The 1968 Medicines Act legislates for the licensing of all medicinal products that claim to have a relevant medicinal action or function. A medicinal product is therefore understood as any administered substance that is used in the diagnostic processes or in the treatment and prevention of disease. In the UK, the Medicines Act encompasses all processes involved in the manufacture, marketing, advertisement, wholesale and supply of medicinal products.

Currently the BNF has around 6,000 medicines within it many of which are potent and require very careful monitoring. The increase in the number and potency of medicines since the establishment of the NHS is one reason for the Act. Another is the thalidomide tragedy. There was little in the way of robust quality assurance, safety monitoring or scrutinising the effectiveness of products claiming to have a medicinal usage prior to the 1968 Medicines Act although most historical legislation prior to this aimed to deal with poisons or known harmful substances. The Medicines Act also covers the labelling of medicinal products and the criteria for the containers used.

The purpose of the Human Medicines Regulations in 2012 (fully implemented by 2015) is to synthesize the key aspects of the Medicines Act, 1968 with the many subsequent medicines regulations. It also dovetails and brings the UK in agreement with relevant European legislation and guidelines (see The European Medicines Agency http://www.ema.europa.eu/ema). The overarching aim of the Human Medicines regulations is to reduce the risk and harm to patients from drugs, improve and provide consistency in managing drug safety thereby assuring public health through transparent reporting processes.

Medicinal Product Licensing

The Medicines and Healthcare Products Regulatory Agency (MRHA) was founded as a result of the enactment of the Medicines Act. The MHRA is responsible for licensing medicinal products and quality assuring safety issues such as clinical trials and the clinical effectiveness of products. The MHRA is independent from the pharmaceutical industry. Of necessity, the approval and licensing of a medicinal product is robust and subject to strict testing. For further information on the process see MRHA website. Once a license (Marketing Authorisation - MA) previously known as a Product License and which you shall still see on medicine packs is issued by the MHRA it usually lasts for five years. The MHRA continues to monitor medicinal products by collating the information supplied by the Yellow Card Scheme for suspected adverse drug reactions and has the authority to revoke a MA (see Adverse Drug Reactions). The Medicines Act classifies medicinal products as:

• Prescription Only Medicines (POM)
• General Sales List (GSL)
• Pharmacy (P)

POMs, as you might expect, require a valid prescription from an appropriate practitioner in order for them to be supplied or sold. Most POMs can be supplied under Patient Group Directions.

GSL medicines can be purchased from non-pharmacy premises e.g. supermarkets, garage forecourt shops. GSL medicines are sold in the manufacturer’s packs and the dose, strength and pack size is restricted. As its name implies this is a list of named preparations and this list can be amended as necessary. If it was thought that a general sales list preparation was being abused, then it can be reclassified as a P or even a POM.

P medicines are those which can be supplied without a prescription but under the supervision and personal control of a pharmacist in suitably registered premises. Drugs can also be deregulated from POM to P or from P to GSL. Two examples of changes from POM to P are omeprazole and diclofenac though the P packs may be in lower doses, restricted age groups or smaller pack sizes than the POM equivalent. In the case of naproxen for example, they can be sold to the public for the treatment of dysmenorrhoea in women aged between 15-50 years subject to a maximum single dose of 500mg and a maximum daily dose of 750mg for a maximum of three days. There is also a restriction on the pack size that can be sold. A drug which moved from POM to P and then to GSL is ranitidine. This can be sold as a GSL again with age restrictions (adults only) and for a maximum pack size. The strength is also restricted to 75mg as a single dose and a maximum daily dose of 300mg. Less frequently, medicines which were previously classified as P are made POM if new risks are identified which require involvement of a doctor to ensure safe use of the medicine. In the same way a GSL medicine could be reclassified as P if new information showed that it was no longer safe to supply it without a pharmacist checking that it was suitable for the patient. MHRA, 2012.

Prescribing Controlled Drugs

Since the revision of existing regulations – the Misuse of Drugs Regulations and the introduction of others - The Controlled Drugs - Supervision of Management and Use Regulations 2006 - along with adopting some of the recommendations of the Fourth Report of the Shipman Inquiry (2004), the prescribing of CDs has been subject to much tighter controls and monitoring than previously. It should be noted that you as a doctor, may not use a patient-specific prescription in order to replenish practice stocks or your personal doctor’s bag stock.

