Is Alcover only prescribable in acute abstinence? Statement by the National SITD Directorate

a recent decision by the Scientific Technical Committee of AIFA, the Italian agency of the drug, may lead to a restriction of the indications authorized for Alcover .

In practice it would only be indicated in acute withdrawal syndrome, and it would no longer be possible to use it in later stages, such as anticraving and to prevent relapse .

It is easy to understand how such a change worries the addiction clinicians. The drug has been in use in Italy for almost thirty years without significant problems, and has allowed thousands of people to free themselves from alcohol addiction. Such a restriction of indications would not only deprive addiction medicine of a unique instrument (there are no other drugs authorized in Italy for alcoholism with the same pharmacodynamic profile) but would pose a serious problem for existing drug treatments, for which one should hypothesize a suspension with times and modalities all to be determined, and a concrete risk of inducing relapse into alcoholism .

For this reason, the SITD National Executive issued a press release that we report below and also in printable PDF.

We invite members and clinicians interested in contacting AIFA through the online form made available to health professionals indicating their personal details, the company and the membership service, and their motivated opinion on this restriction of indications.

To WHOM IT MAY CONCERN

SITD COMMUNICATION FOLLOWING THE AIFA DECISION " Outcome Area Supervision Post Marketing CTS 29, 30 and 31 October 2018"

In recent days we have been informed that during the CTS meeting of 29-30-31 us, among the various drugs analyzed, a restriction of the indications of use of the drug Alcover oral solution was proposed .

Recall that the drug is distributed both in Italy and in Austria. In particular, in Italy it has been prescribed since 1991. The use of this drug during these 27 years has marked a fundamental and significant step in the pharmacological treatment of alcohol use disorder associated with psychosocial interventions (Biggio et al., 1992; Ferrara et al., 1992; Gallimberti et al., 1992; June et al., 1995; Addolorato et al., 1996, 1999, Beghè and Carpanini, 2000; Gessa et al., 2000; Stella et al., 2008) . Currently it is used with good results both for the treatment of the withdrawal syndrome and for the maintenance of abstention from alcohol, in particular in subjects with very high risk alcohol consumption (more than 100 g / day of alcohol for men) and more than 60 g / day of alcohol for women).(Gallimberti et al., 1989; Addolorato et al., 1996, 1998, 1999; Moncini et al., 2000; Nimmerrichter et al., 2002; Caputo et al., 2003, 2007; Nava et al., 2007; al., 2001, 2008, 2011; Maremmani et al., 2001, 2011, Cacciaglia et al., 2013; Skala et al., 2014, Caputo et al., 2015) .

Among the various treatments available, the Alcover is a therapeutic device of proven efficacy, witnessed by thousands of patients and numerous works in the literature (Addolorato et al., 1996; Stella et al., 2001, 2008; Keating, 2014; den Brink et al., 2018, etc.) , in an extremely disabling pathology, both in terms of life expectancy and in terms of social and health costs, direct or indirect (Rehm et al., 2018).

The limitation of therapeutic indications would certainly create a problem with unforeseeable consequences with a serious risk to the health of patients with alcohol dependence . In fact, the reduction of the indications given only for use in the abstinence crisis, would preclude treatment for a significant number of alcoholic patients with possible repercussions on the functioning of the Services with serious consequences for both health care workers and patients. It will be necessary to understand how it will be possible to guarantee the therapeutic continuity for the thousands and thousands of patients in maintenance treatment for the control of craving and how to manage a phase of transition that should lead to prescribe the drug only in control of withdrawal symptoms.

It is therefore obvious that, according to the above, our Company would urge all the Authors involved in the issue of reconsidering this decision, so that professionals can continue to prescribe in science and conscience the drug as happened in this almost last thirty years. , avoiding further unnecessary problems also because many have been told that denying access to the best care is a crime against humanity .

November 16, 2018

The National Direction
SITD Società Italiana Tossicodipendenze

BIBLIOGRAPHY

ADDOLORATO, Giovanni, et al. An open multicentric study evaluating 4-hydroxybutyric acid sodium salt in the medium-term treatment of 179 alcohol dependent subjects. Alcohol and Alcoholism, 1996, 31.4: 341-345.

ADDOLORATO, Giovanni, et al. Maintaining abstinence from alcohol with γ-hydroxybutyric acid. The Lancet, 1998, 351.9095: 38.

