The prescriber agrees to provide a prescription within 72 hours
- The medicine is supplied in accordance with the directions of the prescriber requesting it
- The POM is not from Schedule 1, 2 or 3 of the Misuse of Drugs Regulations 2001 (except for Phenobarbital for epilepsy) – note that EEA/Swiss prescribers cannot request an emergency supply of any schedule 1,2, or 3 CD or any POM that does not have a UK marketing authorisation
- An entry is made in the POM register stating
a. The date of supply
b. The name, quantity and, where appropriate, the pharmaceutical form and strength
c. The name and address of the practitioner requesting the emergency supply
d. The name and address of the patient
e. Date on the prescription
f. Date the prescription is received in the pharmacy
Who pays for emergency supplies?
As an emergency supply is provided without a prescription, it is at the pharmacist’s discretion whether to charge and how much to charge for an emergency supply. As a guide, an emergency supply could be charged like a private prescription, e.g. the cost of the drug, plus a percentage mark-up and dispensing fee. The RPS advise that this cost should not be a restricting factor in patients receiving medicines that they urgently need, and in some areas, there are NHS services commissioned to cover the cost of emergency supplies.
Emergency Supply Services
At present there are two types of emergency supply service commissioned to community pharmacies; NHS Urgent Medicines Supply Advanced Service (NUMSAS), and locally commissioned emergency supply services. The NUMSAS pilot is due to end in March 2018, with locally commissioned emergency supply services varying from area to area. These services allow patients to obtain emergency supplies at the expense of the NHS rather than at cost to the patient, and the main objectives of these services are to reduce the pressure on GP surgeries and referrals to NHS 111 or out-of-hours services, particularly during the ‘winter pressures’ season.
Licensing of Medicines
- Human Medicines Regulations 2012
- Medicines Act 1968
- Medical Devices Regulations 2002
- EU Regulation on Medical Devices 2017/745
- EU Regulation on In Vitro Diagnostic Medical Devices 2017/746
Who regulates Medicinal Products and Medical Devices?
In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) is the regulator of medicines and medical devices. For Europe this role is undertaken by the European Medicines Agency (EMA). Medicinal products are covered by the Human Medicines Regulations 2012, with medical devices covered by the Medical Devices Regulations 2002, which is in transition to coverage by two new pieces of legislation
Who are the MHRA?
The MHRA are ‘an executive agency of the Department of Health’. The role of the MHRA includes:
• Ensuring medicines, medical devices and blood components meet standards of safety, quality and efficacy
• Maintaining a safe and secure supply chain for medicines, devices and blood components
• Promoting international standardisation of biological medicines
• Educating the public and healthcare professionals about the risks and benefits of medicines, devices and blood components to encourage safe and effective use
• Supporting innovation and research beneficial to public health
• Influencing UK, EU and international regulatory frameworks to ensure they are effective at protecting public health
Medicinal Product or Medical Device?
There is often a blurred line between what is classed as a ‘medicinal product’ and what is a ‘medical device’ – in these cases it will be the claims being made and the mode of action that will decide which regulatory regime will apply.
In order to decide whether a product is considered a medical device or medicinal product, the following should be considered:
• The intended purpose of the product taking into account the way the product is presented
• The method by which the principal intended action is achieved
In the case of a medical device, the principal intended action is typically fulfilled by physical means e.g. mechanical action, physical barrier, replacement of, or support to, organs or body functions. The action of a medicinal product is typically achieved by pharmacological, immunological or metabolic means. Note that a substance administered for diagnostic purposes e.g. an in-vivo diagnostic substance, even though it does not act in such ways, is usually considered to be a medicinal product. Medical devices may contain medicinal
substances which act on the body in a manner ancillary to the device; however where such substances act in a manner than is more than ancillary, the product is regulated as a medicinal product rather than a medical device.
Borderline Products
Some products are hard to distinguish from a medicine or a medical device, e.g. cosmetics, food supplements or biocidal products – these are known as borderline products until their status has been decided. Products in the ‘borderline’ classification include:
• Cosmetics
• Food products and supplements
• Herbal products
• Medical devices
• Biocides
• Machinery and laboratory equipment
MHRA decide whether the claims made about a product or the active ingredient(s) present would mean that the product is regarded to be a medicinal product. The inclusion of herbal or ‘natural’ ingredients does not exclude a product from being a medicinal product – the
MHRA takes the same factors into account when deciding the status of a product with herbal ingredients. These factors are:
• The claims about what the product does – both implicit and explicit
• The pharmacological, metabolic or immunological properties of the ingredients – including any herbal ingredients
• The primary intended purpose of the product
• Whether there are any similar licensed or registered products on the market
• How it is presented to the public through labelling, packaging, promotional literature and advertisements
Update to legislation surrounding licensing of medical devices
New EU regulations came in to effect on 25th May 2017 for the licensing of medical devices and in-vitro medical devices. These are known as EU Regulation on Medical Devices 2017/745 and EU Regulation on In Vitro Diagnostic Medical Devices 2017/746
At present there is a transition phase that allows devices to be placed on the market under the existing Medical Devices Regulations 2002 up until the new legislation takes full effect from 2020.
Pharmacovigilance - What is it?
The processes implemented to aid the monitoring of adverse events associated with medicinal products and medical devices.
Pharmacovigilance is “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem”
(EMA, 2018). In the UK this is known as “Good Pharmacovigilance Practice (GPvP)”, and is the minimum standard for monitoring the safety of medicines on sale to the public (MHRA, 2016). The MHRA conducts inspections of marketing authorisation holders and their contractors to ensure they:
• Have an adequate effective quality system to monitor the medicines they have licensed
• Maintain a pharmacovigilance system master file
• Document all actions they take
• Have enough competent, appropriately qualified and trained staff to work the system
There are different types of inspection that can be performed and any deficiencies found are rated as either ‘critical’, ‘major’ and ‘minor’. Where necessary, MHRA can issue an infringement notice if a serious breach has been detected