Except for the appropriate treatment of severe and acute pain you should not prescribe Schedule 2 drugs to a known CD addict unless you possess a Home Office license for treating addicts. In addition to the essential requirements for a valid prescription, you should follow the guidelines found in your latest copy of the BNF concerning prescribing CDs.

Repeat prescribing

Hospital doctors do not generally need to be involved in repeat prescribing but in general practice it forms the mainstay of patients’ access to medicines after initial prescribing. Repeat prescribing accounts for 60-70% of prescription costs and 80% of prescription items in primary care (Management of Medicines, 2007 p 28) General practice is the place for repeat prescribing systems. Patients return to you as their doctor or can usually request a repeat prescription over the phone or online.

If you have seen a patient as an inpatient or in one of the clinics and have recommended a long term treatment in a letter to the patient’s GP, are you reassured that the patient will continue to receive the appropriate medications when they are discharged from your care?

There are some drugs where repeat prescribing may not be appropriate usually because they are particularly potent and monitoring is needed prior to a prescription being issued. Examples could be methotrexate, warfarin or lithium. In these cases you need to see the blood results prior to offering a prescription. If the patient is non-adherent to treatment with say warfarin or if the patient has been ill while taking it then doses may need to be adjusted. Renal and hepatic dysfunction may result in a change of dose or even drug. With lithium it may be that you do offer a repeat prescription to those who are stable but that you limit the number of repeats to 2 or 3 before you require to see the patient again. Evidence of monitoring must be available to you as the prescriber before a repeat prescription is issued. The authorisation of repeat prescriptions for other drugs such as disease modifying anti rheumatic drugs (DMARDs) should be limited to the number of issues relating to the frequency of required monitoring to ensure that prescriptions are actively reviewed. Responsibility to define the issue number lies with you.

Repeat Dispensing

Firstly what do you understand by the term repeat dispensing? If you have ever dealt with private prescriptions you’ll know that you can order a drug and write on the private prescription, repeat 6 times. Or how ever many you require. When the oral contraceptive was ordered only on private prescriptions this was the common way to ensure the patient had a continuing supply without the need to return to the doctor until it was time for the usual 6 month monitoring. A NHS prescription could not be repeated until April 2005 (PSNC, 2009) although the department of health guidance was published in 2002 (Archived link)

It allows the prescriber to offer an NHS prescription with a number of repeats for a period of up to 12 months. Unlike the single private repeat prescription, for the NHS, the prescriber issues the number of paper prescriptions related to the number of repeats required. Each will have a note of which one it is for example 1 of 6, 2 of 6 etc. The patient can retain the unused prescriptions or they can be stored in the pharmacy for collection. You need to be conscious of the need to monitor patients regularly and provide repeats in line with this. The joint group who published guidance on repeat dispensing gave some examples of where it might be of particular relevance. Examples of suitable patient groups/situations:
• patients on single, stable therapy, for example, Levothyroxine
• patients with stable long-term conditions on multiple therapy for example, hypertension, diabetes, asthma
• patients who can appropriately self-manage seasonal conditions such as hay fever
You can probably think of other areas that might be suitable for repeat dispensing as long as patient safety is not compromised.

Consent in the prescribing context

Personal autonomy and the availability of choices can be understood as the two essential ingredients for a person to consent (or provide an informed consent) to treatment. Without being presented with treatment options the individual lacks the context for making a decision. Without the ability to be self-determining (autonomous) when faced with decisions to be made about treatment the individual lacks the necessary opportunity to consider what would be appropriate for them and what represents their values, beliefs, and treatment goals.

It is not enough that an individual merely assents to a clinical management plan that is proposed to them, they should be invited to engage and be concordant with the management plan; this requires discussion and negotiation. As a minimum it requires that the patient receives sufficient information to make a decision.