ADDOLORATO, Giovanni, et al. γ-Hydroxybutyric acid in the treatment of alcoholism: dosage fractioning utilities in non-responders alcoholic patients. Drug and alcohol dependence, 1998, 53.1: 7-10.

ADDOLORATO, Giovanni, et al. Gamma-hydroxybutyric acid (GHB) in the treatment of alcohol withdrawal syndrome: a randomized comparative study versus benzodiazepine. Alcoholism: Clinical and Experimental Research, 1999, 23.10: 1596-1604.

BEGHÈ, Franco; CARPANINI, Maria Teresa. Safety and tolerability of gamma-hydroxybutyric acid in the treatment of alcohol-dependent patients. Alcohol, 2000, 20.3: 223-225.

BIGGIO, Giovanni, et al. Suppression of voluntary alcohol intake in rats and alcoholics by gamma-hydroxybutyric acid: a non-GABAergic mechanism. Advances in biochemical psychopharmacology, 1992, 47: 281-288.

CACCIAGLIA, Roberto et al., P30gate 2 Study: Sodium Oxybate in the Maintenance of Alcohol Abstinence and Prevention of Alcohol Relapse. Alcohol and Alcoholism, 2013, 48.suppl_1: i46-i49.

CAPUTO, Fabio, et al. Gamma-hydroxybutyric acid versus naltrexone in maintaining alcohol abstinence: an open randomized comparative study. Drug and alcohol dependence, 2003, 70.1: 85-91.

Law –The 5 common areas of legal practice

When you are looking for a lawyer to represent you, it’s always advisable to know the exact kind of lawyer you are in need of and this will depend on the nature of the legal issue you are facing. There are quite a number of different types of lawyers handling different types of cases, but there are a few types of cases that would be considered as very common today.

This article seeks to look at the 5 common areas of legal practice.

Family law

Family law is the area of law that will involve legal issues pertaining to the family and will often be handled by lawyers with a specialization in family law. Legal issues that fall under the family law docket are issues such as child welfare, adoption, marriage and divorce, domestic partnerships, and civil unions, among a host of other issues that will fall under the context of a family.

Criminal law

Criminal law is the area of law that will focus on matters that are considered as illegal and are considered as violations of the criminal code. Such matters may include but not be limited to violations of basic rights as well as individual liberties. These types of matters are handled by lawyers with a specialization in criminal law.

Labor law

Labor law is an area of law that will primarily address matters pertaining to relations between employers and their employees. Such matters will include but not limited to wages, compensation and benefits, workplace discrimination and harassment, as well as collective bargaining, among others. These matters will always be handled by lawyers with a specialization in labor law.

Corporate law

Corporate law is an area of law that will primarily address matters pertaining to the corporate sector which will include but not limited to their formation as well as dissolution, and these specifically involve internal reorganization, mergers, acquisitions, patents, as well as compliance with regulation, among other things. Lawyers handling such legal matters have to be specialized in corporate law.

Personal injury law

Personal injury law is an area of law that will primarily focus on matters that involve the intentional or unintentional causing of harm to an individual or a group of people which ends up causing physical or psychological damage to them. This will include but not be limited to cases such as wrongful death, product liability, medical malpractice, and workplace injury, among many others. Lawyers handling such legal matters have to be specialized in personal injury law.

As we mentioned at the beginning, there are numerous areas of law but these are just some of the common ones that are likely to be experienced. It’s therefore important for every individual in need of legal counsel to have an idea of where their case falls under so that they can be able to get the right lawyer to handle their case.

The 4 main things to consider when interviewing a lawyer

As a client looking to get a lawyer to handle your legal matters, the process of selecting this lawyer is more like an interviewing process therefore you need to have an idea of what you will be looking for in the lawyer in order to determine whether they fit the bill. Through this article we’ll be looking at things you can consider when interviewing for a lawyer.

These are the 4 main things to consider when interviewing a lawyer.

Ensure they are adequately prepared

Whenever you go to meet a potential lawyer and it feels like they are not prepared for your meeting, you can rest assured that they will not be prepared to handle your legal matters should you award them the job. A good lawyer is one who will show up prepared and will even have done some background search on you so that they can know how best to serve you.

Ensure that they understand your goals

You need a lawyer who will have a proper understanding of your goals because they will essentially be your representative when handling your legal matters. When they understand your goals you can rest assured that they will always make decision on your behalf that serve your best interests and they will figure out how to make your interests serve their own interests and not the other way round.