Lack of capacity

Drug and other medically related information needs to be explained in terms that the individual can understand, believe to be relevant and true, retain and weigh-up before acting upon. In the context of prescribing, the information you provide to your patient regarding drugs must be factual, outlining the therapeutic actions, risks, alternatives and benefits plus any unique or cautionary issues (e.g. side effects or special instructions).

Under the Mental Capacity Act (2005) you must always assume a patient possesses the capability to make a decision unless it is established that they lack capacity at the particular time when the decision needs to be made. Patients with limited, diminishing and fluctuating capacity may still be able to understand and retain sufficient information that is material to the decision to be made and thereby provide a valid consent to treatment. In the event that a patient does lack capacity, decisions concerning treatment are made in consideration of the existence of a valid Advance Decision to Refuse Treatment and their best interests.

Liability in prescribing

As the GMC (2012) report on prescribing in general practice demonstrated, errors with prescriptions are common but do not usually have severe consequences. Errors can occur in the prescribing itself e.g. dose/route, in the monitoring of patients e.g. sub-optimal monitoring or/and not ordering tests and are likely to increase in frequency the more drugs a patient is prescribed. Identified errors associated with the prescriber indicated that insufficient drug knowledge and perception of risk were factors; and in some established doctors, their experience can induce a tendency towards complacency particularly when prescribing for longer-term patients and thereby overlook the relevant caveats applicable to effective clinical management.

When these prescribing issues are added to significant factors associated with patients’ ability to understand their proposed clinical management (e.g. language difficulties, literacy) the need for accuracy both in writing the prescription and communicating essential aspects of the medicines regime to patients becomes clear. See Medication errors section for further details.

Standards for information disclosure

Consider how you give information to patients, parents and carers. What do you include and why? How do you decide on the priorities and the weight that you associate with the explanations given? Do you give patients additional materials such as leaflets as an adjunct to your information or as the principle source of information? How you give information concerning medications is as relevant as what information you give.

What counts as sufficient information is not always easy to establish. An objective standard for disclosure is known as the prudent-patient view – what a reasonable or responsible patient would want to know (Mason and Laurie, 2011). This reflects an application of Bolam (the standard of a reasonable and responsible body of medical opinion). The Bolam test holds that the law imposes a duty of care, but the standard of that care is a matter of medical judgement.

The prudent-practitioner view suggests a more subjective approach and includes what the prescriber ranks as important to disclose. With the advent of negligence related legal cases that challenge the content and degree of disclosure (see Chapter 4 of Mason and Laurie, 2011 for discussion of Sidaway V Board of Governors of the Bethlehem Royal Hospital 1984; Chester V Afshar, 2005) an acceptable standard probably lies somewhere between subjective and objective.

Whilst there may appear to be imprecision as to what constitutes sufficient information provided to inform a decision this can in part be gauged by the dialogue you have with your patient. The greater the complexity, need for monitoring or potential for toxicity of the drug regimen the more comprehensive your information should to be.

This also is a reminder of the importance of questions that patients ask as these can help determine the degree of significance that patients attach to perceived risks even if you, the prescriber, do not view the risks with the same importance. These are material to the decision that a patient makes. Often, the prescribing management options are unlikely to be of the take-it-or-leave-it type and here you must also use professional judgement in recounting the various merits of drug regimens available without overwhelming the patient with choices that might seem quite close in action or application.

Liability and claims for medical negligence related to non-disclosure of information in the consent process are a relatively recent occurrence and are more likely to succeed if the claimant can demonstrate that the standards and duty of care owed them regarding disclosure of information were breached and were shown to be the cause of harm inflicted. For any claim of medical negligence to be successful the claimant must be able to establish the following three principles:

1. A duty of care was owed to them.
2. The standard attached to that duty was not met.
3. Harm was caused by that breach of duty.

In relation to prescribing this can refer to what you prescribe (act) and your failure to prescribe (omission). Whilst the vigilance of the dispensing pharmacist and/or other healthcare professionals who may subsequently administer the prescribed drugs can question and intervene where a prescription is incorrect, the first duty lies with the prescriber to avoid error.

Off-label medicinal products prescribing

What is your understanding about prescribing a licensed medication outside of its product licence, often described as off label prescribing? What do you think you should consider before prescribing any product outside of its product licence?