Ensure that you understand their strengths

When hiring a lawyer, it will be important for you to pay close attention in understanding what their strengths actually are because you will need a lawyer strong enough to handle the specific legal field you require them for. For instance, if you are looking for a family lawyer, you will need to ensure that the lawyer has strength in family law. more information: https://www.defimg.com

Monitor how seriously they take your screening process

Whether you are looking for an independent lawyer or a law firm, the amount of seriousness they approach your screening process with will give you a good idea about the level of seriousness they will put to the legal services that they will offer you. Always watch out so see if they value you enough to work towards creating a good impression.

All in all, the true test to find out whether a lawyer will serve you well is finding out whether they value you enough as a potential client, for them to put in a good pitch to you. They should genuinely express a strong interest in serving you.

If you put these 4 things into consideration when interviewing for a lawyer, we can guarantee you of getting the best. Happy hunting!

The 6 qualities every great lawyer needs

As a client looking for legal representation, you must always be cognizant of the fact that not all lawyers are the same. Different lawyers will have a different level of mastery of the law as well as other qualities that enable them win cases. The lawyers who win cases are those with a perfect balance between their knowledge of the law and personal attributes.

These are the 6 qualities every great lawyer needs, which you should always look out for when looking for legal representation.

1 They must be excellent communicators

Every great lawyer has to be an excellent communicator and this entails both written and verbal communication. This will not only be valuable during the case as they address the judge and jury but will also be valuable as they articulate their legal strategy to their client.

2 They must have good judgment

Every great lawyer should always be able to make good judgments regardless of how much limited information has been presented to them. Their good judgment will entail being able to arrive at logical as well as reasonable conclusions.

3 They ought to have good analytical skills

Lawyers will often be presented with large swatches of information in the form of files, witness statements, evidence and so on therefore great lawyers should have the ability to sieve through such large pieces of information, and be able to make a summary that is logical and manageable. To achieve this, they will need to have really good analytical skills.

4 They must be really good researchers

Any great lawyer makes it their business to have a really good understanding of their client, the opposition team, the judge, the jury as well as the case itself and whether there is any legal precedent. To be able to get all these, they will need to be really good researchers.

5 They must have really good people skills

A great lawyer has to be a peoples’ person because people are their primary client. Whether it’s the person they are defending, the judge, the jury, the opposing counsel or their legal team, great lawyers should be able to relate well and work amicably with everyone they come across.

6 They must be very creative

Great lawyers are essentially problem solvers therefore any case they are handling for their client is essentially a problem that needs solving. Therefore for them to be able to do this well, they will need to be very creative in the way they handle the legal aspects which includes their legal arguments, motions they file and so on.

If you come across a lawyer who checks all these boxes then you can rest assured that they will be able to give you sound legal counsel.

Infographic by: rocketmatter.com

These are the 3 basic things every client needs from their lawyer

When a client makes the decision to seek the services of a lawyer, they do so knowing that the first obligation of the lawyer will be to them therefore their lawyer will go out of their way to offer the best legal representation. During the engagement between a lawyer and their client, there are basic obligations that lawyers must fulfill.

These are the 3 basic things every client needs from their lawyer.

Respecting attorney-client privilege

Attorney-client-privilege essentially means that any information that a client discloses to his/her lawyer is privileged therefore the lawyer is not permitted to share it with anyone else unless with the express permission of their client. This therefore means that any lawyer who violates this privilege is liable to sanctions including disbarment.

Avoiding conflict of interest

A lawyer must be 100 per cent dedicated to the best outcome for their client therefore in the event there is a possibility in the existence of a conflict of interest that may prevent the lawyer from serving the client fully, they must fully disclose this conflict and even remove themselves from the case, and recommend new legal counsel for their client. Denying a client good representation due to a conflict makes the lawyer liable to sanctions including disbarment. for more details: https://www.defimg.com

Keeping personal prejudices in check

Every individual has personal prejudices and lawyers are not an exception. However, lawyers have a higher obligation to keep these prejudices in check because they mustn’t allow such prejudices to hinder their ability of providing the best legal counsel to their client.

Keeping these points in mind, a client should always be fully aware of what they are entitled to when they seek legal representation from a lawyer as well as where to seek recourse if a lawyer ends up violating these entitlements.